Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
tobramycin, Quantity: 80 mg
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; disodium edetate; sodium hydroxide; sulfuric acid
Intravenous, Intramuscular
2mL x 5
(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
Visual Identification: Clear colourless solution, free from visible impurities; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-07-09
TOBRAMYCIN PF _tobramycin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tobramycin PF. 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 PF 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 PF IS USED FOR Tobramycin PF belongs to a group of medicines known as aminoglycoside antibiotics. Aminoglycoside antibiotics work by preventing bacteria from growing thereby killing them. Tobramycin PF 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 PF _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN TOBRAMYCIN PF IF YOU HAVE AN ALLERGY TO: • any medicine containing tobramycin • any of the ingredients listed at the end of this leaflet • any other similar medicines such as aminoglycoside antibiotics e.g. gentamicin, streptomycin, amikacin or neomycin. 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 PF IF YOU HAVE EXPERIENCED SERIOUS REACTIONS (SUCH AS HEARING LOSS OR KIDNEY PROBLEMS) TO TOBRAMYCIN OR OTHER Leggi il documento completo
Version: pfptobai10922 Supersedes: pfptobai10821 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – TOBRAMYCIN PF (TOBRAMYCIN SULFATE) 1. NAME OF THE MEDICINE Tobramycin (as tobramycin sulfate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each steriluer of Tobramycin PF contains 80 mg/2 mL tobramycin (as tobramycin sulfate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Tobramycin PF is a clear, colourless, sterile, preservative-free solution, free from visible impurities. 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. 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, neonatal sepsis or meningitis is suspected, including those in whom concurrent Version: pfptobai10922 Su Leggi il documento completo