RX ITEM-Rapivab 200Mg 20Ml Vial 3 By ASD Healthcare

RAPIVAB- peramivir solution
BioCryst Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

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)].
2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Acute Uncomplicated Influenza


Administer RAPIVAB within 2 days of onset of symptoms of influenza.

The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes.
DOSAGE FORMS AND STRENGTHS

Each vial of RAPIVAB injection contains 200 mg per 20 mL (10 mg per mL) as a clear, colorless solution
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Peramivir is an antiviral drug with activity against influenza virus
Microbiology
Mechanism of Action

Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells. The median neuraminidase inhibitory activity (IC50 values) of peramivir in biochemical assays against influenza A/H1N1 virus, influenza A/H3N2 virus, and influenza B virus clinical isolates were 0.16 nM (n=44; range 0.01-1.77 nM), 0.13 nM (n=32; range 0.05-11 nM), and 0.99 nM (n=39; range 0.04-54.2 nM), respectively, in a neuraminidase assay with a fluorescently labeled MUNANA

RX ITEM-Rapivab 200Mg 20Ml Vial 3 By ASD
NDC 61364-0181-03 UPC/GTIN No.3-61364-18103-4 Mfg.Part No.44095 vial , clear , clear

Rapivab 200Mg 20Ml Vial 3 By ASD Healthc
BRAND: RAPIVAB NDC: 61364-0181-03,61364018103 UPC: 3-61364-18103-4,361364181034 ASD Specialty Healthcare-Special Order

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