Bacteriostatic Water
Water
General Injectables & Vaccine, Inc
Human Prescription Drug
NDC 52584-977Bacteriostatic Water also known as Water is a human prescription drug labeled by 'General Injectables & Vaccine, Inc'. National Drug Code (NDC) number for Bacteriostatic Water is 52584-977. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Bacteriostatic Water drug includes Water - 1 mL/mL . The currest status of Bacteriostatic Water drug is Active.
Drug Information:
| Drug NDC: | 52584-977 |
| 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: | Bacteriostatic 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: | General Injectables & Vaccine, Inc |
| 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 - 1 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | NDA |
| 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: | 01 Aug, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 2024 |
| 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: | NDA018802 |
| 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: | 17 Dec, 2025 |
| 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: | General Injectables & Vaccine, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 52584-977-03 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-977-03) / 30 mL in 1 VIAL, MULTI-DOSE | 01 Aug, 2010 | 01 Jan, 2024 | 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:
Bacteriostatic water water water water
Boxed Warning:
Boxed warning multiple-dose vial warning: not for use in neonates.
Indications and Usage:
Indications and usage this parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Warnings:
Warnings benzyl alcohol, a preservative in bacteriostatic water for injection, usp has been associated with toxicity in neonates. data are unavailable on the toxicity of other preservatives in this age group. where water is required for preparing or diluting medications for use in neonates, only preservative-free sterile water for injection should be used. intravenous administration of bacteriostatic water for injection without a solute may result in hemolysis.
Dosage and Administration:
Dosage and administration the volume of the 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 manufacturer. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions.
Contraindications:
Contraindications due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. parenteral preparations with benzyl alcohol should not be used for fluid replacement. parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. bacteriostatic water for injection, usp must be made approximately isotonic prior to use.
Adverse Reactions:
Adverse reactions reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include 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 countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 ml may be safely given to an adult without toxic effects. administration of an estimated 9 ml to a 6 kg infant or neonate is potentially capab
Read more...le of producing blood pressure changes.
Overdosage:
Overdosage use only as a diluent or solvent. this parenteral preparation is unlikely to pose a threat of fluid overload except possibly in very small infants. in the event these should occur, re-evaluate the patient and institute appropriate corrective measures. see warnings, precautions and adverse reactions.
Description:
Description the following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. bacteriostatic water for injection, usp is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/ml) or 1.1% (11 mg/ml) benzyl alcohol added as a bacteriostatic preservative. it is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. the ph is 5.7 (4.5 to 7.0). water for injection, usp is chemically designated h 2 o. the semi-rigid vial is fabricated from a specially formulated polyolefin. it is a copolymer of ethylene and propylene. the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. the container requires no vapor barrier to maintain the proper labeled volume.
Clinical Pharmacology:
Clinical pharmacology 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. the small volume of fluid provided by bacteriostatic water for injection, usp when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in very small infants.
How Supplied:
How supplied store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] distributed by hospira, inc., lake forest, il 60045 usa lab-0977-2.0 revised: 08/2019 image1.jpg
Package Label Principal Display Panel:
Sample package label label1.jpg