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Medical device according to 93/42/EEC
Description:
AMALIAN SF20 medium Lidocaine is a sterile, apyrogenic and clear gel made from highly purified cross-linked hyaluronic acid in a physiological buffer solution. The hyaluronate is of biofermentative origin and is therefore free of animal components. 0.3% lidocaine is added to the gel.
Composition:
1 ml contains:
- Sodium hyaluronate 20 mg
- Lidocaine hydrochloride 3 mg
- Phosphate buffer 1 ml qs
Contents:
Each sterile single-use syringe with AMALIAN SF20 medium lidocaine, two sterile needles 27G1/2 for single use and for the exclusive injection of AMALIAN SF20 medium lidocaine, one leaflet; one set of labels for the medical file and for passing on to the patient.
Indication:Viscoaugmentation to correct disease-related or age-related volume loss or defects in the facial skin, e.g. to correct medium wrinkles. Lidocaine is added to the gel to reduce the local pain sensation after the injection.
How it works:
The injection of AMALIAN SF20 medium Lidocaine 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 nature of the area to be treated, the injection technique, and biological, habitual and environmental factors. The cross-linking of the hyaluronic acid slows down its degradation.
Application and techniques:
The intradermal injection of AMALIAN SF20 medium Lidocaine 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 fast can lead to increased side effects.
AMALIAN SF20 medium Lidocaine should be used at room temperature. It is suitable for replacing or augmenting tissue volume to compensate for volume loss as a result of skin aging. 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 SF20 medium Lidocaine is contraindicated:
- in case of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or local anesthetics of the amide type
- 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 SF20 medium Lidocaine must not be injected into:
- Glabella
- Blood vessels
- Bone joints
- Breasts
Not recommended for:
- the treatment in the 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.
There are no clinical data on the tolerability and efficacy of AMALIAN SF20 medium Lidocaine for patients with pre-existing conditions, such as an active autoimmune disease, severe multiple allergies or a previous anaphylactic shock.
It is up to the doctor to decide on a case-by-case basis whether AMALIAN SF20 medium Lidocaine can be used depending on the disease and the type of treatment. For these patients, it is recommended to propose a double test beforehand and not to carry out implantation if the disease is active or the condition is worsening. In addition, careful monitoring is recommended for these patients after treatment.
AMALIAN SF20 medium Lidocaine should only be injected into healthy, non-inflamed and disinfected tissue. Wrinkles and lines should not be overcorrected. Excessive implantation 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. 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 thinners should be avoided in the 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.
Warnings:
AMALIAN SF20 medium Lidocaine is only suitable for intradermal implantation. It should not be mixed with other preparations (such as permanent tissue fillers). During the initial phase of effectiveness (5 - 6 months), AMALIAN SF20 medium Lidocaine 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, US).
AMALIAN SF20 medium Lidocaine 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 non-sterile product. Do not resterilize. The packaging of AMALIAN SF20 medium Lidocaine is not autoclavable. Do not use in the operating room as the outside of the syringe is not sterile.
AMALIAN SF20 medium Lidocaine must not be mixed with other substances and the syringe contents must not be transferred into another container.
General information on possible side effects of lidocaine and restrictions on use
The total dose of lidocaine administered should be considered when using different dosage forms (including topical application) at the same time. The same applies when using other local anesthetics or substances that are structurally related to amide-type local anesthetics, as cumulative systemic toxicity may occur.
The maximum dose of lidocaine HCl (without adrenaline) per application must be taken into account in case of prior treatment with lidocaine. 300 mg (or 4.5 mg/kg) should not be exceeded in a normal healthy adult. An overdose of lidocaine HCl regularly leads to central nervous system symptoms or cardiovascular toxicity. In the presence of acidosis, hyperkalaemia, hypocalcaemia and hypoxia, the toxic effects of local anesthetics can be increased and
In case of intoxication by local anesthetics, centrally acting analeptics are contraindicated.
The treating physician must examine in each individual case whether treatment with AMALIAN SF20 medium Lidocaine may be carried out in patients with epilepsy, heart disease, severe liver dysfunction, severe kidney dysfunction or porphyria, depending on the severity of the disease and the type of treatment.
Particular caution is required in patients with congenital methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency. The same applies to patients who are taking methemoglobin-inducing drugs as concomitant medication.
Athletes should note that lidocaine can lead to a positive doping test result.
Side effects:
Immediately after 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 3-7 days. Allergic reactions in the form of urticaria, edema, bronchospasm, anaphylactic reactions/shock (e.g. respiratory distress syndrome, circulatory reaction) are rare, as AMALIAN SF20 medium Lidocaine only contains material of non-animal origin. Small nodules at the injection site and edema may rarely occur. If an inflammatory reaction occurs, it is recommended to consult the treating 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 vessels or due to a blockage caused by filler material pressing on the vessel wall. Lidocaine can cause local redness or hypersensitivity reactions.
Storage:
Store at 2°C to 25°C, dry and protected from light.
Disposal:
Immediately after use, dispose of the syringe containing any unused gel and needles.
