Label: STERILE WATER- water injection, solution

  • NDC Code(s): 0641-6147-01, 0641-6147-10, 0641-6147-25
  • Packager: West-Ward Pharmaceuticals Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION

    This 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.

    Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. For intravenous injection, add sufficient solute to make an approximately isotonic solution.

    Water for Injection, USP is chemically designated H2O.

    The glass vial is a Type I borosilicate glass and meets the requirements according to the USP standards.

  • 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 for 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 Sterile 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 neonates or very small infants.

  • 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.

  • CONTRAINDICATIONS

    Sterile Water for Injection, USP must be made approximately isotonic prior to use.

  • WARNINGS

    Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.

  • PRECAUTIONS

    Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture.

    Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

    Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

    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

    Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

    Drug Interactions

    Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.

    Use aseptic technique for single or multiple entry and withdrawal from all containers.

    When diluting or dissolving drugs, mix thoroughly and use promptly.

    Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

    Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.

  • 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.

  • OVERDOSAGE

    Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGSPRECAUTIONS and ADVERSE REACTIONS.

  • 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.

    This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    Sterile Water for Injection, USP is supplied in the following:
        10 mL single dose vials packaged in cartons of 10 vials (NDC 0641-6147-10) and 25 vials (NDC 0641-6147-25)

    Storage

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.]  DO NOT FREEZE.

    To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For Product Inquiry call 1-877-845-0689.

    Manufactured by:

    WEST-WARD
    A HIKMA COMPANY
    Eatontown, NJ 07724 USA

    Revised July 2018

    462-682-01

  • PRINCIPAL DISPLAY PANEL

    WARNINGS: NOT ISOTONIC. HEMOLYTIC.
    NDC 0641-6147-01
    Rx only
    Sterile Water
    for Injection, USP
    FOR DRUG DILUENT USE ONLY
    10 mL Single Dose Vial
    Contains no antimicrobial
    or other added substance.
    Sterile, nonpyrogenic.
    Do not give intravenously
    unless rendered nearly
    isotonic.
    USUAL DOSAGE:
    See insert.
    Store at 20º to 25ºC (68º to 77ºF)
    [See USP]. DO NOT FREEZE.

    WARNINGS: NOT ISOTONIC. HEMOLYTIC. NDC 0641-6147-01 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 10 mL Single Dose Vial Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Do not give intravenously unless rendered nearly isotonic. USUAL DOSAGE: See insert. Store at 20º to 25ºC (68º to 77ºF) [See USP]. DO NOT FREEZE.

    NDC 0641-6147-25
    Rx only
    Sterile Water
    for Injection, USP
    FOR DRUG DILUENT USE ONLY
    25 x 10 mL Single Dose Vials
    Contains no antimicrobial or other added substance.
    Sterile, nonpyrogenic. Use only if clear and seal
    is intact and undamaged.
    Do not give intravenously unless rendered nearly
    isotonic. Use promptly; discard unused portion.
    USE ASEPTIC TECHNIQUE. Remove cover from
    vial and cleanse stopper with antiseptic.
    With Sterile Syringe and Needle:
    1. Aspirate desired portion of vial contents and
    add to suitable container.
    2. Discard any remaining fluid in vial.
    Store at 20º to 25ºC (68º to 77ºF)
    [See USP Controlled
    Room Temperature].
    DO NOT FREEZE.

    NDC 0641-6147-25 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 25 x 10 mL Single Dose Vials Contains no antimicrobial or other added substance. Sterile, nonpyrogenic. Use only if clear and seal is intact and undamaged. Do not give intravenously unless rendered nearly isotonic. Use promptly; discard unused portion. USE ASEPTIC TECHNIQUE. Remove cover from vial and cleanse stopper with antiseptic. With Sterile Syringe and Needle: 1. Aspirate desired portion of vial contents and add to suitable container. 2. Discard any remaining fluid in vial. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. DO NOT FREEZE.

  • PRINCIPAL DISPLAY PANEL

    NDC 0641-6147-10
    Rx only
    Sterile Water
    for Injection, USP
    FOR DRUG DILUENT USE ONLY
    10 x 10 mL Single Dose Vials
    Contains no antimicrobial or other added substance.
    Sterile, nonpyrogenic. Use only if clear and seal
    is intact and undamaged.
    Do not give intravenously unless rendered nearly
    isotonic. Use promptly; discard unused portion.
    USE ASEPTIC TECHNIQUE. Remove cover from
    vial and cleanse stopper with antiseptic.
    With Sterile Syringe and Needle:
    1. Aspirate desired portion of vial contents and
    add to suitable container.
    2. Discard any remaining fluid in vial.
    Store at 20º to 25ºC (68º to 77ºF)
    [See USP Controlled
    Room Temperature].
    DO NOT FREEZE.

     

    462-788-00

  • SERIALIZATION IMAGE

    Layout 1

  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0641-6147
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0641-6147-2525 in 1 CARTON09/03/2015
    1NDC:0641-6147-0110 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:0641-6147-1010 in 1 CARTON09/03/2015
    2NDC:0641-6147-0110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20636909/03/2015
    Labeler - West-Ward Pharmaceuticals Corp. (946499746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hikma Pharmaceuticals USA Inc.946499746ANALYSIS(0641-6147) , LABEL(0641-6147) , MANUFACTURE(0641-6147) , PACK(0641-6147)