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.
Special caution should be exercised when treating areas in close proximity to permanent implant.
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.
Special caution should be exercised when treating areas with limited collateral circulation, due to increased risk of ischemia.
Special caution should be exercised in patients with previous rhinoplasty since the vascular supply may be affected.
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.
Do not use where there is active disease such as inflammation, infection or tumours, in or near the intended treatment site.
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.
Specific considerations relevant to the use of this product: Do not inject this product into an area where an implant of non hyaluronic acid has been placed.
Patients should avoid excessive sun or extreme cold 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 injection site. This also applies if the product is administered before the skin has healed completely after such a procedure.
Temporary palpable lumpiness has been noted in some patients. Do not inject too large volumes or too superficially, as the product then may cause intradermal lumps.
This product has not been tested in pregnant or breastfeeding women or in children.
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.
Peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction.