sodium chloride

1 INDICATIONS & USAGE Sodium Chloride Injection, USP, 0.9% is indicated for: • Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections ( 1.1 ). 1.1 Dilution or Dissolution of Drugs Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

2 DOSAGE & ADMINISTRATION • Volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration recommended by the drug manufacturer ( 2.1 ). 2.1 Recommended Dosage The volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the drug manufacturer. 2.2 Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping. Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. (Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated. (Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use. Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion. Do not reuse disposable syringes. 2.3 Preparation and Handling Precautions Before use check for any possible incompatibility with sodium chloride. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Do not store reconstituted solution or drugs for injection unless otherwise directed by the manufacturer of the solute. Adding additives may be incompatible. Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. Do not freeze. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. 2.2 Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping. Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. (Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated. (Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use. Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion. Do not reuse disposable syringes.

5 WARNINGS AND PRECAUTIONS • Consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection ( 5.1 ). • Do not use Sodium Chloride Injection, USP, 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged ( 5.1 ). • For single use only. Discard unused portion ( 5.2 ). 5.1 General When used to dilute drug products, consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Do not use Sodium Chloride Injection, USP 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged. 5.2 For Single Use Only Re-use of single-use product creates a potential risk to the user. Contamination of product and/or limited functionality of the syringe may lead to injury, illness or death. Discard any unused portion.

4 CONTRAINDICATIONS None • None

7 DRUG INTERACTIONS Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, the drug product manufacturer’s instructions or other specific references should be checked for any possible incompatibility with sodium chloride. Consult with a pharmacist, if unsure of compatibility. • Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. • Consult with a pharmacist, if unsure of compatibility ( 7 ).

6 ADVERSE REACTIONS Adverse reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include, but are not limited to, air embolization, febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and if possible, retrieve and save the remainder of unused vehicle for examination if deemed necessary. • Reactions that may occur because of this solution, added drugs or the technique of reconstitution or administration include air embolization, febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasations ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact MEDEFIL, INC. at tel:1-630-682-4600 and http://www.medefilinc.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.