Glycine
B. Braun Medical Inc.
Human Prescription Drug
NDC 0264-7390Glycine is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Glycine is 0264-7390. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Glycine drug includes Glycine - 1.5 g/100mL . The currest status of Glycine drug is Active.
Drug Information:
| Drug NDC: | 0264-7390 |
| 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: | Glycine |
| 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: | Glycine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | B. Braun Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| 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: | GLYCINE - 1.5 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | IRRIGATION
|
| 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: | 04 Dec, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | NDA016784 |
| 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: | B. Braun Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310571
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | TE7660XO1C
|
| 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 |
|---|
| 0264-7390-60 | 4 CONTAINER in 1 CASE (0264-7390-60) / 3000 mL in 1 CONTAINER | 04 Dec, 2013 | 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:
Glycine glycine glycine glycine water
Indications and Usage:
Indications and usage 1.5% glycine irrigation usp is indicated as an irrigant during transurethral prostatic or bladder surgery.
Warnings:
Warnings solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. the amount of fluid absorbed during a transurethral resection is a function of the volume and hydrostatic pressure of the irrigant used, the number and size of venous sinuses opened, and the duration of the procedure. since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug. absorption of large amounts of fluids containing glycine and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics. absorption of large amounts of irrigating solution can also result in pronounced hyponatremia and water intoxication. after opening container, the contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. discard unused portion of irrigating
Read more...solution since it contains no preservative.
Dosage and Administration:
Dosage and administration as required for irrigation. 1.5% glycine irrigation usp should be administered only by the appropriate transurethral urologic instrumentation. it has been reported that absorption is significantly increased if the container is higher than 60 cm (24 inches) above the patient. this drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications 1.5% glycine irrigation usp is not for injection. it is contraindicated in patients with anuria.
Adverse Reactions:
Adverse reactions adverse reactions may include fluid and electrolyte disorders such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain and thrombophlebitis; other possible reactions include visual disturbances, convulsions, nausea, vomiting, diarrhea, vertigo and urticaria. literature includes reports on hyponatremia, hyperammonemia, transient blindness, coma (immediate or delayed), and digitalis toxicity in digitalized patients. if an adverse reaction occurs, discontinue the irrigant and reevaluate the clinical status of the patient.
Description:
Description each 100 ml contains: glycine usp ..................................................................................... 1.5 g water for injection usp ................................................................... qs ph: 6.1 (4.5-6.5) calculated osmolarity: 200 mosmol/liter the formula of the active ingredient is: ingredient molecular formula molecular weight glycine usp nh 2 ch 2 cooh 75.07 1.5% glycine irrigation usp is a sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. this solution is slightly hypotonic. the plastic container is made from a multilayered film specifically developed for parenteral drugs. it contains no plasticizers and exhibits virtually no leachables. the solution contact layer is a rubberized copolymer of ethylene and propylene. the container is nontoxic and biologically inert. the container-solution unit is a closed system and is not dependent upon entry of external air during administration. the container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. not made with natural rubber latex, pvc or dehp.
Clinical Pharmacology:
Clinical pharmacology 1.5% glycine irrigation usp is nontoxic and nonhemolytic with a refractive index close to that of water. these properties make it useful as a urologic irrigating fluid, particularly during transurethral surgical procedures where the irrigant may be absorbed through cut venous sinuses. systemically absorbed glycine is primarily metabolized by transamination to serine, and by deamination to ammonia which is normally removed by its conversion to urea. a portion of the absorbed glycine is excreted by the kidneys.
How Supplied:
How supplied 1.5% glycine irrigation usp is supplied sterile and nonpyrogenic in single-dose 3000 ml flexible irrigation containers packaged 4 per case. ndc ref size 0264-7390-60 r8406 3000 ml exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. it is recommended that the product be stored at room temperature (25°c); however, brief exposure up to 40°c does not adversely affect the product. do not warm container over 150°f (66°c).
Spl Patient Package Insert:
Instructions for preparation and administration for irrigation use only. not for injection. not for use with pressurized irrigation systems. aseptic technique is required. inspect irrigation bag: overwrap and primary bag. do not use if overwrap has been damaged. do not use unless solution is clear and closure is intact. 1. to open: tear overwrap starting from the tear notches. (figure 1) 2. prepare medication port by removal of aluminum foil. (figure 2a) puncture resealable medication port by using 19 â 22 gauge needle and inject additive(s). (figure 2b) medication port must be swabbed with disinfection agent before re-puncturing. mix solution and medication thoroughly. (figure 3a) check admixture visually for particulate matter. (figure 3b) 3. remove aluminum foil from outlet/set port at the bottom of container (figure 4a) and attach administration set (figure 4b): use non-vented infusion set or close air vent on a vented set. refer to directions for use accompanying the administ
Read more...ration set. 4. hang bag on iv pole. (figure 5) tear notches, overwrap illustration figure 1 illustration figure 2 illustration figure 3 illustration figure 4 illustration figure 5 illustration
Package Label Principal Display Panel:
Principal display panel - 3000 ml 1.5% glycine irrigation usp for urologic irrigation ref r8406 ndc 0264-7390-60 lot exp. 3000 ml each 100 ml contains: glycine usp 1.5 g water for injection usp qs ph: 6.1 (4.5-6.5) calc. osmolarity: 200 mosmol/liter not for injection. use only if solution is clear and container and seal are intact. warning: do not warm container over 150°f (66°c). sterile, nonpyrogenic. single unit container. discard unused portion. use aseptic technique. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. do not remove overwrap until ready for use. see package insert. not made with natural rubber latex, pvc or dehp. rx only y38-000-067 ld-257-6 set b. braun medical inc. bethlehem, pa 18018-3524 usa 1-800-227-2862 y38-000-067 recycle symbol set picture r8406 container label