Prostin E2

Prostin E2

Prostin E2 Recall

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Questions & Answers

Side Effects & Adverse Reactions

Not for injection.

Because fluids used to irrigate joints may be absorbed into the general circulation, solutions containing sodium ion should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

0.9% Sodium Chloride Irrigation, USP is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

History

There is currently no drug history available for this drug.

Other Information

0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 9 g Sodium Chloride, USP (NaCl) in Water for Injection. pH 5.5 (4.5 to 7.0). Milliequivalents per liter: Sodium - 154, Chloride - 154. Osmolarity 308 mOsmol/L (calc.). No antimicrobial agent has been added.

The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Prostin E2 Manufacturers


  • Pharmacia And Upjohn Company
    Prostin E2 (Dinoprostone) Suppository [Pharmacia And Upjohn Company]

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