IMPORTANT SAFETY INFORMATION:

JULÄINE™ is an injectable implant for adult immune-competent individuals and is intended for augmentation of shallow to deep nasolabial folds to compensate for skin depression due
to connective tissue imperfections, scars, or for cosmetic purposes. JULÄINE™ should only be used by Medical Doctors with expertise in facial anatomy (including location of blood vessels and nerves) and procedures for correcting volume deficiencies with injectable soft tissue fillers. JULÄINE™ must not be injected into the blood vessels, as this may result in vessel occlusion that could cause ischemia, skin infarction and embolism. The physicians should have first familiarized themselves with the product and the entire INSTRUCTIONS FOR USE.JULÄINE™ should be used in a medical office or facility specializing in aesthetic procedures where aseptic conditions are available. Strictly adhere to the principles of sterile operation and hygiene and disinfect the injection site before injection. Skin depressions should not be overfilled since they will improve over the course of several weeks as the treatment effect develops.
JULÄINE™ should not be injected into the lip. Like other injections, JULÄINE™ may cause a haematoma or injection site bleeding in patients treated with anticoagulants. The possible side effects of this product include the following: Short-term pain and short-term bleeding at the site of needle penetration during injection, redness, ecchymosis, haematoma, bruising, petechia, or visible oedema at the injection site, which are usually relieved within a few days. Based on clinical studies and post-market surveillance of poly-L-lactic acid fillers, skin nodules, late granulomas, subcutaneous papules, or hardened skin may appear between 1 and 14 months post-injection. The risk of these events appearing in the first six weeks may be reduced by following recommended product reconstitution and injection techniques, avoiding injecting into areas of thin skin, and the patient following a facial massage regime after injections. Clinical studies and post-market surveillance of poly-L-lactic acid soft tissue fillers have also shown the following rarely reported adverse events: mouth pain, injection site abscess, injectionsite infection, injection site urticaria, injection site atrophy, allergic reaction, skin hypertrophy, angioedema, telangiectasis, skin sarcoidosis, scarring, and skin discoloration. Very rarely, vascular complications can occur, including embolism, ischemic events, visualimpairment (including permanent blindness) and stroke. JULÄINE™ is available only through a licensed practitioner.

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View the complete instruction for use