Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
flucloxacillin sodium monohydrate, Quantity: 544.1 mg (Equivalent: flucloxacillin, Qty 500 mg)
Fresenius Kabi Australia Pty Ltd
Injection, powder for
Excipient Ingredients:
Intramuscular, Intravenous, Intrapleural, Intraarticular
10 vials, 5 vials
(S4) Prescription Only Medicine
For the treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.
Visual Identification: white or almost white powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2021-06-07
FLUCLOXACILLIN KABI 1 FLUCLOXACILLIN KABI CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FLUCLOXACILLIN KABI? Flucloxacillin Kabi contains the active ingredient flucloxacillin sodium monohydrate. Flucloxacillin Kabi, belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria causing your infection. For more information, see Section 1. Why am I using Flucloxacillin? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FLUCLOXACILLIN KABI? Do not use if you have ever had an allergic reaction to flucloxacillin or other penicillin’s or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Flucloxacillin Kabi? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Flucloxacillin Kabi and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FLUCLOXACILLIN KABI? Flucloxacillin Kabi will be given to you by a doctor or nurse. Your doctor will decide what dose and how long you will receive Flucloxacillin Kabi for. This depends on your infection and other factors, such as your weight. For most infections, Flucloxacillin Kabi is usually given in divided doses throughout the day. More instructions can be found in Section 4. How do I use Flucloxacillin Kabi? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FLUCLOXACILLIN KABI? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Flucloxacillin Kabi. • If symptoms of your infection do not improve within a few days, or if they become worse tell your doctor. • If you develop itching with swelling or skin rash or diffic Read the complete document
AUSTRALIAN PRODUCT INFORMATION – FLUCLOXACILLIN KABI (FLUCLOXACILLIN AS SODIUM MONOHYDRATE) 1 NAME OF THE MEDICINE Flucloxacillin (as sodium monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg or 1000 mg of flucloxacillin (as sodium monohydrate). Each gram of flucloxacillin sodium monohydrate contains approximately 2.2 mmol (51 mg) sodium. This product contains no excipients. 3 PHARMACEUTICAL FORM Flucloxacillin sodium is white or almost white, hygroscopic, crystalline powder. The substance is freely soluble in water and in methanol and soluble in ethanol (96 %). Flucloxacillin Kabi is provided as a powder for Injection, for Intraarticular, Intramuscular, Intrapleural or Intravenous use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of confirmed or suspected staphylococcal infections and other Gram- positive coccal infections. Indications include pneumonia, osteomyelitis, 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 1000 mg 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. _ _ _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 may need modification in patients with renal failure, as the half life in patients with renal failure is increased. However, dosage recommendations for various plasma Read the complete document