Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction  Company name: Dechra Veterinary Products Limited Address: (A business unit of Dechra Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS Telephone: 01939 211200 Fax: 01939 211201 Email: info@dechra-uk.com Website: www.dechra.com Presentation
Fuciderm® gel is a white translucent gel containing:
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 Uses
Fuciderm® gel is used for the topical treatment of certain skin diseases (surface pyoderma) in the dog, such as wet eczema (acute moist dermatitis) which can occur in isolated patches on the body ('hot spots') or in skin folds (intertrigo).
Wet eczema is often made worse by the dog scratching or licking the affected area because of itching or pain.
The skin problem may be associated with flea allergy and your veterinary surgeon may treat your dog for fleas at the same time.
Fuciderm® gel contains a well known antibiotic which helps kill the bacteria and a corticosteroid anti-inflammatory which will help relieve the itching and inflammation. Dosage and administration
If necessary, clean the infected area of any pus or other material before applying the gel. Use cotton wool dampened with water. Dry before applying the gel.
Squeeze a little of the gel onto the affected area of the skin and spread it gently 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 you forget to use the gel at any time, use it as soon as you remember. Then go on as before. Complete the normal course as prescribed by your veterinary surgeon. Advice on correct administration: Follow your veterinary surgeon's instructions about when and how to use the gel. Read the label carefully. Use the gel as your veterinary surgeon has told you.
Avoid getting the gel into your own or your dog's eyes, since it may cause stinging. If it gets into eyes bathe with water.
Wash your hands well after applying the gel.
After a few days of using the gel, the dog's skin condition should start to improve. However, if the problem gets worse or doesn't improve, or if there are any other unexpected problems, consult your veterinary surgeon. Contraindications, warnings, etc
As with other topical antibiotic/corticosteroid combinations for treating skin ailments, the gel should not be used if your dog is allergic to the ingredients. Discontinue use if hypersensitivity develops to the product.
Do not use on skin conditions other than those for which your veterinary surgeon has prescribed Fuciderm® gel.
The use of the gel over large surface areas and prolonged treatment should be avoided.
Do not apply to the eye. 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.
If you notice any serious effects or other effects not mentioned in the data sheet, please inform your veterinary surgeon. Special warnings: For animal treatment only.
For external use only.
Keep all medicines out of the reach and sight of children. Precautions when used on the dog: The dog should be prevented from licking the affected area. It may be helpful to apply the gel immediately before feeding, or before taking the dog for a walk, in order to distract the dog's attention.
Where there is a risk of the dog scratching or chewing the affected area, preventative measures such as the use of an Elizabethan collar should be considered.
Remember, this treatment is for your dog only. Should the skin condition occur again at a later date, do not use the gel without consulting your veterinary surgeon. Do not use it on other dogs. Special precautions to be taken by the person administering Fuciderm® gel to the dog: When applying the gel, please remember that 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 animals. Wash hands after use. Use during pregnancy and lactation: Do not use on a pregnant bitch, or if you suspect she is pregnant. Pharmaceutical precautions
Do not refrigerate or freeze.
Do not use after the expiry date stated on the carton. Disposal: Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon. Legal category
POM-V Packaging quantities
Nature and composition of immediate packaging: tubes of 5 g, 15 g or 30 g.
Not all pack sizes may be marketed. Further information
This data sheet gives you some helpful information about Fuciderm® gel. If you have any questions or are not sure about anything, ask your veterinary surgeon.
To be supplied only on veterinary prescription.
Veterinary medicinal product authorised for use in UK and IE. Manufacturer: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW. Marketing authorisation holder (if different from distributor)
Dechra Veterinary Products A/S, Mekuvej 9, DK-7171 Uldum, Denmark. Marketing authorisation number
Vm 24883/4001. |