Excipients: human albumin - 125 mcg, lactose monohydrate - 2.5 mg.
Glass vials (1) in the holder made of cardboard - packs cardboard.
* Unit of activity of the firm.
Description of the preparation is based on an approved instruction for use and approved by the manufacturer for the 2013 edition.
PHARMACHOLOGIC EFFECT
Miorelaxant. The active ingredient is Clostridium botulinum toxin 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 the transmission of the nerve impulse occurs gradually, as new nerve endings are formed and contacts with the postsynaptic motor end plate are restored.
PHARMACOKINETICS
Data on the pharmacokinetics of Dysport В® are not available.
INDICATIONS
- Blepharospasm, hemifacial spasm, spasmodic torticollis, spasticity of the arm muscles after a stroke, hyperkinetic folds (facial wrinkles) of the face in adults;
- dynamic deformation of the foot caused by spasticity, in cerebral palsy in children aged 2 years and older;
- Treatment of underarm hyperhidrosis.
DOSING MODE
Bilateral and unilateral blepharospasm, hemifacial spasm
The contents of 300 ED bottle are diluted in 1.5 ml of 0.9% solution of sodium chloride for injection, the contents of 500 ED bottle are diluted in 2.5 ml of 0.9% sodium chloride solution for injection. 1 ml of both solutions contains 200 units of Dysport В® .
For adults and elderly patients for treatment of bilateral blepharospasm, the recommended initial dose is 120 units per eye. The drug is administered SC in a volume of 0.1 ml (20 units) medially, in a volume of 0.2 ml (40 units) - laterally into the junction between the preseptal and ophthalmic parts of the upper and lower parts of the circular muscle (m.orbicularis oculi) of the affected eye. For injection in the upper eyelid, 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.
The manifestation of the clinical effect can be expected within 2-4 days, the maximum therapeutic effect develops within 2 weeks.
Injections should be repeated every 12 weeks or on indications to prevent recurrence of symptoms. For each subsequent administration, the dose should be reduced to 80 units per eye. For example, 0.1 ml (20 units) medially and 0.1 ml (20 U) laterally above the eye and below the eye. In the future, the dose of the drug can be reduced to 60 units per eye, due to the exclusion of medication medially in the lower eyelid. The doctor will determine the subsequent dose in accordance with the effect obtained.
With unilateral blepharospasm, injections should be limited to the area of ​​the affected eye. Similar treatment is performed with hemifacial spasm .
Spasmodic torticollis
The contents of 300 ED bottle are diluted in 0.6 ml of a 0.9% solution of sodium chloride for injection, and a 500 ED bottle in 1 ml of 0.9% sodium chloride solution for injection. 1 ml of both solutions contains 500 units of Dysport В® .
Doses recommended for the treatment of torticollis are used in adults of all ages who have a normal body weight and satisfactory development of the neck muscles. Decrease in the dose of the drug is possible with a significant deficit in body weight or in the elderly, with reduced muscle mass.
To treat spastic torticollis, the initial total single dose is 500 units. This dose is distributed between 2 or 3 of the most active muscles of the neck.
When rotational, the curved drug at a dose of 500 units is administered 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 (m. Sternocleidomastoideus), contralateral rotation.
With laterocollis (head-to-shoulder tilt), the dose of 500 ED is distributed as follows: 350 units are inserted ipsilateral into the ribbon muscle of the head (m.splenius capitis) and 150 units - ipsilateral into the sternocleidomastoid muscle (M. sternocleidomastoideus). In cases involving a shoulder lift due to a trapezius muscle (m.trapezius) or a muscle lifting the scapula (m.levator scapulae) , treatment may be required in accordance with apparent muscle hypertrophy or electromyography.
When the administration of the drug in 3 muscles is required, the dose of 500 units is distributed as follows: 300 units are injected into the head muscle of the head (m.splenius capitis), 100 units into the sternocleidomastoid muscle (m.sternocleidomastoideus), 100 units into the third muscle (trapezius muscle or muscle that lifts the scapula).
With anterocollis (tilt head forward) , 150 units are inserted into both the sternocleidomastoid muscles (m. Sternocleidomastoideus).
In retrocollis (tilt of the head back), the dose of 500 units is distributed as follows: 250 units are injected into each rib muscle of the head (m.plenius capitis).In case of insufficient clinical effect after injection, it is possible to inject the drug into the trapezius muscles (m.trapezius) bilaterally (at a dose of up to 250 units per muscle) after 6 weeks. Bilateral injections into the belt muscles (m.splenius capitis) may increase the risk of developing weakness in the neck muscles.
With the subsequent administration of the drug, the doses can be adapted in accordance with the clinical effect and the resulting side effects. Recommended total doses are 250-1000 units. The use of the drug in higher doses may be accompanied by an increase in the frequency of side effects, in particular dysphagia.
Clinical improvement with spastic krivoshee is noted within 1 week after the injection. Injections should be repeated every 8-12 weeks or as needed.
For the treatment of other forms of torticollis, 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 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 after a stroke in adults
Determination of indications for the administration of Dysport В® in the treatment of spasticity of the hand after a stroke is performed by a neurologist 3 months after a stroke.
In a vial containing a drug containing 300 units, 0.6 ml of a 0.9% solution of sodium chloride is injected, and 1 ml of 0.9% sodium chloride solution is injected into a bottle containing a drug containing 500 units. In both cases, obtaining a solution containing 500 units of DportВ® in 1 ml.
The maximum total single dose is 1000 U, which is distributed between the following 5 muscles: the deep flexor of the fingers (m.flexor digitorum profundus), the superficial flexor of the fingers (m.flexor digitorum superficialis), the ulnar flexor of the wrist (m.flexor carpi ulnaris), the radial flexor wrists (m.flexor carpi radialis) and biceps arm muscle (m.biceps brachii).
When choosing the site of injection should be guided by standard EMG points, and the immediate injection site is determined by palpation. In all muscles, except the biceps arm (m.biceps brachii), injections are carried out at one point. In the biceps arm muscle (m.biceps brachii), the injection is carried out at 2 points. The recommended dose distribution between muscles is given in the table.
Muscles Dysport В® (ED)
The biceps musculature of the shoulder is 300-400
Deep Finger Flexor 150
Superficial flexor of fingers 150-250
Elbow wrist flexor 150
Radial wrist flexor 150
Total dose 1000
The initial total dose of the drug can be reduced to 500 units to prevent excessive weakness of the injected muscles when the target muscles are small in volume when the injection into the biceps muscle of the shoulder (m.biceps brachii) is not performed, or when patients are injected several times points of the same muscle.
Clinical improvement occurs within 2 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.
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 subject to correction by introducing botulinum toxin much less often.
The contents of the 300 ED bottle are diluted with 1.5 ml of a 0.9% solution of sodium chloride for injection, and the contents of the 500 ED bottle are diluted with 2.5 ml of 0.9% sodium chloride solution for injection. At this dilution, 1 ml of both solutions contains 200 units of Dysport В® .
The total recommended dose for single administration to all four areas (interbroplet, forehead, outer corner of the eye and the back of the nose) should not exceed 200 units of Dysport В® .
To correct vertical folds in the interbrove area, injections of the drug are produced in the muscle, wrinkling eyebrow (m.corrugator supercilii) by 8-10 ED at 2-4 points and m.procerus at 5-10 units at 2 points. The total dose is from 42 to 100 units.
Elimination of hyperkinetic folds in the forehead area is done by injecting the drug into the region of maximum frontal muscle tension (m.frontalis). The number of insertion points can be arbitrary. All of them should be placed 2 cm above the eyebrow line on one line or V-shaped. The optimal total dose of Dysport В® 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.
Correction of folds in the outer corner of the eye ("crow's feet") is carried out by insertion into points located 1 cm lateral from the outer corner of the eye, at the rate of 5-15 units of Dysport В® per one injection point. The number of points is from 2 to 4 for each 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 the Dysport В® drug 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.
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.
The miorelaksiruyuschee action of the drug Dysport В® on the facial muscles of the face is clinically manifested 2-3 days after the administration and reaches a maximum of 14-15 days.
The recommended doses of Dysport В® , used in aesthetic medicine, do not cause systemic side effects.
Dynamic deformation of the foot caused by spasticity in cerebral palsy in children aged 2 years and older
The contents of the 300 ED bottle are dissolved in 0.6 ml of 0.9% sodium chloride solution for injection, and the contents of the 500 ED bottle in 1 ml of a 0.9% solution of sodium chloride for injection, and in both cases a solution containing 500 U in 1 ml.
The drug is injected in / m in the gastrocnemius muscles (m. Gastrocnemius). The initial recommended dose is 20 U / kg of body weight and is divided equally between the gastrocnemius muscles (m. Gastrocnemius). When one gastrocnemius is injured (m.gastrocnemius), the drug is administered at a dose of 10 U / kg. The optimal dose is determined individually, the subsequent treatment should be planned after the evaluation of the results of the application of the initial dose. To avoid the development of side effects, do not exceed the maximum dose of 1000 units. The drug is mainly introduced into the gastrocnemius muscle (m.gastrocnemius), but it is possible to insert the soleus muscle (m.soleus) and the posterior tibialis muscle (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 of the drug 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, with the administered dose varying from 10 to 30 units per kg of body weight, depending on the effect of the previous injection.
Treatment of underarm hyperhidrosis
The contents of the 300 ED bottle are diluted with 1.5 ml of a 0.9% solution of sodium chloride for injection, and the contents of the 500 ED bottle are diluted with 2.5 ml of a 0.9% solution of sodium chloride for injection, and in both cases a solution containing 200 U in 1 ml.
The recommended initial dose is 100 units per axillary area. If the desired effect is not achieved, then a subsequent dose increase of up to 200 units is possible.
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 test, 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 napkin 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 2 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 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.
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 injections into the vial by puncturing the plug with a sterile needle of size 23 or 25. The resulting solution is a colorless transparent 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 В° to 8 В° C.
Rules for processing tools and waste disposal
Immediately after the injection, the remaining solution in a vial or syringe should be inactivated with a dilute sodium hypochlorite solution containing 1% active chlorine. All auxiliary materials in contact with the drug should be disposed of in accordance with standard hospital practice.
Spilled drug should be removed with an absorbent cloth soaked in a 1% sodium hypochlorite solution.
SIDE EFFECT
During the various clinical trials of Dysport В® with the participation of about 7800 patients, adverse reactions developed at the following frequency: very often (? 1/10), often (? 1/100, to <1/10), sometimes (? 1/1000 , to <1/100), rarely (<1/1000), very rarely (? 1 / 10,000).
From the nervous system: rarely - neuralgic amyotrophy.
Dermatological reactions: rarely - skin rash.
Local reactions: often - pain and bruising at the injection site; sometimes - irritation, a burning sensation at the injection site, which lasts 1-2 minutes.
Other: often - general weakness, fatigue, flu-like syndrome.
Spasticity of the hand in adults after a stroke
Adverse reactions have been reported in 14 clinical trials involving 141 patients.
On the part of the digestive system: often - dysphagia (was recorded when doses exceeding 2700 U, administered at one point or distributed between several injection points were used).
From the musculoskeletal system: often - weakness of the arm muscles.
Other: often - accidental injury / fall.
Dynamic deformation of the foot caused by spasticity in children with cerebral palsy
Adverse reactions have been reported in 14 clinical trials involving about 900 patients.
From the digestive system: often - diarrhea.
From the osteomuscular system: often - weakness of the leg muscles.
From the urinary system: often - urinary incontinence.
Other: often - accidental injury due to falling and abnormal gait, which are the result of excessive muscle weakness and / or spread of toxin effect on other, nearby to the site of the injection, the muscles involved or participating in certain motor act and in the maintenance of the patient's body balance in standing position and during walking.
Spasmodic torticollis
Adverse events reported in 21 clinical trial involving about 4100 patients.
From the nervous system: often - dysphonia; sometimes - headache.
On the part of the organ of vision: sometimes - diplopia, disturbance of accommodation.
The respiratory system: seldom - respiratory disorders.
From the digestive system:very often - dysphagia; sometimes - dry mouth.
Dysphagia effect is dose-dependent and occurs most often when administered drug in the sternocleidomastoid muscle. You may need a diet with exception of roughage before the disappearance of the symptoms of
blepharospasm and hemifacial spasm
Adverse reactions reported in 13 clinical studies involving approximately 1400 patients.
From the nervous system: often - the weakness of the facial muscles; sometimes - paresis of the facial muscles.
From the side of view: very often - ptosis; often - double vision, dry eyes, tearing; rarely - ophthalmoplegia.
Dermatologic reactions: often - swelling of the eyelids; rarely - volvulus century.
Side effects may occur when non-compliance rules physician performing injection (dilution accurate calculation of the administered dose, administration of a correct choice of the points of the needle direction and insertion depth) and the associated excessive diffusion of the drug and a temporary paralysis of adjacent muscle groups to the site of injection.
Axillary hyperhidrosis
Adverse reactions reported in 4 clinical trials involving approximately 217 patients.
Dermatological reactions: often - a compensatory sweating.
Hyperkinetic folds (wrinkles) of the person
are registered adverse reactions usually mild to moderate intensity.
From a sight organ: often - swelling of the eyes; sometimes - dry eye (keratoconjunctivitis sicca).
On the part of the musculoskeletal system: often - a weakness adjacent to the site of the introduction of muscle that often leads to ptosis, eyelid, asthenopia (weak sight) or, rarely, a paresis of facial muscles and visual disturbances.
From the nervous system : very often - headache (often observed in the placebo group).
Dermatological reactions: sometimes - rashes, itchy skin; rarely - urticaria.
Local reactions: often - pain, bruising, pruritus, paresthesia, erythema, rash at the injection site (which is also often observed in the placebo group).
Post-registration experience of application
Most side effects are mild and transient.
Rare: indigestion, allergic skin reactions, dizziness, and headaches.
Very rarely (1/10 000): severe muscle weakness, dysphagia, aspiration pneumonia, which can cause death.
CONTRAINDICATIONS
- acute disease (administration of the preparation is carried out after recovery);
- pregnancy;
- lactation (breast feeding);
- hypersensitivity to the drug.
PREGNANCY AND LACTATION
Dysport В® is contraindicated in pregnancy and lactation (breast feeding).
Studies of the effect Dysport В® on reproduction and teratogenicity was conducted. Safety of Dysport В® in pregnancy and lactation has not been confirmed.
SPECIAL INSTRUCTIONS
Treatment with Dysport В® should be carried out by experts with experience in the diagnosis and treatment of these diseases and have been trained to conduct the treatment with this drug.
It has been reported side effects resulting from the action of the toxin on muscle distant from the site of administration. Patients receiving Dysport В® in therapeutic doses may experience general muscle weakness. The risk of such side effects may be reduced, subject to the recommendations of dosing of drug and the drug in the lowest effective doses.
With care and under strict medical control drug prescribed to patients with subclinical or clinical signs of neuromuscular transmission losses (e.g., myasthenia gravis). Such patients may have an increased sensitivity to botulinum toxin, which can cause them pronounced muscle weakness.
Precautions should be administered Dysport В® patients with reduced swallowing and breathing, since these violations may be exacerbated as a result of widespread toxin action on the relevant muscles.
In patients suffering from chronic respiratory diseases, in rare cases, may develop aspiration.
In the treatment of botulinum toxins type A and B have been reported few cases of death caused by dysphagia (swallowing disorder), pneumopathy or in patients with significant asthenia.
Patients and carers for them, should be aware of the urgent need to see a doctor in case of any violation of swallowing, speech, and respiratory disorders.
Protivobotulinicheskih antibody formation observed in a minority of patients undergoing therapy with Dysport В® . Clinically it is manifested decrease in the therapeutic effect, which required constant increase doses of the drug.
In patients with delayed clotting time and in inflammation in the proposed site of injection of Dysport В®should apply in cases of extreme necessity.
AUs Dysport В® are specific and can not be compared with those of other formulations containing botulinum toxin.
Effects on ability to drive vehicles and management mechanisms
Data on the effect of the drug on the ability to drive vehicles and management mechanisms are absent.
OVERDOSE
Symptoms: generalized muscle weakness.
Treatment: shows a maintenance therapy, mechanical ventilation in paralysis of the respiratory muscles. In overdose administering antitoxin (protivobotulinicheskoy serum) it is expedient for the first 3 hours. As a rule, the treatment is directed to overdose overall maintenance therapy with constant monitoring of patients.
DRUG INTERACTION
While the use of drugs affecting neuromuscular transmission, such as aminoglycoside antibiotics, caution is required.
STORAGE CONDITIONS AND SHELF LIFE
The preparation should be stored and transported all types covered transport at a temperature of from 2 В° to 8 В° C; Do not freeze. Shelf life - 2 years.
Dysport В® stored in a separate closed the marked box refrigerated hospital where the holding is performed drug injection.
Dysport В® can not issue deposited patient.
Keep out of the reach of children.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
