ATOPICA 100 MGML ORAL SOLUTION FOR CATS AND DOGS VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CICLOSPORIN

Available from:

EUROMAR LTD

Pharmaceutical form:

SOLUTION (ORAL)

Composition:

CICLOSPORIN 100 MG / 1 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ELANCO FRANCE S.A.S, FRANCE

Therapeutic indications:

Atopica 100 mg/ml oral solution for cats and dogs veterinary is indicated for:Symptomatic treatment of chronic allergic dermatitis in cats. Treatment of chronic manifestations of atopic dermatitis in dogs.

Authorization date:

2021-10-19

Patient Information leaflet

PACKAGE LEAFLET FOR
VETERINARY MEDICINAL PRODUCT
This medicine is dispensed with
a veterinarian's prescription only
For veterinary use only
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 100 mg/ml oral solution for cats and dogs
Veterinary
2.
ACTIVE SUBSTANCE:
Each ml contains 100 mg ciclosporin
3.
WHAT IS THE MEDICINE INTENDED FOR
Symptomatic treatment of chronic allergic dermatitis in cats.
Treatment of chronic manifestations of atopic dermatitis in dogs.
Therapeutic group: Selective immunosuppressant
Allergic dermatitis and atopic dermatitis are common skin diseases in
cats and dogs,
respectively. They are caused by allergens such as house dust mites or
pollens which
stimulate an exaggerated immune response. The diseases are chronic and
recurrent.
Ciclosporin selectively acts on the immune cells involved in the
allergic reaction. Ciclosporin
reduces the inflammation and itching associated with allergic
dermatitis.
4.
CONTRAINDICATIONS
Do not use in animals with hypersensitivity to the active substance or
to any of the
excipients.
Do not use in cats infected with FeLV or FIV.
Do not use in animals 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.
Do not use in dogs less than six months of age or less than 2 kg in
weight.
5.
ADVERSE REACTIONS
Cats:
The most frequently observed undesirable effects are gastrointestinal
disturbances such as
vomiting and diarrhea. These effects are generally mild and transient
and do not require
cessation of the treatment.
Other
undesirable
effects
observed
in
clinical
studies
included:
lethargy,
anorexia,
hypersalivation, weight loss and low levels of white blood cells.
These effects generally
resolve spontaneously after treatment is stopped or following a
decrease in the dosing
frequency. Side effects may be severe in individual animals.
Dogs:
The
occurrence
of
adverse
reactions
is
uncommon.
The
most
frequently
observed
undesirable effects are

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 100 mg/ml oral solution for cats and dogs VETERINARY
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ciclosporin
100 mg
EXCIPIENT(S):
α
-tocopherol) 1.05 mg
Ethanol, anhydrous
94.70 mg
Propylene glycol
94.70 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution
Clear, yellow to brownish liquid
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cat
Dog (weighing more than 2 kg)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment of chronic allergic dermatitis in cats.
Treatment of chronic manifestations of atopic dermatitis in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals with hypersensitivity to the active substance or
to any of the
excipients.
Do not use in animals 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.
Do not use in dogs less than six months of age or less than 2 kg in
weight.
4.4 SPECIAL WARNINGS
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 or allergic 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 practice to treat flea
infestations before and
during treatment of atopic or allergic dermatitis.
A complete clinical examination should be performed before treatment.
It