产品特点
ATOPICA 10 MG SPC.
_[update of ADR section, January 2013] _
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ATOPICA 10 mg soft capsules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ciclosporin
10.00 mg
EXCIPIENT(S):
-tocopherol (E-307)
0.10 mg
Titanium dioxide (E-171) 1.13 mg
Carminic acid (E-120) < 1.00
g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule
Yellow-white oval capsules bearing the following imprint: N_V_R 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 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”).
4.4 SPECIAL WARNINGS
None.
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
2
bacterial and funga
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