国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Cyanocobalamin; Butaphosphan (Butafosfan)
Interchemie Werken De Adelaar Eesti AS.
QA12CX99
Cyanocobalamin; Butaphosphan (Butafosfan)
100.0 + 0.05 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
other mineral products, combinations
Authorised
2021-07-23
Health Products Regulatory Authority 23 July 2021 CRN00C1TH Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Butasal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the solution for injection contains: ACTIVE SUBSTANCES: Butafosfan 100.0 mg Cyanocobalamin (vitamin B12) 0.05 mg EXCIPIENTS: Benzyl alcohol (E1519) 10.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear red solution without visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As supportive treatment of metabolic or reproductive disorders, when supplementation of phosphorous and cyanocobalamin is needed. In case of peri-parturient metabolic disorders, tetany and paresis (milk fever), the product should be administered in addition to magnesium and calcium, respectively. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is recommended to determine the cause(s) of the metabolic or reproductive disorders to define the most appropriate measures of prevention and treatment and the need for a therapy with supplemental phosphorus and vitamin B12. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Due to a deficiency in glucuronidating metabolic pathways in cats, which are involved in benzyl alcohol metabolism, this veterinary medicinal product should be used with caution and the recommended dose should be strictly observed in this species. Special precautions to be taken by the person administering the veterinary medicinal product to animals Benzyl alcohol may cause hypersensitivity (allergic reactions). People with known hypersensitivity to benzyl alcohol should Health Products Regulatory Authority 23 July 完全なドキュメントを読む