Sporimune 50 mg/ml oral solution for cats and dogs

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ciclosporin

Beschikbaar vanaf:

Le Vet Beheer B.V.

ATC-code:

QL04AA01

INN (Algemene Internationale Benaming):

Ciclosporin

Dosering:

50 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:

ZZZ Ciclosporin

therapeutische indicaties:

Miscellaneous

Autorisatie-status:

Authorised

Autorisatie datum:

2013-07-19

Productkenmerken

Health Products Regulatory Authority
16 October 2018
CRN000XW9
Page 1 of 10
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
50mg
​
​
EXCIPIENT(S):
​
Ethanol, anhydrous (E-1510)
100mg
all-rac-alfa-Tocopheryl acetate (E-307)
1.00mg
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.
Health Products Regulatory Authority
16 October 2018
CRN000XW9
Page 2 of 10
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.
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