ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-09-2016
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Active ingredient:
CICLOSPORIN
Available from:
Novartis Animal Health UK Ltd
ATC code:
QL04A
INN (International Name):
CICLOSPORIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Feline
Therapeutic area:
IMMUNOSUPPRESSIVE AGENTS
Therapeutic indications:
Miscellaneous
Authorization status:
Authorised
Authorization date:
2011-10-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 100 mg/ml oral solution for cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ciclosporin
100 mg
EXCIPIENT(S):
all-_rac_- -tocopherol (E-307)
1.05 mg
Ethanol, anhydrous (E-1510)
94.70 mg
Propylene glycol (E-1520)
94.70 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, yellow to brownish liquid
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cat
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment of chronic allergic dermatitis in cats.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats infected with FeLV or FIV.
Do not use in cats 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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 16/09/2016_
_CRN 7024593_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Allergic dermatitis in cats can have various manifestations, including eosinophilic plaques, head and neck excoriation,
symmetrical alopecia and/or miliary dermatitis. Clinical signs of allergic dermatitis such as pruritus and skin
inflammation are not
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