Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
flucloxacillin sodium monohydrate, Quantity: 27.2 mg/mL (Equivalent: flucloxacillin, Qty 25 mg/mL)
Aspen Pharmacare Australia Pty Ltd
flucloxacillin sodium monohydrate
Oral Liquid, powder for
Excipient Ingredients: ammonium glycyrrhizinate; sodium benzoate; sucrose; saccharin sodium; disodium edetate; sodium citrate; erythrosine; Flavour
Oral
1s
(S4) Prescription Only Medicine
For the treatment of confirmed or suspected Staphylococcal and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.
Visual Identification: pink coloured dry granular powder which gives a pink coloured solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-01-27
FLUCIL oral solution – CMI Page 1 of 4 FLUCIL ORAL SOLUTION _Flucloxacillin _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FLUCIL. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking it against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT FLUCIL IS USED FOR FLUCIL is an antibiotic used to treat some infections in different parts of the body caused by bacteria. FLUCIL will not work against infections caused by viruses, such as colds. FLUCIL is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection. ASK YOUR DOCTOR WHY FLUCIL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor s prescription. There is no evidence that FLUCIL ® is addictive. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT BE GIVEN IT _ DO NOT TAKE FLUCIL IF: • YOUR SKIN AND/OR EYES HAVE TURNED YELLOW (JAUNDICE) WHILE, OR SOON AFTER TAKING FLUCLOXACILLIN (FLUCIL). • YOU HAVE AN ALLERGY TO FLUCIL, OTHER PENICILLINS OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching and difficult breathing. • YOU HAVE HAD AN ALLERGIC REACTION TO CEPHALOSPORINS. You may have an increased chance of being allergic to FLUCIL if you are allergic to cephalosporins. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING FLUCIL, TALK TO YOUR DOCTOR. _ _ _BEFORE YOU START TO TAKE IT_ FLUCLOXACILLIN (FLUCIL) CAN CAUSE JAUNDICE (YELLOWING OF SKIN AND/OR EYES) AND SEVERE LIVER DISEASE WHICH MAY LAST FOR A LONG TIME. THIS REACTION IS MORE FREQUENT IN OLDER PATIENTS Przeczytaj cały dokument
Flucil-inj-pi-26nov19 1 AUSTRALIAN PRODUCT INFORMATION FLUCIL FLUCLOXACILLIN (AS FLUCLOXACILLIN SODIUM) POWDER FOR ORAL LIQUID 1 NAME OF THE MEDICINE Flucloxacillin (as flucloxacillin sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FLUCIL powder for oral liquid 125 mg/5 mL - When dispensed, each 5 mL contains flucloxacillin sodium equivalent to 125 mg of flucloxacillin. 250 mg/5 mL - When dispensed, each 5 mL contains flucloxacillin sodium equivalent to 250 mg of flucloxacillin. Each gram of flucloxacillin sodium contains 2.2 mmol of sodium. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM FLUCIL powder for oral liquid 125 mg/5 mL and 250 mg/5 mL are pink coloured dry granular powder which gives a pink coloured solution on reconstitution 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the treatment of confirmed or suspected _ Staphylococcal_ and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis. 4.2 D OSE AND METHOD OF ADMINISTRATION The oral dose should be administered ½ to 1 hour before meals. USUAL ADULT DOSE 250 mg 6-hourly USUAL CHILDREN'S DOSE 2 to 10 years Half of the adult dose under 2 years Quarter of the adult dose NOTE In severe infections the dosage may be increased. Flucil-inj-pi-26nov19 2 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 (See 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 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 creatinine levels for patients with impa Przeczytaj cały dokument