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

Active substanceBotulinum toxin type A - hemagglutinin complexBotulinum toxin type A - hemagglutinin complex

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Disport®

lyophilizate for injections

IPSEN PHARMA France

Disport®

lyophilizate for injections

IPSEN PHARMA France

RELATOX®

lyophilizate w / m

MICROGEN FGUP Scientific and Production Association Russia

Dosage form: & nbspLIofilizate for solution for injection.

Composition:

One bottle contains

Active substance:

Complex botulinum toxin type A - hemagglutinin 300 BD *

Excipients:

Human albumin 125 mcg

Lactose 2.5 mg

* DB unit of activity of the firm.

Pharmacotherapeutic group:muscle relaxant of peripheral action

ATX: & nbsp

M.03.A.X.01 Botulinum toxin

Pharmacodynamics:

The active ingredient is toxin Clostridium botulinum 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 transmission of the nerve impulse occurs gradually in proportion to formation of new nerve endings and restoration of contacts with postsynaptic motor end plate.

Indications:

Treatment of blepharospasm, hemifacial spasm, spasmodic torticollis, spasticity of the hand after a stroke, hyperkinetic folds (facial wrinkles) of the face in adults.

Treatment of dynamic foot deformation caused by spasticity in children with cerebral palsy from 2 years of age.

Treatment of hyperhidrosis of the axillary region.

Contraindications:

Dysport® is contraindicated in pregnancy and during breastfeeding.

In acute diseases, the administration of the drug is carried out after recovery.

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

Pregnancy and lactation:

Teratological and other reproductive studies with Disport® were not conducted.

The safety of the use of Dysport® in pregnant and lactating women has not been confirmed.

Dosing and Administration:

Bilateral and unilateral blepharospasm, hemifacial spasm

The contents of the vial are diluted with 1.5 ml of 0.9% sodium chloride solution for injection. 1 ml of this solution contains 200 units of Disport®.

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

The recommended initial dose with bilateral blepharospasm - is 120 units per eye.

Subcutaneous injection in a volume of 0.1 ml (20 units) should be done medially and in a volume of 0.2 ml (40 units) laterally into the connection between the presepital and orbital parts of both the lower and upper orbital muscles of the affected eye. For injection in the upper eyelid, the needle should be directed away from the center to Do not touch the muscle that lifts the upper eyelid.

Below is a diagram showing the location of injections.

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

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

In the case of unilateral blepharospasm, the injection should be limited to the area of the affected eye.

Patients suffering from hemifacial spasm should be treated in the same way as patients with unilateral blepharospasm.

Spasmodic torticollis

The contents of the vial are diluted with 0.6 ml of a 0.9% solution of sodium chloride for injection. 1 ml of this solution contains 500 units of Dysport ®.

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

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

With rotational curvature 500 units are administered as follows: 350 units in the belt muscle of the head, ipsilateral to the direction of rotation of the head and 150 units in the sternocleidomastoid muscle, contralateral rotation.

When laterocollis (tilt head to shoulder) The dose of the preparation (500 units) is distributed as follows: 350 units are administered ipsilateral into the belt muscle of the head and 150 units ipsilateral into the sternocleidomastoid muscle.

In cases accompanied by a shoulder lift due to a trapezius muscle or muscle lifting the shoulder blade may require treatment in accordance with apparent muscle hypertrophy or according to electromyographic examination. When an insertion into three muscles is required, a dose of 500 units is distributed as follows: 300 units of the drug are injected into the rib muscle, 100 units into the sternocleidomastoid muscle and 100 units into the third muscle.

With anterocollis (tilt head forward) Introduce 150 units in each of the sternocleidomastoid muscles.

When retrokollis (tilt head back) a dose of 500 units of the drug is distributed as follows: 250 units per each rib muscle of the head. In case of insufficient clinical response to the injection, it is possible after 6 weeks to insert the drug into the trapezius muscles bilateral (at a dose of up to 250 units per muscle). Bilateral injection into the muscle can increase the risk of neck weakness.

With the subsequent administration of the drug, the doses can be adapted in accordance with the effect obtained and the reported side effects. Recommended total doses range from 250 to 1,000 units. The use of higher doses may be accompanied by an increase in the incidence of side effects, in particular dysphagia.

Improvement of symptoms with spastic krivoshe is manifested during the first week after the injection. Injections should be repeated every 8-12 weeks or as needed.

For the treatment of other forms of torticollis great importance is the use of electromyography (EMG) to identify and introduce the drug into the most active muscles. 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 in adults after a stroke

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 a stroke.

0.6 ml of a 0.9% solution of sodium chloride for injections is injected into the vial with the drug, to obtain a solution containing 500 units of Dysport® in 1.0 ml.

The maximum total single dose is 1000 units divided between the following five muscles: m. flexor digitorum profundus (FDP), m. flexor digitorunr superficialis (FDS), m. flexor carpi ulnaris (FCU), m. flexor carpi radialis (FCR) and biceps brachii (BB).

When choosing the site of injection should be guided by standard points of electromyography, and the immediate injection site is determined by palpation.

All muscles except biceps brachii, are injected at one point. Muscle biceps brachii injected at two points. The recommended dose distribution between muscles is given below.

Muscle

FDP

FDS

FCU

FCR

Total dose

Disport®

(units)

300-400

150

150_-250

150

1000

The initial total dose of the drug can be reduced to 500 units to prevent excessive weakness of the injected muscles when the patient's target muscles are small in volume when the injection into the muscle is not injected or when patients are injected into several points of the same muscle. Clinical improvement occurs within two weeks after injections. Injections can be repeated about every 6 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 exposed, correction by introducing botulinum toxin is much less common.

The contents of the vial are diluted with 1.5 ml of 0.9% sodium chloride solution for injection. At this dilution, 1 ml of the solution contains 200 U of Disport®.

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

Interbrozen area

To correct vertical folds in the interbrother area, injections of the drug are made in m. corrugator supercilii for 8-10 units for 2-4 points and in 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 forehead area is done by injecting the drug into the area of maximum stress 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 Dysport® in this area is 30-40 units (maximum 90 units) at a rate of 5-15 units per point, the total number of points is 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 the rate of 5-15 ED of Dysport® per one 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, the total dose of Dysport® 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 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 on 5-10 units for 1-2 points in each muscle.

The miorelaksiruyuschee action of 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.

Dynamic deformation of the foot caused by spasticity in children with cerebral palsy

The contents of the vial are dissolved in 0.6 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 calf muscles. The initial recommended dose is 20 units per 1 kg of the child's body weight divided equally between the gastrocnemius muscles. If only one gastrocnemius is affected, a dose of 10 units per 1 kg of the case is administered. The optimal dose is individual, the subsequent treatment should be planned after the evaluation of the results of the application of the initial dose. To prevent side effects, the total dose should not exceed 1000 units. The drug is administered predominantly in m.gastrocnemius, however, an introduction in m.soleus and 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 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, the administered dose can vary in the range of 10-30 units per kg of body weight, depending on the effect of the previous injection.

Treatment of hyperhidrosis of the axillary region

The contents of the vial are diluted with 1.5 ml of 0.9% solution of sodium chloride for injection, to obtain a solution containing 200 units per ml.

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

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 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 two 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 not more often than 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 injection into the vial by puncturing the plug with a sterile needle of size 23 or 25. The resulting solution is a colorless, clear 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.

Side effects:

During various clinical trials with the drug Disport® involving approximately 7800 patients data were collected on the incidence of adverse reactions, which have the following classification: very common (≥1 / 10), commonly (≥1 / 100 - <1/10) , infrequently (≥1 / 1,000 to <1/100), rarely (<1 / 1,000), very rarely (≥1 / 10,000).

Common side effects:

From the nervous system:

Rarely: neuralgic amyotrophy.

From the skin and subcutaneous tissues:

Infrequent: irritation. Injections can be accompanied by a burning sensation that lasts 1-2 minutes.

Rarely: skin rash.

General and local reactions:

Often: general weakness, fatigue, flu-like syndrome, pain and bruising at the injection site.

Spasticity of the hand in adults after a stroke

In 14 clinical trials involving 141 patients, the following adverse reactions were reported:

From the gastrointestinal tract:

Often: dysphagia.

From the side of the musculoskeletal system and connective tissue:

Often: weakness of the arm muscles.

Injuries and complications of procedures:

Often: accidental injury / fall.

Dysphagia was recorded when doses exceeding 2700 U, administered at one point or distributed between several injection points were used.

Dynamic deformation of the foot caused by spasticity in children with cerebral palsy

In 14 clinical studies involving about 900 patients, the following adverse reactions were reported:

From the gastrointestinal tract:

Often: diarrhea.

From the side of the musculoskeletal system and connective tissue:

Often: weakness of the leg muscles.

From the kidneys and urinary system:

Often: urinary incontinence.

General and local reactions:

Often: abnormal gait.

Injuries and complications of procedures:

Often: accidental injury due to fall.

Accidental injury due to falls and abnormal gait may be the consequence of excessive muscle weakness and / or the spread of the toxin to other nearby injection sites, muscles involved or participating in a particular motor act and in maintaining the balance of the patient's body in a standing and walking position.

Spasmodic torticollis

In 21 clinical studies involving about 4,100 patients, the following adverse reactions were reported:

From the nervous system:

Often: dysphonia.

Infrequently: a headache.

From the side of the organ of vision:

Infrequently: diplopia, a violation of accommodation.

Changes in the respiratory, thoracic and mediastinal systems:

Rarely: respiratory disorders.

From the gastrointestinal tract:

Very often: dysphagia.

Infrequent: dry mouth.

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

Blepharospasm and hemifacial spasm

In 13 clinical studies involving about 1400 patients, the following adverse reactions were reported:

From the nervous system:

Often: weakness of facial muscles.

Infrequently: paresis of facial muscles.

From the side of the organ of vision:

Very often: ptosis.

Often: diplopia, dryness of the mucous membrane of the eye, tearing.

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 injection points, the direction of the needle and the depth of administration) and the resulting excessive diffusion of the drug and temporary paralysis of the muscle group nearby to the injection site.

Axillary hyperhidrosis

In 4 clinical trials involving about 217 patients, the following adverse reactions were recorded:

From the skin and subcutaneous tissues:

Often: compensatory sweating.

Hyperkinetic folds (facial wrinkles) of the face

The following adverse reactions (usually mild to moderate intensity) have been reported with the use of Dysport® to correct hyperkinetic facial creases.

From the side of the organ of vision:

Often: edema of the eyelids and mucous membranes of the eye.

Infrequent: dryness of the mucous membrane of the eye (dry keratoconjunctivitis).

General and local reactions:

Very often: reactions at the injection site (including pain, hematoma, skin itching, paresthesia, erythema, rash, which were also often noted in the placebo group).

From the side of the musculoskeletal system and connective tissue:

Often: the weakness of the adjacent to the site of the introduction of muscles, which also often leads to ptosis of the eyelids, asthenopia (visual fatigue) or, rarely, to the paresis of the facial muscles and vision disorders.

From the nervous system:

Very often: headache (also commonly observed in the placebo group).

From the skin and subcutaneous tissues:

Infrequent: rash, itchy skin.

Rarely: urticaria.

Post-registration application experience

Most side effects are mild and transient. Severe muscle weakness, dysphagia, aspiration pneumonia, which can cause death, occur very rarely at a frequency of 1 per 10,000 (see section "Warnings and Precautions").

Rarely: digestive disorders (diarrhea), skin allergic reactions, dizziness, headaches.

Overdose:

The use of large doses of the drug may lead to generalized muscle weakness. When the paralysis of the respiratory muscles requires artificial ventilation.In case of an overdose, administration of an antitoxin (anti-botulinum serum) is appropriate within the first three hours. As a rule, treatment of an overdose is aimed at general supportive therapy with constant monitoring of the patient.

Interaction:

Drugs that affect neuromuscular transmission, such as antibiotics of the aminoglycoside group, should be used with caution.

Special instructions:

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.

With extreme caution, the drug should be re-administered to patients who are allergic to the previous injection.

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 following the recommendations for dosing the drug and applying the minimum effective doses of the drug.

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

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

Against the background of ongoing therapy with botulinum toxins of type A or B, single deaths were caused by dysphagia (impaired swallowing), pneumopathy, or in patients with severe 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 Disport®. 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.

Note: When administering Disport®, it should be borne in mind that the units of action of the drug are specific and can not be compared with those of other preparations containing botulinum toxin.

INSTRUCTIONS FOR PROCESSING OF RESIDUES OF SOLUTIONS OF THE PREPARATION

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.

Effect on the ability to drive transp. cf. and fur:No information.

Form release / dosage:

Liofilizate for the preparation of solution for injection, 300 units.

Packaging:

300 IU in a glass vial, sealed with a rubber stopper covered with aluminum burnishing with a needle hole in the center and closed protective plastic cover of the first control opening.

1 vial, fixed in the cardboard holder, together with the application put in a pack of cardboard.

Storage conditions:Store and transport all types of indoor transport at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

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

Dysport® can not be given to the patient for storage.

Shelf life:

2 years.

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

Terms of leave from pharmacies:For hospitals

Registration number:LP-001486

Date of registration:08.02.2012 / 14.06.2016

Expiration Date:08.02.2017

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: & nbsp10.11.2016

Illustrated instructions

Instructions

Disport® (Dysport®)