PestiGon Combo 268 mg / 241.2 mg spot-on solution for large dogs

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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제품 특성 요약 제품 특성 요약 (SPC)
23-01-2018

유효 성분:

Fipronil ; (S)-methoprene

제공처:

Norbrook Laboratories Limited

ATC 코드:

QP53AX65

INN (International Name):

Fipronil ; (S)-methoprene

복용량:

268/241.2 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, combinations

치료 징후:

Ectoparasiticide

승인 상태:

Authorised

승인 날짜:

2017-05-12

제품 특성 요약

                                Health Products Regulatory Authority
22 January 2018
CRN000WT2
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PestiGon Combo 268 mg / 241.2 mg spot-on solution for large dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 2.68 ml contains:
ACTIVE SUBSTANCES:
Fipronil
268
mg
(S)-methoprene
241.2
mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.54
mg
Butylhydroxytoluene (E321)
0.27
m
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution
A clear, yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of dogs weighing 20 to 40 kg bodyweight.
To be used against infestations with fleas, alone or in association
with ticks and/or
biting lice.

Treatment of flea infestations _(Ctenocephalides spp.)_. Insecticidal
efficacy
against new infestations with adult fleas persists for 8 weeks.
Prevention of
the multiplication of fleas by inhibiting the development of eggs
(ovicidal
activity) and larvae and pupae (larvicidal activity) originating from
eggs laid
by adult fleas for eight weeks after application.

Treatment of tick infestations _(Ixodes ricinus, Dermacentor
variabilis, _
_Dermacentor reticulatus, Rhipicephalus sanguineus)._ The product has
persistent acaricidal efficacy for up to 4 weeks against ticks.

Treatment of infestations with biting lice _(Trichodectes canis)._
Health Products Regulatory Authority
22 January 2018
CRN000WT2
Page 2 of 8
The product can be used as part of a treatment strategy for the
control of Flea
Allergy Dermatitis (FAD).
4.3 CONTRAINDICATIONS
In the absence of available data, the product should not be used on
puppies less
than 8 weeks old.
Do not use in rabbits, as adverse reactions with even mortality could
occur.In
absence of studies, the use of the product is not recommended in
non-target species.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
This product is specifically developed for dogs. Do not use in cats
and ferrets, 
                                
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