Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE
Richter Pharma AG
QA03DB04
METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE
500.0/4.0
Solution for Injection
POM
Bovine, Canine, Equine, Porcine
Butylscopolamine and analgesics
N.S.A.I.D
Authorised
2015-09-18
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 18/09/2015_ _CRN 7018452_ _page number: 1_ 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 stenoses in the gastro-intestinal system - paralytic ileus in horses - disorders of the haematopoietic system - coagulopathies - renal insufficiency - tachyarrhythmia - glaucoma - prostate adenoma. 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 adminis read_full_document