Land: Storbritannien
Språk: engelska
Källa: myHealthbox
linezolid
INFOMED FLUIDS
J01XX08
linezolid
2mg/ml
Solution for infusion
intravenous route
Pack sizes of one, ten or 25 infusion bags
POM - Prescription Only Medicine
INFOMED FLUIDS
Other antibacterials
It is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram-positive bacteria. In determining whether Linezolid 2 mg/ml Solution for Infusion is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Grampositive bacteria should be taken into consideration. (See section 5.1 for the appropriate organisms).
Authorised
2015-04-02
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Linezolid 2 mg/ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg of linezolid. Each 300 ml infusion bag contains 600 mg of linezolid. Excipients with known effect: Each 300 ml bag contains approximately 13.7 g of glucose and 114 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Linezolid 2 mg/ml Solution for Infusion is an isotonic, clear, colourless to yellowish solution, free from visible particles. The pH value of the solution for infusion ranges from 4.6 to 5.0 and the solution has an osmolality between 270 to 330 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Nosocomial pneumonia • Community acquired pneumonia Linezolid is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram-positive bacteria. In determining whether Linezolid 2 mg/ml Solution for Infusion is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram- positive bacteria should be taken into consideration. (See section 5.1 for the appropriate organisms). Linezolid is not active against infections caused by Gram-negative pathogens. Specific therapy against Gram-negative organisms must be initiated concomitantly if a Gram-negative pathogen is documented or suspected. • Complicated skin and soft tissue infections (see section 4.4). Linezolid is indicated in adults for the treatment of complicated skin and soft tissue infections ONLY when microbiological testing has established that the infection is known to be caused by susceptible Gram-positive bacteria. Linezolid is not Läs hela dokumentet