Click Here To Download Data Sheet Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Calciject 40 3 Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Calcium gluconate 332 mg Boric acid 68 mg Magnesium hypophosphite hexahydrate 30 mg For a full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 Target Species Cattle. 4.2 Indications for use, specifying the target species The product is indicated in the treatment of hypocalcaemia complicated by deficiency of magnesium. 4.3 Contraindications Do not use in animals with known hypersensitivity to the active ingredients. Health Products Regulatory Authority 21 December 2018 CRN008SQR 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals The solution should be warmed to body temperature before administration. Intravenous injections should be given slowly and stopped on the first signs of adverse reaction. Rapid intravenous injection may result in cardiac arrhythmias and, in severely toxaemic animals, collapse and death. As intravenous administration of this product could cause death, this route should only be used by a veterinary surgeon. Special precautions to be taken by the person administering the product to animals None. 4.6 Adverse reactions (frequency and seriousness) None known. 4.7 Use during pregnancy, lactation or lay The product can be safely administered to pregnant and lactating animals. 4.8 Interaction with other medicinal products and other forms of interactions None known. 4.9 Amounts to be administered and administration route Administer by subcutaneous or slow intravenous injection Cattle: 150 - 400 ml 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Not applicable. 4.11 Withdrawal period(s) Meat: Nil Milk: Nil 5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES Milk fever characterised by hypocalcaemia is caused by an acute drop in the level of calcium in the blood. At parturition, hypophosphataemia and hypomagnesaemia can also occur. The product is administered by subcutaneous or slow intravenous injection replenishes plasma concentrations of calcium, phosphate and magnesium ions. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium Hydrogen Carbonate Water for Injection 6.2 Major incompatibilities None known. 6.3 Shelf-life Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 6.4 Special precautions for storage Do not store above 25°C. Protect from light. 6.5 Nature and composition of immediate packaging 400 ml Type III glass vials (amber) which are sealed using rubber wads (black) and aluminium screw caps or 400 ml polypropylene containers sealed with bromobutyl bungs (grey) and aluminium caps. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products Any unused product or waste material should be disposed of in accordance with national requirements. 7. MARKETING AUTHORISATION HOLDER Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate Monaghan Ireland 8. MARKETING AUTHORISATION NUMBER(S) VPA22664/032/001 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 1991 Date of last renewal: 01 October 2006 10. DATE OF REVISION OF THE TEXT December 2018
