KSEOMIN

Active material: botulinum toxin type A
When ATH: M03AX01
CCF: Miorelaksant. The inhibitor of acetylcholine release
ICD-10 codes (testimony): G24.3, G24.5
When CSF: 02.10.02
Manufacturer: MERZ PHARMA GmbH & Co. KGaA (Germany)

Pharmaceutical form, composition and packaging

Valium for drug of a solution for the / m white.

Excipients: sucrose, human serum albumin.

Bottles (1) – trays, plastic (1) – packs cardboard.

Pharmacological action

Miorelaksant. The inhibitor of acetylcholine release. Kseomin acts selectively on peripheral holinergicakie nerve endings, inhibiting acetylcholine. Introduction of acetylcholine the nerves occurs in 3 Phase: the binding of the molecules of the membrane with external components, the internalization of the toxin by Endocytosis and translocation domain jendopeptidaznogo toxin of jendosomy into the cytosol. In citozoli jendopeptidaznyj domain molecule toxin selectively cleaves SNAP-25, important protein component of the mechanism, controlling membrane movement jekzovezikul, terminating, thus, acetylcholine. The end effect is the relaxation of the muscle in'ecirovannoj.

The drug action begins, average, during 4-7 days after injection. The effect of each procedure lasts, usually, 3-4 Months, Although it can last much longer or less.

Pharmacokinetics

The farmakokinetike drug Kseomin not available.

Testimony

- Blepharospasm;

-idiopathic cervical dystonia (spasmodic torticollis), mostly Rotary forms.

Dosage regimen

The drug can enter only physicians, possessing special training, as well as the experience of the treatment of botulinum toxin and with equipment for electromyography. Dosage and number of seats injection in the muscle doctor sets for each patient.

Nictitating spasm

After the dissolution of the Kseomin introduce sterile needle No. 27-30 (G). The recommended initial dose – 1.25-2.5 ED (0.05-0.1 ml) in each place the injection. Drug ingeziruut medial and lateral parts of the circular muscle of the eye (m. 54 oculi) upper eyelid and into the lateral part of the circular eye muscles of the lower eyelid.

If vision is disturbed because of spasms in the forehead, the lateral sections of circular muscle of the eye and in the upper part of the face, in these areas can be made more injections. The drug action begins, average, during 4 days after injection. The effect of each procedure is saved, usually, 3-4 Months, Although it can last much longer or less.

If the effect of the initial dose was insufficient (duration of less than 2 Months), repeated procedures dose can be increased in 2 times. The initial dose should not exceed 25 U in one eye. In each seat there should be a dose, exceeding 5 ED. When treating nictitating spasm total dosage for 12 weeks of treatment should not exceed 100 ED.

Spasmodic torticollis

In the treatment of spastic krivoshei dosage should be tailored individually, Depending on the position of the head and neck, localization of pain, the volume of muscles (hypertrophy, atrophy), the body weight of the patient, and his reaction to therapeutic treatments. In practice, the maximum dose of the drug in the course of one treatment usually should not exceed 200 ED, However, the dosage is possible until 300 ED. In the same place should not be injected dose, exceeding 50 ED.

Therapy of spastic krivoshei includes injection-sterno kljuchichno-soscevidnuju muscle, in muscle, the shoulder, in stair muscles, in muscle belt, and/or got a trapezium muscle (muscle).

It is not necessary to do the injections in both sterno-kljuchichno-a mammillary muscles, because this increases the risk of adverse drug effects (in particular, Dysphagia), which take place at bilateral injections of the drug in this muscle, or when doses, exceeding 100 ED. For injection into superficial muscles use needles No. 25, 27 and 30 G, and for deep muscle – needle No. 22 G.

In spastic muscle to determine the study involved electromyography may be needed. Injections in a few places allows drug evenly cover muscle sites, prone to Dystonia (especially when large injections of the muscle). The optimum number of seats injection depends on the size of the muscles. The drug action begins, average, during 7 days after injection. The effect of each procedure remains approximately 3-4 Months, but can last much longer or less. The interval between treatments must be at least 10 weeks.

The dissolution of the drug

Dilution of the drug may not open a bottle, Remove the plug.

With bottle remove protective plastic cover. Immediately prior to breeding the central portion of the vial stopper should be treated with alcohol.

The solution for injection is prepared, piercing sterile needle CAP and introducing into the vial sterile 0.9% sodium chloride solution. Gently rotate the vial, mixing valium with the solvent to dissolve. After the dissolution of the formed transparent, colourless solution.

The drug does not use, If after the dissolution of the resulting solution is opaque or contains visible flakes and particles. The drug dissolved in necessary volume, According to the table.

Dosage, recommended for Kseomina, may not be used to recalculate when you use other drugs, containing botulinum toxin.

Because the preparation does not contain antimicrobial agents, It is recommended that you use it immediately after the dissolution of the. If necessary you can store the drug dissolved the original vial prior to 24 h in the refrigerator at a temperature from 2° to 8° c, provided, that dissolution was held in aseptic conditions.

Side effect

Nictitating spasm

Often: ptosis (6.1%), dry eyes (2%).

Infrequently: paraesthesia, conjunctivitis, dry mouth, skin rash, headache, muscular weakness.

Besides, When you use a similar drug, contains botulinum toxin type a, and used in clinical trials, along with drug Kseomin, experienced the following side effects. They are possible and in applying the drug Kseomin.

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

Infrequently: keratit, jektropija, diplopia, dizziness, diffuse skin rashes, dermatitis, entropion, focal paralysis of facial nerves, the weakness of the facial muscles, fatigue, visual disturbances, blurred vision.

Rarely: local induced swelling of the lower eyelid skin.

Rarely: acute angle-closure glaucoma, Corneal ulceration.

Spasmodic torticollis

Often: dysphagia (10%), muscular weakness (1.7%), back pain (1.3%).

Infrequently: Inflammation or needing sensation at the injection site, headache, asthenia, increased perspiration, tremor, hoarseness, colitis, vomiting, diarrhea, dry mouth, ostealgias, myalgia, skin rashes, itch, peeling of the skin, sore eyes.

Besides, When you use a similar drug, contains botulinum toxin type a, and used in clinical trials, along with drug Kseomin, experienced the following side effects. They are possible and in applying the drug Kseomin.

Often: pain.

Often: dizziness, elevated blood pressure, a feeling of numbness, generalized weakness, catarrhal symptoms, general malaise, dry mouth, nausea, headache, Muscle rigidity, irritation at the injection site, rhinitis, infections of the upper respiratory tract.

Infrequently: breathlessness, diplopia, fever, ptosis, speech disorders.

Dysphagia is usually of varying degrees of severity (from very mild to severe, with the possibility of aspiration); in rare cases, this requires medical assistance. Dysphagia may persist for 2-3 weeks after injection, However, fixed three-month case of dysphagia. Dysphagia develops dozozawisimo. According to clinical studies, Dysphagia is rare, If the total dose does not exceed 200 U for one procedure.

Common side effects

The following information is based on data on the effects of other complex preparations, containing botulinum toxin type a. Information about severe adverse reactions, that may be associated with a lesion of the cardiovascular system (such, as arrhythmia and myocardial infarction, incl. fatal), Ultra slim. Whether these deaths are caused by botulinum toxin type a injection, or concomitant cardio-vascular diseases, not determined. It is reported one case of anaphylactic shock after the introduction of the integrated drug, contains botulinum toxin type a.

Observed side effects such, as exudative mnogoformnaya Erythema, hives, psoriasiform rash, itching and allergic reactions, However, their integrated action conditionality drug, contains botulinum toxin type a is not confirmed. Sometimes after the injection of botulinum toxin type a year-to-year fluctuations in electrophysiological background in some remote muscles; This side effect is not associated with muscle weakness, nor with other jelektrofiziologicheskimi anomalies.

Contraindications

— violation of neuromuscular transmission (myastenia gravis, Lambert-Eaton syndrome);

-fever;

-acute infectious and non-infectious diseases;

- Pregnancy;

- Lactation (breast-feeding);

- Up to 18 years;

- Hypersensitivity to the drug.

FROM caution assign product when side amiotroficescom EMG, When neurological diseases as a result of degeneration of the motor neurons and other diseases with impaired neuromuscular transmission.

Pregnancy and lactation

The drug is contraindicated in pregnancy and during breastfeeding.

Cautions

Immediately after the injection of the remaining solution in the vial or syringe should inactivate solution of sodium hydroxide (0.1 NNaOH). All auxiliary materials, were in contact with the product, must be avtoklavirovany or inaktivirovany for a period of not less than 18 h solution of sodium hydroxide (0.1 NNaOH). Spilled preparation should be floors are worn adsorbing cloth, moistened with a solution of sodium hydroxide.

Effects on ability to drive vehicles and management mechanisms

Due to the nature of diseases, medication to treat bacterial, the patient's ability to manage different equipment can be reduced. Besides, side effects of the drug may have to operate on the patient's ability to manage technology; respectively, the patient should refrain from such activities until the, While his ability did not recover fully.

Overdose

In applying Kseomina in high doses may develop pronounced muscle paralysis in places, distant from the injection sites (generalized weakness, ptosis, diplopia, poor speech and swallowing, as well as paralysis of respiratory muscles, leading to the development of aspiration pneumonia).

Treatment: overdose requires hospitalization to common supporting activities. When paralysis of respiratory muscles require intubation and MECHANICAL VENTILATION until the normalization condition.

Drug Interactions

The combined application with aminoglikozidami or spektinomicinom is not recommended.

Muscle relaxants peripheral actions should be applied with caution.

The effect of the drug can be reduced while action 4-aminohinolina derivatives.

Conditions of supply of pharmacies

The drug is released only to specialized medical institutions.

Conditions and terms

The drug should be stored and transported out of the reach of children, at room temperature (above 25 ° C). Shelf life – 3 year.