Rycarfa 100 mg tablets for dogs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

지금 구매하세요

제품 특성 요약 제품 특성 요약 (SPC)
03-11-2018
공공 평가 보고서 공공 평가 보고서 (PAR)
02-07-2019
DSU DSU (DSU)
01-12-2023

유효 성분:

Carprofen

제공처:

Krka, d.d., Novo mesto

ATC 코드:

QM01AE91

INN (International Name):

Carprofen

복용량:

100 mg/tablet

약제 형태:

Tablet

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Dogs

치료 영역:

carprofen

치료 징후:

N.S.A.I.D.

승인 상태:

Authorised

승인 날짜:

2014-05-02

제품 특성 요약

                                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
                                
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