Composition & Content
1 ml contains 16 mg sodium hyaluronate.
2 sterile, single-use syringes containing RX.HA.16; 4 sterile needles 27G for single-use and intended exclusively for the injection of RX.HA.16; instructions for use, as well as a set of 4 labels of which 2 are provided for the patient and the 2 others for the health record.
Note
Intradermal injection of RX.HA.16 must only be performed by medical specialists with appropriate training in dermal filler injection. The correct injection technique is essential for the success of the treatment. Injection into the wrong skin layer, an inappropriate technique or a high injection rate may lead to pronounced side effects.
Properties
RX.HA.16 is a monophasic, sterile, isotonic, apyrogenic clear gel made of highly purified crosslinked hyaluronic acid of biofermentative origin and thus free of animal traces. Hyaluronic acid, a natural polydisaccharide, is present as an important structural element in skin, in subcutaneous and connective tissue, in synovial tissue as well as in synovial fluid, and it belongs to the few substances that are chemically identical in all living organisms.
Mode of action
The injection of RX.HA.16 into the extracellular matrix adds volume to the tissue. Wrinkles, creases and folds are smoothened. The effect may last between 5-6 months; however, it is influenced by the depth of the treated wrinkles, the technique of injection, as well as biological, lifestyle and environmental factors.
Degradation of crosslinked hyaluronic acid occurs enzymatically through the endogenous enzyme hyaluronidase as well as by oxidative hydroxylation.
Storage & Disposal
Store between 2ºC and 25ºC, in a dry place, protected from sun light.
Directly after use dispose of syringe with unused gel and needles.
