Sterile Water (Page 2 of 2)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Appropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. There are no available data on Sterile Water for Irrigation use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

8.2 Lactation

Risk Summary

Appropriate administration of Sterile Water for Irrigation is not expected to cause harm to a breastfed infant. There are no data on the presence of Sterile Water for Irrigation in either human or animal milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Sterile Water for Irrigation to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sterile Water for Irrigation and any potential adverse effects on the breastfed infant from Sterile Water for Irrigation or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, if there is excessive absorption of Sterile Water for Irrigation [see Warnings and Precautions (5.2)].

8.5 Geriatric Use

Sterile Water for Irrigation should be used cautiously in older patients. Geriatric patients are more likely to have decreased cardiac, renal, or hepatic function, and other diseases or concomitant drug therapy.

10 OVERDOSAGE

Excessive rate, volume, pressure or duration of irrigation with hypotonic fluid can result in excessive fluid absorption and permanent morbidity or death as a result of hyponatremia, hypoosmolality and/or fluid overload. In the event of clinically relevant absorption of Sterile Water for Irrigation, immediate intervention may be required [see Warnings and Precautions (5.2)].

11 DESCRIPTION

Sterile Water for Irrigation contains water that is sterilized and packaged for use as an irrigant. No antimicrobial agent or other substance has been added. The pH is 5.5 (5.0 to 7.0). Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the fluid significantly. Water in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

The plastic pour bottle is fabricated from specially formulated polyolefin. The polyolefin is a copolymer of ethylene and propylene. The container requires no vapor barrier.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sterile Water for Irrigation is supplied in single-dose plastic pour bottles and flexible plastic containers as follows:

Container

Product Codes

Fill Volume (mL)

NDC

Plastic Pour Bottle

2F7112

250

0338-0004-02

2F7113

500

0338-0004-03

2F7114

1000

0338-0004-04

2F7115

1500

0338-0004-05

Flexible Plastic Container

2B7114

1000

0338-0003-44

2B7116

2000

0338-0003-46

2B7117

3000

0338-0003-47

Storage

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

17 PATIENT COUNSELING INFORMATION

Inform patients, caregivers, or home healthcare providers of the following risks of Sterile Water for Irrigation:

Hypotonicity [see Warnings and Precautions (5.1)]
Excessive Water Absorption [see Warnings and Precautions (5.2)]

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA07-19-77-916

Baxter is a registered trademark of Baxter International Inc.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative bottle label 0338-0004-04
(click image for full-size original)

Container Label

2F7114 NDC 0338-0004-04

1000 mL

Baxter Logo

Not for Injection

For Irrigation Only

Sterile Water for
Irrigation USP

Prepared by distillation. No antimicrobial agent
or other substance has been added. pH 5.5 (5.0
to 7.0). Osmolarity 0 mOsmol/L (calc.). Sterile,
nonpyrogenic. Pour Bottle. Warning: This
solution is not isotonic and is hemolytic. Dosage
and Administration: As directed by a physician.
Cautions: Warm in oven to not more than 50ºC for
a maximum of 60 days. Discard after 60 days of
warming. Do not use unless solution is clear and
seal is intact. Discard unused portion.
Rx only. Recommended storage: Room
temperature (25ºC). Avoid excessive heat.

PL 325 Plastic

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA

LOT
EXP

FPO
(91)0709000246
Bar Code

07-09-00-0246

Bar Code Position Only*303380004041

Representative Container Label 0338-0003-46
(click image for full-size original)

LOT
EXP
2000 mL
NOT FOR INJECTION
2B7116
NDC 0338-0003-46
STERILE WATER
For Irrigation USP

For irrigation only Prepared by distillation
No antimicrobial agent or other substance has been added
pH 5.5 (5.0 TO 7.0). Osmolarity 0 mOsmol/L (calc) Sterile
Nonpyrogenic Single dose container

Do not use unless fluid is clear Discard unused portion

Cautions This fluid is not isotonic and is hemolytic
Squeeze and inspect inner bag which maintains product
sterility Discard if leaks are found Rx Only Store unit in
moisture barrier overwrap at room temperature (25ºC) until
Ready to use Avoid excessive heat See insert

Sterile Water
H2 0
For Irrigation USP

UROMATIC container

Baxter Logo
Baxter Healthcare Corporation
Deerfield IL 60015 USA

Made in USA

PL 146 Plastic

Baxter UROMATIC and
PL 146 are trademarks of
Baxter International Inc

For product information
1-800-933-0303

1800
1600
1400
1200
1000
800
600
400200

STERILE WATER water irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0003
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 100 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0003-44 14 BAG in 1 CARTON contains a BAG
1 1000 mL in 1 BAG This package is contained within the CARTON (0338-0003-44)
2 NDC:0338-0003-46 6 BAG in 1 CARTON contains a BAG
2 2000 mL in 1 BAG This package is contained within the CARTON (0338-0003-46)
3 NDC:0338-0003-47 4 BAG in 1 CARTON contains a BAG
3 3000 mL in 1 BAG This package is contained within the CARTON (0338-0003-47)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017866 05/30/1980
STERILE WATER water irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0004
Route of Administration IRRIGATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 100 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0004-02 24 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 250 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0338-0004-02)
2 NDC:0338-0004-03 18 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 500 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0338-0004-03)
3 NDC:0338-0004-04 12 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 1000 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0338-0004-04)
4 NDC:0338-0004-05 9 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 1500 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0338-0004-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017428 12/31/1974
Labeler — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS (0338-0003), ANALYSIS (0338-0004)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 001728059 ANALYSIS (0338-0004), MANUFACTURE (0338-0004), LABEL (0338-0004), PACK (0338-0004), STERILIZE (0338-0004)

Revised: 10/2017 Baxter Healthcare Corporation

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