Zeronil 268 mg Spot-on Solution for large dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Fipronil
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QP53AX15
INN (International Name):
Fipronil
Dosage:
268 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
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10987/093/003
Authorization date:
2012-07-13

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Health Products Regulatory Authority

21 August 2018

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Zeronil 268 mg Spot-on Solution for large dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One 2.68 ml pipette contains:

Active substance:

Fipronil 268 mg

Excipients:

Butylhydroxyanisole E320 0.536 mg

Butylhydroxytoluene E321 0.268 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Spot-on solution.

Clear, pale amber solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Dogs.

4.2 Indications for use, specifying the target species

Treatment of flea (Ctenocephalides spp.) and tick (Rhipicephalus sanguineus and

Ixodes ricinus) infestations.

Insecticidal efficacy against new infestations with adult fleas persists for 2 months.

The product has a persistent acaricidal efficacy for 1 month against ticks

(Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). For Ixodes ricinus

and Rhipicephalus sanguineus, ticks will normally be killed within the first 48 hours

following first application of the product. For established infestations of Dermacentor

reticulatus, an immediate acaricidal effect has not been demonstrated. However, ticks

will normally be killed within a week following first application of the product.

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

Allergy Dermatitis (FAD) where this has been previously diagnosed by a veterinary

surgeon.

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4.3 Contraindications

Do not use on puppies less than 2 months old or puppies or dogs weighing less than

2kg.

Do not use on sick (e.g. 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 hypersensitivity to the active substance or to any of excipients.

4.4 Special warnings for each target species

Avoid frequent swimming/bathing or shampooing the animal because the

maintenance of effectiveness of the product in these cases has not been tested.

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 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 removed with a gentle pull.

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.

When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly

applications to the allergic patient and to other dogs and cats in the household are

recommended.

For optimal control of flea infestation in multi-pet household, all dogs and cats in the

household should be treated with a suitable insecticide.

4.5 Special precautions for use

Special precautions for use in animals

Animals should be weighed accurately prior to treatment to ensure that the correct

size of pipette is applied.

Avoid contact with the animal’s eyes. In the case of accidental eye contact,

immediately and thoroughly flush the eyes with water.

Do not apply the product on wounds or damaged skin.

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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Special precautions to be taken by the person administering the veterinary

medicinal product to animals

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

between the product and the mouth or eyes should be avoided.

In the case of accidental eye contact, immediately and thoroughly flush the eyes with

water. If eye irritation persists seek medical advice and show the package leaflet or

the label to the physician.

Do not smoke, drink or eat during application. Avoid contents coming into contact

with the skin. If this occurs, wash hands with soap and water. Wash hands after use.

Animals or operators with a known hypersensitivity to fipronil or excipients (see

section 6.1) should avoid contact with the veterinary medicinal product.

Treated animals should not be handled until the application site is dry, and children

should be kept away from 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 should not be

allowed to sleep with owners, especially children.

Other precautions

Fipronil may adversely affect aquatic organisms.Dogs should not be allowed to swim

in water courses for 2 days after application.

The product may have adverse effects on painted, varnished or other household

surfaces or furnishings.

This product is flammable. Keep away from heat, sparks, open flame or other sources

of ignition

4.6 Adverse reactions (frequency and seriousness)

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

- very common (more than 1 in 10 animals displaying adverse reactions during the

course of one treatment)

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

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

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

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

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

nature of the carrier.

Among the extremely rare suspected adverse reactions, transient cutaneous

reactions at the application site (skin discoloration, local alopecia, pruritus, erythema)

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

hypersalivation, reversible neurologic symptoms (hyperaesthesia, depression,

nervous symptoms), vomiting or respiratory symptoms have been observed after use.

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4.7 Use during pregnancy, lactation or lay

Laboratory studies using fipronil have not shown any evidence of teratogenic or

embryotoxic effect. Studies have not been carried out with this product in pregnant

and lactating bitches. Use in pregnancy and lactation only in accordance with

professional veterinary advice and a benefit/risk assessment.

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 administration and dosage:

External use only.

Administer by topical application to the skin according to the bodyweight as follows:

1 pipette of 4.02 ml per dog weighing over 40 kg and up to 60 kg bodyweight.

An appropriate combination of pipettes should be used for dogs weighing > 60 kg

bodyweight.

Method of administration:

Remove the pipette from the sachet. Hold the pipette upright. Tap the narrow part of

the pipette to ensure the contents are within the main body of the pipette. Snap

back the tip.

Part the pet’s coat until the skin is visible. Place the tip of the pipette directly against

the bared skin and squeeze gently to empty its contents at two points along the

dog’s back, preferably at the base of the head and between the shoulder blades,

emptying approximately half the volume at each site. Squeeze the pipette several

times to ensure dosing is complete.

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.

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. Scaling and crystalline

deposits on the hairs may also be observed at the site of application for up to 48

hours.

Treatment schedule:

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For optimal control of flea and/or tick infestation the treatment schedule can be

based on the local epidemiological situation.

In the absence of safety studies, the minimum treatment interval is 4 weeks.

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

No adverse effects were observed in target animal safety studies in 2 month-old

puppies, growing dogs and dogs weighing about 2 kg treated with 5 times the

therapeutic dose once a month for 3 consecutive months. The risk of adverse effects

(see section 4.6) may increase in cases of overdose.

4.11 Withdrawal period(s)

Not applicable.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Ectoparasiticides for topical use.

ATCvet code: QP53AX15

5.1 Pharmacodynamic properties

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

by inhibiting the GABA complex, binding to the chloride channel and 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

acarids.

Fipronil exhibits an insecticidal and acaricidal activity against fleas (Ctenocephalides

spp.), ticks (Rhipicephalus spp, Dermacentor spp, Ixodes spp including Ixodes ricinus)

in the dog.

Fleas will be killed within 48 hours. Ticks will usually be killed within 48 hours after

contact with fipronil, however if ticks of some species (Dermacentor spp) are already

present when the product is applied, all of the ticks may not be killed within the first

48 hours.

5.2 Pharmacokinetic particulars

Absorption

Absorption of fipronil through the skin is slight.

Distribution

After topical application, the product will spread from the site of treatment to cover

the entire surface of the animal within 24-48 hours.

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Biotransformation

Fipronil is mainly metabolised to its sulfone derivative, which also possesses

insecticidal and acaricidal properties.

Elimination

The concentrations of fipronil on the hair decrease with time.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Butylhydroxyanisole E320

Butylhydroxytoluene E321

Benzyl alcohol E1519

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: 2 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in a dry place. Store in the original container.

6.5 Nature and composition of immediate packaging

A 2.68ml white pipette composed of a heat-formed shell of a polypropylene/cyclic

olefin copolymer/polypropylene layer and a polyethylene/ethylene vinyl

alcohol/polyethylene layer.

A Cardboard box with 1, 2, 3, 4, 6, 8, 9, 10, 12, 15, 18, 20, 21, 24, 30, 60, 90 or 150

pipettes in individual foil sachets.

Italy : 1, 3, 6, 9, 12, 21 & 30 pipettes in individual foil sachets.

Not all pack sizes may be marketed.

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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 products should be disposed of in accordance with local

requirements.

Fipronil may adversely affect aquatic organisms. Do not contaminate ponds,

waterways or ditches with the product or empty container.

7 MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea

Co. Galway

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

VPA10987/093/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13 July 2012

Date of last renewal: 16 February 2017

10 DATE OF REVISION OF THE TEXT

August 2018

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