Calciject 40+3 is a Calcium injection for the treatment of hypocalcaemia/ Milk Fever in cattle. Each 400ml contains: 11.88g Calcium provided by Calcium Gluconate and Calcium Borogluconate. Calciject 40+3 should be administered subcutaneously or via a slow intravenous injection at the following rate: Cattle : 150 - 500 ml. The solution should be warmed to body temperature before administration.
Active Substance
Calcium gluconate 332 mg
Boric acid 68 mg
Magnesium hypophosphite hexahydrate 30mg
Target Species
Cattle
Treats and Controls
Hypocalcaemia/ Milk Fever in cattle
Application Method
Administer by subcutaneous or slow intravenous injection
Withdrawal Period
Meat: Nil
Milk: Nil
Dosage
Cattle: 150 - 400 ml
Key Features of Calciject 40+3
In most cases cows will show some excitement or agitation with a tremor or spasm in muscles of the head and limbs. Then they will often stagger and go down to a "sitting" position, often with a 'kink' in her neck, and finally lie flat on their side before circulatory collapse, coma and even death.
A dry muzzle, staring eyes, cold legs and ears, constipation and drowsiness are seen after going down.
The heart beat becomes weaker and faster.
The body temperature falls below normal, especially in cold, wet, windy weather.
These signs are due mainly to lowered blood calcium levels.
Sometimes there are additional signs due to complicating factors.
Bloat is common in cows unable to "sit up" because the gas in the rumen is unable to escape.
Pneumonia and exposure may affect cows left out in bad weather.
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Summary of Product Characteristics
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Calciject 40 + 3 Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Calcium gluconate 332 mg
Boric acid 68 mg
Magnesium hypophosphite hexahydrate 30 mg
For a full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Target Species
Cattle.
4.2 Indications for use, specifying the target species
The product is indicated in the treatment of hypocalcaemia complicated by deficiency of magnesium.
4.3 Contraindications
Do not use in animals with known hypersensitivity to the active ingredients.
Health Products Regulatory Authority 21 December 2018 CRN008SQR
4.4 Special warnings for each target species
None.
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 and stopped on the first signs of adverse reaction. Rapid intravenous injection may result in cardiac arrhythmias and, in severely toxaemic animals, collapse and death. As intravenous administration of this product could cause death, this route should only be used by a veterinary surgeon.
Special precautions to be taken by the person administering the product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy, lactation or lay
The product can be safely administered to pregnant and lactating animals.
4.8 Interaction with other medicinal products and other forms of interactions
None known.
4.9 Amounts to be administered and administration route
Administer by subcutaneous or slow intravenous injection Cattle: 150 - 400 ml
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal period(s)
Meat: Nil
Milk: Nil
5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Milk fever characterised by hypocalcaemia is caused by an acute drop in the level of calcium in the blood. At parturition, hypophosphataemia and hypomagnesaemia can also occur. The product is administered by subcutaneous or slow intravenous injection replenishes plasma concentrations of calcium, phosphate and magnesium ions.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Hydrogen Carbonate Water for Injection
6.2 Major incompatibilities
None known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
6.4 Special precautions for storage
Do not store above 25°C. Protect from light.
6.5 Nature and composition of immediate packaging
400 ml Type III glass vials (amber) which are sealed using rubber wads (black) and aluminium screw caps or 400 ml polypropylene containers sealed with bromobutyl bungs (grey) and aluminium caps. Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate
Monaghan
Ireland
8. MARKETING AUTHORISATION NUMBER(S)
VPA22664/032/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 01 October 1991
Date of last renewal: 01 October 2006
10. DATE OF REVISION OF THE TEXT
December 2018
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