Disport

General characteristics. Structure:

Active agent: a complex botulinum toxin like A - hemagglutinin of 300 PIECES *

Excipients: albumine of the person - 125 mkg, lactose - 2.5 mg.

Active agent: a complex botulinum toxin like A - hemagglutinin of 500 PIECES *

Excipients: albumine of the person - 125 mkg, lactose monohydrate - 2.5 mg.

Pharmacological properties:

Muscle relaxant of peripheral action. An effective agent is Clostridium botulinum toxin of type A which blocks release of acetylcholine in neuromuscular connection that leads to removal of a muscular spasm in the field of administration of drug. Recovery of transfer of nervous impulse happens gradually, in process of formation of new nerve terminations and recovery of contacts with a postsynaptic motor trailer plate.

Pharmacokinetics. Data on pharmacokinetics of the drug Disport® are not available.

Indications to use:

— a nictitating spasm, a gemifatsialny spasm, a spastic wryneck, spasticity of muscles of a hand after a stroke, hyperkinetic folds (mimic wrinkles) of the person at adults;
— the dynamic deformation of foot caused by spasticity at a cerebral palsy at children at the age of 2 years is also more senior;
— hyperhidrosis of axillary area.

Route of administration and doses:

Bilateral and unilateral nictitating spasm, gemifatsialny spasm

Contents of a bottle of 300 PIECES dissolve in 1.5 ml 0.9% of solution of sodium of chloride for injections, contents of a bottle of 500 PIECES dissolve in 2.5 ml 0.9% of solution of sodium of chloride for injections. 1 ml and that and other solution contains 200 PIECES of the drug Disport®.

For adults and patients of advanced age for treatment of a bilateral nictitating spasm the recommended initial dose makes 120 PIECES on each eye. The drug is administered п / to of 0.1 ml (20 PIECES) medially, of 0.2 ml (40 PIECES) - lateralno in connection between preseptalny and orbital parts of upper and lower parts of a circular muscle (m.orbicularis oculi) of the affected eye. For carrying out injections the needle should be sent to an upper eyelid from the center aside not to touch the muscle raising an upper eyelid (m.levator palpebrae superioris). The scheme showing venues of injections is included below.

Manifestation of clinical effect can be expected within 2-4 days, the maximum medical effect develops within 2 weeks.

The injection should repeat each 12 weeks or according to indications for the prevention of a recurrence of symptoms. At each subsequent introduction it is necessary to reduce a dose of drug to 80 PIECES approximately. For example, 0.1 ml (20 PIECES) medially and 0.1 ml (20 PIECES) lateralno over an eye and are lower than an eye. Further the dose of drug can be lowered to 60 PIECES approximately, at the expense of an exception of administration of drug medially in a lower eyelid. The doctor defines the subsequent doses according to the gained effect.

At a unilateral nictitating spasm of an injection it is necessary to limit to area of the affected eye. Similar treatment is carried out at a gemifatsialny spasm.

Spastic wryneck

Contents of a bottle of 300 PIECES dissolve in 0.6 ml 0.9% of solution of sodium of chloride for injections, and a bottle of 500 PIECES in 1 ml of 0.9% of solution of sodium of chloride for injections. 1 ml and that and other solution contains 500 PIECES of the drug Disport®.

The doses recommended for treatment of a wryneck apply at the adult all age having the normal body weight and satisfactory development of muscles of a neck. The dose decline of drug is possible at significant deficit of body weight or at elderly people, with the reduced muscle bulk of a body.

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

At a rotational wryneck the drug in a dose of 500 PIECES is administered as follows: 350 PIECES in a belt muscle of the head (m. splenius capitis), ipsilateralno to the direction of rotation of the head and 150 PIECES in грудино - a clavicular and mastoidal muscle (m. sternocleidomastoideus), counterlateral rotation.

At a laterokollisa (a ducking to a shoulder) the dose of drug of 500 PIECES is distributed as follows: 350 PIECES enter ipsilateralno into a belt muscle of the head (m.splenius capitis) and 150 PIECES - ipsilateralno in грудино - a clavicular and mastoidal muscle (m. sternocleidomastoideus). In the cases which are followed by a shoulder raising at the expense of a trapezoid muscle (m.trapezius) or a muscle raising a shovel (m.levator scapulae) treatment according to a visible myopachynsis or according to an electromyography can be required.

When administration of drug in 3 muscles is required, the dose of 500 PIECES is distributed as follows: 300 PIECES enter into a belt muscle of the head (m.splenius capitis), 100 PIECES - in грудино - a clavicular and mastoidal muscle (m.sternocleidomastoideus), 100 PIECES - into the third muscle (the trapezoid muscle or a muscle raising a shovel).

At an anterokollisa (a ducking forward) enter 150 PIECES into both грудино - clavicular and mastoidal muscles (m. sternocleidomastoideus).

At a retrokollisa (a ducking back) the dose of 500 PIECES is distributed as follows: enter 250 PIECES into each belt muscle of the head (m.splenius capitis). In case of insufficient clinical effect after an injection it is possible to administer in 6 weeks the drug in trapezoid muscles (m.trapezius) bilateralno (in a dose to 250 PIECES on each muscle). Bilateral injections in belt muscles (m.splenius capitis) can increase risk of development of weakness of muscles of a neck.

At the subsequent purpose of drug of a dose can be adapted according to clinical effect and the arisen side effects. The recommended total doses make 250-1000 PIECES. Use of drug in higher doses can be followed by increase in frequency of side effects, in particular dysphagies.

Clinical improvement at a spastic wryneck is noted within 1 week after an injection. The injection should repeat each 8-12 weeks or as required.

For treatment of other forms of a wryneck use of an electromyography (EMG) is of great importance for identification and administration of drug in the most active muscles. EMG should be used for diagnosis of all irregular shapes of a wryneck or at repeated inspection of patients with lack of positive dynamics after administration of drug, for carrying out injections in deep muscles and at patients with excess body weight and difficult the palpated neck muscles.

Spasticity of a hand after a stroke at adults

Definition of indications at treatment of spasticity of a hand after a stroke is made by the neurologist in 3 months after the had stroke for administration of the drug Disport®.

Enter 0.6 ml of 0.9% of solution of sodium of chloride into the bottle with drug containing 300 PIECES, and enter 1 ml of 0.9% of solution of sodium of chloride into the bottle with drug containing 500 PIECES. In both cases receiving the solution containing 500 PIECES of the drug Disport® in 1 ml.

The maximum total single dose makes 1000 PIECES which is distributed between the following 5 muscles: deep sgibatel of fingers (m.flexor digitorum profundus), superficial sgibatel of fingers (m.flexor digitorum superficialis), elbow sgibatel of a wrist (m.flexor carpi ulnaris), beam sgibatel of a wrist (m.flexor carpi radialis) and biceps of a shoulder (m.biceps brachii).

At the choice of the place of an injection it is necessary to be guided standard by EMG points, and the direct place of an injection is defined by a palpation. In all muscles, except a biceps of a shoulder (m.biceps brachii), injections carry out to one point. To a biceps of a shoulder (m.biceps brachii) the injection is carried out in 2 points. The recommended distribution of a dose between muscles is given in the table.

Muscles	Диспорт® (PIECE)
Shoulder biceps	300-400
Deep sgibatel of fingers	150
Superficial sgibatel of fingers	150-250
Elbow sgibatel of a wrist	150
Beam sgibatel of a wrist	150
General dose	1000

The initial total dose of drug can be lowered to 500 PIECES for prevention of excessive weakness of the injected muscles when muscles targets are small on the volume when the injection is not carried out to a biceps of a shoulder (m.biceps brachii) or when to patients the injection becomes in several points of one muscle.

Clinical improvement occurs within 2 weeks after an injection. The injection can repeat approximately each 16 weeks or as necessary for maintenance of effect, but not more often than each 12 weeks.

Hyperkinetic folds (mimic wrinkles) of the person

The main scope of the drug Disport® for the purpose of cosmetic correction is the upper half of the face. The lower half of the face and a neck are exposed to correction by administration of botulinum toxin much less often.

Contents of a bottle of 300 PIECES are parted by 1.5 ml of 0.9% of solution of sodium of chloride for injections, and contents of a bottle of 500 PIECES are parted by 2.5 ml of 0.9% of solution of sodium of chloride for injections. At this cultivation of 1 ml and that and other solution contains 200 PIECES of the drug Disport®.

The total recommended dose at single introduction to all four areas (mezhbrovny area, area of a forehead, an outside corner of an eye and a ridge of the nose) should not exceed 200 PIECES of the drug Disport®.

In mezhbrovny area of an injection of drug are made for correction of vertical folds in the muscle wrinkling an eyebrow (m.corrugator supercilii) on 8-10 PIECES on 2-4 points and a muscle of arrogant men (m.procerus) on 5-10 PIECES in 2 points. The general dose makes from 42 to 100 PIECES.

Elimination of hyperkinetic folds in a forehead is made by administration of drug to the area of the maximum tension frontal a muscle (m.frontalis). The quantity of points of introduction can be any. All of them have to be located 2 cm above the line of eyebrows on one line or V is-shaped. The optimum total dose of the drug Disport® in this area makes 30-40 PIECES (maximum - 90 PIECES) of calculation for 5-15 PIECES on one point, total quantity of points 4-6.

Correction of folds in the field of an outside corner of an eye ("goose pads") is carried out п / to introduction to the points located on 1 cm lateralny from an outside corner of an eye at the rate of 5-15 PIECES of the drug Disport® on one point of introduction. Quantity of points - from 2 to 4 on each eye. The maximum recommended total dose on both parties makes 120 PIECES.

Frequency of repeated injections depends on terms of recovery of mimic activity of muscles. Duration of effect makes 3-4 months.

If during the first injection the adequate dose of drug was entered, then when carrying out the second and the subsequent injections the total dose of the drug Disport® can be reduced by 15-20 PIECES for the respective areas. At the same time increase in an interval between drug injections up to 6-9 months is possible. If the initial dose of drug was insufficient, then at repeated injections it should be increased.

For correction of wrinkles in the field of a ridge of the nose of an injection are carried out in the middle of an abdomen of nasal muscles. The dose is distributed on 5-10 PIECES on 1-2 points in each muscle.

Myorelaxation effect of the drug Disport® on mimic face muscles is clinically shown for 2-3 day after introduction and reaches a maximum for 14-15 day.

The recommended drug Disport® doses used in esthetic medicine do not cause system side effects.

The dynamic deformation of foot caused by spasticity at a cerebral palsy in children at the age of 2 years is also more senior

Contents of a bottle of 300 PIECES dissolve in 0.6 ml 0.9% of solution of sodium of chloride for injections, and contents of a bottle of 500 PIECES in 1 ml of 0.9% of solution of sodium of chloride for injections, receiving both in that and in other case the solution containing 500 PIECES in 1 ml.

The drug is administered in oil in gastrocnemius muscles (m. gastrocnemius). The initial recommended dose makes 20 PIECES/kg of body weight and shares equally between gastrocnemius muscles (m. gastrocnemius). At damage of one gastrocnemius muscle (m.gastrocnemius) the drug is administered in a dose 10 PIECES/kg. The optimum dose is defined individually, the subsequent treatment should be planned after assessment of results of use of an initial dose. In order to avoid development of side effects it is not necessary to exceed the maximum dose of 1000 PIECES. The drug is preferential administered in a gastrocnemius muscle (m.gastrocnemius), however introduction to a soleus muscle (m.soleus) and a back tibial muscle (m.tibialis posterior) is possible. For definition of the most active muscles it is possible to use an electromyography method.

In cases when muscles targets of the patient are small on volume, the initial dose of drug should be lowered for prevention of development of their excessive weakness. Clinical improvement occurs within 2 weeks after administration of drug. Injections repeat as required bucketed not less than 12 weeks, at the same time the entered dose can vary from 10 to 30 PIECES on 1 kg of body weight depending on effect of the previous injection.

Treatment of a hyperhidrosis of axillary area

Contents of a bottle of 300 PIECES are parted by 1.5 ml of 0.9% of solution of sodium of chloride for injections, and contents of a bottle of 500 PIECES are parted by 2.5 ml of 0.9% of solution of sodium of chloride for injections, receiving both in that and in other case the solution containing 200 PIECES in 1 ml.

The recommended initial dose - 100 PIECES on one axillary area. If the desirable effect is not reached, then the subsequent increase in a dose up to 200 PIECES is possible.

Area of administration of drug define breakdown of the Minor. Test is carried out before treatment and, if necessary, in dynamics, at the room temperature (22-24 °C) after 15-minute rest of the patient. It is necessary for conducting test: 5% spirit solution of iodine; potato starch; marker; antiseptic agent; brush; gauze napkins.

The patient is in a prone position, hands under the head. The area of sweating is processed by 5% spirit solution of iodine and in 1 min. on this zone a napkin or a brush apply with a thin layer potato starch. Test results estimate in 5 min. In the presence of sweating coloring of the processed surface in blue color is visually observed. Intensity of coloring (from pale blue to blue-black) correlates with activity of sweating. After the carried-out test the area of a hyperhidrosis is noted a marker, then starch is washed away alcohol or other antiseptic agent.

Intradermal injections carry out to ten points in each axillary area, enter into each point on 10 PIECES of drug of 0:05 ml, 100 PIECES on one area. The maximum therapeutic effect develops within 2 weeks. In most cases the recommended initial dose suppresses sweating for a period of up to 48 weeks. Frequency of repeated injections is defined individually at recovery of initial level of sweating, but not more often than time in 12 weeks. If there are any proofs of cumulative effect at repeated injections, terms of carrying out repeated injections for each patient define individually.

Rules of preparation of solution for injections

From a bottle delete a protective plastic cover of control of the first opening.

At cultivation of drug it is forbidden to open a bottle, deleting a stopper. Just before cultivation of contents of a bottle the central part of a stopper has to be processed by alcohol. Lyophilisate is dissolved, entering into a bottle the regulated volume of 0.9% of solution of sodium of chloride for injections, by a stopper puncture a sterile needle of the size 23 or 25. The received solution represents colourless transparent liquid. As drug does not contain preservative, it is recommended to use it at once after dissolution. Divorced drug can be stored no more than 8 h at a temperature from 2 ° up to 8 °C.

Rules of processing of tools and destruction of waste

At once after carrying out an injection the remained solution in a bottle or in the syringe should be inactivated the weak solution of sodium of hypochlorite containing 1% of active chlorine. All auxiliary materials which were in contact with drug should be utilized according to standard hospital practice.

The spilled drug should be removed with the absorbing napkin moistened in 1% hypochlorite sodium solution.

Features of use:

The specialists having experience of diagnosis and treatment of these diseases and who had training on performing treatment by this drug have to carry out by the drug Disport® treatment.

With extra care patients at whom allergic reactions to the previous injection are noted should administer the drug repeatedly.

The side effects resulting from effect of toxin on the muscles remote from a drug injection site were registered. The patients receiving Disport® in therapeutic doses can test the general muscular weakness. The risk of emergence of similar side effects can be reduced at observance of recommendations about a drug dosing and use of drug in minimal effective doses.

With care and under strict medical control appoint drug to patients with subclinical or clinical manifestations of defeats of neuromuscular transmission (for example, bulbospinalny paralysis). Such patients can have hypersensitivity to drugs of botulinum toxin which can cause in them sharply expressed muscular weakness.

With care it is necessary to enter Disport® to patients with disturbances of functions of swallowing and breath since these disturbances can be aggravated owing to widespread effect of toxin on the corresponding muscles.

At the patients having chronic respiratory diseases aspiration development is in rare instances possible.

At therapy botulinum toxins of type A and B registered the isolated cases of a lethal outcome caused by a dysphagy (swallowing disturbance), a pneumopathy or in patients with a considerable adynamy.

The patients and persons who are carrying out care of them have to be warned about need of the urgent address to the doctor for cases of emergence of disturbances of swallowing, the speech and disturbances of breath.

Formation of antibotulinic antibodies is noted at a small number of patients which carried out therapy by the drug Disport®. Clinically it was shown by decrease in therapeutic effect that demanded continuous increase in doses of drug.

Patients with the slowed-down time of coagulability have blood and at an inflammation in an estimated injection site of Disport® it is necessary to apply in emergency cases.

Units of effect of the drug Disport® are specific and cannot be compared to those of other drugs containing botulotoxin.

Influence on ability to driving of motor transport and to control of mechanisms
Data on influence of drug on ability to driving of motor transport and control of mechanisms are absent.

Side effects:

During performing various clinical trials of the drug Disport® with participation about 7800 patients side reactions developed with the following frequency: very often (≥1/10), it is frequent (≥1/100, to <1/10), infrequently (≥1/1000, to <1/100), seldom (<1/1000), is very rare (≤1/10 000).

Cumulative side effects

From a nervous system: seldom - neuralgic amyotrophy.

Dermatological reactions: seldom - skin rash.

Local reactions: often - pain and a hematoma in an injection site; infrequently - irritation, burning sensation in the place of an injection which lasts 1-2 min.

General reactions: often - the general weakness, fatigue, a grippopobodny syndrome.

Spasticity of a hand at adults after a stroke

Side reactions are registered in 14 clinical trials with participation of 141 patients.

From the alimentary system: often - a dysphagy (it was registered when doses the exceeding 2700 PIECES entered into one point or distributed between several points of introduction were used).

From a musculoskeletal system: often - weakness of muscles of a hand.

Others: often - an accidental injury / falling.

The dynamic deformation of foot caused by spasticity in children with a cerebral palsy

Side reactions are registered in 14 clinical trials with participation about 900 patients.

From the alimentary system: often - diarrhea.

From a musculoskeletal system: often - weakness of muscles of a leg.

From an urinary system: often - an urine incontience.

Others: often - an accidental injury owing to falling and abnormal gait which are a consequence of excessive weakness of muscles and/or distribution of effect of toxin on injections, other, adjacent to the place, the muscles involved or participating in a certain motive act and in maintenance of balance of a body of the patient in a standing position and when walking.

Spastic wryneck

Side reactions are registered in 21 clinical trials with participation about 4100 patients.

From a nervous system: often - a dysphonia; infrequently - a headache.

From an organ of sight: infrequently - a diplopia, accommodation disturbance.

From respiratory system: seldom - respiratory frustration.

From the alimentary system: very often - a dysphagy; infrequently - dryness in a mouth.

The dysphagy carries dozozavisimy effect and occurs most often at administration of drug in грудино - a clavicular and mastoidal muscle. The diet with an exception of rough food before disappearance of symptoms can be required

Nictitating spasm and gemifatsialny spasm

Side reactions are registered in 13 clinical trials with participation about 1400 patients.

From a nervous system: often - weakness of face muscles; infrequently - paresis of face muscles.

From organs of sight: very often - a ptosis; often - a diplopia, a xerophthalmus, a slezootdeleniye; seldom - an ophthalmoplegia.

Dermatological reactions: often - the century swelled; seldom - torsion of a century.

Side effect can take place at non-compliance by the doctor with rules of performance of an injection (cultivation, exact calculation of the entered dose, a right choice of points of introduction, the direction of a needle and depth of introduction) and the excessive diffusion of drug connected with it and temporary paralysis of muscles, adjacent to the place of an injection of group.

Axillary hyperhidrosis

Side reactions are registered in 4 clinical trials with participation about 217 patients.

Dermatological reactions: often - compensatory sweating.

Hyperkinetic folds (mimic wrinkles) of the person

The following side reactions are registered (usually from easy to moderate intensity).

From an organ of sight: often - the century and a slizity cover of an eye swelled; infrequently - dryness of a mucous membrane of an eye (a dry keratoconjunctivitis).

From a musculoskeletal system: often - weakness of the muscles, next to an injection site, that the century, an asthenopia (weakness of sight) or, infrequently, to paresis of face muscles and visual disturbances also often leads to a ptosis.

From a nervous system: very often - the headache (which is also often observed in group of placebo).

Dermatological reactions: infrequently - rash, a skin itch; seldom - a small tortoiseshell.

Local reactions: very often - pain, a hematoma, a skin itch, paresthesias, an erythema, rash in a drug injection site (which were also often noted also in group of placebo).

Post-registration experience of use

The majority of side effects are moderate and passing.

Seldom: digestive disturbances, skin allergic reactions, dizziness, headaches.

Very seldom (1/10 000): the expressed muscular weakness, a dysphagy, aspiration pneumonia which can cause a lethal outcome.

Interaction with other medicines:

At simultaneous use with the drugs influencing neuromuscular transmission such as antibiotics of group of aminoglycosides, care is required.

Contraindications:

— acute diseases (administration of drug is carried out after recovery);
— pregnancy;
— period of a lactation (breastfeeding);
— hypersensitivity to drug components.

Use of the drug DISPORT® at pregnancy and feeding by a breast
Диспорт® it is contraindicated to use at pregnancy and in the period of a lactation (breastfeeding).

Researches of influence of the drug Disport® on reproductibility and teratogenecity were not conducted. Safety of use of the drug Disport® at pregnancy and during breastfeeding is not confirmed.

Overdose:

Symptoms: generalized muscular weakness.

Treatment: the maintenance therapy, IVL at paralysis of respiratory muscles is shown. At overdose administration of antitoxin (antibotulinic serum) is reasonable during the first 3 h. As a rule, overdose treatment directionally on the general maintenance therapy at constant observation of the patient.

Storage conditions:

It is necessary to store and transport drug all types of the covered transport at a temperature from 2 ° to 8 °C; not to freeze.

Диспорт® store in the separate closed marked box in the refrigerator of medical institution where carrying out injections of drug is carried out.

Диспорт® it is impossible to give out on storage to the patient.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for пригот. solution for injections of 500 PIECES: фл. 1 pieces.

Lyophilisate for пригот. solution for injections of 300 PIECES: фл. 1 pieces.