Acticarp 50 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Carprofen

Available from:

Ecuphar NV

ATC code:

QM01AE91

INN (International Name):

Carprofen

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Expired

Authorization date:

2012-05-09

Summary of Product characteristics

Revised: February 2017
AN: 00603/2016
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Acticarp 50 mg/ml Solution for Injection for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Carprofen
50 mg
EXCIPIENTS:
Ethanol anhydrous
0.1 ml
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 cases of hypersensitivity to the active substance or to
any of the
excipients.
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: February 2017
AN: 00603/2016
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 GI or renal impairment,
adjunctive fluid
therapy should be considered especially in the case of acute mastitis
treatment.
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 contact with skin and eyes. Should this occur, wash the affected
areas
immediately. Seek medical attention if irritation