Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
tobramycin, Quantity: 80 mg
Pfizer Australia Pty Ltd
Tobramycin
Injection, solution
Excipient Ingredients: sodium hydroxide; sodium metabisulfite; phenol; water for injections; sulfuric acid; disodium edetate
Intravenous, Intramuscular
5 x 2mL Ampoules
(S4) Prescription Only Medicine
For the treatment of serious infections of the following type where they are caused by susceptible organisms: Skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,Aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,Tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. If susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,Note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If the organisms are resistant, other appropriate therapy should be instituted. In patients in whom Gram-negative septicaemia, neonatal sepsis or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cefalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. The decision to continue tobramycin therapy should be based upon the results of susceptibility studies, the severity of infection and the important additional concepts discussed in the Product Information leaflet.
Visual Identification: Clear, colourless to pale brown aqueous solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2004-05-04
TOBRAMYCIN INJECTION _tobramycin sulfate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tobramycin 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 benefits and risks. Your doctor has weighed the risks of you taking Tobramycin Injection against the benefits this medicine is expected to 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 TOBRAMYCIN INJECTION IS USED FOR Tobramycin Injection belongs to a group of medicines known as aminoglycoside antibiotics. Aminoglycoside antibiotics work by preventing bacteria from growing, thereby killing them. Tobramycin Injection is used to treat serious bacterial infections in many different parts of the body such as: • meningitis (infection of the brain) • septicaemia (infection of the blood) • respiratory tract infections (such as pneumonia, bronchitis) • gastrointestinal tract infections • skin and bone infections, including burns • urinary tract infections. 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. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN TOBRAMYCIN INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN TOBRAMYCIN INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing tobramycin • any other similar medicines such as aminoglycoside antibiotics e.g. gentamicin, streptomycin, amikacin or neomycin • any of the ingredients listed at the end of this leaflet • sulfites. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN TOBRAMYCIN INJECTION IF YOU HAVE EXPERIENC Lesen Sie das vollständige Dokument
Version: pfptobri10922 Supersedes: pfptobri10821 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – TOBRAMYCIN INJECTION (TOBRAMYCIN SULFATE) 1. NAME OF THE MEDICINE Tobramycin (as tobramycin sulfate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tobramycin Injection is a sterile solution containing tobramycin (as tobramycin sulfate) 80 mg/2 mL. EXCIPIENT(S) WITH KNOWN EFFECT • sulfites For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Tobramycin Injection is a clear, colourless to pale brown, sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of serious infections of the following type where they are caused by susceptible organisms: • skin and skin structure infections including burns, bone infections • gastrointestinal infections including peritonitis • central nervous system infections including meningitis, septicaemia and neonatal sepsis • lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis • complicated and recurrent urinary tract infections such as pyelonephritis and cystitis Aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics. Tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. If susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted. Version: pfptobri10922 Supersedes: pfptobri10821 Page 2 of 17 Note that bacterial cultures should be obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If the organisms are resistant, other appropriate therapy should be instituted. In patients in whom Gram-negative septicaemia Lesen Sie das vollständige Dokument