Lotilaner Elanco 12 mg Chewable Tablets for Cats (0.5–2.0 kg)

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Lotilaner

Tersedia dari:

Elanco GmbH

Kode ATC:

QP53BE04

INN (Nama Internasional):

Lotilaner

Bentuk farmasi:

Chewable tablet

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cats

Area terapi:

Ectoparasiticide

Status otorisasi:

Authorized

Tanggal Otorisasi:

2023-10-03

Karakteristik produk

Issued: October 2023
AN: 03086/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lotilaner Elanco 12 mg chewable tablets for cats (0.5–2.0 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each chewable tablet contains:
LOTILANER ELANCO CHEWABLE TABLETS
LOTILANER (MG)
for cats (0.5–2.0 kg)
12
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White to brownish round chewable tablets with brownish spots.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of flea and tick infestations on cats.
This veterinary medicinal product provides immediate and persistent
killing
activity for 1 month against fleas (_Ctenocephalides felis and C.
canis_) and ticks
(_Ixodes ricinus_).
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).
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Issued: October 2023
AN: 03086/2022
Page 2 of 6
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.
Acceptable levels of efficacy may not be achieved if the veterinary
medicinal
product is not administered with food or within 30 minutes after
feeding.
Due to insufficient data to support efficacy against ticks in young
cats, this
product is not recommended for the treatment of ticks in kittens 5
months of
age or younger.
4.5
SPECIAL PRECAUTIONS FOR USE
i). Special precautions for use in animals
Safety and efficacy data has been studied in cats aged 8 weeks and
older with
a body weight of 0.5 kg or more. Therefore, use of this veterinary
medicinal
product in ki