Sterile Water for Injection USP

STERILE WATER- water solution 
B. Braun Medical Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

 PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Warning

Hypotonic and hemolytic. For prescription compounding of parenteral nutrition solutions. Do not inject until made approximately isotonic by addition of appropriate solute.

DESCRIPTION

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion.

Sterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent or solvent suitable for intravascular injection after first having been made approximately isotonic by addition of suitable solute.

pH 6.0 (5.0–7.0)

CLINICAL PHARMACOLOGY

Sterile Water for Injection USP is used as a diluent or solvent for other parenteral drugs. As such, Sterile Water for Injection USP contributes to the water of hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to approximate isotonicity.

INDICATIONS AND USAGE

Sterile Water for Injection USP is indicated for use in adults and pediatric patients as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration.

CONTRAINDICATIONS

None known.

WARNINGS

Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of an appropriate solute, due to the possibility of hemolysis.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

To minimize the risk of possible incompatibilities arising from the mixing of additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Do not use unless solution is clear, closure is intact and vacuum is present. Discard container and unused contents within 12 hours of initial entry.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Refer to the Package Insert of the solute used.

Usage In Pregnancy

Refer to the Package Insert of the solute used.

Nursing Mothers

Refer to the Package Insert of the solute used.

Pediatric Use

Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum.

Geriatric Use

Refer to the Package Insert of the solute used. See WARNINGS section regarding aluminum.

ADVERSE REACTIONS

Refer to the Package Insert of the solute used.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

Overdosage (hypotonic expansion) is a function of an increase in fluid intake over fluid output, and occurs when the increase in the volume of body fluids is due to water alone. Overdosage may occur in patients who receive large quantities of electrolyte-free water to replace abnormal excessive fluid losses, in patients whose renal tolerance to water loads is exceeded, or in patients who retain water postoperatively in response to stress.

Manifestations of water intoxication are behavioral changes (confusion, apathy, disorientation and attendant hyponatremia), central nervous system disturbances (weakness, muscle twitching, headaches, nausea, vomiting, convulsions) and weight gain.

Treatment consists of withholding fluids until excessive water is excreted. In severe hyponatremia it may be necessary to cautiously administer hypertonic saline to increase extracellular osmotic pressure and excretion of excess water by the kidneys.

DOSAGE AND ADMINISTRATION

Not for direct patient injection.

For use as a diluent or solvent in the aseptic preparation of parenteral solutions or as a vehicle for drug administration. Do not inject until made approximately isotonic by addition of appropriate solute.

The dosage and administration of Sterile Water for Injection USP is dependent upon the recommended dosage and administration of the solute used. Fluid administration should be based on calculated maintenance or replacement fluid requirement for each patient.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

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

HOW SUPPLIED

Sterile Water for Injection USP is supplied sterile and nonpyrogenic in glass containers, Pharmacy Bulk Packages. The 1000 mL and 2000 mL containers are packaged 6 per case, and the 500 mL containers are packaged 12 per case.

NDC Cat. No. Size
 Sterile Water for Injection USP  
 0264-9200-55 S9200-SS 1000 mL
 0264-9201-55 S9201-SS   500 mL
 0264-9205-55 S9205-SS 2000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Rx only

Revised: March 2009

Directions for Use of Pharmacy Bulk Packagesin B. Braun Glass Containers

Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion.

Warning: Hypotonic and hemolytic. Do not inject until made approximately isotonic by addition of appropriate solute.

The pharmacy bulk package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood. Additives should not be made to Pharmacy Bulk Packages.

Designed for use with a vented sterile dispensing set. Use 18 to 22 gauge needle size for spiking/admixing or withdrawing solutions from the glass bottle.

Before use, perform the following checks:

  1. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
  2. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
  3. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away.
    Figure 1
  4. Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface.
  5. Check for vacuum at first puncture of stopper. Insert the spike fully into the outlet port of the stopper (See Figure 2) and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present. Refer to Directions for Use of set to be used.
    Figure 2
  6. If set insertion is not performed immediately following removal of protective metal disk, swab stopper with a suitable disinfectant.

Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.
Do not store.

After admixture and during use, reinspect the solution frequently. If any evidence of solution contamination or instability is found, discontinue use immediately.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y36-002-682

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

1000 mL

NDC 0264-9200-55
S9200-SS

Sterile Water for
Injection USP

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

WARNING: Hypotonic and hemolytic. Do not inject until made
approximately isotonic by addition of appropriate solute.

B. Braun Medical Inc.
Irvine, CA USA 92614-5895

Opened:   Date                                  Time

No antimicrobial or other substance has been added.

pH: 6.0 (5.0-7.0)
Contains no more than 25 μg/L of aluminum.

Sterile, nonpyrogenic.
Dosage and Administration:
See Package Insert.

Caution: Do not use unless solution is clear, closure is intact
and vacuum is present.

Discard container and unused contents within 12 hours
of initial entry.

Recommended Storage:
Room temperature (25°C). Avoid excessive heat.
Protect from freezing.
See Package Insert.

Rx only

Made in USA
Y37-002-142

Principal Display Panel - 1000 mL Container Label

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

500 mL

NDC 0264-9201-55
S9201-SS

Sterile Water for
Injection USP

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

WARNING: Hypotonic and hemolytic. Do not inject until made
approximately isotonic by addition of appropriate solute.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA

Opened:       Date                                         Time

No antimicrobial or other substance has been added.

pH: 6.0 (5.0-7.0)

Contains no more than 25 μg/L of aluminum.

Sterile, nonpyrogenic.

Dosage and Administration:
See Package Insert.

Caution: Do not use unless solution is clear, closure is intact
and vacuum is present.

Discard container and unused contents within 12 hours
of initial entry.

Recommended Storage:
Room temperature (25°C).
Avoid excessive heat. Protect from freezing.
See Package Insert.

Rx only

Made in USA
Y37-002-279  LD-282-1

500 mL Container Label S9201-SS

PRINCIPAL DISPLAY PANEL - 2000 mL Container Label

2000 mL

NDC 0264-9205-55
S9205-SS

Sterile Water for Injection USP

PHARMACY BULK PACKAGE        NOT FOR DIRECT INFUSION

B. Braun Medical Inc.
Irvine, CA USA 92614-5895

Opened:    Date                               Time

WARNING:
Hypotonic and hemolytic.
For prescription
Compounding of parenteral
nutrition solutions. Do not
inject until made
approximately isotonic by
addition of appropriate
solute.

No antimicrobial or other substance
has been added.
pH: 6.0 (5.0-7.0)
Contains no more than 25 μg/L of aluminum.
Sterile, nonpyrogenic.

Dosage and Administration:
See Package Insert.

Caution: Do not use unless solution is clear, closure is intact and vacuum is present.

Discard container and unused contents within 12 hours of initial entry.

Recommended Storage:
Room temperature (25°C). Avoid excessive heat. Protect from freezing.
See Package Insert.

Rx only

Made in USA
Y37-002-144

Principal Display Panel - 2000 mL Container Label
STERILE WATER 
water solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0264-9200
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER1 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:0264-9200-556 in 1 CASE
11000 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/24/201009/01/2013
STERILE WATER 
water solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0264-9201
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER1 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:0264-9201-5512 in 1 CASE
1500 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/07/201109/01/2013
STERILE WATER 
water solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0264-9205
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER1 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:0264-9205-556 in 1 CASE
12000 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER06/24/201009/01/2013
Labeler - B. Braun Medical Inc. (002397347)

Revised: 03/2013
 
B. Braun Medical Inc.