STRONGHOLD GATO PLUS 60/10MG 3 PIPETTES 5-10KG

STRONGHOLD PLUS Spot Anointing Solution for Cats

Antiparasitic in solution for punctual dorsal anointing

LABORATORY

ZOETIS SPAIN, SLU

PHARMACEUTICAL FORM

Spot-on anointing solution (Sol.udp)

COMPOSITION PER PIPETTE:

Stronghold Plus 15mg/2,5mg: 0,25mL (selamectin 15mg; sarolaner 2,5mg).

Stronghold Plus 30mg/5mg: 0,5mL (selamectin 30mg; sarolaner 5mg).

Stronghold Plus 60mg/10mg: 1mL (selamectin 60mg; sarolaner 10mg).

INDICATIONS AND TARGET SPECIES

Cats: For cats with, or at risk of, mixed parasitic infestations with ticks and fleas, lice, mites, gastrointestinal nematodes, or heartworms.

• The veterinary medicinal product is exclusively indicated when the use against ticks and one or more of the other target parasites is indicated at the same time.

Ectoparasites:

Treatment and prevention of infestations by fleas (Ctenocephalides spp.). The veterinary medicinal product has immediate and persistent activity against new flea infestations for 5 weeks. The product kills adult fleas before they lay eggs for 5 weeks. Through its ovicidal and larvicidal action, the veterinary medicinal product can help control existing environmental flea infestations in areas to which the animal has access.

The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Treatment of tick infestations. The veterinary medicinal product has an immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against Dermacentor reticulatus and Rhipicephalus sanguineus.

Treatment of ear mites (Otodectes cynotis).

Treatment of infestations of biting lice (Felicola subrostratus).

Ticks must attach to the host and begin feeding in order to be exposed to sarolaner.

Nematodes:

Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).

Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.

CONTRAINDICATIONS

• Do not use in cats that are suffering from a concomitant disease, or that are debilitated and underweight (for their size and age).

• Do not use in case of hypersensitivity to the active substances or to any of the excipients.

SIDE EFFECTS

• The use of the veterinary medicinal product may cause mild and transient pruritus at the application site.

• Mild or moderate alopecia at the application site.

• Rarely erythema and drooling have been observed.

ROUTE OF ADMINISTRATION

Topical use.

• Apply to the skin at the base of the neck in front of the shoulder blades.

POSOLOGY

Cats: Single topical application administering a minimum of 6 mg/kg of selamectin and 1 mg/kg of sarolaner.

Cats weighing 2,5 kg or less: Dispense 15 mg selamectin and 2,5 mg sarolaner.

Cats weighing 2,5-5 kg: Dispense 30 mg selamectin and 5 mg sarolaner.

Cats weighing 5-10 kg: Dispense 60 mg selamectin and 10 mg sarolaner.

Cats weighing more than 10 kg: Dispense appropriate combination of pipettes.

SPECIAL PRECAUTIONS

• The use of this veterinary medicinal product is indicated in cats of at least 8 weeks of age and a minimum weight of 1,25 kg.

• This veterinary medicinal product should only be applied to the skin. Do not administer orally or parenterally.

• Do not apply if the animal has wet hair.

• For the treatment of ear mites, do not apply directly to the ear canal.

• It is important to apply the dose as indicated to prevent the animal from licking or ingesting the product. If significant ingestion occurs, effects on intestinal transit such as hypersalivation, emesis, loose stools or reduced food intake may be observed which should normally resolve without treatment.

• People with sensitive skin or known hypersensitivity to this type of medicinal product should handle the veterinary medicinal product with caution.

• Keep treated animals away from fire or other sources of ignition for at least 30 minutes or until the hair is dry.

WAIT TIME

Not applicable.

PRESERVATION MODE

• Store at a temperature below 30 °C.

• Do not remove the pipette from the blister pack until ready to use.

OBSERVATIONS

With veterinary prescription.

PRESENTATION

Stronghold Plus 15 mg/2,5 mg: Boxes of 3 and 6 pipettes.

Stronghold Plus 30 mg/5 mg: Boxes of 3 and 6 pipettes.

Stronghold Plus 60 mg/10 mg: Boxes of 3 and 6 pipettes.

REG. No.

Stronghold Plus 15mg/2,5mg:

Box of 3 pipettes: EU/2/16/204/001

Box of 6 pipettes: EU/2/16/204/002

Stronghold Plus 30mg/5mg:

Box of 3 pipettes: EU/2/16/204/003

Box of 6 pipettes: EU/2/16/204/004

Stronghold Plus 60mg/10mg:

Box of 3 pipettes: EU/2/16/204/005

Box of 6 pipettes: EU/2/16/204/006