ISADERM VETERINARY

Land: Israël

Taal: Engels

Bron: Ministry of Health

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Download Bijsluiter (PIL)
16-03-2023

Werkstoffen:

BETAMETHASONE AS VALERATE; FUSIDIC ACID AS HEMIHYDRATE

Beschikbaar vanaf:

VETMARKET LTD, ISRAEL

farmaceutische vorm:

GEL

Samenstelling:

BETAMETHASONE AS VALERATE 0.1 %; FUSIDIC ACID AS HEMIHYDRATE 0.5 %

Toedieningsweg:

TOPICAL

Prescription-type:

Required

Geproduceerd door:

DECHRA VETERINARY PRODUCTS A/S ,DENMARK

therapeutische indicaties:

For the topical treatment of surface pyoderma in dogs such as acute moist dermatitis ("hot spots") and intertrigo (skin fold dermatitis) in dogs.

Autorisatie datum:

2023-05-31

Bijsluiter

                                CONSUMER LEAFLET FOR A VETERINARY PRODUCT
The medicine is marketed according to a veterinarian's prescription
only
For use in animals only
1. NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE
Isaderm Veterinary, gel for topical skin application in dogs.
Betamethasone (as valerate) 0.1% w/w
Fusidic Acid (as hemihydrate) 0.5% w/w
2.
ACTIVE INGREDIENTS
and their quantity per dose unit
Betamethasone (as valerate) 0.1% w/w
Fusidic Acid (as hemihydrate) 0.5% w/w
Each 1 g gel contains:
1 mg Betamethasone (as valerate)
5 mg Fusidic Acid (as hemihydrate)
For the list of inactive ingredients and allergens in the product -
see section 13 ("Additional
information") in this leaflet.
3. WHAT IS THE MEDICINE INTENDED FOR?
Topical treatment of surface pyoderma in dogs such as acute moist
dermatitis (hot spots)
and skin fold dermatitis (intertrigo).
Therapeutic group: Potent corticosteroid (Betamethasone) in
combination with a
bacteriostatic antibiotic (Fusidic Acid).
4. 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 or viral infection is already present.
Do not apply to the eyes.
Do not use over large surface areas, do not use for prolonged
treatment.
Do not use in dogs with known hypersensitivity to the active
ingredients or to any of the
inactive ingredients.
See section 10 ("Warnings").
5. SIDE EFFECTS
Prolonged and intensive use of topical corticosteroid preparations or
treatment
of a large cutaneous surface (>10%) is known to trigger local or
systemic
effects including suppression of adrenal function, thinning of the
epidermis and
delayed healing of lesions.
Locally applied steroids may cause depigmentation of the skin.
Discontinue use if hypersensitivity to the product develops.
Side effects can be reported to the Ministry of Health by clicking the
link "Report side
effects due to medication" which can be found on the homepage of the
Ministry of Health
website
                                
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