Frontline Spray 0.25 %w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QP53AX15

INN (International Name):

Fipronil

Dosage:

0.25 percent weight/volume

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

fipronil

Authorization status:

Authorised

Authorization date:

1995-07-07

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2018
CRN000YJ8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Frontline Spray 0.25 %w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Fipronil 0.25 % w/v
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
A clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The treatment and prevention of infestation by fleas and the treatment
and control
of ticks in dogs and cats.
The product rapidly controls infestations with _Trichodectes canis_
biting lice of dogs
and _Felicola subrostratus_ biting lice of cats.
Treatment with Frontline Spray has been shown to significantly reduce
the incidence
of flea allergy dermatitis in both dogs and cats.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance.
Do not use on sick (systemic diseases, fever…) or convalescent
animals. Do not use
Frontline Spray in rabbits as adverse reactions and even death could
occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
For external use only.
Avoid spraying in the animals’ eyes.
Do not spray directly onto areas of broken skin.
Health Products Regulatory Authority
27 July 2018
CRN000YJ8
Page 2 of 7
Ticks will usually detach from the treated host within 24 to 48 hours
after infestation,
without having had a blood meal. However, some ticks may attach. For
this reason,
transmission of infectious diseases by ticks cannot be completely
prevented.
Treatment of bedding, carpets and soft furnishings with a suitable
insecticide will aid
reduction in environmental challenge and maximise the duration of
protection
against re-infestation provided by Frontline Spray. Frontline Spray is
not suitable for
direct treatment of the environment.
For optimum efficacy, it is not recommended to bathe or shampoo
animals in the
two days prior to or following treatment with Frontline Spray. Bathing
or
shampooing up to four t