Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Fipronil ; (S)-methoprene

Dostupné z:

Krka, d.d., Novo mesto

ATC kód:

QP53AX65

INN (Medzinárodný Name):

Fipronil ; (S)-methoprene

Dávkovanie:

402, 361.8 mg/pipette

Forma lieku:

Spot-on solution

Typ predpisu:

LR: Licensed Retailer as defined in national legislation

Terapeutické oblasti:

fipronil, combinations

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2018-07-06

Súhrn charakteristických

Health Products Regulatory Authority
22 July 2019
CRN008SP0
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amflee Combo 402 mg/361.8 mg spot-on solution for extra large dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4.02 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil 402 mg
S-Methoprene 361.8 mg
EXCIPIENTS:
Butylhydroxyanisole (E320) 0.80 mg
Butylhydroxytoluene (E321) 0.40 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs >40 kg (dogs weighing over 40 kg)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_).
4.3 CONTRAINDICATIONS
In the absence of available data, the product should not be used on
puppies less than 8 weeks old and/or weighing less than 2
kg.
Do not use on sick (e.g. systemic diseases, fever) or convalescent
animals.
Do not use if your dog has a hypersensitivity to fipronil or
S-methoprene or the other ingredients.
Do not apply on wounds or damaged skin.
Do not use in cats, as this could lead to overdosing.
DO NOT USE IN RABBITS, AS ADVERSE REACTIONS WITH EVEN MORTALITY COULD
OCCUR.
Do not use in any other non-target species.
Health Products Regulatory Authority
22 July 2019
CRN008SP0
Page 2 of 5
4.4 SPECIAL WARNINGS