Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FUSIDIC ACID; BETAMETHASONE VALERATE
PAHANG PHARMACY SDN. BHD.
FUSIDIC ACID; BETAMETHASONE VALERATE
15 gm
ENCUBE ETHICALS PVT LTD
_Consumer Medication Information Leaflet (RiMUP) _ BACTAFUZ-B FUSIDIC ACID AND BETAMETHASONE VALERATE CREAM Fusidic Acid (micronized) (2% w/w) and Betamethasone (as Valerate ester) 0.10% w/w 1 WHAT IS IN THIS LEAFLET 1. What BACTAFUZ-B Fusidic Acid and Betamethasone Valerate Cream is used for. 2. How BACTAFUZ-B works. 3. Before you use BACTAFUZ-B . 4. How to use BACTAFUZ-B . 5. While you are using it. 6. Side effects. 7. Storage and Disposal of BACTAFUZ-B . 8. Product Description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. 1. WHAT BACTAFUZ-B IS USED FOR BACTAFUZ-B is used to treat conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria). 2. HOW BACTAFUZ-B WORKS BACTAFUZ-B contains two different types of medicine. One medicine is called Fusidic acid. It is a type of antibiotic. The other medicine is called Betamethasone Valerate. It is a type of corticosteroid (steroid). BACTAFUZ-B works by the antibiotic killing germs that cause infections and corticosteroid help to reduce any swelling, redness or itchiness of your skin. Your doctor may have prescribed this medication for another reason. Ask your doctor if you have any questions about why this medication has been prescribed for you. 3. BEFORE YOU USE BACTAFUZ-B -_When you must not use it _ • If you are allergic (hypersensitive) to Fusidic acid or Betamethasone Valerate. • If you are allergic (hypersensitive) to any of the other ingredients in this medicine. • If you have skin condition caused by fungus. • If you have skin conditions caused by a virus such as cold sores or chickenpox. • If you have skin conditions such as boils or spots. • If you have skin conditions caused by tuberculosis (TB) or syphilis. • If you have perioral dermatitis. This is a red spotty rash around your mouth or chin • If you have a skin condition called acne rosacea. This is the redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure. _ _ _Pregnancy and lactation _ _Pregnan Baca dokumen lengkapnya
EMA9SPBJBJMY64100 Font Size : 8 Point (Times new roman) BACTAFUZ-B Fusidic Acid and Betamethasone Valerate cream PRODUCT NAME: BACTAFUZ-B : Fusidic Acid and Betamethasone Valerate cream NAME AND STRENGTH OF ACTIVE INGREDIENTS: BACTAFUZ-B: Fusidic Acid Ph. Eur 2.0%w/w, Betamethasone (as Valerate ester) Ph. Eur. 0.10% w/w and Chlorocresol Ph. Eur. (As preservative) 0.10%w/w PRODUCT DESCRIPTION: BACTAFUZ-B : A white to off white smooth, homogeneous cream. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS PROPERTIES PHARMACOTHERAPEUTIC GROUP: BETAMETHASONE AND ANTIBIOTICS, ATC CODE: D07CC01 Fusidic Acid and Betamethasone Valerate cream combines the well-known anti-inammatory and antipruritic effects of Betamethasone with the potent topical antibacterial action of Fusidic Acid. Betamethasone valerate is a topical steroid rapidly effective in those inammatory dermatoses which normally respond to this form of therapy. More refractory conditions can often be treated successfully. When applied topically, Fusidic Acid is effective against _Staphylococcus _ _aureus, Streptococci, Corynebacteria, Neisseria_ and certain _Clostridia_ and _Bacteroides_ . Concentrations of 0.03 to 0.12 microgram per ml inhibit nearly all strains of _S. aureus_ . The antibacterial activity of Fusidic Acid is not diminished in the presence of Betamethasone. PHARMACOKINETICS PROPERTIES There are no data which dene the pharmacokinetics of Fusidic Acid and Betamethasone Valerate cream, following topical administration in man. However, in vitro studies show that Fusidic Acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic Acid and the condition of the skin. Fusidic Acid is excreted mainly in the bile with little excreted in the urine. Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent Baca dokumen lengkapnya