Restylane Gel for injection 20mg/mL

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Hyaluronic acid

Disponibbli minn:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dożaġġ:

20mg/mL

Għamla farmaċewtika:

Gel for injection

Unitajiet fil-pakkett:

Syringe, glass, Type I glass barrel, silicon oil lubricant, PP/PI cap, chlorobuytl stopper, s/steel needle, 0.5 mL

Klassi:

Prescription

Manifatturat minn:

Apoteket AB

Data ta 'l-awtorizzazzjoni:

2008-06-11

Karatteristiċi tal-prodott

1 (8) 
QMS-4706 ver 5.0 
RESTYLANE
_®_
 INSTRUCTIONS FOR USE 

COMPOSITION: 
Hyaluronic acid, stabilized 
20 mg/ml 
Phosphate buffered saline 
q.s. 

DESCRIPTION _ _
Restylane is a sterile, transparent gel of stabilized hyaluronic
acid of non-animal origin. Restylane is 
supplied in a glass syringe with a luer-lock fitting. The contents
of the syringe have been sterilized 
using moist heat. The product is for single use only._ _Disposable
sterile needles are provided with 
each syringe. Information about the sterilization method and size
of the needle is printed on its 
packaging. The number of units per package and the volume contained
in each syringe is as stated 
on the outer package. A patient record label is a part of the syringe
label. This label is to be attached 
to patient records to ensure traceability of the product_._  

INTENDED USE 
Restylane is intended to be used for facial tissue augmentation. It
is recommended to be used for the 
correction of wrinkles and for lip enhancement. It should be injected
into the middle part of the 
dermis layer. For facial areas with limited soft tissue support and
soft tissue cover, e.g. the 
periorbital region, injection into the subcutaneous fatty tissue
or supraperiostal administration are 
recommended. 

MODE OF ACTION 
Restylane is a filler that adds volume to the tissue, thereby
restoring the skin contours or enhancing 
the lips to the desired level of correction. The volume and the
lifting capacity originate from the 
ability of hyaluronic acid to attract high amount of water, which is
further increased by the 
stabilization process. Restylane will in time undergo isovolemic
degradation, which means that the 
product maintains its volume even during degradation. 

WARNING 
-  Do not inject intravascularly. As for other injectable medical
devices, inadvertent injection into 
blood vessels could potentially lead to vascular occlusion, ischemia
and necrosis. Aspiration 
prior to in