Atopica 100 mg/ml Oral Solution for Cats
Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Lastnosti izdelka
(SPC)
01-08-2016
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Aktivna sestavina:
Ciclosporin A
Dostopno od:
Novartis Animal Health UK Ltd
Koda artikla:
QL04AD01
INN (mednarodno ime):
Ciclosporin A
Farmacevtska oblika:
Oral solution
Tip zastaranja:
POM-V - Prescription Only Medicine – Veterinarian
Terapevtska skupina:
Cats, Dogs
Terapevtsko območje:
Anti Inflammatory immunosuppressive
Status dovoljenje:
Authorized
Datum dovoljenje:
2011-09-16
Lastnosti izdelka
Revised: August 2016
AN: 01505/2015
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Page 1 of 7
Revised: August 2016
AN: 01505/2015
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
specific for this disease
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