Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Metamizole sodium monohydrate; Hyoscine butylbromide
Richter Pharma AG
QA03DB04
Metamizole sodium monohydrate; Hyoscine butylbromide
500.0/4.0 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Dogs, Horses, Pigs
butylscopolamine and analgesics
N.S.A.I.D.
Authorised
2015-09-18
Health Products Regulatory Authority 20 July 2020 CRN009GP4 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection 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 (as preservative) 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 spasms or sustained increased tonus of smooth muscles of the gastro-intestinal tract or of the urine and bile excretory organs associated with pain. Horses only: Spasmodic colics. Cattle, pigs, dogs only: As supportive therapy for acute diarrhoea. 4.3 CONTRAINDICATIONS Do not use in known cases 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 stenoses in the gastro-intestinal system -paralytic ileus in horses -disorders of the haematopoietic system -coagulopathies -renal insufficiency -tachyarrhythmia -glaucoma -prostate adenoma. Health Products Regulatory Authority 20 July 2020 CRN009GP4 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 reactions such as skin allergy. Take care to avoid self-injection. In case of accidental s Прочитать полный документ