Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM FUSIDATE
HOE PHARMACEUTICALS SDN. BHD.
SODIUM FUSIDATE
15gm mcg/mL; 5gm mcg/mL
HOE PHARMACEUTICALS SDN. BHD.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 FOBAN OINTMENT Sodium Fusidate (2% w/w) _ _ WHAT IS IN THIS LEAFLET 1. What Foban Ointment is used for 2. How Foban Ointment works 3. Before you use Foban Ointment 4. How to use Foban Ointment 5. While you are using it 6. Side effects 7. Storage and Disposal of Foban Ointment 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision This leaflet answers some common questions about Foban Ointment. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. Keep this leaflet with the medication. You may need to read it again. WHAT FOBAN OINTMENT IS USED FOR Foban Ointment is used for skin lesions primarily or secondarily infected by skin germs (bacteria) such as Staphylococcus or Streptococcus. HOW FOBAN OINTMENT WORKS Foban Ointment contains the active ingredient sodium fusidate. Every gram of ointment contains 20 mg of sodium fusidate. SODIUM FUSIDATE is an antibiotic that provides antibacterial activity against most germs (bacteria) on skin. Ask your pharmacist or doctor if you have any questions about this medicine. BEFORE YOU USE FOBAN OINTMENT _ _ _When you must not use it _ DO NOT APPLY FOBAN OINTMENT IF: • You are hypersensitive to Fusidic acid and its salts or to any of this medicine’s ingredients. _Before you start to use it _ TELL YOUR PHARMACIST OR DOCTOR: • If you have an infection on your skin and specify the infected area. • If you are using any other prescription or non-prescription medicines or skin products. PREGNANCY AND BREAST FEEDING: • Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast- feeding. • Safety of usage during pregnancy and lactation has not been established. • Fusidic acid has been detected in breast milk, but with topical use the possible amount of medicine present is unlikely to affect the infant. _Taking other medicines _ Tell your pharmacist or doctor if you are taking any o Baca dokumen lengkap
Est. 1979 FOBAN CREAM AND OINTMENT NAME AND STRENGTH OF ACTIVE SUBSTANCES : CREAM: Fusidic Acid 2% w/w. OINTMENT: Sodium Fusidate 2% w/w. PRODUCT DESCRIPTION : CREAM: A white cream. Other ingredients: Propyl Paraben, Methyl Paraben, White Soft Paraffin, Cetostearyl Alcohol, Cetomacrogol 1000 (Macrogol Cetostearyl Ether), Propylene Glycol, Liquid Paraffin and Purified Water. OINTMENT: A colourless ointment. Other ingredients: Liquid Paraffin and White Soft Paraffin. PHARMACODYNAMICS : Fusidic acid and its salts exert antibacterial activity against most Gram positive organisms; in particular, they are effective against pathogenic Staphylococci, including the penicillinase-producing strains. They have slight or no activity against Gram negative organisms and fungi. PHARMACOKINETICS : Fusidic acid and its salts are widely distributed into tissues and body fluids, including bone, pus, and synovial fluid; they penetrate cerebral abscesses but do not enter cerebrospinal fluid in appreciable amounts. They have been found in foetal circulation and in breast milk. About 95% or more of Fusidic acid or Sodium fusidate in the circulation is bound to plasma protein. Fusidic acid or Sodium fusidate is excreted in the bile, almost entirely as metabolites, some of which have weak antimicrobial activity. About 2% appears unchanged in the faeces. Little is excreted in the urine or removed by haemodialysis. INDICATIONS : Skin lesions primarily or secondarily infected with _Staphylococcus_ or _Streptococcus._ CONTRAINDICATIONS : Known hypersensitivity to Fusidic acid, it salts and propylene glycol. DRUG INTERACTIONS : No synergy has been demonstrated in vitro in most studies between Fusidic acid and rifampicin or vancomycin, and antagonism of the effects of ciprofloxacin has been reported. Interactions with the penicillins are complex, with either antagonism of the effect of one or both agents, or lack of any efffect. However, the combination of an antistaphylococcal penicillin with Fusidic acid may prevent the emergence of Fusidic a Baca dokumen lengkap