Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Metamizole sodium monohydrate; Hyoscine butylbromide
Veyx-Pharma GmbH
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
butylscopolamine and analgesics
Authorised
2020-05-29
Health Products Regulatory Authority 05 August 2021 CRN00CGMM Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Spasmalgan compositum 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 500.00 mg (equivalent to 443.00 mg metamizole) Hyoscine butylbromide 4.00 mg (equivalent to 2.76 mg hyoscine) EXCIPIENTS: Benzyl alcohol (E1519) 10.00 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, pigs and dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. Horse: Spasmodic colics Cattle/Calf, pig, dog: As supportive therapy for acute diarrhoea. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Due to the content of metamizole sodium, do not use in case of: - disorders of the haematopoietic system - gastrointestinal ulcers - chronic gastro-intestinal disorders - renal insufficiency - coagulopathies Due to the content of hyoscine butylbromide do not use in case of: - mechanic stenoses in the gastro-intestinal system - tachyarrhythmia - glaucoma - prostate adenoma. Health Products Regulatory Authority 05 August 2021 CRN00CGMM 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 reve Διαβάστε το πλήρες έγγραφο