Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
CALCIUM GLUCONATE MONOHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, BORIC ACID
Bela-Pharm GmbH & Co. KG
QA12AX
CALCIUM GLUCONATE MONOHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, BORIC ACID
Unknown
Solution for Infusion
LM-Licensed Merchant
Bovine, Caprine, Equine - Food, Ovine, Porcine
Calcium, combinations with other drugs
Vitamins & Minerals
Authorised
2016-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Calcium gluconate 240 mg (equivalent to 21.5 mg calcium) Magnesium chloride hexahydrate 60 mg (equivalent to 7.2 mg magnesium) Boric acid 60 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless to slightly yellowish solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse, cattle, sheep, goat, pig. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Acute hypocalcaemic conditions. 4.3 CONTRAINDICATIONS - hypercalcaemia and hypermagnesaemia, - idiopathic hypocalcaemia in foals, - calcinosis in cattle and small ruminants, - septicaemic processes in the course of acute mastitis in cattle, - application after high doses of vitamin D 3 preparations, - chronic renal insufficiency, - concomitant or immediately following application of inorganic phosphorous solutions. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of acute hypomagnesaemia, the administration of a solution with a higher concentration of magnesium may be necessary. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/06/2016_ _CRN 7024103_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS During intravenous infusion, the product must be administered slowly and at body temperature. During infusion, cardiac rate and rhythm and circulation must be monitored. If any sign of overdose (disturbances of the cardiac rhythm decrease in blood pressure, restlessness) appears, the infusion should be stopped immedi Lue koko asiakirja