Baby Gas And Colic Plus Stomach Cramps Recall
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FDA Labeling Changes
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RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.
Limitations of Use:
- Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4)].
- The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.2)].
There is currently no drug history available for this drug.
RAPIVAB (peramivir) is an inhibitor of influenza virus neuraminidase. The chemical name is (1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-(carbamimidoylamino)-2-hydroxycyclopentanecarboxylic acid, trihydrate. The chemical formula is C15H28N4O4 ∙ 3H2O, representing a molecular weight of 382.45. The molecular structure is as follows:
RAPIVAB injection is a clear, colorless, sterile, isotonic solution (200 mg per 20 mL) in glass vials fitted with rubber stoppers and royal blue flip-off seals. Each mL contains 10 mg peramivir (on an anhydrous basis) in 0.9% sodium chloride solution. The pH may have been adjusted with sodium hydroxide, USP and/or hydrochloric acid, USP. The pH is 5.5 – 8.5.
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