Trigoderm Gel 0.5% w/w Fusidic Acid, 0.1% w/w Betamethasone

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:

1995-03-07

Summary of Product characteristics

Revised: December 2014
AN: 01203/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trigoderm Gel 0.5 % w/w Fusidic acid, 0.1 % w/w Betamethasone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Fusidic acid 0.5 % w/w
Betamethasone 0.1 % w/w (as the valerate ester)
PRESERVATIVES:
Methylparahydroxybenzoate (E 218) 0.27 % w/w
Propylparahydroxybenzoate (E 216) 0.03 % w/w
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 surface pyoderma in the dog such as acute
moist dermatitis
(‘hot spots’) and intertrigo (skin fold dermatitis).
4.3 CONTRAINDICATIONS
Do not use in animals with hypersensitivity to any of the components.
Discontinue use if
hypersensitivity develops to the product.
Do not use for the treatment of deep pyoderma as glucocorticoids are
contra-indicated in
this condition.
Do not use where fungal infection is present.
Do not apply to the eye.
Revised: December 2014
AN: 01203/2014
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The dog should be prevented from licking treated lesions and so
ingesting the product.
Where there is a risk of self trauma, preventative measures such as
the use of an
Elizabethan collar should be considered.
4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
Betamethasone valerate can be absorbed percutaneously and may cause
temporary
suppression of adrenal function. Prolonged treatment or the treatment
of large surface
areas should be avoided.
Avoid eye contact.
ii)
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Corticosteroids may produce irreversible effects in the skin; they can
be absorbed and
may have harmful effects, especially with frequent and extensive
contact or in pregnancy.
Always wear single-use disposable gloves when applying this product to
ani