Selenious Acid
Woodward Pharma Services Llc
Human Prescription Drug
NDC 69784-840Selenious Acid is a human prescription drug labeled by 'Woodward Pharma Services Llc'. National Drug Code (NDC) number for Selenious Acid is 69784-840. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Selenious Acid drug includes Selenium - 40 ug/mL . The currest status of Selenious Acid drug is Active.
Drug Information:
| Drug NDC: | 69784-840 |
| 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: | Selenious Acid |
| 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: | Selenious Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Woodward Pharma Services Llc |
| 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: | SELENIUM - 40 ug/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: | UNAPPROVED DRUG OTHER |
| 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: | 15 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 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. |
| 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: | Woodward Pharma Services LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 562352
|
| 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. |
| UPC: | 0369784840012
|
| UPC stands for Universal Product Code. |
| UNII: | H6241UJ22B
|
| 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 |
|---|
| 69784-840-05 | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (69784-840-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-840-01) | 15 Mar, 2022 | 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:
Selenious acid selenious acid selenium selenium water nitric acid
Indications and Usage:
Indications and usage selenium injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (tpn). administration of selenium in tpn solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Warnings:
Warning selenium injection can be toxic if given in excessive amounts. supplementation of tpn solution with selenium should be immediately discontinued if toxicity symptoms are observed. frequent determination of plasma selenium levels during tpn support and close medical supervision is recommended. selenium injection is a hypotonic solution and should be administered in admixtures only. 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
Read more...at even lower rates of administration.
Dosage and Administration:
Dosage and administration selenium injection provides 40 mcg selenium/ml. for metabolically stable adults receiving tpn, the suggested additive dosage level is 20 to 40 mcg selenium/day. for pediatric patients, the suggested additive dosage level is 3 mcg/kg/day. in adults, selenium deficiency states resulting from long-term tpn support, selenium as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity. aseptic addition of selenium injection to parenteral nutrition solutions under laminar flow hood is recommended. selenium is physically compatible with the electrolytes and other trace elements usually present in parenteral nutrition formulations. frequent monitoring of plasma selenium levels is suggested as a guideline for subsequent administration. the normal whole blood range for selenium is approximately 10 to 37 mcg/100 ml. do not directly mix asco
Read more...rbic acid injection with selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications:
Contraindications selenium injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Adverse Reactions:
Adverse reactions the amount of selenium present in selenium injection is small. symptoms of toxicity from selenium are unlikely to occur at the recommended dosage level. to report suspected adverse reactions, contact woodward pharma services llc at 1-888-514-4727 or fda at 1-800-fda-1088 or www.fda.gov/medwatch
Use in Pregnancy:
Pregnancy teratogenic effects pregnancy category c: selenium at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. there are however, no adequate and well controlled studies in pregnant women. selenium injection should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. presence of selenium in placenta and umbilical cord blood has been reported in humans.
Description:
Description selenium injection is a sterile, nonpyrogenic solution for use as an additive to solutions for total parenteral nutrition (tpn). each ml contains selenious acid 65.4 mcg (equivalent to elemental selenium 40 mcg/ml) and water for injection q.s. ph may be adjusted with nitric acid to 1.8 to 2.4.
Clinical Pharmacology:
Clinical pharmacology selenium is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism. prolonged tpn support in humans has resulted in selenium deficiency symptoms which include muscle pain and tenderness. the symptoms have been reported to respond to supplementation of tpn solutions with selenium. pediatric conditions, keshan disease, and kwashiorkor, have been associated with low dietary intake of selenium. the conditions are endemic to geographical areas with low selenium soil content. dietary supplementation with selenium salts has been reported to reduce the incidence of the conditions among affected children. normal blood levels of selenium in different human populations have been found to vary and depend on the selenium content of the food consumed. results of surveys carried out in some countries are tabulated below: country number of samples selenium (mcg/100ml) (a) whole blood blood cells plasma
Read more.../ serum canada 254 adults (37.9 ± 7.8) (23.6 ± 6.0) (14.4 ± 2.9) england 8 (b) 26 - 37 (32) - - guatemala & southern usa 10 adults 9 children (c) 19 - 28 (22) (23 ± 5) - (36 ± 12) - (15 ± 5) new zealand (d) 113 adults (5.4 ± 0.1) (6.6 ± 0.3) (4.3 ± 0.1) thailand 3 adults 9 children (e) 14.4 - 20.2 (12.0 ± 3.6) (f) 17.8 - 35.8 (19.5 ± 8.2) 8.1 - 12.5 (8.3 ± 2.2) usa 210 adults 15.7 - 25.6 (20.6) - - (a) mean values with or without standard deviation in parentheses, all other ranges. (b) age group unknown. (c) three children recovered from kwashiorkor and the other six under treatment for other diseases. (d) low selenium-content soil area. (e) well nourished children, three recovered from kwashiorkor and the other six under treatment for other diseases. (f) mean values from seven subjects. plasma selenium levels of 0.3 and 0.9 mcg/100 ml have been reported to produce deficiency symptoms in humans. selenium is eliminated primarily in urine. however, significant endogenous losses through feces also occur. the rate of excretion and the relative importance of two routes varies with the chemical form of selenium used in supplementation. ancillary routes of elimination are lungs and skin.
How Supplied:
How supplied selenium injection containing selenious acid 65.4 mcg/ml (equivalent to elemental selenium 40 mcg/ml). how supplied ndc number pharmacy bulk package 5 x 10 ml vials per carton 69784-840-05 pharmacy bulk package 10 ml single-use vial 69784-840-01 store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) (see usp controlled room temperature). manufactured for: woodward pharma services llc wixom, mi 48393 rev. 03/2022
Package Label Principal Display Panel:
Prinicipal display panel - vial labeling ndc 69784-840-01 10 ml single use vial rx only selenious acid injection, usp 400 mcg*/10 ml (40 mcg*/ml) of selenium for intravenous use after dilution and admixing preservative free. 10 ml pharmacy bulk package vial label 10 ml
Prinicipal display panel - carton labeling ndc 69784-840-05 rx only selenious acid injection, usp 400 mcg*/10 ml (40 mcg*/ml) of selenium for intravenous use after dilution and admixing sterile preservative free. 5x 10 ml vials pharmacy bulk package carton labeling (5 pack)