Rimadyl Cattle 50 mg/ml Solution for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Carprofen

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QM01AE91

INN (Kansainvälinen yleisnimi):

Carprofen

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle

Terapeuttinen alue:

Anti Inflammatory NSAID

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2008-11-11

Valmisteyhteenveto

Revised December 2019
AN: 01184/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
RIMADYL Cattle 50 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Carprofen 50 mg
EXCIPIENTS:
Ethanol 0.1 ml
Benzyl Alcohol 10 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, pale straw yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated as an adjunct to antimicrobial therapy to
reduce clinical
signs in acute infectious respiratory disease and acute mastitis in
cattle.
4.3
CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal
impairment.
Do not use in animals suffering from gastro-intestinal ulceration or
bleeding.
Do not use where there is evidence of a blood dyscrasia.
Do not use in cases of known hypersensitivity to the active substance
or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Revised December 2019
AN: 01184/2019
Page 2 of 5
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as
there is
a potential risk of increased renal toxicity. Concurrent
administration of
potentially nephrotoxic drugs should be avoided.
Do not exceed the stated dose or the duration of treatment.
Do not administer other NSAID’s concurrently or within 24 hours of
each other.
As NSAID therapy can be accompanied by gastro-intestinal or renal
impairment, adjunctive fluid therapy should be considered especially
in the
case of acute mastitis treatment.
ii)
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals.
Carprofen, in common with other NSAIDs, has been shown to exhibit
photosensitising potential in laboratory studies. Avoid skin contact
with the
veterinary medicinal product. Should this occur, wash the affected