1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MARKETING AUTHORISATION HOLDER
MANUFACTURING, RESPONSIBLE FOR THE RELEASE OF PRODUCT BATCHES, IF THEY ARE DIFFERENT

Marketing Authorisation Holder: Vet-Agro Multi Trade Company Sp. z oo, ul.Gliniana 32, 20-616 Lublin, Tel:+48 81 445 23 00, Fax: +48 81 445 23 20, e-mail [email protected]

Manufacturer responsible for batch release: Vet-Agro Multi Trade Company Sp. z oo, ul. Melgiewska 18, 20-234 Lublin.

2. NAME OF THE VETERINARY MEDICINAL PRODUCT
FIPREX DUO 50 mg+ 60 mg spot-on solution for cats and ferrets Fipronil/(S)-methoprene

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each 0.5 ml pipette contains:

Active substances:
Fipronil 50.00 mg

(S)-methoprene 60.00 mg

Excipients:
Butylhydroxyanisole (E320) 0.10 mg Butylhydroxytoluene (E321) 0.05 mg Clear, greenish-yellow solution.

4. INDICATION(S)

In cats:

For use against flea infestations or mixed infestations with ticks and/or malophagous lice.
Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas is 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity), which originate from eggs laid by adult fleas, persists for six weeks after application of the product.
Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data).
Elimination of pubic lice (Felicoia subrostratus).
The product can be used as part of a treatment strategy to combat flea allergy dermatitis (FAD) where it has been previously diagnosed by a veterinarian. In ferrets:

For use against flea infestations or mixed infestations with ticks.
Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas is 4 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity), which originate from eggs laid by adult fleas.
Elimination of ticks (Ixodes ricinus). The product has a persistent acaricidal efficacy for 4 weeks against ticks (based on experimental data).

5. CONTRAINDICATIONS
In the absence of available data, the product should not be used in cats less than 8 weeks of age and/or weighing less than 1 kg. The product should not be used in ferrets less than 6 months of age.

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

rabbits, as adverse reactions or even mortality may occur.
In the absence of studies, the use of the product is only recommended in the target species.

Do not use in cases of hypersensitivity to the active substance or any of the excipients.

6. ADVERSE REACTIONS

Cats:

Among the very rare suspected adverse reactions, transient skin reactions at the application site (desquamation, localized hair loss, itching, redness) and generalized itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs) or vomiting have been observed after use.

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

- Very common (more than 1 in 10 animals treated displaying adverse reactions)

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

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

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

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

If animals lick themselves, a brief period of excessive salivation may be observed mainly due to the nature of the excipients. Do not overdose.

If you notice any adverse reactions, even those not already included in this leaflet or you think that the medicine has not had any effect, please inform your veterinarian.

Alternatively, you can report through the national reporting system {[email protected]}.

7. TARGET SPECIES
Cats and ferrets.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
Route of administration and dosage:

Spot-on administration.

One pipette of 0.5 ml/cat, corresponding to the minimum recommended dose of 5 mg/kg for fipronil and 6 mg/kg for (S)-methoprene, by topical application to the skin.

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

One pipette of 0.5 ml / ferret, corresponding to a dose of 50 mg for fipronil and 60 mg for (S)-methoprene per ferret, by topical application to the skin.

The minimum interval between treatments is 4 weeks. Method of administration:

Hold the pipette upright. Press the narrow part of the pipette to ensure that all the contents remain in the main body of the pipette. Pull back the tip. Make a path in the fur on the animal’s back at the base of the neck in front of the shoulder blade, 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.

9. RECOMMENDATIONS ON CORRECT ADMINISTRATION
It doesn't exist.

10. WAITING TIME(S)
That's not the case.

11. SPECIAL STORAGE PRECAUTIONS
Keep out of sight and reach of children.

Store in the original package in order to protect from light and moisture. Store below 25°C.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton and pipette after EXP.

12. SPECIAL WARNING(S)

Special precautions for each target species:

No data are available on the effect of bathing/shampooing on the efficacy of the product in cats and ferrets. However, based on the information available for dogs shampooed starting 2 days after application of the product, it is not recommended to bathe animals within 2 days of application of the product.

Fleas on pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furniture, which should be treated, in case of massive infestation and at the beginning of control measures, with an appropriate insecticide and vacuumed regularly.

Other animals living in the same household should also be treated with an appropriate product. Special precautions for use in animals:

Avoid contact of the product with the eyes of animals.

Do not apply the product to damaged skin or wounds.

It is important to ensure that the product is applied to an area where the animal cannot lick it and animals should be avoided from licking each other after treatment.

Attachment of single ticks may be present. For this reason, transmission of infectious diseases cannot be completely ruled out if conditions are unfavorable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

This product may cause irritation of mucous membranes, skin and eyes. Therefore, contact of the product with the mouth, skin and eyes should be avoided. People with known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product.

Avoid contact of the contents with fingers. In case of accidental contact, wash hands with soap and water. In case of accidental contact with eyes, rinse eyes thoroughly and immediately with clean water.

After use, wash your hands.

Ingestion of the product may be harmful. Keep pipettes out of reach of children and throw away used pipettes immediately after application of the product. In case of accidental ingestion of the 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 not be treated during the day but should be treated in the early evening and recently treated animals should not be allowed to sleep with their owners, especially children.

During application, do not smoke, drink or eat.

Solvent alcohol may have adverse effects on painted or varnished furniture or other finished surfaces. Pregnancy and lactation:

Cats:

The product can be used during pregnancy. Laboratory studies in cats have not demonstrated teratogenic, fetotoxic or maternotoxic effects.

The potential toxicity of the product to kittens less than 8 weeks of age in contact with the treated mother cat is not documented.

Special attention should be taken in this case.

Ferrets:

The safety of the veterinary medicinal product has not been established in ferrets during pregnancy and lactation. Use only according to the benefit-risk assessment by the responsible veterinarian.

Interactions with other medicinal products and other forms of interaction:

They don't know each other.

Overdose (symptoms, emergency procedures, antidote):

The risk of adverse reactions may increase with overdose (see section 4.8). In cats:

No adverse reactions were observed in safety studies in target animals, cats and kittens 8 weeks of age or older and weighing approximately 1 kg, treated monthly with doses five times the recommended dose for six consecutive months.

Itching may occur after treatment.

Overdosing the product may cause the hairs at the treatment site to appear sticky. However, if this occurs, it will disappear within 24 hours after application.

In ferrets:

In ferrets aged 6 months and older treated once every 2 weeks for four treatment sessions with doses five times the recommended dose, decreased body weight was observed in some animals.

Incompatibilities:

That's not the case.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be thrown away in wastewater or household waste.

Ask your veterinarian for information on how to dispose of medicines no longer required. These measures help protect the environment.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

OTHER INFORMATION

Packaging dimensions:

1 pipette x 0.5 ml in a cardboard box

Currently, product safety information is not available.

Currently, manufacturer information is not available.

Currently, information about the person responsible is not available.

Presentation type: Pipette

Action: Ticks, Fleas, Lice

Pieces Set: 1 piece

Cat Weight: No

Quantity: 1 Pipette