País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Flucloxacillin sodium monohydrate 250mg;
Douglas Pharmaceuticals Limited
Flucloxacillin sodium monohydrate 250 mg
250 mg
Powder for injection
Active: Flucloxacillin sodium monohydrate 250mg
Vial, glass, 5x250mg, 5 dose units
Prescription
Prescription
Aurobindo Pharma Limited
Package - Contents - Shelf Life: Vial, glass, - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
1983-08-17
CONSUMER MEDICINE INFORMATION FLUCLOXIN® _flucloxacillin 250 mg, 500 mg and 1 g _ _powder for solution for injection _ • Please read this leaflet carefully before you start using Flucloxin® injection. • This leaflet answers some common questions about Flucloxin® injection. 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 Flucloxin® injection against the benefits they expect it will have for you. • If you have any questions, concerns or experience any side effect, then talk to your doctor or pharmacist. • Keep this leaflet with the medicine. You may need to read it again. IN THIS LEAFLET: 1. What is Flucloxin® and what is it used for 2. Before you are given Flucloxin® Injection 3. How Flucloxin® should be given 4. Possible side effects 5. How to store Flucloxin® 6. Further information 1. WHAT IS FLUCLOXIN® AND WHAT IS IT USED FOR? Flucloxin® is an antibiotic which belongs to a group of medicines called penicillins. These medicines work by killing bacteria that cause infections. Flucloxin® Injection is used for the treatment of skin and soft tissue infections, for example: infections in joints or within the lining of the heart (endocarditis), respiratory tract or urinary tract or middle ear infections, infected blood and meningitis. It is also used to prevent infections that can occur during major surgical operations such as heart and lung operations (cardiothoracic surgery) and bone, joint and muscle operations (orthopaedic surgery). Your doctor may have prescribed Flucloxin® injection for another reason. Ask your doctor if you have any questions about why Flucloxin® injection has been prescribed for you. This medicine is available only with a doctor’s prescription. 2. BEFORE YOU TAKE FLUCLOXIN® YOU SHOULD NOT BE GIVEN FLUCLOXIN® INJECTION IF YOU: • are allergic to flucloxacillin, cephalosporins, penicillin, or any other ß-lactam Llegiu el document complet
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Flucloxin® 250 mg powder for injection Flucloxin® 500 mg powder for injection Flucloxin® 1 g powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The flucloxacillin is present as flucloxacillin sodium monohydrate in Flucloxin. Each 1.088 g (1088 mg) of flucloxacillin sodium monohydrate is equivalent to approximately 1 g (1000 mg) of anhydrous flucloxacillin. Flucloxin 250 mg powder for injection/infusion contains 250mg flucloxacillin. Flucloxin 500 mg powder for injection/infusion contains 500 mg flucloxacillin. Flucloxin 1 g powder for injection/infusion contains 1 g flucloxacillin. EXCIPIENT(S) WITH KNOWN EFFECT Flucloxin contains only flucloxacillin sodium monohydrate, with no additional ingredients. Each one gram of flucloxacillin sodium monohydrate contains approximately 2.2 mmol of sodium. 3. PHARMACEUTICAL FORM Flucloxin powder for injection vials: Glass vials containing a white powder for reconstitution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Flucloxin is indicated in adults and children for the following: - The treatment of skin and soft tissue infections caused by susceptible organisms and infections due to penicillinase producing staphylococci and for mixed streptococcal and staphylococcal infections where the staphylococci are resistant to penicillin. For example, infections of the joints, respiratory tract and urinary tract, otitis media, endocarditis, septicaemia, and meningitis. - Prophylaxis of staphylococcal infections during major surgical procedures, particularly in cardiothoracic or orthopaedic surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 2 | P a g e 4.2. DOSE AND METHOD OF ADMINISTRATION The dosage depends on the severity and nature of the infection. The usual routes of administration are by intramuscular injection, slow intravenous injection and intravenous infusion. Flucloxin may also be administered by intra-articular or intrapleural injection. DOSE Llegiu el document complet