Effipro Spot-on for Extra Large Dogs 40 - 60kg (pack of 4)

What is the active ingredient in Effipro spot-on?

The active ingredient in EFFIPRO® SPOT-ON is Fipronil, an insecticide and acaricide.

What does this ingredient do?

Fipronil causes uncontrolled activity in the central nervous system (CNS) of insects or acarids, resulting in their death. 

Fleas (Ctenocephalides spp) are killed within 24 hours of application. Ticks (Rhipicephalus spp, Dermacentor spp, Ixodes spp. including Ixodes ricinus) will usually be killed within 48 hours of contact with fipronil. However, if Rhipicephalus sanguineus and Ixodes ricinus ticks are already present on the animal when the product is applied, they may not be killed within the first 48 hours.

The solution is indicated for cutaneous (skin) administration.

What is in Effipro spot-on?

One 4.02 ml pipette contains:

Active substance:
Fipronil 402 mg

Excipients:
Butylhydroxyanisole E320: 0.804 mg
Butylhydroxytoluene E321: 0.402 mg

Benzyl alcohol 
Diethylene glycol monoethyl ether

How do I use Effipro spot-on?

For external use only.

Administer by topical application to the skin according to the bodyweight as follows:
1 pipette of  EFFIPRO® SPOT-ON 4.02 ml per dog weighing over 40 kg and up to 60 kg bodyweight.
For dogs over 60 kg use two pipettes of 2.68 ml.

Animals should be weighed accurately prior to treatment.

The product has a persistent insecticidal efficacy for up to 8 weeks against fleas (Ctenocephalides spp).
The product has a persistent acaricidal efficacy for up to 4 weeks against ticks (Rhipicephalus sanguineus, Ixodes ricinus, Dermacentor reticulatus). If ticks of some species (Rhipicephalus sanguineus and 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.

Treatment schedule:
For optimal control of flea and/or tick infestation the treatment schedule can be based on the local epidemiological situation. Ask your veterinary surgeon for advice based on your geographical location and flea/tick risk.

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

Method of Administration

Hold the pipette upright. Tap the narrow part of the pipette to ensure that the contents are within the main body of the pipette. Break the snap-off top of the spot-on pipette along the scored line.

1. Part the pet’s coat until its skin is visible.
2. Place the tip of the pipette directly against the bared skin and squeeze gently several times to empty its contents.
3. Repeat this procedure at one or two different points along the dog’s back.

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.

White deposits may also be seen at the site for up to 48 hours after application.

Special precautions for use in animals

In the absence of available data, the product should not be used on puppies less than 2 months old and /or weighing less than 2kg.
Do not use on sick (systemic diseases, fever…) or convalescent animals.
Do not use in rabbits, as adverse drug reactions and even death could occur.
Do not use in cases of hypersensitivity to the active substance or to any of excipients.

Shampooing an hour prior to treatment does not affect the efficacy of the product against fleas.
Bathing/immersion in water within two days after application of the product should be avoided. Weekly immersion in water for one minute reduces the period of persistent insecticidal efficacy against fleas by one week and therefore it is advisable to avoid frequent swimming and shampooing

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.
Use in pregnancy and lactation only in accordance with professional veterinary advice and a benefit/risk assessment.

Special precautions to be taken by the person administering the 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.
Avoid contents coming into contact with the fingers. If this occurs, wash hands with soap and water. Wash hands after use.
Do not smoke, drink or eat during application.
People with known hypersensitivity to fipronil or excipients should avoid contact with the 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 should be treated during the early evening, and that recently treated animals should not be allowed to sleep with owners, especially children.

Other precautions

The alcohol carrier may have adverse effects on painted, varnished or other household surfaces or furnishings.

The product should not enter water courses as this may be dangerous for fish or other aquatic organisms. Dogs should not be allowed to swim in water courses for 2 days after application. Do not contaminate ponds, waterways or ditches with the product or empty container.

Adverse reactions (frequency and seriousness)

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 (squamosis, local alopecia, pruritus, erythema) and general pruritus or alopecia have been reported after use. Exceptionally, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms) or vomiting have been observed after use.

If any adverse reactions are noted, they should be reported to your veterinary surgeon.

MARKETING AUTHORISATION HOLDER

Virbac S.A.
1ère avenue – 2065 m – L.I.D.
06516 Carros
FRANCE
+ 33 (0)4 92 08 73 04
+ 33 (0)4 92 08 73 48

MARKETING AUTHORISATION NUMBER(S)

Vm 05653/4154

Is there any further advice I should know about Effipro spot-on?

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. Re-infestation from emergence of new fleas in the environment may continue to occur for six weeks or longer after treatment is initiated. More than one treatment may therefore be required, depending on the level of fleas in the environment. 

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.

Shampooing an hour prior to treatment does not affect the efficacy of the product against fleas.
Bathing/immersion in water within two days after application of the product should be avoided. Weekly immersion in water for one minute reduces the period of persistent insecticidal efficacy against fleas by one week and therefore it is advisable to avoid frequent swimming and shampooing.

When used as part of a strategy for the treatment of Flea Allergy Dermatitis, monthly applications to the allergic patient and to other pets in the household are recommended.

For optimum control of flea problems in a multi-pet household, all dogs, cats and rabbits in the household should be treated with a suitable insecticide (DO NOT use fipronil-based products on rabbits).