Sterile Water
Water
Becton Dickinson And Company
Human Prescription Drug
NDC 17271-750Sterile Water also known as Water is a human prescription drug labeled by 'Becton Dickinson And Company'. National Drug Code (NDC) number for Sterile Water is 17271-750. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sterile Water drug includes Water - 1000 mL/1000mL . The currest status of Sterile Water drug is Active.
Drug Information:
| Drug NDC: | 17271-750 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sterile Water |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Becton Dickinson And Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | WATER - 1000 mL/1000mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 28 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA209689 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Becton Dickinson and Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 059QF0KO0R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 17271-750-07 | 10 BAG in 1 CASE (17271-750-07) / 1000 mL in 1 BAG | 28 Feb, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sterile water water water water
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, 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 and container permit (see precautions ).
Indications and Usage:
Indications and usage: sterile water for injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. for intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mosmol/liter) is essential to avoid intravascular hemolysis.
Warnings:
Warnings: for drug diluent use only. intravenous administration of sterile water for injection without additives may result in hemolysis. the intravenous administration of sterile water for injection with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. 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. re
Read more...search 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.
Dosage and Administration:
Dosage and administration: following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, 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 and container permit (see precautions ).
Contraindications:
Contraindications: do not administer without the addition of a solute.
Adverse Reactions:
Adverse reactions: reactions which may occur because of 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. 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.
Drug Interactions:
Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, 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 and container permit (see precautions ).
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with sterile water for injection. it is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sterile water for injection with additives should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. this product contains no more than 25 mcg/l of aluminum.
Overdosage:
Overdosage: in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures (see warnings ).
Description:
Description: sterile water for injection, usp is a sterile, nonpyrogenic, solute-free preparation of distilled water for injection. it is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. the ph is 5.5 (5.0 to 7.0). sterile water for injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single dose injection after admixture with an appropriate solute or solution. when smaller amounts are required, the unused portion should be discarded. sterile water for injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute. water for injection, usp is chemically designated h 2 o. the flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). the amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. the suitability of the container material has been confirmed by tests in animals according to usp biological tests for plastic containers.
Clinical Pharmacology:
Clinical pharmacology: when administered intravenously as a vehicle for drugs, sterile water for injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of 112 mosmol or more per liter. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water balance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.
How Supplied:
How supplied: sterile water for injection, usp is supplied in a single dose flexible plastic container as follows: product no. ndc no. bag size bags per carton 1727175007 17271-750-07 1,000 ml bag 10 bags the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.
Package Label Principal Display Panel:
Package label - principal display â sterile water for injection bag label ndc 17271-750-07 free flex ® 1,000 ml sterile water for injection, usp do not give intravenously. for drug diluent use only. for intravenous use. rx only package label - principal display â sterile water for injection bag label
Package label - principal display â sterile water for injection case label ndc 17271-750-07 ref 1727175007 sterile water for injection, usp 1,000 ml x 10 rx only package label - principal display â sterile water for injection case label