Sporimune 50 mg/ml Oral Solution for Cats and Dogs

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Ciclosporin A

可用日期:

Le Vet Beheer B.V.

ATC代码:

QL04AD01

INN（国际名称）:

Ciclosporin A

药物剂型:

Oral solution

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Cats, Dogs

治疗领域:

Anti Inflammatory immunosuppressive

授权状态:

Authorized

授权日期:

2014-06-13

产品特点

Revised: December 2018
AN: 02325/2017
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sporimune 50 mg/ml oral solution for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ciclosporin
50
mg
EXCIPIENT(S):
Ethanol, anhydrous (E-1510)
100 mg
all-rac-alfa-Tocopheryl acetate (E-307)1.00
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Colourless to yellowish oily solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog, cat.
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 any
of the
excipients.
Do not use in dogs less than six months of age or less than 2 kg in
weight.
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 cats infected with FeLV or FIV.
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.
Revised: December 2018
AN: 02325/2017
Page 2 of 9
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 this disease.
Therefore 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 evaluated and eliminated where possible.
It is good
practice to treat