Label: STERILE WATER- water injection
- NDC Code(s): 65219-187-01, 65219-187-10
- Packager: Fresenius Kabi USA, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 22, 2022
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- Official Label (Printer Friendly)
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DESCRIPTION
This preparation is designed solely for parenteral use only after addition to 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 IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.
Water for Injection, USP is chemically designated H 2O.
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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 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 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
- CONTRAINDICATIONS
- WARNINGS
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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
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.
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ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
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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 WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
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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.
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HOW SUPPLIED
Product
CodeUnit of Sale Volume Each 918510 NDC 63323-185-10
Unit of 2510 mL in a
10 mL vialNDC 63323-185-07
10 mL Single
Dose Vial918520 NDC 63323-185-20
Unit of 2520 mL in a
20 mL vialNDC 63323-185-08
20 mL Single
Dose Vial918550 NDC 63323-185-50
Unit of 2550 mL in a
50 mL vialNDC 63323-185-09
50 mL Single
Dose Vial187100 NDC 65219-187-10
Unit of 25100 mL in a
100 mL vialNDC 65219-187-01
100 mL Single Dose Vial18505 NDC 63323-185-05
Unit of 255 mL in a
6 mL vialNDC 63323-185-04
5 mL Single Dose VialStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Single dose use. No preservative added.
Unused portion of vial should be discarded.
Use only if solution is clear and seal intact.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STERILE WATER
water injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65219-187 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 1 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65219-187-10 25 in 1 TRAY 04/29/2022 1 NDC:65219-187-01 100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088400 04/29/2022 Labeler - Fresenius Kabi USA, LLC (013547657) Establishment Name Address ID/FEI Business Operations Fresenius Kabi USA, LLC 840771732 manufacture(65219-187) , analysis(65219-187)
