Dysport, 1pc

Composition

Active ingredient:

botulinum toxin type A complex-hemagglutinin 500 UNITS;

Auxiliary substances:  

human albumin-125 mcg;

lactose-2.5 mg

Pharmacological action

Dysport-muscle relaxant.

Pharmacodynamics

The active ingredient is the Clostridium botulinum toxin type A, which blocks the release of acetylcholine in the neuromuscular junction, which leads to the relief of muscle spasm in the area of drug use.

Restoration of nerve impulse transmission occurs gradually as new nerve endings are formed and contacts with the postsynaptic motor end plate are restored.

Indications

For adults:

• blepharospasm;
• hemifacial spasm;
• spastic torticollis;
• spasticity of the arm muscles after a stroke;
• hyperkinetic folds (facial wrinkles) of the face.

For children over 2 years of age:

• dynamic deformity of the foot caused by spasticity in cerebral palsy.

Contraindications

Pregnancy; acute phase of concomitant diseases.

Side effects

Blepharospasm and hemifacial spasm. A side effect may occur if the doctor does not follow the rules for performing the injection (dilution, accurate calculation of the administered dose, correct choice of injection points, needle direction and injection depth) and the associated excessive diffusion of the drug into muscle groups nearby to the injection site. It is also necessary to take into account the anatomical and physiological features of the injected muscles of the patient.

Blepharoptosis is most common. Several patients had diplopia or symptoms that indicate the spread of muscle relaxant action to neighboring facial muscles (these phenomena disappear within 2-4 weeks after the injection). It is possible to develop dry eyes and keratitis due to a decrease in the frequency of blinking (in these cases, the use of artificial tears is indicated), the appearance of hematoma and swelling of the eyelids of a short-term nature, as well as the occurrence of reversible external ophthalmoplegia when using the drug in high doses.

Injections may be accompanied by a burning sensation at the injection site, which lasts for 1-2 minutes.

Allergic reactions in the form of skin rash and flu-like symptoms are extremely rare.

Spastic torticollis. The side effect develops as a result of a deep injection or injection into incorrectly selected muscles and points, which leads to excessive weakness of nearby muscles. Injections may be accompanied by a burning sensation at the injection site, which lasts for 1-2 minutes.

Dysphagia is most common. In a double-blind placebo-controlled trial, dysphagia was observed in 29% of patients treated with Dysport ® 500 units and in 10% of patients treated with placebo. Dysphagia is dose-dependent and is most often observed when the drug is injected into the sternocleidomastoid muscle. If dysphagia develops, it is necessary to refrain from eating coarse food until the symptoms disappear. In patients with severe dysphagia, saliva accumulation was observed during laryngoscopy. In rare cases, saliva aspiration may be required in such patients, especially in cases of airway obstruction.

It is possible to develop weakness of the neck muscles, dry mouth, and a change in voice.

In rare cases, there was general weakness, visual disturbances (including diplopia and blurred vision), difficulty breathing (when using the drug in high doses).

These side effects disappear within 2-4 weeks. Allergic reactions may occur in the form of skin rashes and flu-like symptoms.

The formation of anti-botulinum antibodies was observed in a small number of patients who were treated with Dysport® in the treatment of torticollis. Clinically, this was manifested by a decrease in the therapeutic effect, which required a constant increase in drug doses.

Spasticity of the hand in adults after a stroke. The most common symptoms are muscle weakness in the vicinity of the injection site, flu-like symptoms (6.1%), dry mouth, pain at the injection site, pharyngitis, general weakness, constipation, diarrhea, drowsiness (each adverse reaction was observed in no more than 4.1% of patients). Most of these side effects disappear within 2 weeks.

Dynamic deformity of the foot caused by spasticity in cerebral palsy in children over 2 years of age. Leg pain, pharyngitis (up to 8%), muscle weakness leading to accidental injuries (falls) (up to 7%), bronchitis and fever (up to 6%) may develop.

Viral infection, upper respiratory tract infections, asthenia, asthma, rhinitis, convulsions, cough, vomiting, runny nose, diarrhea, urinary incontinence, abnormal gait, gastroenteritis, laryngitis, and drowsiness may occur with a frequency of 1 to 5%. The frequency of many of these reactions (pharyngitis, bronchitis, fever, viral infections, rhinitis, upper respiratory tract infections, cough, vomiting, runny nose) is similar to that observed in patients receiving placebo.

Asthenia and urinary incontinence occurred with the use of Dysport® in high doses (20-30 U / kg) and could be the result of systemic exposure to the toxin.

Correction of hyperkinetic folds (facial wrinkles) of the face. Reversible ptosis of the upper eyelid (3%), soreness at the injection site, headache (1.3%), hematoma at the injection site (3-10%), lowering or raising of the eyebrows (® when correcting hyperkinetic folds (facial wrinkles) of the face and taking into account the anatomical and physiological characteristics of each individual patient.

Interaction

Caution is required when used concomitantly with drugs that affect neuromuscular transmission, such as aminoglycoside antibiotics.

How to take, course of use and dosage

Subcutaneously, intramuscularly.

Bilateral and unilateral blepharospasm, hemifacial spasm

For adults and elderly patients for the treatment of bilateral blepharospasm, the recommended initial dose is 120 units per eye.

The drug is administered subcutaneously in a volume of 0.1 ml (20 units) medially, in a volume of 0.2 ml (40 units) laterally at the junction between the preseptal and orbital parts of both the lower and upper orbital muscles of each eye.

For injections into the upper eyelid, the needle should be directed away from the center, so as not to touch the muscle that raises the upper eyelid.

Overdose

Symptoms:  generalized muscle weakness.

Treatment:  maintenance therapy, mechanical ventilation for paralysis of the respiratory muscles is indicated.

There is no specific antidote. use of anatoxin (anti-botulinum serum) is not effective.

Special instructions

Treatment with the drug Dysport should be carried out by a specialist who has experience in the diagnosis and treatment of these diseases and has been trained in the method of use of the drug Dysport.

It should be borne in mind that electromyography is used for all complex forms of torticollis, with repeated use of the drug or in cases of ineffectiveness of treatment. Electromyography is indicated when the drug is injected into deep muscles in overweight patients with weak palpable muscles.

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 corrected by introducing botulinum toxin much less often. In these areas, it is preferable to use other methods.

With extreme caution, the drug should be re-administered to patients who have allergic reactions to the previous injection. The risk of an allergic reaction should be considered when evaluating the possible benefits of treatment.

With caution and under strict medical supervision, the drug is prescribed to patients with subclinical or clinical manifestations of neuromuscular transmission lesions, since severe muscle weakness may develop.

In acute stages of concomitant diseases, the drug use is resumed after recovery.

Currently, there are no data on the occurrence of immune responses in the treatment of blepharospasm or hemifascial spasm. However, some patients showed the formation of anti-botulinum antibodies in the treatment of spastic torticollis. Clinically, this was manifested by a decrease in the therapeutic effect, which required a constant increase in drug doses.

It is possible to minimize the probability of occurrence and severity of side effects by strictly following the methods of use of the drug Dysport and taking into account the anatomical and physiological characteristics of each individual patient.

The concomitant use of Dysport with antibiotics-aminoglycosides, as well as with drugs that increase the intracellular concentration of calcium (aminopyridine, tetraethylammonium) is not recommended.

Influence on the ability to drive motor vehicles and manage mechanisms

The question of the possibility of engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions should be resolved only after evaluating the individual response of the patient.

Form of production

Lyophilizate for solution preparation for intramuscular and subcutaneous use

Storage conditions

At a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Botulinum toxin Type A-Hemagglutinin complex

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Adult Doctor’s prescription