Enrox Flavour 50 mg Tablets for dogs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Enrofloxacin

제공처:

Krka, d.d., Novo mesto

ATC 코드:

QJ01MA90

INN (International Name):

Enrofloxacin

복용량:

50 mg/tablet

약제 형태:

Tablet

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Dogs

치료 영역:

enrofloxacin

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2009-06-12

제품 특성 요약

Health Products Regulatory Authority
12 February 2021
CRN00C3CG
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox Flavour 50 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Enrofloxacin 50 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round slightly biconvex, cream to light brownish tablets with possible
visible white or darker spots, one side scored. The
tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs for the treatment of bacterial
infections of the alimentary, respiratory and urogenital tracts, skin,
secondary wound infections and otitis externa where clinical
experience, supported where possible by sensitivity testing of the
causal organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use in dogs less than 1 year of age or in exceptionally large
breeds of dog with a longer growth period less than 18
months of age, as articular cartilage may be affected during the
period of rapid growth.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in dogs having seizure disorders, since enrofloxacin may
cause CNS stimulation.
Do not use for prophylaxis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please see point 4.3.
4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
Fluoroquinolones should be reserved for the treatment of clinical
conditions
which have responded poorly, or are expected to respond poorly to
other classes of antimicrobials. Whenever possible, use of
fluoroquinolones should be based on susceptibility testing. Use of the
product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the poten