País: Reino Unido
Idioma: inglés
Fuente: VMD (Veterinary Medicines Directorate)
Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate
Bela-Pharm GmbH & Co. KG
QA12AX
Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Goats, Horses, Pigs, Sheep
Mineral
Authorized
2021-11-02
Issued: November 2021 AN: 00927/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Calcibel Forte, 380/60/50 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Calcium gluconate for injection 380 mg (equivalent to 34.0 mg calcium) Magnesium chloride hexahydrate 60 mg (equivalent to 7.2 mg magnesium) Boric acid 50 mg For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for infusion Clear, slightly, yellow-brownish solution, free from visible particles Strongly hypertonic solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, cattle, sheep, goats, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Acute hypocalcaemic conditions. 4.3 CONTRAINDICATIONS Do not use in cases of hypercalcaemia and hypermagnesemia. Do not use in cases of idiopathic hypocalcaemia in foals. Do not use in cases of calcinosis in cattle and small ruminants. Do not use following administration of high doses of vitamin D3. Do not use in cases of chronic kidney insufficiency or in cases of circulatory or cardiac disorders. Do not use in cattle suffering septicaemic processes in the course of acute mastitis in cattle. Do not administer inorganic phosphate solutions simultaneously or shortly after the infusion. Do not use in case of known hypersensitivity to the active substances. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. Issued: November 2021 AN: 00927/2020 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The medicinal product must be administered only slowly intravenously. The solution should be warmed to body temperature before administration. During infusion, heart rate, rhythm and circulation must be monitored. In case of symptoms of overdosing (cardiac arrhythmia, fall in blood pressure, agitation), the infusion should be stopped immediately. Special precautions to be taken by the person administering the veterin Leer el documento completo