Amflee Combo 268 mg/ 241.2 mg Spot-on Solution for Large Dogs

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

(S)-Methoprene, Fipronil

可用日期:

Krka d.d., Novo Mesto

ATC代码:

QP53AX65

INN（国际名称）:

(S)-Methoprene, Fipronil

药物剂型:

Spot-on solution

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Dogs

治疗领域:

Ectoparasiticide; Insect Growth Regulator

授权状态:

Authorized

授权日期:

2016-07-13

产品特点

Revised: April 2021
AN: 01008/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMFLEE combo 268 mg/ 241.2 mg spot-on solution for large dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.68 ml pipette contains:
ACTIVE SUBSTANCE:
Fipronil
268 mg
S-Methoprene
241.2 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.54 mg
Butylhydroxytoluene (E321)
0.27 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 20-40 kg
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of dogs, dosage defined by bodyweight grouping
(refer to section
4.9):
-
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_).
The product can be used as part of a treatment strategy for the
control of Flea Allergy
Dermatitis (FAD), where this has been previously diagnosed by a
veterinary surgeon.
Revised: April 2021
AN: 01008/2020
Page 2 of 7
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 IN RABBITS DUE TO A RISK OF ADVERSE REACTIONS OR EVEN
DEATH.
This product is specifically developed for dogs. Do not use in cats