Virbac Effipro 2.5mg/ml skin spray for dogs and cats, 100 ml

€14.99

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Brand Virbac

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NAME OF VETERINARY DRUG

Effipro Duo 50 mg/60 mg solution for drops for cats

QUALITATIVE AND QUANTITATIVE COMPOSITION

One 0.5 ml pipette contains:

active ingredients:

fipronil 50 mg,
pyroxyfene 60 mg;

excipients:

butylhydroxyanisole E320 0.1 mg,
butylhydroxytoluene E321 0.05 mg.

For the full list of excipients, see page 6.1.

DOSAGE FORM

Solution for instillation.

Clear, colourless or yellowish solution.

CLINICAL DATA

Target animal species

Cats.

Indications indicating the target animal species

For use only in cats with fleas or fleas and ticks.

Application against fleas

For the treatment and protection of cats infested with fleas (Ctenocephalides felis). A single application of the medicinal product provides protection against fleas for 5 weeks.

The product prevents the reproduction of fleas and stops the development of adult fleas from eggs 12 weeks after application.

The product can be used as part of a comprehensive therapy for flea allergic dermatitis (dietary supplement).

Contraindications

Do not use in rabbits, as this may cause side effects or even death.

Do not use in case of hypersensitivity to the active ingredients or any of the excipients.

Special instructions for use for individual target species

In two laboratory tests, wool was moistened 2 hours before application of the product and twice during the period of declared efficacy of the product against fleas (every two weeks when studying the effect on adults and every four weeks when studying developing fleas). Wetting the fur with water will reduce the effectiveness of the product.

The effect of shampooing animals on the effectiveness of the product has not been studied. If it is necessary to shampoo the cat, it is recommended to do so before applying the veterinary product.

If control measures are taken, animal cages, beds and common resting areas in case of infestation, such as carpets and upholstered furniture, should be treated with a suitable insecticide and regularly vacuumed.

To reduce the number of fleas in the environment, all animals kept in the house should also be treated with an appropriate flea control product.

The drug does not protect animals from ticks. if swallowed. If the animal was treated with the drug before the tick infestation, the ticks will die within 48 hours of ingestion. This is usually done before they become covered in blood or medication to reduce, but not eliminate, the risk of disease transmission.

Dead ticks often fall off the animal and the remainder must be carefully removed to ensure that the tick's mouth does not remain in the skin.

Special precautions for use

For external use only. Do not use internally.

Animals must be accurately weighed before treatment.

The safety of this product in cats under 10 weeks of age or weighing less than 1 kg has not been proven.

Care must be taken to ensure that the product does not come into contact with the animal's eyes. In case of accidental contact with eyes, rinse with water.

Care must be taken to ensure that the product is applied correctly as described on page 4.9. The product must not be applied to wounds or damaged skin. It is important to ensure that the veterinary medicinal product is applied directly to a dry area of skin that the animal cannot lick off, and to ensure that animals do not lick each other after application of the medicinal product.

The use of this veterinary medicinal product in sick or weakened cats has not been studied. In sick or weakened animals, the product may only be administered after the responsible veterinarian has assessed the benefit/risk ratio.

No additional safety studies have been conducted, so treatment may not be repeated earlier than after 4 weeks.

Side effects (frequency and severity)

A short-term cosmetic effect such as wet fur or mild flaking may occur at the site of application of the veterinary product.

Experience with the use of intravenous veterinary medicinal products containing these active ingredients has shown short-term skin reactions (flaking, localized hair loss, itching, redness, skin discoloration) and generalized itching or hair loss.

Very rare - increased salivation, reversible neurological symptoms (hyperesthesia, depression, signs of nervousness), breathing problems or vomiting.

Use during pregnancy, lactation or egg-laying

Laboratory studies have not revealed any teratogenic or embryotoxic effects of fipronil and pyriroxifene.

The safety of this veterinary drug in cats during pregnancy and lactation has not been studied. The veterinary drug should be used during pregnancy and lactation only after the responsible veterinarian has assessed the benefit-risk ratio.

Interaction with other medicinal products and other interactions

Unknown.

Dosage and administration

Apply to the skin.

Dosage

A cat weighing 1-6 kg should be instilled with the contents of one pipette with a volume of 0.5 ml, which corresponds to the smallest pipette. The recommended dose is 8.3 mg fipronil and 10 mg pyriroxifene per 1 kg of body weight.

Cat Weight Pipette Volume Fipronil (mg) Pyriroxifene (mg)

1-6 kg 0.5 ml 50 60

6-12 kg 1 ml 100 120

Cats over 6 kg can be administered in two doses. The recommended dose of the contents of a 0.5 ml pipette is 1 ml.

Directions for use

Remove the pipette from the blister pack. Hold the pipette vertically. Tap the narrow part of the pipette to ensure that the liquid is in the main part of the pipette. Break the tip of the pipette along the dividing line.

Part the hair on the back of the neck to expose the skin. Place the tip of the dropper on the skin and squeeze the dropper firmly several times to distribute the contents evenly in one or two areas. It is important to ensure that the solution is applied to intact skin and not to the cat's fur and does not leak.

Drip prevention system (the product only drips when the dropper is squeezed).

Treatment can be planned according to the local epidemiological situation to ensure optimal control of fleas and ticks, as well as flea breeding. Since additional safety studies have not been conducted, treatment should not be repeated more frequently than every 4 weeks (see page 4.10).

Waiting

Not applicable.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: ectoparasiticides for external use, fipronil, combinations.

ATCvet code: QP53AX65.

Pharmacodynamic properties

Fipronil is an insecticidal and acaricidal agent belonging to the phenylpyrazole group. Fipronil and its metabolite fipronil sulfone act on ligand-gated chloride channels, particularly gamma-aminobutyric acid-regulated (GASR), glutamate (Glu - only in invertebrates that contain ligand-gated chloride channels), desensitizer (D) and desensitizer non-reducing (N) channels, thereby blocking presynaptic and postsynaptic chloride transfer across cell membranes. It causes uncontrolled activity of the central nervous system of insects and ticks, leading to death.

Pyryroxifene is an insect growth regulator (IGR) that belongs to a class of chemicals known as juvenile hormone analogues. Pyryroxifene sterilizes adult fleas and stops their development to immature stages. The contact molecule prevents the maturation of the insect by stopping the development of its eggs (ovicidal action), larval and pupal stages (larvicidal action). As a result, mature fleas die on contact and / or ingestion. In addition, the drug sterilizes mature eggs before they are laid. The drug suppresses the infestation of immature fleas in the habitat of treated animals.

The combination of fipronil and pyryroxifene has an insecticidal and acaricidal effect on fleas (Ctenocephalides felis), ticks (Rhipicephalus turanicus, Ixodes ricinus), and also prevents the development of adult fleas from eggs.

This combination provides comprehensive flea control and can be used only against fleas or flea infestations.

Pharmacokinetic properties

Under normal conditions, when the veterinary drug is applied to a cat, fipronil and pyriroxifene are well absorbed into the cat's fur. They are distributed within the first 24 hours after instillation. The main metabolite of fipronil is a sulfone derivative, which also has insecticidal and acaricidal properties.

Fipronil and pyriroxifene concentrations in fur decrease over time, but both active substances remain for at least 84 days after treatment (i.e. above the lower limit of quantification (LOQ) of 100 ng/g fipronil and 50 ng/g pyriroxifene). The concentration of fipronil sulfone after treatment is below the lower limit of quantification (LOQ 100 ng/ml).

The maximum concentration of fipronil and pyriroxifene in blood plasma is achieved quickly - within 24 hours after administration of treatment. Fipronil concentrations were measured in all cats for 3 days after treatment (LOD 1 ng/mL). Pyriroxifene concentrations were measured in all cats for 42 days after treatment (LOD 0.2 ng/mL). Fipronil sulfone concentrations after treatment are below the limit of quantification (LOQ 1 ng/ml).

PHARMACEUTICAL INFORMATION

List of excipients

butylhydroxyanisole E320,

butylhydroxytoluene E321,

diethylene glycol monoethyl ether.

Incompatibility

Unknown.

Shelf life

The shelf life of the veterinary medicinal product, provided that the original packaging is intact, is 3 years.

Special storage instructions

Store at temperatures up to 30 °C.

Store in a dry place. place.

Store the capsule in a cardboard box to protect the medicine from light.

Characteristics and components of the primary packaging

Transparent multilayer plastic pipettes for single use with a volume of 0.5 ml, consisting of a transparent base made of thermoformed material (polyacrylonitrile methacrylate, polypropylene or polyethylene-ethylene vinyl alcohol polyethylene, cyclic olefin copolymer, polypropylene) and a heat-sealable cap (polyacrylonitrile methacrylate or polyethylene-ethylene vinyl alcohol polyethylene, aluminum, polyethylene terephthalate).

In boxes, individual pipettes are placed in external nests made of polypropylene, cyclic olefin.

Boxes contain 1, 4, 24 and 60 pipettes (large boxes have envelopes for smaller pipettes in quantity).

Not all the sizes of the packages may be distributed.

Special provisions for the handling of unused veterinary medicinal products or waste associated with their use

Unused veterinary medicinal products or waste associated with their use must be disposed of in accordance with the requirements of national regulations.

Veterinary medicinal products or empty packaging must not pollute ponds, watercourses or drainage ditches, as this may be harmful to fish and other aquatic organisms.