FDA Label for Sterile Water
View Indications, Usage & Precautions
Sterile Water Product Label
The following document was submitted to the FDA by the labeler of this product Fresenius Kabi Usa, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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
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.
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.
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 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.
This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
How Supplied
| Product Code | Unit of Sale | Volume | Each |
| 918510 | NDC 63323-185-10 Unit of 25 | 10 mL in a 10 mL vial | NDC 63323-185-07 10 mL Single Dose Vial |
| 918520 | NDC 63323-185-20 Unit of 25 | 20 mL in a 20 mL vial | NDC 63323-185-08 20 mL Single Dose Vial |
| 918550 | NDC 63323-185-50 Unit of 25 | 50 mL in a 50 mL vial | NDC 63323-185-09 50 mL Single Dose Vial |
| 187100 | NDC 65219-187-10 Unit of 25 | 100 mL in a 100 mL vial | NDC 65219-187-01
100 mL Single Dose Vial |
| 18505 | NDC 63323-185-05 Unit of 25 | 5 mL in a 6 mL vial | NDC 63323-185-04 5 mL Single Dose 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.
Other
Lake Zurich, IL 60047
www.fresenius-kabi.com/us
45768H
Revised: April 2022
Package Label.Principal Display Panel
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label
NDC 63323-185-07
918510
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
10 mL Single Dose Vial
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label
NDC 63323-185-10
918510
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
10 mL Single Dose Vial
25 Vials
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label
NDC 63323-185-08
918520
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
20 mL Single Dose Vial
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label
NDC 63323-185-20
918520
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
20 mL Single Dose Vial
25 Vials
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label
NDC 63323-185-09
918550
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
50 mL Single Dose Vial
PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label
NDC 63323-185-50
918550
STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
50 mL Single Dose Vial
25 Vials
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label
NDC 63323-185-04
18505
STERILE WATER
FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
5 mL Single Dose Vial
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label
NDC 63323-185-05
18505
STERILE WATER
FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
5 mL Single Dose Vial
25 Vials
* Please review the disclaimer below.