Norbrook Fipronil 50 mg Spot-On Solution for cats

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:

50 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 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norbrook Fipronil 50 mg Spot-On Solution for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
One 0.5 ml pipette contains:
​
​
ACTIVE
​
​
Fipronil
​
50 mg
​
EXCIPIENTS
​
​
Butylhydroxyanisole E320
​
0.1 mg
Butylhydroxytoluene E321
​
0.05 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
Cats.
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 5 weeks.
The product shows acaricidal efficacy with killing effect against
ticks (_Ixodes ricinus_)
within 48 hours.
4.3 CONTRAINDICATIONS
In the absence of available data, the product should not be used on
kittens less than
8 weeks old and/or weighing less than 1 kg.
Do not use on sick (systemic diseases, fever…) or convalescent
animals.
Health Products Regulatory Authority
13 February 2019
CRN008TQS
Page 2 of 7
Do not use in rabbits, as adverse drug reactions and even death could
occur.
Do not use in cases of known hypersensitivity to the active substance
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. If
the animal has
been treated prior to exposure to the ticks, the ticks will start to
be killed in the first
24-48 hours after attachment. This will usually be prior to
engorgement, minimising
but not excluding the risk of transmission of diseases. Once dead
ticks will often drop
off the animal but any remaining ticks may be easily removed by a
gentle pull.
For optimum control of flea problems in a multi-pet household, all
dogs and cats in
the household should be treated with