General considerations relevant to injectable medical devices: Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be observed.
Knowledge of the anatomy of treatment site and special caution are required in order to avoid perforation or compression of vessels, nerves and other vulnerable structures.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
Patients who are using substances that affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.
Patients with unattainable expectations are not suitable candidates for treatment.
Do not use the product if package is damaged.
Restylane/Restylane Defyne/Restylane Lyft/Restylane Refyne/Restylane Volyme: Special caution should be exercised when treating areas with limited collateral circulation, due to increased risk of ischemia.
Special caution should be exercised in treating facial areas with limited soft tissue support or soft tissue cover, such as the periorbital area, to avoid formation of palpable lumps.
Patients with pre-existing pigmented dark lower eye lid circles, thin skin and pre-existing tendency toward edema formation are not suitable candidates for treatment of the lower periorbital region.
Restylane/Restylane Lyft/Restylane Lyps Lidocaine: Special caution should be exercised when treating areas in close proximity to permanent implant.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Patients using immunosuppressants are not suitable candidates for treatment.
Special caution should be exercised in treating patients with a tendency to form hypertrophic scars or any other healing disorders.
Do not use the product if the contents of the syringe are cloudy.
Specific considerations relevant to the use of this product: If the product is injected too superficially this may result in visible lumps and/or bluish discoloration.
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 patient must avoid exposing the treated area to heat (sunbathing, sauna, steam baths, etc.) or extreme cold until any signs of local inflammation have disappeared.
This product has not been tested in pregnant or breast-feeding women.
Restylane Defyne/Restylane Kysse/Restylane Lyps Lidocaine/Restylane Refyne/Restylane Volyme: 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 cautiously in patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Restylane/Restylane Lyft/Restylane Lyps Lidocaine: This product has not been tested in children.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Do not use in children.
Restylane Volyme: The product is not indicated for injection other than into the supraperiostic zone or subcutis.