البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
flucloxacillin, Quantity: 1 g
Juno Pharmaceuticals Pty Ltd
Injection, powder for
Excipient Ingredients:
Intravenous, Intramuscular, Intrapleural, Intraarticular
1 x 5 vials, 10 vials
(S4) Prescription Only Medicine
Treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.
Visual Identification: CLEAR GLASS VIALS CONTAINING A WHITE TO OFF-WHITE POWDER; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2003-02-14
FLUBICLOX™ FOR INJECTION Flucloxacillin for Injection _(floo-klox-s-SILL-in) _ _ _ CONSUMER MEDICINE INFORMATION _ _ _Consumer Name _ _ _ _Consumer Address _ _ _ _Date of Dispensing _ _ _ _Pharmacist Name _ _ _ _Pharmacist Address _ _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FLUBICLOX. 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 taking FLUBICLOX against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE You may need to read it again. WHAT IS FLUBICLOX USED FOR FLUBICLOX is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection. FLUBICLOX, like other antibiotics, will not work against infections caused by viruses such as colds or the flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN FLUBICLOX _ _ _WHEN YOU MUST NOT BE GIVEN _ _IT _ DO NOT USE FLUBICLOX IF: 1. You have had an allergic reaction to flucloxacillin or other penicillins. Symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling. 2. You have had an allergic reaction to cephalosporin antibiotics. You may have an increased chance of being allergic to FLUBICLOX if you are allergic to cephalosporins. 3. You have a previous history of inflammation of the liver or yellow skin caused by flucloxacillin. 4. The packaging is torn or shows signs of tampering. 5. 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 as well. اقرأ الوثيقة كاملة
Australian Product Information PI v 1.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION FLUBICLOX -_ (FLUCLOXACILLIN (AS SODIUM) FOR INJECTION) _ _ _ 1 NAME OF THE MEDICINE The name of the medicine is Flubiclox and it contains the active ingredient flucloxacillin as the sodium salt. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flubiclox is a white to off-white powder contained in a clear glass vial. Each vial contains 95- 105% of the stated amount of flucloxacillin. Each gram of flucloxacillin sodium monohydrate contains approximately 2 mmol of sodium. Each 2 g product vial contains 2g flucloxacillin (as flucloxacillin sodium monohydrate) and approximately 4.52 mmol (104 mg) sodium. This product contains no excipients. 3. PHARMACEUTICAL FORM Flucloxacillin 500 mg powder for injection. Flucloxacillin 1 gram powder for injection. Flucloxacillin 2 gram powder for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis. 4.2 DOSE AND METHOD OF ADMINISTRATION _USUAL ADULT DOSAGE: _ _Intramuscular: _ 250 mg 6 hourly. _IV injection/infusion: _ 250 mg to 1 g 6 hourly. _Intrapleural: _ 250 mg once daily. _Intra-articular: _ 250 to 500 mg once daily. NOTE : Systemic doses may be doubled where necessary in severe infections. Australian Product Information PI v 1.0 Page | 2 _ _ _ _ _CHILDREN'S DOSAGE: _ 2 to 10 years: half adult dose. Under 2 years: quarter adult dose. NOTE : In severe infections dosage may be increased. _ _ _DOSAGE IN PATIENTS WITH IMPAIRED LIVER FUNCTION: _ Adjustment of dosage may not be necessary as flucloxacillin is not metabolised in the liver to any appreciable extent. However, during prolonged treatment it is advisable to check periodically for hepatic dysfunction. _ _ _DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION: _ As flucloxacillin is excreted to a large extent by the kidney, the dose or dose interval اقرأ الوثيقة كاملة