Parex 50 mg spot-on solution for cats

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Fipronil

Disponibil de la:

CF Pharma Limited

Codul ATC:

QP53AX15

INN (nume internaţional):

Fipronil

Dozare:

50 milligram(s)

Forma farmaceutică:

Spot-on solution

Tip de prescriptie medicala:

LR: Licensed Retailer as defined in national legislation

Grupul Terapeutică:

Cats

Zonă Terapeutică:

fipronil

Indicații terapeutice:

Ectoparasiticide

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-11-25

Caracteristicilor produsului

Health Products Regulatory Authority
15 January 2021
CRN008Q0M
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Parex 50 mg spot‐on solution for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml pipette contains
ACTIVE SUBSTANCE:
Fipronil
50.00
mg
EXCIPIENTS
Butylhydroxyanisole (E 320)
0.10
mg
Butylhydroxytoluene (E 321)
0.05
mg
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Spot‐on solution
Clear, colourless to yellowish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cat
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of cats against flea infestations (_Ctenocephalides_
spp.).
Insecticidal efficacy against new infestation with fleas persists for
up to 4 weeks.
Although the product has not demonstrated an immediate acaricidal
effect, acaricidal efficacy for up to 1 week against the tick
_Ixodes ricinus_ has been shown. If ticks of _Ixodes ricinus_ are
present when the product is applied, all the ticks may not be killed
within the first 48 hours, but they may be killed within a week.
4.3 CONTRAINDICATIONS
In the absence of available data, the veterinary medicinal 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 disease, fever, etc.) or convalescent
animals.
Do not use on rabbits, as adverse drug reactions and even death could
occur.
Do not use on animals with hypersensitivity to the active substance or
any other excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The veterinary medicinal product does not prevent an infestation of
the animal by ticks.
For the optimal control of flea problems in households with several
animals all dogs and cats should be treated with an
authorised insecticide.
Health Products Regulatory Authority
15 January 2021
CRN008Q0M
Page 2 of 5
Fleas from pets often infest animal's baskets, bedding and regular
resting areas such as carpets and soft furnishings which
should be treated, in case of massive infestati