Modulis 100 mg/ml Oral Solution for Dogs

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Ciclosporin A

Fáanlegur frá:

Ceva Animal Health Ltd

ATC númer:

QL04AD01

INN (Alþjóðlegt nafn):

Ciclosporin A

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Dogs

Lækningarsvæði:

Anti Inflammatory immunosuppressive

Leyfisstaða:

Authorized

Leyfisdagur:

2014-12-22

Vara einkenni

Revised: August 2023
AN: 00458/2023 & 00459/2023
Page 1 of 8
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Modulis 100 mg/ml oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ciclosporin
................................................................................100
mg
EXCIPIENT(S):
all-rac-a-tocopherol (E-307)
.........................................................1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear to slightly yellow opalescent solution. A veil, minor flakes or
slight sediment
may be observed.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ciclosporin or to 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”).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Consideration should be given to the use of other measures and/or
treatment to
control moderate to severe pruritus when initiating therapy with
ciclosporin.
Revised: August 2023
AN: 00458/2023 & 00459/2023
Page 2 of 8
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin
inflammation are not
specific
for
this
disease
and
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
ruled out before treatment is started. It is good pract