Fypryst Combo Spot-on antiparasitic drops (pipettes) for dogs >40 kg 402 mg N1

Means against fleas, ticks for dogs – Fypryst combo dog 402/361.8 mg (40–60 kg), 1 pip., non-prescription vet. medicine - reg. NO - VA - 089588/1

NAME OF THE VETERINARY MEDICINE
Fypryst Combo 402 mg/ 361.8 mg dermal solution for very large dogs

QUALITATIVE AND QUANTITATIVE COMPOSITION
One 4.02 ml pipette contains:

Active substances:
Fipronil 402 mg;
S-methoprene 361.8 mg.
Excipients:

Butylhydroxyanisole (E320) 0.80 mg;
Butylhydroxytoluene (E321) 0.40 mg;
Povidone (K25);
Polysorbate 80;
Ethyl alcohol 96%;
Diethylene glycol monoethyl ether.
PHARMACEUTICAL FORM

Solution for instillation on the skin.
Clear, yellow solution.

TARGET SPECIES
Dogs heavier than 40 kg.

INDICATIONS

• For the prevention of flea infestations and mixed infestations of fleas and ticks and/or lice.
• For the treatment of flea (Ctenocephalides spp.) infestation. The effect of the insecticide against the infestation of young adult fleas remains for 8 weeks. For the prevention of flea reproduction by inhibiting the development of eggs (ovicidal action), larvae and pupae (larvicidal action) from eggs laid by adult fleas, 8 weeks after application.
• For the treatment of tick (Ixodes ricinus, Dermacentor variablis, Dermacentor reticulatus, Rhipicephalus sanguineus) infestation. The acaricidal effect of this drug against ticks remains for 4 weeks.
• For the treatment of lice (Trichodectes canis) infestation. This veterinary medicine can be used as part of a treatment strategy for flea allergy dermatitis if it has been previously diagnosed by a veterinarian.

CONTRAINDICATIONS

• Due to a lack of data, this veterinary medicinal product should not be used in puppies under 8 weeks of age and/or puppies weighing less than 2 kg.
• Do not use in sick animals (systemic diseases, fever, etc.) and animals in the recovery period.
• Do not use in rabbits, as side effects and even death are possible.
• In the absence of studies, the use of this medicinal product is not recommended in animals other than the target species.
• This medicine is for use in dogs only. Do not use in cats and ferrets, as overdose is possible.

SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:

Avoid getting the medicine into the animal's eyes.
It is important to make sure that the medicine is applied in a place where the animals cannot lick it and to ensure that the animals do not lick each other after treatment.

Special precautions to be taken by a person using veterinary medicinal products for the treatment of animals:

This medicine can cause irritation of the mucous membrane, skin and eyes, so avoid contact of the medicine with the mucous membrane of the mouth, skin and eyes.
Persons with known hypersensitivity to insecticides or alcohol should avoid contact with this veterinary medicinal product. Be careful not to let the medicine come into contact with the skin. If this has happened, wash your hands with soap and water.
If the medicine accidentally gets into the eyes, rinse the eyes thoroughly with clean water.
Wash hands after use.
Do not smoke, drink or eat during treatment.
Treated animals should not be petted until the application site is dry, and children should not be allowed to play with freshly treated animals. For this reason, it is recommended to treat animals not during the day, but early in the evening, and not to allow recently treated animals to sleep with their owners, especially children.
Other Precautions:

Fipronil and S-methoprene may be hazardous to aquatic organisms. Dogs should not be allowed to swim in water for two days after taking the medicine

POSSIBLE SIDE EFFECTS
Among the very rare (less than 1 animal in 10,000 animals treated, including individual reports) possible side effects after the use of the drug, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and generalized itching or hair loss have been reported. Increased salivation, depression, reversible neurological symptoms (increased sensitivity, depression, nervous symptoms), vomiting or respiratory symptoms have also been observed after taking the drug.
In case of licking the application site, temporary increased salivation may be observed mainly due to the properties of the carrier.

USE DURING PREGNANCY, LACTATION OR LAYING
May be used during pregnancy and lactation.

INTERACTIONS WITH OTHER DRUGS AND OTHER TYPES OF INTERACTIONS
Not known.

DOSAGE AND METHOD OF ADMINISTRATION

Dosage:
For external use only (instillation).
Use by applying to the skin; one 4.02 ml pipette (402 mg fipronil + 361.8 mg (S)-methoprene) for dogs weighing more than 40 kg.
This corresponds to the minimum recommended dose of 6.7 mg/kg fipronil and 6 mg/kg (S)-methoprene for dermal application.
Due to the lack of drug safety studies, the minimum interval between applications is 4 weeks.
Method of use:

• Remove the pipette from the package. Hold the pipette vertically with the cap upwards, unscrew and remove the cap.
• Turn the cap upside down and put the other end back on the pipette. Press and twist the cap to break the seal and then remove the cap from the pipette.
• Apply to the skin at the base of the neck in front of the shoulder blades.
• Part the hair so that the skin is visible. Place the tip of the pipette on the skin and squeeze the single-dose pipette several times to empty the contents directly onto the skin at one point.
• Transient changes in the coat (sticky/greasy coat) may appear at the site of application.

OVERDOSE
In laboratory studies on the safety of the drug, no side effects were observed in 8-month-old puppies, growing dogs, and dogs weighing around 2 kg, at a single dose of five times the recommended dose.
The risk of side effects can increase with an overdose of the drug, so choose the most suitable pipette size for animals, taking into account the animal's body weight.
PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: means against ectoparasites for external use, including insecticides.

Pharmacodynamic properties:

• Fipronil is an insecticide and acaricide belonging to the phenylpyrazole group. It interacts with ligand-gated chloride channels, especially those regulated by the neurotransmitter gamma-aminobutyric acid (GASS), thereby blocking the pre- and postsynaptic transfer of chloride ions across cell membranes. It causes uncontrolled central nervous system activity and death in insects and mites. Fipronil kills fleas within 24 hours, ticks (Dermacentor variablis, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes ricinus) and lice 48 hours after application.
• (S)-Methoprene is an insect growth regulator (IAR), from a class of compounds known as juvenile hormone analogues, which arrest the development of insects at one stage of development. This substance acts similar to juvenile hormones and causes impaired development and death of fleas at all stages of their development. The ovicidal effect of (S)-methoprene on the animal occurs either by direct penetration into newly laid eggs or by penetration through the cuticle into the body of an adult flea. (S)-methoprene effectively stops the further development of flea eggs and larvae, which protects against contamination of the immediate surroundings of animals with fleas in various stages of their development.