Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Metamizole sodium monohydrate; Hyoscine butylbromide
Dechra Regulatory B.V.
QA03DB04
Metamizole sodium monohydrate; Hyoscine butylbromide
500, 4 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
butylscopolamine and analgesics
Authorised
2019-06-26
Health Products Regulatory Authority 03 April 2020 CRN009P51 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sympagesic 500 mg/ml + 4 mg/ml solution for injection for horses, cattle, pigs and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Metamizole sodium monohydrate 500.0 mg (equivalent to 443 mg metamizole) Hyoscine butylbromide 4.0 mg (equivalent to 2.76 mg hyoscine) EXCIPIENTS: Phenol 5.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, pigs, dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Horses, cattle, pigs, dogs: treatment of smooth muscle spasms and pain associated with underlying disorders of the gastro-intestinal tract, urogenital system and bile excretory organs. Horses only: Spasmodic colics. Cattle, pigs, dogs: Supportive therapy for acute diarrhoea and gastroenteritis. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use in cases of: - gastro-intestinal ulceration - chronic gastro-intestinal disorders - mechanic obstruction in the gastro-intestinal system - paralytic ileus - disorders of the haematopoietic system - coagulopathies - renal insufficiency - tachyarrhythmia - glaucoma - prostate adenoma. Health Products Regulatory Authority 03 April 2020 CRN009P51 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Due to the risk of anaphylactic shock, metamizole-containing solutions should be administered slowly when given intravenously. Special precautions to be taken by the person administering the veterinary medicinal product to animals In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other rea Lees het volledige document