Calciject 40 Cm Solution For Injection
Revised: July 2010
ATCVet code amended
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Calciject 40 CM Solution For Injection
2. Qualitative and quantitative composition
Contains Calcium Borogluconate 40% w/v
Magnesium Hypophosphite Hexahydrate 5% w/v
Each 400ml contains :
11.9g calcium (provided by calcium gluconate and calcium borogluconate)
1.85g magnesium (provided by magnesium hypophosphite).
Also contains 6.84% w/v boric acid.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection
A clear pale yellow solution
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
Indicated in the treatment of hypocalcaemia in cattle where increased blood magnesium levels are required.
4.4 Special Warnings for each target species
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 in order to avoid possible neuromuscular dysfunction and cardiac insufficiency.
Normal aseptic precautions should be observed.
Sites of subcutaneous administration should be massaged gently.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection: may cause irritation at site of injection.
4.6 Adverse reactions (frequency and seriousness)
Occasional temporary swelling may occur at sites of subcutaneous administration.
4.7 Use during pregnancy, lactation or lay
Safe for use during pregnancy and lactation
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Administer by subcutaneous or slow intravenous injection
Cattle: 200 to 400 ml
Overdose (symptoms, emergency procedures, antidotes), if necessary
Meat : Zero Days
Milk : Zero Hours
5. pharmacological properties
Pharmacotherapeutic group: Mineral Supplements, Calcium, Calcium, combinations with other drugs
ATC Vet Code: QA12AX
5.1 Pharmacodynamic properties
Calcium Borogluconate and Magnesium Hypophosphite are soluble salts of calcium and magnesium respectively used extensively in fluid infusions in correction of metabolic disturbances. On parenteral administration they rapidly increase plasma concentrations of calcium, magnesium and phosphorus. This is effective in the treatment of hypocalcaemia with associated magnesium and phosphorus deficiencies.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium Bicarbonate 10% or Boric Acid 5%
Water for Injections
Shelf life of the veterinary medicinal product as packaged for sale;
Glass bottles: 2 years
Polypropylene vials: 18 months
Special precautions for storage
Do not store above 25oC. Protect from light.
The product does not contain an antimicrobial preservative. The product is intended for single use only. Any product remaining in the bottle after withdrawal of the required dose should be discarded.
Nature and composition of immediate packaging
Marketed in either 400 ml Amber Type III glass vials sealed using black rubber wads and aluminium screw caps, or 400ml polypropylene containers sealed with bromobutyl bungs and aluminium caps.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Co. Down, BT35 6JP
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
5th July 1994
10. DATE OF REVISION OF THE TEXT