Isaderm vet Gel

Држава: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

betametasonvalerat; fusidinsyra (hemihydrat)

Доступно од:

2care4 ApS

АТЦ код:

QD07CC01

INN (Међународно име):

betamethasone valerate; fusidic acid (hemihydrate)

Фармацеутски облик:

Gel

Састав:

metylparahydroxibensoat Hjälpämne; betametasonvalerat 1,214 mg Aktiv substans; fusidinsyra (hemihydrat) 5 mg Aktiv substans; propylparahydroxibensoat Hjälpämne

Тип рецептора:

Receptbelagt

Терапеутска група:

Hund

Резиме производа:

Förpacknings: Tub, 15 g

Статус ауторизације:

Avregistrerad

Датум одобрења:

2023-03-28

Информативни летак

1
PACKAGE LEAFLET
FUCIDERM GEL FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Dechra Veterinary Products A/S Mekuvej 9
7171 Uldum
Denmark
Manufacturer for the batch release:
Dales Pharmaceuticals
Snaygill Industrial Estate
Keighley Road
Skipton, North Yorkshire
BD23 2RW, United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fuciderm gel for dogs
Fusidic acid 0.5% and Betamethasone 0.1% (as valerate)
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
1 g Fuciderm gel contains:
_Active substance:_
Fusidic acid 5 mg, Betamethasone 1 mg (as valerate)
_Other ingredients:_
Methyl parahydroxybensoate (E218), Propyl parahydroxybensoate (E216),
Carbomer, Polysorbate 80, Dimethicone, Sodium hydroxide and Purified
water.
4.
INDICATION(S)
Fusidic acid is an abtibiotic. Betamethasone valerate is a
glucocorticoid with anti-inflammatory and
antiprutic effects.
For the topical treatment of localised, mild or moderate acute moist
dermatitis (“hot spots”).
Considerations should be given to official guidance on the appropriate
use of antibacterial agents.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to
any of the other ingredients.
Should not be used for deeper infections of the skin such as pustules
(impetigo), infection of the hair
follicles (follicullitis) and acne as well as for very deep infections
of the skin (deep pyoderma) as
glucocorticoids are contraindicated in these conditions.
Should not be used for fungal infection or in Cushings disease.
Do not use in dogs with extensive lesions, infected lesions of fungal,
viral or parasitic origin or in dogs
with ulcerated lesions.
6.
ADVERSE REACTIONS
Locally applied steroids may cause thinning of the skin and capillary
fragility. Hypersensitivity is a
possible adverse effect from treatment with Fuciderm.
Corticosteroids may delay wound healing. Topically-applied
betamethasone is a