Restylane Classic Lidocaine 1ml (D16)

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.

Specifically designed for the correction of moderate facial wrinkles and for lip enchancement, Restylane has an intermediate gel particle size.

It should be injected into the middle part of the dermis layer or in the submucosal layer of the lip. 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.

The addition of lidocaine provides a pain relieving effect during treatment

Composition:-

• Stabilised hyaluronic acid 20 mg/mL
• Lidocaine hydrochloride 3mg/ml
• Phosphate buffered saline q.s.

Indication: Cheeks.

Disposable sterile 29G TW (thin-walled) needles are provided. In case a replacement needle is required a needle within the range of 29-30G should be used.

Alternatively, a sterile blunt cannula 27-28G can be used. The size and the length of the cannula will affect the force needed to extrude the gel. If a thinner cannula is used the resistance during injection may be too high resulting in an increased risk for leakage or separation of the cannula and syringe. The same considerations are applicable for needles.

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Adverse events should be reported

For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For Ireland, suspected adverse events can be reported via HPRA Pharmacovigilance, www.hpra.ie

Adverse events should also be reported to Galderma (UK) Ltd.

E-mail: Medinfo.uk@galderma.com Tel: +44 (0) 300 3035674