Cyclavance 100 mg/ml Oral Solution for Dogs and Cats

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Ciclosporin A

Διαθέσιμο από:

Virbac

Φαρμακολογική κατηγορία (ATC):

QL04AD01

INN (Διεθνής Όνομα):

Ciclosporin A

Φαρμακοτεχνική μορφή:

Oral solution

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

Anti Inflammatory immunosuppressive

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2014-04-03

Αρχείο Π.Χ.Π.

Revised: January 2019
AN: 02461/2017
Page 1 of 16
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
EXCIPIENT(S):
All-rac-

-tocopherol (E-307)
1.00 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear to slightly yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
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 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 4.5 “Special
precautions for use” and 4.8
“Interaction with other medicinal products”).
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).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Revised: January 2019
AN: 02461/2017
Page 2 of 16
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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 and
fungal infections should be ruled out before treatment is started. It
is good practice to