Juvederm Ultra Solution for injection 24mg/mL

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Kjøp det nå

Last ned Preparatomtale (SPC)
22-12-2008

Aktiv ingrediens:

Hyaluronic acid

Tilgjengelig fra:

Allergan New Zealand Ltd

Dosering :

24mg/mL

Legemiddelform:

Solution for injection

Enheter i pakken:

Syringe, 0.8 mL Schott Topas syringe with luer lock adaptor, plunger-stopper and -rod, tip cap, 2 syringes, 2 dose units

Klasse:

Prescription

Produsert av:

Allergan France

Autorisasjon dato:

2009-09-17

Preparatomtale

                                 
1 of 4 
DATA SHEET 
NAME OF MEDICINE 
_Juvéderm ULTRA™ _24mg/mL injectable gel implant 
 
 
PRESENTATION 
_Juvéderm ULTRA™_
_ _
injectable gel implant is a sterile pyrogen-free physiological
solution of cross-linked 
hyaluronic acid which is not of animal origin. The gel is presented
in a graduated pre-filled and disposable 
syringe. 
 
 
USES 
_ACTIONS _
_Juvéderm _consists of hyaluronic acid (HA) a polysaccharide
naturally present in the body at different 
concentrations, especially in the skin, muscular system and
skeleton. 
The concentration of HA in the skin naturally decreases with age. The
result is a decrease in the skin’s 
elasticity and ability to hold water. This renders the dermis less
voluminous and increases the tendency of 
the skin to form wrinkles. 
In its natural unmodified state, implanted exogenous HA rapidly
degrades quickly _in situ_, it is cross-linked 
to enhance _in vivo_ persistence when used as a dermal filler.
By chemically cross-linking molecules of HA 
more stable macromolecules are formed which have the
same biocompatibility as native HA. 
Because HA cannot penetrate into the skin when applied topically HA
derivatives are injected into the 
dermal tissue to provide a space-occupying viscoelastic matrix of
the connective tissue.  
 
 
 
INDICATIONS 
_Juvéderm ULTRA™_
_ _
injectable gel implant is indicated for use in filling of
medium size and deep wrinkles 
of the face by injection into the mid dermis and to create definition
and pouting of lips. 
 
 
DOSAGE AND ADMINISTRATION 
_Juvéderm ULTRA™_
_ _
contains 24mg/mL cross-linked hyaluronic acid in a physiological
buffer. 
 
_Juvéderm ULTRA_
_TM_
_ _is designed_ _to be injected into the dermis by a practitioner.
The technique used for 
this is essential in the success of treatment and therefore Juvederm
ULTRA must be used by doctors who 
have received specific training in the injection technique for
filling wrinkles. 

                                
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