Atopica 10 mg Soft Capsules for Dogs

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Ciclosporin A

Fáanlegur frá:

Elanco Europe Ltd

ATC númer:

QL04AD01

INN (Alþjóðlegt nafn):

Ciclosporin A

Lyfjaform:

Capsule, soft

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Dogs

Lækningarsvæði:

Anti Inflammatory immunosuppressive

Leyfisstaða:

Authorized

Leyfisdagur:

2003-10-06

Vara einkenni

Revised: June 2023
AN: 01276/2022 + 01304/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 10 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin 10 mg
EXCIPIENT(S):
α-tocopherol (E-307) 0.10 mg
Titanium dioxide (E-171) 1.13 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 oval soft capsules bearing the following imprint: NVR 10.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (weighing from 2 to 4 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 any 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 “Special
precautions
for use” and “Interaction with other medicinal products and other
forms of
interaction”).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Consideration should be given to the use of other measures and/or
treatments
to control moderate to severe pruritus when initiating therapy with
ciclosporin.
Revised: June 2023
AN: 01276/2022 + 01304/2022
Page 2 of 7
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 ato