Imipenem cilastatin how supplied

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Imipenem Cilastatin
PRIMAXIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Compatibility, Reconstitution, and Stability
Directions For Use
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied

PRIMAXIN I.V. is supplied as a sterile powder mixture in single dose containers including vials and ADD-Vantage® vials containing imipenem (anhydrous equivalent) and cilastatin sodium as follows:

No. 3514 — 250 mg imipenem equivalent and 250 mg cilastatin equivalent and 10 mg sodium bicarbonate as a buffer

NDC 0006-3514-58 in trays of 25 vials.

No. 3516 — 500 mg imipenem equivalent and 500 mg cilastatin equivalent and 20 mg sodium bicarbonate as a buffer

NDC 0006-3516-59 in trays of 25 vials.

No. 3551 — 250 mg imipenem equivalent and 250 mg cilastatin equivalent and 10 mg sodium bicarbonate as a buffer

NDC 0006-3551-58 in trays of 25 ADD‑Vantage® vials.

No. 3552 — 500 mg imipenem equivalent and 500 mg cilastatin equivalent and 20 mg sodium bicarbonate as a buffer

NDC 0006-3552-59 in trays of 25 ADD‑Vantage® vials.[1]

References

  1. "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050587s065,050630s028lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.