Երկիր: Շվեդիա
Լեզու: շվեդերեն
Աղբյուրը: Läkemedelsverket (Medical Products Agency)
betametasonvalerat; fusidinsyra (hemihydrat)
2care4 ApS
QD07CC01
betamethasone valerate; fusidic acid (hemihydrate)
Gel
metylparahydroxibensoat Hjälpämne; betametasonvalerat 1,214 mg Aktiv substans; fusidinsyra (hemihydrat) 5 mg Aktiv substans; propylparahydroxibensoat Hjälpämne
Receptbelagt
Hund
Förpacknings: Tub, 15 g
Avregistrerad
2023-03-28
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 Կարդացեք ամբողջական փաստաթուղթը