INDICATIONS

SKINVIVE™ by JUVÉDERM® is indicated for treatment of the face (cheek and forehead) and neck, by filling of superficial cutaneous depressions such as fine lines and for additional improvement of hydration.

IMPORTANT SAFETY INFORMATION
WARNINGS

• Check the expiry date on the product label
• In the event that the content of a syringe shows signs of separation and/or appears cloudy, do not use the syringe.
• Do not re-use. Sterility of this device cannot be guaranteed if the device is re-used.
• Do not re-sterilise
  For the needles (CE 0123 TSK Laboratory, Japan):
  • Used needles must be thrown away in the appropriate containers. Do the same for the syringes. Please consult the current applicable directives to ensure their correct elimination
  • Never try to straighten a bent needle, throw it away and replace it.

PRECAUTIONS

• SKINVIVE by JUVEDERM® is indicated only for intra-dermal injections
• Medical practitioners must take into account the fact that this product contains lidocaine.
• As a matter of general principle, injection of a medical device is associated with a risk of Infection Standard precautions associated with injectable materials shall be followed .
• There is no available clinical data about injection of SKINVIVE” by JUVEDERM into an area which has already been treated with a non-ALLERGAN dermal filler
• It is recommended not to inject into a site which has been treated with a permanent implant.
• No clinical data is available regarding the efficiency and tolerance of SKINVIVE” by JUVEDERM® injections in patients having a history of or currently suffering from, autoimmune disease or autoimmune deficiency or being under immunosuppressive therapy. The medical practitioner shall therefore decide on the indication on a case-by-case basis, according to the nature of the disease and its corresponding treatment, and shall also ensure the specific monitoring of these patients. In particular it is recommended that these patients undergo a preliminary skin testing for hypersensitivity, and to refrain from injecting the product if the disease is active .
• There is no available clinical data concerning the tolerance of SKINVIVE” by JUVEDERM injection in patients presenting a history of severe and/or multiple allergies. The medical practitioner shall therefore decide on the indication on a case-by-case basis, according to the nature of the allergy, and shall also ensure the specific monitoring of these at-risk patients. In particular, the decision may be taken to propose a skin testing for hypersensitivity or suitable preventive treatment prior to any injection. In case of history of anaphylactic shock, it is recommended not to inject the product.
• Patients showing a history of streptococcal disease recurrent sore throats, acute rheumatic faver) shall be subjected to a skin testing for hypersensitivity before any injection is administered In the event of acute rheumatic fever with heart complications, it is recommended not to inject the product.
• Patients on anti-coagulation medication or using substances that can prolong bleeding warfarin, acetylsalicylic acid nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as herbal supplements with garlic or ginkgo biloba, etc) must be wamed of the potential increased risks of bleeding and haematomas during injection.
• There is no data available regarding the safety of injecting greater amount than 20 mL of ALLERGAN dermal fillers per 60 kg (130 lbs) body mass per year
• Due to presence of lidocaine, the combination of SKINNE by JUVEDERM® with certain drugs that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.) is not recommended • Due to presence of lidocaine, SKINVIVE” by JUVEDERM® should be used with caution in patients showing symptoms of cardiac conduction disorders.
• Please recommend that the patient not use any makeup during the 12 hours following the injection treatment and that any extended exposure to the sun, UV rays and temperatures below 0°C be avoided as well as any sauna or hammam sessions during the two weeks following the injection treatment
• The composition of this product is compatible with fields used for magnetic resonance imaging.

UNDESIRABLE EFFECTS

The patents must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed  These include, but are not limited to:

• Inflammatory reactions (redness, oedema, erythema, etc) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection. These reactions may last for aweek
• Haematomas.
• Induration or nodules at the injection site
• Staining or discolouration of the injection site might be observed, especially when HA dermal filler is injected too superficially and/or in thin skin (Tyndall effect)
• Poor effect or weak filling effect
• Rare but serious adverse events associated with intravascular injection of dermal fillers in the face and tissue compression have been reported and include temporary or permanentvision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in the vision, signs of stroke blanching of the skin or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate medical practitioner specialist should an intravascular injection occur. Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported. It is therefore advisable to take these potential risks into account.
• Patients must report inflammatory reactions which persist for more than one week, or any other side effect which develops, to their medical practitioner as soon as possible. The medical practitioner should use an appropriate treatment
• Any other undesirable side effects associated with injection of SKINVVE* by JUVEDERM® must be re e reported to the distributor and/or to the manufacturer.

FOR COMPLETE SAFETY INFORMATION

Refer to the Directions for Use (DFU) for SKINVIVE” by JUVEDERM® for important information relating to contraindications, precautions, undesirable effects, and methods of use which now have been discussed in this piece.

The DFU for SKINVIVE” by JUVEDERM® is available by calling AbbVie at 1-800-668-6424 or by visiting www.allerganaesthetics.ca/en/our-products/medical-devices.

Adverse events should be reported to your local regulatory authority and AbbVie office.