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Medical device according to 93/42/EEC
Composition:1 ml contains 14 mg sodium hyaluronate.
Contents:
Each sterile single-use syringe with AMALIAN SF14 natrual lips contains two sterile needles 27G1/2 for single use and for the exclusive injection of AMALIAN SF14 natural lips, an instruction leaflet, a set of labels for the medical file and for passing on to the patient.
Indication:
Correction of disease-related or age-related volume losses or defects, e.g. to facilitate volume augmentation of lips.
Danger:
The injection of AMALIAN SF 14 natural lips may only be carried out by sufficiently trained doctors. The correct injection technique is crucial for the success of the treatment. An unsuitable technique, overdose or too rapid injection can lead to increased side effects.
Characteristics:
AMALIAN SF 14 natural lips 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:
Injecting AMALIAN SF 14 natural lips into the lips adds volume to the tissue. This is how the desired volume build-up is achieved. The duration of the effect can be 5 to 6 months, but depends on the injection technique as well as 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 SF 14 natural lips should be used at room temperature. It is a light gel that is suitable for light lip augmentation to compensate for volume loss as a result of skin aging or to create the desired volume. It is injected into the lip tissue, in which volume deposits are placed in the deep red of the lips. The injection volume varies from individual to individual. It is recommended to undercorrect slightly. The choice of injection technique depends on the extent of the volume desired.
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 areas for about 10 minutes after the injection. In individual cases, booster injections may be necessary after the first treatment to achieve the desired correction.
Contraindications:
AMALIAN SF 14 natural lips 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 SF 14 natural lips must not be injected into:
- Blood vessels
- Bone joints
- Breasts
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 SF 14 natural lips should only be injected into healthy, non-inflamed and disinfected tissue. In principle, the area for lip augmentation should be pre-treated with an anesthetic cream, plaster or local block. Overcorrections should be avoided. Excessive implantation of hyaluronic acid gel can lead to nodule formation, 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 ginkgo and blood thinners 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 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 SF 14 natural lips only contains material of non-animal origin. Small nodules may rarely appear. If an inflammatory reaction occurs, it is recommended to consult your doctor.
In the literature, isolated cases of granulomas, abscesses, hypersensitivity reactions and discoloration have been reported for hyaluronic acid-based filler materials.
Warnings:
AMALIAN SF 14 natural lips is only suitable for injection into the lip tissue. It should not be mixed with other preparations (such as permanent tissue fillers). AMALIAN SF 14 natural lips should not be combined with other aesthetic medicine treatment methods such as peeling during the effective phase (5-6 months).
AMALIAN SF 14 natural lips 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 SF 14 natural lips is not autoclavable. Do not use in a sterile 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.
