Active substanceClemastineClemastine
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  • Clemastin-Eskom
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    ESKOM NPK, OAO     Russia
  • Tavegil®
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  • Tavegil®
    solution w / m in / in 
  • Dosage form: & nbspsolution for intravenous and intramuscular administration
    Composition:

    1 ml contains:

    active substance: Clemastine hydrofumarate (equivalent to 1 mg clemustine) 1.34 mg;

    Excipients: sorbitol 45 mg, ethanol 96% 70 mg, propylene glycol 300 mg, sodium citrate dihydrate to pH 6.3, water for injection up to 1 ml.

    1 ampoule (2 ml) contains:

    active substance: clemastine hydrofumarate (equivalent to 2 mg clemustine) 2.68 mg,

    Excipients: sorbitol 90 mg, ethanol 96% 140 mg, propylene glycol 600 mg, sodium citrate dihydrate to pH 6.3, water for injection up to 2 ml.

    Description:

    Transparent, colorless or from light yellow to pale greenish-yellow liquid.

    Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker
    ATX: & nbsp

    A.06.A.A.04   Clemastine

    Pharmacodynamics:

    H1-gistamine receptor blocker, ethanolamine derivative. Has a strong antihistamine and antipruritic effect with a rapid onset of action and duration of up to 12 hours, prevents the development of vasodilation and smooth muscle contractions induced by histamine.Possessing an antiallergic effect, reduces the permeability of blood vessels, capillaries, inhibits exudation and formation of edema, reduces itching, exerts an m-cholinoblock effect.

    Pharmacokinetics:

    Distribution. The connection with plasma proteins is 95%.

    Metabolism. Clemastin undergoes significant metabolism in the liver.

    Excretion. The elimination from the plasma is biphasic, the corresponding half-lives are 3.6 ± 0.9 hours and 37 ± 16 hours. Metabolites in the main (45-65%) are excreted through the kidneys with urine; The unchanged active substance is found in urine only in trace amounts. During lactation, a small amount of klemastin can penetrate into breast milk.

    Indications:

    Prophylaxis or treatment of allergic and pseudoallergic reactions (including with the introduction of contrast agents, blood transfusion, diagnostic use of histamine).

    Angioedema, anaphylactic or anaphylactoid shock (as an additional remedy).

    Contraindications:

    Hypersensitivity to klemastin or other ingredients of the drug, pregnancy, lactation period, administration of monoamine oxidase inhibitors (MAO),diseases of the lower respiratory tract (including bronchial asthma), porphyria, children under 1 year of age, intravenous (children under 18 years of age).

    The drug is not recommended for patients suffering from rare hereditary diseases associated with intolerance to fructose.

    Intraarterial administration of the drug is not permitted!

    Carefully:

    In patients with a stenosing ulcer of the stomach, pyloroduodenal obstruction, with obstruction of the neck of the bladder, prostatic hyperplasia accompanied by a delay in urine, with increased intraocular pressure, angle-closure glaucoma, hyperthyroidism, cardiovascular diseases, including hypertension.

    Alcoholism, liver disease, epilepsy, children's age (the drug contains ethanol 140 mg / 2 ml).

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    Intravenous or intramuscular. Do not administer intraarterially. Intravenously injected slowly (within 2-3 minutes).

    Adults: 2 mg (2 ml), intravenously or intramuscularly, that is, the contents of 1 ampoule, 2 times a day (morning and evening). For prophylactic purposes, the drug is administered intravenously slowly at a dose of 2 mg immediately before the possible occurrence of an anaphylactic reaction or reaction in response to the use of histamine. The drug solution can be further diluted with 0.9% sodium chloride solution or 5% dextrose solution in a ratio of 1: 5.

    Children over 1 year old: 0.025 mg / kg / day intramuscularly, divided into 2 injections.

    Side effects:

    Classification of incidence of adverse reactions:

    Often (1/10); often (1/100. <1/10); infrequently (1/1000, <1/100); rarely (1/10000, <1/1000); very rarely (<1/10000).

    Impaired nervous system:

    often: increased fatigue, drowsiness, sedation, weakness, fatigue, inhibition, impaired coordination of motion;

    infrequently: dizziness;

    rarely: headache, tremor, stimulating effect (usually in children), anxiety, increased irritability, agitation, nervousness, insomnia, hysteria, euphoria, tremor, convulsions, paresthesia, neuritis.

    Disorders from the gastrointestinal tract:

    rarely: dyspepsia, nausea, vomiting, gastralgia, dry mouth;

    very rarely: constipation.

    Disorders from the side of the organ of vision:

    rarely: violation of the clarity of the visual perception, diplopia.

    Hearing disorders and labyrinthine disturbances:

    rarely: acute labyrinthitis, tinnitus.

    Disorders from the kidneys and urinary tract:

    very rarely: rapid or difficult urination.

    Disturbances from the respiratory system, chest and mediastinal organs:

    rarely: condensation of bronchial secretion and difficulty in sputum discharge, a feeling of pressure in the chest, a violation of breathing, nasal congestion.

    Disorders from the cardiovascular system:

    rarely: lowering blood pressure (more often in elderly patients), extrasystole;

    aboutchen rarely: tachycardia.

    Violations from the blood and lymphatic system:

    rarely: hemolytic anemia, thrombocytopenia, agranulocytosis.

    Disturbances from the skin and subcutaneous tissues:

    rarely: skin rash.

    Immune system disorders:

    rarely: hypersensitivity reactions (rash, dyspnea, anaphylactic shock).

    Overdose:

    Symptoms. An overdose of antihistamines can lead to both a depressing and stimulating effect on the central nervous system, more often observed in children. Also, the phenomenon of anticholinergic action may develop: dry mouth, fixed dilatation of the pupils, "tides" of blood to the upper half of the body, tachycardia, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).

    Treatment. Symptomatic therapy is indicated.

    Interaction:

    Tavegil® enhances the effect of drugs that depress the central nervous system (hypnotics, sedatives, anxiolytics, tricyclic antidepressants, opioid analgesics), m-holinoblokatorov, as well as alcohol. Incompatible with simultaneous administration of MAO inhibitors.

    Special instructions:

    For the period of treatment should stop drinking alcohol.

    Careful monitoring of children and elderly patients is necessary (sensitivity to antihistamines is increased).

    Effect on the ability to drive transp. cf. and fur:

    Clemastin has a minor sedative effect (from mild to moderate in intensity), so people taking Tavegil® are advised to refrain from driving vehicles.work with mechanisms, as well as other activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection, 1 mg / ml.

    Packaging:

    2 ml of solution into ampoules of glass type 1 (Hept. F.).

    5 ampoules per plastic pallet.

    One plastic pallet along with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature of 15 to 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N008878 / 02
    Date of registration:02.06.2010
    The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
    Information update date: & nbsp30.06.2015
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