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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Betamethasone, Fusidic Acid

Available from:

Norbrook Laboratories Limited

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:

2016-08-02

Summary of Product characteristics

Revised: September 2021
AN: 01566/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fuselieve 1 mg/g + 5 mg/g gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCES:
Betamethasone (as betamethasone valerate)
1 mg
Fusidic acid (as fusidic acid hemihydrate)
5 mg
EXCIPIENTS:
Sodium methyl parahydroxybenzoate (E219)
3.1 mg
Sodium propyl parahydroxybenzoate
0.337 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
An off-white to white gel.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute surface pyoderma, such as acute moist
dermatitis (‘hot
spots’) and intertrigo (skin fold dermatitis), caused by
Gram-positive bacteria
sensitive to fusidic acid.
4.3
CONTRAINDICATIONS
Do not use in cases of deep pyoderma.
Do not use in cases of pyotraumatic furunculosis and pyotraumatic
folliculitis with
‘satellite’ lesions of papules or pustules.
Do not use where fungal or viral infection, or demodicosis 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 impetigo or acne.
Revised: September 2021
AN: 01566/2020
Page 2 of 6
Do not use in cases of unstabilised or untreated Cushing’s syndrome
or diabetes
mellitus.
Do not use in cases of pancreatitis.
Do not use in cases of gastrointestinal ulcers.
Do not use in cases of known hypersensitivity to the active substances
or to any of
the excipients.
Do not use in the case of resistance to fusidic acid.
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Pyoderma is often secondary in nature. The underlying cause should be
identified
and treated.
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.
It is recommended that use of the product should be based on
bacteriological
sampling an