The following Structured Product Label (SPL) was submitted to the FDA by Haver Farma Ilac Anonim Sirketi for the product Isotonic Sodium Chloride (NDC 85184-0001). 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 general precautions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.
biofleks
100 mL
0.9 % ISOTONIC
SODIUM CHLORIDE SOLUTION
STERILE
Per 100 mL
Sodium Chloride
Water for Injection
Electrolyte Concentrations (mEq/L)
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC
Phone: (201) 676-3232 / E-Mail: [email protected] Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024
OSEL llaç San. ve Tic. A.Ş.
Beykoz / İstanbul / TURKEY
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