Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Tobramycin
TOBRAMYCIN INJECTION 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 nurse. 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. This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR NURSE. 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 Tobramycin Injection may be prescribed for other reasons that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed it. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN TOBRAMYCIN INJECTION DO NOT USE TOBRAMYCIN INJECTION IF: • you have an allergy to tobramycin or any of the ingredients listed at the end of this leaflet • you have an allergy to other aminoglycoside antibiotics such as gentamicin, streptomycin, amikacin or neomycin Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty Les hele dokumentet
Version: pfptobri10211 Supersedes: pfptobrt10704 Page 1 of 14 PRODUCT INFORMATION TOBRAMYCIN INJECTION NAME OF THE DRUG Tobramycin BP DESCRIPTION Tobramycin is _O_-3-amino-3-deoxy- -D-glucopyranosyl-(1→6)-_O_-[2,6-diamino-2,3,6- trideoxy- -D-_ribo_-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine, an antimicrobial substance produced by _Streptomyces tenebrarius_. It is a white or almost white powder that is freely soluble in water; very slightly soluble in ethanol (96%); practically insoluble in chloroform and in ether. The structural formula is represented below: Molecular formula: C 18 H 37 N 5 O 9 Molecular weight: 467.5 CAS No: 32986-56-4 Tobramycin Injection is a sterile solution containing 80 mg/2 mL Tobramycin BP (as tobramycin sulfate), Disodium Edetate BP, Phenol BP, 40% v/v Sulfuric Acid and Sodium Metabisulfite BP in Water for Injections BP. PHARMACOLOGY CLASS: Aminoglycoside antibiotic. Version: pfptobri10211 Supersedes: pfptobrt10704 Page 2 of 14 PHARMACOKINETICS _ABSORPTION _ In adults with normal renal function, a single intramuscular injection of 1 mg/kg body weight will produce peak plasma levels of about 4 g/mL within 30-90 minutes. Serum concentrations can be measured for as long as eight hours. Following intravenous infusion over one hour, the serum concentrations achieved are similar to those obtained after intramuscular administration. Tobramycin is poorly absorbed from the gastrointestinal tract. _DISTRIBUTION _ Tobramycin has been detected in body fluids such as sputum, peritoneal fluid, synovial fluid and abscess fluids following intravenous administration but only low concentrations are found i Les hele dokumentet