Effipro Duo^®

FOR EXTERNAL ANIMAL USE ONLY

Effipro Duo 50 mg/60 mg Spot-On Solution For Kittens 

STORAGE INSTRUCTIONS

Store at or below 30 °C in a dry place. Keep the blister pack in the outer carton in order to protect from light. Use immediately once opened. Keep out of reach of children, uninformed persons and animals.

COMPOSITION

Each 0,5 ml pipette contains 50 mg Fipronil and 60 mg Pyriproxyfen.

TARGET SPECIES 

Kittens and Cats (1 - 6 kg).

INDICATIONS

For the treatment and prevention of infestations by fleas alone or in association with ticks in kittens and cats weighing 1 - 6 kg. Use as an aid in the treatment of Flea Allergy Dermatitis (FAD) in kittens and cats, where this has been previously diagnosed by a veterinarian. 

CONTRA-INDICATIONS

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

Do not use in case of hypersensitivity to the active substances

WARNINGS 

• Wetting of the haircoat with water 2 hours before product application and twice during the claimed period of efficacy against fleas (at two week intervals against adult fleas or four week intervals against developing flea stages) was investigated during two laboratory studies. Wetting of the haircoat with water as described did not adversely affect product effectiveness. 
• The impact of shampooing on product effectiveness has not been investigated. If a cat requires shampooing it is recommended that this is done before applying the product.
• At the beginning of the control measures, in case of massive infestation, animal’s basket, bedding and regular resting areas such as carpets and soft furnishings should be treated, with a suitable insecticide and vacuumed regularly. 
• To reduce environmental flea challenge, all animals living in the same household should also be treated with a suitable flea control product. 
• Effipro Duo Spot-on Solution for Kittens does not prevent ticks from attaching to animals. If the animal has been treated prior to exposure to the ticks, the ticks will be killed within 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. Any remaining ticks should be carefully removed, ensuring that their mouth parts are not left within the skin. 
• Keep out of reach of children, uninformed persons and animals. 
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide  range of reasons. If this is suspected, seek veterinary advice and notify the registration holder. 

PRECAUTIONS 

• For external use only. Do not administer orally.
• Animals should be weighed accurately prior to treatment.
• The safety of the product has not been established in cats younger than 10 weeks of age or in cats weighing less than 1,0 kg.
• Avoid contact with the animal’s eyes. In the case of accidental eye contact, flush the eyes with water.
• Care should be taken to administer Effipro Duo Spot-on Solution for Kittens correctly as described under “Directions for use”.
• Do not apply Effipro Duo Spot-on Solution for Kittens on wounds or damaged skin. It is important to make sure that Effipro Duo Spot-on Solution for Kittens is applied directly onto an area of dry skin where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
• The use of Effipro Duo Spot-on Solution for Kittens has not been studied in sick or debilitated cats. Use in sick or debilitated animals only in accordance with benefit/risk assessment performed by the responsible veterinarian.
• In the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks.
• Laboratory studies using fipronil and pyriproxyfen have not shown any evidence of teratogenic or embryotoxic effect. Studies have not been carried out with this product in pregnant and lactating queens. Use in pregnancy and lactation only in accordance with a benefit/risk assessment performed by the responsible veterinarian.

Special precautions to be taken by the person administering Effipro Duo Spot-on Solution for Kittens to animals:

Effipro Duo Spot-on Solution for Kittens may cause neurotoxicity and may be harmful if swallowed.
Avoid ingestion including hand-to-mouth contact. Avoid contact with skin and mouth.
Do not smoke, drink or eat during application.
Wash hands after use. In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the doctor.
In the case of accidental skin contact, flush with water.
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.
Keep the pipettes in the original packaging until ready for use and dispose of used pipettes immediately.

Other precautions:

Effipro Duo Spot-on Solution for Kittens may have adverse effects on painted, varnished or other household surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.

DIRECTIONS FOR USE 

Use only as directed. 
For a Kitten or cat weighing 1 - 6 kg apply one pipette of 0,5 ml per kitten or cat, which corresponds to the minimum recommended dose of 8,3 mg fipronil/kg body weight and 10 mg pyriproxyfen/kg body weight. 
Administer the contents of the whole pipette. 

Kitten or Cat	Effipro Duo Spot-on Solution for Kittens or Cats
Weight 1 - 6 kg	One (1) pipette of 0,5 ml per kitten or cat

Do not repeat the treatment at intervals of less than 4 weeks.

Method of administration:

Remove the pipette from the overblister. 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.

Part the coat on the back of neck area until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents evenly at one or two spots. Ensure the solution is applied to healthy skin only and avoid superficial application to the cat’s hair or run off, especially in large cats (>6 kg).

 

Drop stop system (the product is released only by pressing the body of the pipette).

For optimal control of flea and tick infestations and flea multiplication, the treatment schedule can be based on the local epidemiological situation. However, in the absence of additional safety studies, do not repeat the treatment at intervals of less than 4 weeks. 

RESIDUAL EFFECTS:

Fleas: A single dose is effective against new flea infestations for approximately 5 weeks. Prevention of the multiplication of fleas by preventing flea eggs developing into adult fleas for 12 weeks after application.

Ticks: One treatment provides persistent efficacy against ticks for one week. If ticks are present at the time of application, not all ticks may be killed within 48 hours.

SIDE EFFECTS: 

Transient cosmetic effects such as wet appearance or slight scaling may occur at the application site. According to the accumulated experience on these active ingredients within spot on pharmaceutical forms, transient cutaneous reactions at the application site (squamosis, local alopecia, pruritus, erythema, skin discolouration) and general pruritus or alopecia may be observed after use. In very rare instances, hypersalivation, reversible neurologic symptoms (hyperesthesia, depression, nervous symptoms), respiratory signs or vomiting might occur. The risk of experiencing adverse reactions may increase with overdosing, so animals should always be treated with correct pipette size according to bodyweight.

PRESENTATION:

Effipro Duo Spot-on Solution for kittens weighting 1 - 6 kg is presented in 0,5 ml transparent multi-layer plastic single-dose pipettes. Pipettes are obtained by thermoforming a transparent bottom complex and closed by heat sealing with a lid complex. The bottom complex consists of polypropylene / cyclic olefin copolymer / polypropylene / polypropylene with a natural polyacrylonitrile-methacrylate foil or polyethylene-ethylene vinyl alcohol-polyethylene foil. The lid complex consists of polyethylene-terephtalate foil with an aluminium foil and a polyacrylonitrile-methacrylate foil or polyethylene-ethylene vinyl alcohol-polyethylene foil. Pipettes will be individually over-blistered and packed into cardboard cartons in quantities of 4 or 24 pipettes.

REGISTRATION NUMBER:

G4376 (Act 36/1947)