Credelio 450 mg Chewable Tablets for Dogs (>11–22 kg)

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Lotilaner

Disponível em:

Elanco GmbH

Código ATC:

QP53BE04

DCI (Denominação Comum Internacional):

Lotilaner

Forma farmacêutica:

Chewable tablet

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Dogs

Área terapêutica:

Ectoparasiticide

Status de autorização:

Authorized

Data de autorização:

2017-04-23

Características técnicas

Revised: March 2024
AN: 02202/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Credelio 450 mg chewable tablets for dogs (>11–22 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each chewable tablet contains:
CREDELIO CHEWABLE TABLETS
LOTILANER (MG)
for dogs (>11–22 kg)
450
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White to beige round chewable tablets with brownish spots.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent
killing activity for 1
month for fleas (_Ctenocephalides felis_ and _C. canis_) and ticks
(_Rhipicephalus sanguineus, _
_Ixodes ricinus, I. hexagonus_ and _Dermacentor reticulatus_).
Fleas and ticks must attach to the host and commence feeding in order
to be exposed to
the active substance.
The veterinary medicinal product can be used as part of a treatment
strategy for the
control of flea allergy dermatitis (FAD).
For the treatment of demodicosis (caused by _Demodex canis_).
Revised: March 2024
AN: 02202/2023
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Parasites need to start feeding on the host to become exposed to
lotilaner; therefore the
risk of the transmission of parasite borne diseases cannot be
completely excluded.
4.5
SPECIAL PRECAUTIONS FOR USE
i). Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies
8 weeks of age
and older and 1.3 kg of body weight and greater. Use of this
veterinary medicinal product
in puppies younger than 8 weeks of age or less than 1.3 kg of body
weight should be
based on a benefit-risk assessment by the responsible veterinarian.
ii). Special precautions to be taken by the person ad