Dysport: instructions for using the medicine, structure, Contraindications

Active material: botulinum toxin type A
When ATH: M03AX01
CCF: Miorelaksant. The inhibitor of acetylcholine release
ICD-10 codes (testimony): G24.3, G24.5, G80, H50, R25.2
When CSF: 02.10.02
Manufacturer: BEAUFOUR IPSEN INTERNATIONAL (France)

Dysport: dosage form, composition and packaging

Excipients: human albumin (125 g), lactose (2.5 mg).

* – 1 ED is equivalent to LD₅₀ dose for mice after intraperitoneal injection.

Units of the drug Dysport are specific and can not be compared with those of other drugs, containing botulinum toxin.

Bottles glass volume 3 ml (1) – packs cardboard.

Dysport: pharmachologic effect

Miorelaksant. The therapeutic effect is due to the biological effects of Clostridium botulinum toxin type A, that blocks the release of acetylcholine at the neuromuscular synapse, that leads to the removal of muscle spasm in injection. Recovery of neuromuscular transmission occurs gradually, as the formation of new nerve endings and restore contacts with the postsynaptic motor endplate.

Dysport: pharmacokinetics

Data on the pharmacokinetics of the drug Dysport^® not available.

Dysport: testimony

For use in adults:

• Nictitating spasm;
• hemifacial spasm;
• spasmodic torticollis;
• muscle spasticity after a stroke;
• hyperkinetic folds (wrinkles) person.

For use in children older 2 years:

• dynamic deformation of the foot, caused by spasticity, for cerebral palsy.

Dysport: dosing regimen

Bilateral and unilateral blepharospasm, hemifacial spasm

To adults and elderly patients to the treatment of bilateral blepharospasm The recommended starting dose is 120 U per eye. The drug is administered s / c in a volume 0.1 ml (20 ED) medially, in volume 0.2 ml (40 ED) – laterally into the connection between preseptalnoy and orbital parts of both the lower, and the upper orbital muscles of each eye. For injections into the upper lid the needle should be directed away from the center, not to touch the muscle, lifting the upper eyelid. Below is a diagram, showing the place of injection.

SCHEME

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

To relapse prevention administration of the drug should be repeated every 8 or weeks depending on the clinical situation. Each subsequent introduction of the dose should be reduced to 80 ED on the eye. For Example, 0.1 ml (20 ED) and medially 0.1 ml (20 ED) laterally above and below the eye by the method, to the above. Subsequently, the dose can be reduced to 60 ED on the eye, by avoiding the introduction in the medial lower eyelid. Subsequent doses are determined depending on the resulting effect.

At unilateral blepharospasm injections should be limited to the area of ​​the affected eye. A similar treatment is carried out at hemifacial spasm.

Spasmodic torticollis

The contents of the vial is diluted 1 ml 0.9% sodium chloride solution for inektsiy.1 ml of this solution contains 500 U of Dysport^®. Doses, Recommended for treatment of torticollis, apply at Adult, having a normal body weight and satisfactory development of the neck muscles. Reducing the dose may in severe weight loss or the elderly, with reduced lean body mass.

For the treatment of spasmodic torticollis Initial recommended single dose of 500 ED, the drug is administered in installments 2 or 3 The most active neck muscles.

At rotational torticollis 500 ED drug is administered as follows:: 350 ED splenius capitis muscle ipsilateral to the direction of rotation of the head and 150 ED sternocleidomastoid muscle, contralateral rotation.

At laterokollise (tilting the head to one side) dose 500 Units are distributed as follows: 350 U injected into the ipsilateral splenius capitis muscle and 150 ED – ipsilateral to sternocleidomastoid muscle. In cases, accompanied by raising arm by the trapezius muscle or muscle, levator scapula, It may require treatment in accordance with the visible muscle hypertrophy or according electromyography.

When administered drug 3 muscle dose 500 ED is distributed as follows: 300 U injected into the muscle of the belt, 100 ED – in the sternocleidomastoid muscle, 100 ED – a third arm.

At anterokollise (tilt your head forward) administered by 150 ED both sternocleidomastoid muscle.

At retrokollise (Tilt your head back) dose 500 Units are distributed as follows: administered by 250 IU each splenius capitis muscle. Then may follow injections bilaterally in the trapezius muscles (to 250 ED on the muscle). Repeated injections may be made later 6 weeks, if a sufficient effect is not observed.

It should be taken into account, bilateral injections into the muscle belt can increase the risk of neck muscle weakness.

At the subsequent administration of the drug according to the clinical effect and there are side effects of the dose can be brought to optimum. The recommended dose – 250-1000 ED. In applying the drug in a dose of 1000 ED increases the risk of side effects, especially dysphagia. Therefore, use of the drug in a dose of 1000 ED is not recommended.

Clinical improvement in spastic torticollis celebrated for 1 weeks after injection. It is recommended that the reintroduction of the drug every 8-12 weeks or as required to prevent recurrence.

Treatment of all other forms of torticollis held on individual schemes, which selects the physician with the EMG data on the most active muscles. EMG should be used for the diagnosis of complex forms of torticollis, or on patients with the lack of positive dynamics after administration. EMG is also used when administered Dysport^® deep muscles or in patients who are overweight when poorly palpable neck muscles.

Spasticity hands after stroke in adults

The vial is introduced 1 ml 0.9% solution of sodium hloida, to give a solution, comprising 500 U of Dysport^® in 1 ml. The maximum dose is 1000 ED, to be distributed among the following 5 muscle: longeal inches deep, Superficial fingers longeal, m. flexor carpi ulnar, m.flexor carpi radialis, m.biceps arm.

When choosing the site of injection should be guided by the standard points electromyography, and direct injection site is determined by palpation. In all muscles, кроме biceps femoris, Injection is performed at one point. M.biceps arm инъецируют в 2 points. The recommended dose distribution between the muscles is shown in Table.

The initial total dose can be reduced to 500 IU to prevent excessive weakness of the muscles injected in cases, when the target muscle small volume, when injected into m.biceps brachii not performed, or when the patient is injected at several points one muscle.

Clinical improvement occurs within 2 weeks after injection. Injections may be repeated approximately every 16 weeks or as needed to maintain the effect, but not more, than every 8 weeks.

Treatment of hyperkinetic wrinkles (facial wrinkles) person

The main area of ​​use of the drug for the purpose of cosmetic correction is the upper half of the face. The lower half of the face and neck is adjusted by the introduction of botulinum toxin is much less (in these areas it is preferred to use other methods).

The contents of the vial is diluted 2.5 ml 0.9% sodium chloride solution for injection. At this dilution 1 ml solution contains 200 U of Dysport^®.

The total recommended dose for a single injected all four areas (mezhbrovnaya region, the forehead, the outer corner of the eye and the bridge of the nose) should not exceed 200 U of Dysport^®.

• Correction brow area;
• Correction of the forehead;
• Correction of the nasal bridge area;
• correction of the outer corner of the eye.

To correction of vertical folds in brow area injections are made in m.corrugator supercilii on 10-20 ED 2-4 points and m.procerus on 5-10 ED 1-2 score. The total dose of 30 to 100 ED.

Elimination of hyperkinetic wrinkles in forehead produced by injection to the maximum voltage m.frontalis. The number of injection points may be arbitrary. All of them should be placed on 2 cm above the eyebrows on the same line or V-shaped. The injections are made in a total dose 20-90 U of Dysport^® based on 5-15 IU per point, the total number of points 4-6.

Correction of folds in the area of ​​the outer corner of the eye (“crow's feet”) made n / a point of introduction, located at 1 cm laterally from the outer corner of the eye, calculated 5-15 U of Dysport^® One point of administration. Number of points 2 to 4 in each eye. The maximum recommended total dose of both sides of 120 ED.

The frequency of injections depends on the timing of recovery of facial muscle activity. The duration of effect is 3-4 Months. If during the first injection was administered dose is adequate, during the second and subsequent injections total dose of Dysport^® It can be reduced to 15-20 ED for respective areas. It is possible to increase the period of preparation before 6-9 Months. If the initial dose was insufficient, then when repeated injections should increase its.

To correction of wrinkles in the back of the nose injection performed in the middle of the abdominal muscles nasal. The dose is distributed over the 5-10 ED 1-2 point of each muscles.

Muscle relaxant effect of Dysport^® on facial muscles clinically for 2-3 day after administration and reaches a maximum at 14-15 day. The doses of Dysport^®, used in aesthetic medicine, do not have systemic side effects.

Dynamic foot deformity, spasticity caused by cerebral palsy in children under age 2 years

The contents of the vial is dissolved in 1 ml 0.9% sodium chloride solution for injection, to give a solution, comprising 500 ED 1 ml.

The drug is introduced into / m in the calf muscles. The initial recommended dose is 20 U / kg body weight and divided equally between the calf muscles. With the defeat of only one calf muscle drug is administered at a dose of 10 U / kg. The optimal dose is determined individually, and subsequent treatment should be planned after the evaluation of the application of the starting dose. To avoid side effects, do not exceed the maximum dose 1000 ED. Preferably the drug is administered in m.gastrocnemius, However, the introduction in m.soleus and m.tibialis posterior. In order to determine the most active muscles can use the method electromyography. The initial dose of the drug reduced to prevent excessive weakness of the muscles injected in cases, when the target muscle of the patient is small or when the volume requires administering the drug in additional muscle groups. In a subsequent evaluation of treatment the dosage administered can vary from 10 to 30 ED 1 kg body weight of the patient and is distributed between the muscles of both legs. Clinical improvement occurs within 2 weeks after injection. Injections may be repeated approximately every 16 weeks or as needed to maintain the effect, but not more than 8 weeks.

Terms of solution for injection

On the bottle is removed the protective plastic cover of the first control opening.

Dilution of the drug may not open a bottle, Remove the plug. Immediately prior to breeding the central portion of the vial stopper should be treated with alcohol. Lyophylisate divorce, introducing the desired amount in a bottle 0.9 % sodium chloride solution for injection, by cork sterile needle puncture size 23 or 25. The resulting solution is a colorless transparent liquid. Since the product does not contain a preservative, it is recommended to use it immediately after dissolution. The product can be stored for no more than 8 hours at a temperature of from 2 ° to 8 ° C after dissolution, provided, that the dissolution was carried out under aseptic conditions.

Rules for handling tools and waste destruction

Immediately after the injection of the remaining solution in a vial or in a syringe should inactivate a dilute solution of sodium hypochlorite, contains 1% chlorine. All supporting materials must be disposed of by methods, provided for the destruction of biological waste. Spilled preparation should be removed absorbent cloth, dipped in a solution of sodium hypochlorite.

Dysport: side effects

Allergic reactions: skin rash.

Local reactions: burning sensation during 1-2 m.

Other: flu-like symptoms. When correction of hyperkinetic facial wrinkles, this is not a side effect.

At the treatment of blepharospasm and hemifacial spasm side effects can occur with non-compliance of the rules physician performing the injection (breeding, exact calculation of the administered dose, correct choice of injection points, direction and depth of insertion of needle) and related excessive diffusion of the drug into surrounding the injection site muscle groups. It is also necessary to take into account the anatomical and physiological characteristics of the patient injected muscles. The most common blepharoptosis. A few patients had diplopia or symptoms, evidence of the spread of miorelaksiruyuschego action on neighboring muscles of the face (These phenomena are within 2-4 Weeks after injection produced). There may be a dry eye, and the development of keratitis due to reduced frequency of blinking (In these cases, it shows the use of artificial tears). There may be bruising and swelling eyelids short-term nature. Also, you may experience a reversible outer ophthalmoplegia when using the drug in high doses.

At the treatment of spasmodic torticollis side effect is the result of deep injection or for injection into the muscle correctly selected and points, resulting in excessive weakness of nearby muscles. The most common dysphagia. In a double-blind, placebo-controlled trial of the drug, dysphagia was observed in 29% patients, which was administered Dysport^® dose 500 ED, and 10% patients, placebo. Dysphagia is dose dependent and the most frequently observed during administration of the drug in the sternocleidomastoid muscle. With the development of dysphagia should refrain from eating roughage until symptoms. In patients with severe dysphagia during laryngoscopy mentioned accumulation of saliva. In rare cases, such patients may require aspiration, especially when airway obstruction.

Perhaps the development of weak neck muscles, dry mouth, voice changes.

In rare cases, there is a general weakness, visual impairment (including diplopia and blurred vision), difficulty breathing (when used in high doses of the drug).

These side effects are tested for 2-4 weeks.

Education protivobotulinicheskih antibodies was observed in a small number of patients, undergoing treatment Dysport^® in the treatment of torticollis. Clinically it is manifested decrease of the therapeutic effect, which required constant increase doses.

At the treatment of spasticity in adult hands after a stroke: common – weakness surrounding the injection site muscle, flu-like symptoms (6.1%), dry mouth, pain at the injection site, pharyngitis, generalized weakness, constipation, diarrhea, drowsiness (no more 4.1% everyone). Most of these side effects disappear within 2 weeks.

At treatment of dynamic deformation of the foot, spasticity caused by cerebral palsy in children under age 2 years: scelalgia, pharyngitis (to 8%), muscle weakness, resulting in accidental injury (drops) (to 7%), bronchitis and fever (to 6%). With a frequency of 1 to 5% a viral infection may occur, upper respiratory tract infection, asthenia, asthma, rhinitis, convulsions, cough, vomiting, cold, diarrhea, urinary incontinence, abnormal gait, gastroenteritis, laryngitis, and somnolence. Frequency many of these reactions (pharyngitis, bronchitis, fever, viral infections, rhinitis, upper respiratory tract infection, cough, vomiting, cold) analogous he, which is observed in patients, placebo. Asthenia and urinary incontinence occurred with the introduction of Dysport^® high dose (20-30 U / kg) and could be the result of systemic exposure to the toxin.

At hyperkinetic wrinkles correction (facial wrinkles) person: reversible ptosis of the upper eyelid (3%), soreness at the injection site, headache (1.3%), hematoma at the injection site (3-10%), omission or raising eyebrows (less 1%). Diplopia is extremely rare. The probable cause of upper eyelid ptosis is the diffusion of the drug into the muscle, lifting the upper eyelid, the correction of vertical folds over the bridge or horizontal wrinkles on the forehead. Ptosis is reversible and disappears by the end of 3-4 weeks after injection. To minimize the likelihood and severity of these side effects can be achieved by strict adherence to methods of administration Dysport^® the correction of hyperkinetic wrinkles (facial wrinkles) Face and accounting anatomical and physiological characteristics of the individual patient.

Dysport: Contraindications

• pregnancy;
• acute phase of comorbidities.

Dysport: Pregnancy and lactation

Dysport^® contraindicated during pregnancy.

Dysport: Special instructions

Treatment with Dysport^® It must be carried out by experts, with experience in the diagnosis and treatment of these diseases and trained in the method of administering the drug.

With extreme caution should be re-administered to patients, in which the marked allergic reactions to the previous injection. The risk of an allergic reaction should be considered when evaluating the potential benefits of treatment.

With caution and under strict medical control is prescribed to patients with subclinical or clinical manifestations of lesions of neuromuscular transmission. Such patients may have an increased sensitivity to drugs such as Dysport^®, which may cause a pronounced muscle weakness.

Units of the drug Dysport^® They are specific and can not be compared with those of other drugs, containing botulinum toxin.

Effects on ability to drive vehicles and management mechanisms

The possibility of activities potentially hazardous activities, require increased attention and psychomotor speed reactions, It should be addressed only after the evaluation of the individual patient's response.

Dysport: overdose

Symptoms: generalized muscle weakness.

Treatment: It shows the maintenance therapy, IVL paralysis of respiratory muscles. No specific antidote. Introduction toxoid (protivobotulinicheskoy serum) inefficiently.

Dysport: drug interaction

In an application with drugs, affecting neuromuscular transmission, antibiotics such as aminoglycoside, requires caution, tk. may increase the action of Dysport^®.

Dysport: terms of dispensing from pharmacies

The free sale in pharmacies medication is not supplied.

Dysport: terms and conditions of storage

The drug should be stored and transported all kinds of covered transport at 2 ° to 8 ° C; Do not freeze. Shelf life – 2 year.

Special precautions for storage

The drug is released, stored and used only in specialized medical institutions in the presence of qualified and trained medical staff.

Dysport^® are stored in separate closed the marked box in the refrigerator hospital, which carries out the injections.

Dysport^®you can not give out the deposit of the patient.