Atopica 50 mg Soft Capsules for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Ciclosporin A

Commercializzato da:

Elanco Europe Ltd

Codice ATC:

QL04AD01

INN (Nome Internazionale):

Ciclosporin A

Forma farmaceutica:

Capsule, soft

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Anti Inflammatory immunosuppressive

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2003-10-06

Scheda tecnica

Revised: September 2020
AN: 00839/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ATOPICA 50 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin
50.00 mg
EXCIPIENT(S):

-tocopherol (E-307)
0.50 mg
Titanium dioxide (E-171)
4.50 mg
Carminic acid (E-120)
< 1.00 μg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Yellow-white oblong capsules bearing the following imprint: NVR 50 mg.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (weighing from 7.5 to 36 kg)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ciclosporin or one of the
excipients.
For all capsule strengths, do not use in dogs less than six months of
age or less
than 2 kg in weight.
Do not use in cases with a history of malignant disorders or
progressive
malignant disorders.
Do not vaccinate with a live vaccine during treatment or within a
two-week
interval before or after treatment. (see also sections 4.5 “Special
precautions for
use” and 4.8 “Interaction with other medicinal products”).
Revised: September 2020
AN: 00839/2020
Page 2 of 7
4.4
SPECIAL WARNINGS
Consideration should be given to the use of other measures and/or
treatments to
control moderate to severe pruritus when initiating therapy with
ciclosporin.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin
inflammation
are not specific for this disease and therefore other causes of
dermatitis
such as ectoparasitic infestations, other allergies which cause
dermatological signs (e.g. flea allergic dermatitis or food allergy)
or
bacterial and fungal infections should be ruled out before treatment
is
started. It is good practice to treat flea infestations before and
during
treatment of atopic dermatitis.
It is recommended to clear bacterial an