{"adverse_reactions":["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."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Refer to the Package Insert of the solute used."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Sterile Water for Injection USP is used as a diluent or solvent for other parenteral drugs. As such, Sterile Water for Injection USP contributes to the water of hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to approximate isotonicity."],"contraindications":["CONTRAINDICATIONS None known."],"description":["Warning Hypotonic and hemolytic. For prescription compounding of parenteral nutrition solutions. Do not inject until made approximately isotonic by addition of appropriate solute.","DESCRIPTION A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. 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 or solvent suitable for intravascular injection after first having been made approximately isotonic by addition of suitable solute. pH 6.0 (5.0–7.0)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Not for direct patient injection. For use as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration. Do not inject until made approximately isotonic by addition of appropriate solute. 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 requirement for each patient. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit."],"effective_time":"20130319","general_precautions":["General To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry."],"geriatric_use":["Geriatric Use Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum."],"how_supplied":["HOW SUPPLIED Sterile Water for Injection USP is supplied sterile and nonpyrogenic in glass containers, Pharmacy Bulk Packages. The 1000 mL and 2000 mL containers are packaged 6 per case, and the 500 mL containers are packaged 12 per case. NDC Cat. No. Size Sterile Water for Injection USP 0264-9200-55 S9200-SS 1000 mL 0264-9201-55 S9201-SS 500 mL 0264-9205-55 S9205-SS 2000 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."],"how_supplied_table":["
NDC
Cat. No.
Size
Sterile Water for Injection USP
0264-9200-55
S9200-SS
1000 mL
0264-9201-55
S9201-SS
500 mL
0264-9205-55
S9205-SS
2000 mL
"],"id":"a895a947-4331-4c4a-808f-ed28387762ac","indications_and_usage":["INDICATIONS AND USAGE Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration."],"nursing_mothers":["Nursing Mothers Refer to the Package Insert of the solute used."],"openfda":{},"overdosage":["OVERDOSAGE Overdosage (hypotonic expansion) is a function of an increase in fluid intake over fluid output, and occurs when the increase in the volume of body fluids is due to water alone. Overdosage may occur in patients who receive large quantities of electrolyte-free water to replace abnormal excessive fluid losses, in patients whose renal tolerance to water loads is exceeded, or in patients who retain water postoperatively in response to stress. Manifestations of water intoxication are behavioral changes (confusion, apathy, disorientation and attendant hyponatremia), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions) and weight gain. Treatment consists of withholding fluids until excessive water is excreted. In severe hyponatremia it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and excretion of excess water by the kidneys."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 1000 mL NDC 0264-9200-55 S9200-SS Sterile Water for Injection USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION WARNING: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. B. Braun Medical Inc. Irvine, CA USA 92614-5895 Opened: Date Time No antimicrobial or other substance has been added. pH: 6.0 (5.0-7.0) Contains no more than 25 μ g/L of aluminum. Sterile, nonpyrogenic. Dosage and Administration: See Package Insert. Caution: Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Rx only Made in USA Y37-002-142 Principal Display Panel - 1000 mL Container Label","PRINCIPAL DISPLAY PANEL - 500 mL Container Label 500 mL NDC 0264-9201-55 S9201-SS Sterile Water for Injection USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION WARNING: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. B. Braun Medical Inc. Irvine, CA 92614-5895 USA Opened: Date Time No antimicrobial or other substance has been added. pH: 6.0 (5.0-7.0) Contains no more than 25 μ g/L of aluminum. Sterile, nonpyrogenic. Dosage and Administration: See Package Insert. Caution: Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Rx only Made in USA Y37-002-279 LD-282-1 500 mL Container Label S9201-SS","PRINCIPAL DISPLAY PANEL - 2000 mL Container Label 2000 mL NDC 0264-9205-55 S9205-SS Sterile Water for Injection USP PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION B. Braun Medical Inc. Irvine, CA USA 92614-5895 Opened: Date Time WARNING: Hypotonic and hemolytic. For prescription Compounding of parenteral nutrition solutions. Do not inject until made approximately isotonic by addition of appropriate solute. No antimicrobial or other substance has been added. pH: 6.0 (5.0-7.0) Contains no more than 25 μ g/L of aluminum. Sterile, nonpyrogenic. Dosage and Administration: See Package Insert. Caution: Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Rx only Made in USA Y37-002-144 Principal Display Panel - 2000 mL Container Label"],"pediatric_use":["Pediatric Use Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum."],"precautions":["PRECAUTIONS General To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry. Carcinogenesis, Mutagenesis, Impairment of Fertility Refer to the Package Insert of the solute used. Usage In Pregnancy Refer to the Package Insert of the solute used. Nursing Mothers Refer to the Package Insert of the solute used. Pediatric Use Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum. Geriatric Use Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum."],"pregnancy":["Usage In Pregnancy Refer to the Package Insert of the solute used."],"set_id":"2173b750-0027-4082-a80d-cac5d175008e","spl_patient_package_insert":["Directions for Use of Pharmacy Bulk Packagesin B. Braun Glass Containers Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion. Warning: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Additives should not be made to Pharmacy Bulk Packages. Designed for use with a vented sterile dispensing set. Use 18 to 22 gauge needle size for spiking/admixing or withdrawing solutions from the glass bottle. Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away. Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface. Check for vacuum at first puncture of stopper. Insert the spike fully into the outlet port of the stopper (See Figure 2) and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present. Refer to Directions for Use of set to be used. If set insertion is not performed immediately following removal of protective metal disk, swab stopper with a suitable disinfectant. Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. After admixture and during use, reinspect the solution frequently. If any evidence of solution contamination or instability is found, discontinue use immediately. Figure 1 Figure 2"],"spl_product_data_elements":["Sterile Water WATER WATER WATER Sterile Water WATER WATER WATER Sterile Water WATER WATER WATER"],"spl_unclassified_section":["PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION","Rx only Revised: March 2009","B. Braun Medical Inc. Irvine, CA 92614-5895 USA Made in USA Y36-002-682"],"spl_unclassified_section_table":["
PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION
"],"storage_and_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."],"version":"3","warnings":["WARNINGS 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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly 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."]}