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L I P A U G M E N TAT I O NWRINKLES SMOOTHENINGL I P A U G M E N TAT I O NWRINKLES SMOOTHENING
L C A P H A R M A C E U T I C A L
HYALUDERM®
FACIAL REJUVENATIONS o d i u m h y a l u r o n a t e
FACIAL REJUVENATIONI N J E C T A B L E D E R M A L F I L L E R
NaHANEW FORMULATION
PRODUCT ORIGIN
• HYALUDERM is an intradermal,viscoelastic, sterile, apyrogenic, transparentstructuring gel composed of geneticallyengineered sodium hyaluronate with ahigh molecular weight, in accordancewith the European Pharmacopeia. Noanimal protein is contained in HYALUDERM.
• HYALUDERM is a natural derivative ofhyaluronic acid found in the extracellularmatrix of various types of connective tissuein the human body, particularly the skin.The hyaluronic acid polymers (polysac-charides) are essential for the metabolismof skin and vital to its hydrationand elasticity.
COMPOSITION
Sodiumhyaluronate (FB)
Sodiumchloride
Water forinjection
SO
DIU
M H
YA
LUR
ON
AT
E
TH
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PRESENTATIONHYALUDERM comes in two concentrations of
sodium hyaluronate :- 2.0% for moderately deep wrinkles- 2.5% for more severe, longer and deeper wrinkles(below or equal to 2 mm)
HYALUDERM is used during intradermal proceduresfor lip augmentation.For the smoothing of wrinkles, HYALUDERM addsfullness to the wrinkle without spreading into thehypodermis. It immediately, easily and rapidlycorrects wrinkles and scars.HYALUDERM enhances the volume and contourof lips.
HYALUDERM®
FACIAL REJUVENATIONS o d i u m h y a l u r o n a t e
FACIAL REJUVENATIONI N J E C T A B L E D E R M A L F I L L E R
L I P A U G M E N TAT I O NWRINKLES SMOOTHENING
L C A P H A R M A C E U T I C A L
INDICATIONSN
aHA
2.0
%
NaH
A 2
.5%
NaHA
MECHANISMOF ACTION
• HYALUDERM 2.0% is indicated for the treatment ofmoderate wrinkles and fine lines of the face and forthe enhancement of lips.
• HYALUDERM 2.5% is indicated for the treatment ofdeep wrinkles and folds of the face.
• HYALUDERM is specifically recommended for :• Smoothing wrinkles and folds- Infraorbital wrinkles- Perioral rhytides- Upper lip rhytides- Lower face- Crow’s feet - Marionette lines- Forehead lines- Glabellar lines- Nasolabial foldDeficient skin tissue should be supple and easilystretched for the defects to be observed.
• HYALUDERM 2.0% enhances the volume andcontour of the lips and cheeks.
• HYALUDERM is an intradermal, viscoelasticstructuring gel composed of geneticallyengineered sodium hyaluronate available ina single-use, luer lock, prefilled glass syringe :HYALUDERM 2.0% : 0.5 ml, 1.0 ml and 2.0 mlHYALUDERM 2.5% : 1.0 ml
HYALUDERM is sterilised by steam autoclavein an individual sterility protector.A single-use, sterile 30g intradermal injection needle is provided in an individualsterility protector.
Skin tests
are not
necessary
due to the
bio-
availability
of sodium
hyaluronate
GE
NE
TIC
EN
GIN
EE
RIN
GHYALUDERM®
FACIAL REJUVENATIONS o d i u m h y a l u r o n a t e
FACIAL REJUVENATIONI N J E C T A B L E D E R M A L F I L L E R
L I P A U G M E N TAT I O NWRINKLES SMOOTHENING
L C A P H A R M A C E U T I C A L
ADVANTAGESDoes not contain any
animal protein
NaHA
NaH
A
RESULTS
THE EPIDERMIS
THE DERMIS
THESUBCUTANEOUSTISSUE
• The rheological proper t ies ofHYALUDERM enable the intradermalanatomical space to be rapidlyreconstituted. HYALUDERM eliminatesfolds and reduces depressions in the skindue to wrinkles. T
HE
N
EW
A
NT
I-
AG
EI
NG
W
EA
PO
N
ADVANTAGES100% bioavailableVery well-tolerated
• HYALUDERM is a solution of highviscosity for intradermal injection :
NO
N-C
ROSS
-LIN
KED
ADVANTAGESDoes not contain any
Chemical Agent or anyparticles in suspension
TH
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-A
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WE
AP
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Raw material : Sodium Hyaluronate. EuropeanPharmacopaeia Pharmaceutical Grade
Origin : Genetic engineering/Non-cross-linked
Perfectly clear and transparent
Sterile, apyrogenic and non-cytotoxicfor subcutaneous tissues
Physiological pH 7.2
Osmolarity : 360 mOs/kg
Sterile (autoclave / steam)
Dynamic viscosity at rest (25°C - 0.01 s-1) 100 000 mPa.s (NaHA 2.0%)170 000 mPa.s (NaHA 2.5%)
High molecular weight : 2 400 000 Daltons
High concentration : 2.0% NaHA (20 mg/mL)2.5% NaHA (25 mg/mL)
Volume per syringe : 0.5 mL ; 1.0 mL ; 2.0 mL
Storage : room temperature
NaH
A
RHEOLOGY AND BEAUTY• The innovative rheological propertiesof HYALUDERM provide excellent cosmeticresults and enable the intradermalanatomical space to be rapidlyreconstituted. HYALUDERM eliminatesfolds and reduces depressions in the skindue to wrinkles.To obtain an ideal degree of correction,one or several additional injections ofHYALUDERM may be necessary.Efficacy lasts 6 2 months. The treatmentcan be repeated according to needs.
• It is recommended that patients withvery damaged skin (over exposure tosunlight, smoking, medication or dieting)use HYALUDERM 2.5% as viscosupplementinjections to the intercellular spaces of thedeficient dermis.
Wrinkle smoothing implants Rheological comparison
10
100
1000
10000
100000
1000000
0,1 1 10 100 1000 10000
Shear rate (s-1)
Dyna
mic
vis
cosi
ty (m
Pa.s
)
RestylaneHylaformHyaluderm 2%Hyaluderm 2.5%
HYALUDERM®
FACIAL REJUVENATIONS o d i u m h y a l u r o n a t e
FACIAL REJUVENATIONI N J E C T A B L E D E R M A L F I L L E R
L I P A U G M E N TAT I O NWRINKLES SMOOTHENING
L C A P H A R M A C E U T I C A L
ADVANTAGESEasy to inject due toadaptation viscosity(pseudoplasticity)
NaHA
+-
9, allée Prométhée - F - 28000 Chartres - France - Phone : (33) 02 37 33 39 30 - Fax : (33) 02 37 33 39 39l c a f i l e @ w a n a d o o . f rPublic limited company with capital of 185 164,57 € - R.C.S. : Chartres B 311 274 401 - N° VAT : FR 44 311 274 401 00042
L C A P H A R M A C E U T I C A L
1.0ml
The HYALUDERM range
BOX OF 6 SYRINGES
HYALUDERM 2.0% and HYALUDERM 2.5% - 1.0 ml1.0 ml sterile syringe with Needle 30 G
HYALUDERM 2.0% - 0.5 ml0.5 ml sterile syringe with Needle 30 G
HYALUDERM 2.0% - 2.0 ml2.0 ml sterile syringe with Needle 30 G
0.5ml
2.0ml
ISO90012000
Directive 93/42/CEE
ISO134852003
HYALUDERM Production
Reference HYALUDERM 2.0% RANGE Reference HYALUDERM 2.5% RANGE
VD112010 1.0 ml – box of 1 syringe VD112510 1.0 ml – box of 1 syringe
VD162010 1.0 ml – box of 6 syringes VD162510 1.0 ml – box of 6 syringes
VD112020 2.0 ml – box of 1 syringe
VD162020 2.0 ml – box of 6 syringes
VD112005 0.5 ml – box of 1 syringe
VD162005 0.5 ml – box of 6 syringes
BOX OF 1 SYRINGE
VD1
M03
3 05
0501
NaHA 2.0%
NaHA 2.5%