Betafuse 1 mg/g + 5 mg/g gel for dogs

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Betamethasone; Fusidic acid

Доступна с:

Norbrook Laboratories Limited

код АТС:

QD07CC01

ИНН (Международная Имя):

Betamethasone; Fusidic acid

дозировка:

1, 5 milligram(s)/gram

Фармацевтическая форма:

Gel

Тип рецепта:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтическая группа:

Dogs

Терапевтические области:

betamethasone and antibiotics

Терапевтические показания :

Corticosteroid

Статус Авторизация:

Authorised

Дата Авторизация:

2016-09-16

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betafuse 1 mg/g + 5 mg/g gel for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains:
ACTIVE SUBSTANCES:
Betamethasone (as betamethasone valerate) 1 mg
Fusidic acid (as fusidic acid hemihydrate)
5 mg
EXCIPIENTS:
Sodium methyl parahydroxybenzoate (E219)
3.1 mg
Sodium propyl parahydroxybenzoate
0.337 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
An off-white to white gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute surface pyoderma in the dog, such as acute
moist dermatitis (‘hot spots’) and intertrigo (skin
fold dermatitis), caused by Gram-positive bacteria sensitive to
fusidic acid.
4.3 CONTRAINDICATIONS
Do not use for the treatment of deep pyoderma.
Do not use in pyotraumatic furunculosis and pyotraumatic folliculitis
with ‘satellite’ lesions of papules or pustules.
Do not use where fungal, viral infection or demodicosis is present.
Do not apply to the eye.
Do not use over large surface areas or for prolonged treatment.
Do not use in dogs suffering from impetigo or acne.
Do not use in dogs with unstabilised or untreated Cushing’s syndrome
or diabetes mellitus.
Do not use in dogs with pancreatitis.
Do not use in dogs with gastrointestinal ulcers.
Do not use in cases of known hypersensitivity to the active substances
or to any of the excipients.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Pyoderma is often secondary in nature. The underlying cause should be
identified and treated.
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