Sterile Water
Water
Icu Medical Inc.
Human Prescription Drug
NDC 0990-7118Sterile Water also known as Water is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Sterile Water is 0990-7118. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Sterile Water drug includes Water - 1 mL/mL . The currest status of Sterile Water drug is Active.
Drug Information:
| Drug NDC: | 0990-7118 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sterile Water |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Water |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Icu Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | WATER - 1 mL/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA019869 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | ICU Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 059QF0KO0R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0990-7118-07 | 6 BAG in 1 CASE (0990-7118-07) / 2000 mL in 1 BAG | 01 Jun, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sterile water water water water
Boxed Warning:
Pharmacy bulk package â not for direct infusion. for use only with automated compounding devices.
Indications and 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.
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 co
Read more...ntain 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.
Dosage and 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 d
Read more...o 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.
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.
Description:
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.
Clinical Pharmacology:
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.
How Supplied:
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
Package Label Principal Display Panel:
Principal display panel - 2000 ml bag label 2000 ml ndc 0990-7118-07 sterile water for injection, usp pharmacy bulk package â 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