Manual de radiofarmacos

11

Indication: Glomerular clearance measurement/cerebral angioscintigraphy.Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• (DTPA) CaNa3diethylene triamine penta acetate 20.0 mg • Stannous chloride dehydrate 0.50 mg• Ascorbic acid 0.018 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc - (Sn)-DTPA with the following characteristics:

• Volume 2 - 5 ml• Max. Activity 300 mCi• Radiochemical purity > 95.0 %• PH 5 - 6

Storage• Store the kit 2 - 8 °c and protect from light• Store the reconstituted kit 15-25°C

Preparation• Injection sterile 99mTc (up to 300 mCi) aseptically into the vial in a volume of 2-5 ml• Dissolve the lyophilized material by shaking the vial for 10 seconds and

KIT FOR THE PREPARATION OF DIETHYLENE TRIAMINE PENTA ACETATE (Sn) Tc-99m INJECTION

wait for 15 minutes.• Examine the radiochemical purity (RCP).• Labelled preparation is to be used within 6 hrs. Within this period the total RCP of 99mTc-DTPA should be more than 95.0%.

Quality control of 99mTc-DTPA• Whatman paper chromatography No.1 /Methanol- Acetone (1: 1) Rf 99mTcO-4 = 0.75-1.0• Whatman paper chromatography No.1 /normal saline Rf 99mTcO2 = 0.0 - 0.2

Biological distribution of 99mTc-DTPA in rat (n = 3), expressed in % injected dose per critical organ:

• Urine (24 hrs) > 97.0%

Sterility testTest for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Pyrogen testLAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

DTPA Tck-pars-100

2

Indication: Diagnostic and study of primary cancers or metastatic bone lesions .and other bone diseases such as Paget, osteomylitis, fractures,Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• MDP (methylene diphosphonic acid) 5.0 mg• Stannous chloride dehydrate 0.80 mg• Ascorbic acid 0.50 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one ob-tains an injectable solution of 99mTc -(Sn)-MDP with the following characteristics:

• Volume 2 - 5 ml• Max. Activity 300 mCi• Radiochemical purity > 95.0 %• PH 5.0-6.5

Storage• Store the kit 2 - 8 °C• Store the reconstituted kit 15 - 25 °C

Preparation • Injection sterile 99mTc (up to 300 mCi) aseptically into the vial in a volume of 2-5 ml.• Dissolve the lyophilized material by shaking the vial for 10 seconds and wait for 15 minutes.

MDPKIT FOR THE PREPARATION OF MEDRONATE (Sn) 99mTc INJECTION

• Examine the radiochemical purity (RCP).• Labelled preparation is to be used within 6 hrs. Within this period the total RCP of 99mTc-MDP should be more than 95.0%.

Quality control of 99mTc-MDP• Whatman paper chromatography No.1 /Methanol-Acetone (1: 1) Rf 99mTcO-4 = 0.75-1.0• Whatman paper chromatography No.1 /Phosphoric Acid 15% Rf 99mTcO-4 = 0.0 - 0.2

Biological distribution of 99mTc-MDP in rat (n = 3), expressed in % injected dose per critical organ:

• Liver, Kidney < 5.0%• Bone (one femur) > 2.0%• Stomach, Intestine < 1.0%


Pyrogen testLAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in US. pharmacopeia.

Tck-pars-200

33

Indication:exploration of the renal morphology and the functional state of each kidney by measurement of the renal uptakeEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• DMSA (Dimercaptosuccinic Acid) 1.20 mg• Stannous chloride dihydrate 0.35 mg• Ascorbic acid 0.30 mg• Myo-inositol 50.0 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc-(Sn)-DMSA with the following characteristics:

• Volume up to 6.0 ml• Activity 40.0 mCi• Radiochemical purity > 90.0 %• PH 2.3-3.5

Storage• Store the kit 2-8 ºC, protect from light• Store the reconstituted kit 15-25 ºC

Preparation• Inject sterile 99mTc (up to 40 mCi) aseptically into the vial in a volume of 2.5 ml• Dissolve the lyophilized material by shaking the vial for 10 seconds

KIT FOR THE PREPARATION OF DIMERCAPTOSUCCINIC ACID (Sn) 99mTc INJECTION

• Wait for 15 min at the room temperature• Examine the radiochemical purity (RCP)• Labelled preparation is to be used within 4 hours after labelling. Within this period the total RCP of 99mTc-DMSA should be more than 90.0%.Quality control of 99mTc-DMSA• P.Chromatography No.1 (Whatman)/MEK/Glycine 5%• Rf 99mTcO-4=0.8-1.0• Rf 99mTcO2=0.0-0.2

Biological distribution of 99mTc-DMSA in Rat (n=3), Expressed in % injected dose/Critical organ:

• Liver and spleen < 5.0 %• Stomach, Intestine < 1.0 %• Ratio of kidney to liver and spleen > 6.0

Sterility TestTest for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Pyrogen TestLAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

DMSA Tck-pars-500

44

Indication: GI bleeding, blood pool imagingEach package contains 3 lyophilized kits and 2 vials solution.1- Each of 3 lyophilized vials contains, in vacuum sterile and pyrogen free mixture of:

• Sodium citrate dehydrate 3.70 mg• Stannous chloride dihydrate 0.105 mg• Anhydrous dextrose 5.5 mg

2- Each of two vials for three times labelling contains:a.Brown color vial; sodium hypochlorite 2.3 mlb.Colorless vial; ACD solution 3.6 ml

Storage• Store the kit and solutions 2-8 ºC • Store the reconstituted kit 15-25 ºC

Preparation (Labelling procedure In-vitro) • Take 0.1 ml of ACD solution by the syringe (19-21G needle). • Collect patient’s blood in 1-3 ml, mix gently. • Inject the patient’s blood to lyophilized vial (reaction vial), mix slowly and wait for 5 min.• Inject 0.6 ml of sod. Hypochlorite (2-a) to the reaction vial, then mix gently.• Inject 1.0 ml of ACD solution (2-b) to the reaction vial and then mix gently.• Inject 10-100 mCi of sodium pertechnetate (99mTcO-4) in 1-3 ml to the

Sn++KIT FOR THE PREPARATION OF (Sn) 99mTc Red Blood Cell (RBC) In-vitro labelling, for INJECTION

reaction vial, then mix gently and wait for 20 minutes.• Inject the labelled 99mTc-RBC to the patient within 30min after labelling time (by syringe19-21G needle).

Quality control of 99mTc-RBC• Take 0.2 ml of labelled 99mTc-RBC and transfer to the centrifuge tube.• Add 2 ml of normal saline to the centrifuge tube and shake well.• Centrifuge in 500 RCF at 10 min.• Separate accurately the 99mTc-RBC from plasma.• %99mTc-RBC=(Activity of 99mTc-RBC /Total activity of RBC and plasma) x100• Labelling efficiency >95 %



Tck-pars-600

55

Indication: Myocardial imaging agentEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Sodium pyrophosphate decahydrate 14.0 mg• Stannous chloride dehydrate 1.0 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc - (Sn)-PYP with the following charac-teristics:

• Volume 2-6 ml• Max activity 80 mCi• Radiochemical purity > 95.0 %• PH 5-6

Storage• Store the kit 2-25°C• Store the reconstituted kit 15-25°C

Preparation• Inject sterile 99mTc (up to 80 mCi) aseptically into the vial a volume of 2-6 ml• Dissolve the lyophilized material by shaking the vial for 10 seconds. Wait for 15 min.• Examine the radiochemical purity (RCP).

KIT FOR THE PREPARATION OF PYROPHOSPHATE (Sn) Tc-99m INJECTIO1V

• Labeled preparation is to be used within 6 hours. Within this period the total RCP of • 99mTc-PYP should be more than 95.0 %.

Quality control of 99mTc-PYP• P.Chromatography No.1 (Whatman) /Methanol- Acetone (1: 1)• Rf 99m TcO-4 = 0.75• P.Chromatograghy No.1 (Whatman) /phosphoric Acid 15% • Rf 99m TcO2 = 0.0-0.2

Biological Distribution of 99mTc-PYP in Rat (n=3), Expressed in % dose/ Critical organ:

• Liver, Kidney < 5.0• Bone (one femur) >1.0 • Stomach, Intestine < 1.0

Sterility TestTest for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as de-scribed in U.S. pharmacopeia.

Pyrogen TestLAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

PYP Tck-pars-900

66

Indication: Visualization of the hepatobiliary system, examination of the hepatobiliary function.Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• N-(2,4,6- trimethyl-3-bromoacetanilido iminodiacetic acid(Mebrofenin)25.0 mg• Stannous chloride dehydrate 0.20 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an inject able solution of 99mTc -(Sn)-Br-IDA with the following char-acteristics:

• Volume up to 5.0 ml• Max. Activity 50.0 mCi• Radiochemical purity > 95.0 %• PH 5-6

Storage• Store the kit 2-8 °C• Store the reconstituted injection 15-25 °C

Preparation• Inject sterile 99mTc (up to 50 mCi) aseptically into the vial in a volume of 2-5 ml• Dissolve the lyophilized material by shaking the vial for 10 seconds. • Wait for 15 minutes. • Examine the radiochemical purity (RCP).

BRIDAKIT FOR THE PREPARATION OF TRIMETHYL- BROMO- IDA (Sn) 99mTc INJECTION

• Labelled preparation is to be used within 4 hours. Within this period the total RCP of 99mTc-Br-IDA should be more than 95.0 %.

Quality control of 99mTc-BrIDA• P. Chromatography No.1 (What man) /D.W Rf 99mTcO2 = 0.0-0.1• ITLC-SG/N. saline Rf 99mTcO-4 = 0.9-0.1

Biological Distribution of 99mTc-BrlDA in Rat (n=3), expressed in %dose/Critical organ:

• Intestine >80.0%• Liver (per gram) < 1.0• Kidney (per gram) < 2.5 %• Stomach < 1.0• Bladder + urine < 15.0

Sterility TestTest for sterility on kits for 99mTc- Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.


Tck-pars-1000

77

Indication: exploration of the renal morphology and the functional state of each kidney by measurement of the renal uptakeEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• DMSA (Dimercaptosuccinic Acid) 1.20 mg• Stannous chloride dihydrate 0.35 mg• Ascorbic acid 0.30 mg• Myo-inositol 50.0 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one ob-tains an injectable solution of 99mTc-(Sn)-DMSA with the following characteristics:

• Volume up to 6.0 ml • Activity 40.0 mCi• Radiochemical purity > 90.0 %• PH 2.3-3.5

Storage• Store the kit 2-8 ºC, protect from light• Store the reconstituted kit 15-25 ºC

Preparation• Inject sterile 99mTc (up to 40 mCi) aseptically into the vial in a volume of 2.5 ml• Dissolve the lyophilized material by shaking the vial for 10 seconds• Wait for 15 min at the room temperature

KIT FOR THE PREPARATION OF DIMERCAPTOSUCCINIC ACID (Sn) 99mTc INJECTION

• Examine the radiochemical purity (RCP)• Labelled preparation is to be used within 4 hours after labelling. Within this period the total RCP of 99mTc-DMSA should be more than 90.0%.

Quality control of 99mTc-DMSA• P.Chromatography No.1 (Whatman)/MEK/Glycine 5%• Rf 99mTcO-4=0.8-1.0• Rf 99mTcO2=0.0-0.2

Biological distribution of 99mTc-DMSA in Rat (n=3), Expressed in % injected dose/Critical organ:

• Liver and spleen < 5.0 %• Stomach, Intestine < 1.0 %• Ratio of kidney to liver and spleen > 6.0



DMSA(V) Tck-pars-1100

88

Indication: Myocardial perfusion scintigraphyEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Cu (MIBI)4BF4 0.50 mg• Stannous chloride dihydrate 0.30 mg• Glycine 32.0 mg• Sodium pyrophosphate 5.20 mg• Cysteine 2.0 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake the vial for 10 seconds. Then, place the vial into a boiling water bath for 10 minutes. Wait for 15 minutes until it cools to room temperature. 99mTc -(Sn)-MIBI has the following characteristics:

• Volume 1 - 3 ml• Max. Activity up to 150 mCi• Radiochemical purity > 95.0 %• PH 5.5 -6.5• Stability of 99mTc -MIBI 6 h

Storage• Store the kit 2 - 8 °C• Store the reconstituted kit 15 - 25 °C

Preparation• Add aseptically sterile and non-pyrogenic 99mTc (10 - 150 mCi) in app. 1 to 3 ml.• Shake the contents of the vial for a few seconds.

MIBIKIT FOR THE PREPARATION OF MIBI (Sn) 99mTc INJECTION

• Place upright the vial in a boiling water bath for 10 minutes.• Wait for 15 minutes at the room temperature.• The reconstituted solution is stable for 6 hrs.

Quality control of 99mTc-MIBI • What man paper chromatography No.1 /Methanol Rf 99mTcO2 = 0.0 - 0.3• ITLC-SG/Normal saline Rf 99mTcO-4 = 0.9 - 1.0

Biological distribution of 99mTc-MIBI in mice (n = 3), expressed in % injected dose per critical organ:

• Liver > 20.0%• Heart > 1.3%• Kidney > 7.0%• Intestine > 30.0%• Stomach < 1.0%



Tck-pars-1200

99

INDICATION: Liver/ spleen scintigraphy Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Phytic acid 10.0mg• Stannous chloride dehydrate 1.0mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one obtains an injectable solution of 99mTc-(Sn)-phytate with the following char-acteristics:

• Volume 3-6ml• Max activity 100mci• Radiochemical purity >95.0%• PH 5.5-6.5

Storage• Store the kit 2-8°c• Store the reconstituted injection 15-25°c

Preparation• Inject sterile 99mTc (up to 100mCi) aseptically into the vial in a volume of 3-6 ml.• Dissolve the lyophilized material by shaking the vial for 10 seconds. Wait for 15 minutes.• Examine the radiochemical purity(RCP)

KIT FOR THE PREPARATION OF PHYTATE (Sn)Tc-99m INJECTION

• Labelled preparation is to be use within 6 hrs. Within this period the total • RCP of 99mTc-phytate should be more than 95.0%.

Quality control of 99mTc-phytate• P.Chromatography No.1(Whatman) / Methanol-Acetone(1:1)• Rf 99mTc0-4=0.75-1.0

Biological Distribution of 99mTc-phytate in mice (n=3), Expressed in %dose/Critical organ:

• Lung <5.0• Liver and spleen >80.0• Stomach, Intestine <1.0



Phytate Tck-pars-1400

1010

Indication: Renal tubular function imagingEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Ethylene dicysteine 1.0 mg• Stannous chloride dihydrate 0.125 mg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake the vial for 10 seconds.Add 2 ml of phosphate buffer solution, shake for 10 seconds. Wait for 15 min. 99mTc (Sn)-EC has the following characteristics:

• Volume up to 5 ml • Activity 10-100 mCi• Radiochemical purity > 95.0 %• PH 7.5-8.5• Stability of 99mTc-EC 4 hrs

Storage• Store the kit 2-8 ºC• Store the reconstituted kit 15-25 ºC

Preparation• Add aseptically sterile, non-pyrogenic 99mTc (10-150mCi) in app.1 to 3 ml.• Shake the contents of the vial for a few seconds.

ECKIT FOR THE PREPARATION OF 99mTc (Sn)-EC INJECTION

• Add 2.0 ml phosphate buffer.• Shake again for a few seconds.• Wait for 15 min at the room temperature• The reconstituted solution is stable for 4 hrs.

Quality control of 99mTc-EC• P.Chromatography No.3 (Whatman)/Acetic Acid 0.5M Rf 99mTcO2=0.0• ITLC-SG/Acetone Rf 99mTcO-4=0.9-1.0

Biological distribution of 99mTc-EC in Rat (n=3), Expressed in % dose/Critical organ:

• Stomach < 5.0• Kidney > 35.0



Tck-pars-1600

1111

Indication: Brain perfusion imagingEach vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Ethyl cysteinate Dimer 1.0 mg• EDTA 360.0 µg• Mannitol 24.0 mg• Stannous chloride dihydrate 100.0 µg

After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake the vial for 10 seconds.Add 2 ml of phosphate buffer solution, shake for 10 seconds. Wait for 45 min. 99mTc (Sn)-ECD has the following characteristics:

• Volume up to 5 ml • Activity 10-100 mCi• Radiochemical purity > 90.0 %• PH 7.5-8.0• Stability of 99mTc-ECD 4 hrs

Storage• Store the kit 2-8 ºC• Store the reconstituted kit 15-25 ºC

Preparation• Add aseptically sterile, non-pyrogenic 99mTc (10-100mCi) in app.1 to 2 ml.• Shake the contents of the vial for a few seconds.

KIT FOR THE PREPARATION OF 99mTc (Sn)-ECD INJECTION

• Add 2.0 ml phosphate buffer.• Shake again for a few seconds.• Wait for 45 min at the room temperature• The reconstituted solution is stable for 4 hrs.

Quality control of 99mTc-ECD• Revers Phase Chromatography MKC-18/Acetone-Am.Acetate(6:4) Rf 99mTcO2=0.0 Rf 99mTcO-4=1.0

Biological distribution of 99mTc-ECD in mice (n=3), Expressed in % dose/Critical organ (1 min after injection):

• Brain 0.9-1.3• Stomach < 1.5• Liver >10.0• Kidney , Intestine <10.0

Sterility TestTest for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.Pyrogen TestLAL test and rabbit test on kit for 99mTc-Radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

ECD Tck-pars-1700

1212

Indication: lung scintigraphy.Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Human serum albumin macroaggrigates 3.0 mg• Stannous chloride dehydrate 0.03 mg• Tween-80 0.057 mg

After adding a sterile and pyrogen free solution of pertechnetate Tc-99m, one obtains an injectable solution of 99mTc - (Sn) - macroaggrigates with the follow-ing characteristics:

• Volume up to 5.0 ml• Activity 5 - 30.0 mCi• Radiochemical purity > 95.0 %• PH 5.5 -6.5• Size of particles after labelling 10 - 90 μm• Number of particles per vial 700000 - 1000000• Number of particles for injection (adult) 200000 - 300000

Storage• Store the kit 2 - 8 °C• Store the reconstituted kit 15-25°C

Preparation• Injection sterile 99mTc (5 - 40 mCi) aseptically into the vial in a volume of 2 - 5 ml.• Dissolve the lyophilized material by shaking the vial for 10 seconds and

MAAKIT FOR THE PREPARATION OF AN INJECTABLE SUSPENSION OF HUMAN SERUM ALBUMIN MACROAGGRIGATES (Sn) 99mTc

wait for 15 minutes.• Examine the radiochemical purity (RCP).• Labelled preparation is to be used within 6 hours. Within this period the total RCP of 99mTc-MAA should be more than 95.0%.• Shake before using.

Quality control of 99mTc-MAA• What man paper chromatography No.1 /Methanol-Acetone (1: 1)

Rf 99mTcO-4 = 0.75 Rf 99mTcO2 + 99mTc-Complex = 0.0 - 0.2Biological distribution of 99mTc-MAA in mice (n = 3), expressed in % injected dose per critical organ:

• Liver and spleen < 5.0%• Lung > 80.0%• Stomach, Intestine < 1.0



Tck-pars-1800

1313

Indication: GI system, Liver / Spleen scintigraphy.Each package contains 3 kits as solution (reaction vial) and 2 solution vials, sterile and pyrogen free.1- Each of 3 reaction vials contains:

• Sodium thiosulfate anhydrous 2.72 mg2- Each of two solution vials contains:

a.Hydrochloric acid solution (for 3 labelling) 1.2 mlb.Phosphate buffer solution (for 3 labelling) 4.0 ml

Storage• Store the kit and solutions 2-8 ºC • Store the reconstituted kit 15-25 ºC

Preparation • Add 0.1 ml of hydrochloric acid solution (2-a) to the reaction vial.• Add 10-100 mCi of freshly pertechnetate (99mTcO-4) in 1-2 ml to the reaction vial.• Heat 30 min in boiling water bath.• Cool, add 1.3 ml of phosphate buffer solution (2-b) to reaction vial.• The reconstituted solution is stable for 4 hrs.

Quality control of 99mTc-Sulfurcolloid• P.Chromatography No.3 (Whatman)/Normal saline

KIT FOR THE PREPARATION OF 99mTc Sulfurcolloid INJECTION

• Rf 99mTcO2+99mTc- Sulfurcolloid 0.0-0.20• Rf 99mTcO-4 0.20-1.0• Radiochemical purity > 95.0 %

Biological distribution of 99mTc- Sulfocolloid in mice (n=3) after 30 min, Expressed in % dose/Critical organ:

• Liver+ spleen >75.0 • lung <5.0



Sulfurcolloid Tck-pars-1900

1414

Indication: Lymphoscintigraphy.Each package contains 3 red solution vials (reaction vial) and 2 colorless solu-tion vials, as sterile and pyrogen free.1- Each of 3 reaction vials contains:

• Antimony trisulfide 1.50 mg2- Each of two colorless solution vials contains:

a.Hydrochloric acid solution (for 3 labelling) 2.0 mlb.Phosphate buffer solution (for 3 labelling) 4.0 ml

Storage•Store the kit and solutions 2-8 ºC •Store the reconstituted kit 15-25 ºC

Preparation • Add 0.5 ml of hydrochloric acid solution (2-a) to the reaction vial (red solution).• Add 10-100 mCi of freshly pertechnetate (99mTcO-4) in 1-3 ml to the reac-tion vial.• Heat 30 min in boiling water bath.• Cool, add 1.0 ml of phosphate buffer solution (2-b) to reaction vial.• The reconstituted solution is stable for 4 hrs.

Antimony TSKIT FOR THE PREPARATION OF 99mTc Antimony trisulfide INJECTION

Quality control of 99mTc-Antimony trisulfide•P.Chromatography No.3 (Whatman)/Normal saline•Rf 99mTcO2+99mTc-Antimony trisulfide 0.0-0.20•Rf 99mTcO-4 0.20-1.0•Radiochemical purity > 95.0%

Biological distribution of 99mTc- Antimony trisulfide in mice (n=3) after 20 min, Expressed in % dose/Critical organ:

•Liver+ spleen > 75.0 •Lung < 5.0



Tck-pars-2100

1515

Indication: Recommended for localization, staging and therapy follow-up of tumors of neuroendocrine origin with positive somatostatin receptors. Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• HYNIC-Tyrosine-Octreotide 20 µg• Stannous chloride dihydrate 40 µg• Tricine 15 mg• EDDA 5 mg

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incubation of the vial for 10 min at 95 °C, one obtains an injectable solution 99mTc-Tyrosine-Octreotide with the following characteristics:

• Volume 1 ml• Max. Activity up to 1,480 MBq• Radiochemical purity > 95.0 %• PH 7

Storage:• Store the kit - 20 °C, keep away from light and humidity • Store the reconstituted kit 15 - 25 °C

Preparation:• Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min. • Add aseptically sterile and non-pyrogenic solution of 99mTcO4- (370-1,480 MBq) in 0.5 mL saline.• Shake the contents of the vial slowly for a few seconds.• Incubate the vial for 10 minutes at 95 °C.• Wait 10 minutes for cooling to room temperature.

KIT FOR THE PREPARATION OF 99mTc-TYROSINE-OCTREOTIDE INJECTION

• The reconstituted solution is stable for 6 hrs.Quality control: ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The ra-dioactivity was quantified by cutting the strip (1.5 × 10 cm2) into 1 cm pieces and counting in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 15 min. Percent of complex should be over %90.

Sterility test:Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Pyrogen test:LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as de-scribed in U.S. pharmacopeia.

Imaging protocols: For scintigraphy, a bolus injection of 99mTc-Tyrosine-Octreotide, corresponding to activ-ity in the range 555–740 MBq added to 20 μg of peptide, should be given. Whole-body anterior and posterior images followed by SPECT views of the region of interest should also be obtained at 90 min post injection. A high activity adsorption compared to back-ground is considered as a positive result.

TYROSINE OCTREOTIDE Tck-pars-2300

1616

Indication: Recommended for localization, staging and therapy follow-up of tumors of neuroendocrine origin especially for somatostatin receptor 2 (sstr2) positive tumors in abdomen due to low background activity and rapid clearance in comparisons with Octreotide. Characteristics:Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• HYNIC-Tyrosine-Octreotate 20 µg• Stannous chloride dihydrate 40 µg• Tricine 15 mg• EDDA 5 mg

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incubation of the vial for 10 min at 95 °C, one obtains an injectable solution 99mTc-Tyrosine-Octreotate with the following Characteristics:


Storage:• Store the kit - 20 °C, keep awa from light and humidity • Store the reconstituted kit 15 - 25 °C

Preparation:• Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min. • Add aseptically sterile and non-pyrogenic solution of 99mTcO4– (370-1,480 MBq) in 0.5 mL saline.• Shake the contents of the vial slowly for a few seconds.• Incubate the vial for 10 minutes at 95 °C.

TYROSINE OCTREOTATEKIT FOR THE PREPARATION OF 99mTc-TYROSINE-OCTREOTATE INJECTION

• Wait 10 minutes for cooling to room temperature.• The reconstituted solution is stable for 6 hrs.

Quality control: ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to de-termine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of metha-nol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity was quantified by cutting the strip (1.5 × 10 cm2) into 1 cm pieces and counting in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 15 min. Percent of complex should be over %90.


Pyrogen test:LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.Imaging protocols: For scintigraphy, a bolus injection of 99mTc-Tyrosine-Octreotate, corresponding to activity in the range 555–740 MBq added to 20 μg of peptide, should be given. Whole-body anterior and posterior images followed by SPECT views of the region of interest should also be obtained at 60 min post injection. A high activity adsorption compared to background is considered as a positive result.

Tck-pars-2400

1717

Indication: Recommended for infection detection especially discrimination between infection and sterile inflammation.Characteristics:Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• HYNIC-Ubiquicidine (29-41) 40 µg• Stannous chloride dihydrate 40 µg• Tricine 20 mg

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incubation of the vial for 10 min at 95 °C, one obtains an injectable solution 99mTc-Ubiquicidine with the following Characteristics:



Preparation:• Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min. • Add aseptically sterile and non-pyrogenic solution of 99mTcO4– (370-1,480 MBq) in 0.5 mL saline.• Shake the contents of the vial slowly for a few seconds.• Incubate the vial for 10 minutes at 95 °C.• Wait 10 minutes for cooling to room temperature.• The reconstituted solution is stable for 6 hrs.

KIT FOR THE PREPARATION OF 99mTc-UBIQUICIDINE INJECTIONQuality control:

ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity was quantified by cutting the strip (1.5 × 10 cm2) into 1 cm pieces and counting in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Sol-vent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 14 min. Percent of complex should be over %90.


Pyrogen test:LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Imaging protocols: For scintigraphy, a bolus injection of 99mTc-Ubiquicidine, corresponding to activity in the range 555–740 MBq added to 40 μg of peptide, should be given. Immediately after injection, dynamic imaging should be acquired for the suspected infection area and the contralateral healthy side as a non-target area. The dynamic study should be performed immediately after injection with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed by SPECT views of the region of interest should also be obtained at 30 min post injection. A high and stable activity adsorption compared to background is considered as a positive result.

HYNIC UBI Tck-pars-2500

1818

Indication: Recommended for localization, staging and therapy follow-up of breast and prostate tumors with positive gastrin releasing peptide receptor (GRPr).Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• HYNIC-GABA-Bombesin (7-14) 20 µg• Stannous chloride dihydrate 40 µg• Tricine 15 mg• EDDA 5 mg

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incubation of the vial for 10 min at 95 °C, one obtains an injectable solution 99mTc-Bombesin with the following Characteristics:



Preparation:• Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min. • Add aseptically sterile and non-pyrogenic solution of 99mTcO4– (370-1,480 MBq) in 0.5 mL saline.• Shake the contents of the vial slowly for a few seconds.• Incubate the vial for 10 minutes at 95 °C.• Wait 10 minutes for cooling to room temperature.

HYNIC BOMBESINKIT FOR THE PREPARATION OF 99mTc-BOMBESIN INJECTION

• The reconstituted solution is stable for 6 hrs.Quality control:ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to de-termine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The radioactivity was quantified by cutting the strip (1.5 × 10 cm2) into 1 cm pieces and counting in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound 99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 16 min. Percent of complex should be over %90.Sterility test:

Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Pyrogen test:LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as de-scribed in U.S. pharmacopeia.

Imaging protocols:For scintigraphy, a bolus injection of 99mTc-Bombesin, corresponding to activity in the range 555–740 MBq added to 20 μg of peptide, should be given. Immediately after injection, dy-namic imaging should be acquired for the suspected tumor area and the contralateral healthy side as a non-target area. The dynamic study should be performed immediately after injection with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed by SPECT views of the region of interest should also be obtained at 60 min post injection. A high and stable activity adsorption compared to background is considered as a positive result.

Tck-pars-2600

1919

Indication:Recommended for infection detection specially in legs and hands. Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:

• Ciprofloxacin 2 mg• Stannous chloride dihydrate 100 µg

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incubation of the vial for 20 min at room temperature, one obtains an injectable solution 99mTc-Ciprofloxacin with the following Characteristics:

• Volume 1 ml• Max. Activity up to 740 MBq• Radiochemical purity > 90.0 %• PH 4


Preparation:• Add aseptically sterile and non-pyrogenic solution of 99mTcO4– (370-740 MBq) in 1 mL saline.• Shake the contents of the vial slowly for a few seconds.• Incubate the vial for 20 minutes at room temperature.• The reconstituted solution is stable for 6 hrs.

KIT FOR THE PREPARATION OF 99mTc-CIPROFLOXACIN INJECTION

Quality control: ITLC-SG using different mobile phases: Acetone for free 99mTcO4- (Rf = 1) and ethanol: water: ammonium hydroxide (2: 5: 1 v/v) for 99mTc colloid (Rf = 0). The radioactivity was quantified by cutting the strip (1.5 × 10 cm2) into 1 cm pieces and counting in a well type gamma counter. Percent of complex is equal to: 100 - (% 99mTcO4- + % 99mTc colloid) which should be over %90.


Pyrogen test: LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.

Imaging protocols: For scintigraphy, a bolus injection of 99mTc-Ciprofloxacin, corresponding to activ-ity in the range 555–740 MBq added to 2 mg of antibiotic, should be given. Imme-diately after injection, dynamic imaging should be acquired for the suspected in-fection area and the contralateral healthy side as a non-target area. The dynamic study should be performed immediately after injection with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed by SPECT views of the region of interest should also be obtained at 60 min post injection. A high and stable activity adsorption compared to background is considered as a positive result.

CIPROFLOXACIN Tck-pars-2700

20

Indication: Recommended for Imaging of dopamine transporters (DAT) located in the dopaminergic presynaptic neuron terminals in the striatum which is useful in (1) differential diagnosis of Parkinson’s disease (PD) from non- Parkinson’s disease (with a focus on Parkinsonism), (2) early diagnosis of Parkinson’s disease, (3) the diagnosis of other movement disorders such as Machado Joseph’s Disease, (4) the reduction of DAT due to other genetic mutations, (5) blocking of DAT due to drugs such as methylphenidate (or heavy metal exposure), (6) monitoring the effective-ness of deep brain stimulation and (7) coupling imaging procedures to patient.Characteristics: Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of: TRODAT-1 Stannous chloride dihydrate Mannitol Tricine

After adding a sterile and pyrogen free solution of 99mTcO4– in saline and incuba-tion of the vial for 30 min at 95 °C, one obtains an injectable solution 99mTc-TRO-DAT-1 with the following characteristics:Volume 1 ml Max. Activity up to 1,480 MBqRadiochemical purity > 95.0 %PH 6-7Storage:Store the kit - 20 °C, keep away from light and humidity l Store the reconstituted kit 15 - 25 °C

TRODOT-1KIT FOR THE PREPARATION OF 99mTc-TRODAT-1 INJECTION

Preparation: l Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to prein-cubate for 5 min. l Add aseptically sterile and non-pyrogenic solution of 99mTcO4- (925-1,480 MBq) in 0.5 mL saline.l Shake the contents of the vial slowly for a few seconds.l Incubate the vial for 30 minutes at 95 °C.l Wait 30 minutes for cooling to room temperature.lThe reconstituted solution is stable for 6 hrs.

Quality control: l HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gra-dient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 18 min. Percent of complex should be over %90.Sterility test:Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.Pyrogen test:LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S. pharmacopeia.Imaging protocols: l For scintigraphy, a bolus injection of 99mTc-TRODAT-1, corresponding to activity in the range 814-1036 MBq should be given. SPECT views of the region of interest should be obtained at 240 min post injection.

Tck-pars-2800

Manual de radiofarmacos

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