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| Product NDC Code | 0990-7118 | ||||
|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| Application Number | NDA019869 | ||||
| Labeler Name | ICU Medical Inc. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Sterile Water for Injection, USP is a sterile, nonpyrogenic water for injection intended only for dilution purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. Sterile Water for Injection, USP contains no bacteriostat, antimicrobial agent or added buffer. Sterile Water for Injection, USP may be classified as a sterile diluent and pharmaceutical vehicle. Sterile Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique 1. During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood. 2. Remove cover from outlet port at bottom of container. 3. Insert piercing pin of transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. 4. Sequentially dispense aliquots of Sterile Water for Injection, USP into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Sterile Water WATER WATER WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 2000 mL NDC 0990-7118-07 STERILE WATER FOR INJECTION, USP PHARMACY BULK PACKAGE — Not For Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES. STERILE, NONPYROGENIC. pH 5.4 (5.0 TO 7.0). INDICATIONS: FOR PREPARATION OF INTRAVENOUS ADMIXTURES USING AUTOMATED COMPOUNDING DEVICES. CONTRAINDICATIONS: NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: NOT ISOTONIC. HEMOLYTIC. DO NOT HEAT OVER 66°C (150°F). CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. SEE INSERT FOR COMPLETE INFORMATION. DATE ENTERED:___________________________ TIME OF ENTRY:___________________________ CAUTION: USE ONLY IN LAMINAR FLOW HOOD. ONCE THE OUTLET SITE HAS BEEN ENTERED, THE WITHDRAWAL OF CONTAINER CONTENTS SHOULD BE PROMPTLY COMPLETED IN ONE CONTINUOUS OPERATION. DISCARD CONTAINER NOT LATER THAN 4 HOURS AFTER INITIAL CLOSURE PUNCTURE. SEE INSERT. CONTAINS NO MORE THAN 25 mcg/L OF ALUMINUM. Rx ONLY 3 V CONTAINS DEHP IM-4366 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label
PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM 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. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Flexible Container R x only
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Sterile Water for Injection, USP is supplied in 2000 mL flexible Pharmacy Bulk Packages. NDC No. Product Container Size (mL) 0409-7118-07 Sterile Water for Injection, USP 2000 0990-7118-07 Sterile Water for Injection, USP 2000 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Patent 4,368,765 Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4665
| NDC No. | Product | Container Size (mL) |
|---|---|---|
| 0409-7118-07 | Sterile Water for Injection, USP | 2000 |
| 0990-7118-07 | Sterile Water for Injection, USP | 2000 |
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.Pharmacy Bulk Package — Not for Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Do not use unless water is clear, seal is intact and container is undamaged. Aseptic technique is essential with the use of sterile preparations for compounding admixtures. Discard container within 4 hours of entering closure.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API