TIXORA® Chewable Tablets

Fluralaner Chewable Tablets

Systemic Flea & Tick Protection for Dogs
For Veterinary Use Only

COMPOSITION

TIXORA® 500

Each chewable tablet contains:

Fluralaner ............................................. 500 mg

Excipients .............................................. q.s.

PHARMACEUTICAL FORM

Light to dark brown, palatable chewable tablets with a smooth or slightly rough surface.

TARGET SPECIES

Dogs

INDICATIONS

TIXORA® is indicated for the treatment and prevention of ectoparasite infestations in dogs.

It provides:

• Treatment and prevention of flea infestations (Ctenocephalides felis)

• Treatment and control of tick infestations

• Persistent flea control for up to 12 weeks

• Persistent tick control for up to 12 weeks (depending on tick species and local registration)

• Can be used as part of a treatment strategy for Flea Allergy Dermatitis (FAD)

PHARMACOLOGICAL PROPERTIES

Fluralaner is a systemic isoxazoline ectoparasiticide.

It acts by inhibiting ligand-gated chloride channels (GABA- and glutamate-gated channels) in fleas and ticks, leading to hyperexcitation, paralysis and death of susceptible parasites.

Parasites must attach to the host and begin feeding to be exposed to the active substance.

CLINICAL BENEFITS

• Long-lasting protection with a single dose

• Rapid flea killing activity

• Rapid tick killing activity

• Helps break the flea life cycle

• Convenient oral administration

• Water-resistant efficacy (systemic activity)

DOSAGE AND ADMINISTRATION

For oral administration.

Administer once every 12 weeks at a minimum dose of:

25–56 mg Fluralaner/kg body weight

Administer with food or around feeding time to optimize absorption.

DOSAGE GUIDE

For dogs outside this weight range, use the appropriate tablet strength or a suitable combination of tablets according to the approved dosage recommendations.

Do not divide chewable tablets unless supported by the final product registration.

CONTRAINDICATIONS

Do not use in:

• Puppies younger than 8 weeks of age

• Dogs weighing less than 2 kg

• Animals with known hypersensitivity to Fluralaner or any excipient.

SPECIAL WARNINGS

Parasites must attach and commence feeding before exposure to Fluralaner.

Use with caution in dogs with a history of seizures or neurological disorders, as is recommended for isoxazoline-class products.

ADVERSE REACTIONS

Common (generally mild and transient):

• Vomiting

• Diarrhea

• Reduced appetite

• Drooling

Very rarely:

• Lethargy

• Pruritus

• Muscle tremors

• Ataxia

• Convulsions

USE DURING PREGNANCY AND LACTATION

May be used during pregnancy, lactation or in breeding dogs only if supported by the approved registration dossier in the target market.

DRUG INTERACTIONS

No clinically significant interactions have been reported with commonly used veterinary medicinal products.

TIXORA® may be administered alongside:

• Vaccines

• Anthelmintics

• Antibiotics

• NSAIDs

under veterinary supervision.

OVERDOSE

Fluralaner has demonstrated a wide safety margin when administered according to label recommendations.

In case of overdose, provide symptomatic and supportive treatment.

STORAGE

Store below 30°C.

Protect from moisture.

Keep in the original blister until use.

SHELF LIFE

36 months

PRESENTATION

Available strengths:

• TIXORA® 112.5 mg

• TIXORA® 250 mg

• TIXORA® 500 mg

• TIXORA® 1000 mg

• TIXORA® 1400 mg

Pack sizes:

• 1 chewable tablet

• 2 chewable tablets

• 4 chewable tablets