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| Product NDC Code | 0264-7385 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | INTRAVENOUS | ||||||
| Dosage Form | INJECTION | ||||||
| Application Number | NDA019633 | ||||||
| Labeler Name | B. Braun Medical Inc. | ||||||
| Packages |
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Overdosage of Sterile Water
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sterile Water for Injection USP is used as a diluent for other parenteral drugs. As such, Sterile Water for Injection USP contributes to the water for 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
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS None known.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND 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.
Spl product data elements
Usually a list of ingredients in a drug product.Sterile Water Water WATER WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Refer to the package insert of the solute used.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug 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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Warning: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. Pharmacy Bulk Package Not For Direct Infusion
Rx only Revised: May 2019
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 www.bbraun.com Made in USA Y36-002-998 LD-454-2
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Directions for use of Plastic Container Warning: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration, whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible. Sterile Water for Injection USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of Sterile Water for Injection USP. Preparation Inspect overwrap and primary bag. Do not use if overwrap has been damaged. Do not use unless solution is clear and closure is intact. 1. To open: Tear overwrap starting from the tear notches. (Figure 1) For Pharmacy Bulk Packages The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area). For compounding only. Do not use for direct infusion. Do not use/penetrate blocked port (see Figure 2, left upper corner). Suspend container. Remove aluminum foil of set port at the bottom of container (see Figure 3). Attach suitable transfer device or compounding set (Figure 2). Refer to complete directions accompanying device. Hang bag on suitable fixture (Figure 4). Once container closure has been penetrated, withdrawal of content should be completed within 4 hours. Important Admixing Instructions The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion or, through a sterile transfer device, for the filling of empty sterile syringes. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS, General ) . Tear Notches, Overwrap illustration Figure 1 Bag hanger, Set Port (Green Ring), Blocked Port (Red Ring) Illustration Figure 2 Figure 3 Figure 4
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers Refer to the package insert of the solute used.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Usage in Pregnancy Refer to the package insert of the solute used.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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.
| NDC | REF | Size |
|---|---|---|
| 0264-7385-50 | S8505 | 2000 mL |
| 0264-7385-60 | S8506 | 3000 mL |
Storage and handling
Information about safe storage and handling of the drug product.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.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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. Do not use plastic container in series connection. If administration of Sterile Water for Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. The drug product contains no more than 25 mcg/L of aluminum.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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. Do not use plastic container in series connection. If administration of Sterile Water for Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. The drug product contains no more than 25 mcg/L of aluminum. 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API