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Date: Monday, April 29, 2024 4:44

Release 2.88
Calciject 40 CM Solution for Injection
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Mineral replacements - injectable, Vitamin mineral preparations - injectable
Active ingredient: Calcium Gluconate, Magnesium
Product:Calciject 40 CM Solution for Injection
Product index: Calciject 40 CM
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active Substance:
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.
Excipients:
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Solution for Injection.
A clear pale yellow solution.
Clinical particulars
Target species
Cattle
Indications for use, specifying the target species
Indicated in the treatment of hypocalcaemia in cattle where increased blood magnesium levels are required.
Contraindications
None.
Special Warnings for each target species
None.
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.
Adverse reactions (frequency and seriousness)
Occasional temporary swelling may occur at sites of subcutaneous administration.
Use during pregnancy, lactation or lay
Safe for use during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None.
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
Not applicable.
Withdrawal period
Cattle: Meat: Zero Days, Milk: Zero Hours
Pharmacological particulars
Pharmacotherapeutic group: Mineral Supplements, Calcium, Calcium, combinations with other drugs
ATC Vet Code: QA12AX
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.
Pharmaceutical particulars
List of excipients
Sodium Bicarbonate 10% or Boric Acid 5%.
Water for Injections.
Incompatibilities
None known.
Shelf life
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 25°C. 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.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited, Station Works, Camlough Road, NEWRY, Co. Down, BT35 6JP Northern Ireland
Marketing Authorisation Number
Vm 02000/4125
Significant changes
Date of the first authorisation or date of renewal
5th July 1994
Date of revision of the text
July 2010
Any other information
Nil.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Calciject 40CM (400ml)
GTIN:5023534001485