Calciject 20 Cm Solution For Injection
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Calciject 20 CM Solution for Injection
2. Qualitative and quantitative composition
Each 400 ml contains 5.92g Calcium (provided by Calcium Gluconate and Calcium Borogluconate) and 1.85g magnesium (provided by magnesium hypophosphite). Also contains 3.23% w/v boric acid.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection
A clear colourless to pale yellow solution.
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
For the treatment of hypocalcaemia in cattle complicated by a deficiency of magnesium in cattle and sheep.
4.4 Special Warnings for each target species
In the treatment of acute hypomagnesaemia, the administration by appropriate routes of a solution with a higher concentration of magnesium may also be necessary.
4.5 Special precautions for use
Special precautions for use in animals
Solutions for intravenous injection should be warmed to body temperature and infused slowly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
4.6 Adverse reactions (frequency and seriousness)
Rapid intravenous injection may result in cardiac arrythmias and in severely toxaemic cows, collapse and death.
4.7 Use during pregnancy, lactation or lay
Provided the necessary precautions are observed the product should be 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
Slow intravenous injection.
Massage site gently after administration
Cattle : 400 - 800 ml
Sheep : 50 - 80 ml
Overdose (symptoms, emergency procedures, antidotes), if necessary
Rapid intravenous injection may result in cardiac arrythmias or heart block. Therefore intravenous injections should be given slowly and stopped on the first signs of adverse reaction.
Meat : Zero Days
Milk : Zero Hours
Meat : Zero Days
Milk : Zero Hours
5. pharmacological properties
Pharmacotherapeutic group: Metabolic Preparation
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 metabolite preparations. On parenteral administration they rapidly increase plasma concentrations of calcium, magnesium and phosphorus. This is effective in the treatment of hypocalcaemia with associated (hypomagnesaemia).
5.2 Pharmacokinetic properties
The absorption of magnesium takes place in the proximal small intestine by active transport in a common pathway with calcium. Magnesium ions are inefficiently absorbed from the gastro-intestinal tract where absorption may be enhanced by the presence of vitamin D. Magnesium salts are excreted mainly in the urine with small amounts in milk, saliva and faeces. The normal range for magnesium in large animals is 1.7-3.0mg/100ml and clinical signs appear when the level drops below 1.0mg/100ml.
6. Pharmaceutical particulars
6.1 List of excipients
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.
Any solution remaining in the vial following 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/RENEWAL OF THE AUTHORISATION
15th November 1994/15th November 2004
10. DATE OF REVISION OF TEXT