PestiGon Combo 402 mg / 361.8 mg spot-on solution for very large dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Fipronil ; (S)-methoprene
Available from:
Norbrook Laboratories Limited
ATC code:
QP53AX65
INN (International Name):
Fipronil ; (S)-methoprene
Dosage:
402/361.8 mg/pipette
Pharmaceutical form:
Spot-on solution
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs
Therapeutic area:
fipronil, combinations
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10999/190/004
Authorization date:
2017-05-12

Read the complete document

Health Products Regulatory Authority

22 January 2018

CRN000WT2

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

PestiGon Combo 402 mg / 361.8 mg spot-on solution for very large dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pipette of 4.02 ml contains:

Active substances:

Fipronil

(S)-methoprene

361.8

Excipients:

Butylhydroxyanisole (E320)

Butylhydroxytoluene (E321)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Spot-on solution

A clear, yellow solution

4 CLINICAL PARTICULARS

4.1 Target Species

Dogs

4.2 Indications for use, specifying the target species

For the treatment of dogs weighing over 40 kg bodyweight:

To be used against infestations with fleas, alone or in association with ticks and/or

biting lice

Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy

against new infestations with adult fleas persists for 8 weeks. Prevention of

the multiplication of fleas by inhibiting the development of eggs (ovicidal

activity) and larvae and pupae (larvicidal activity) originating from eggs laid

by adult fleas for eight weeks after application.

Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis,

Dermacentor reticulatus, Rhipicephalus sanguineus). The product has a

persistent acaricidal efficacy for up to 4 weeks against ticks.

Treatment of infestations with biting lice (Trichodectes canis).

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The product can be used as part of a treatment strategy for the control of Flea

Allergy Dermatitis (FAD).

4.3 Contraindications

In the absence of available data, the product should not be used on puppies less

than 8 weeks old

Do not use in rabbits, as adverse reactions with even mortality could occur.In

absence of studies, the use of the product is not recommended in non-target species.

Do not use on sick (e.g. systemic diseases, fever) or convalescent animals.

This product is specifically developed for dogs. Do not use in cats and ferrets, as this

could lead to overdosing.

Do not use in cases of hypersensitivity to the active substances or to any of the

excipients.

4.4 Special warnings for each target species

Bathing/immersion in water within 2 days after application of the product and more

frequent bathing than once a week should be avoided, as no study has been

performed to investigate how this affects the efficacy of the product. Emollient

shampoos can be used prior to treatment, but reduce the duration of protection

against fleas to approximately 5 weeks when used weekly after application of the

product. Weekly bathing with a 2% chlorhexidine medicated shampoo did not affect

efficacy against fleas during a 6 week long study.

Dogs should not be allowed to swim in watercourses for 2 days after application (See

section 6.6)

There may be an attachment of a few ticks. For this reason a transmission of

infectious diseases cannot be completely excluded if conditions are unfavorable.

Fleas from pets often infest the animal's basket, 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.

4.5 Special precautions for use

Special precautions for use in animals

Avoid contact with the animal’s eyes.

It is important to make sure that the product is applied to an area where the animal

cannot lick it off and to make sure that animals do not lick each other following

treatment.

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22 January 2018

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Special precautions to be taken by the person administering the veterinary medicinal

product to animals

This product can cause mucous membrane, skin and eye irritation. Therefore, contact

of the product with mouth, skin and eyes should be avoided. In case of accidental

eye contact, immediately and thoroughly rinse the eyes with clean water. If eye

irritation persists seek medical advice and show the package leaflet or the label to

the physician. If contact with the skin occurs, wash hands with soap and water.

People with a known hypersensitivity to insecticides or alcohol should avoid contact

with the veterinary medicinal product.

Wash hands after use.

Ingestion of the product is harmful. Prevent children getting access to the pipettes

and discard the used pipettes immediately after applying the product. In case of

accidental ingestion of product, seek medical advice immediately.

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 should be

treated during the early evening, and that recently treated animals are not allowed to

sleep with owners, especially children.

4.6 Adverse reactions (frequency and seriousness)

Among the very rare suspected adverse reactions, transient skin reactions on the

application site (skin discoloration, local hair loss, itching, redness) and general

itching or hair loss have been reported after use. Excessive salivation, reversible

nervous signs (increased sensitivity to stimulation, depression, other nervous signs),

vomiting or respiratory symptoms have also been observed after use.

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

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

If licking occurs, a brief period of excessive salivation may be observed due mainly to

the nature of the carrier.

Do not overdose.

4.7 Use during pregnancy, lactation or lay

The product can be used during pregnancy and lactation.

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4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Dosage: one pipette of 4.02 ml per dog weighing over 40 kg, corresponding to a

minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for

(S)-methoprene.

Route of administration: External use only, spot-on use.

Only remove pipette from sachet immediately prior to use.

Method of Administration:

Remove the pipette from the outer sachet using scissors or fold along diagonal line

to expose nick; tear back at nick.

Hold the pipette upright. Tap the narrow part of the pipette to ensure the contents

remain within the main body of the pipette. Twist or snap back the tip.

Part the coat on the back of the animal at the base of the neck in front of 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 contents completely and directly onto

the skin in one spot.

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Temporary changes to the coat (clumped/greasy hair) may be noted at the

application site.

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

No adverse effects were observed in target animal safety studies in 8 week-old

puppies, growing dogs and dogs weighing about 2 kg treated once at five times the

recommended dose. 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 bodyweight.

4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use, fipronil combinations.

ATCvet code: QP53AX65

5.1 Pharmacodynamic properties

Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family. It acts

by interacting with ligand-gated chloride channels, in particular those gated by the

neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and

post-synaptic transfer of chloride ions across cell membranes. This results in

uncontrolled activity of the central nervous system and death of insects or acarines.

Fipronil kills fleas within 24 hours and ticks (Dermacentor reticulatus, Dermacentor

variabilis, Rhipicephalus sanguineus, Ixodes scapularis, Ixodes ricinus, Haemaphysalis

longicornis, Haemaphysalis flava, Haemaphysalis campanulata) and lice within 48

hours post-exposure.

(S)-Methoprene is an insect growth regulator (IGR) of the class of compounds

known as juvenile hormone analogues that inhibit the development of immature

stages of insects. This compound mimics the action of juvenile hormone and causes

impaired development and death of the developing stages of fleas. The on-animal

ovicidal activity of (S)-methoprene results from either direct penetration of the

eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas.

(S)-methoprene is also effective in preventing flea larvae and pupae from developing,

which prevents contamination of the environment of treated animals with the

immature stages of fleas.

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5.2 Pharmacokinetic particulars

Studies of metabolism of fipronil have demonstrated that the major metabolite is the

sulfone derivative of fipronil.

(S)-methoprene is extensively degraded into carbon dioxide and acetate that are

subsequently incorporated into endogenous materials.

The pharmacokinetic profiles after topical application of fipronil and (S)-methoprene

in combination were studied in dogs in comparison to intravenous dosing of fipronil

or (S)-methoprene alone. This established absorption and other pharmacokinetic

parameters. The topical application resulted in low systemic absorption of fipronil

(11%) with a mean maximum concentration (C

) of approximately 35 ng/ml fipronil

and 55 ng/ml of fipronil sulfone in plasma. Peak fipronil plasma concentrations are

slowly attained (mean t

approximately 101 h), and decline slowly (mean terminal

half-life approximately 154 h, highest values are observed for males). Fipronil is

extensively metabolised to fipronil sulfone after topical administration.

Plasma concentrations of (S)-methoprene were below the limit of quantitation (20

ng/ml) in dogs after topical application.

Both (S)-methoprene and fipronil, together with its major metabolite, are

well-distributed in the haircoat of a dog within one day after application. The

concentrations of fipronil, fipronil sulfone and S-methoprene in the hair coat

decrease with time and are detectable for at least 60 days after dosing. Parasites are

killed through contact rather than systemic exposure.

No pharmacological interaction between fipronil and (S)-methoprene was noted.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxyanisole (E320)

Butylhydroxytoluene (E321)

Ethanol anhydrous

Polysorbate 80

Povidone K17

Diethylene glycol monoethyl ether

6.2 Major incompatibilities

None known.

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22 January 2018

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6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

6.4 Special precautions for storage

Store in the original package in order to protect from light and moisture.

This veterinary medicinal product does not require any special temperature storage

conditions.

6.5 Nature and composition of immediate packaging

4.02 ml pipette, moulded from a film composed of 3 layers: a

polypropylene/COC/polypropylene, solvent free lacquer laminate and a copolymer of

polyethylene/EVOH/polyethylene. The pipettes are sealed within a child resistant

4-ply foil sachet composed of LDPE/nylon/aluminium foil/polyester film and

presented in an outer box.

Boxes of 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90, 120 or 150 pipettes. Each pipette is

individually sealed in a foil sachet.

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 and (S)-methoprene may adversely affect aquatic organisms. Do not

contaminate ponds, waterways or ditches with the product or empty containers.

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7 MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA10999/190/004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 12

May 2017

10 DATE OF REVISION OF THE TEXT

January 2018

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