Isaderm 5 mg/g + 1 mg/g Gel for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Betamethasone, Fusidic Acid

Available from:

Dechra Veterinary Products A/S

ATC code:

QD07CC01

INN (International Name):

Betamethasone, Fusidic Acid

Pharmaceutical form:

Gel

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial; Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2014-03-27

Summary of Product characteristics

AN: 00862/2018
Issued: May 2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Isaderm 5 mg/g + 1 mg/g gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g gel contains:
ACTIVE SUBSTANCES:
Fusidic acid
5 mg
Betamethasone (as valerate)
1 mg
EXCIPIENTS:
Methylparahydroxybenzoate (E218)
2.7 mg
Propylparahydroxybenzoate
0.3 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
White translucent gel.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the topical treatment of surface pyoderma in the dog such as acute
moist
dermatitis (‘hot spots’) and intertrigo (skin fold dermatitis).
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 or viral infection is present.
Do not apply to the eye.
Do not use over large surface areas or for prolonged treatment.
Do not use in cases of known hypersensitivity to the active substances
or to any of
the excipients.
See section 4.7.
AN: 00862/2018
Issued: May 2019
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Betamethasone valerate can be absorbed percutaneously and may cause
temporary
suppression of adrenal function.
The dog should be prevented from licking treated lesions and so
ingesting the product.
Where there is a risk of self-trauma or a risk of accidental transfer
to the eye, for
example, application of the product on the forelimb, preventative
measures such as the
use of an Elizabethan collar should be considered.
Pyoderma is often secondary in nature. The underlying cause should be
identified
and treated.
It is recommended that use of the product should be based on
bacteriolog