Restylane Perlane 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, chlorobutyl stpr, 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-4933 ver 5.0 
RESTYLANE PERLANE™ INSTRUCTIONS FOR USE 
COMPOSITION 
Hyaluronic acid, stabilized 

20 mg/ml 
Phosphate buffered saline 

q.s.  
DESCRIPTION  
Restylane Perlane is a sterile, transparent gel of stabilized
hyaluronic acid of non-animal origin. 
Restylane Perlane 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 Perlane is intended to be used for facial tissue
augmentation. It is recommended to be 
used for shaping the contours of the face, the correction of folds and
for lip enhancement. It should 
be injected into the deep layer of the dermis and/or the surface
layer of the subcutis.  
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 Perlane 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 Perlane 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 c