Carprofen KRKA 50 mg/ml solution for injection for dogs and cats

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Carprofen

Disponible depuis:

Krka, d.d., Novo mesto

Code ATC:

QM01AE91

DCI (Dénomination commune internationale):

Carprofen

Dosage:

50 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

carprofen

indications thérapeutiques:

N.S.A.I.D.

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-06-21

Résumé des caractéristiques du produit

Health Products Regulatory Authority
23 December 2019
CRN000X1W
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Carprofen KRKA 50 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Carprofen for veterinary use
50
mg
​
​
​
Excipients
Benzyl alcohol (E1519)
10
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs: For the control of post-operative pain and inflammation
following orthopaedic and soft tissue (including intraocular)
surgery.
Cats: For the control of post-operative pain following surgery.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal disease
or gastrointestinal problems, where there is a possibility
of gastrointestinal ulceration or bleeding.
Do not use in known cases of hypersensitivity to the active substance
or any other NSAIDs or any excipients of this product.
As with other NSAIDs there is a risk of rare renal or idiosyncratic
hepatic adverse events.
Do not administer by intramuscular injection.
Do not use after surgery which was associated with considerable blood
loss.
Do not use in cats on repeated occasions.
Do not use in cats less than 5 months of age.
Do not use in dogs less than 10 weeks of age.
See also section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Due to the longer half life in cats and narrower therapeutic index,
particular care should be taken not to exceed the
recommended dose and the use of a 1 ml graduated syringe is
recommended to measure the dose accurately.
Health Products Regulatory Authority
23 December 2019
CRN000X1W
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended dose or duration of treatment.
Due to the longer half life in cats and narrower therapeut