Magniject 25% Solution for Injection
Magniject is indicated in the treatment of hypomagnesaemia in cattle and sheep.
Dosage & Administration
By subcutaneous injection only.
Cattle: Up to 400ml
Sheep: Up to 75ml
Meat/milk - Nil.
Do not administer intravenously.
Observe aseptic precautions.
For single use only.
Warm to body temperature before administration.
Avoid the introduction of contamination during use.
Should any apparent growth or discoloration occur the product should be discarded.
Do not store above 25ºC.
This product does not contain an antimicrobial preservative.
Any solution remaining in the vial following withdrawal of the required dose should be discarded.
For Animal Treatment Only
Keep out of reach and sight of Children
A clear solution for injection containing:
Magnesium Sulphate Heptahydrate 25.0% w/v
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Magniject 25% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Magnesium Sulphate Heptahydrate 25.0 % w/v
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle, Sheep.
4.2 Indications for use, specifying the target species
Magniject is 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
Warm to body temperature prior to administration.
Special precautions to be taken by the person administering the veterinary medicinal product to animals None.
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy, lactation or lay
Magniject 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.
Cattle: Up to 400 ml
Sheep: Up to 75 ml
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal Period(s)
Meat: zero days.
Milk: zero days.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Magniject administered by subcutaneous injection corrects the ionic disturbance that results from hypomagnesaemia.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric Acid
Water for Injection 6.2 Incompatibilities None known.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. This product is for single use only. 6.4 Special precautions for storage Do not store above 25oC.
6.5 Nature and composition of immediate packaging
Magniject, a clear colourless solution, 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 bromobutyl bungs and aluminium caps.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused product or waste material should be disposed of in accordance with national requirements.
7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited,
Station Works,
Newry,
Co. Down, BT35 6JP,
Northern Ireland.
MARKETING AUTHORISATION NUMBER(S)
VPA 10999/45/1
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st October 2006
10 DATE OF REVISION OF THE TEXT
None.