Download the package leaflet
Medical device according to 93/42/EEC
composition
1 ml contains 12 mg non-cross-linked hyaluronate.
Contents
A sterile disposable syringe with amalian balance, two sterile needles 32G1/2 for single use and for the exclusive injection of amalian balance, an instruction manual and a set of labels, one of which is for the patient and the second for the medical file.
indication
Viscoaugmentation to correct disease-related or age-related volume loss or defects in the face, neck and décolleté, e.g. for skin rejuvenation (biorevitalization) and treatment of fine lines.
Danger
The intradermal injection of amalian balance 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 balance is a monophasic, sterile, isotonic, apyrogenic clear gel made from highly purified 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
As we age, the concentration of hyaluronic acid in the skin decreases significantly. As a result, the skin loses elasticity and tone, and wrinkles appear due to the loss of firmness. Adding amalian balance to the skin tissue leads to the reconstruction of the extracellular matrix and hydration, thanks to the high water-binding capacity of hyaluronic acid. In this way, the skin's elasticity and firmness are restored. Fine wrinkles are smoothed and the skin looks younger. In addition, hyaluronic acid is said to have the ability to stimulate the synthesis of collagen and intercept radicals. This is said to delay skin aging. Hyaluronic acid is broken down both enzymatically by the body's own enzyme hyaluronidase and oxidatively by the body's own hydroxylation.
Application and techniques
amalian balance should be used at room temperature. It was developed for mesotherapy. This gel is used to hydrate and rejuvenate the dermis, but is not suitable for filling wrinkles. It is applied by injecting the entire surface of the face, neck, décolleté and hands into the upper layer of skin. Using a gun allows for time-saving, even distribution. The effect lasts for around 3 months. As part of mesotherapy, the treatment is repeated 3 times at intervals of around 2-3 weeks in order to achieve optimal skin rejuvenation results. To maintain the effect, a refresher twice a year is sufficient.
Contraindications
amalian balance 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
- in patients under 18 years of age
amalian balance 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 illnesses, other anti-aging treatments and individual factors that increase the risk of unwanted side effects. Before treatment, the patient should be informed about the treatment concept of skin rejuvenation through hyaluronic acid injections, injection-related side effects and possible side effects.
amalian balance should only be injected into healthy, non-inflamed and disinfected tissue. It is recommended that the facial areas to be injected be pre-treated with an anesthetic cream or plaster.
The intake of aspirin, preparations containing gingko and other blood thinners should be avoided one week before treatment. After treatment, strong sun exposure and heat (tanning beds, 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 sites may occur due to the injection. Allergic reactions are extremely rare, as amalian balance only contains material of non-animal origin.
If an inflammatory reaction occurs, it is recommended to consult your doctor.
Isolated and very rare cases of granulomas, abscesses, discoloration and necrosis have been reported in the literature.
Warnings
amalian balance is only suitable for intradermal injection. Due to a lack of clinical comparative data, it should not be mixed with preparations from other manufacturers (such as tissue fillers). It should also 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 balance should not be used with products containing quaternary ammonium salts due to possible incompatibilities. Before use, the integrity of the packaging and the expiry date of the product must be checked. Do not use if the packaging is damaged. If the 32G1/2 needle becomes blocked, the injection should be stopped and the needle replaced. For single use only. Discard any leftover quantities. If reused, there may be a risk of infection from the product becoming unsterile. Do not resterilize. The packaging cannot be autoclaved. 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.
