The following Structured Product Label (SPL) was submitted to the FDA by Assure Infusions, Inc. for the product Water (NDC 83155-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, health care provider letter, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HEMOLYTIC and HYPOTONIC. Additives may be incompatible. Consultation with a pharmacist is recommended. When introducing additives, use aseptic technique, mix thoroughly and do not store. Not for Intravenous unless rendered nearly Isotonic. For usual dosage see insert. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Must not be used in a series connections.
Purpose:
This product is being distributed in response to a shortage of Sterile Water For Injection, USP product in the United States as per U.S. Food and Drug; FDA Drug Shortgae List.
Regulatory Status:
This product has not been approved by the U.S. Food and Drug Administration but is being made available under enforcement discretion during a drug shortage.
Product Descritpion:
This product only have Water for Injection, USP.
Dosing and Administration:
The route of administration is intravenous. Product is not for direct intravenous use unless rendered nearly Isotonic. It can be used as a drug diluent. Following suitable admixture of prescribed additive, the final product dose is usually dependent upon the age, weight and clinical condition of the patient.
Safety Information:
Additives may be incompatible. Please confirm compatibility.
Storage and Handling:
Store at 20 to 25C (68F to 77F) [See USP Controlled Room Temperature].
Reporting Adverse Events:
Report adverse events to wwww.fda.gov/medwatch or 1-800-FDA-1088.
Contact Information:
For any question or concern, please contact 1-863-292-2211. Email: [email protected].
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