Fluralaner Injection

Product Name: Fluralaner Injection

Ingredient: Fluralaner

Indications:

1.Treat and prevent flea infestations in dogs with 12 months of continuous protection.

2.Treat and control infestations of various ticks: 12 months of protection against black-legged ticks, brown dog ticks and American dog ticks; 8 months of protection against lone star ticks.

3.Adjunctive treatment for sarcoptic mange, demodicosis and otodectic mange infestations.

Description:

This product is a compound preparation with powder for injection and special solvent packed separately. The powder is white and prone to agglomeration, the solvent is a clear liquid. A homogeneous white suspension with a concentration of 150mg/mL is prepared before use.

Pharmacology：

Fluralaner, an isoxazoline insecticidal and acaricidal agent, interferes with the γ-aminobutyric acid (GABA)-gated chloride channels, inhibits the chloride ion penetration across the postsynaptic membrane, disrupts the transmembrane signal transmission of the nervous system, and causes neurological disorder and death of arthropods. This product has no cross-resistance with amidines, macrolides, pyrethroids, dieldrin and other agents.

Key Advantages:

1.Long-acting efficacy: Provides 12-month continuous protection against fleas and most ticks (black-legged ticks, brown dog ticks, American dog ticks) in dogs, and 8-month protection against lone star ticks, requiring only annual administration.

2.Broad-spectrum antiparasitic effect: Effective for flea and multiple tick infestations in dogs, and also acts as an adjunctive therapy for sarcoptic mange, demodicosis and otodectic mange infestations.

3.No cross-resistance: Shows no cross-resistance with amidines, macrolides, pyrethroids, dieldrin and other antiparasitic agents, with reliable curative effect for drug-resistant parasite infestations.

4.Convenient administration: Subcutaneous injection with a simple procedure, and the prepared suspension has a 28-day valid period for clinical flexibility.

5.Rapid and sustained action: The drug takes effect gradually within 3 days after injection, and exerts a persistent antiparasitic effect for a long time after a single administration.

Dosage and Administration

Preparation

1. Shake powder vial thoroughly to break up agglomerates.

2. Invert solvent vial ≥ 3 times to homogenize.

3. Withdraw 15 mL solvent using 18G needle + 20 mL syringe.

4. Insert 25G vent needle into powder vial, inject solvent slowly with horizontal rotation.

5. Shake continuously to form homogeneous white suspension.

Administration

Subcutaneous injection only at dorsal interscapular region (disinfect first, avoid intravascular injection). Once every 12 months; advance if needed.

Recommended Dosage

Adverse Reactions:

1.Common (transient): Somnolence, anorexia, vomiting, diarrhea, mild swelling/itching at injection site, resolving spontaneously within 1-3 days.

2.Occasional: Slight elevation of liver enzymes, skin erythema/itching.

3.Rare (severe): Tremor, ataxia, epileptic seizure (more in dogs with neurological history); discontinue use and give symptomatic treatment immediately.

Precautions:

1.Forbidden in dogs allergic to fluralaner or excipients, puppies <6 months old or dogs weighing <4kg; strictly not for felines (may cause severe poisoning).

2.For subcutaneous injection only; intravenous injection is strictly prohibited.

3.Use cautiously in dogs with epilepsy, neurological history or hepatic/renal insufficiency.

4.Use in pregnant/lactating dogs only after veterinary evaluation.

5.The drug takes effect gradually within 3 days after injection; administer 3 days in advance for tick bite prevention.

6.This is a veterinary prescription drug, to be prescribed and administered only by licensed veterinarians.

7.Dispose of the remaining liquid as medical waste; do not reuse.

Specification:

1 vial of powder for injection (2.51 g) + 1 vial of solvent (16 mL); the concentration of the prepared suspension is 150 mg/mL.

Storage and Shelf Life:

1.Unprepared: Sealed and stored below 30℃, shelf life 24 months.

2.Prepared: Stored in the dark at 2-25℃, use up within 28 days.

3.Freezing is strictly prohibited for both; dispose of remaining liquid as medical waste.