Atopica 100 mg/ml Oral Solution for Cats and Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ciclosporin A

Available from:

Elanco Europe Ltd

ATC code:

QL04AD01

INN (International Name):

Ciclosporin A

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Anti Inflammatory immunosuppressive

Authorization status:

Authorized

Authorization date:

2011-09-16

Summary of Product characteristics

Revised: July 2023
AN: 01282/2022 & 00938/2023
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 100 mg/ml oral solution for cats and dogs
Atoplus (IT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE: Ciclosporin 100 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF
THAT
INFORMATION
IS
ESSENTIAL
FOR
PROPER
ADMINISTRATION
OF
THE
VETERINARY
MEDICINAL PRODUCt
all-_rac_-

-tocopherol (E-307)
1.05 mg
Ethanol, anhydrous (E-1510)
94.70 mg
Propylene glycol (E-1520)
94.70 mg
Corn oil-mono-di-triglycerides
Macrogolglycerol hydroxystearate
Clear, yellow to brownish liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats
Dogs (weighing more than 2 kg).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Symptomatic treatment of chronic allergic dermatitis in cats.
Treatment of chronic manifestations of atopic dermatitis in dogs.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in animals 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 3.5 “Special
precautions for use” and 3.8
“Interaction with other medicinal products and other forms of
interaction”).
Do not use in cats infected with FeLV or FIV.
Revised: July 2023
AN: 01282/2022 & 00938/2023
Page 2 of 13
Do not use in dogs less than six months of age or less than 2 kg in
weight.
3.4
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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Clinical signs of atopic or allergic dermatitis such as pruritus and
skin inflammation
are not specific for this disease and therefore other causes of
dermatitis suc