Disport

Disport – drug with myorelaxation action.

Form of release and structure

The disport is released in the form of lyophilisate for preparation of solution for injections (in glass bottles in the holder from a cardboard, on 1 bottle in a cardboard pack).

Is a part of 1 bottle:

• Active agent: hemagglutinin (a complex botulinum toxin like A) – 300 or 500 PIECES (an activity unit of firm);
• Auxiliary components: albumine of the person – 0,125 mg, lactose – 2,5 mg.

Indications to use

• Gemifatsialny spasm, nictitating spasm, spasticity of muscles of a hand after a stroke, a spastic wryneck, mimic wrinkles (hyperkinetic folds of the person) at adults;
• The dynamic deformation of foot connected with spasticity at the cerebral palsy (CP) at children of 2 years;
• Hyperhidrosis of axillary area.

Contraindications

• Diseases with an acute current (Disport's introduction perhaps after recovery);
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Route of administration and dosage

Nictitating spasm (bilateral and unilateral), gemifatsialny spasm

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 1,5 ml, contents of a bottle of 500 PIECES – in 2,5 ml (both cases in 1 ml of the received solution contain 200 PIECES of Disport).

At treatment of a bilateral nictitating spasm adult patients, including elderly, are recommended to administer the drug in an initial dose 120 PIECES on each eye. The disport is entered subcutaneously of 20 PIECES (0,1 ml) medially, of 40 PIECES (0,2 ml) – lateralno into connection between orbital and preseptalny parts of the lower and upper parts of a circular muscle of the affected eye. A needle for carrying out injections needs to be sent to an upper eyelid from the center aside not to touch the muscle raising an upper eyelid.

The effect of treatment is observed, as a rule, in 2-4 days, the maximum therapeutic effect develops within 14 days.

For the prevention of a recurrence of symptoms or according to indications of an injection it is necessary to enter repeatedly each 3 months. At each following use of Disport the dose needs to be reduced to 80 PIECES approximately. For example, 20 PIECES (0,1 ml) medially and 20 PIECES (0,1 ml) are lateralno lower than an eye and over an eye. Further it is possible to reduce a dose to 60 PIECES approximately, by an exception of introduction of Disport medially in a lower eyelid. The doctor defines the following doses on the basis of the gained effect.

At treatment of a unilateral nictitating spasm of an injection it is necessary to limit to area of the affected eye. At a gemifatsialny spasm carry out similar therapy.

Spastic wryneck

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 0,6 ml, contents of a bottle of 500 PIECES – in 1 ml (both cases in 1 ml of the received solution contain 500 PIECES of Disport).

The wrynecks of a dose recommended at treatment are appointed the adult of all age having satisfactory development of muscles of a neck and normal body weight. Decrease in a dose of Disport is possible at a significant lack of body weight or elderly patients with reduced muscle bulk have bodies.

The initial total single dose at a spastic wryneck makes 500 PIECES. This dose is distributed between 2 or 3 most active muscles of a neck. Depending on indications the dose is entered as follows:

• Rotational wryneck: 350 PIECES – ipsilateralno to the direction of rotation of the head in a belt muscle of the head, 150 PIECES – in грудино - a clavicular and mastoidal muscle, counterlateral rotation;
• Laterokollis (a ducking to a shoulder): 350 PIECES – in a belt muscle of the head ipsilateralno, 150 PIECES – in грудино - a clavicular and mastoidal muscle ipsilateralno. If латероколлис is followed by a shoulder raising at the expense of a trapezoid muscle or the muscle raising a shovel, therapy according to an electromyography or according to a visible myopachynsis can be required. If there is a need to enter Disport into 3 muscles, the dose is distributed as follows: 300 PIECES – in a belt muscle of the head, 100 PIECES – in грудино - a clavicular and mastoidal muscle, 100 PIECES – in the third muscle (raising a shovel or a trapezoid muscle);
• Retrokollis (ducking back): in each belt muscle of the head on 250 PIECES. In 6 weeks after an injection (on condition of insufficient clinical effect) it is possible to enter Disport into trapezoid muscles bilateralno (in each muscle in a dose to 250 PIECES). Bilateral injections in belt muscles can increase probability of development of weakness of muscles of a neck.

At treatment of an anterokollis (a ducking forward) into both грудино - clavicular and mastoidal muscles enter 150 PIECES.

Further doses can be adapted on the basis of clinical effect and side effects. The recommended total doses – from 250 to 1000 PIECES. Higher doses can lead to increase in frequency of development of side effects, in particular, dysphagies.

As a rule, at a spastic wryneck clinical improvement is noted within 7 days after an injection. The disport is entered by each 2-3 months or as required.

At therapy of other forms of a wryneck use of an electromyography (EMG) is of great importance for identification of the most active muscles and administration of drug in them. EMG needs to be used for diagnosis of all irregular shapes of a disease or at repeated inspection of patients with lack of improvement after Disport's introduction, for carrying out injections in deep muscles, and also at patients with difficult palpated muscles of a neck and excess body weight.

Spasticity of a hand at adults after a stroke

The neurologist estimates need of use of Disport in 3 months after the had stroke.

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 0,6 ml, contents of a bottle of 500 PIECES – in 1 ml (both cases in 1 ml of the received solution contain 500 PIECES of Disport).

The maximum total single dose of 1000 PIECES is distributed between 5 muscles: deep sgibatel of fingers, elbow sgibatel of a wrist, superficial sgibatel of fingers, biceps of a shoulder and beam sgibatel of a wrist.

Choosing the place of an injection it is necessary to be guided by standard points of EMG, and the doctor determines the direct place of an injection by a palpation. In all muscles, except for a biceps of a shoulder, injections are carried out to one point (in a shoulder biceps – in two points). The dose is recommended to be distributed as follows:

• Shoulder biceps: 300-400 PIECES;
• Deep sgibatel of fingers, elbow sgibatel of a wrist, beam sgibatel of a wrist: 150 PIECES;
• Superficial sgibatel of fingers: 150-250 PIECES.

The general dose makes 1000 PIECES.

The doctor can lower an initial total dose to 500 PIECES for the purpose of prevention of excessive weakness of the injected muscles in situations when the injection is not carried out to a biceps of a shoulder or the injection becomes in several points of one muscle, and also in case of muscles targets, small on volume.

As a rule, clinical improvement is observed for 14 days after administration of drug. The injection can repeat approximately each 4 months or as necessary for maintenance of effect, but not more often than each 3 months.

Mimic wrinkles (hyperkinetic folds of the person)

For cosmetic correction the main scope of Disport is the upper half of the face. A neck and the lower half of the face corrections by administration of botulinum toxin in more exceptional cases are exposed.

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 1,5 ml, contents of a bottle of 500 PIECES – in 2,5 ml (both cases in 1 ml of the received solution contain 200 PIECES of Disport).

At single introduction to all four areas (mezhbrovny area, area of a ridge of the nose, a forehead and an outside corner of an eye) the recommended dose totally should not be more than 200 PIECES.

When carrying out correction of vertical folds in mezhbrovny area of an injection of Disport make: on 8-10 PIECES on 2-4 points in the muscle wrinkling an eyebrow, on 5-10 PIECES in 2 points in a muscle of arrogant men. The general dose – 42-100 PIECES.

For elimination of hyperkinetic folds in a forehead solution is entered into the area of the maximum tension of a frontal muscle. For this purpose it is possible to use any quantity of points. All of them have to be located above the line of eyebrows on 2 cm (V-shapedly or on one line). An average total dose of Disport in this area – 30-40 PIECES (as much as possible – 90 PIECES), on 5-15 PIECES on one point at total quantity of points 4-6.

For correction of folds in the field of an outside corner of an eye ("goose pads") solution is entered subcutaneously into points which are located on 1 cm lateralny from an outside corner of an eye, on 5-15 PIECES on 1 point of introduction at total quantity of points 2-4 on each eye. The maximum total dose on both parties – 120 PIECES.

The doctor determines the frequency of repeated injections depending on terms of recovery of mimic activity of muscles. Effect duration – from 3 to 4 months.

If when holding the first procedure the adequate dose of Disport was entered, at the second and the subsequent injections for the respective areas the total dose can be lowered by 15-20 PIECES. At the same time it is possible to increase a break between injections up to 6-9 months. At insufficiency of an initial dose, when carrying out repeated injections it needs to be increased.

At correction of wrinkles in the field of a ridge of the nose the Disport is entered into the middle of an abdomen of nasal muscles on 5-10 PIECES on 1-2 points of each muscle.

The myorelaxation effect of drug clinically develops for 2-3 day after introduction and for 14-15 day reaches a maximum.

At Disport's use in esthetic medicine, systemic side effects usually do not develop.

The dynamic deformation of foot caused by spasticity at a cerebral palsy in children of 2 years

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 0,6 ml, contents of a bottle of 500 PIECES – in 1 ml (both cases in 1 ml of the received solution contain 500 PIECES of Disport).

The disport is entered into gastrocnemius muscles intramusculary. The recommended initial dose – 20 PIECES/kg of body weight which is divided equally between gastrocnemius muscles. At damages only of one gastrocnemius muscle Disport enter 10 PIECES/kg in a dose. The doctor defines an optimum dose individually, the subsequent therapy needs to be planned after evaluating results of use of an initial dose. To avoid development of side effects it is not necessary to exceed the maximum dose of 1000 PIECES. Preferential the drug is administered in a gastrocnemius muscle, however its introduction to back tibial and kambalovidny muscles is also possible. To define the most active muscles, it is possible to apply an electromyography method.

At muscles targets, small on volume, the initial dose is reduced (to avoid development of their excessive weakness). As a rule, improvement is observed within 14 days after Disport's introduction. As required injections repeat with breaks not less than 3 months. Depending on effect of the previous injection the entered dose can fluctuate ranging from 10 to 30 PIECES on 1 kg of body weight.

Hyperhidrosis of axillary area

Before introduction lyophilisate should be dissolved in 0,9% sodium chloride solution for injections: contents of a bottle of 300 PIECES – in 1,5 ml, contents of a bottle of 500 PIECES – in 2,5 ml (both cases in 1 ml of the received solution contain 200 PIECES of Disport).

Drug appoint in an initial dose 100 PIECES to one axillary area. At insufficiency of effect the subsequent increase in a dose is possible twice.

The doctor determines area of introduction of Disport by test of the Minor which is carried out prior to therapy and, in need cases, in dynamics, at the room temperature after 15-minute rest. For conducting test 5% spirit solution of iodine, potato starch, an antiseptic agent, a marker, gauze napkins, a brush are used.

The drug is administered vnutrikozhno in 10 points in each axillary area, on 10 PIECES in each point, on 100 PIECES on one area. The maximum medical effect develops within 14 days. Most often use of an initial dose suppresses sweating for a period of up to 11 months. Frequency of repeated injections is defined individually, but not more often than time in 3 months.

The disport is recommended to be used at once after dissolution. Its storage is possible till 8 o'clock at a temperature of 2-8 °C.

Side effects

Depending on indications during Disport's use various disturbances can develop (> 10% – very often;> 1% and <10% – is frequent;> 0,1% and <1% – infrequently;> 0,01% and <0,1% – are rare; <0,01% – are very rare).

Cumulative side effects:

• Nervous system: seldom – neuralgic amyotrophy;
• Local reactions: often – a hematoma and pain in an injection site; infrequently – irritation, burning sensation in an injection site of drug lasting 1-2 minutes;
• Dermatological reactions: seldom – skin rash;
• General reactions: often – fatigue, the general weakness, a grippopodobny syndrome.

Spasticity of a hand after a stroke (at adults):

• Musculoskeletal system: often – weakness of muscles of a hand;
• Alimentary system: often – a dysphagy;
• Others: often – falling / accidental injuries.

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

• Urinary system: often – an urine incontience;
• Musculoskeletal system: often – weakness of muscles of a leg;
• Alimentary system: often – diarrhea;
• Others: often – the abnormal gait and accidental injuries because of falling connected with excessive weakness of muscles and/or distribution of effect of toxin on other muscles located close to the place of an injection and participating in a certain motive act and in maintenance of balance of a body of the patient when walking and in a standing position.

Spastic wryneck:

• Alimentary system: very often – a dysphagy (disturbance has dozozavisimy character and is most often observed at Disport's introduction in грудино - a clavicular and mastoidal muscle; before disappearance of symptoms observance of a diet with an exception of rough food can be required); infrequently – dryness in a mouth;
• Respiratory system: seldom – respiratory frustration;
• Nervous system: often – a dysphonia; infrequently – a headache;
• Organ of sight: infrequently – accommodation disturbance, a diplopia.

Gemifatsialny spasm and nictitating spasm:

• Organ of sight: very often – a ptosis; often – a slezootdeleniye, a xerophthalmus, a diplopia; seldom – an ophthalmoplegia;
• Nervous system: often – weakness of face muscles; infrequently – paresis of face muscles;
• Dermatological reactions: often – the century swelled; seldom – torsion of a century.

Side effect can be observed at non-compliance by the doctor with rules of administration of drug (cultivation, a right choice of points of introduction, exact calculation of the entered dose, depth of introduction and the direction of a needle) and the excessive diffusion of Disport connected with it and short paralysis of group of the muscles located close to the place of an injection.

Axillary hyperhidrosis: dermatological reactions (it is frequent – compensatory sweating).

Mimic wrinkles (hyperkinetic folds of the person) (side effects with intensity, as a rule, from easy to moderated):

• Organ of sight: often – hypostasis of a mucous membrane of an eye and a century; infrequently – a dry keratoconjunctivitis (dryness of a mucous membrane of an eye);
• Nervous system: very often – a headache;
• Musculoskeletal system: often – weakness of the muscles, next to an injection site of solution, that can lead to a ptosis a century, weaknesses of sight (asthenopia) or, in more exceptional cases, to visual disturbances and paresis of face muscles;
• Dermatological reactions: infrequently – a skin itch, rash; seldom – a small tortoiseshell;
• Local reactions: very often – a hematoma, pain, a skin itch, an erythema, paresthesias, rash in Disport injection site.

Post-registration experience of use (in most cases disturbances have moderate and passing character):

• Seldom: headaches, skin allergic reactions, digestive disturbances, dizziness;
• Very seldom: a dysphagy, the expressed muscular weakness, aspiration pneumonia which can lead to a lethal outcome.

Special instructions

Doctors with experience of diagnosis and therapy of these diseases have to apply Disport.

At allergic reactions to the previous injection repeatedly the drug should be administered with care. It is also necessary to be careful at subclinical or clinical manifestations of defeats of neuromuscular transmission, disturbances of functions of breath and swallowing.

The risk of development of side effects because of effect of toxin on the muscles located remotely from a drug injection site decreases at observance of recommendations about dosing and Disport's use in the smallest effective doses.

Against the background of chronic respiratory diseases aspiration in rare instances can develop.

During use of botulinum toxins of type A and B the separate cases of a lethal outcome connected with a pneumopathy, a dysphagy (swallowing disturbance) or at patients with a considerable adynamy were registered.

At development of disturbances of the speech, swallowing and disturbances of breath it is necessary to see a doctor urgently.

The Action Unit (AU) of Disport are specific, and they cannot be compared to PIECE of other medicines with the content of botulotoxin.

Medicinal interaction

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

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 2-8 °C, not to freeze. The disport needs to be stored in the separate marked closed box in the refrigerator of medical institution where injections are carried out.

Period of validity – 2 years.