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Medical device according to 93/42/EEC
Composition:1ml contains 16 mg sodium hyaluronate.
Contents:Each sterile single-use syringe with AMALIAN SF16 fine contains two sterile needles 27G1/2 for single use, for the exclusive injection of AMALIAN SF16 fine; one leaflet; one set of labels for the patient file and for passing on to the patient.
Indication:Viscoaugmentation to correct disease-related or age-related volume loss or defects of the facial skin, e.g. light to moderate wrinkles.
Danger:The intradermal injection of AMALIAN SF16 fine may only be carried out by doctors who have received sufficient training in dermal injections. The correct injection technique is crucial for the success of the treatment. Injections into the wrong layer of skin, an unsuitable technique or injections that are too quick can lead to increased side effects.
Characteristics:AMALIAN SF16 fine is a monophasic, sterile, isotonic, apyrogenic clear gel made from highly purified cross-linked hyaluronic acid of biofermentative origin and is therefore free of animal components. Hyaluronic acid, a natural polydisaccharide, is an important structural element in the skin, subcutaneous and connective tissue, synovial tissue and synovial fluid and is one of the few substances that are identical in all living organisms.
How it works:The injection of AMALIAN SF16 fine into the extracellular matrix adds volume to the tissue. In this way, wrinkles and lines are smoothed out. The duration of the effect can be 5 to 6 months, but depends on the severity of the wrinkles treated, the injection technique and biological, habitual and environmental factors.
The hyaluronic acid stabilized by cross-linking is degraded both enzymatically by the body's own enzyme hyaluronidase and oxidatively by hydroxylation.
Application and techniques:AMALIAN SF16 fine should be used at room temperature. It is suitable for replacing or augmenting tissue volume to compensate for volume loss as the skin ages. It should be applied to the upper to middle dermis. The injection volume varies from individual to individual and depends on the depth of the wrinkle. It is recommended to undercorrect slightly. The choice of injection technique depends on the type and severity of the wrinkle. Clearly hardened wrinkles that do not disappear through stretching are difficult to smooth out.
Care should be taken to ensure that the gel is evenly distributed to avoid the formation of nodules. Slow injection helps to reduce or avoid side effects. After the injection, the gel should be distributed in the tissue by gentle massage. It is recommended to cool the treated facial areas for about 10 minutes after the injection. After the first treatment, booster injections may be necessary in individual cases to achieve the desired wrinkle correction.
Contraindications:AMALIAN SF16 fine is contraindicated: - in case of hypersensitivity to hyaluronic acid, - in case of autoimmune disease or during immunotherapy, - in case of acute skin inflammation in the area to be treated (e.g. acne), - in case of acute flu or flu-like infection, - in case of acute systemic infections (herpes, psoriasis), - in patients with coagulation disorders or a tendency to scarring, - during pregnancy or breastfeeding, - in persons under 18 years of age
AMALIAN SF16 fine must not be injected into:
- Blood vessels
- Bone joints
- Breasts
Not recommended for:
- treatment in the outer eye area and on the forehead
Precautions:In principle, the doctor should carefully examine the patient's medical history with regard to diseases, other anti-aging treatments and individual factors that increase the risk of unwanted side effects. The patient should be informed about tissue augmentation with hyaluronic acid, injection-related side effects and possible side effects before treatment.
AMALIAN SF16 fine should only be injected into healthy, non-inflamed and disinfected tissue. It is generally recommended that the facial areas to be injected be pre-treated with an anesthetic cream, plaster or local block.
Wrinkles and lines should not be overcorrected. Excessive implantation of hyaluronic acid gel can lead to nodule formation, severe swelling and dislocation. When using sharp needles to implant the gel, injury to the finest blood vessels can lead to hematomas. Improper use of blunt cannulas can lead to increased trauma and swelling of the skin tissue.
The intake of aspirin, preparations containing ginkgo and other blood thinning agents should be avoided one week before treatment.
After the treatment, strong sun exposure and heat (tanning bed, sunbathing, sauna) should be avoided until the treatment reactions (redness, swelling) have subsided.
Side effects:Immediately after the treatment, redness and swelling and sometimes itching or discoloration at the injection site may occur due to the injection. The following day, there may be significant swelling, which disappears spontaneously after 3-5 days. Allergic reactions are extremely rare, as AMALIAN SF16 fine only contains material of non-animal origin. In rare cases, small nodules at the injection site and edema may occur. If an inflammatory reaction occurs, it is recommended to consult your doctor.
Isolated cases of granulomas, abscesses, hypersensitivity reactions and discoloration have been reported in the literature for filler materials based on hyaluronic acid. Very rare isolated cases of necrosis have also been described in the literature, due to injection into arterial vessels or due to an occlusion caused by filler material pressing on the artery wall.
Warnings:AMALIAN SF16 fine is only suitable for intradermal implantation. It should not be mixed with other preparations (such as permanent tissue fillers). During the effective phase (5-6 months), AMALIAN SF16 fine should not be combined with other aesthetic medicine treatment methods such as peeling, dermabrasion and all types of treatment with energetic waves (laser, radio frequency, ultrasound).
AMALIAN SF16 fine should not be used with products containing quaternary ammonium salts due to possible incompatibilities. Before use, the integrity of the packaging and the expiration date of the product must be checked. Do not use if the packaging is damaged. If the 27G1/2 needle becomes blocked, the injection should be stopped and the needle replaced. For single use only. Discard any remaining quantities. If reused, there is a risk of infection from unsterile product. Do not resterilize. The packaging of AMALIAN SF16 fine is not autoclavable. Do not use in the operating room.
Storage:Store at room temperature between 25°C and frost-free and protected from light.
Disposal:Immediately after use, dispose of the syringe containing any unused gel and needles.
