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| Product NDC Code | 0990-7990 | ||||
|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | INTRAVENOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| Application Number | NDA018233 | ||||
| Labeler Name | ICU Medical Inc. | ||||
| Packages |
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Overdosage of Sterile Water
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS .)
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 Reactions which may occur because of 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. 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.
Sterile Water Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, 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 and container permit. (See PRECAUTIONS ).
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY When administered intravenously as a vehicle for drugs, sterile water for injection provides a source of water for parenteral fluid replenishment after sufficient solute is introduced to achieve an osmolarity of 112 mOsmol or more per liter. 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 Do not administer without the addition of a solute.
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, solute-free preparation of distilled water for injection. It is for use only as a sterile solvent or diluent vehicle for drugs or solutions suitable for parenteral administration. The pH is 5.5 (5.0 to 7.0). Sterile Water for Injection contains no bacteriostat, antimicrobial agent or added buffer and is intended only for single-dose injection after admixture with an appropriate solute or solution. When smaller amounts are required, the unused portion should be discarded. Sterile Water for Injection is a pharmaceutic aid (vehicle) and parenteral fluid replenisher after addition of an appropriate solute. 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 chemical components of the plastic 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 Following suitable admixture of prescribed additive, the dose is usually dependent upon the age, weight and clinical condition of the patient.
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 is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.
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 - 1000 mL Bag Label 1000 mL NDC 0990-7990-09 STERILE WATER for Injection, USP DO NOT GIVE INTRAVENOUSLY. FOR DRUG DILUENT USE ONLY. CONTAINS NO ANTIMICROBIAL OR OTHER SUBSTANCE. ADMIXTURES SHOULD BE USED PROMPTLY WITH ADEQUATE PRECAUTIONS FOR MAINTAINING STERILITY. WARNINGS: NOT ISOTONIC. HEMOLYTIC. ADDITIVES MAY BE INCOMPATIBLE. CONSULTATION WITH A PHARMACIST IS RECOMMENDED. WHEN INTRODUCING ADDITIVES, USE ASEPTIC TECHNIQUE, MIX THOROUGHLY AND DO NOT STORE. SINGLE-DOSE CONTAINER. FOR INTRAVENOUS USE. DO NOT GIVE INTRAVENOUSLY UNLESS RENDERED NEARLY ISOTONIC. USUAL DOSAGE: SEE INSERT. STERILE, NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. pH 5.5 (5.0 to 7.0) RX ONLY 3 V CONTAINS DEHP icumedical IM-4423 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label
PRINCIPAL DISPLAY PANEL - 1000 mL Bag Overwrap 2 HDPE TO OPEN TEAR AT NOTCH 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 - 1000 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.FOR DRUG DILUENT USE ONLY Flexible Plastic Container Rx 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 a single-dose 1000 mL flexible plastic container (NDC 0409-7990-09 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA , Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA and 0990-7990-09 , ). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. 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. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly. Preparation for Administration (Use aseptic technique) Close flow control clamp of administration set. Remove cover from outlet port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber. Open flow control clamp and clear air from set. Close clamp. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. Regulate rate of administration with flow control clamp. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: September, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4689
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Do not use for intravenous injection unless the osmolar concentration of additives totals at least 112 mOsmol/liter (two-fifths of the normal osmolarity of the extracellular fluid — 280 mOsmol/liter). Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy Category C: Animal reproduction studies have not been conducted with sterile water for injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile water for injection with additives should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. This product contains no more than 25 mcg/L of aluminum.
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 DRUG DILUENT USE ONLY. Intravenous administration of Sterile Water for Injection, USP without additives may result in hemolysis. The intravenous administration of sterile water for injection 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 parenteral 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.
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