Isaderm 5 mg/g + 1 mg/g gel for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fusidic acid; Betamethasone valerate

Available from:

Dechra Veterinary Products A/S

ATC code:

QD07CC01

INN (International Name):

Fusidic acid; Betamethasone valerate

Dosage:

5, 1 milligram(s)/gram

Pharmaceutical form:

Gel

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

betamethasone and antibiotics

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2014-03-14

Summary of Product characteristics

Health Products Regulatory Authority
27 May 2019
CRN008NC6
Page 1 of 4
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.
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.
Health Products Regulatory Authority
27 May 2019
CRN008NC6
Page 2 of 4
It is recommended that use of