Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
meropenem trihydrate, Quantity: 570 mg (Equivalent: meropenem, Qty 500 mg)
Lupin Australia Pty Limited
Meropenem trihydrate
Injection, powder for
Excipient Ingredients: sodium carbonate
Intravenous
10 x 10 mL vials
(S4) Prescription Only Medicine
Meropenem is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics: *Community acquired lower respiratory tract infection *Hospital acquired lower respiratory tract infection *Complicated urinary tract infection *Febrile neutropenia *Intra-abdominal and gynaecological (poly microbial) infections *Complicated skin and skin structure infections *Meningitis *Septicaemia
Visual Identification: Before reconstitution : White to yellowish powder,,After reconstitution: Clear solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-06-19
CONSUMER MEDICINE INFORMATION MEROPENEM GH (MEROPENEM TRIHYDRATE) POWDER FOR INJECTION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Meropenem GH. 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 Meropenem GH against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS, ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MEROPENEM GH IS USED FOR Meropenem GH is an antibiotic used in adults and children to treat certain serious infections caused by bacteria, such as: • Infections of the lungs; • Infections of the kidney or bladder (urinary tract infection); • Febrile neutropenia; • Infections around the stomach or bowel; • Infections of the vagina and womb; • Serious skin infections; • Infections in the lining of the brain (meningitis); • Infections in the blood stream (septicaemia). Meropenem GH belongs to a group of medicines called carbapenem antibiotics. These medicines work by killing the bacteria that are causing your infection. Meropenem GH will not work against fungal or viral infections (such as colds or flu). Meropenem GH is an injection and is usually only used in hospitals. It is available only with a doctor's prescription. 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. Meropenem GH is not addictive. MEROPENEM GH IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER THE AGE OF 3 MONTHS. Safety and effectiveness in children younger than 3 months have not been established. BEFORE YOU ARE GIVEN MEROPENEM GH _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT USE MEROPENEM GH IF YOU HAVE AN ALLERGY TO: • any medicine containing meropenem; • any other carbopenems, penicillins or other beta- lactam antibiotics; • any of th Διαβάστε το πλήρες έγγραφο
AUSTRALIAN PRODUCT INFORMATION – MEROPENEM GH (MEROPENEM (AS TRIHYDRATE)) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Meropenem (as meropenem trihydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MEROPENEM GH 500 MG 1 G _ACTIVE INGREDIENT _ Meropenem (as trihydrate) 570 mg 1.14 g Equivalent to anhydrous meropenem 500 mg 1 g For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Meropenem GH: sterile powder with a white to yellow appearance. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meropenem is indicated for treatment of the following infections in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics: • Community acquired lower respiratory tract infection; • Hospital acquired lower respiratory tract infection; • Complicated urinary tract infection; • Febrile neutropenia; • Intra-abdominal and gynaecological (polymicrobial) infections; • Complicated skin and skin structure infections; • Meningitis; • Septicaemia. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Usual dose 500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. Meropenem GH v5.0 Page 2 of 13 (meropenem (as trihydrate)) powder for injection Exceptions 1. Febrile episodes in neutropenic patients - the dose should be 1 g every 8 hours. 2. Meningitis - the dose should be 2 g every 8 hours. As with other antibiotics, caution may be required in using meropenem as monotherapy in critically ill patients with known or suspected _Pseudomonas aeruginosa_ lower respiratory tract infection. Regular sensitivity testing is recommended when treating _Pseudomonas aeruginosa_ infection. Meropenem should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes (see CONSTITUTION AND COMPATIBILITY). There is Διαβάστε το πλήρες έγγραφο