Index of drugs

Symptomatic treatment of blepharospasm, cervical dystonia with the predominance of the rotational component (spasmodic torticollis) and post-stroke spasticity of the upper limb with signs of bent wrist and clenched fist in adults.

1 vial contains 100 U of botulinum toxin type A free of complexing proteins (1 unit = 1 LD₅₀ mouse toxins).

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 step of the toxin is to bind to the cholinergic nerve endings; the second stage is penetration or internalization with nerve endings; in the last step, the toxin blocks the release of acetylcholine through the effect of intracellular intoxication within the nerve end. Return to baseline occurs within 3-4 months after injection.

Hypersensitivity to botulinum neurotoxin type A or to other components of the preparation. Generalized muscle dysfunction (e.g.myasthenia gravis, Lambert-Eaton syndrome). The presence of inflammation at the site of the planned injection.

In patients with neurological diseases, including those with difficulty swallowing, the preparation should be used under the supervision of a specialist, only in cases where the benefit exceeds the risk. Particular care should be taken in patients with swallowing disorders and history of intravenous fluids. 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. Special care should be taken when injecting into areas close to sensitive structures, i.e. the carotid artery, lung tops. Especially careful use in patients with bleeding disorders, taking anticoagulants, patients with amyotrophic lateral sclerosis or other diseases causing neuromuscular dysfunction and when the muscles to which the drug is to be injected are in a state of marked weakness or disappearance. Too often using botulinum toxin may result in the formation of antibodies that may lead to the development of resistance to treatment. Patients previously inactive or sedentary should be urged to gradually increase their activity after injecting the drug. The preparation contains human albumin and therefore the risk of transmission of infectious agents can not be completely excluded.
Caution in patients at risk of developing glaucoma with a closed-angle glaucoma. Decreased blinking frequency after injecting the preparation into the ocular myocardium may lead to corneal exposure to external factors, persistent epithelial defects and corneal ulcers, especially in patients with nerve disease VII. In patients after previous eye surgery, a careful examination of corneal sensation should be performed. Carefully use in patients with lower neck muscle mass or in patients requiring bilateral injections into the sternocleidomastoid muscle, due to the possible occurrence of swallowing disorders. The drug for the treatment of focal spasticity was tested in combination with the standard treatment regimen used; the drug does not replace standard treatments. There is little likelihood of the drug's effectiveness in improving the range of motion in the joint affected by the contracture. Safety and efficacy of the drug in children and adolescents (0-17 years) have not been established - it is not recommended to use the drug in this age group. If the medicine is not used within 1 month of the first injection, the following measures should be taken: clinical verification of the neurotoxin's effect on the muscle under test, analysis of the clinical cause of resistance to treatment, evaluation of the choice of treatment. If no adverse drug reactions have occurred during the initial treatment, an additional series of injections may be performed under the following conditions: dose titration based on a non-clinical response to the last drug administration, drug administration under the control of EMG, and a recommended minimum interval between the first and second administrations It has been exceeded.

It must not be used during pregnancy unless clearly necessary and the expected benefit does not outweigh the possible risks. Animal studies have shown reproductive toxicity. Use during breastfeeding is not recommended.

Blepharie - often: eyelid drooping, dry eye syndrome; uncommon: paresthesia, headache, conjunctivitis, dry mouth, skin rash, decreased muscle strength, possible injury.Chicken torticollis - often: dysphagia (with varying degrees of severity and risk of aspiration), decreased muscle strength, back pain; uncommon: headache, tremor, eye pain, dysphonia, diarrhea, dry mouth, vomiting, colitis, skin rash, erythema, pruritus, hyperhidrosis, bone pain, muscle pain, weakness, inflammation and tenderness in the face injection site.Post-stroke spasticity of the upper limb - often: muscle weakness, pain and hematoma at the injection site; uncommon: hyperaesthesia, headache, hypoaesthesia, hematoma, cough, swallowing difficulty / discomfort, nausea, dry mouth, erythema, limb pain, swollen joints, muscle pain, feeling hot, weak, peripheral edema. Since the medicine has been on the market, flu-like symptoms and hypersensitivity reactions have been reported, including swelling, edema (also outside the injection site), erythema, pruritus, rash (local and generalized) and dyspnea. In addition, publications regarding conventional drugs containing botulinum toxin type A complex have reported: pneumonia due to aspiration (with fatal outcome in some cases); speech disorders, abdominal pain, excessive sweating, lack of appetite, hearing loss, tinnitus, radiculopathy; rarely cardiovascular disorders such as arrhythmia and myocardial infarction (some with fatal consequences, it is not explained whether the use of type A botulinum toxin caused these ailments or pre-existing cardiovascular disease); rare severe and / or sudden hypersensitivity reactions, including anaphylactic shock, serum sickness, urticaria, soft tissue swelling and shortness of breath; very rarely glaucoma with closed-angle glaucoma and new cases of recurrent cases and recurrent glaucoma attacks. In addition, erythema multiforme, urticaria, rash similar to psoriasis, pruritus and allergic reactions have been reported, but the causal relationship with drug administration has not been elucidated. In addition, a case of peripheral neuropathy and paralysis of the shoulder plexus have been described.

Intramuscularly. Adults. The dosage units recommended for the drug are not equivalent to the dosage units of other botulinum toxin drugs. The optimal dose and number of injection sites should be determined individually, start with a low dose and increase until the intended effect. The preparation should be used during one injection session and only by one patient. Decreasing or increasing the dose is possible by providing a smaller or larger volume of the preparation. Reducing the injected volume results in less pressure and less toxin in the treated muscle. This is beneficial in the treatment of small muscle groups, because it reduces the effect of the preparation on adjacent muscles.Blepharie: the starting dose is 1.25-2.5 units at each injection site. The starting dose should not exceed 25 units per eye. The preparation is injected into the medial and lateral part of the ocular muscle of the eye of the upper eyelid and into the lateral part of the oculi of the eye of the lower eyelid. In addition, the preparation is administered within the eyebrows, lateral part of the ocular muscle of the eye and the upper part of the face, if their contractions impair vision. Avoid administration near the upper eyelid lifting muscle to reduce the risk of the eyelid falling into the medial part of the lower eyelid to reduce the risk of double vision. Gentle pressure at the injection site immediately after it reduces the risk of their formation. The effect of the preparation occurs on average over 4 days and lasts for about 3-4 months, then treatment can be repeated. During the Next treatment, the dose may be doubled if the therapeutic effect of the first treatment is insufficient.The maximum dose is 100 U / 12 weeks. It is not recommended to inject more than 5 U in one place. No additional improvement is achieved by repeated administration of the drug more frequently than every 3 months.Chicken torticollis: the dose is selected individually depending on the position of the head and neck, the location of possible pain, muscle hypertrophy, body weight, response to treatment. The preparation is given to the sternocleidomastoid muscle, levator muscle, skeletal muscle, the lobed head of the head and / or the trapezius muscle. In case of difficulties with isolation of individual muscles an injection should be performed under the control of the electromyographic examination. Muscle mass and the degree of hypertrophy or muscular atrophy are taken into account when choosing the right dose of medicine. The maximum total dose does not usually exceed 200 U, a dose of up to 300 U is allowed; Do not administer more than 50 U at any injection site. Do not perform bilateral injections into the sternocleidomastoid muscle due to the increased risk of swallowing disorders. The effect of the preparation occurs within 1 week and lasts for about 3-4 months, the treatment can be repeated after at least 10 weeks.Post-stroke spasticity of the upper limbThe exact dose and number of injection sites should be adjusted according to the size, number and location of the affected muscles (using electromyography or nerve stimulation techniques), the severity of spasticity and the presence of local muscle weakness. Injecting the drug into multiple sites may allow a more homogeneous contact of the drug with the innervated areas of the muscle, which is particularly beneficial when injecting the drug into larger muscles. The following initial doses were given during the main clinical examination: flexion of the wrist - muscle of the radial flexor of the wrist: 50 U, muscle of the elbow flexor of the wrist: 40 j; clenched fist - muscle of the surface flexor of the fingers: 40 j., the muscle of the deep flexor of the fingers: 40 j .; bent elbow - brachial-radial muscle: 60 U, double-headed muscle: 80 U, arm muscle: 50 U; converted forearm - trapezius reversible muscle: 25 j., reversible pivotal muscle: 40 j; thumb in the palm of your hand - flexor muscle long thumb: 20 j., muscle adductor thumb: 10 j .; muscle: flexor flexor / muscle of the thumb deflector: 10 units. In the pivotal clinical trial, the minimum and maximum doses were 170 U and 400 U, respectively, in one session. For multiple dose treatments, the recommended dose range is as follows: bent wrist - muscle of the radial flexor of the wrist: 25-100 units in 1-2 sites of muscle injection, muscle in the elbow flexor: 20-100 units in 1-2 injection sites on the muscle; clenched fist - muscle of the surface flexor of the fingers: 40-100 j. in 2 places of injection into the muscle, muscle of the deep flexor of the fingers: 40-100 j. in 2 places of injection into the muscle; bent elbow - brachial-radial muscle: 25-100 units in 1-3 sites of muscle injection, biceps muscle: 75-200 units in 1-4 places of muscle injection, humeral muscle: 25-100 units in 1- 2 injection sites per muscle; converted forearm - trapezius reversible muscle: 10-50 units in the first injection site, muscle reversible in the limbs: 25-75 in 1-2 injection sites per muscle; thumb in the palm of your hand - flexor muscle of the long thumb: 10-50 j. in 1 place of injection on the muscle, muscle adductor thumb: 5-30 j. in the first place of injection into the muscle; muscle flexor short thumb / muscle the thumb deflector: 5-30 j. in the first injection site on the muscle. Patients reported that the onset of action was felt 4 days after drug administration, the maximum result of muscle tone reduction felt within 4 weeks. In general, the effect of treatment lasted 12 weeks, do not inject the next dose at intervals of less than 12 weeks.