Frontline Combo Spot-on Dog M

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Hent Produktets egenskaber (SPC)
12-01-2024
Hent DSU (DSU)
12-01-2024

Aktiv bestanddel:

Fipronil; (S)-Methoprene

Tilgængelig fra:

Boehringer Ingelheim Vetmedica GmbH

ATC-kode:

QP53AX65

INN (International Name):

Fipronil; (S)-Methoprene

Dosering:

134.0, 120.6 mg/pipette

Lægemiddelform:

Spot-on solution

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

fipronil, combinations

Autorisation status:

Authorised

Autorisation dato:

2004-05-14

Produktets egenskaber

                                1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Frontline Combo 134.00 mg / 120.60 mg spot-on solution for dog M
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pipette of 1.34 ml contains:
ACTIVE SUBSTANCES:
Fipronil
...........................................................................................................................
134.00 mg
(S)-methoprene
...............................................................................................................
120.60 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
_Butylhydroxyanisole (E320)_
_0.27 mg_
_Butylhydroxytoluene (E321)_
_0.13 mg_
_Ethanol_
_Polysorbate 80 (E433)_
_Polyvidone_
_Diethylene glycol monoethyl ether_
Clear amber spot-on solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (weighing 10 to 20 kg bw).
3.2
INDICATIONS FOR USE FOR EACH 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 veterinary medicinal product has a persistent acaricidal
efficacy
for up to 4 weeks against ticks.
-
Treatment of infestations with biting lice (
_Trichodectes canis_
).
The veterinary medicinal product can be used as part of a treatment
strategy for the control of Flea
Allergy Dermatitis (FAD).
3.3
CONTRAINDICATIONS
In the absence of available data, the veterinary medicinal product
should not be used on puppies less
than 8 weeks old.
Do not use
                                
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