Parex 50 mg spot-on solution for cats

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Fipronil
Available from:
CF Pharma Limited
ATC code:
QP53AX15
INN (International Name):
Fipronil
Dosage:
50 milligram(s)
Pharmaceutical form:
Spot-on solution
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Cats
Therapeutic area:
fipronil
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10515/001/001
Authorization date:
2013-11-25

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Health Products Regulatory Authority

15 January 2021

CRN008Q0M

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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

Excipients

Butylhydroxyanisole (E 320)

0.10

Butylhydroxytoluene (E 321)

0.05

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

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.

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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 infestation and at the beginning of the control measures, with a suitable insecticide and

vacuumed regularly.

The influence of bathing/shampooing on the efficacy of this veterinary medicinal product in cats has not been investigated.

However, from studies conducted in dogs, shampooing with a medicated shampoo, followed by thorough drying, 1 to 2 hours

before treatment application and bathing once weekly over a period of 6 weeks has been shown not to affect the efficacy of

this veterinary medicinal product against fleas in dogs. Bathing and intensive wetting of the coat should be avoided for the first

2 days following administration of the product.

4.5 Special precautions for use

Special precautions for use in animals:

It is important to make sure that the product is applied to an area where the animal cannot lick it off.

Do not allow recently treated animals to lick each other.

Avoid contact with the animal's eyes. Should the veterinary medicinal product come into contact with the eyes, rinse

thoroughly at once with water.

Do not apply the veterinary medicinal product to wounds or skin lesions.

There may be an attachement of some ticks. For this reason transmission of infectious diseases cannot be excluded if

conditions are unfavourale.

Specific studies investigating the safety of the product following repeated administration or at overdosage have not been

conducted due to the known safety profile of the active substance and excipients.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

This veterinary medicinal product can cause mucous membrane and eye irritation. Therefore avoid contact of the product with

mouth and eyes.

Should the veterinary medicinal product come into contact with the eyes, rinse thoroughly at once with water. If the eye

irritation persists, seek medical help at once and show the package insert or label.

Avoid contact with the skin. Should the product come into contact with the skin, wash with soap and water. Wash hands after

use.

Do not eat, drink or smoke during application.

People with known hypersensitivity to fipronil or any of the excipients should avoid contact with this veterinary medicinal

product.

Treated animals should not be handled until the application site is dry, and children should not be allowed to play with treated

animals until the application site is dry.

It is therefore recommended that animals are not treated during the day but during the early evening. Moreover recently

treated animals should not be allowed to sleep with owners, especially children.

Other precautions:

The product may have adverse effects on painted, vanished or other household surfaces or furnishing.

4.6 Adverse reactions (frequency and seriousness)

If licking occurs, a brief period of hypersalivation may be observed due mainly to the nature of the carrier substance.

Among the very rare suspected adverse reactions, transient cutaneous reactions at the application site (scaling, local alopecia,

pruritus, erythema) and general pruritus or alopecia have been reported after use.

Very rarely, hypersalivation, reversible neurological signs (hyperaesthesia, depression, nervous signs) or vomiting have been

observed after use.

The frequency of adverse reactions is defined using the following convention:

‐ very common (more than 1 in 10 animals treated displaying adverse reaction(s))

‐ common (more than 1 but less than 10 animals in 100 animals treated)

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‐ uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

‐ rare (more than 1 but less than 10 animals in 10,000 animals treated)

‐ very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies using fipronil have not shown any teratogenic or embryotoxic effect. No studies have been carried out on

pregnant or lactating cats using this veterinary medicinal product. Therefore its use during pregnancy and lactation should only

be after a relevant benefit‐risk analysis made by the treating veterinarian.

4.8 Interaction with other medicinal products and other forms of interactions

None known.

4.9 Amounts to be administered and administration route

Route of application and posology:

Spot‐on use. Only by topical application to the skin.

1 pipette of 0.5 ml is sufficient for the treatment of a cat corresponding to a recommended minimum dose of 5 mg fipronil/kg

body weight.

The minimum interval between two treatments should be not less than 4 weeks.

Method of administration:

Disconnect one of the blisters from the blister card. This helps to avoid accidental opening of the adjacent blister package in

order to protect the still unopened pipettes from exposure to humidity. Open the blister with scissors. To avoid damaging of

the pipette cut along the line marked with the scissors icon. Carefully peel back the foil from the cut off end and withdraw the

pipette.

Hold the pipette upright. Tap lightly to ensure the entire liquid contents are within the main body of the pipette. Bend the

upper border strip backwards. Then the pipette can be set aside, if necessary. To open the pipette snap off the top of the

pipette along the scored line.

Part the coat between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze the

pipette several times to empty its content completely and directly onto the skin in one spot.

Application of the solution near the base of the head minimises the possibility that the animal will lick the solution off. Care

should be taken after the application that animals do not mutually lick off the solution.

Care should be taken to avoid excessive wetting of the hair with the product since this will cause a sticky appearance of hairs at

the treatment spot.

However should this occur, it will disappear within 24 hours post application.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The toxicity of the veterinary medicinal product administered to the skin is very low. The risk of experiencing adverse effects

(see section 4.6) may however increase when overdosing, so animals should always be treated with the correct pipette size

according to body weight.

4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic Group: Ectoparasiticides; FipronilATCvet Code: QP53AX15

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5.1 Pharmacodynamic properties

Fipronil is an insecticide belonging to the group of phenylpyrazole. It acts by inhibiting the GABA complex, binding to the

chloride channel thereby blocking pre‐ and post‐synaptic transfer of chloride ions across the membrane. This results in

uncontrolled activity of the central nervous system and hence to death in insects.

Fipronil acts as an insecticide against fleas (Ctenocephalides spp.) and as an acaricide against ticks (Ixodes ricinus).

Fleas are killed within 24 hours.

5.2 Pharmacokinetic particulars

The veterinary medicinal product distributes itself within 24 – 48 hours over the entire skin of the animal.

The absorption of fipronil is negligible in cats following topical application.The concentration of fipronil on the fur decreases

over time.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxyanisole (E 320)

Butylhydroxytoluene (E 321)Diethylene glycol monoethyl ether

6.2 Major incompatibilities

None known.

6.3 Shelf-life

Shelf‐life of the veterinary medicinal product as packaged for sale: 30 months

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Store in the original package.

6.5 Nature and composition of immediate packaging

Pipettes containing an extractable volume of 0.5 ml.

The pipettes are made of:

‐ bottom foil: polyethylene terephthalate/polypropylene

‐ lidding foil: polyethylene terephthalate/aluminium

To protect the content of the pipettes from moisture and light the pipettes are individually packed in blister foils made of:

‐ cold‐form foil for blister: polyvinyl chloride/(biaxially) oriented polyamide/aluminium/polyvinyl chloride

‐ lidding foil for blister: polyethylene terephthalate/aluminium

A blister card consists of 3 blisters, each containing a single pipette.

Packs containing 3, 6, 12, 24, 60 and 120 pipettes

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the

use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be

disposed of in accordance with local requirements. Fipronil may be harmful to aquatic organisms. Do not contaminate ponds,

waterways or ditches with the product or empty container.

Health Products Regulatory Authority

15 January 2021

CRN008Q0M

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7 MARKETING AUTHORISATION HOLDER

CF Pharma Limited

The Racecourse

Danesfort

Kilkenny

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA10515/001/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 25 November 2013

Date of last renewal: 24 November 2018

10 DATE OF REVISION OF THE TEXT

January 2021

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