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
3.10, 42.960, 1.32, 6.50 grams/100 millilitres
Solution for injection/infusion
LR: Licensed Retailer as defined in national legislation
Cattle
Calcium
Vitamins and minerals
Authorised
1999-10-01
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Calcitat 50, solution for infusion and injection in cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 ml 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 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. 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 transient cardiac distress. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The product may safely be used during pregnancy and lactation and most clinical indications occur at this time. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The use of admixtures should be avoided because of possible incompatibility with other substances in solution. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Administe Read the complete document