Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CALCIUM GLUCONATE MONOHYDRATE, CALCIUM BOROGLUCONATE, CALCIUM HYDROXIDE, MAGNESIUM CHLORIDE HEXAHYDRATE
aniMedica GmbH
QA12AA
CALCIUM GLUCONATE MONOHYDRATE, CALCIUM BOROGLUCONATE, CALCIUM HYDROXIDE, MAGNESIUM CHLORIDE HEXAHYDRATE
Unknown
Solution for Inj/Inf
LM-Licensed Merchant
Bovine
Calcium
Vitamins & Minerals
Authorised
1999-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Calcitat 50, solution for infusion and injection in cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion and injection. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Bovine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Paresis resulting from hypocalcaemia before, during and after parturition or during lactation. Downer cow syndrome. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances. Do not use in animals suffering from hypercalcaemia, hyperparathyroidism, acidosis, severe kidney damage. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Caution must be exercised when this product is used intravenously. As intravenous administration of this product could cause death, this route should only be used by a veterinary surgeon. Each 100ml of solution contains: Active Substances Calcium Gluconate Monohydrate 3.10 g Calcium Borogluconate 42.90 g Calcium Hydroxide 1.32 g Magnesium Chloride Hexahydrate 6.50 g Excipients Methyl parahydroxybenzoate (E219) 0.10 g HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/11/2014_ _CRN 7019298_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Intravenous - administer slowly and at body temperature. Monitor cardiac performance during administration. Subcutaneous - divide large volumes into several injection sites. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Rapid intravenous infusion may result in Read the complete document