CIS catalogue int 40 p - Mareen Group CompanyYMM-1 ELUMATIC® III (18F)-FDG MIBG-131-D MIBG-131-T...

PRODUCTCATALOGUEA completepalette inNuclearMedicine

Neurology

Cardiology

Oncology

2 | IBA Molecular |

This is a comprehensive list of all products.

Some products may not be available in your country, depending upon registration status.

IBA reserves the right to modify the availability date of the products contained herein.

Please contact your local distributor for further information.

Approved SPC are available for download at:www.ibamolecular.eu

INTERNATIONAL CCAATTALOGUEALOGUE

3 | IBA Molecular |

PRODUCT INDEX

BY INDICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6BY NUCLIDE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

PRODUCT SPECIFICATIONS

PET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Radiopharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

SPECT & THERAPY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Radiopharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Cold kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

RADIOCHEMICAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

PACKAGING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

SERVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

GENERAL INFORMATION

COMMERCIAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54SCIENTIFIC AND TECHNICAL INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55UNITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58NUCLIDE INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59RADIOACTIVE DECAY TABLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61LOCATIONS AND CONTACTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Contents

4 | IBA Molecular |


5 | IBA Molecular |

Product indexBy indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

By nuclide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Offering a comprehensive rangein Nuclear Medicine

Fulfilling the needs of our customers can not be conceived in part only. Our productoffering reflects our commitment to offer a complete radiopharmaceutical solution to

nuclearists, from widespread to niche indications. With major applications inOncology, Cardiology and Neurology, in PET, SPECT and Therapy, our range is one

of the most comprehensive in the industry.

6 | IBA Molecular |


ANGIOCIS®

SERALB-125STAMICIS®

TL-201-S-1VASCULOCIS®

NORCHOL-131PENTACIS®

RENOCIS®

EDICIS™ 2 mg

NANOCIS®

ERMM-1RE-186-MM-1YMM-1

ELUMATIC® III (18F)-FDGMIBG-131-DMIBG-131-TTEKCIS™

YTRACIS®

ZEVALIN®

GA-67-MM-1SCINTIMUN® 1 mg

CAPSION®

I-123-S-2I-131-S-1I-131-S-2

PENTACIS®

PULMOCIS®

VENTIBOXVENTICIS® II

PHYTACIS®

NANOCIS®

CISNAF®

OSTEOCIS®

TECEOS®

QUADRAMET®

DOPACIS®

Cardio-vascular system

Adrenal glands/Kidneys

Lymphatic system

Joints (various sizes)

Inflammation/infection

Others

Thyroid

Lung

Liver

Sentinel nodes

Bones

Brain

Products by indication

7 | IBA Molecular |

PETRadiopharmaceuticalsCISNAF® p 12Sodium Fluoride (18F) is used with positron

emission tomography (PET) in bone imaging.

DOPACIS® p 12(18F) Fluorodopa is a solution used with

positron emission tomography in neurology

and oncology.

FARNA FDG 3000 p 13Fludeoxyglucose (18F) is indicated for use with

positron emission tomography.

FDG-IBA P 13Fludeoxyglucose (18F) is indicated for use with

positron emission tomography in Oncology,

Cardiology, Neurology and Infectious.

FLUORSCAN 3000 p 14Fludeoxyglucose (18F) is indicated for use with


SPECT and TherapyRadiopharmaceuticals

DIAGNOSISGA-67-MM-17 p 17Gallium (67Ga) citrate :

- non-specific tumor imaging and/or localizing

agent.

- localization of inflammatory lesions.

I-123-S-2 p 17Sodium iodide (123I) for functional and

morphological study of the thyroid gland.

MIBG-131-D p 19Iobenguane (131I) for calculation of a

therapeutic iobenguane (131I) dose from a

prior tracer-dose.

NORCHOL-131 p 206 - iodomethylnorcholesterol (131I) for

investigation of adrenocortical diseases.

SERALB-125 p 21Iodinated (125I) human serum albumin for

determination of plasma and total blood

volume, and examination of albumin turnover.

TL-201-S-1 p 22Thallium (201Tl) chloride for myocardial

scintigraphy.

THERAPYCAPSION® p 16Sodium iodide (131I) capsules for thyroid

therapy.

ERMM-1 p 16

Erbium (169Er) citrate for isotopic radiation

synovectomy (small size joints).

I-131-S-1 p 18

Oral sodium iodide (131I) for thyroid therapy.

I-131-S-2 p 18

Sodium iodide (131I) injection for thyroid

diagnosis and therapy.

MIBG-131-T p 19

Radiation therapy of tumour-tissue that is

capable of retaining iobenguane.

QUADRAMET® p 20

Samarium (153Sm)-EDTMP for the relief of

bone pain in patients with multiple painful

osteoblastic skeletal metastases which take

up technetium (99mTc)-labelled

bisphosphonates on bone scan.

RE-186-MM-1 p 21

Rhenium (186Re) sulphide for isotopic radiation

synovectomy (medium size joints).

YMM-1 p 23

Yttrium (90Y) citrate colloidal suspension for

isotopic radiation synovectomy (big size

joints).

YTRACIS® p 23

Yttrium (90Y) chloride radiopharmaceutical

precursor solution for the radiolabelling of

carrier molecules.

Kits for radiopharmaceutical

preparation

ANGIOCIS® p 26

Kit for radiopharmaceutical preparation.

EDICIS™ 2 mg® p 26


NANOCIS® p 27


OSTEOCIS® p 27


PENTACIS® p 28


PHYTACIS® p 28


PULMOCIS® p 29


RENOCIS® p 29


SCINTIMUN® 1 mg p 30


STAMICIS® p 31


TECEOS® p 33


VASCULOCIS® p 33


ZEVALIN® p 34

Radiopharmaceutical preparation for infusion

(labelleing with yttrium (90Y)).

Generators

ELUMATIC® III p 36

Technetium (99mTc) generator 2-20GBq.

TEKCIS™ p 37

2-50 GBq radionuclide generator.

Accessories

ELUMATIC/TEKCIS

ACCESSORIES

CONT-ELU p 40

Lead shielding for elution vial.

CONT-ELU-SP p 40

All lead glass shielding for elution vial.

PROTEC-ELU p 40

Lead shielding for ELUMATIC III generator

supplied in parts.

OTHER

VENTICIS® II RADIOAEROSOL

DELIVERY SYSTEM p 41

Radioaerosol delivery system for lung

investigation supplied in box of 5 circuits.

Medical device, class IIa, in compliance with

the Medical Devices Directive 93/42/EEC.

0459.

VENTIBOX p 41

Lead shielded box for one VENTICIS® II

System.

CAPSION® accessories p 42

EDICIS® accessories p 42

SCINTIMUN® accessories p 43

STAMICIS® accessories p 43

Radiochemical

upon request

I-123-MPUP p 46

Other possibilities upon request.

The availability of these products is dependant upon their registration status in each country. Please contact your local IBA Molecular representative formore information. Please refer to the Summary of Product Caracteristics available on www.iba-molecular.com for complete product information

8 | IBA Molecular |


Products by nuclideRadiopharmaceuticals

169ErERMM-1 p 16Erbium (169Er) citrate for isotopic radiation

synovectomy (small size joints).

18FCISNAF® p 12Sodium Fluoride (18F) is used with positron

emission tomography (PET) in bone imaging.

DOPACIS® p 12(18F) Fluorodopa is a solution used with

positron emission tomography in neurology

and oncology.

FARNA FDG 3000 p 13Fludeoxyglucose (18F) is indicated for use with


FDG-IBA P 13Fludeoxyglucose (18F) is indicated for use with

positron emission tomography in Oncology,

Cardiology, Neurology and Infectious.

FLUORSCAN 3000 p 14Fludeoxyglucose (18F) is indicated for use with


67GaGA-67-MM-17 p 17Gallium (67Ga) citrate:

- non-specific tumor imaging and/or localizing

agent.

- localization of inflammatory lesions.

123II-123-S-2 p 17Sodium iodide (123I) for functional and

morphological study of the thyroid gland.

125ISERALB-125 p 21Iodinated (125I) human serum albumin for

determination of plasma and total blood

volume, and examination of albumin turnover.

131ICAPSION® p 16Sodium iodide (131I) capsules for thyroid

therapy.

I-131-S-1 p 18

Oral sodium iodide (131I) for thyroid therapy.

I-131-S-2 p 18

Sodium iodide (131I) injection for thyroid

diagnosis and therapy.

MIBG-131-D p 19

Iobenguane (131I) for calculation of a

therapeutic iobenguane (131I) dose from a

prior tracer-dose.

MIBG-131-T p 19

Radiation therapy of tumour-tissue that is

capable of retaining iobenguane.

NORCHOL-131 p 20

6-iodomethylnorcholesterol (131I) for

investigation of adrenocortical diseases.

186Re

RE-186-MM-1 p 21

Rhenium (186Re) sulphide for isotopic radiation

synovectomy (medium size joints).

153Sm

QUADRAMET® p 20

Samarium (153Sm)-EDTMP for the relief of

bone pain in patients with multiple painful

osteoblastic skeletal metastases which take

up technetium (99mTc)-labelled

bisphosphonates on bone scan.

99mTc

ANGIOCIS® p 26


EDICIS™ 2 mg® p 26


ELUMATIC® III p 36

Technetium (99mTc) generator 2-20GBq.

NANOCIS® p 27


OSTEOCIS® p 27


PENTACIS® p 28


PHYTACIS® p 28


PULMOCIS® p 29


RENOCIS® p 29


SCINTIMUN® 1 mg p 30


STAMICIS® p 31


TECEOS® p 33


TEKCIS™ p 37

2-50 GBq radionuclide generator

VASCULOCIS® p 33


ZEVALIN® p 34

Radiopharmaceutical preparation for infusion

(labelling with Yttrium (90Y))

201Tl

TL-201-S-1 p 22

Thallium (201Tl) chloride for myocardial

scintigraphy.

90Y

YMM-1 p 23

Yttrium (90Y) citrate colloidal suspension for

isotopic radiation synovectomy (big size

joints).

YTRACIS® p 23

Yttrium (90Y) chloride radiopharmaceutical

precursor solution for the radiolabelling of

carrier molecules.

Radiochemical

123I p 46

Upon request.

The availability of these products is dependant upon their registration status in each country. Please contact your local IBA Molecular representative formore information. Please refer to the Summary of Product Caracteristics available on www.iba-molecular.com for complete product information

Productspecifications

PETRadiopharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

SPECT & TherapyRadiopharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Cold kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Radiochemical45

Packaging47

Services51

9 | IBA Molecular |

10 | IBA Molecular |



PETRadiopharmaceuticals



DOPACIS®Fluorine-18 T1/2 = 109.8 min Fluorodopa (18F) SOLUTION FOR INJECTION

Availability

Ordering deadline

Radioactive concentrations

Calibration

Available quantities

Expiry

Volume per vial

Radiochemical purity

pH and composition

Storage

Indication

Depending upon regions

Please, contact your local IBA representative



90 MBq/mL at the date and time of calibration

2 to 3 hours from the time of production

90 to 900 MBq per vial at calibration time

8 hours from the date of production

1 to 10 mL

≥ 95%

4.0-5.5 ; Fluorodopa (18F), acetic acid, sodium acetate, ascorbic acid

and water for injections

Store in the original lead shielding. After first withdrawal, store in

refrigerator (2°C to 8°C).

Medicinal product for diagnostic use only. Indicated for use with

positron emission tomography in neurology and oncology.

Please, refer to the SPC.

CISNAF®Fluorine-18 T1/2 = 109.8 min Sodium Fluoride (18F) solution for injection

Availability

Ordering deadline


Calibration


Expiry

Volume per vial


pH and composition

Storage

Indication





100 MBq/mL at the date and time of calibration

6 to 10 hours from the time of production

50 to 1500 MBq per vial at calibration time

14 hours from the date of production

0.5 to 15 mL

≥ 98,5%

5.0-8.5 ; Sodium fluoride (18F), sodium chloride and water for injections

Store in the original packaging

Medicinal product for diagnostic use only. Indicated for use with

positron emission tomography (PET) in bone imaging.

Please, refer to the SPC.

IMPORTANT: Read package leaflet before using the radiopharmaceutical product.Availability of the products in the different countries according to the registration status.


FDG-IBAFluorine-18 T1/2 = 109.8 min Fludeoxyglucose (18F) SOLUTION FOR INJECTION

Availability

Ordering deadline

Radioactive concentration

Calibration


Expiry


pH and composition

Storage

Indication

From Monday to Friday (Saturday in some instances)

Variable, depending on production sites

185 MBq/mL at time and date of calibration

5h, 5h30, 6h, 7h up to 9 hours from production

From 0.5 to 10.0 mL per vial (90 to 1850 MBq/mL)

12 hours from the time of production

≥ 95%

4.5 - 8.5 ; Fludeoxyglucose (18F), sodium chloride and water for

injections

Store in the original package. After first withdrawal, store below 25°C

and use within 12 hours without exceeding the expiry time.

Medicinal product for diagnostic use only. Fludeoxyglucose (18F) is

indicated for use with Positron Emission Tomography.

Please, refer to the SPC

FARNA FDG 3000Fluorine-18 T1/2 = 109.8 min Fludeoxyglucose (18F) SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry


pH and composition

Storage

Indication

From Monday to Friday


3000 MBq/mL at calibration

End of synthesis

From 1.0 to 10.0 mL per vial

14 hours from the end of synthesis

≥ 95%

4.5-8.5 ; Fludeoxyglucose (18F); sodium chloride, sodium dihydrogen

phosphate dihydrate and water for injections, Ethanol.

No special conditions are required


indicated for use with positron emission tomography.





FLUORSCAN3000Fluorine-18 T1/2 = 109.8 min Fludeoxyglucose (18F) SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry


pH and composition

Storage

Indication

From Monday to Friday


3000 MBq/mL at time and date of calibration

End of synthesis

From 1.0 to 10.0 mL per vial

14 hours from the end of synthesis

≥ 95%

4.5-8.5 ; Fludeoxyglucose (18F); sodium chloride, sodium dihydrogen

phosphate dihydrate and water for injections, Ethanol.

No special conditions are required.


indicated for use with positron emission tomography.




SPECT& Therapy

Radiopharmaceuticals



Availability

Ordering deadline


Calibration

Expiry

Specific activity at calibration


Radionuclidic purity

Storage

Indication

Every working day

Shipment Ordering deadline

Monday Wednesday week before (before 11.00 am)

Tuesday Thursday week before (before 11.00 am)

Wednesday Thursday week before (before 11.00 am)

Thursday Monday week before (before 11.00 am)

Friday Tuesday (before 11.00 am)

From 50 MBq to 3700 MBq per capsule at calibration

(100 mCi maxi per capsule)

On request 1 - 4 days

21 days after the manufacturing date

� 185 GBq/mg of iodine at calibration

Iodide : � 98%131I � 99.9%; 130I + 133I + 135I � 0.1%

Not above 25°C, in its original packaging.

• Treatment of Graves’ disease, toxic multinodular goitre orautonomous nodules

• Treatment of papillary and follicular thyroid carcinoma includingmetastatic disease

CAPSION®

Iodine-131 T1/2 = 8.02 d SODIUM IODIDE (131I) CAPSULE FOR THERAPY


ERMM-1Erbium-169 T1/2 = 9.4 d ERBIUM (169Er) CITRATE SUSPENSION FOR INJECTION (THERAPY)

Availability

Ordering deadline


Calibration


Expiry

Specific activity

pH and composition

Storage

Indication

Tuesday

Friday before 11 a.m.

111 MBq/mL (3 mCi/mL) at calibration date

Saturday 12 a.m.

From 37 to 1110 MBq

18 days from the manufacting date

37 to 1110 MBq/mg (1 to 30 mCi/mg) at calibration date

5.5 - 7.5 in sodium chloride solution

• Do not store above 25°C

• After first withdrawal, store at 2-8°C and use within 8 hours.

Treatment of rheumatoid mono or oligo-arthritis involving one or few of

the small joints of the hands and feet following failure of intra-articular

corticosteroid therapy or when the latter is contra-indicated

17 | IBA Molecular |IMPORTANT: Read package leaflet before using the radiopharmaceutical product.Availability of the products in the different countries according to the registration status.

GA-67-MM-1Gallium-67 T1/2 = 3.26 d GALLIUM (67Ga) CITRATE SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH and composition

Storage

Indication

Monday, Friday

Thursday week before (before 11.00 am CET)

74 MBq/mL (2 mCi/mL)

Monday (next week) Friday (next week) 12 a.m.

From 37 to 1110 MBq


Carrier free

� 95 %

� 99 %; 66Ga � 0.2 %

5 - 8 in sodium citrate solution

Not above 25°C

2 - 8°C after the first withdrawal and use within the working day.

• Non-specific tumor imaging and/or localising agent

• Localisation of inflammatory lesions

I-123-S-2Iodine-123 T1/2 = 13.2 h SODIUM IODIDE (123I) SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH and composition

Storage

Indication

Every working day except Friday and the day before

a french banking holiday

One day before (before 11 a.m.)

18,5 MBq/mL

Following day at 5 p.m.

37 to 185 MBq


Carrier free

� 95 %

� 99.7 %

6.5 - 7.5 phosphate-thiosulfate buffer

15-25°C

Functional and morphological study of the thyroid gland




I-131-S-1Iodine-131 T1/2 = 8.02 d SODIUM IODIDE (131I) ORAL SOLUTION

Availability

Ordering deadline


Calibration


Expiry

Specific activity at calibration


Radionuclidic purity at calibration

pH and composition

Storage

Indication

Tuesday / Wednesday

Thursday week before (before 4.00 pm CET)

1110 MBq/mL (30 mCi/mL) at calibration date

Wednesday (following week) 12 a.m.

From 1 110 to 11 100 MBq


� 185 GBq/mg iodine

Iodide : � 95 %

� 99.9 %; 133I + 135I + other alpha impurities � 0.1 %

7 - 10 in sterile solution with carbonate-thiosulfate buffer

Not above 25°C

Diagnostic• Estimation of thyroid uptake and effective half life• Identification of thyroid remnant and metastases (after ablation)Therapy• Treatment of Graves’ disease, toxic multinodular goitre orautonomous nodules


I-131-S-2Iodine-131 T1/2 = 8.02 d SODIUM IODIDE (131I) SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH and composition

Storage

Indication

Thursday

Tuesday week before (before 11.00 am CET)


Friday (following week) 12 a.m.

From 74 to 1110 MBq


� 185 GBq/mg at calibration

Iodide : � 95 %

� 99.9 %; 133I + 135I + other alpha impurities � 0.1 %

6 - 8 in phosphate-thiosulfate buffer

Not above 25°C

Diagnostic• Estimation of thyroid uptake and effective half life• Management of thyroid carcinoma : identification of thyroid remnantand metastases (after ablation)

Therapy• Treatment of Graves' disease, toxic multinodular goitre orautonomous nodules



Availability

Ordering deadline


Calibration

Precalibred quantities

Expiry

Specific activity



pH and composition

Storage

Indication

Monday (one batch on 2 weeks)

Wednesday 11 a.m., the week before the shipment day

9.25 MBq/mL (0.25 mCi/mL)

Tuesday (following week) 12 a.m.

Monodose of 46.25 MBq (1.25 mCi)


46.25 MBq/vial = 54.5 GBq of 131I/g iobenguane at calibration

� 94 %131I � 99.9 % ; 133I + 135I + other impurities � 0.1 %

4 - 6 in saline acetate buffer

At - 18°C

Calculation of a therapeutic iobenguane (131I) dose from a priortracer-dose (used for dosimetry in pheochromocytomas,neuroblastomas, carcinoids and medullary carcinomas of the thyroidgland)

MIBG-131-DIodine-131 T1/2 = 8.02 d IOBENGUANE (131I) SOLUTION FOR INJECTION (DIAGNOSIS)

MIBG-131-TIodine-131 T1/2 = 8.02 d IOBENGUANE (131I) SOLUTION FOR INJECTION (THERAPY)

Availability

Ordering deadline


Calibration


Maximum activity / vial

Expiry

Specific activity



pH and composition

Storage

Indication

Two first Tuesday of each month

Wednesday week before (before 11.00 am CET)


Thursday 12 a.m.

1850 - 3700 and 5550 MBq (50 - 100 and 150 mCi)

5550 MBq (150 mCi)


� 400 GBq of 131I/g iobenguane at calibration

� 92 % at expiry131I � 99.9 % ; 133I + 135I + other impurities � 0.1%

3.5 - 5.5 in saline acetate buffer

At - 18°C

Radiation therapy of tumour-tissue that is capable of retainingmetaiodobenzylguanidine: pheochromocytomas, neuroblastomas,carcinoids and medullary carcinomas of the thyroid gland




NORCHOL-131Iodine-131 T1/2 = 8.02 d (131I) IODOMETHYLNORCHOLESTEROL SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH

Storage

Indications

Thursday

Friday, before 11 a.m.

7.5 - 15 MBq/mL (0.2 - 0.4 mCi/mL) at calibration

Wednesday 12 a.m.

From 37 to 74 MBq per vial at calibration


11 - 33 MBq/mg (0.3 - 0.9 mCi/mg)

� 85 %

� 99.9 %

3.5 to 8.5

At - 18°C

• Diagnostic evaluation of the functional state of adrenal corticaltissue

• Differentiation between metastatic disease to the adrenals (“coldarea”) and non-malignant adrenal enlargement in cancer patients

• Detection of remnants of functioning tissue in hypercortisonismafter adrenalectomy, or of ectopic endocrine tissue

• Detection and follow-up of euadrenal tumours

QUADRAMET®Samarium-153 T1/2 = 46.3 h SAMARIUM (153Sm) LEXIDRONAM PENTASODIUM SOLUTION FOR INJECTION (THERAPY)

Composition

Available activities

Posology and methodof administration

Availability and Calibration

Ordering deadline

Expiry

Storage

Therapeutic indications

(153Sm-EDTMP) : 1.3 GBq/mL (at calibration date)(Corresponding to 20 to 80 µg/mL of samarium)Total EDTMP (as EDTMP.H20) : 33 mg/mLCalcium-EDTMP sodium salt (as Ca)Total sodium (as Na)Water for injections

2 to 4 GBq per vial at calibration date

• 37 MBq per kg body weight• Slow intravenous route through an established intravenous line overa period of one minute

• Should not be diluted before use

On Monday calibrated Thursday 12 a.m.

Friday week before (before 11.00 am CET)

4 days after the manufacturing date (1 day after the calibration date)

• Delivered frozen in dry ice, should be stored frozen at -10°C to-20°C in its original packaging

• Use within 6 hours of thawing• After thawing, do not freeze again

Relief of bone pain in patients with multiple painful osteoblasticskeletal metastases which take up technetium (99mTc)-labelledbiphosphonates on bone scan


RE-186-MM-1Rhenium-186 T1/2 = 3.77 d RHENIUM (186Re) SULPHIDE SUSPENSION FOR INJECTION (THERAPY)

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH and composition

Storage

Indication

Tuesday


220 to 335 MBq/mL (6 to 9 mCi/mL) at calibration date

Saturday 12 a.m.

From 37 to 3700 MBq


2000 to 7400 MBq/mg (54 to 200 mCi/mg)

� 95 %186Re � 99 %; 184Re + 188Re � 1%

3.5 - 5.5, colloidal suspension stabilised with gelatine

Not above 25°C

• Treatment of rheumatoid mono or oligo arthritis involving medium-sized joints (shoulders, elbows, wrists, ankles, hips) and particularlyrheumatoid polyarthritis

• Treatment of haemophilic or chronic arthropathy associated witharticular chondrocalcinosis.

SERALB-125Iodine-125 T1/2 = 59.9 d IODINATED (125I) HUMAN ALBUMIN SOLUTION FOR INJECTION

Availability

Ordering deadline


Calibration


Expiry



pH and composition

Storage

Indication

Thursday (once a month)

Monday, before 11 a.m.

185 kBq/mL (5 µCi/mL) at calibration date

Saturday (2 weeks after) 12 a.m.

Per 4 vials of 320 kBq (8.6 µCi)


� 80 %

� 99 %

5 - 9

At 2 to 8°C in its original packaging

• Determination of plasma volume and total blood volume

• Examination of albumin turnover.




TL-201-S-1Thallium-201 T1/2 = 3.05 d THALLIUM (201Tl) CHLORIDE SOLUTION FOR INJECTION

Availability and calibration

Ordering deadline



Expiry

Specific activity



pH and composition

Storage

Indication

On Monday calibrated Friday noonOn Tuesday calibrated Sunday noonOn Wednesday calibrated Tuesday noonOn Thursday calibrated Wednesday noonOn Friday calibrated Thursday noon

1 day before the shipment day, before 11 a.m.

37 MBq/mL (1mCi/mL)

From 185 to 555 MBq


� 3.7 MBq/µg (0.1 mCi/µg)

� 95 %

� 97 %

Release Expiry200Tl < 0.25 % < 0.01 %202Tl < 0.50 % < 2.00 %203Pb < 0.10 % < 0.05 %

4 - 7 in sterile isotonic solution

Between 15-25°C in its original packaging.

2 - 8°C after the first withdrawal and used within 24h.

• Myocardial scintigraphy in the evaluation of coronary perfusionand cellular viability.

• Scintigraphy of the muscles.• Parathyroid scintigraphy.• Thallium avid tumour visualisation in different organs,especially for the brain tumours and thyroid tumoursand metastases.


YMM-1Yttrium-90 T1/2 = 2.67 d YTTRIUM (90Y) CITRATE SUSPENSION FOR INJECTION (THERAPY)

Availability

Ordering deadline


Calibration


Expiry

Specific activity

Non filtrable fraction

of Yttrium-90 citrate colloidal

suspension

pH and composition

Storage

Indication

Tuesday


145 to 370 MBq/mL (1 to 10 mCi/mL) at calibration date

Saturday 12 a.m.

From 37 to 3700 MBq


59 to 300 MBq/mg

� 85% at release - � 80% at expiry

5.5 - 7.5 in sodium chloride solution

Not above 25°C

Therapeutic irradiation of synovial hypertrophy of knee joints mainly

for mono- or oligo-articular arthritis of chronic inflammatory

rheumatism particularly rheumatoid polyarthritis

Availability

Ordering deadline


Calibration


Expiry

Specific activity


Acidity

Storage

Indication

Tuesday

Thursday before 2 p.m.

1.85 GBq/mL

Friday 12 a.m. CET

0.925 to 3.700 GBq/vial


Carrier free

� 97 %

0.035M-0.045M

Store in its original packaging

To be used only for in vitro radiolabelling of medicinal products which

are subsequently administered by approved route.

YTRACIS®Yttrium-90 T1/2 = 2.67 d YTTRIUM (90Y) CHLORIDE RADIOPHARMACEUTICAL PRECURSOR SOLUTION


SPECTCold kits

(Kits for radiopharmaceutical preparation)



ANGIOCIS®

Kit for radiopharmaceutical preparation

Each vial contains :Sodium pyrophosphate decahydrate 20.12 mgStannous chloride dihydrate

Volume of 0.9% sodium chloride sterilesolution to use for reconstitution 3 mL

Storage 12 months at 2 to 8°C

Stability of reconstituted product 6 h at 2 to 8°C

Indications /Posology • Angiocardioscintigraphy• Organ perfusion and vascular abnormality imaging• Diagnosis and localisation of occult gastro-intestinal bleedingActivity injected for blood pool scintigraphy (740 - 925 MBq)

Time between injection of Angiocis and 30 minutes before administration of pertechnetate 99mTcpertechnetate 99mTc

Time between injection and examination Immediatly after injection of the tracer (pertechnetate 99mTc)

Availability From stock

Number of radiolabelled preparations per kit 5

Each vial 1 contains:Ethylene-dicysteine: 2 mgDisodium phosphate dihydrate (E339)D-mannitol (E421)Ascorbic acid (E300)Disodium edetate dihydrate

Each vial 2 contains:Reducing agent:Stannous chloride dihydrate (E512)Tartaric acid (E334)Ascorbic acid (E300)

Each vial 3 contains:Buffering agent:Potassium dihydrogen phosphate (E340)Ascorbic acid (E300)

Volume of pertechnetate 99mTc to use for reconstituton 2 mL

Radiochemical purity � 95%

Storage 1 year at 2-8°C

Activity per vial 0,8 to 1,6 GBq

Indications /Posology Dynamic scintigraphy in adults for:• Evaluation of nephropathies and uropathies especially forassessing relative kidney function, renal morphology, and renalperfusion.

• Drainage of the upper urinary tract.The recommended activity for a patient of 70 kg average bodyweight is between 90 MBq and 120 MBq injected intravenously

Stability of labelled product 8 hours not above 25°C

Time between injection and examination The scintigraphic examination begins immediately after injection ofthe product. The total duration of the examination is approximately30 minutes.


Number of radiolabelled preparations 4

EDICIS™ 2 mgKit for radiopharmaceutical preparation

IMPORTANT: Read package leaflet before using the kit.Availability of the products in the different countries according to the registration status


Each vial A containsRhenium sulfide (as Re element 0.15 mg) 0.24 mgGelatinAscorbic acidWater for injectionsConcentrated hydrochloric acid

Each vial B containsSodium pyrophosphate decahydrateStannous chloride dihydrateSodium hydroxide

Particle size 31.6 nm < 70% < 178 nm

Volume of pertechnetate 99mTc to add into vial A 1 to 2 mL


Aspect of reconstituted product Dark brown colloidal solution

Storage 6 months at 2 - 8°C

Stability of labelled product 4 h at 2 - 8°C

Activity per vial 370 to 5550 MBq

Indications /Posology • Imaging and detection of sentinel lymph node :5 to 200 MBq: activity and volume injected depending on theindication.

• Lymphatic flow scintigraphy :20 to 200 MBq in 0.2 to 0.3 mL / siteVol max/injection site: 0.5 mL

• Gastro Oesophageal Reflux :3.5 to 12 MBq



NANOCIS®


OSTEOCIS®


Each vial contains :Sodium oxidronate (HMDP) 3.0 mgStannous chloride dihydrateAscorbic acidSodium chlorideUnder nitrogen atmosphere

Volume of pertechnetate 99mTcto use for reconstitution 2 to 10 mL

Radiochemical purity � 95 %


Activity per vial 0.74 to 11.1 GBq

Indications / Posology Bone scintigraphy300 to 700 MBq / 50 or 70kg adult500 MBq average activity

Stability of labelled product 8h at 2 - 8ºC

Time between injection and examination Not earlier than 2h after injection







PENTACIS®


Each vial contains :Calcium trisodium pentetate (DTPA Ca Na3) 9.10 mgStannous chloride dihydrateSodium chlorideUnder a nitrogen atmosphere

Volume of pertechnetate 99mTcto use for reconstitution 5 mL



Activity per vial 3.7 to 2000 MBq

Indications / Posology 1) Intravenous use :- Renal glomerular filtration 1.8 to 3.7 MBq (plasma)- Renal glomerular filtration 37 to 370 MBq (scanning)- Brain scanning 185 to 740 MBq2) Oral use : Study of gastro-oesophageal reflux and gastric

emptying : 10 to 20 MBq

Stability of labelled product 4h at 2 - 8°C with a maximum of 5 withdrawals per vial

Time between administration and examination Optimal static renal imaging : 1 hourRenal and brain sequentialscanning : immediatelyBrain static images : 1 hour to several hoursDynamic recording : first minutes up to 120 minutes for

gastroduodenal transit.



PHYTACIS®


Each vial contains :Sodium phytate 20 mgStannous chloride dihydrateSodium hydroxideUnder nitrogen atmosphere

Volume of pertechnetate 99mTcto use for reconstitution 10 mL max.




Activity per vial 9250 MBq max.

Indications /Posology Hepatic scintigraphy : 37 to 100 MBq

Time between injection and examination 10 to 60 min



29 | IBA Molecular |IMPORTANT: Read package leaflet before using the kit.Availability of the products in the different countries according to the registration status

PULMOCIS®


Each vial contains :Human Albumin Macroaggregates (MAA) 2.0 mgStannous chloride dihydrateSodium chlorideNon denaturated human albuminUnder nitrogen atmosphere

Particles number per vial 2 to 4 million

Particle size Number of MAA � 150 �m : 0Number of MAA � 100 �m : 0.2 %

Volume of pertechnetate 99mTcto use for reconstitution 2.5 - 10 mL

Radiochemical purity* � 90 %

Colour Whitish homogeneous suspension

Storage 12 months at 2 - 8 °C


Indications Pulmonary perfusion scintigraphyVenoscintigraphy

Posology 37 to 185 MBq


Time between injection and examination Immediately

Availability from stock


*Non filterable radioactivity

RENOCIS®


Each vial contains :Dimercaptosuccinic acid (DMSA) 1.0 mgStannous chloride dihydrateInositolAscorbic acidSodium hydroxide (pH adjustment)Under nitrogen atmosphere





Activity per vial Maximum 3.7 GBq

Indications /Posology Static planar or tomographic renal imaging :- Morphological studies of renal cortex- Individual kidney function- Location of ectopic kidney30 to 120 MBq

Time between injection and examination Image acquisitions : 1 to 3 hWhere there is renal impairment or obstruction, delayed viewsmay be needed (6 to 24 hours respectively)






SCINTIMUN® 1 mgKit for radiopharmaceutical preparation

Each vial 1 contains 5.02 mg dry substance :Besilesomab 1 mgDisodium hydrogen phosphate, anhydrousSodium dihydrogen phosphate, anhydrousUnder nitrogen atmosphereSorbitol E420Each vial 2 contains 2.82 mg dry substance :1,1,3,3-propane tetraphosphonic acid,tetrasodium salt, dihydrate (PTP) 2.7 mgTin (II) chloride dihydrateSodium hydroxyde 1N (pH adjustment)Hydrochloric acid 1N (pH adjustment)Under nitrogen atmosphere

Volume of pertechnetate 99mTcto use for reconstitution into vial 1 2 to 7 mL


Storage 2 years at 2 - 8°C, protected from light

Stability of labelled product 3 h not above 25°C, protected from light

Activity per vial 400 to 1800 MBq

Indications /Posology In conjunction with other appropriate imaging modalitiesdetermination of the location of inflammation/infection peripheralbone in adults with suspected osteomyelitis (400-800 MBq).Should not be used for the diagnosis of diabetic foot infection

Time between injection and examination 3 to 6h and late image 24h




STAMICIS®


Each vial 2 containsTetrakis (2-methoxy isobutyl isonitrile) 1.0 mgcopper (I) tetrafluoroborateStannous chloride dihydrateL-cysteine hydrochloride monohydrateSodium Citrate DihydrateMannitol

Volume of 99mTc pertechnetate to use for reconstitution 1 to 3 mL

Radiochemical purity > 94%

Indications /Posology AdultsThe suggested activity range for intravenous use to a patient ofaverage weight (70 kg) is:Myocardial perfusion scintigraphy: 400-900 MBqAssessment of global ventricular function: 600-800 MBq injectedas a bolus.For diagnosis of ischaemic heart disease two injections (stressand rest) are required in order to differentiate transiently frompersistently reduced myocardial uptake.The recommended activity range for diagnosis of ischaemic heartdisease according to the European procedural guideline is:- Two-day protocol: 600–900 MBq/study- One-day protocol: 400–500 MBqfor the first injection, three times more for the second injection.

Not more than a total of 2000 MBq should be administered for aone-day protocol and 1800 MBq for a two-day-protocol. For a oneday protocol, the two injections (stress and rest) should be doneat least two hours apart but may be performed in either order.After the stress injection, exercise should be encouraged for anadditional one minute (if possible).

For diagnosis of myocardial infarction one injection at rest may besufficient.

The injection of activities greater than local DRLs (DiagnosticReference Levels) should be justified.

Scinti-mammography for the detection of suspected breastcancer: 750-1000 MBq injected as a bolus in the arm opposite tothe lesion.

Localisation of hyperfunctioning parathyroid tissue:200–1000 MBq injected as a bolus (the activity used should inevery case be as low as reasonably practical). The typical activityis 740 MBq.Children and adolescentsFor pediatric use, please refer to the full SPC.

Time between injection and examination Myocardial perfusion scintigraphyIf possible, patients should fast for at least four hours prior to thestudy. It is recommended that patients eat a light fatty meal ordrink a glass or two of milk after each injection, prior to imaging.This will promote rapid hepatobiliary clearance of technetium(99mTc) sestamibi resulting in less liver activity in the image.

Imaging should begin approximately after 60 min after injection toallow for hepatobiliary clearance. Longer delay can be requiredfor resting images and for stress with vasodilatators alonebecause of the risk of higher subdiaphragmatic 99mTc activity.There is no evidence for significant changes in myocardial tracerconcentration or redistribution, therefore imaging for up to 6 hourspost injection is possible. Test may be done in a one day or twodays protocol.

Preferably tomographic imaging (SPECT) with or without ECG




STAMICIS®(continued)

gating should be performed according to current internationalguidelines.

Breast imagingThe product is administered in an arm vein contralateral to thebreast with the suspected abnormality. If the disease is bilateral,the injection is ideally administered in a dorsal vein of the foot.

Breast imaging is optimally initiated 5 to 10 minutes post injectionwith the patient in the prone position with breast freely pendant. A10 minute lateral image of the breast suspected of containingcancer should be obtained with the camera face as close to thebreast as practical.

The patient should then be repositioned so that the contralateralbreast is pendant and a lateral image of it should be obtained. Ananterior supine image may then be obtained with the patient’sarms behind her head.

Parathyroid imagingAcquisition depends on the protocol chosen. The most usedstudies are either the dual-phase and/or the subtractiontechniques, which can be performed together.• Subtraction technique of the activity of the thyroid:In order to visualize the parathyroid, either pertechnetate(99mTc) oriodine (123I) can be given first, followed by technetium (99mTc)sestamibi, or technetium (99mTc) sestamibi can be given first,followed by pertechnetate (99mTc).

When iodine (123I) is used, 10 to 20 MBq of oral iodine (123I) areadministered. Four hours after the administration of 123I, neck andthorax images are obtained. After iodine (123I) image acquisition,185 to 370 MBq of technetium (99mTc) sestamibi are injected andimages are acquired 10 minutes post injection in doubleacquisition with 2 peaks of gamma energy (140 keV fortechnetium (99mTc) and 159 keV for iodine (123I)).

When pertechnetate (99mTc) is used to visualize the parathyroid,40-150 MBq of sodium pertechnetate(99mTc) are injected and neckand thorax images are acquired 30 minutes later. Then 185-370 MBq of technetium (99mTc) sestamibi are injected and asecond acquisition of images is acquired 10 minutes later.• Dual-phase study:350-1000 MBq of technetium (99mTc) sestamibi are injected. Early(10 min. postinjection) and delayed (1.5-2.5 h postinjection) high-count images are obtained.

In case of kidney failure, exposure to ionising radiation can beincreased. This must be taken into account when calculating theactivity to be administered.

In general, activity selection for patients with a decreased hepaticfunction should be cautious, usually starting at the low end of thedosing range.

Storage 1 year not above 25°C. Keep the vial in the outer carton, in orderto protect from light.

Stability of labelled product 10 h not above 25°C.

Activity per vial 200 MBq to 11 GBq




TECEOS®


Each vial contains :3,3-diphospho - 1,2 -propanedicarboxylicacid, tetrasodium salt (DPD) 13.0 mgtin (II) - oxideN - (4 - aminobenzoyl) - L - glutamic acid,monosodium salt



Storage 13 months, not above 25°C

Stability of labelled product 8 h not above 25°C.

Activity per vial 0.37 to 11.1 GBq

Indications /Posology Bone scintigraphy 500 MBq(300 - 700 MBq)

Time between injection and examination Late phase static scintigraphy should be performednot earlier than 2 hours



VASCULOCIS®


Each vial contains :Human Serum Albumin (HSA) 10 mgStannous chloride dihydrateSodium chlorideUnder nitrogen atmosphere





Indications /Posology 1) Static blood pool imaging : 111 to 185 MBq2) Angiography : 370 to 740 MBq3) Circulation, blood flow studies : 18.5 to 185 MBq4) Ventriculography : 185 to 925 MBq

Stability of labelled product 8 h not above 25°C

Time between injection and examination Shortly or immediately






ZEVALIN®

Kit for radiopharmaceutical preparations for infusion

Vial 1: Ibritumomab tiuxetan 3 ml glass septum vial containing 2 ml ibritumomab tiuxetan(1.6 mg/ml) in 0.9% NaCl solution

Vial 2: Sodium acetate 3 ml glass septum vial containing 2 ml 50 mM sodiumacetate which is used to adjust the 90Y-chloride solution to pH 4

Vial 3: Formulation buffer Glass septum vial containing 10 ml PBS (pH 7.2) with 7.5%human serum albumin and 1 mM DTPA

Vial 4: Reaction vial: 10 ml empty glass septum vial

Storage Components stored in refrigerator (2–8 ºC).Do not freeze !

Indications [90Y]-radiolabelled Zevalin is indicated as consolidation therapyafter remission induction inpreviously untreated patients withfollicular lymphoma. The benefit of Zevalin following rituximab incombination with chemotherapy has not been established.[90Y]-radiolabelled Zevalin is indicated for the treatment of adultpatients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin’s lymphoma (NHL).

Stability After radiolabelling, an immediate use is recommended. Chemicaland physical in-use stability has been demonstrated for 8 hours at2°C - 8°C and protected from light.

Number of radiolabeled preparations per kit 1

SPECTGenerators




ELUMATIC® IIITechnetium 99mTc generator

ELUMATIC® III / TEKCIS™ are automatic and highly protected generators which produce a sterile and pyrogen free99mTc solution, in the form of sodium pertechnetate (T = 6.02 h).

This solution is eluted from an alumina chromatographic column on which fission 99Mo is fixed (T = 66 h).

The ELUMATIC® III / TEKCIS™ GENERATORS have an activity expressed in 99mTc at the dateindicated on the label.

Elution solution : aqueous sterile and pyrogen free 0.9 % sodium chloride and 0.005% sodium nitrate solution.


Ordering deadline

Expiry

Elution volume



pH

Storage


Indications

on Monday calibrated Saturday 12 a.m.

on Tuesday calibrated Saturday or Wednesday

(following week) 12 a.m.

on Wednesday calibrated Wednesday (following week) 12 a.m.

on Thursday calibrated Wednesday 12 a.m.

on Friday calibrated Wednesday or Saturday

(following week) 12 a.m.

5 days before the shipment day, before 11 a.m.

20 days from the date of manufacturing.

5, 10 or 15 mL

� 95 %99Mo � 0.1 %, 131I � 5.10-3 %, 103Ru � 5.10-3 %, 89Sr � 6.10-5 %,90Sr � 6.10-6 %, � emitting impurities � 1.10-7 %,

other gamma-emitting impurities � 0,01 %.

4.0-8.0

- Generator : 20 days between +15°C and +25°C

- Sodium (99mTc) pertechnetate solution : store at 2-8°C and use within

10 hours after elution.

2 - 4 - 6 - 8 - 10 - 12 - 16 - 20 GBq

1.Reagent for labelling various kits to be used with 99mTc

2.Administered intravenously the eluate might be used in:

• Thyroid scintigraphy

• Salivary gland scintigraphy

• Localization of ectopic gastric mucosa

• Cerebral scintigraphy

3.In conjunction with a reducing agent for labelling red blood cells

for :

• Cardiac and vascular scintigraphy

• Diagnosis and localisation of occult gastrointestinal bleeding

4.Administered by instillation into the eye for:

• Lacrymal duct scintigraphy



TEKCIS™

2-50 GBq radionuclide generator


Ordering deadline

Expiry

Elution volume


Storage

Precalibrated activity

Indications

Every working days

Calibration 5 and 8 days

5 days before the shipment day, before 11 a.m. CET

21 days after manufacturing date

5, 10 or 15 mL

� 95 %

This medicinal product does not require any special storage

conditions.

2-4-6-8-10-12-16-20-25-50 GBq

• Labelling of various kits for radiopharmaceutical preparation

developed and approved for radiolabelling with such solution.

• Thyroid scintigraphy:

• Salivary gland scintigraphy

• Location of ectopic gastric mucosa (Meckel's diverticulum).

• Lacrimal duct scintigraphy.



SPECTAccessories



ELUMATIC® III / TEKCIS™ generatorsaccessories

ELUMATIC® III

CONT - ELU

Lead container for the protection ofvacuum vials for the elution of theELUMATIC® III / TEKCIS™ generators (witha flat lead glass window).

CONT - ELU - SP

Total vision lead glass and lead containerfor the protection of vacuum vials for theelution of the ELUMATIC® III / TEKCIS™

generators.

PROTEC - ELU

Additional shielding for storage andelution of the ELUMATIC® III / TEKCIS™

generators (160 kg).

Depending on national regulations.

TC - ELU - 5 - 10

Kit containing 10 vials of 5 mL vacuum, sterile and pyrogenfree, for the elution of the ELUMATIC® III / TEKCIS™

generators.

TC - ELU - 10 - 10

Kit containing 10 vials of 10 mL vacuum, sterile andpyrogen free, for the elution of the ELUMATIC® III / TEKCIS™

generators.

TC - ELU - 15 - 10

Kit containing 10 vials of 15 mL vacuum, sterile andpyrogen free, for the elution of the ELUMATIC® III / TEKCIS™

generators.

ELU-TIPS

Package of 10 units of sterilized needlecaps are to protect the elution needle ofELUMATIC III (+ filter).

TEKCIS™

PROT-STE-ELU

Plastic container for the protection ofsterile vial (STE-ELU).

STE-ELU

Kit containing 5 protective vials of sterileelution needle for 99mTc.


Venticis® II and accessories

1 - Nebulizer

2 - Air supply tubing

3 - Externalloader

4 - Reservoir bag

5 - Valves

6 - Mouthpiece

7 - Filter trap

8 - Lead shielded box

99mTc aérosol inhaléInhaled 99mTc aerosol

99mTc aérosol exhaléExhaled 99mTc aerosol

Availability : from stock, by 5 units

VENTICIS® II - RADIOAEROSOL DELIVERY SYSTEM

VENTIBOX - LEAD SHIELDED BOX FOR ONE VENTICIS® II SYSTEM

Size closed box

l. : 220 mm

w. : 154 mm

h. : 360 mm

w. : 16 kg

Venticis® is an aerosol generator intended for- Study of pulmonary ventilation- Study of alveolar-capillary permeabilityusing radiopharmaceutical products labelled with technetium 99mTc.

Medical device, class IIa, CE marked, in compliance with the Medical Devices Directive 93/42/EEC.

0459



CAPSION® accessories

EDICIS accessory

Tong Lead transportation pot for 131Iodine capsule

Perforator Guide

EDI-STRIPSChromatographic paper Whatman 31 ET chr (10 perunit) for EDICIS QC


STAMICIS® accessories

SCINTIMUN® accessory

Tong Wet boiler

QC strips (according to SPC)

HAMA-POCTQuick HAMA kit (5 tests per kit)

Lead protection for Stamicis® vials


RadiochemicalI-123-MPUP



I-123-MPUPIodine-123 T1/2 = 13.2 h SODIUM IODIDE (123I) SOLUTION FOR LABELLING

Availability

Ordering deadline


Calibration


Expiry

Specific activity



pH and composition

Storage

Indication

Every working day except Thursday, Friday and the day before a

day off

One day before (before 11 a.m.)


Following day at 5 p.m.

92.5 - 148 - 185 - 259 - 296 MBq

2.5 - 4 - 5 - 7 - 8 mCi


Carrier free

� 95 %

� 99.7 %

� 7 in sodium hydroxide 0.02 M

Not above 25°C

Labelling of radiopharmaceuticals API (Active Pharmaceutical

Ingredients)


PackagingPET

SPECT



FDG-IBAPET

Vial Lead pot Box


SPECTRadiopharmaceuticals

15 mL penicillin type vial Lead shields (according to nominal activities)

ELUMATIC® III TEKCIS™

Drum Plastic packaging

Metallic box (easy open system) Packaging

Services




Imagem

Imagem is a web plateform on molecular imaging proposing a unique

database on Molecular Imaging (scientific articles, news and events)

updated daily by information specialists.

Molecular imaging review

Molecular Imaging Review consolidates the key information published in

the Molecular Imaging world. It includes PET/SPECT scientific articles in

the major clinical axis (books, abstracts, events, news/press).

Frequency: Monthly


GeneralInformation

Commercial information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Scientific and technical information . . . . 57

Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Nuclides index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Radioactive decay table . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Locations and contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67



Commercial information

ORDERING INFORMATION

1. HOW TO ORDER ?Orders may be placed by mail, telefax or telephone to yourlocal contact (see list on the back of the catalogue). Toavoid errors and delay, each order should include thefollowing information :- ship to : CUSTOMER’S NAME + ADDRESS- invoice : NAME + ADDRESS (if different)- PURCHASE ORDER NUMBER- CATALOGUE CODE + NAME OF PRODUCT- QUANTITY REQUIRED- DELIVERY DATE REQUIRED- SPECIAL PACKAGING OR SHIPPING INSTRUCTIONS.

If a written order is confirmation of an order alreadyplaced by telephone, this must be clearly indicated.Duplicate shipment resulting from improperly confirmedformal order may not be returned for credit and bothinvoices are integrally payable.

Standing orders :We welcome standing orders. They can be modified orcancelled at any time, with at least one week’s notice.

2. WHEN TO ORDER ?Please, refer to our « PRODUCTION CALENDAR » andremember that orders should arrive at the customerservice at least two working days before production datesof all items concerned.

Production Calendars are available online at:www.ibamolecular.eu

3. WHERE TO ORDER ?In countries where we have no local representative, ordersshould be sent to :

CIS bio internationalB.P. 3291192 Gif-sur-Yvette Cedex - FRANCETelefax : 33 1 69 85 75 21 or 33 1 69 85 72 89

Enquiries should be sent to :

CIS bio internationalB.P. 3291192 Gif-sur-Yvette Cedex - FRANCE

PACKAGING

Radioactive products are delivered in packaging inaccordance with procedures complying with the :

• RECOMMENDATIONS of the International AtomicEnergy Agency in Vienna (IAEA) (1990 revised edition)and with the ensuing regulat ions, codes andagreements.

• International Air Transport Association (IATA) Regulations.

• International Rail Transport Regulations (RID).

• International Maritime Code (OMCI)

• European Agreement on International Road Transport(ADR)

• French regulations on transport of radioactive materials.

Determination of the type of packaging is settled by thedangerous nature of the transported material : dependingon its radiotoxicity, radioactivity and its tendency to spread.

For each radioactive nuclide, regulations lay downmaximum quantity limits of radioactivity defined as :

• type A packaging : low and medium radioactivity,

• type B packaging : high radioactivity.

Packaging used for radiopharmaceutical products is typeA non-returnable packaging ; it complies with theregulatory tests for mechanical resistance and protectionfrom radiation.

It consists of a “crimped metal box” containing cylindricallead shielding, whose thickness varies from 5 to 35 mm,and an absorbent sponge. The shielding is kept in positioninside the box by a mould of expanded polystyrene. Thebox is fixed inside cardboard packaging. The weight ofthe packaging varies from 0.5 to 10 kg.


Scientific and technical information

QUALITY CONTROL

1. DEFINITIONSRADIOPHARMACEUTICAL PREPARATION(Directive 2004/27/EC amending Directive 2001/83/EC)

RadiopharmaceuticalAny medicinal product which, when ready for use, containsone or more radionuclides (radioactive isotopes) includedfor a medicinal purpose.

Radionuclide generatorAny system incorporating a fixed parent radionuclidefrom which is produced a daughter radionuclide which isto be obtained by elution or by any other method andused in a radiopharmaceutical.

KitAny preparation to be reconstituted or combined withradionuclides in the final radiopharmaceutical, usuallyprior to its administration.

Radionuclide precursorAny other radionuclide produced for the radiolabellingof another substance prior to administration.

RADIOCHEMICAL PREPARATION :The designation radiochemical preparation refers to achemical product including one or more radiochemicalpreparations.

Must not be injected in human.

2. PRESENTATIONRADIOPHARMACEUTICAL PREPARATIONProducts are generally presented in vials (penicillin type)of 15 mL.

Some products appear in

• gelatin capsules

• unidose plastic syringes, ready to use

• generators : chromatography columns allowing theelution of short half-life radionuclides.

Each package has a label showing the name of theproduct, the radioactive concentration, the specificradioactivity at a given date, the volume, the lot number,the expiry date and the conditions of storage. It containsalso a package leaflet to read before using the product.

RADIOCHEMICAL PREPARATIONProducts are generally presented in vials (penicillin type)of 2, 15 and 30 mL. Some of them are packaged in sealedampoules.

Each package has one or two labels showing : the natureof the product, the radioactive concentration at a givendate, the volume and the lot number.

A red symbol indicates the radioactive character of theproduct.

3. QUALITY CONTROLRADIOPHARMACEUTICAL PREPARATIONThe manufacturing and distribution of radiopharmaceuticalpreparations(1) must respond to official standards, or indefault, to protocols established in agreement with thecompetent authorities. The standards, which are renderedobligatory, are published in the pharmacopoeia (French,European, British pharmacopoeia, Pharmacopoeia ofthe USA, etc.)(1) Acceptance put in concrete form by the the opening authorization ofpharmaceutical branch CIS bio international.

According to these documents, the establishment of aquality control of the radiopharmaceutical preparationsseems to be relatively easy. In fact, if the general methodsof manufacturing, distribution and control are effectivelydescribed, all the radiopharmaceutical preparations arenot included in monographs.

Moreover, as the various pharmacopoeia do not alwaysprescribe the same methods or the same standards, it isnecessary to render them compatible. All these factsexplain the difficulty to imagine a control system whichtakes into consideration the whole international statutoryrestraints.

The qual i ty control of the radiopharmaceuticalpreparation is effected at three levels :

RAW MATERIAL CONTROLAll the raw materials entering the manufacturing of theradiopharmaceutical products are stored and analysedbefore use following the rules of Quality Assurance.

The delivery system used allows immediate cross-checking, in case of anomaly both in production and inthe finished product.



CONTROL OF THE MANUFACTURINGPROCESSESThe manufacturing of radiopharmaceutical preparationsimperatively requires the respect of Good ManufacturingPractices describing the premises, the qualification ofthe manufacturing and control employees, and theadjustment of the materials used to the consideredoperations.

The verification of the respect of these rules is effectedby the Quali ty Assurance which uses two innercharacteristics : the impartiality towards the producerand the availability of a suitable analytic procedure.

CONTROL OF THE FINISHED PRODUCTSSystematic control of the raw materials and respect of themanufacturing procedures assure a quality guaranteewhich must be confirmed by the control of the finishedproduct.

There are 3 types of controls of the finished products :

• Radiometrological controls allowing theidentification of the radionuclides (in particular with gspectrometry), the measuring of radioactivity whichensures the radioactive concentration and the specificradioactivity.

• Physical and chemical controls :The dosage of the active ingredients, the analysis of theradionuclidic and of the radiochemical purity, themeasuring of the pH and the osmotic pressure demandvarious methods such as potentiometry, chromatography,electrophoresis, etc.

• Biological controls :The injectable aqueous or colloidal solutions are,according to the monographs of the var iousPharmacopoeia, submitted to controls of sterility, absenceof abnormal toxicity, submitted to controls of sterility,bacterial endotoxin concentration and absence ofabnormal toxicity.

Besides, the quantitative analysis of the biodistribution ofsome radiopharmaceutical preparations is performed inanimals.

RADIOCHEMICAL PREPARATIONThe radiochemical preparations are submitted to certaincontrols at various levels of their production.

There are 2 types of control :

• Radiometrological controls allowing theidentification of the radionuclides (in particular with gspectrometry), the measuring of radioactivity whichensures the radioactive concentration.

• Physical and chemical controls allowing thedetermination of the chemical purity of the radioactivesolutions delivered.

Radiochemical preparations must not be administeredto human.

4. STORAGEThe decomposit ion of the radiopharmaceuticalpreparations under the influence of their own radiation isa general phenomenon : in some cases it may shorten theduration of use.

It is recommended

• to maintain the products, as soon as they arrive, at atemperature suitable with their physical properties (theparticular conditions of storage are notified on the label).

• to use them as rapidly as possible, the expiry dateis mentioned on each radiopharmaceutical preparation.

Scientific and technical information(continued)

QUALITY CONTROL


Units

Each radionuclide is characterized :- by an unvarying period expressed in time unit- by the nature and the energy of the radiation(s)

This energy is expressed in electronvolts (eV),kiloelectronvolts (keV), megaelectronvolts (MeV).

The radioactivity (activity) of a preparation is defined bythe amount of desintegrations or nuclear transformationsoccuring in this preparation per unit of time.

The quantities of radioactivity in the International System(IS) are expressed in becquerel (Bq), corresponding toone nuclear transformat ion per second (dps =disintegration per second).

The quantities of radioactivity may also be expressed incurie (Ci), the curie corresponding to 3.7 x 1010disintegrations per second, in millicurie, microcurie, orin nanocurie.

The following factors make the conversion easier betweenthe 2 unit systems :

Becquerel in Curie: 1 Bq = 27.027 pCi = 1 dps

1 Becquerel (Bq) = 27.027 Picocurie (pCi)

1 Kilobecquerel (kBq) = 27.027 Nanocurie (nCi)

1 Megabecquerel (MBq)= 27.027 Microcurie (µCi)

1 Gigabecquerel (GBq) = 27.027 Millicurie (mCi)

1 Terabecquerel (TBq) = 27.027 Curie (Ci)

Curie in Becquerel: 1 Ci = 3.7 x 1010 Bq

1 Nanocurie (nCi) = 37 Becquerel (Bq)

1 Microcurie (µCi) = 37 Kilobecquerel (kBq)

1 Millicurie (mCi) = 37 Megabecquerel (MBq)

1 Curie (Ci) = 37 Gigabecquerel (GBq)

1 Decacurie (daCi) = 0.37 Terabecquerel (TBq)

Rad in Gray: 1 Rad/mCi = 0.27 mGy/MBq

1 Millirad (mrad) = 10 Microgray (µGy)

1 Rad = 10 Milligray (mGy)

1 Rad = 1 Centigray (cGy)

Gray in Rad:1 Microgray (µGy) = 0.1 Millirad (mrad)

1 Milligray (mGy) = 100 Millirad (mrad)

1 Centigray (cGy) = 1 Rad

1 Gray (Gy) = 100 Rad

Rem in Sievert :1 Millirem (mrem) = 10 Microsievert (µSv)

1 Rem = 10 Millisievert (mSv)

1 Rem = 1 Centisievert (cSv)

Sievert in Rem :1 Microsievert (µSv) = 0.1 Millirem (mrem)

1 Millisievert (mSv) = 100 Millirem (mrem)

1 Centisievert (cSv) = 1 Rem

1 Sievert (Sv) = 100 Rem

kBqMBqGBq

3.77.49.25

11.114.818.5

377492.5

111148185

222259296

333370444

µCimCiCi

0.10.20.25

0.30.40.5

122.5

345

678

91012

MBqGBqTBq

1.111.481.85

2.222.592.96

3.333.74.62

5.557.49.25

11.114.818.5

22.225.927.75

29.633.337

µCimCiCi

304050

607080

90100125

150200250

300400500

600700750

8009001000

CONVERSION TABLE FROM BECQUERELSINTO CURIES



Definitions(*)

RADIONUCLIDIC PURITYThe ratio, expressed as a percentage, of the radioactivityof the radionuclide concerned to the total radioactivity ofthe radiopharmaceutical preparation. The relevantradionuclidic impurities are listed with their limits in theindividual monographs.

RADIOCHEMICAL PURITYThe ratio, expressed as a percentage, of the radioactivityof the radionuclide concerned which is present in theradiopharmaceutical preparation in the stated chemicalform, to the total radioactivity of that radionuclide presentin the radiopharmaceutical preparation. The relevantradiochemical impurities are listed with their limits in theindividual monographs.

CHEMICAL PURITYIn monographs on radiopharmaceutical preparationschemical purity is controlled by specifying limits onchemical impurities.

ISOTOPIC CARRIERA stable isotope of the element concerned either presentor added to the radioactive preparation in the samechemical form as that in which the radionuclide is present.

SPECIFIC RADIOACTIVITYThe radioactivity of a radionuclide per unit mass of theelement or of the chemical form concerned.

RADIOACTIVE CONCENTRATIONThe radioactivity of a radionuclide per unit volume.

(*) Refer to the European Pharmacopoeia, current edition, Monograph

“Radiopharmaceutical preparations”.


Nuclides index

Radionuclides Half lifeDecay Emitted Energy

% IntensityModes Radiations (Rev)

ERBIUM-169 169Er 9.3 d �- e- 373 max 42351 max 58

e-C 6-7 33.48 8.4

� 8.4 0.2

FLUORINE-18 18F 1.83 h �+ e+ 633 max 96.6(average 250)

EC 3.1

� � annihilation 511 96.9

GALLIUM-67 67Ga 3.25 d EC 100%

� 912 3.1932 35.4185 22209 2.4300 16.5393 4.5

IODINE-123 123I 13.2 h EC 100%

e- 127 13.6154 1.77158 0.4322-32 12.42.3-4.8 98

� 159 83.3529 1.4

XK 27 7031 16

XL 3.3-4.9 7.8

IODINE-125 125I 59.9 d EC 100%� 34.8 6.7e- 22-31 20.8

34.4 2.4

Xk 27-32 1394-5 13

IODINE-131 131I 8.02 d �- e- 248 max 2.1334 max 7.3606 max 89.5

e- 46 3.5

� 80 2.6284 6364 81.3637 7.2722 1

Energies of main radiations emitted by the radionuclides used as radiopharmaceuticals.



Nuclides index(continued)

Radionuclides Half lifeDecay Emitted Energy

% IntensityModes Radiations (Rev)

RHENIUM-186 186Re 3.77 d �- e- 1076 max 71939 max 7.3308 max 7.3

EC 7.6

� 123 0.6137 9.5

e- 63 4.1

e- 124-126 6

e- 5-13 12

XK 58-74 10.2

XL 7-13 5.2

SAMARIUM-153 153Sm 46.3 h �- e- 640 max 30710 max 50810 max 20

e-C 21 2455 4195 6

� 41 4947 12103 29

TECHNETIUM-99m 99mTc6.02 h � � 140 89.3

IC e- 119 8.7121-142 2.14

2 99.115-18 2

XK 18-21 7.2

THALLIUM-201 201TI 3.05 d EC 100%

e- 27-31 2.752 7.484 15

� 135 2.6167 9.8

XK 69-83 95

YTTRIUM-90 90Y 2.67 d �- e- 2284 max 99.98%average 939average 523 0.02average 188

Radiations used for a medical purposeEC : electron captureIC : internal conversion electrons


Radioactive decay table

Hours Days Tc - 99m I - 123 Sm - 153 Y - 90 Mo - 99T1/2 = 6.02 h T1/2 = 13.2 h T1/2 = 46.3 h T1/2 = 64.1 h T1/2 = 66.2 h

-168 -7 6.149 5.805-156 5.401 5.119-144 -6 4.744 4.515-132 4.167 3.982-120 -5 3.660 3.512-102 3.012 2.909-96 -4 4.209 2.823 2.732-84 3.517 2.480 2.409-72 -3 2.938 2.178 2.125-60 2.455 1.913 1.874-48 -2 2.052 1.680 1.653-36 1.714 1.476 1.458-24 -1 1.432 1.296 1.286-12 3.999 1.877 1.197 1.139 1.134-8 2.519 1.521 1.127 1.090 1.087-4 1.587 1.233 1.062 1.044 1.043-3 1.414 1.170 1.046 1.033 1.032-2 1.260 1.111 1.030 1.022 1.021-1 1.122 1.054 1.015 1.011 1.011

Calibration 1 1 1 1 11 0.891 0.949 0.985 0.989 0.9902 0.794 0.900 0.971 0.979 0.9793 0.707 0.854 0.956 0.968 0.9694 0.630 0.811 0.942 0.958 0.9595 0.561 0.769 0.928 0.947 0.9496 0.500 0.730 0.914 0.937 0.9397 0.446 0.693 0.901 0.927 0.9298 0.397 0.657 0.887 0.917 0.9209 0.354 0.624 0.874 0.907 0.91010 0.315 0.592 0.861 0.898 0.90112 0.250 0.533 0.836 0.878 0.88214 0.480 0.811 0.860 0.86416 0.432 0.787 0.841 0.84620 0.350 0.741 0.806 0.81124 1 0.284 0.698 0.771 0.77836 0.151 0.583 0.678 0.68648 2 0.081 0.487 0.595 0.60560 0.043 0.407 0.523 0.53472 3 0.340 0.459 0.47184 0.403 0.41596 4 0.354 0.366108 0.311 0.323120 5 0.273 0.285144 6 0.211 0.221168 7 0.163 0.172



Radioactive decay table(continued)

Hours Days Tl - 201 Ga - 67 Re - 186T1/2 = 3.05 d T1/2 = 3.26 d T1/2 = 3.77 d

-168 -7-156 4.380 3.983 3.303-144 -6 3.909 3.582 3.013-132 3.489 3.220 2.748-120 -5 3.114 2.895 2.507-102 2.779 2.603 2.248-96 -4 2.481 2.340 2.086-84 2.214 2.104 1.903-72 -3 1.977 1.892 1.736-60 1.764 1.702 1.583-48 -2 1.575 1.530 1.444-36 1.406 1.376 1.317-24 -1 1.255 1.237 1.202-12 1.120 1.112 1.096-8-4-3-2-1

Calibration 1 1 11234567891012 0.893 0.899 0.91214162024 1 0.797 0.808 0.83236 0.712 0.727 0.75948 2 0.635 0.654 0.69260 0.566 0.588 0.63272 3 0.506 0.528 0.57684 0.452 0.475 0.52696 4 0.403 0.427 0.479108 0.360 0.384 0.437120 5 0.321 0.345 0.399144 6 0.256 0.279 0.332168 7 0.204 0.226 0.276192 8 0.162 0.182 0.230


Radioactive decay table(continued)

Hours Days I - 131 Er - 169 I - 125T1/2 = 8.02 d T1/2 = 9.40 d T1/2 = 59.9 d

-180 -7.5 2.373-168 -7 1.831 1.084-156 -6.5 1.371 1.615-144 -6 1.679 1.556-132 -5.5 1.608 1.500-120 -5 1.540 1.446 1.060-108 -4.5 1.475 1.393-96 -4 1.413 1.343-84 -3.5 1.353 1.294-72 -3 1.296 1.248 1.035-60 -2.5 1.241 1.202-48 -2 1.189 1.159-36 -1.5 1.138 1.117-24 -1 1.090 1.077 1.012-12 -0.5 1.044 1.038

Calibration 1 1 112 0.5 0.958 0.96424 1 0.917 0.929 0.98836 1.5 0.878 0.89548 2 0.841 0.86360 2.5 0.806 0.83272 3 0.772 0.802 0.96684 3.5 0.739 0.77396 4 0.708 0.745108 4.5 0.678 0.718120 5 0.649 0.692 0.944132 5.5 0.622 0.667144 6 0.595 0.643156 6.5 0.570 0.619180 7 0.546 0.597 0.922204 8 0.501 0.554228 9 0.460 0.515 0.901252 10 0.421 0.478 0.891276 11 0.387 0.444300 12 0.355 0.413 0.870324 14 0.298 0.356348 15 0.274 0.331 0.841

20 0.178 0.229 0.79325 0.158 0.74930 0.70740 0.63045 0.59450 0.56155 0.52960 0.499


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PRODUCTCATALOGUE

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2015

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