Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fipronil

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP53AX15

INN (International Name):

Fipronil

Dosage:

67 mg/pipette

Pharmaceutical form:

Spot-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

fipronil

Authorization status:

Authorised

Authorization date:

2012-07-06

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2019
CRN008TQS
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
One 0.67 ml pipette contains:
​
​
ACTIVE SUBSTANCE:
​
​
Fipronil
​ 67 mg
​
EXCIPIENTS:
​
​
Butylhydroxyanisole (E320)
​0.134 mg
​
Butylhydroxytoluene (E321)
​0.067 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Spot-on solution.
A clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infestations by fleas (_Ctenocephalides felis_).
The product shows
immediate insecticidal effect and persistent insecticidal activity
against new
infestations by adult fleas for up to 8 weeks.
The product has a persistent acaricidal efficacy against Ixodes
ricinus for up to 2
weeks, _Rhipicephalus sanguineus_ for up to 3 weeks and _Dermacentor
reticulatus _for
up to 4 weeks.
If ticks of these species are present when the product is applied, all
ticks will not be
killed within the first 48 hours but they may be killed within a week.
Health Products Regulatory Authority
13 February 2019
CRN008TQS
Page 2 of 8
4.3 CONTRAINDICATIONS
Do not use in dogs weighing less than 2 kg.
In the absence of available data, the product should not be used in
puppies less than
8 weeks old.
Do not use in 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.
Do not use in cases of known hypersensitivity to the active or to any
of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product does not prevent ticks from attaching to the animals, but
ticks may be
killed in the first 24-48 hours after attachment prior to full
engorgement and
therefore minimisin