Cyclavance 100 mg/ml oral solution for dogs and cats

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ciclosporin

Beschikbaar vanaf:

Virbac S.A.

ATC-code:

QL04A

INN (Algemene Internationale Benaming):

Ciclosporin

Dosering:

100 milligram(s)/millilitre

farmaceutische vorm:

Oral solution

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Cats, Dogs

Therapeutisch gebied:

IMMUNOSUPPRESSANTS

therapeutische indicaties:

Miscellaneous

Autorisatie-status:

Authorised

Autorisatie datum:

2014-03-14

Productkenmerken

1
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 PRODUC
t
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.
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.
2
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 ectoparasitic
infestations, other allergies which cause dermatological signs (e.g.
flea allergic dermatitis or food
allergy) or bacterial