Download the package leaflet
Medical device according to 93/42/EEC
Composition:
ml contains 28 mg sodium hyaluronate.
Contents:
Each sterile single-use syringe with AMALIAN SF28 macro contains two sterile needles 27G1/2 for single use and for the exclusive injection of AMALIAN SF28 macro, an instruction leaflet, a set of labels for the medical record and for distribution to the patient.
Indication:
Viscoaugmentation to correct disease-related or age-related volume loss or defects in the face, e.g. to build volume in the cheek area or to correct medium to deep wrinkles such as marionette lines and nasolabial folds.
Danger:
The intradermal injection of AMALIAN SF28 macro 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. Injection into the wrong layer of skin, an unsuitable technique or injection that is too fast can lead to increased side effects.
Characteristics:
AMALIAN SF28 macro 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 SF28 macro into the extracellular matrix adds volume to the tissue. In this way, wrinkles are smoothed and the desired volume is achieved. The duration of the effect is at least 6 - 9 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 broken down both enzymatically by the body's own enzyme hyaluronidase and oxidatively by hydroxylation.
Application and techniques:
AMALIAN SF28 macro should be used at room temperature. It is suitable for replacing or augmenting tissue volume in order to compensate for volume loss as a result of skin aging or to create the desired volume build-up. It should be applied to the middle to deep 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 by tightening the skin 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 correction.
Contraindications:
AMALIAN SF28 macro is contraindicated:
- in case of hypersensitivity to hyaluronic acid
- in 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 acute systemic infections (herpes, psoriasis)
- in patients with coagulation disorders or a tendency to scarring
- during pregnancy or breastfeeding
- for persons under 18 years of age
AMALIAN SF28 macro must not be injected into:
- Blood vessels
- Orbital area, glabella and forehead
- Bone joints
- Breasts
Not recommended for:
- the 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 SF28 macro should only be injected into healthy, non-inflamed and disinfected tissue. The facial area to be injected should always be pre-treated with an anesthetic cream, a plaster or a local block. Do not overcorrect. Excessive injection of hyaluronic acid gel can lead to the formation of nodules, severe swelling and dislocation. When using sharp needles to implant the gel, damage to the finest blood vessels can lead to hematomas. If blunt cannulas are used improperly, this can lead to increased trauma and swelling of the skin tissue.
The intake of aspirin, preparations containing gingko and other blood thinning agents should be avoided one week before treatment.
After the treatment, strong exposure to sunlight and heat (solarium, sunbathing, sauna) as well as heavy alcohol consumption 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 more severe swelling, which disappears spontaneously after 3-5 days. Allergic reactions are extremely rare, as AMALIAN SF28 macro 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 SF28 macro is only approved for intradermal implantation. It must not be mixed with other preparations (such as permanent tissue fillers). During the effective phase (6 - 9 months), AMALIAN SF28 macro should not be combined with other aesthetic medicine treatment methods such as peeling, dermabrasion and all types of wave treatment (laser, radio frequency, ultrasound). AMALIAN SF28 macro should not be used with products that contain quaternary ammonium salts due to possible incompatibilities.
Before use, check the integrity of the packaging and the expiration date of the product. 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 the product becoming unsterile. Do not resterilize. The packaging is not autoclavable. Do not use in the operating room.
Storage:
Store at 2°C to 25°C, frost-free and protected from light.
Disposal:Immediately after use, dispose of the syringe containing any unused gel and needles.
