Dugnixon 50 mg/ml solution for injection for cattle, pigs and horses

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Flunixin meglumine

Commercializzato da:

GLOBAL VET HEALTH SL

Codice ATC:

QM01AG90

INN (Nome Internazionale):

Flunixin meglumine

Dosaggio:

50 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Cattle, Horses, Pigs

Area terapeutica:

flunixin

Indicazioni terapeutiche:

N.S.A.I.D.

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2017-12-15

Scheda tecnica

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Dugnixon 50 mg/ml solution for injection for cattle, pigs and horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Flunixin
50.0 mg
(Equivalent to flunixin meglumine 82.9 mg)
Excipients
Phenol
5.0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Colourless liquid
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses and pigs.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
For the control of acute inflammation associated with respiratory
disease.
The product has also been shown to have some benefit in the treatment
of experimental
acute bovine pulmonary emphysema (Fog Fever).
The product may be used as adjunctive therapy in the treatment of
acute mastitis.
HORSES
For the alleviation of inflammation and pain associated with
musculo-skeletal disorders.
For the alleviation of visceral pain associated with colic in the
horse.
PIGS
For use as an adjunctive therapy in the treatment of swine respiratory
diseases.
4.3. CONTRAINDICATIONS
Do not exceed the stated dose or the duration of treatment.
Do not use in animals suffering from cardiac, hepatic or renal disease
or where there
is the possibility of gastro-intestinal ulceration or bleeding.
Do not use in known cases of hypersensitivity to flunixin meglumine,
other NSAIDs or to
any of the excipients.
Do not use the product within 48 hours before expected parturition in
cows
_ _
in such
cases an increase in the number of still births has been observed.
Do not administer to pregnant mares.
Do not administer to pregnant sows, gilts at mating and in breeding
boars.
Do not use in animals suffering from colic caused by ileus and
associated with
dehydration.
4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5. SPECIAL PRECAUTIONS FOR USE.
Special precautions for use in animals
Avoid intra-arterial injection.
NSAIDS are known to have the potential to delay parturition through a
tocolytic effect by
inhibiting prostaglandins that ar