Metamizole Sodium Injection 500mg 5ml I.M./I.V. COMPOSITION: Each ampoule of 5ml contains: Metamizole sodium......................................500mg Excipients: Sodium pyrosulfite, Disodium EDTA PROPERTIES: Analgesic, Antipyretic. FORM AND PRESENTATION Solution for injection in ampoule of 5ml, Box of 10. INDIATIONS: Metamizole injection is indicated in the cases of spasmodic pains, acute pains and high fever. CONTRA-INDICATIONS: - Metamizole injection should not be used in case of hypersensitivity to Metamizole, to pyrazolone derivatives. It is contraindicated in patients suffering to disturbance of blood cell formation. -Metamizole passes the placental barrier, and should therefore be used during pregnancy, especially during the first 3 months and the last 6 weeks only after careful considerations of the indications. -Certain metabolic diseases like hepatic porphyria. PRECAUTIONS FOR USE AND WARNINGS: -Interrogate the patient on previous allergy. -Attention: Metamizole could cause mortal agranulocytosis. -Breast feeding: Passage in breast milk of this drug should be considered in order to avoid all toxic effects and allergy in new born. -A red colouration could appear in urine, with acidic pH. SIDE-EFFECTS: -Haematological accidents: Agranulocytosis. This accident is rare. -Exceptional cases of anemia or thrombopenia have been observed. -Skin reactions like cutaneous allergy. -Crisis of asthma have been reported. DOSAGE AND ADMINISTRATION: Adults: 1 to 2 ampoules (500mg to 1g) daily in intramuscular or intravenous route. INTERACTION DRUGS: -Metamizole is likely to reinforce the action of alcoohol; It is important to strongly avoid alcohol during treatment; -The effects of drugs inhibiting blood coagulation may be reinforced. -Metamizole is likely the action of drugs affecting the immune system (Cyclosporin). If is taken simultaneously with sedatives (Chlorpromazine) Metamizole may cause severe hypothermia. -Drugs containing Colestyramin can transfer metamizole in the blood (reabsorption). STORAGE: Store in a dry place and away from light; Keep out of reach of children.
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