Magnidown 25% W/V Solution For Injection
Revised: 01 September 2010
AN: 00706/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Magnidown 25%w/v Solution for Injection
2. Qualitative and Quantitative composition
Active Substance:
Magnesium Sulphate Heptahydrate 25.0% w/v
Excipients:
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
A clear, colourless solution.
4. CLINICAL PARTICULARS
4.1 Target species
Cattle
Sheep
4.2 Indications for use, specifying the target species
Indicated in the treatment of hypomagnesaemia in cattle and sheep.
4.3 Contraindications
Do not administer intravenously.
4.4 Special warnings for each target species
None
4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
If accidental self-injection or ingestion occurs, seek medical advice immediately.
In case of eye or skin contact, rinse the affected area immediately with plenty of clean water.
Seek medical attention if irritation persists.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
Magnidown can be safely administered during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Administer by subcutaneous injection only, observing aseptic technique.
Cattle: Up to 400 ml
Sheep: Up to 75 ml
Warm to body temperature before administration, and gently massage the site of injection. Divide the total dose volume to be administered between 2 or more sites.
4.10 Overdose (symtoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal period
Cattle Sheep
Meat: Zero Days Meat: Zero Days
Milk: Zero Hours Milk: Zero Hours
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group:
ATC Vet Code: QA12CC02
5.1 Pharmacodynamic properties
Magnesium is an essential mineral involved in metabolism, muscle activity and nerve function.
When administered by subcutaneous injection the product corrects the ionic disturbance associated with hypomagnesaemia.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric Acid
Water for Injection
6.2 Incompatabilities
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.
This product does not contain an antimicrobial preservative.
Any solution remaining in the vial following withdrawal of the required dose should be discarded.
6.5 Nature and composition of immediate packaging
400ml amber Type III glass vials sealed using black rubber wads and aluminium screw caps
400ml polypropylene containers sealed with bromobutyl bungs and aluminium caps.
Not all pack sizes may be marketed.
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
Station Works
Newry
Co. Down
BT35 6JP
Northern Ireland
8. MARKETING AUTHORISATION NUMBER
Vm02000/4287
9. DATE OF RENEWAL OF AUTHORISATION
03 March 2010
10. DATE OF REVISION OF THE TEXT
September 2010