PACKAGE LEAFLET
Fypryst Combo 50 mg/60 mg spot-on solution for cats and ferrets
Fypryst Combo 50 mg/60 mg spot-on solution for cats and ferrets
1. NAME AND PERMANENT ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND OF THE MANUFACTURER, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Fypryst Combo 50 mg/60 mg spot-on solution for cats and ferrets
Fipronil, S-Methoprene
Fypryst Combo 50 mg/60 mg spot-on solution for cats and ferrets
Fipronil, S-Methoprene
3. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each 0.5 ml pipette contains:
Active substances:
Fipronil 50 mg
S-Methoprene 60 mg
Excipients:
Butylhydroxyanisole (E320) 0.1 mg
Butylhydroxytoluene (E321) 0.05 mg
Clear, yellow solution.
4. THERAPEUTIC INDICATIONS
In cats:
To be used against infestations with fleas, alone or in combination with ticks and /
or biting lice:
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new
infestations by adult fleas for 4 weeks. Prevention of
flea multiplication by inhibiting the development of eggs (ovicidal activity),
larvae and pupae (larvicidal activity), originating from eggs laid by
adult fleas, for 6 weeks after application.
- Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus).
The product has a persistent acaricidal activity up to 2 weeks against ticks (based on
experimental data).
- Elimination of biting lice (Felicola subrostratus).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD),
when diagnosed by a veterinary surgeon.
In ferrets:
To be used against infestations with fleas, alone or in combination with ticks:
- Elimination of fleas (Ctenocephalides spp.). Insecticidal efficacy against new
infestations by adult fleas for 4 weeks. Prevention of
flea multiplication by inhibiting the development of eggs (ovicidal activity),
larvae and pupae (larvicidal activity), originating from eggs laid by
adult fleas.
- Elimination of ticks (Ixodes ricinus). The product has persistent acaricidal
activity up to 4 weeks against ticks (based on experimental data).
5. CONTRAINDICATIONS
Do not use on kittens under 8 weeks of age and / or weighing less than 1 kg,
due to lack of sufficient data. Do not use on ferrets under 6 months of age.
Do not use on sick animals (e.g. systemic diseases, fever) or on animals during
convalescence.
Do not use on rabbits due to the risk of adverse reactions or even death.
Due to lack of studies, the use of this product is not recommended for animals for
which it is not intended.
6. ADVERSE REACTIONS
Do not overdose.
In cats:
Among the very rare suspected adverse reactions after use, transient skin reactions at the
application site (skin flaking, local alopecia, itching, erythema) and generalised itching, or
alopecia have been observed. Increased salivation, reversible neurological symptoms
(hypersensitivity, depression, other nervous symptoms) or vomiting have also been observed
after use.
If licking occurs at the application site, a short period of hypersalivation may be observed,
due to the nature of the excipient.
If you notice any serious adverse reactions or other effects not mentioned in this leaflet, please
inform your veterinary surgeon.
7. TARGET SPECIES
Cats and ferrets.
8. DOSAGE FOR EACH SPECIES, ROUTE OF ADMINISTRATION AND METHOD OF
ADMINISTRATION
One 0.5 ml pipette for a cat, corresponding to a minimum recommended dose of 5 mg/kg
fipronil and 6 mg/kg S-methoprene, by topical application to the skin.
One 0.5 ml pipette for a ferret, corresponding to a recommended dose of 5 mg/kg fipronil and 6
mg/kg S-methoprene, by topical application to the skin.
Method of administration:
1. Remove the pipette from the package. Hold the pipette upright, twist and
remove the cap.
2. Turn the cap over and place it back with the other end onto the pipette. Press it and
twist the cap to break the seal, then remove the cap from
the pipette.
3. Part the animal’s coat in the area at the base of the neck before the shoulder blades so that
the skin is visible. Place the tip of the pipette on the skin and press it several
times until the contents are completely emptied directly onto the skin at the designated
spot.
9. ADVICE ON CORRECT ADMINISTRATION
The minimum treatment interval is 4 weeks.
10. WITHDRAWAL PERIOD(S)
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store below 30 °C.
Store in the original package to protect from light and moisture.
Do not use this veterinary medicinal product after the expiry date,
stated on the label after "EXP".
12. SPECIAL WARNINGS
Special precautions for each target species:
Fleas from pets often infest the animal’s baskets, bedding and resting areas, such as carpets
and upholstered furniture, which, in case of massive infestation and at the beginning of
control measures, should also be treated with suitable insecticides and regularly
vacuumed.
There is no data available on the effect of bathing/shampooing on the efficacy of the
product in cats and ferrets. However, based on information available for dogs,
shampooed 2 days after product application, it is not recommended to bathe the
animals up to 2 days after product application.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals:
Avoid contact of the product with the animal’s eyes.
It is important to ensure that the product is applied to an area that the animal cannot
lick and to prevent mutual licking by other animals after its application.
Single ticks may attach. For this reason, transmission of
infectious diseases under unfavourable conditions cannot be completely excluded.
The product can be used during pregnancy in cats. The potential toxicity
of the product in kittens under 8 weeks of age in contact with treated female cats, has not
been documented. Special measures are required in this case.
Pregnancy and lactation:
Laboratory studies in cats have not shown any evidence of teratogenicity,
fetotoxicity or maternal toxicity. The safety of the veterinary medicinal
product has not been established in ferrets during pregnancy and lactation. Apply only after
a benefit/risk assessment by the responsible veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals:
The product may cause irritation to mucous membranes, skin and eyes. Therefore, contact of the
product with the mouth, skin and eyes should be avoided.
Persons with known hypersensitivity to insecticides or alcohol should avoid
contact with the veterinary medicinal product.
Avoid contact of the product with the fingers. If this happens, hands should be
washed with soap and water.
In case of accidental eye contact, rinse thoroughly with clean water.
Hands should be washed after each use.
Do not smoke, drink or eat during product application.
Treated animals should not be handled until the application site has dried.
Children should not be allowed to play with treated animals until the application site has dried.
For this reason, it is not recommended to treat animals during the day, but early in the evening,
and these animals should not be allowed to sleep with owners and especially with children.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT
OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such
products should be disposed of in accordance with local requirements.
Fipronil and S-methoprene can cause adverse reactions in aquatic organisms. Do not
contaminate ponds, waterways or ditches with the product or empty packaging.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
15. ADDITIONAL INFORMATION
Cardboard box containing 1, 3, 6 or 10 pipettes.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the
local representative of the marketing authorisation holder.
