Fuciderm vet. Gel

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

betametasonvalerat; fusidinsyra (hemihydrat)

Tillgänglig från:

Orifarm AB

ATC-kod:

QD07CC01

INN (International namn):

betamethasone valerate; fusidic acid (hemihydrate)

Läkemedelsform:

Gel

Sammansättning:

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

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapeutisk grupp:

Hund

Terapiområde:

Betametason och antibiotika

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2014-12-10

Bipacksedel

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

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fuciderm gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCES:
Fusidic acid
5 mg
Betamethasone
1 mg (as valerate)
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White gel
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to
any of the excipients.
Should not be used for superficial pyoderma such as impetigo,
follicullitis and acne as well as for
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.
4.4
SPECIAL WARNINGS
Please see section 4.6
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Betamethasone valerate is absorbed percutaneously and may cause
temporary suppression of adrenal
function. Prolonged treatment or treatment of large surface areas as
well as application under
occlusive dressing and in cases where the dog can lick the gel, the
risk for systemic effects must be
taken into consideration. The product should be used with caution in
small dogs and puppies (less
than 12 weeks). If the dog scratches or licks the treated lesions a
protective collar could be used.
2
The glycaemic control of diabetic patients should be monitored with
care during treatment with the
product.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
Corticosteroids, especially with frequent and extensive use (during a
period), may cause atrophy of
the skin a