Index of drugs

The preparation is indicated to achieve a temporary improvement in the appearance of the following wrinkles in adults, when their severity has a significant psychological impact on the patient: vertical wrinkles between moderate or severe eyebrows visible at the maximum wrinkle of the eyebrows (so-called forehead wrinkles); wrinkles in the area of ​​the lateral angle of the eye of moderate or severe intensity visible with a full smile (crow's feet wrinkles); simultaneously treated with moderate or severe crow's feet visible with a full smile and wrinkles of forehead of moderate or severe intensity visible at the maximum wrinkling of the eyebrows.

0.1 ml of the reconstituted solution contains 4 units of Allergan botulinum toxin type A. 1 vial contains 50 units. Allergan units are not equivalent to other products containing botulinum toxin.

Botulinum toxin type A inhibits the release of acetylcholine in presynaptic cholinergic nerve endings by cleaving the structure of SNAP-25, a protein necessary to effectively combine and release acetylcholine from vesicles in the nerve endings, leading to denervation of the muscle and thus its paralysis. Clinical symptoms appear within 2-3 days, the maximum therapeutic effect is obtained within 5-6 weeks after the injection. The effect of the preparation usually disappears within 12 weeks.

Hypersensitivity to botulinum toxin type A or to any of the preparation's excipients. Mastenia or the Eaton-Lambert band. Infections at the proposed injection sites.

Familiarize yourself with the anatomy and possible changes resulting from previous surgeries where the injection is planned prior to administration, and injections in the vicinity of sensitive anatomical structures should also be avoided. Due to the risk of anaphylactic reaction, it is necessary to ensure the availability of adrenaline or other agents used to treat anaphylactic reactions. Patients with unrecognized neuromuscular disorders may be at an increased risk for systemic clinical effects including severe dysphagia and respiratory disorder, following administration of typical doses of type A botulinum toxin. In some of these cases, dysphagia persisted for several months and required inserting a tube into the stomach for feeding. Caution should be exercised when administering the drug to patients suffering from amyotrophic lateral sclerosis or peripheral neuromuscular disorders. Patients receiving therapeutic doses may experience severe muscle weakness. Swallowing and breathing disorders can be serious and can cause death. It is not recommended to inject the preparation in patients with a history of dysphagia and aspiration. Patients or their carers should be advised to immediately seek medical attention if swallowing, speech or breathing disorders occur. Too frequent use or too high doses may increase the risk of developing antibodies. Antibody formation may lead to treatment failure with type A botulinum toxin, even in other indications. As with any injection procedure, local pain, inflammation, paresthesia, weakness, tenderness, swelling / edema, erythema, local infection, bleeding and / or bruising are expected to occur with the injection. Pain and / or anxiety associated with the use of the needle resulted in a vasovagal response, including transient symptomatic hypotension and fainting. Caution should be exercised when administering the product at the sites of the proposed injection where the inflammation occurred and when there is significant weakness or atrophy of the muscles selected for injection. Care should be taken to ensure that the preparation is not administered to the blood vessel during the injection within the wrinkles of the forehead visible at the maximum wrinkling of the eyebrows and wrinkles like "crow's feet" visible with a full smile.Following treatment, there is a risk of eyelid drooping. The use of VISTABEL is not recommended in people under 18 years of age. Data in patients over 65 years of age are limited.

The preparation is not recommended in pregnant women and in women of childbearing potential who do not use effective methods of contraception. The preparation can not be recommended during breast-feeding.

Common: headache, paresthesia, eyelid droop, nausea, erythema, skin tension, local muscle weakness, facial pain, injection site swelling, bruising, pain at the injection site, irritation at the injection site. Uncommon: infection, anxiety, dizziness, blepharitis, eye pain, blurred vision (including blurred vision), nausea, dry mouth, swelling (face, eyelids, around the eye socket), hypersensitivity reaction to light, pruritus, dryness skin, muscle twitching, flu symptoms, asthenia, fever."Crow's feet" wrinkles. After injecting 24 units of the preparation: common: eyelid edema, bleeding at the injection site, hematoma at the injection site; uncommon: pain at the injection site, paresthesia at the injection site."Crow's feet" wrinkles and forehead wrinkles. After injecting 44 units of the preparation: often: a hematoma at the injection site; uncommon: bleeding at the injection site, pain at the injection site. After post-marketing experience (all indications): anaphylaxis, angioneurotic edema, serum sickness and urticaria, anorexia, brachial plexus dysfunction, hoarseness, dysarthria, facial nerve paresis, sensory weakness, muscle weakness, myasthenia, peripheral neuropathy, paresthesia, radiculopathy, fainting and paralysis of the facial nerve, glaucoma of the closing angle (in the treatment of blepharospasm), eyelid regurgitation, squint, reduced visual acuity and visual disturbances, hearing loss, tinnitus and dizziness, aspiration pneumonia, dyspnea, bronchospasm, respiratory depression and respiratory failure, abdominal pain, diarrhea, dry mouth, swallowing disorders, nausea and vomiting, alopecia, psoriasis dermatitis, erythema multiforme, excessive sweating, loss of eyelashes, pruritus and rash, muscular atrophy and muscle pain, muscular atrophy caused by denervation, bad mood and fever and. Very rarely, side effects have been reported after using the botulinum toxin, probably associated with the penetration of the toxin to distant sites from the site of administration (eg muscle weakness, dysphagia, constipation or aspiration pneumonia, which can be fatal).

The recommended dosage units of Allergan are not equivalent to the dosage units of other botulinum toxin preparations. The preparation should be administered only by physicians with appropriate qualifications and expertise in conducting therapy and using the required equipment. After reconstitution, the preparation must only be used as part of a single injection / injection session in the patient. Special precautions should be taken during preparation and administration as well as during inactivation and removal of the remaining unused solution. The recommended volume for each injection site is 0.1 ml. When injecting the preparation into vertical wrinkles between the eyebrows visible at the maximum wrinkle of the eyebrows (so-called forehead wrinkles) or wrinkles around the lateral angle of the eye, visible with a full smile, special care should be taken to avoid injections into the blood vessels.The wrinkles in the brow of the forehead are visible at the maximum wrinkling of the eyebrows. After reconstitution, the preparation (50 units / 1.25 ml) is injected using a 30 Ga sterile needle. At each of the five injection sites, give 0.1 ml (4 units) of the preparation: 2 injections in each of the brow-forming muscles and one injection into the oblong muscle of the nose, giving a total of 20 units. To prevent extravasation below the orbital rim, press the thumb or index finger firmly below the orbital rim before injecting. During injection, the needle should be directed upwards and medially. To reduce the risk of eyelid drooping, do not exceed the maximum recommended dose of 4 units for each injection site, or the recommended number of injection sites.In addition, injections in the vicinity of the upper eyelid lifting muscle should be avoided. This applies in a special way to patients with well-developed lowering eyebrows. Injections in the muscles with frowning eyebrows should be performed in the middle of these muscles, at least 1 cm above the brow arch. The improvement in the appearance of wrinkles in the forehead visible at the maximum wrinkle of the eyebrows is generally visible within a week after treatment. The therapeutic effect is maintained for up to 4 months after the injection. The intervals between therapeutic procedures should not be shorter than 3 months. In case of treatment failure or limited effect after repeated injections, alternative methods of treatment should be used.Wrinkles like "crow's feet" visible with a full smile. After reconstitution, the preparation (50 units / 1.25 ml) is injected using a 30-gauge sterile needle. At each of the three injection sites on either side (a total of 6 injection sites), 0.1 ml (4 units) of in the lateral part of the ocular muscle of the eye, giving a total of 24 units in a total volume of 0.6 ml (12 units on each side). To reduce the risk of eyelid drooping, do not exceed the maximum recommended dose of 4 units for each injection site, or the recommended number of injection sites. In addition, injections should be done temporally to the orbital edge, thus maintaining a safe distance to the muscles responsible for lifting the eyelid. During the injection, the needle should be pointed up and away from the eye. The first injection should be given about 1.5 to 2.0 cm temporally in relation to the lateral angle of the eye and immediately to the temporal to the orbital edge. Subsequent injection sites will depend on whether the wrinkles are above and below the lateral angle of the eye, or mainly below the lateral angle of the eye. In the case of simultaneous treatment of forehead wrinkles visible at the maximum wrinkle of the eyebrows, the dose for wrinkles around the lateral angles of the eyes, visible at full smile is 24 units and 20 units for frontline wrinkles (see recommendations for administration in the case of frontline wrinkles), giving a total a dose of 44 units in a total volume of 1.1 ml. The reduction in the severity of "crow's feet" wrinkles visible during a full smile occurred in 1 week of treatment. The therapeutic effect was demonstrated for a median of 4 months after injection. Intervals between therapeutic sessions should not be shorter than 3 months.General information. In the case of treatment failure after the first treatment, defined as the absence of significant improvement one month after the administration compared to baseline, the following strategies should be considered: analysis of the causes of failure, which include, among others: injection into inappropriate muscles, abnormal injection technique, development of antibodies toxin neutralizing and too low dose; reconsidering the indication for treatment with botulinum toxin type A. In the absence of any side effects after the first treatment, the preparation should be repeated, with an interval of at least 3 months between one administration and the other. For the treatment of forehead wrinkles visible at the maximum wrinkling of the eyebrows, if the dose is too low during the first treatment, the preparation should be re-administered, increasing the total dose to 40 or 50 units, including analysis of previous therapeutic failure. The safety and efficacy of the repeated injections administered for more than 12 months has not been studied.Special groups of patients. Limited availability is available for patients over 65 years of age. There are no special recommendations for dose adjustment in elderly patients. The safety and efficacy of the preparation in the treatment of forehead wrinkles visible at maximum wrinkling of the eyebrows and crow's feet visible with a full smile in people under 18 years of age have not been demonstrated. It is not recommended for people under 18 years of age.