Transcription of FOR INTRAVENOUS USE ONLY
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FOR INTRAVENOUS USE ONLY
NDA 50-706/S-022 Page 3 MERREM (meropenem for injection) FOR INTRAVENOUS USE ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM (meropenem for injection) and other antibacterial drugs, MERREM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION MERREM (meropenem for injection) is a sterile, pyrogen-free, synthetic, broad-spectrum, carbapenem antibiotic for INTRAVENOUS administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbam oyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydr oxyethyl]-4-methyl-7-oxo-1-azabicyclo[ ]hept-2-ene-2-carboxylic acid trihydrate.
At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoints for meropenem. However, the safety and effectiveness of meropenem in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled trials.
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