Definisse™ Filler - Relife

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The beauty of the moment REsurface, REstore, REshape. Definisse™ Filler REstore beauty PP-RL-UK-0074 January 2021 GB20005 Model for illustrative purposes only.

Transcript of Definisse™ Filler - Relife

The beauty of the moment

REsurface, REstore, REshape.

Definisse™ Filler

REstore beauty

PP-RL-UK-0074 January 2021 GB20005Model for illustrative purposes only.

PP-RL-UK-0074 January 2021 GB20005 PP-RL-UK-0074 January 2021 GB20005

Designed with innovation in mind

Developed and tested by experts

Easy and fast visual

orientation

Low contamination

risk

Extra grip for safe

application

Comfortable handling

Conical shaped plunger stopper for smooth application

Less bruising and side effects

High G’ and XTRTM technology ensures a stable matrix, high lifting capacity and the ability to remodel1,2

A sharp thin-walled needle for ease of extrusion, resulting in less pain for the patient3

Stable plunger

Premium glass syringe provides a barrier to the filler ensuring product purity

Easy to use with a low complication rate3

Premium quality glass syringes with a low extrusion force for smooth, predictable injections.3

Now with

Stable, long-lasting hyaluronic acid (HA) filler through a controlled 3-step process2

EXcellent Three-dimensional Reticulation (XTRTM) Technology

1 2 3

Medium 2.5x106 – 3.2x106 Dalton

High 3.2x106 – 3.5x106 Dalton

• Low extrusion force and controlled injection

• Filling and more durable volume

PRETREATMENT2

Controlled fracturing of the long chains of HA to obtain two fractions with different molecular weights

CROSS-LINKING2

Stable 3D HA matrix

PURIFICATION2

A highly efficient purification process reduces the amount of free 1,4-Butanediol diglycidyl ether (BDDE)

Well tolerated by patients with an excellent safety profile after treatment

PP-RL-UK-0074 January 2021 GB20005 PP-RL-UK-0074 January 2021 GB20005

Definisse™ core filler

Definisse™restore filler

Indication4–6 Shaping and building facial contours

Medium lines and wrinkles

HA concentration7,8

25mg/ml 23mg/ml

Level of crosslinking

● ● ●

With lidocaine● ● ●

With lidocaine

Depth of injection

Deep dermis, subcutis, or supraperiosteal

Deep dermis or subcutis

Pack size 1x1ml premium glass syringe

2x27G 1/2” thin wall needle

1x1ml premium glass syringe

2x27G 1/2” thin wall needle

Definisse™touch filler

Definisse™ hydrobooster

Fine lines and delicate areas

Refreshing and boosting skin moisture

23mg/ml 18mg/ml + Glycerol

● ● ●

With lidocaine

● ● ●

No lidocaine

Mid-to-deep dermis Superficial dermal tissue

1x1ml premium glass syringe

2x27G 1/2” thin wall needle

1x1ml premium glass syringe

2x30G 1/2” thin wall needle

The DefinisseTM range of filler

PP-RL-UK-0074 January 2021 GB20005 PP-RL-UK-0074 January 2021 GB20005

DefinisseTM touch filler (with lidocaine)

DefinisseTM core filler (with lidocaine)

250

150

200

100

50

0XTR™

Technology

153.58

53.84

RHATechnology

CPMTechnology

Vycross Technology

49.90

206.73

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

26.67

21.13

24.45 24.08

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.174

0.392

0.490

0.116

G'* G"* Tan *

250

150

200

100

50

0XTR™

Technology

153.58

53.84

RHATechnology

CPMTechnology

Vycross Technology

49.90

206.73

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

26.67

21.13

24.45 24.08

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.174

0.392

0.490

0.116

G'* G"* Tan *

INDICATIONS AND USE5

• DefinisseTM core filler is intended for facial tissue augmentation in order to correct midface volume deficit, for restoring facial volume and shaping the contours of the face.

• Aims to address reconstructive purposes in the treatment, e.g. HIV-drug related facial lipoatrophy.

• To be injected subcutaneously, supraperiosteally or into deep dermis.

INDICATIONS AND USE4

• DefinisseTM touch filler is intended to correct moderate to severe facial wrinkles and folds and to increase lip volume.

• Aims to address reconstructive purposes in the treatment, for instance, of facial lipoatrophy, debilitating scars or morphological asymmetry.

• To be injected into the mid to deep dermis.

RHEOLOGY SUPPORTS THE INDICATION

Amplitude and frequency sweep analysis9

RHEOLOGY SUPPORTS THE INDICATION

Amplitude and frequency sweep analysis9

500

300

400

200

100

0XTR™

Technology

426.76

293.46

RHATechnology

CPMTechnology

Vycross Technology

233.50

329.85

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

26.87

34.93

45.24

22.99

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.063

0.119

0.193

0.067

G'* G"* Tan *

500

300

400

200

100

0XTR™

Technology

426.76

293.46

RHATechnology

CPMTechnology

Vycross Technology

233.50

329.85

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

26.87

34.93

45.24

22.99

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.063

0.119

0.193

0.067

G'* G"* Tan *

*Rheology, 30°C at 0.7Hz. Internal Data. *Rheology, 30°C at 0.7Hz. Internal Data.

PP-RL-UK-0074 January 2021 GB20005 PP-RL-UK-0074 January 2021 GB20005

DefinisseTM restore filler (with lidocaine)

DefinisseTM hydrobooster

*Rheology, 30°C at 0.7Hz. Internal Data.

500

300

400

200

100

0XTR™

Technology

292.37

164.37

RHATechnology

CPMTechnology

Vycross Technology

136.41

265.65

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

27.86

30.53

42.82

27.44

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.095

0.186

0.313

0.103

G'* G"* Tan *

500

300

400

200

100

0XTR™

Technology

292.37

164.37

RHATechnology

CPMTechnology

Vycross Technology

136.41

265.65

50.0

30.0

40.0

20.0

10.0

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

27.86

30.53

42.82

27.44

0.50

0.30

0.40

0.20

0.10

0.00XTR™

TechnologyRHA

TechnologyCPM

TechnologyVycross

Technology

0.095

0.186

0.313

0.103

G'* G"* Tan *

INDICATIONS AND USE10

• DefinisseTM hydrobooster is a viscoelastic solution to replenish the loss of HA due to ageing, to improve hydration, tone and elasticity of the skin.

• Indicated to be injected into the superficial dermal tissue, preferably deeper.

INDICATIONS6

• DefinisseTM restore filler is intended to correct deeper wrinkles and folds, increase or restore volume to the face and to remodel facial contours.

• Aims to address reconstructive purposes in the treatment, e.g. facial lipoatrophy, debilitating scars or morphological asymmetry.

• To be injected into the deep dermis or subcutis.

RHEOLOGY SUPPORTS THE INDICATION

Amplitude and frequency sweep analysis9

PP-RL-UK-0074 January 2021 GB20005PP-RL-UK-0074 January 2021 GB20005

Definisse™ touch filler

Definisse™ restore filler

Definisse™ core filler

Model for illustrative purposes only.

Where to use DefinisseTM Filler

ASSESSMENT OF CAUCASIAN FEMALE TREATED WITH DEFINISSE™ FILLER + LIDOCAINE

Before: Before the treatment, the lid-cheek groove and pre-jowl was altered by gravitational forces and ageing. Soft tissue deflation is also seen due to the normal ageing process.

After: After the intervention, the volume in the zygomatic arch is restored, and the pre-jowl has been reshaped. The lid-cheek groove has been eliminated and the patient’s appearance is rejuvenated. The patient was treated with Definisse™ filler + Lidocaine as follows (Definisse™ touch filler + Lidocaine can be used for thinner skins):

• Malar area: 0.2-0.3ml per side of injection of Definisse™ Core + Lidocaine, supraperiosteal

• Zygomatic arch: 0.1-0.2ml per point of injection of Definisse™ core + lidocaine, supraperiosteal

• Red lips: 0.3-0.5ml per lip of Definisse™ Touch + lidocaine, submucosal

• Pre-jowl: 0.5ml per side of injection of Definisse™ core + lidocaine, supraperiosteal

• Pre-auricular area: 0.3-1.0ml per side of injection of Definisse™ restore + lidocaine, subcutaneous

• Lid cheek groove: 0.2-0.3ml per side of injection of Definisse™ restore + lidocaine, supraperiosteal

ASSESSMENT OF CAUCASIAN FEMALE TREATED WITH DEFINISSE™ FILLER + LIDOCAINE

Before: The patient wanted to address the ageing process which had resulted in a soft tissue loss in the malar area and in the upper orbital rim & eyelid.

After: After the intervention, the volume in both areas is restored, giving the skin a more rejuvenated appearance. The patient was treated with Definisse™ filler + lidocaine as follows:

• Malar area: 0.1-0.2ml per point of injection of Definisse™ restore + lidocaine, periosteal

• Upper orbital rim and eyelid: 0.1-0.2ml per side of injection of Definisse™ Restore + lidocaine, supraperiosteal (ROOF)

• Red lips: 0.3-0.5ml per lip of Definisse™ touch + lidocaine

Before: Before the treatment, the patient’s lips presented a lack of volume due to the ageing process and the marionette lines affected the volume in the perioral area.

After: After the intervention, the aesthetic look of our patient’s lips has been re-established and her lips appear more well-proportioned and voluminous. The marionette lines are less evident, resulting in a natural and rejuvenated appearance. The patient was treated with Definisse™ filler + lidocaine as follows:

• Red lips: 0.3-0.5ml per lip of Definisse™ touch + lidocaine, submucosal

• Marionette lines: 0.1-0.5ml per area of injection of Definisse™ restore + lidocaine, subcutaneous

• Jawline: 0.2-0.5ml per point of injection (bolus) of Definisse™ core + lidocaine, supraperiosteal

ASSESSMENT OF CAUCASIAN FEMALE TREATED WITH DEFINISSE™ FILLER + LIDOCAINE

Before After

Before After

Before After

PP-RL-UK-0074 January 2021 GB20005

Discover your full potential

1. Salti G and et al. Polymers 2020, 12, 1644; doi:10.3390/polym12081644

2. Prime Journal Volume. 2020. Available at https://primejournal.online/magazine/International/Vol10/Issue1/18/index.html Accessed June 2020.

3. Terumo Needle Instruction Sheet. Data on File.

4. Definisse™ touch filler + Lidocaine. Information for Use.

5. Definisse™ core filler + Lidocaine. Information for Use.

6. Definisse™ restore filler + Lidocaine. Information for Use.

7. Rigano Laboratories srl. Prot 228/19.

8. Rigano Laboratories srl. Prot 221/19.

9. Rigano Laboratories srl. Prot 192/19.

10. Definisse™ hydrobooster. Information for Use.

Abbreviations:

BDDE, 1,4-Butanediol diglycidyl ether; HA, Hyaluronic acid; XTR, Excellent Three-dimensional Reticulation technology

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or App Store. Adverse events

should also be reported to A. Menarini Farmaceutica Internazionale SRL. Phone no. 01628 531171 or email: [email protected]

CE Indications

Definisse™ Filler: CE0123 (CROMA-PHARMA GmbH), CE0459 (CROMA GmbH)Definisse™ Threads: CE0373 (ASSUT EUROPE SPA)Definisse™ Peel Program: CE Mastelli Srl

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A. MENARINI FARMACEUTICA INTERNAZIONALE SRL

Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH

Incorporated in Italy with Limited Liability

Branch registered in England No. BR016024

Tel: 01628 531171 Email: [email protected]

For general enquiries contact: [email protected]