Juvederm ULTRA XC Solution for injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyaluronic acid, Lidocaine

Available from:

Allergan New Zealand Ltd

Pharmaceutical form:

Solution for injection

Units in package:

Syringe, COC sterile filled 2 x 0.8 ml in blister, packed wiith 4 needles in carton, 1.6 mL

Class:

Prescription

Manufactured by:

Allergan France

Therapeutic indications:

Indicated for use in filling of medium size depressions of the skin via mid dermis injection and to create definition and pouting of lips.

Authorization date:

2011-07-14

Summary of Product characteristics

1 of 4 
DATA SHEET 
NAME OF MEDICINE 
_Juvéderm ULTRA_
_®_
_ XC _24mg/mL injectable gel implant 

PRESENTATION 
_Juvéderm ULTRA_
_®_
_ _
_XC_
_ _
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. 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.  
The development of solutions based on cross-linked hyaluronic
acid made it possible to improve the _in _
_situ_ remanence, but these products can be painful during
injection. Addition of 0.3% lidocaine 
hydrochloride intends to limit pain directly linked to the
injection, without using other techniques of 
anaesthesia. 

INDICATIONS 
_Juvéderm ULTRA_
_®_
_ _
_XC _injectable gel implant is indicated for use in filling of medium
size depressions of 
the skin via mid dermis injection and to create definition and
pouting of lips. 

DOSAGE AND ADMINISTRATION 
_Juvéderm ULTRA_
_®_
_ _
_XC_ contains 24mg/mL cross-linked hyaluronic acid in a
physiological buffer. 
_ _
_Juvéderm ULTRA_
_® _
_XC _is designed_ _to be injected into the dermis or the
mucous membrane of the lips by 
a practitioner. The