Sterile Water

STERILE WATER- water injection
Fresenius Kabi USA, LLC

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 2 O.

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 newborns 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 must be made approximately isotonic prior to use.

WARNINGS

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

Where Water for Injection is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used.

PRECAUTIONS

General

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.

Drug Interactions

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

Pregnancy Category C

Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether Sterile Water for Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection should be given to a pregnant woman only if clearly needed.

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.

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 newborn 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).

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.

Use aseptic technique for single entry and withdrawal from all containers. Single dose vials should be entered just once.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Product

No.

NDC

No.

Volume

918501

63323-185-01

1 mL in a 3 mL vial

918510

63323-185-10

10 mL in a 10 mL vial

918520

63323-185-20

20 mL in a 20 mL vial

918550

63323-185-50

50 mL in a 50 mL vial

Packaged in a plastic vial. Vials are packaged 25 vials per tray.

Store 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.

logo

45768F

Revised: July 2008

PACKAGE LABEL — PRINCIPAL DISPLAY — STERILE WATER — 10 mL Single Dose Vial Label

NDC 63323-185-10

918510

Sterile Water for Injection, USP

FOR DRUG DILUENT USE ONLY

Rx only

10 mL Single Dose Vial

918510-vial
(click image for full-size original)
STERILE WATER
water injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-185
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-185-10 25 VIAL in 1 TRAY contains a VIAL
1 10 mL in 1 VIAL This package is contained within the TRAY (63323-185-10)
2 NDC:63323-185-50 25 VIAL in 1 TRAY contains a VIAL
2 50 mL in 1 VIAL This package is contained within the TRAY (63323-185-50)
3 NDC:63323-185-20 25 VIAL in 1 TRAY contains a VIAL
3 20 mL in 1 VIAL This package is contained within the TRAY (63323-185-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088400 09/05/2000
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 manufacture (63323-185)

Revised: 10/2019 Fresenius Kabi USA, LLC

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