Xeomin lyophilisate 50 units 1 pcs

Kseomin acts selectively on the peripheral cholinergic nerve endings to inhibit the release of acetylcholine.

The introduction of the cholinergic nerve endings occurs in three stages: the binding of the molecule to the external components of the membrane, internalization of the toxin by endocytosis and translocation of the toxin endopeptidase domain from the endosome into the cytosol.

In cytosol endopeptidase domain of toxin molecules selectively cleaves SNAP-25, an important protein components of the mechanism that controls the movement of exo-membrane vesicles stopping thus release of acetylcholine. The net effect is a relaxation of the injected muscles.

Effect of the drug begins within four to seven days after the injection. The effect of each treatment generally lasts three to four months, although it may last significantly longer or less.

Active substance:
Botulinum toxin type A

Manufacturer

Merz Pharma GmbH & Ko.KGaA, Germany

Composition

1 vial contains:

Active substance:

Botulinum toxin type A 50 U;

Excipients:

sucrose,

human serum albumin.

Indications

Blepharospasm, idiopathic cervical dystonia (spasmodic torticollis) preferably forms a rotating, arms spasticity following stroke, hyperkinetic wrinkles (wrinkles) of the person.

Contraindications

The drug is contraindicated for people with allergies to components of the drug, disorders of neuromuscular transmission (masteniya gravis, Lambert-Eaton syndrome, prescribed with caution in amyotrophic lateral sclerosis, neurological diseases resulting from degeneration of motor neurons and other diseases with impaired neuromuscular transmission) .

The drug is not administered at an elevated temperature and acute infectious or non-infectious diseases.

The drug is contraindicated during pregnancy and lactation.

The drug is not administered to children and adolescents under 18 years of age.

Side effects

In the treatment of blepharospasm

Often – ptosis (6.1%), dry eye (2%).

It is not often – paresthesia, conjunctivitis, dry mouth, skin rash, headache, muscle weakness.

Furthermore, by using a similar formulation containing botulinum toxin type A and is used in clinical trials along with the drug Kseomin, the following were observed side effects. They are possible when using Kseomin drug.

Often – superficial keratitis, lagophthalmos, irritation, photophobia, lacrimation.

Infrequently – keratitis, ectropion, diplopia, dizziness, diffuse skin rash / dermatitis, entropion century, focal facial paralysis, weakness of facial muscles, fatigue, visual disturbances, blurred vision.

Rarely – local swelling of the skin century.

Very rarely – acute angle-closure glaucoma, corneal ulceration.

In the treatment of spasmodic torticollis

Often – dysphagia (10%), muscle weakness (1.7%), back pain (1.3%).

Infrequently – inflammation or pressing sensation at the injection site, headache, fatigue, sweating, tremor, hoarseness, colitis, vomiting, diarrhea, dry mouth, bone pain, myalgia, skin rash, itching, peeling skin, eye pain . Furthermore, by using a similar formulation containing botulinum toxin type A and is used in clinical trials along with the drug Kseomin, the following were observed side effects. They are possible when using Kseomin drug.

Very often – pain.

Often – dizziness, high blood pressure, numbness, weakness, catarrhal symptoms, malaise, dry mouth, nausea, headache, muscle rigidity, irritation at the injection site, rhinitis, upper respiratory tract infection.

It is not often – shortness of breath, diplopia, fever, ptosis, speech disorder.

Dysphagia may be expressed from very slight to a great extent, with the possibility of aspiration; in rare cases, it requires medical attention. Dysphagia may persist for 2-3 weeks after injection, but in case a three-month fixed dysphagia.

Dysphagia is dose-dependent complication: According to clinical studies, dysphagia is rare if the total dose does not exceed 200 units per procedure.

Common side effects

The following information is based on information about the action of other complex formulations containing botulinum toxin Type A.

Information about serious adverse effects that may be associated with damage to the cardiovascular system – such as arrhythmia and myocardial infarction, including fatal – negligible. Were these deaths are caused by injection of botulinum toxin type A or concomitant cardiovascular diseases is not clearly determined. One case of anaphylactic shock after administration of the complex formulation containing botulinum toxin type A.

There have side effects such as poliformnaya exudative erythema, urticaria, psoriasiform rashes, itching and allergic reactions, however, their conditioning action integrated formulation containing botulinum toxin type A, has not been confirmed.

Sometimes after injections of botulinum toxin type A marked background oscillations Electrophysiologic in some remote muscles; this side effect is not associated with muscle weakness or other electrophysiological abnormalities.

How to accept, acceptance rate and dosage

V / m. The drug may be administered only doctors having special training and experience of treatment with botulinum toxin and equipment for electromyography. The dosage and number of injections into the muscle the doctor places set individually for each patient.

Blepharospasm: administered after dissolution Kseomin sterile needle 27-30 G.

The recommended initial dose – 1.25-2.5 U (0.05-0.1 ml) into each injection site; formulation is injected into the medial and lateral parts of the circular muscles of the eyes (m. orbicularis oculi) of the upper eyelid and the lateral portion of the circular muscles of the lower eyelid.

If the vision impaired due to spasms in the forehead, the lateral sections of the circular muscles of the eye and the upper part of the face, in the area of ​​additional injections can be made. Effect of the drug begins, on average, within 4 days after the injection. The effect of each treatment generally lasts 3-4 months, although it may last significantly longer or less.

If the effect of the initial dose was insufficient (duration

Spasmodic torticollis: in the treatment of spasmodic torticollis dosage should be titrated for each patient individually, depending on the position of the neck and head, location of pain, muscle size (hypertrophy, atrophy), body weight and response to therapies. In practice, the maximum dose treatment during one treatment should normally not exceed 200 units, but can be up to 300 dosage units. At one and the same spot should not be injected dose exceeding 50 IU.

Therapy spasmodic torticollis includes injection sternocleidomastoid muscle, a levator scapulae muscle; in the scalene muscles in the arm belt and / or the trapezius muscle.

You should not give injections into both sternocleidomastoid muscle because it increases the risk of adverse drug effects (in particular dysphagia), which occur in the preparation of bilateral injections into the muscle, or at doses exceeding 100 units.

For injection into the muscle using a needle surface numbers 25, 27, and 30 G, and for the deep muscles – the needle number 22 G.

When spasmodic torticollis to determine the muscles involved may be necessary electromyography. The injection of a few places allows drug evenly cover the areas of the muscles prone dystonia (especially when injected into large muscles). The optimum amount of injection sites depends on the muscles. Effect of the drug begins, on average, within 7 days after injection. The effect of each treatment lasts about 3-4 months, but can last much longer or less. The interval between treatments should be at least 10 weeks.

Storage conditions

The drug should be stored and transported out of the reach of children, at room temperature (not higher than 25 ° C).

Active substance

Botulinum toxin type A

Interaction

Peripherally acting muscle relaxants should be used with caution while carrying antibiotic aminoglycosides or spectinomycin (possibly increasing Kseomina action).

The effect of the drug can be reduced by the action of 4-aminoquinoline.

Special conditions

Immediately after injection the remaining solution in a vial or in a syringe should inactivate sodium hydroxide solution (0.1 N NaOH).

All support materials that were in contact with the drug should be autoclaved or inactivated for at least 18 hours with a solution of sodium hydroxide (0.1 N NaOH). Spilled preparation should be wiped with absorbent cloth soaked in sodium hydroxide solution.

Effects on ability to drive vehicles and management mechanisms

Due to the nature of diseases treatable drug, the patient’s ability to control various equipment can be reduced.

In addition, drug side effects may adversely affect the patient’s ability to control appliances; Accordingly, the patient should refrain from these activities as long as its capacity is not restored fully.

Overdose

High doses Kseomina can lead to the development of pronounced muscle paralysis at locations remote from the injection areas (in particular: generalized weakness, ptosis, diplopia, slurred speech and swallowing, and respiratory muscle paralysis, which leads to the development of aspiration pneumonia).

In case of overdose, hospitalization with general supportive measures. Paralysis of respiratory muscles require intubation and mechanical ventilation until the normalization of the state.