Disport - instructions for use, analogs, testimonials and release forms (injections in ampoules for injections intramuscularly and subcutaneously) for the treatment of spasms, wrinkles and cerebral palsy in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Dysport. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Disport in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Disport in the presence of existing structural analogs. Use to treat spasms, wrinkles and cerebral palsy in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Dysport - muscle relaxant. The active ingredient is Clostridium botulinum toxin type A, which blocks the release of acetylcholine in the neuromuscular junction, which leads to the removal of muscle spasm in the area of ​​drug administration. The restoration of the transmission of the nerve impulse occurs gradually, as new nerve endings are formed and contacts with the postsynaptic motor end plate are restored.

Composition

Complex botulinum toxin type A - hemagglutinin + auxiliary substances.

Indications

• blepharospasm, hemifacial spasm, spasmodic torticollis, spasticity of the arm muscles after a stroke, hyperkinetic folds (facial wrinkles) of the face in adults;
• dynamic foot deformation caused by spasticity, in cerebral palsy in children aged 2 years and older;
• treatment of underarm hyperhidrosis.

Forms of release

Lyophilizate for the preparation of solution for intramuscular and subcutaneous injection (injections in ampoules for injections).

Instructions for use and how to use them

Bilateral and unilateral blepharospasm, hemifacial spasm

The contents of the vial are diluted with 2.5 ml of a 0.9% solution of sodium chloride for injection.1 ml of this solution contains 200 units of Dysport.

For adults and elderly patients for treatment of bilateral blepharospasm, the recommended initial dose is 120 units per eye. The drug is administered subcutaneously in a volume of 0.1 ml (20 units) medially, in a volume of 0.2 ml (40 units) - laterally into the joint between the upper and lower parts of the circular muscle (m.orbicularis oculi) of the affected eye. For injection in the upper eyelid, the needle should be directed away from the center, so as not to hurt the muscle lifting the upper eyelid (m.levator palpebrae superioris).

The manifestation of the clinical effect can be expected within 2-4 days, the maximum therapeutic effect develops within 2 weeks.

Injections should be repeated every 12 weeks or on indications to prevent recurrence of symptoms. For each subsequent administration, the dose should be reduced to 80 units per eye. For example, 0.1 ml (20 units) medially and 0.1 ml (20 U) laterally above the eye and below the eye. In the future, the dose of the drug can be reduced to 60 units per eye, due to the exclusion of medication medially in the lower eyelid. The doctor will determine the subsequent dose in accordance with the effect obtained.

With unilateral blepharospasm, injections should be limited to the area of ​​the affected eye. Similar treatment is performed with hemifacial spasm.

Spasmodic torticollis

The contents of the vial are diluted with 1 ml of a 0.9% solution of sodium chloride for injection. 1 ml of this solution contains 500 units of Disport.

Doses recommended for the treatment of torticollis are used in adults of all ages who have a normal body weight and satisfactory development of the neck muscles. Decrease in the dose of the drug is possible with a significant deficit in body weight or in the elderly, with reduced muscle mass.

For treatment of spastic torticollis, the initial total single dose is 500 This dose is distributed between 2 or 3 of the most active muscles of the neck.

When rotational, the curved drug at a dose of 500 units is administered as follows: 350 units in the belt muscle of the head (m. Splenius capitis), ipsilateral to the direction of rotation of the head and 150 units in the sternocleidomastoid muscle (m. Sternocleidomastoideus), contralateral rotation.

With laterocollis (head-to-shoulder tilt), the dose of 500 ED is distributed as follows: 350 units are inserted ipsilateral into the belt muscle of the head (m.splenius capitis) and 150 units - ipsilateral in the sternocleidomastoid muscle (m. sternocleidomastoideus). In cases accompanied by a shoulder lift due to a trapezius muscle (m. Trapezius) or a muscle lifting the scapula (m. Levator scapulae), treatment may be required in accordance with apparent muscle hypertrophy or electromyography.

When the administration of the drug to 3 muscles is required, the dose of 500 units is distributed as follows: 300 units are injected into the belt muscle of the head (m. Splenius capitis), 100 units into the sternocleidomastoid muscle, 100 units into the third muscle (trapezius muscle or muscle that lifts the scapula).

With anterocollis (tilt head forward), 150 units are inserted into both the sternocleidomastoid muscles (m. Sternocleidomastoideus).

With a retrocollis (head incline backwards), the dose of 500 units is distributed as follows: 250 U units are injected into each head muscle of the head (m. Splenius capitis). In case of insufficient clinical effect after injection, it is possible to inject the preparation into the trapezius muscles (m. Trapezius) bilaterally (at a dose of up to 250 units per muscle) after 6 weeks.

Bilateral injections into the waist muscles (m. Splenius capitis) may increase the risk of developing weakness in the neck muscles.

With the subsequent administration of the drug, the doses can be adapted in accordance with the clinical effect and the resulting side effects. Recommended total doses are 250-1000 units.The use of the drug in higher doses may be accompanied by an increase in the frequency of side effects, in particular dysphagia.

Clinical improvement with spastic krivoshee is noted within 1 week after the injection. Injections should be repeated every 8-12 weeks or as needed.

For the treatment of other forms of torticollis, the use of electromyography (EMG) for the detection and administration of the drug in the most active muscles is of great importance. EMG should be used to diagnose all complex forms of torticollis, or when re-examining patients with a lack of positive dynamics after drug administration, for injections into the deep muscles and in patients with excessive body weight and difficult palpable neck muscles.

Spasticity of the hand after a stroke in adults

Determination of indications for the administration of Dysport in the treatment of spasticity of the hand after a stroke is performed by a neurologist 3 months after the stroke.

1 ml of a 0.9% solution of sodium chloride is injected into the vial of the drug, to obtain a solution containing 500 units of Dysport in 1 ml.

The maximum total single dose is 1000 units,which is distributed between the following five muscles: the deep flexor of the fingers (m.flexor digitorum profundus), the superficial flexor of the fingers (m.flexor digitorum superficialis), the ulnar flexor of the wrist (m.flexor carpi ulnaris), the radial flexor of the wrist (m.flexor carpi radialis) and the biceps arm muscle (m.biceps brachii).

When choosing the site of injection should be guided by standard EMG points, and the immediate injection site is determined by palpation. In all muscles, except the biceps brachii muscles, the injections are carried out at one point. In the biceps arm muscle (m.biceps brachii), the injection is carried out at 2 points.

The initial total dose of the drug can be reduced to 500 units to prevent excessive weakness of the injected muscles when the target muscles are small in volume when the injection into the biceps muscle of the shoulder (m.biceps brachii) is not performed, or when patients are injected several times points of the same muscle.

Clinical improvement occurs within 2 weeks after the injection. Injections can be repeated about every 16 weeks or as necessary to maintain the effect, but not more often than every 12 weeks.

Hyperkinetic folds (facial wrinkles) of the face

The main area of ​​application of Dysport for cosmetic correction is the upper half of the face. The lower half of the face and neck are subject to correction by introducing botulinum toxin much less often.

The contents of the vial are diluted with 2.5 ml of a 0.9% solution of sodium chloride for injection. At this dilution, 1 ml of the solution contains 200 units of Dysport.

The total recommended dose for single administration to all four areas (interbroplet, forehead, outer corner of the eye and the back of the nose) should not exceed 200 units of Dysport.

To correct vertical folds in the interbrove area, injections of the drug are produced in the muscle, wrinkling eyebrow (m.corrugator supercilii) by 8-10 ED at 2-4 points and m.procerus at 5-10 units at 2 points. The total dose is from 42 to 100 units.

Elimination of hyperkinetic folds in the forehead area is done by injecting the drug into the region of maximum frontal muscle tension (m.frontalis). The number of insertion points can be arbitrary. All of them should be placed 2 cm above the eyebrow line on one line or V-shaped. The optimal total dose of Dysport in this area is 30-40 units (maximum - 90 units) at the rate of 5-15 units per point, the total number of points is 4-6.

Correction of folds in the area of ​​the outer corner of the eye ("crow's feet") is performed by subcutaneous injection at points located 1 cm lateral from the outer corner of the eye, at a rate of 5-15 units of Dysport preparation per one injection point.The number of points is from 2 to 4 for each eye. The maximum recommended total dose on both sides is 120 units.

The frequency of repeated injections depends on the timing of recovery of facial muscle activity. The duration of the effect is 3-4 months.

If an adequate dose of the drug was administered during the first injection, then during the second and subsequent injections the total dose of Dysport can be reduced by 15-20 units for the corresponding areas. It is possible to increase the interval between injections of the drug to 6-9 months. If the initial dose of the drug was insufficient, then with repeated injections it should be increased.

To correct wrinkles in the area of ​​the back of the nose, injections are carried out in the middle of the abdomen of the nasal muscles. The dose is distributed at 5-10 units per 1-2 points in each muscle.

The miorelaksiruyuschee effect of the drug Dysport on the facial muscles of the face is clinically manifested on day 2-3 after administration and reaches a maximum of 14-15 days.

The recommended doses of Dysport, used in aesthetic medicine, do not cause systemic side effects.

Dynamic deformation of the foot caused by spasticity in cerebral palsy in children aged 2 years and older

The contents of the vial are dissolved in 1 ml of a 0.9% solution of sodium chloride for injection, to obtain a solution containing 500 units per ml.

The drug is injected intramuscularly into the gastrocnemius muscles (M. gastrocnemius). The initial recommended dose is 20 U / kg of body weight and is divided equally between the gastrocnemius muscles (m. Gastrocnemius). When one gastrocnemius (m. Gastrocnemius) is injured, the drug is administered at a dose of 10 U / kg. The optimal dose is determined individually, the subsequent treatment should be planned after the evaluation of the results of the application of the initial dose. To avoid the development of side effects, do not exceed the maximum dose of 1000 units. The drug is mainly introduced into the gastrocnemius muscle (m. Gastrocnemius), but it is possible to insert into the soleus muscle (m.soleus) and the posterior tibialis muscle (m.tibialis posterior). To determine the most active muscles, you can use the method of electromyography.

In cases where the patient's target muscles are small in volume, the initial dose of the drug should be reduced to prevent the development of their excessive weakness. Clinical improvement occurs within 2 weeks after the administration of the drug. Injections are repeated as necessary at intervals of not less than 12 weeks, with the administered dose varying from 10 to 30 units per kg of body weight, depending on the effect of the previous injection.

Treatment of underarm hyperhidrosis

The contents of the vial are diluted 2.5 ml with a 0.9% solution of sodium chloride for injection, to obtain a solution containing 200 U / ml.

The recommended initial dose is 100 units per axillary area. If the desired effect is not achieved, then a subsequent dose increase of up to 200 units is possible.

The area of ​​administration of the preparation determines the breakdown of Minor. The sample is performed before treatment and, if necessary, in dynamics, at room temperature (22-24 ° C) after a 15-minute rest period of the patient. To carry out the test, you need: 5% alcohol solution of iodine; potato starch; marker; antiseptic; brush; gauze wipes.

The patient is lying down, hands under the head. The area of ​​sweating is treated with 5% alcohol solution of Iodine and after 1 minute a small layer of potato starch is applied to this area with a tissue or brush. The test results are evaluated after 5 minutes. In the presence of sweating, the color of the treated surface is visually observed in blue. The intensity of the color (from pale blue to blue-black) correlates with the activity of sweating. After the test, the area of ​​the hyperhidrosis is marked with a marker, then the starch is washed off with alcohol or another antiseptic.

Intradermal injections are carried out at ten points in each axillary region, 10 ED of the preparation in a volume of 0.05 ml, 100 ED per region are injected into each point. The maximum therapeutic effect develops within 2 weeks. In most cases, the recommended initial dose inhibits perspiration for up to 48 weeks. The frequency of repeated injections is determined individually by restoring the initial level of sweating, but no more often than once every 12 weeks. If there is any evidence of a cumulative effect with repeated injections, the timing of repeated injections for each patient is determined individually.

Rules for the preparation of solution for injection

From the vial, remove the protective plastic cover of the first autopsy control.

When diluting the drug, it is forbidden to open the bottle, removing the stopper. Immediately before diluting the contents of the vial, the central part of the stopper must be treated with alcohol. The lyophilizate is diluted by injecting a regulated volume of 0.9% solution of sodium chloride for injections into the vial by puncturing the plug with a sterile needle of size 23 or 25. The resulting solution is a colorless transparent liquid.Since the preparation does not contain a preservative, it is recommended to use it immediately after dissolution. Diluted preparation can be stored for no more than 8 hours at a temperature of 2 ° to 8 ° C.

Rules for processing tools and waste disposal

Immediately after the injection, the remaining solution in a vial or syringe should be inactivated with a dilute sodium hypochlorite solution containing 1% active chlorine. All auxiliary materials in contact with the drug should be disposed of in accordance with standard hospital practice.

Spilled drug should be removed with an absorbent cloth soaked in a 1% sodium hypochlorite solution.

Side effect

• neuralgic amyotrophy;
• skin rash;
• pain and bruising at the injection site;
• irritation, burning sensation at the injection site, which lasts 1-2 minutes;
• general weakness;
• fatigue;
• influenza-like syndrome;
• dysphagia (was recorded when doses exceeding 2700 U, administered at one point or distributed between several injection points were used);
• weakness of the arm muscles;
• weakness of facial muscles;
• paresis of facial muscles;
• diarrhea;
• urinary incontinence;
• accidental injury due to fall and abnormal gait, which are the result of excessive muscle weakness and / or the spread of toxin action to others near the injection site, muscles involved or participating in a particular motor act and maintaining the balance of the patient's body in standing and walking position;
• dysphonia;
• violation of accommodation;
• swelling of the eyelids;
• the turn of the century;
• compensatory sweating;
• rash;
• itching;
• hives;
• skin allergic reactions;
• Aspiration pneumonia, which can cause death.

Contraindications

• acute diseases (the introduction of the drug is carried out after recovery);
• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Disport is contraindicated for use in pregnancy and lactation (breastfeeding).

Studies of the effect of the drug Dysport on reproductive and teratogenicity were not conducted. Safety of the drug Dysport during pregnancy and during breastfeeding is not confirmed.

special instructions

Treatment with Dysport should be carried out by specialists with experience in the diagnosis and treatment of these diseases and trained in the treatment of this drug.

Side effects were observed as a result of the action of toxin on the muscles distant from the site of administration of the drug. Patients receiving Dysport in therapeutic doses may experience general muscle weakness. The risk of such side effects can be reduced by observing the recommendations for dosing the drug and applying the drug at the lowest effective doses.

With caution and under strict medical supervision prescribe the drug to patients with subclinical or clinical manifestations of lesions of the neuromuscular transmission (eg, bulbospinal paralysis). Such patients may have increased sensitivity to botulinum toxin preparations, which can cause them to have a pronounced muscle weakness.

With care, Dysport should be administered to patients with impaired swallowing and breathing functions, these disorders can be exacerbated due to the widespread effect of toxin on the corresponding muscles.

In patients suffering from chronic respiratory diseases, aspiration is rare in rare cases.

In the treatment of botulinum toxins type A and B, single cases of death were reported, caused by dysphagia (impaired swallowing), pneumopathy, or in patients with significant asthenia.

Patients and persons caring for them should be warned about the need for urgent medical attention in cases of violations of swallowing, speech and breathing disorders.

Antibotulinic antibodies were detected in a small number of patients who were treated with Dysport. Clinically, this was manifested by a decrease in the therapeutic effect, which required a constant increase in the doses of the drug.

In patients with delayed coagulation time and inflammation at the intended site of administration, Dysport should be used in cases of extreme need.

The units of action of the Dysport preparation are specific and can not be compared with those of other preparations containing botulinum toxin.

Impact on the ability to drive vehicles and manage mechanisms

Data on the effect of the drug on the ability to drive vehicles and control mechanisms are absent.

Drug Interactions

With simultaneous use with drugs that affect neuromuscular transmission, such as the antibiotics of the aminoglycoside group, caution is required.

Data on the interaction of the drug with ethanol (alcohol) before and after the introduction of Disport are absent.

Analogues of the drug Dysport

Structural analogs for the active substance and the effect:

• Botox;
• Xeomin;
• Lantox;
• Miolastane;
• Relatox Toxin botulinum type A in combination with hemagglutinin.

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