IMPORTANT SAFETY CONSIDERATIONS FOR USE FOR THE Restylane FAMILY OF PRODUCTS

Contraindications
Do not use Restylane-L and Restylane Fine Lines-L on patients with known hypersensitivity to lidocaine or amide type local anaesthetics.

Warning
Restylane is only intended for use as an intradermal implant. Do not resterilize Restylane. Do not inject intravascularly. Do not mix with other products.

Precautions
Normal precautions associated with intradermal injections must be observed. Like any such procedure, the implantation of Restylane is associated with an inherent risk of infection. Restylane should not be used in or near anatomic sites where there is active skin disease, inflammation or related conditions. Do not use Restylane together with any other injectable implant, except for Restylane Fine Lines and Perlane products.

Restylane should not be injected into an area where a permanent implant has been placed.

Restylane should not be used for patients with unattainable expectations. The patient should be informed that he or she should not expose the treated area to intense heat (e.g. solarium and sunbathing) or extreme cold at least until the initial swelling and redness have resolved.

If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane is administered before the skin has healed completely after such a procedure.

There is a potential risk with the procedure that the material could be inadvertently injected into dermal blood vessels, which could lead to vascular occlusion in an end-artery with corresponding consequences. Restylane has not been tested in pregnant or lactating women or in children.

Anticipated side-effects
After the injection of Restylane, some common injection-related reactions might occur. These reactions include erythema, swelling, pain, itching, discoloration or tenderness at the implant site. Typically resolution is spontaneous within a few days after injection into the skin and within a week after injection into the lips. Additionally, temporary palpable lumpiness has been noted after the use of Restylane in some patients. The composition of Restylane is set to balance a normal tissue pressure. However, because the tissue pressure is sometimes disturbed to a higher value such as during oedema or to a lower value such as during dehydration, a small but significant change (swelling or shrinkage) may occur.

Adverse events
Reactions thought to be of a hypersensitivity nature have been reported in about 1 in every 10,000 treatments. These have consisted of swelling and induration at the implant site, sometimes with oedema in the surrounding tissues. Erythema, tenderness and rarely acne form papules may also occur. The reactions have started either shortly after injection or after a delay of 2–4 weeks and have generally been described as mild to moderate and self-limiting, with an average duration of 2 weeks. In pronounced cases a short course of oral corticosteroids may prove effective. In addition, rare cases (less than 1 in 15,000 treatments) of granuloma formation, superficial necrosis and urticaria have been reported. Patients who have experienced this type of reaction should not be re-treated with a Restylane product.

Adverse events must be reported to Galderma Canada Inc.