Norbrook Fipronil 268 mg Spot-On Solution for Large Dogs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
12-06-2017

유효 성분:

Fipronil

제공처:

Norbrook Laboratories Limited

ATC 코드:

QP53AX15

INN (국제 이름):

Fipronil

복용량:

268 mg/pipette

약제 형태:

Spot-on solution

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Dogs

치료 영역:

fipronil

치료 징후:

Ectoparasiticide

승인 상태:

Authorised

승인 날짜:

2012-07-06

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 268 mg Spot-On Solution for Large Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 2.68 ml pipette contains:
Active substance:
Fipronil
268 mg
Excipients:
Butylhydroxyanisole (E320)
0.536 mg
Butylhydroxytoluene (E321)
0.268 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infestations by fleas (Ctenocephalides felis).
The product shows immediate insecticidal effect and
persistent insecticidal activity against new infestations by adult
fleas for up to 8 weeks.
The product has a persistent acaricidal efficacy against Ixodes
ricinus for up to 2 weeks, Rhipicephalus sanguineus for
up to 3 weeks and Dermacentor reticulatus for up to 4 weeks. If ticks
of these species are present when the product is
applied, all ticks will not be killed within the first 48 hours but
they may be killed within a week.
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 20 kg.
In the absence of available data, the product should not be used in
puppies less than 8 weeks old.
Do not use in sick (systemic diseases, fever…) or convalescent
animals.
Do not use in rabbits, as adverse reactions and even death could
occur.
This product is specifically developed for dogs.
Do not use in cats, as this could lead to overdosing.
Do not use in cases of known hypersensitivity to the active or to any
of the excipients.
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