Juvederm VOLUMA 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, glass, sterile filled 1 x 2.0 mL in blister packed with 2 needles, 2 cannulae in carton, 2 mL

Class:

Prescription

Manufactured by:

Allergan France

Therapeutic indications:

Injectable gel implant intended to restore the volume of the face. The presence of lidocaine reduces patient pain during the treatment.

Authorization date:

2011-07-14

Summary of Product characteristics

1 of 4 
DATA SHEET 
NAME OF MEDICINE 
_Juvéderm_
_® _
_VOLUMA_
_® _
_ XC  _20mg/mL injectable gel implant 

PRESENTATION 
_Juvéderm_
_® _
_VOLUMA_
_®   _
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, single 
use syringe. 

USES 
_ACTIONS _
_Juvéderm_
_® _
_VOLUMA_
_®_
 XC 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 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_
_® _
_VOLUMA_
_® _
_XC_
_ _
injectable gel implant intended to restore the volume of the face.
The presence 
of lidocaine reduces patient pain during the treatment. 

DOSAGE AND ADMINISTRATION 
_Juvéderm_
_® _
_VOLUMA_
_® _
_XC_
_ _
contains 20mg/mL cross-linked hyaluronic acid in a physiological
buffer. 

_Juvéderm_
_® _
_VOLUMA_
_® _
_XC_
_ _
is designed_ _to be injected slowly into the deep dermis,
subcutaneously or in the 
upper periostea by a practitioner. The technique used for this is
essential in the success of treatment and 
therefore _Juvéderm_