Sterile Water

STERILE WATER- water injection, solution
Medefil, Inc.

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. pH 5.0 to 7.0.

Water for Injection, USP is chemically designated H2O.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

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.

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.

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

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

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.

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.

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.

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.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

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.

Sterile Water for Injection, USP is supplied in the following:

Product NDC Number

Sterile Water for Injection, USP

1 mL, Single-dose pre-filled syriinge, carton of 10s

64523-020-41

Sterile Water for Injection, USP

2.5 mL, Single-dose pre-filled syringe, carton of 10s

64253-020-51

Sterile Water for Injection, USP

3 mL, Single-dose pre-filled syringe, carton of 10s

64253-020-61

Sterile Water for Injection, USP*

5 mL, Single-dose pre-filled syringe, carton of 10s

64253-020-71

Sterile Water for Injection, USP**

5 mL, Single-dose pre-filled syringe, carton of 10s

64253-020-81

Sterile Water for Injection, USP

10 mL, Single-dose pre-filled syringe, carton of 10s

64253-020-91

Sterile Water for Injection, USP

1 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-21

Sterile Water for Injection, USP

2.5 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-52

Sterile Water for Injection, USP

3 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-23

Sterile Water for Injection, USP*

5 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-25

Sterile Water for Injection, USP**

5 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-35

Sterile Water for Injection, USP

10 mL, Single-dose pre-filled syringe, carton of 60s

64253-020-30

*in 6 mL Syringe **in 12 mL Syringe

Discard unused portion

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Protect from freezing

Syringe Label -- 1 mL
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Box Label -- 1 mL
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Syringe Label -- 2.5 mL
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Box Label -- 2.5 mL
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Syringe Label -- 3 mL
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Box Label -- 3 mL
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Syringe Label -- 5 mL
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Box Label -- 5 mL
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Syringe Label -- 10 mL
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Box Label -- 10 mL
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Pouch Label -- 10 mL
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Syringe Label -- 5 mL
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Box Label -- 5 mL
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Dispenser Box Label -- 10 mL
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Package Insert Rev 002 -- Page 1
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Package Insert Rev 002-Page 2
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STERILE WATER
sterile water for injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64253-020
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 100 in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64253-020-21 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
1 1 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-21)
2 NDC:64253-020-23 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
2 3 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-23)
3 NDC:64253-020-30 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
3 10 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-30)
4 NDC:64253-020-35 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
4 5 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-35)
5 NDC:64253-020-52 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
5 2.5 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-52)
6 NDC:64253-020-25 60 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
6 5 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-25)
7 NDC:64253-020-91 10 SYRINGE, PLASTIC in 1 BOX contains a SYRINGE, PLASTIC
7 10 mL in 1 SYRINGE, PLASTIC This package is contained within the BOX (64253-020-91)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211188 01/27/2020
Labeler — Medefil, Inc. (016448669)
Establishment
Name Address ID/FEI Operations
Medefil, Inc. 016448669 manufacture (64253-020)

Revised: 09/2020 Medefil, Inc.

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