البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: VMD (Veterinary Medicines Directorate)
Hyoscine Butylbromide, Metamizole sodium monohydrate
Dechra Regulatory BV
QA03DB04
Hyoscine Butylbromide, Metamizole sodium monohydrate
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Dogs, Horses, Pigs
Neurological Agent muscle relaxant
Authorized
2019-05-21
Unlimited Renewal: August 2023 AN: 01489/2023 Page 1 of 6 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. Unlimited Renewal: August 2023 AN: 01489/2023 Page 2 of 6 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. 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 self-inje اقرأ الوثيقة كاملة