Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Flucloxacillin sodium monohydrate 27.2 mg/mL equivalent to Flucloxacillin 25 mg/mL; ; Flucloxacillin sodium monohydrate 28.63 mg/mL equivalent to Flucloxacillin 25 mg/mL
AFT Pharmaceuticals Ltd
Flucloxacillin sodium monohydrate 27.2 mg/mL (=Flucloxacillin 25 mg/mL)
125 mg/5mL
Powder for syrup
Active: Flucloxacillin sodium monohydrate 27.2 mg/mL equivalent to Flucloxacillin 25 mg/mL Excipient: Ammonium glycyrrhizinate Disodium edetate dihydrate Erythrosine Menthol flavour 17410157 Pineapple flavour 17410011 Saccharin sodium Sodium benzoate Sodium citrate dihydrate Sucrose Active: Flucloxacillin sodium monohydrate 28.63 mg/mL equivalent to Flucloxacillin 25 mg/mL Excipient: Citric acid monohydrate Colloidal silicon dioxide Disodium edetate dihydrate Lemon flavour 17.41.0212 Menthol flavour 17410157 Saccharin sodium Sodium benzoate Sodium citrate Sorbitol Strawberry flavour 17.43.2172 Xanthan gum
Bottle, plastic, HDPE with child-resistant PP or HDPE cap (sugar free), 100 mL
Prescription
Prescription
Fresenius Kabi Anti-Infectives S.r.l.
The treatment of infections due to Gram-positive organisms, including infections caused by ?-lactamase producing staphylococci
Package - Contents - Shelf Life: Bottle, plastic, HDPE with Al pouch and child-resistant PP or HDPE cap (sugar free) - 100 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2001-08-24
1 New Zealand Consumer Medicine Information FLUCLOXACILLIN _FLUCLOXACILLIN (AS THE SODIUM SALT) 250 MG AND 500 MG CAPSULES _ _FLUCLOXACILLIN (AS THE SODIUM SALT) 125 MG/5 ML AND 250 MG/5 ML _ _POWDER FOR ORAL SOLUTION_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using FLUCLOXACILLIN. This leaflet answers some common questions about FLUCLOXACILLIN. 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 using FLUCLOXACILLIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT FLUCLOXACILLIN IS USED FOR FLUCLOXACILLIN contains the active ingredient flucloxacillin. Flucloxacillin is an antibiotic that belongs to a group of medicines called penicillins. These medicines work by killing the bacteria that are causing infection. FLUCLOXACILLIN is used to treat infections caused by bacteria. Examples of some of the infections that may be caused by bacteria include respiratory tract infections and skin or fleshy tissue skin infections. FLUCLOXACILLIN will not work against infections caused by viruses, such as colds or the flu. Your doctor may have prescribed FLUCLOXACILLIN for another reason. Ask your doctor if you have any questions about why FLUCLOXACILLIN has been prescribed for you. There is no evidence that FLUCLOXACILLIN is addictive. 2 FLUCLOXACILLIN is available only with a doctor's prescription. BEFORE YOU TAKE FLUCLOXACILLIN _ _ WARNING: FLUCLOXACILLIN CAN CAUSE SEVERE LIVER DAMAGE, PARTICULARLY IN OLDER PATIENTS AND THOSE WHO TAKE IT FOR MORE THAN 14 DAYS. _ _ _WHEN YOU MUST NOT TAKE IT _ Do not take FLUCLOXACILLIN if you are allergic to: • medicines containing flucloxacillin or any other penicillin; • cephalosporin antibiotics; • beta-lactam antibiotics; • any of the ingredien Lees het volledige document
Page 1 of 11 NEW ZEALAND DATA SHEET 1. FLUCLOXACILLIN Flucloxacillin 250 mg capsules. Flucloxacillin 500 mg capsules. Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution. Flucloxacillin Oral Solution 250 mg/5 mL powder for oral solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flucloxacillin 250 mg capsules: Each capsule contains 250 mg flucloxacillin (as sodium). Flucloxacillin 500 mg capsules: Each capsule contains 500 mg flucloxacillin (as sodium). Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution: Following reconstitution, each 5 mL of solution contains 125 mg flucloxacillin (as sodium). Flucloxacillin Oral Solution 250 mg/5 mL powder for oral solution: Following reconstitution, each 5 mL of solution contains 250 mg flucloxacillin (as sodium). Excipients with known effect: Sodium Sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules: 250 mg: Size ‘2’ hard gelatine capsule having an opaque caramel body fitted with opaque grey cap. Both printed 'FXN 250' in black. 500 mg: Size ‘0E’ hard gelatine capsule having an opaque caramel body fitted with opaque grey cap. Both printed 'FXN 500' in black. Powder for oral solution: Free-flowing white granular powder with a slight lemon odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by β-lactamase producing staphylococci. Page 2 of 11 Typical indications include: • Skin and soft tissue infections: boils, abscesses, carbuncles, furunculosis, cellulitis, infected wounds, infected burns, protection of skin grafts, and impetigo. • Infected skin conditions: ulcer, eczema and acne. • Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy, otitis media and externa. • Other infections caused by flucloxacillin-sensitive organisms such as osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, se Lees het volledige document