Peramivir Fact Sheet for Health Care Providers (cont.)
In this Article
- Peramivir Injection 200 mg/20mL (10 mg/mL) is an Unapproved Product
- Mandatory Requirements for Peramivir IV Administration Under Emergency Use Authorization (EUA)
- Other Considerations Prior to Peramivir IV Use
- Authorized Use
- Dosage and Administration
- Warnings and Precautions
- Drug Interactions
- Clinical Pharmacology
- How Supplied
- Product Description
- Patient Information
Peramivir Injection is a clear, iso-osmotic, sterile, nonpyrogenic solution in 200 mg per 20 mL (10 mg/mL) glass vials fitted with rubber stoppers and aluminum flip-off seals with blue buttons. Each mL of solution contains 10 mg Peramivir and 9 mg sodium chloride in Water for Injection. The pH is adjusted with sodium hydroxide, NF and/or hydrochloric acid, NF.
No preservative or bacteriostatic agent is present in the product.
Peramivir Injection is supplied in a 200 mg/20 mL single use vial. Five (5) single use vials, are packaged in a carton
Vials should be stored at room temperature (15 to 30°C; 59 to 86°F). [see DOSAGE AND ADMINISTRATION]
Peramivir is a neuraminidase inhibitor for influenza virus. The chemical name is (1S,2S,3R,4R)-3-[(1S)-1-(acetylamino)-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2- hydroxycyclopentanecarboxylic acid, trihydrate. The empirical formula is C15H34N4O7, representing a molecular weight of 382.45. The molecular structure is as follows
See Fact Sheet for Patients and Parents/Caregivers
- Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-4.
- Schartz GJ, Gauthier B. JPediatric 1985 March;106(3):522-6.
- Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, Chatelut E, Grubb A, Veal GJ, Keir MJ, Holford NH.; Human renal function maturation: a quantitative description using weight and postmenstrual age.; Pediatr Nephrol. 2009 Jan; 24(1):67-76.
Peramivir EUA, Fact Sheet for HCP Authorized by FDA on October 23, 2009
Last Editorial Review: 11/4/2009 11:24:16 AM
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