Fuciderm Gel

Presentation

Contains: Active substances:

Fusidic acid 0.5% w/w

Betamethasone 0.1% w/w (as the valerate ester)

Preservatives:

Methyl parahydroxybenzoate (E218) 0.27% w/w

Propyl parahydroxybenzoate (E216) 0.03% w/w

Excipients: Carbomer, polysorbate 80, dimeticone, sodium hydroxide, purified water.

White gel.

Uses

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

Dosage and administration

Apply a quantiity of the gel to the affected area, twice daily for a minimum period of 5 days. Treatment should continue for 48 hours after the lesion has resolved. The treatment period should not exceed 7 days.

If there is no response within 3 days, or the condition deteriorates, the diagnosis should be re-evaluated.

Contraindications, warnings, etc

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 contraindicated in this condition.

Do not use where fungal infection is present.

Do not apply to the eye.

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.

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.

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 the product to animals.

Wash hands after applying the product.

Adverse reactions: Anti-inflammatory corticosteroids, such as betamethasone valerate, are known to exert a wide range of side effects. Whilst single high doses are generally well tolerated, they may induce severe side effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms.

Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage, and osteoporosis may result.

During therapy, effective doses suppress the hypothalamo-pituitreal-adrenal axis.

Following cessation of treatment, symptoms of adrenal insufficiency can arise and this may render the animal unable to deal adequately with stressful situations.

Locally applied steroids may cause thinning of the skin.

Corticosteroids may delay wound healing and the immunosuppressant action may weaken resistance to or exacerbate existing infections. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.

Gastrointestinal ulceration has been reported in animals treated with corticosteroids, and gastrointestinal ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma.

Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

Use during pregnancy and lactation: Corticosteroids are not recommended for use on pregnant animals. Administration during pregnancy may cause abortion or early parturition.

Interactions: None known.

Overdose: For possible signs see Adverse reactions.

Incompatibilities: None known.

Pharmaceutical precautions

Do not refrigerate or freeze. Do not use after the expiry date stated on the carton.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging quantities

Tubes of 5 g, 15 g or 30 g. Not all pack sizes may be marketed.

Further information

For animal treatment only. To be supplied only on veterinary prescription. Keep out of the reach and sight of children.

Manufacturer: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW.

Date of last review: March 2011

Marketing authorisation holder (if different from distributor)

Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark.

Marketing authorisation number

Vm 24883/4001.

GTIN (Global Trade Item No)

Fuciderm Gel for Dogs 15 g:

05701170099003

Fuciderm Gel for Dogs 30 g:

05701170113464