Flunazine 50 mg/ml Solution for Injection for cattle, horses and pigs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Flunixin meglumine

Tilgængelig fra:

Bimeda Animal Health Limited

ATC-kode:

QM01AG90

INN (International Name):

Flunixin meglumine

Dosering:

50 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

flunixin

Autorisation status:

Authorised

Autorisation dato:

2001-07-27

Produktets egenskaber

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flunazine 50 mg/ml Solution for Injection for cattle, horses and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Flunixin
50 mg
(as Flunixin meglumine
83 mg)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Phenol
5 mg
Sodium formaldehyde sulfoxylate
2.2 mg
Propylene glycol
207.2 mg
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection
Clear, colourless to light yellow solution, free from foreign matter.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
Horses
Pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle: For the alleviation of acute inflammation associated with
bronchopneumonia.
Horses: For the alleviation of inflammation associated with
musculoskeletal disorders, especially in
acute to subchronic stages. It is also indicated for the alleviation
of visceral pain associated with colic.
Pigs: For use as an adjunctive therapy in the treatment of swine
respiratory diseases.
3.3
CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is the possibility of
gastro-intestinal ulceration or bleeding, where there is evidence of a
blood dyscrasia.
Do not use in animals suffering from colic caused by ileus and which
is associated with dehydration.
Do not use in animals suffering from chronic musculoskeletal
disorders.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in horses producing milk for human consumption.
Do not administer to pregnant mares or pregnant sows.
Do not use the veterinary medicinal product within 48 hours before
expected parturition in cows.
Do not administer to gilts at mating, breeding boars or piglets less
than 6 kg bodyweight.
See also section 3.7 and 3.8.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FO