Rycarfa 100 mg tablets for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Carprofen

Fáanlegur frá:

Krka, d.d., Novo mesto

ATC númer:

QM01AE91

INN (Alþjóðlegt nafn):

Carprofen

Skammtar:

100 mg/tablet

Lyfjaform:

Tablet

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

carprofen

Ábendingar:

N.S.A.I.D.

Leyfisstaða:

Authorised

Leyfisdagur:

2014-05-02

Vara einkenni

Health Products Regulatory Authority
02 November 2018
CRN000YDN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rycarfa 100 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
Carprofen​
100.00​
mg​
​
EXCIPIENTS:
​
​
​
Ferric oxide red (E172)
3.04​
mg​
​
Ferric oxide black (E172)
1.90​
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Tablet.
Round, dark brown, marbled tablets with visible darker spots, one-side
scored and
bevel-edged.
The tablet can be divided into equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of inflammation and pain caused by musculoskeletal disorders
and
degenerative joint disease. As a follow up to parenteral analgesia in
the management
of post-operative pain.
4.3 CONTRAINDICATIONS
Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in dogs less than 4 months of age.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in dogs suffering from cardiac, hepatic or renal disease,
where there is a
Health Products Regulatory Authority
02 November 2018
CRN000YDN
Page 2 of 5
possibility of gastrointestinal ulceration or bleeding, or where there
is evidence of a
blood dyscrasia.
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 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.
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.
See section 4.8