Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Fusidic acid 2%{relative}
AFT Pharmaceuticals Ltd
Fusidic acid 2% w/w
2% w/w
Topical cream
Active: Fusidic acid 2%{relative} Excipient: Cetomacrogol 1000 Cetostearyl alcohol Liquid paraffin Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Purified water White soft paraffin
Tube, aluminium, white, lacquered, PE cap, physician' s sample pack, 5 g
Prescription
Prescription
Ercros S A
Indicated either alone or in combination with systemic therapy, in the treatment of primary and Indicated for secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts / abrasions.
Package - Contents - Shelf Life: Tube, aluminium, white, lacquered, PE cap, physician' s sample pack - 5 g - 3 years from date of manufacture stored at or below 30°C - Tube, aluminium, white, lacquered, PE cap - 15 g - 3 years from date of manufacture stored at or below 30°C
2002-09-10
FOBAN ® FUSIDIC ACID 2% CREAM & SODIUM FUSIDATE 2% OINTMENT WHAT IS IN THIS LEAFLET This leaflet contains information about Foban Cream and Ointment. Please read it carefully before you start to use your medicine. Keep it, as you may want to read it again. The information in this leaflet answers some common questions. Your doctor or pharmacist has more information. This leaflet is not intended to take the place of discussion with your doctor. Talk to your doctor or pharmacist if there is anything that is worrying you or you do not understand. WHAT IS FOBAN USED FOR? Foban Cream and Ointment contain an antibiotic (called fusidic acid or sodium fusidate). This is an antibiotic used to treat skin infections. Examples of such infections are: • Impetigo - contagious skin infections with blisters or red spots • infected cuts and abrasions • infected eczema • infected contact dermatitis Foban is effective only against those bacteria which fusidic acid or sodium fusidate can kill. Do not use Foban for other skin conditions, unless your doctor has told you to. This medicine is available only with a doctor's prescription. BEFORE YOU USE FOBAN CREAM AND OINTMENT _DO NOT USE FOBAN IF: _ • You have an allergy to Foban cream, ointment, fusidic acid or sodium fusidate or any of the ingredients listed at the end of this leaflet. • The packaging is torn or shows signs of tampering. • The expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work. If you are not sure whether you should start using Foban cream or ointment, contact your doctor. Do not give this medicine to anyone else. Your doctor has prescribed it specifically for you and your condition. _BEFORE YOU START TO USE FOBAN CREAM OR OINTMENT _ TELL YOUR DOCTOR IF: • You have any allergies to any other medicines o Belgenin tamamını okuyun
Page 1 of 4 NEW ZEALAND DATA SHEET 1. FOBAN TOPICAL CREAM Fusidic acid 2% cream & sodium fusidate 2% ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Foban cream contains fusidic acid 20mg each gram and Foban ointment contains sodium fusidate 20mg each gram. Excipients with known effect: Foban cream: Liquid paraffin, white soft paraffin, cetomacogol 1000, cetostearyl alcohol, propylene glycol, methyl paraben, propyl paraben and water Foban ointment: Liquid paraffin, white soft paraffin 3. PHARMACEUTICAL FORM Topical cream. Foban cream is a smooth and white cream and Foban ointment is a colourless ointment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts / abrasions. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults and Children: Uncovered lesions - apply gently three or four times daily. Covered lesions - less frequent applications may be adequate. 4.3 CONTRAINDICATIONS Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa. Page 2 of 4 Foban Cream and Ointment is contraindicated in patients with hypersensitivity to fusidic acid and its salts. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bacterial resistance has been reported to occur with the use of fusidic acid applied topically. As with all topical antibiotics, extended or recurrent application may increase the risk of contact sensitisation and the development of antibiotic resistance. The sodium salt of fusidic acid has been shown to cause conjunctival irritation. The ointment should not Belgenin tamamını okuyun