GERNEBCIN tobramycin 80mg/2mL solution for injection, infusion or inhalation ampoule (Germany)

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 therapy with a penicillin or cephalosporin 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 documents.