Cyclavance 100 mg/ml Oral Solution for Dogs and Cats

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Ciclosporin A

Beschikbaar vanaf:

Virbac

ATC-code:

QL04AD01

INN (Algemene Internationale Benaming):

Ciclosporin A

farmaceutische vorm:

Oral solution

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Cats, Dogs

Therapeutisch gebied:

Anti Inflammatory immunosuppressive

Autorisatie-status:

Authorized

Autorisatie datum:

2014-04-03

Productkenmerken

Revised: April 2024
AN: 03937/2022
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclavance 100 mg/ml oral solution for dogs and cats
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)
1.00 mg
Glycerol monolinoleate
Ethanol, anhydrous (E-1510)
Macrogolglycerol hydroxystearate
Propylene glycol (E-1520)
Clear to slightly yellow solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
Symptomatic treatment of chronic allergic dermatitis in cats.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in cases with a history of malignant disorders or
progressive malignant
disorders.
Revised: April 2024
AN: 03937/2022
Page 2 of 17
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 dogs less than six months of age or less than 2 kg in
weight.
Do not use in cats infected with Feline Leukemia Virus (FeLV) or
Feline
Immunodeficiency Virus (FIV).
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 dermatitis in dogs and allergic dermatitis in
cats such as
pruritus and skin inflammation are not specific for these diseases.
Other causes of
dermatitis such as ectoparasiti