Calciject Lv Solution For Injection
Revised: June 2010
ATCVet code amended
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Calciject LV Solution For Injection
2. Qualitative and quantitative composition
Each 100 ml contains 4.2 g calcium (provided by calcium gluconate, calcium borogluconate and calcium hydroxide) and 0.78 g magnesium (provided by magnesium chloride hexahydrate). Also contains 7.34% 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 for injection
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
Indicated in the treatment of hypocalcaemia in cattle complicated by a deficiency of magnesium
4.4 Special Warnings for each target species
In cases of acute hypomagnesaemia the administration, by appropriate routes, of a solution with a higher concentration of magnesium may be necessary.
4.5 Special precautions for use
i. Special precautions for use in animals
Solutions for intravenous injection should be warmed to body temperature and infused slowly.
The product does not contain an antimicrobial preservative. Any solution remaining in the vial following withdrawal of required dose should be discarded.
ii. 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)
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 above precautions are observed the product should be safe for use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Slow intravenous injection
Massage the site gently after administration.
Dosage: Cattle - 100 - 200 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.
Cattle - Meat: Zero Days
Milk: Zero Hours
5. pharmacological properties
Pharmacotherapeutic group: Mineral supplements, Calcium, Calcium, combinations with other drugs
ATC Vet Code: QA12AX
Calcium borogluconate, calcium hydroxide and magnesium chloride hexahydrate are soluble salts of calcium and magnesium respectively, used extensively in fluid metabolite preparations. On parenteral administration they rapidly increase plasma concentrations of calcium and magnesium. This is effective in the treatment of hypocalcaemia with associated hypomagnesaemia.
After injection of Calciject LV plasma levels of calcium and magnesium were recorded at 2.51 +0.039 mmol/L and 0.889 +0.041 mmol/L respectively which are within the normal ranges for plasma calcium and magnesium.
Mean Cmax values for calcium of 4.2 +0.08 mmol/L were obtained following administration of Calicject LV. The corresponding mean AUC values for calcium were 61.38 +0.59 mmol/L.hr
6. Pharmaceutical particulars
6.1 List of excipients
Phosphoric Acid, Concentrated.
Water for Injections
Shelf life of the veterinary medicinal product as packaged for sale: 2 Years.
Special precautions for storage
Do not store above 25ºC.
Protect from light.
This product does not contain an antimicrobial preservative.
Any solution remaining in the vial following withdrawal of the required dose should be discarded.
Nature and composition of immediate packaging
Packaged in 100 ml clear grade II glass vials with bromobutyl bungs and aluminium caps
6.6 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
20th December 1994
10. DATE OF REVISION OF THE TEXT
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