Magniject 25% W/V Solution For Injection
Revised: July 2010
ATCVet code amended
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Magniject 25% w/v Solution for Injection
2. Qualitative and quantitative composition
Active Substance:
Contains Magnesium Sulphate Heptahydrate 25.0% w/v
(equivalent to Magnesium Sulphate anhydrous 12.21% w/v)
Excipients:
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for Injection
A clear colourless/pale yellow solution for Injection
4. Clinical Particulars
4.1 Target species
Cattle and 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
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
None
4.7 Use during pregnancy, lactation or lay
Can be safely administered during pregnancy and lactation
4.8 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. For subcutaneous injection only, observing aseptic precautions. Divide the total dose volume to be administered between 2 or more sites.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period
Cattle Sheep
Meat : Zero Days Meat : Zero Days
Milk : Zero Hours Milk : Zero Hours
5. pharmacological properties
Pharmacotherapeutic group:Mineral supplements, Other mineral supplements, Magnesium
ATC Vet Code: QA12CC
Pharmacodynamic properties
When administered by subcutaneous injection the product corrects the ionic disturbance associated with hypomagnesaemia. Magnesium is an essential mineral involved in metabolism, muscle activity and nerve functions.
6. Pharmaceutical particulars
List of excipients
Hydrochloric Acid, Concentrated
Water for Injections
Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
This product does not contain an antimicrobial preservative. Do not store above 25oC.
Any solution remaining in the vial following 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 white polypropylene bottles sealed with grey 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.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Camlough Road
Newry, Co. Down
BT35 6JP
Northern Ireland
8. MARKETING AUTHORISATION NUMBER
Vm02000/4129
9. DATE OF FIRST AUTHORISATION
19thOctober 1994
10. DATE OF REVISION OF THE TEXT
July 2010
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