Dysport - instructions for use, doses, side effects, contraindications

Active substance:
Complex botulinum toxin type A - hemagglutinin	500 units *
Excipients:
Human albumin	125 μg
Lactose	2.5 mg
* Unit of activity of the firm.

Pharmacotherapeutic group:muscle relaxant of peripheral action

ATX: & nbsp

M.03.A.X.01 Botulinum toxin

Pharmacodynamics:

Complex toxin Clostridium botulinum type A - hemagglutinin blocks the release of acetylcholine from the presynaptic nerve end, thus disrupting the peripheral cholinergic transmission in the neuromuscular synapse. The toxin has an antagonistic effect on the processes leading to the release of the neurotransmitter, whose trigger is the Ca²⁺. This does not affect postganglionic cholinergic transmission or postganglionic sympathetic transmission.

The toxin action includes the initial stage in which the toxin binds rapidly and intensively to the membrane of the presynaptic end. The second is the stage of internalization, during which the toxin crosses the presynaptic membrane without causing paralysis. Finally, the toxin inhibits the release of acetylcholine, disrupting the mechanism of Ca²⁺mediated release of acetylcholine, thereby reducing the potential of the terminal plate and causing paralysis.

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 (a process that takes 6-8 weeks in experimental animals).

Indications:

Dysport® is indicated for the treatment of focal spasticity, including:

- symptomatic treatment of focal spasticity of the upper extremities in adults;

- dynamic deformation of the foot caused by spasticity in children with cerebral palsy from 2 years of age;

Also, Dysport® is indicated for the treatment of the following disorders:

- cervical dystonia in adults;

- Blepharospasm in adults;

- hemifacial spasm in adults;

- hyperhidrosis of the axillary region;

- temporary improvement in the appearance of hyperkinetic folds (facial wrinkles) of the face from moderate to severe in adults patients younger than 65 years of age, when the severity of these wrinkles has a serious psychological impact on the patient.

Contraindications:

Dysport® is contraindicated in patients with hypersensitivity to any of the components of the drug.

Pregnancy and lactation:

There is a limited amount of data on the application of the toxin complex Clostridium botulinum type A - hemagglutinin in pregnant women. Animal studies did not show a direct or indirect adverse effect on the course of pregnancy, embryonic / fetal development of the fetus, the course of labor or postnatal development, with the exception of toxic effects on the maternal organism when high doses are applied. Dysport® can be used during pregnancy only if the expected benefit of treatment exceeds the possible risk to the fetus. Therefore, special care should be taken when using the drug in pregnant women.

It is not known whether the toxin is excreted Clostridium botulinum type A - hemagglutinin in female milk. These studies have not been conducted in animals. Therefore, the use of Dysport® during breastfeeding is contraindicated due to the lack of data.

Dosing and Administration:

Blepharospasm and hemifacial spasm in adults

In the treatment of blepharospasm and hemifacial spasm, Dysport® is diluted to a concentration of 200 U / ml (see Table 1). The drug is used as a subcutaneous injection medially and laterally into the connection between the presapeptal and ophthalmic parts of the upper and lower parts of the circular eye muscle (m. orbicularis oculi).

Based on the range of doses used in clinical trials, the initial dose of Dysport®, for the treatment of blepharospasm, is 40 units per eye (based on the efficacy / tolerability ratio).

The maximum dose for the treatment of blepharospasm and hemifacial spasm should not exceed 120 units per eye.

Injections in the volume of 0.05 ml (10 units) should be done medially and laterally in the joint between the pre-osseous and orbital parts of the upper (3 and 4) and lower (5 and 6) parts of the circular musclem. orbicularis oculi) each eye.For injections into the upper eyelid, in order to reduce the risk of ptosis, the needle should be directed away from the center, so as not to hurt the muscle lifting the upper eyelid (m. levator palpebrae superioris). Below is a diagram showing the location of injections.

Injections should be repeated approximately every 12 weeks or according to indications to prevent recurrence of symptoms (but no more often than once every 12 weeks).

Depending on the severity of the disease, if the effect of the previous injection was not achieved, with each subsequent administration of the drug, the total dose should be increased to:

- 60 units / eye (for example, 0.05 ml (10 U) medially and 0.1 ml (20 U) laterally),

- 80 units / eye: (for example, 0.1 ml (20 units) medially and 0.1 ml (20 U) laterally),

- or up to 120 U / eye: (for example, 0.1 ml (20 U) medially and 0.2 ml (40 U) laterally), above and below each eye, as described previously. If the spasm affects visual acuity, additional insertion points in the frontal muscle (m. frontalis) above the eyebrow (1 and 2). Doses of 80 units and 120 units per eye have a longer lasting effect. However, the incidence of adverse reactions, including ptosis, is dose-dependent.

In the case of unilateral blepharospasm, injections should be limited to the area of the affectedeyes.

Patients with hemifacial spasm are treated in the same way as patients with unilateral blepharospasm.

Recommended doses are used in adults of any age, including elderly patients.

The safety and efficacy of Dysport® in the treatment of blepharospasm and hemifacial spasm in children has not been confirmed.

Cervical dystonia in adults

In the treatment of cervical dystonia, Dysport® is diluted to a concentration of 500 U / ml (see Table 1). The drug is used as intramuscular injection according to the scheme given below.

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

The initial total single dose of the drug for the treatment of cervical dystonia is 500 units. This dose is distributed between two or three of the most active muscles of the neck.

With a rotational krivoshee 500 units are introduced 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 (t. sternocieidomastoideus), contralateral rotation.

With laterocollis (head-to-shoulder tilt), the dose of the drug (500 units) is distributed as follows: 350 units are inserted ipsilateral into the belt muscle of the head (m. splenius capitis) and 150 ED and ipsilateral in the sternocleidomastoid muscle (m. sternocieidomastoideus). In cases involving a shoulder lift due to a trapezius muscle (m. trapezius or the muscle that lifts the scapula (m. levator scapulae), may require treatment in accordance with apparent muscle hypertrophy or according to electromyographic examination. When an injection into three muscles is required, the dose of 500 units is distributed as follows: 300 units of the drug are injected into the belt muscle of the head (m. splenius capitis), 100 ED - in the sternocleidomastoid muscle (m. sternocieidomastoideus) and 100 units - in the third muscle (trapezius muscle or muscle lifting the scapula).

With retrocollis (tilt head back), the dose of 500 units of the drug is distributed as follows: 250 units per each rib muscle of the head (m. splenius capitis). Bilateral injection into the rib muscle of the head (m. splenius capitis) may increase the risk of weakness of the neck muscles.

For the treatment of other forms of cervical dystonia, 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 cervical dystonia or to re-examine 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 to palpable neck muscles.

With the subsequent administration of the drug, the doses can be adapted in accordance with the effect obtained and the resulting side effects. The recommended total doses are in the range of 250 to 1000 units, the use of higher doses may be accompanied by an increase in the incidence of side effects, in particular dysphagia. The maximum total single dose should not exceed 1000 units.

Injections can be repeated every 16 weeks or as needed, but not more often than every 12 weeks.

The safety and efficacy of Dysport® in the treatment of cervical dystonia in children has not been confirmed.

Symptomatic treatment of focal spasticity of the upper limbs in adults

The maximum total single dose should not exceed 1000 units.

In the treatment of focal spasticity of the upper limb, Dysport® is diluted to a concentration of 100 U / ml,200 U / ml or 500 U / ml (see Table 1). The drug is used as intramuscular injection according to the scheme given below.

Dosage in the initial and subsequent treatment sessions should be associated with individual characteristics and be based on the size, amount and location of the involved muscles, the degree of spasticity, the presence of local muscle weakness, the patient's response to previous treatment and / or anamnesis of adverse events in the treatment of botulinum toxin type complex A - hemagglutinin. In clinical studies, doses of 500 U, 1000 U were distributed between the muscles involved in the injection session and indicated in the table below.

No more than 1 ml of solution can be injected into a single point.

Table. Dosport® dosage for the treatment of focal spasticity of the upper limbs by muscles

Injectable muscles	Recommended doses of Dysport® (ED)
Radial wrist flexor (m. flexor carpi radialis (FCR))	100-200
The ulnar flexor of the wrist (m. flexor carpi ulnaris (FCU))	100-200
Deep flexor of fingers (m. flexor digitorum profundus (FDP))	100-200
Superficial flexor of fingers (m. flexor digitorum superficialis (FDS))	100-200
The long flexor of the thumb of the hand (m. flexor pollicis longus)	100-200
The muscle that leads the thumb of the hand (m. adductor pollicis)	25-50
Shoulder Muscle (m. brachialis)	200-400
Bronchial muscle (m. brachioradialis)	100-200
The biceps brachialis muscle (m. biceps brachii)	200 - 400
Round pronator (m. pronator teres)	100 -200
Triceps brachialis (m. triceps brachii) long head	150-300
Large pectoralis muscle (m. pectoralis major)	150-300
Subscapular muscle (m. subscapularis)	150-300
The widest back muscle (m. latissimus dorsi)	150-300

Despite the fact that the immediate injection site is determined by palpation, it is recommended to follow the standard definition techniques, such as electromyography, electrical stimulation or ultrasound, to choose the site of injection.

Repeated injections of Dysport® should be performed after the effect of the previous injection has decreased, but not earlier than 12 weeks. Most patients in clinical trials received repeated injections in 12-16 weeks; however, some patients had a longer lasting effect - up to 20 weeks.

The degree and pattern of spasticity of the muscles at the time of re-injection may require a change in the dose of Dysport® and muscle for injection. Clinical improvement can be expected one week after the injection of Dysport®.

The safety and efficacy of Dysport® in the treatment of focal spasticity of the upper limb in children has not been confirmed.

Elderly patients (≥65 years of age): the clinical experience of the application did not reveal differences in response in the elderly and in young patients.

Temporarily improve the appearance of hyperkinetic folds (facial wrinkles) of the face from moderate to severe in adults younger than 65 years of age, when the severity of these wrinkles has a serious psychological effect on the patient

In the treatment of facial wrinkles, Dysport® is diluted to a concentration of 200 U / ml (see Table 1). The drug is used according to the schemes given below.

The main area of application of the drug 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.

When carrying out injections, it is recommended to use sterile needles of caliber 29-30 G.

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

Interbrozen area

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

Forehead area

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

The area of the outer corner of the eye

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® per single injection point. The number of points from 2 to 4 per 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 the total dose of Dport® can be reduced by 15-20 units for the respective areas during the second and subsequent injections.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.

Nasal adhesion area

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.

Points of introduction

The miorelaksiruyuschee action 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® for use in aesthetic medicine do not cause systemic side effects.

Use in children

The safety and effectiveness of the treatment of interbrow wrinkles with botulinum toxin type A in children younger than 18 years has not been confirmed.

Dynamic deformation of the foot caused by spasticity in children with cerebral palsy from 2 years of age

In the treatment of spasticity in children with cerebral palsy, Dysport® is diluted to a concentration of 500 U / ml (see Table 1). The drug is used as intramuscular injections in gastrocnemius muscles (m. gastrocnemius) according to the scheme given below.

The initial recommended dose is 20 units per 1 kg of the child's body weight divided equally between the gastrocnemius muscles (m. gastrocnemius). When one calf muscle is injured (m. gastrocnemius) it is administered a dose of 10 units per 1 kg of body weight. Consideration should be given to reducing this initial dose if there is reason to believe that it can lead to excessive weakness of target muscles, for example in patients in which target muscles are small in volume or in patients who require concomitant injections into other muscle groups. After evaluating the results of the application of the initial dose, the subsequent dose administered may vary in the range from 10-30 ED per kg of body weight, divided between two legs. The maximum total dose should not exceed 30 units / kg or 1000 units / patient (the lower of the two). The drug is introduced mainly into the gastrocnemius muscle (m. gastrocnemius), but it is possible to insert into soleus muscle (m. soleus) and posterior tibialis muscle (m. tibialis posterior). To determine the most active muscles, you can use the method of electromyography.

Clinical improvement can be expected within the first two 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.

Hyperhidrosis of the axillary region

In the treatment of hyperhidrosis of the axillary region, Dysport® is diluted to a concentration of 200 U / ml (see Table 1). The drug is used intradermally according to the schemes given below.

The recommended initial dose of treatment for axillary hyperhidrosis is 100 units per axillary area. If the desired effect is not achieved, then a subsequent dose increase of up to 200 units of Dysport® is possible. The maximum single dose should not exceed 200 units per axillary area.

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 sample 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 units of drug are injected into each point in a volume of 0.05 ml, i.e. 100 units per area. 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.

The safety and efficacy of Dysport® in the treatment of hyperhidrosis of the axillary region in children has not been confirmed.

RULES OF PREPARATION OF SOLUTION FOR INJECTIONS

Remove the protective plastic cover of the first opening from the vial.

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.

For each indication to use the necessary concentrations are specific.

Table 1

The resulting dose in U / ml	The amount of solvent (0.9% solution of sodium chloride for injection), ml
500	1,0
200	2,5
100	5

The resulting solution is a colorless transparent liquid. Diluted preparation can be stored for no more than 24 hours at a temperature of 2 ° C to 8 ° C.

Side effects:

Adverse reactions described in this section have the following classification: very often (> 1/10), often (> 1/100 - <1/10), infrequently (> 1/1000 - <1/100), rarely (> 1/10000 - <1/1000), very rarely (<1/10000).

Common side effects.

In 25% of patients treated with Dysport®, adverse events were noted during clinical trials for indications: blepharospasm; hemifacial spasm; cervical dystonia, spasticity caused by cerebral insufficiency, stroke or traumatic head injury; axillary hyperhidrosis; hyperkinetic folds of the face.

From the nervous system:

Rarely: neuralgic amyotrophy.

From the skin and subcutaneous tissues:

Infrequently: itching.

Rarely: rash.

General and local reactions:

Often: asthenia, fatigue, flu-like syndrome, pain / hematoma at the injection site.

Symptomatic treatment of focal spasticity of the upper limbs in adults

In controlled clinical trials, the following adverse reactions were reported:

General and local reactions:

Often: the expected manipulations in the form of injections were announced: pain at the injection site, erythema at the injection site, swelling at the injection site, and the like.

Infrequently: asthenia, fatigue, flu-like syndrome.

From the side of the musculoskeletal system and connective tissue:

Often: muscle weakness.

In the open clinical trials, the following adverse reactions were reported:

General and local reactions:

Disturbances of gait, bruising or bleeding at the injection site.

From the side of the musculoskeletal system and connective tissue:

Musculoskeletal pain, pain in the extremities.

From the nervous system:

Increased muscle tone.

From the gastrointestinal tract:

Often: dysphagia.

Dynamic deformation of the foot, caused by spasticity in children with cerebral palsy from 2 years of age

From the gastrointestinal tract:

Often: diarrhea.

From the side of the musculoskeletal system and connective tissue:

Often: muscle weakness.

From the kidneys and urinary system:

Often: urinary incontinence.

General and local reactions:

Often: violations of gait.

Injuries and complications of procedures:

Often: accidental injury / fall.

Accidental injury due to falls and abnormal gait may result from excessive muscle weakness and / or the spread of toxin to other nearby muscles that are involved in or involved in a particular motor act and to maintain the balance of the patient's body in standing and walking position.

Cervical dystonia in adults

From the nervous system:

Often: headache, dizziness, paresis of the facial nerve.

From the side of the organ of vision:

Often: blurred vision, reduced visual acuity.

Changes in the respiratory, thoracic and mediastinal systems:

Often: dysphonia, dyspnoea.

From the gastrointestinal tract:

Very often: dysphagia, dry mouth.

Infrequently: nausea.

From the side of the musculoskeletal system and connective tissue:

Very often: muscle weakness.

Often: pain in the neck, musculoskeletal pain, myalgia, pain in the limbs, musculoskeletal stiffness.

Infrequent: muscle atrophy, weakness of the muscles of the lower jaw.

Dysphagia has a dose-dependent effect and occurs most often when the drug is injected into the sternocleidomastoid muscle (m. stemocleidomastoideus). You may need a diet with the exception of rough food until the symptoms disappear.

Blepharospasm and hemifacial spasm in adults

From the nervous system:

Often: paresis of facial muscles.

Infrequent: paralysis of the facial nerve.

From the side of the organ of vision:

Very often: ptosis.

Often: diplopia, dry eyes, teardrop.

Rarely: ophthalmoplegia.

From the skin and subcutaneous tissues:

Often: swelling of the eyelids.

Rarely: the turn of the century.

Side effects may occur if the doctor fails to comply with the rules of the injection (dilution, precise calculation of the administered dose, the correct choice of the injection points, the direction of the needle and the depth of administration) and the associated excessive diffusion of the drug and temporary paralysis of the muscle groups near the injection site.

Hyperhidrosis of the axillary region

From the skin and subcutaneous tissues:

Often: compensatory sweating.

Temporary improvement in the appearance of hyperkinetic folds (facial wrinkles) of the face from moderate to severe in adults over 65 years of age, When the severity of these wrinkles has a serious psychological effect on the patient

The following adverse reactions (usually from mild to moderate intensity) were recorded with the use of the drug Dysport® to correct hyperkinetic folds of the face.

From the side of the organ of vision:

Often: asthenopia (weakness of vision), ptosis of the eyelids, edema of the eyelids, increased teardrop, dry eyes, twitching of the muscles around the eye.

Infrequent: vision disorders, blurred vision, diplopia, oculomotor disorders.

General and local reactions:

Very often: reactions at the injection site, including pain, hematoma, pruritus, paresthesia, erythema, rash.

(Comment: these reactions were often observed in placebo groups).

From the immune system:

Rarely: hypersensitivity.

From the side of the musculoskeletal system and connective tissue:

Often: weakness of the muscles nearby to the injection site.

From the nervous system:

Very often: headache.

Often: paresis of facial muscles.

From the skin and subcutaneous tissues:

Infrequent: rash, itchy skin.

Post-registration application experience

The profile of the side effects of the drug during post-marketing application reflects the pharmacological properties of the preparation and corresponds to the profile of side effects registered in the clinical trials. In addition, cases of hypersensitivity reactions have been reported.

Side effects associated with the site of the injection, the spread of toxin (widespread muscle weakness, dysphagia, aspiration / aspiration pneumonia) were identified.

Overdose:

The use of large doses of the drug can cause distant and deep neuromuscular paralysis. Overdose can lead to an increased risk of neurotoxin entering the circulatory system and can cause complications that are associated with the effects of food poisoning with botulinum toxins (such as dysphagia and dysphonia). When paralysis of the respiratory muscles caused by an overdose, it may be necessary to carry out artificial ventilation of the lungs. There is no specific antidote; It is not expected that antitoxin will be useful and general supportive care is recommended.If necessary, symptomatic treatment is performed.

Symptoms of overdose may not appear immediately after the injection.

In case of an overdose with injection or accidental ingestion, the patient should be under medical supervision for several weeks to observe possible symptoms of increased muscle weakness or muscle paralysis.

Interaction:

The effect of botulinum toxin can enhance the effect of drugs that directly or indirectly affect neuromuscular function (such as aminoglycosides, curare-like nondepolarizing blockers) and such drugs should be used with caution in patients undergoing botulinum toxin therapy.

Special instructions:

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

The shed preparation should be wiped with an absorbent cloth soaked in a 1% solution of sodium hypochlorite.This preparation / solution can also be inactivated by autoclaving; the minimum temperature is 121 ° С.

PRECAUTIONS FOR USE

Treatment with the drug should be carried out by specialists who have experience in the diagnosis and treatment of such conditions, and trained in the treatment.

Side effects were observed as a result of the action of toxin on the muscles far from the injection site (see section "Side effect"). Patients receiving Dysport® at 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 minimum effective dose of the drug and not exceed the maximum recommended dose.

Against the backdrop of ongoing therapy with botulinum toxins such as A or B, very rare deaths were caused by dysphagia (swallowing), pneumopathy (including but limited to dyspnea, respiratory insufficiency, respiratory arrest), and / or in patients with severe asthenia.

Patients with diseases leading to the defeat of neuromuscular transmission, difficulties in swallowing or breathing have a higher risk of developing these effects. In such patients, treatment with Dysport® should be performed under strict medical supervision and only if the expected benefit exceeds the possible risk.

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

In patients with chronic respiratory diseases, in rare cases there is a risk of aspiration.

Patients with subclinical or clinical manifestations of neuromuscular transmission (because myasthenia gravis) should undergo therapy with the drug only under the careful supervision of medical workers. Such patients may have increased sensitivity to botulinum toxin preparations, which can cause them to have pronounced muscular weakness.

Do not exceed recommended doses and frequency of drug administration, as this can lead to an overdose and an increased risk of side effects.

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

To treat spasticity associated with cerebral palsy, Dysport® should be used in children 2 years of age or older. Before the application, an initial functional evaluation is necessary. When calculating the dose of the drug takes into account the weight of the patient, age, the state of hyperactive muscles involved in the formation of dynamic equinus. To assess the effectiveness of the introduction, the patient is examined, spasticity scales tested, goniometry, if necessary, neurophysiological studies, if possible, video analysis of walking, with the consent of the patient / his parents - photo and video monitoring.

Disport® should not be used to treat spasticity in patients with fixed contracture.

As with other drugs for intramuscular injection, Dport® can be used in patients with delayed coagulation time and inflammation / infection at the intended site of administration only in cases of extreme need.

Before using the drug Dysport ® to correct hyperkinetic folds of the face, it is necessary to take into account the individual features of the facial anatomy: asymmetry, ptosis, excessive dermatochalasis, the presence of scarring and any other changes in anatomy of the face that arose as a result of previous surgical interventions.

A bottle of Dysport® should be used to treat only one patient during one procedure. Remains of the drug should be disposed of in accordance with the recommendations set out in the section "Guidelines for the treatment of drug residue residues". During preparation, use and disposal of residues, specific precautions must be followed.

As part of the drug Dysport ® contains a small amount of albumin, respectively, it is impossible to completely exclude the risk of transmission of viral infections using this drug.

The formation of antibotulin antibodies was observed in rare cases in patients who were treated with Dysport®. Clinically neutralization of antibodies was manifested by a decrease in the therapeutic effect, which required a constant increase in the doses of the drug.In three clinical trials where Dysport® was used to treat focal spasticity of the hand in adults, the presence of these antibodies did not have a significant effect on the efficacy of the drug in those patients who had an antibody neutralization process and did not cause any unexpected manifestation in the incision the safety profile of the drug Dysport®.

Note: When prescribing Dysport®, it should be taken into account that the units of action of the drug are specific and can not be compared with those of other preparations containing botulinum toxin.

Form release / dosage:

Lyophilizate for solution for injection, 500 units.

Packaging:

For 500 units in a glass bottle sealed with a rubber stopper under aluminum with a hole for the needle in the center and closed with a protective plastic cover for the first opening.

1 The vial, fixed in the cardboard holder together with the instruction for use, is placed in a cardboard pack.

Storage conditions:

Store and transport all types of indoor transport, at a temperature of 2 to 8 ° C.

Do not freeze.

Dysport® is stored in a separate closed labeled box in the institution's refrigerator where the injections of the drug are carried out.

Keep out of the reach of children.

Shelf life:

2 of the year.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011520 / 01

Date of registration:15.08.2011 / 01.04.2015

Expiration Date:Unlimited

The owner of the registration certificate:IPSEN PHARMA IPSEN PHARMA France

Manufacturer: & nbsp

IPSEN BIOPHARM, Ltd. United Kingdom

Representation: & nbspIPSEN PHARMA IPSEN PHARMA France

Information update date: & nbsp11.10.2016

Illustrated instructions

Instructions

Disport® (Dysport®)