Frontline Spot On Dog

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Fipronil

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica GmbH

Φαρμακολογική κατηγορία (ATC):

QP53AX15

INN (Διεθνής Όνομα):

Fipronil

Δοσολογία:

10 percent weight/volume

Φαρμακοτεχνική μορφή:

Spot-on solution

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Dogs

Θεραπευτική περιοχή:

fipronil

Θεραπευτικές ενδείξεις:

Ectoparasiticide

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1998-06-12

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
08 September 2021
CRN00C22S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Frontline Spot On Dog
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each pipette contains:
​
​
Active Substance
​
​
Fipronil
​
10 % w/v
​
Excipients
​
​
Butylhydroxyanisole (E320)
​
0.02 % w/v
​
Butylhydroxytoluene (E321)
​
0.01 % w/v
​
Non-aqueous vehicle q.s. to
​
100 % w/v
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
Clear to light brownish-yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The treatment and prevention of infestations by fleas and ticks in
dogs. Frontline Spot On Dog has been shown to significantly
reduce the incidence of Flea Allergy Dermatitis. Ticks will usually
detach from the treated host within 24 to 48 hours after
infestation, without having had a blood meal.
Frontline Spot On Dog rapidly controls infestations with _Trichodectes
canis_ (biting lice) on dogs.
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 (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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid contact with the animal's eyes.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
For external use only.
It is important to make sure that the product is applied to an area
where the animal cannot lick it off, and to make sure that
animals do not lick each other following treatment.
Health Products Regulatory Authority
08 September 2021
CRN00C22S
Page 2 of 5
From 48 hours after treatment, the duration and efficacy of Frontline
Spot On Dog is not affected by bathing or water
imme