Atopica 100 mg Soft Capsules for Dogs

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Ciclosporin A

Inapatikana kutoka:

Elanco Europe Ltd

ATC kanuni:

QL04AD01

INN (Jina la Kimataifa):

Ciclosporin A

Dawa fomu:

Capsule, soft

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Dogs

Eneo la matibabu:

Anti Inflammatory immunosuppressive

Idhini hali ya:

Authorized

Idhini ya tarehe:

2003-10-06

Tabia za bidhaa

Revised: September 2020
AN: 00839/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ATOPICA 100 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin
100.00 mg
EXCIPIENT(S):

-tocopherol (E-307)
1.00 mg
Iron oxide black (E-172)
0.285 mg
Titanium dioxide (E-171)
5.73 mg
Carminic acid (E-120)
< 1.00 μg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Blue-grey oblong capsules bearing the following imprint: NVR 100 mg.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (weighing from 15 to 55 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