SPORIMUNE 50 MG/ML ORAL SOLUTION FOR CATS AND DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-12-2016
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Active ingredient:
CICLOSPORIN
Available from:
Le Vet Beheer B.V.
ATC code:
QL04AA01
INN (International Name):
CICLOSPORIN
Dosage:
50 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Ciclosporin
Therapeutic indications:
Miscellaneous
Authorization status:
Authorised
Authorization date:
2013-07-19
Summary of Product characteristics
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
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.
Per ml:
ACTIVE SUBSTANCES:
Ciclosporin
50
mg
EXCIPIENTS:
Ethanol, anhydrous (E-1510)
100 mg
all-rac-a-Tocopherol acetate (E-307)
1.00 mg
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/12/2016_
_CRN 7024577_
_page number: 1_
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
sp
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