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Date: Thursday, May 30, 2024 9:37

Release 2.133
Calciject 40 Solution For Injection
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Dietary supplements and fluid metabolites: Mineral replacements - injectable
Active ingredient: Calcium Gluconate
Product:Calciject 40 Solution For Injection
Product index: Calciject 40
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active Substance:
Each 400ml contains:- 11.88g Calcium provided by Calcium Gluconate and Calcium Borogluconate. Also contains 6.5% w/v Boric Acid.
Pharmaceutical form
Solution for Injection.
A clear, pale, yellow solution.
Clinical particulars
Target species:
Cattle
Indications for use, specifying the target species
For the treatment of hypocalcaemia in cattle.
Contraindications
None.
Special Warnings for each target species
None.
Special precautions for use
i. Special precautions for use in animals
The solution should be warmed to body temperature before administration. Intravenous injections should be given slowly. Observe aseptic precautions.
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.
Adverse reactions (frequency and seriousness)
Provided the recommendations are followed carefully, undesirable effects should not occur.
Use during pregnancy, lactation or lay
Calciject 40 can be safely administered to pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction
No known interactions.
Amounts to be administered and administration route
Administer by subcutaneous or slow intravenous injection at the following rate:
Cattle : 150 - 500 ml
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period
Meat: Zero days
Milk: Zero hours
Pharmacological particulars
Pharmacotherapeutic group: Mineral supplements, Calcium
ATC Vet Code: QA12AA
Pharmacodynamic properties
Milk fever which is characterised by hypocalcaemia is caused by an acute drop in the level of ionised calcium. Administration of calcium borogluconate by subcutaneous or slow intravenous injection replenishes plasma calcium levels and reverses the hypocalcaemia.
Pharmaceutical particulars
List of excipients
Boric Acid or Sodium Bicarbonate
Water for Injections
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as package for sale: 3 years
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
Calciject 40 is marketed in either 400 ml Amber Type III glass vials sealed with black rubber wads and aluminium screw caps, or 400 ml polypropylene containers sealed with grey bromobutyl bungs and aluminium caps.
Not all pack sizes may be marketed.
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 02000/4069
Significant changes
Date of the first authorisation or date of renewal
19th March 1986
Date of revision of the text
June 2010
Any other information
Nil.
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Calciject 40 (400ml)
GTIN:5023534001348