Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sterile Water for Injection USP is supplied in 2000 and 3000 mL Pharmacy Bulk Package containers packaged 4 per case. NDC REF Size 0264-7385-50 S8505 2000 mL 0264-7385-60 S8506 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.; PRINCIPAL DISPLAY PANEL - 2000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8505 NDC 0264-7385-50 LOT EXP. 2000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-065 LD-455-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Injection 2L Container Label Recycle symbol Sterile Water Injection 2L Container Label; PRINCIPAL DISPLAY PANEL - 3000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8506 NDC 0264-7385-60 LOT EXP. 3000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-066 LD-456-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Recycle symbol 3000 mL Container Label
- HOW SUPPLIED Sterile Water for Injection USP is supplied in 2000 and 3000 mL Pharmacy Bulk Package containers packaged 4 per case. NDC REF Size 0264-7385-50 S8505 2000 mL 0264-7385-60 S8506 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
- PRINCIPAL DISPLAY PANEL - 2000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8505 NDC 0264-7385-50 LOT EXP. 2000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-065 LD-455-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Injection 2L Container Label Recycle symbol Sterile Water Injection 2L Container Label
- PRINCIPAL DISPLAY PANEL - 3000 mL STERILE WATER FOR INJECTION USP WARNING: HYPOTONIC AND HEMOLYTIC. DO NOT INJECT UNTIL MADE APPROXIMATELY ISOTONIC BY ADDITION OF APPROPRIATE SOLUTE. REF S8506 NDC 0264-7385-60 LOT EXP. 3000 mL Pharmacy Bulk Package Not For Direct Infusion No antimicrobial agent or other substance has been added. Sterile. Pharmacy bulk package container. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Do not remove overwrap until ready for use. Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-066 LD-456-3 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Recycle symbol 3000 mL Container Label
Overview
Sterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent suitable for intravascular injection after first having been made approximately isotonic by the addition of suitable solute. pH: 5.5 (5.0-7.0) Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during use. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Indications & Usage
Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration after admixture or dilution.
Dosage & Administration
This solution is for intravenous use only after admixture or dilution. Do not inject until made approximately isotonic by addition of appropriate solute. Following suitable admixture of prescribed drugs, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs. The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient. Some additives may be incompatible. Consult with pharmacist. When performing admixture or dilution, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS This solution is for compounding only, not for direct infusion. Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of an appropriate solute, due to the possibility of hemolysis. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
None known.
Adverse Reactions
Refer to the package insert of the solute used. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Storage & Handling
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
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