Magniject 25% Solution for Injection 400ml

Magniject 25% Solution for Injection 400ml

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Description

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

Withdrawal Period


Meat/milk - Nil.

Contraindictions, Warnings etc


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.

Pharmaceutical Precautions


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.

Further Information


For Animal Treatment Only
Keep out of reach and sight of Children

Presentation


A clear solution for injection containing:
Magnesium Sulphate Heptahydrate 25.0% w/v

Data Sheet

 

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.