Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
meropenem trihydrate
Medis Pharma Pty Ltd
Meropenem trihydrate
Registered
ROPENN POWDER FOR INJECTION _Meropenem (as trihydrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ropenn. 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 Ropenn against the benefits they expect it will 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 ROPENN IS USED FOR Ropenn 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) Ropenn belongs to a group of medicines called carbapenem antibiotics. These medicines work by killing the bacteria that are causing your infection. Ropenn will not work against fungal or viral infections (such as colds or flu). Ropenn is given by 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. Ropenn is not addictive. Ropenn 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 ROPENN _WHEN YOU MUST NOT BE _ _GIVEN IT _ DO NOT TAKE ROPENN IF YOU HAVE AN ALLERGY TO: any medicine containing meropenem any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swel Přečtěte si celý dokument
ROPENN Product Information PI 280115 V.2 Page 1 of 11 NAME OF THE MEDICINE Meropenem (as meropenem trihydrate), powder for injection Meropenem trihydrate Formula: C 17 H 25 N 3 O 5 S.3H 2 O Mw: 437.52 CAS: 119478-56-7 (meropenem trihydrate). DESCRIPTION Meropenem trihydrate occurs as a white to light yellow crystalline powder. It is sparingly soluble in water, practically insoluble in ethanol (96 per cent) and in methylene chloride. ACTIVE: Meropenem (as meropenem trihydrate). INACTIVE: Sodium carbonate. Meropenem powder for intravenous injection or infusion _ _ _ _ _ _ _ _ _ _ 500 MG 1 G _Active ingredient_ MEROPENEM (as the trihydrate) 570 mg 1.14 g Equivalent to anhydrous meropenem 500 mg 1 g _ _ _Excipient_ Sodium carbonate 104 mg 208 mg PHARMACOLOGY Carbapenem antibiotic (for parenteral use) that is stable to human dehydropeptidase-1 (DHP-1). _MICROBIOLOGY _ Meropenem exerts its bactericidal action by interfering with vital bacterial cell wall synthesis. The ease with which it penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs) explain the potent bactericidal action of meropenem against a broad spectrum of aerobic and anaerobic bacteria. Bactericidal concentrations are commonly the same as the minimum inhibitory concentrations (MICs). Meropenem is stable in susceptibility tests and these tests can be performed using normal routine methods. _In vitro_ tests show that meropenem acts synergistically with various antibiotics. It has been demonstrated both _in vitro_ and _in vivo_ that meropenem has a post- antibiotic effect. ROPENN Product Information PI 280115 V.2 Page 2 of 11 Meropenem is usually active, _in vitro_ and in clinical infections, against the following strains of bacteria. _ _ COMMONLY SUSCEPTIBLE SPECIES GRAM-POSITIVE AEROBES _Enterococcus faecalis (note that E.faecalis can naturally display intermediate _ _susceptibility), Staphylococcus aureus _(methicillin-susceptible stains only: methi Přečtěte si celý dokument