Juvederm Ultra Plus Solution for injection 24mg/mL

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hyaluronic acid

Available from:

Allergan New Zealand Ltd

Dosage:

24mg/mL

Pharmaceutical form:

Solution for injection

Units in package:

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

Class:

Prescription

Manufactured by:

Allergan France

Authorization date:

2009-09-17

Summary of Product characteristics

 
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DATA SHEET 
NAME OF MEDICINE 
_Juvéderm ULTRA PLUS™ _24mg/mL injectable gel implant 

PRESENTATION 
_Juvéderm ULTRA PLUS™_
_ _
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 PLUS™_
_ _
injectable gel implant is indicated for use in filling of medium
size and deep 
wrinkles of the face by injection into the mid and/or deep dermis
and to increase volume of lips. 

DOSAGE AND ADMINISTRATION 
_Juvéderm ULTRA PLUS™_
_ _
contains 24mg/mL cross-linked hyaluronic acid in a physiological
buffer. 

_Juvéderm ULTRA PLUS™ _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 _Juvéderm ULTRA PLUS™ _be used by 
doctors who have received specific training in the injection
technique