Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
meropenem trihydrate, Quantity: 570 mg (Equivalent: meropenem, Qty 500 mg)
Sun Pharma ANZ Pty Ltd
Meropenem trihydrate
Injection, powder for
Excipient Ingredients: sodium carbonate
Intravenous Bolus, Intravenous Infusion
5 vials, 10 vials, 1 vial
(S4) Prescription Only Medicine
MEROPENEM RANBAXY is indicated for the 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.
Visual Identification: White to pale yellow crystalline powder in clear glass vial sealed with grey rubber stopper and flip-off seal.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2011-07-07
MEROPENEM RANBAXY 1 MEROPENEM RANBAXY _Meropenem Injection _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MEROPENEM RANBAXY. 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 RANBAXY against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT MEROPENEM RANBAXY IS USED FOR MEROPENEM RANBAXY contains the active ingredient meropenem. Meropenem belongs to a group of medicines called carbapenem antibiotics. These medicines fight bacteria that cause infections in the body. Meropenem will not work against viral (such as colds and flu) or fungal diseases. Your doctor may have prescribed MEROPENEM RANBAXY to you or your child (aged 3 months or above) for the treatment of the following bacterial infections: • Infections of the lungs (pneumonia or bronchitis) • Infections of the bladder or kidney (urinary tract infection) • Infection of tissues around the stomach or gut • Infections of the ovaries, vagina or womb • Skin infections • Infections of the membranes surrounding the brain and spinal cord (meningitis) • Infections of the blood (septicaemia) • High fever and significant reduction in white blood cells resulting decreased resistance to infection (febrile neutropenia) MEROPENEM RANBAXY is given by injection, usually in hospitals, and is available only with a doctor's prescription. MEROPENEM RANBAXY is not addictive. SAFETY AND EFFECTIVENESS OF MEROPENEM RANBAXY IN CHILDREN YOUNGER THAN 3 MONTHS OF AGE HAVE NOT BEEN ESTABLISHED. IT IS NOT RECOMMENDED FOR USE IN THESE CHILDREN. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it for another rea Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION MEROPENEM RANBAXY (MEROPENEM TRIHYDRATE) 1. NAME OF THE MEDICINE Meropenem trihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Meropenem powder for injection or infusion is a white to pale yellow crystalline sterile powder for reconstitution. One vial contains meropenem trihydrate equivalent to meropenem 500 mg or 1000 mg and mannitol. The inactive ingredient sodium carbonate 104 mg or 208 mg respectively. 3. PHARMACEUTICAL FORM MEROPENEM RANBAXY is supplied as a sterile lyophilised powder for intravenous infusion available in single dose clear glass vials. The product is a white to pale yellow crystalline powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS MEROPENEM RANBAXY is indicated for the 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 _ of MEROPENEM RANBAXY is 500 mg to 1 g by intravenous administration every eight hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. _EXCEPTIONS: _ Febrile episodes in neutropenic patients: The dose should be 1 g every eight hours. Meningitis: The dose should be 2 g every eight hours. As with other antibiotics, caution may be required in using meropenem as monotherapy in 2 critically ill patients with known or suspected _Pseudomonas aeruginosa _ lower respiratory tract infection. Regular sensitivity testing is recommended when treating _Pseudomonas _ _aeruginosa _ infection. MEROPENEM RANBAXY should be given as an intravenous b Przeczytaj cały dokument