Magniject 25% Solution for Injection

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Magnesium sulphate heptahydrate

Dostupno od:

Norbrook Laboratories (Ireland) Limited

ATC koda:

QA12CC02

INN (International ime):

Magnesium sulphate heptahydrate

Doziranje:

25 percent weight/volume

Farmaceutski oblik:

Solution for injection

Tip recepta:

LR: Licensed Retailer as defined in national legislation

Područje terapije:

magnesium sulfate

Status autorizacije:

Authorised

Datum autorizacije:

1991-10-01

Svojstava lijeka

Health Products Regulatory Authority
15 January 2019
CRN008T9Q
Page 1 of 3
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.
Health Products Regulatory Authority
15 January 2019
CRN008T9Q
Page 2 of 3
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
INTERACTIONS
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 MAJOR INCOMPATIBILITIES
None known.
Health Products Regulatory Authority
15 January 2019
CRN008T9Q
Page 3 of 3
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 25o