Definisse™ Filler - Relife
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]