Atopica 50 mg soft capsules for dogs

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ciclosporin

可用日期:

Elanco GmbH

ATC代码:

QL04AA01

INN（国际名称）:

Ciclosporin

剂量:

50 Milligrams per capsule

药物剂型:

Capsule, soft

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

ZZZ Ciclosporin

授权状态:

Authorised

授权日期:

2016-06-17

产品特点

Page 2 of 18
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Atopica 50 mg soft capsules for dogs
Atoplus (IT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
ACTIVE SUBSTANCE:
Ciclosporin 50 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _

-tocopherol (E-307)
0.50 mg
Titanium dioxide (E-171)
4.50 mg
Carminic acid (E-120)
< 1.00 µg
Corn oil-mono-di-triglycerides
Ethanol (E-1510)
Gelatine (E-441)
Glycerol (E-422)
Macrogolglycerol hydroxystearate
Propylene glycol (E-1520)
Yellow-white oblong soft capsules bearing the following imprint: NVR
50 mg.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (weighing from 7.5 to 36 kg).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of chronic manifestations of atopic dermatitis in dogs.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to ciclosporin or any of the
excipients.
For all capsule strengths, 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 3.5 “Special precautions for use” and
3.8 “Interaction with other medicinal
products and other forms of interaction”).
3.4
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.
Page 3 of 18
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 bacteri