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:
| 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
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
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
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STERILE WATER water irrigant | |||||||||||||||||||||||||||||||||||||||||
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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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