Rimifin 100 mg Tablets for dogs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Carprofen

MAH:

Chanelle Pharmaceuticals Manufacturing Limited

ATC_code:

QM01AE91

INN:

Carprofen

dosage:

100 mg/tablet

pharmaceutical_form:

Tablet

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Dogs

therapeutic_area:

carprofen

therapeutic_indication:

N.S.A.I.D.

authorization_status:

Authorised

authorization_date:

2006-06-02

SPC

Health Products Regulatory Authority
08 November 2019
CRN0095DQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rimifin 100 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
Carprofen
100.0 mg/tablet
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
A white to off white round shape tablets with a cross breakline on one
side. The tablets can be divided into halves or quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of inflammation and pain caused by musculo-skeletal
disorders and degenerative joint disease. As a follow up to
parenteral analgesia in the management of post-operative pain
following soft tissue surgery.
4.3 CONTRAINDICATIONS
Do not use in cats.
Do not use in case of hypersensitivity to active substance or to any
of the excipients.
Do not use in dogs suffering from cardiac, hepatic or renal disease,
where there is a possibility of gastro-intestinal ulceration or
bleeding, or where there is evidence of a blood dyscrasia.
Refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to Sections 4.3 and 4.5.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in dogs less than 6 weeks of age, or in aged dogs, may involve
additional risk. If such a use cannot be avoided, dogs may
require careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there
is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be
avoided.
NSAIDs can cause inhibition of phagocytosis and hence in the treatment
of inflammatory conditions associated with bacterial
infection, appropriate concurrent antimicrobial therapy should be
instigated.
Do not administer other NSAIDs concurrently or within 24 hours of each
other. Some NSAIDs may be highly bound to plasma
proteins and compete with other highly bound drugs, which can lead