Држава: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Fusidic acid 20.35 mg/g (as the 0.5 hydrate)
Douglas Pharmaceuticals Limited
Fusidic acid 20.35 mg/g (as the 0.5 hydrate)
20 mg/g
Topical cream
Active: Fusidic acid 20.35 mg/g (as the 0.5 hydrate) Excipient: Butylated hydroxyanisole Cetyl alcohol Glycerol Hydrochloric acid Liquid paraffin Polysorbate 60 Potassium sorbate Purified water White soft paraffin
Prescription
Ercros S A
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.
Package - Contents - Shelf Life: Tube, aluminium, with HDPE screw cap - 15 g - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Tube, aluminium, with HDPE screw cap - 30 g - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C
2013-07-04
CONSUMER MEDICINE INFORMATION 1 DP FUSIDIC ACID CREAM _Fusidic Acid _ 20 mg/g cream WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING DP FUSIDIC ACID CREAM This leaflet answers some common questions about DP Fusidic Acid Cream. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using DP Fusidic Acid Cream against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT DP FUSIDIC ACID CREAM IS USED FOR The active ingredient of DP Fusidic Acid Cream is fusidic acid. DP Fusidic Acid Cream should be used on the skin for the local treatment of infections caused by bacteria that are sensitive to fusidic acid such as impetigo (a weeping, crusty and swollen patch of skin), infected cuts and abrasions, infected contact dermatitis (inflammation of the skin), infected eczema. Fusidic Acid Cream belongs to a group of medicines called antibiotics. It works by preventing bacterial protein synthesis and therefore killing the bacteria causing the infection. Your doctor may have prescribed DP Fusidic Acid Cream for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DP FUSIDIC ACID CREAM HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU USE DP FUSIDIC ACID CREAM _WHEN YOU MUST NOT USE IT _ DO NOT SUE DP FUSIDIC ACID CREAM IF YOU HAVE AN ALLERGY TO: • any medicine containing fusidic acid or a class of medicines called antibiotics for topical use • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • difficulty in breathing or wheezing • shortness of breath • swelling of the face, tongue, lips, or other parts of the body • hives on the skin, rash, or itching DO NOT USE Прочитајте комплетан документ
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME DP Fusidic Acid Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of DP Fusidic Acid Cream contains fusidic acid 20.35 mg, as hydrate, equivalent to fusidic acid 20 mg. EXCIPIENT(S) WITH KNOWN EFFECT Butylhydroxyanisole, Cetyl alcohol and Potassium sorbate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Smooth and white cream. 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 DOSE _ADULTS AND CHILDREN _ Uncovered lesions – apply gently three or four times daily. Covered lesions – less frequent applications may be adequate. METHOD OF ADMINISTRATION 2 | P a g e Cutaneous use. 4.3. CONTRAINDICATIONS • Infection caused by non-susceptible organisms, in particular, _Pseudomonas aeruginosa_. • DP Fusidic Acid Cream contraindicated in patients with hypersensitivity to fusidic acid and its salts or to any of the excipients listed in section 6.1 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. Extended or recurrent use may increase the risk of developing contact sensitisation. When DP Fusidic Acid Cream is used on the face, care should be taken to avoid the eyes, because fusidic Прочитајте комплетан документ