Restylane Special Precautions

Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.
This product should only be used by health care practitioners who have appropriate training, experience, and knowledge about the anatomy at and around the site of injection in order to minimize the risks of potential complications (perforation or compression of vessels, nerves and other vulnerable structures).
Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be followed.
Avoid injecting into areas in close proximity to permanent implants, as this could aggravate latent adverse events or interfere with the aesthetic outcome of the treatment. Limited data is available on injecting into an area where a non-permanent implant other than hyaluronic acid has been placed.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
This product should be used with caution in patients on immunosuppressive therapy.
Patients with unattainable expectations are not suitable candidates for treatment.
This product is packaged for single use. Do not resterilize.
Do not use the product if package is opened or damaged, or if the expiry date or lot number is illegible.
Patients should avoid excessive sun, UV lamp exposure and extreme temperatures at least until any initial swelling and redness has resolved.
If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with this product there is a theoretical risk of eliciting an inflammatory reaction at the implant site. This also applies if the product is administered before the skin has healed completely after such a procedure.
The safety for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
Individual variation and treatment area may affect the bio-degradation of this product, in rare cases product remnants have been detected in tissue when the clinical effect has returned to baseline.
Restylane/Restylane Defyne/Restylane Lyft/Restylane Refyne/Restylane Volyme: Injection too superficially, or in facial areas with limited soft tissue support or soft tissue cover, or thin skin, such as the periorbital area, may result in contour irregularities and palpable lumps and/or bluish discolouration.
Injection in the lower periorbital region in patients with pre-existing pigmented dark lower eyelid circles and pre-existing tendency toward oedema formation may be associated with prominent discolouration and excessive swelling due to fluid build-up.
Post inflammatory pigmentation changes may occur after dermal filler injections in people with dark skin (Fitzpatrick Type IV-VI).
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Do not use the product if the contents of the syringe are cloudy.
Considerations should be given to the total dose of lidocaine administered if dental block or topical administration of lidocaine is used concurrently. High doses of lidocaine (more than 400 mg) can cause acute toxic reactions manifesting as symptoms affecting the central nervous system and cardiac conduction.
Lidocaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide-type local anaesthetics e.g., certain anti-arrhythmics, since the systemic toxic effects can be additive.
Lidocaine should be used with caution in patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Restylane Defyne/Restylane Refyne/Restylane Volyme: This product should be used with caution in patients with a tendency to form hypertrophic scars or any other healing disorders.
At each treatment session a maximum dosage of 2 mL per treatment site is recommended.
Restylane Kysse: At each treatment session a maximum dosage of 1.5 mL per treatment site is recommended.
Injection too superficially may result in contour irregularities and palpable lumps and/or bluish discolouration.