Index of drugs

Transient improvement in the appearance of vertical wrinkles between the eyebrows (wrinkles of the forehead glaze) and wrinkles around the lateral angles of eyes visible at full smile (crow's feet), moderate or severe intensity, in adults under 65 years of age, when their severity has a significant psychological impact on the patient.

1 vial contains 50 U of botulinum toxin type A free of complexing proteins (1 unit = 1 LD₅₀ mouse toxins). 0.1 ml of reconstituted solution contains 4 units.

Botulinum toxin blocks cholinergic conduction within the neuromuscular junction by inhibiting the release of acetylcholine. The nerve endings of the neuromuscular plates cease to respond to nerve stimuli, which results in the lack of neurotransmitter secretion. Restoration of the transmission of stimuli occurs through the creation of new nerve endings and motor plates. The first stage of the toxin's action is to bind to the cholinergic terminations of the nerve, in subsequent stages the cell membrane shrinks, the toxin is absorbed into the nerve end and the acetylcholine release is blocked. Full reconstruction of the neuromuscular plate / stimulus transmission is usually 3-4 months after the injection.

Hypersensitivity to the components of the preparation. Generalized muscle disorder (eg myasthenia or Eaton-Lambert syndrome). Infection or inflammation at the site of the planned injection.

Do not give intravascularly. The preparation should be strictly used to treat only one patient during a single treatment. Before using the preparation, one should become familiar with the anatomy of the patient and with changes in his anatomy resulting from earlier surgical procedures. Caution should be used in patients with coagulation disorders, amyotrophic lateral sclerosis or other neuromuscular disorders, in patients taking anticoagulants or other substances in doses that are anticoagulant and when the muscles to which the drug is to be injected are in marked weakness or disappearance. Injecting patients with dysphagia and history of aspiration is not recommended. Too frequent administration or too high doses of toxin may increase the risk of developing antibodies to botulinum toxin that may lead to resistance to treatment. Due to the lack of data, it is not recommended for patients <18 years of age and patients> 65 years.

It must not be used during pregnancy unless it is absolutely necessary. Use during breastfeeding is not recommended.

Common: headache; muscular disorders (raising eyebrows); if the side-angles of the eye are applied in the area: swelling of the eyelids, dry eye, hematoma at the injection site. Uncommon: bronchitis, inflammation of the throat and nasal mucous membranes, influenza; depression, insomnia; facial muscle paresis (eyebrows drooping), swelling or ptosis, blurred vision; pruritus, skin nodules; muscle twitching or cramps, a feeling of heaviness; reactions at the injection site (hematoma, pain, tenderness), fatigue. Rare: severe and / or sudden hypersensitivity reactions including anaphylactic shock, serum sickness, urticaria, soft tissue swelling and shortness of breath. In addition, due to the injection itself, inflammation, paresthesia, hypoesthesia, tenderness, swelling, edema, erythema, pruritus, local infection, bleeding and / or bruising are possible. When botulinum toxin was used in other indications, adverse reactions were observed very rarely due to the spread of the toxin to locations remote from the site of administration (excessive muscle weakness, dysphagia, aspiration pneumonia, also with fatal outcome), however side effects can not be ruled out. this indication.

The preparation should be administered only by physicians with appropriate qualifications and extensive experience in the use of botulinum toxin and with appropriate equipment.
Intramuscularly.Vertical wrinkles between the eyebrows. The recommended dose is 4 units in 5 places: 2 injections in each muscle for brows (in the medial part of the muscle and in the middle part of the muscle at least 1 cm above the orbital bone edge) and 1 injection into the oblong muscle, corresponding to a standard dose of 20 If necessary, the dose may be increased to 30 U, with at least a three-month interval between each cycle of application. To reduce the risk of eyelid drooping, injections in the vicinity of the levator muscle of the upper eyelid and the cranial part of the ocular muscle of the eye should be avoided. The therapeutic effect is observed within 2-3 days after the injection, the maximum effect after 30 days. The effect of the preparation is maintained for up to 4 months. The interval between consecutive cycles of application should not be shorter than 3 months.Wrinkles around the side corners of the eyes. The recommended dose of 4 U is injected bilaterally at each of the 3 injection sites: one injection approximately 1 cm from the orbital edge, the remaining two injections should be made approximately 1 cm above and below the first injection site. The total recommended dose for one treatment session is 12 units for each side (total dose: 24 units). Reduction of wrinkles is usually observed within 6 days after the injection of the product, and the maximum effect occurs after 14 days. The product is maintained for up to 3 months after its administration. The interval between successive injection sessions of the product should not be shorter than 3 months. In the event of treatment failure or a worse effect, other methods of treatment should be used for subsequent injections. In the absence of a therapeutic effect within one month of the first injection, the following actions should be considered: analysis of the cause of failure - injection into inappropriate muscles, incorrect dose or injection technique, generation of neutralizing antibodies to the toxin and reassessment whether the choice of treatment with type A botulinum toxin was correct.