Sterile Water 100 mL/100mL
Sterile Water · IRRIGANT · B. Braun Medical Inc.
Sterile Water is a irrigant containing sterile water at 100 mL/100mL, taken irrigation. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- Sterile Water
- Generic Name
- Sterile Water
- NDC Code (Product)
0264-7386- Manufacturer
- B. Braun Medical Inc.
- Strength
- 100 mL/100mL
- Dosage Form
- IRRIGANT
- Route
- IRRIGATION
- Marketing Status
- Application #
- NDA016734
- Marketing Start
- 09/13/2013
Recall History
IntegraDose Compounding Services LLC
Lack of sterility assurance.
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Lack of sterility assurance.
Advanced Physician Solutions, Inc.
Lack of Assurance of Sterility
Pentec Health
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Leiter's Compounding
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
IntegraDose Compounding Services LLC
Lack of Assurance of Sterility: leaking bags
John W Hollis Inc
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Walgreens Infusion Services
Lack of sterility assurance.
Advanced Physician Solutions, Inc.
Lack of Assurance of Sterility
Nephron Sc Inc
CGMP Deviations: Potential product carryover.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.
Dosage & Administration
DOSAGE AND ADMINISTRATION Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. Sterile Water for Injection, USP is not intended for direct infusion. Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. Drug Interactions The Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous admixtures using automated compounding devices. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS. Some opacity …
Warnings
WARNINGS FOR DILUTION ONLY. Do not heat over 66°C (150°F). This preparation is solute-free and its entry into the circulation undiluted will cause hemolysis . Absorption of large amounts of Sterile Water for Injection, USP with additives can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. 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 …
Contraindications
CONTRAINDICATIONS NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.
Adverse Reactions
ADVERSE REACTIONS Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.
Frequently Asked Questions
What is Sterile Water used for?
Sterile Water contains Sterile Water. It is a irrigant taken irrigation. Consult your doctor for specific uses.
Is Sterile Water a controlled substance?
Sterile Water is not classified as a controlled substance by the DEA.
What is the generic name for Sterile Water?
The generic name for Sterile Water is Sterile Water. There are 6 other brand versions of Sterile Water.
What is the NDC code for Sterile Water 100 mL/100mL?
The NDC (National Drug Code) for Sterile Water 100 mL/100mL is 0264-7386, listed by B. Braun Medical Inc..