Fluralaner Spot-on solution

Fluralaner Spot-on solution

Product Information

Indications: 

Used for the treatment of flea (Ctenocephalides felis) infestations on dogs and cats; for the treatment of tick (Rhipicephalus sanguineus, Haemaphysalis longicornis, Dermacentor variabilis) infestations on dogs; and for the treatment of tick (Rhipicephalus sanguineus, Haemaphysalis longicornis, Dermacentor variabilis) infestations on cats.

This product can be used as part of a clinical treatment regimen for Flea Allergy Dermatitis (FAD).

Dosage and Administration: 

Calculated as fluralaner. For external use only. Apply this product to the skin on the dorsal midline of the dog's back (between the shoulders and hips) or to the skin at the base of the cat's skull. Per 1kg of body weight: dogs ≥25mg, cats ≥40mg. Refer to the recommended dosage table for details. Administer once every 12 weeks. For the treatment of Dermacentor variabilis infestations in cats, administer once every 8 weeks.

Table 1: Recommended Dosage Table for Dogs by Body Weight

Body Weight (kg)

Specification

Quantity (tubes)

2⩽BW⩽4.5

0.4ml : Fluralaner 0.1125g

1

4.5<BW⩽10

0.89ml : Fluralaner 0.25g

1

10<BW⩽20

1.79ml : Fluralaner 0.5g

1

20<BW⩽40

3.57ml : Fluralaner 1.0g

1

40<BW⩽56

5.0ml : Fluralaner 1.4g

1

BW>56

Select appropriate specification combination

Table 2: Recommended Dosage Table for Cats by Body Weight

Body Weight (kg)

Specification

Quantity (tubes)

1.2⩽BW⩽2.8

0.4ml : Fluralaner 0.1125g

1

2.8<BW⩽6.25

0.89ml : Fluralaner 0.25g

1

6.25<BW⩽12.5

1.79ml : Fluralaner 0.5g

1

BW>12.5

Select appropriate specification combination

Precautions:

1.Due to a lack of relevant data, this product must not be used in dogs less than 8 weeks of age or weighing less than 2kg, and must not be used in cats less than 11 weeks of age or weighing less than 1.2kg.

2.This product is for external use only and must not be taken orally. Avoid mutual licking and grooming between treated dogs/cats.

3.Do not use in dogs/cats hypersensitive to this product. Use with caution in dogs/cats with a history of neurological disorders.

4.The dosing interval must not be shorter than 8 weeks.

5.Can be used in breeding dogs, pregnant and lactating bitches. The safety of this product in pregnant and lactating cats has not been studied; it is recommended to determine whether to use the drug after evaluation by a veterinarian.

6.In puppies aged 8-9 weeks weighing 2.0kg~3.7kg, topical administration of 5 times the maximum recommended dose of fluralaner, given once every 8 weeks for a total of 3 doses, showed no adverse reactions. In Beagles orally administered 3 times the maximum recommended dose of fluralaner, no effects on reproductive ability or offspring survival ability were found. In Collies with multidrug resistance gene deficiency (MDR1-/-), oral administration of 3 times the maximum recommended dose of fluralaner was well tolerated, with no treatment-related clinical symptoms observed.

7.In kittens aged 11-13 weeks weighing 1.2kg~1.5kg, topical administration of 5 times the maximum recommended dose of fluralaner, given once every 8 weeks for a total of 3 doses, showed no adverse reactions.

8.Fluralaner has a high plasma protein binding rate and may compete with other high protein binding rate drugs for plasma proteins, such as non-steroidal anti-inflammatory drugs and coumarin derivatives like warfarin. In vitro plasma incubation tests did not find competition between fluralaner and carprofen or warfarin for plasma protein binding. Clinical trials did not find interactions between fluralaner and dogs' daily medications.

9.If any severe reactions or other adverse reactions not mentioned in this instruction occur, consult a veterinarian in a timely manner.

10.This product acts quickly and can reduce the risk of vector-borne disease transmission, but fleas and ticks must contact the host and start feeding to contact the active drug ingredient. Fleas (Ctenocephalides felis) act within 8 hours of contact with dogs and within 12 hours of contact with cats; ticks (Ixodes ricinus) act within 12 hours of contact with dogs and within 48 hours of contact with cats. Therefore, under extremely harsh conditions, the risk of disease transmission via parasites cannot be completely ruled out.

11.This product has slight irritation and must not be dripped onto broken skin of dogs/cats. Contact with the eyes of dogs/cats should be avoided.

12.To ensure efficacy, do not immerse dogs in water, bathe, or let them swim within 3 days of treatment.

13.A small number of people may experience stinging pain or numbness after skin contact. When handling the product and administering it to dogs/cats, wear disposable protective gloves. In case of contact with skin, wash immediately with soap and water; this product is irritating to eyes, in case of contact with eyes, rinse immediately with water. Persons with known hypersensitivity to the active ingredient of this product should not administer it. Persons with sensitive skin or known hypersensitivity, such as those allergic to other similar veterinary drugs, should be cautious when administering or contacting treated animals. Avoid contacting the application site of dogs/cats until the site is dry.

14.Accidental ingestion of this product is toxic. In case of accidental ingestion by operators, seek medical attention immediately, bringing the packaging and instruction manual.

15.Avoid contact with children.

16.This product is highly flammable. Keep away from heat and open flames. In case of spillage, such as on tables or floors, remove the spilled product with paper towels and clean with a detergent.

17.Fluralaner is toxic to aquatic invertebrates. Unused product should not be disposed of in sewers or watercourses.

Withdrawal Period: Not applicable

Specifications:

(1) 0.4 ml : Fluralaner 0.1125g    (2) 0.89ml : Fluralaner 0.25g    

(3) 1.79ml : Fluralaner 0.5g   (4) 3.57ml : Fluralaner 1.0g     (5) 5.0ml : Fluralaner 1.4g

Packaging: 1 tube/box

Storage: Sealed, store below 30°C

Validity: 24 months

Instructions for Use