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Sterile Water for Injection USP | Sterile Water [B. Braun Medical Inc.] | BioPortfolio

12:51 EST 27th January 2019 | BioPortfolio
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Warning: Hypotonic and hemolytic.Do not inject until made approximately isotonic by addition of appropriate solute.

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 the addition of suitable solute.

pH: 5.5 (5.0–7.0)

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

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 for hydration when provided in parenteral drug and fluid therapy, after the introduction of suitable additives and/or mixture with suitable solutes to approximate isotonicity.

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.

None known.

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.

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 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

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.

Do not use plastic containers in series connection.

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. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

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.

Use only if solution is clear and container and seals are intact.

The drug product contains no more than 25 µg/L of aluminum.

Refer to the package insert of the solute used.

Refer to the package insert of the solute used.

Refer to the package insert of the solute used.

Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.

Refer to the package insert of the solute used. See WARNINGS section regarding aluminum.

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 (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.

This solution is for intravenous use only. 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 requirements 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 administration, whenever solution and container permit.

Sterile Water for Injection USP is supplied sterile and nonpyrogenic in EXCEL Containers. The 1000 mL containers are packaged 12 per case; the 500 mL and 250 mL containers are packaged 24 per case.

NDC REF Size
 Sterile Water for Injection USP
(Canada DIN 01927930)
 0264-7850-00  L8500  1000 mL
 0264-7850-10       L8501-01    500 mL
 0264-7850-20  L8502    250 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.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Revised: February 2015

EXCEL is a registered trademark of B. Braun Medical Inc.

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

Caution: Do not use plastic containers in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE: Before use, perform the following checks:

Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact.

Preparation for Administration

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

To Add Medication During Solution Administration

B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA1-800-227-2862www.bbraun.com

In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4

Y36-002-891 LD-241-2

Sterile Water forInjection USP

Warning: Hypotonic and hemolytic.Do not inject until made approximatelyisotonic by addition ofappropriate solute. Y94-003-264   LD-271-2

REF L8500NDC 0264-7850-00DIN 01927930

1000 mL EXCEL CONTAINER

No antimicrobial or other substance has been added.

pH: 5.5 (5.0-7.0)

Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact.

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

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

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA1-800-227-2862www.bbraun.com

In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4

Y94-003-263   LD-131-3

EXPLOT

Sterile Water for Injection USP

Warning: Hypotonic and hemolytic.Do not inject until made approximately isotonic by addition of appropriate solute. Y94-003-342 LD-272-3

REF L8501-01NDC 0264-7850-10DIN 01927930

500 mL EXCEL CONTAINER

No antimicrobial or other substance has been added.

pH: 5.5 (5.0-7.0)

Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact.

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

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

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA1-800-227-2862www.bbraun.com

In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4

Y94-003-265 LD-130-3

EXPLOT

Sterile Water for Injection USP

Warning: Hypotonic and hemolytic.Do not inject until made approximatelyisotonic by addition of appropriate solute. Y94-003-214   LD-273-2

REF L8502NDC 0264-7850-20DIN 01927930

250 mL EXCEL CONTAINER

No antimicrobial or other substance has been added.

pH: 5.5 (5.0-7.0)

Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact.

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

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

Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Not made with natural rubber latex, PVC or DEHP.

Rx only

EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA1-800-227-2862www.bbraun.com 

In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4

Y94-003-213   LD-129-3

EXPLOT

Manufacturer

B. Braun Medical Inc.

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