SELENIUM injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SELENIOUS ACID (UNII: F6A27P4Q4R) (SELENIOUS ACID - UNII:F6A27P4Q4R)

Available from:

American Regent, Inc.

INN (International Name):

SELENIOUS ACID

Composition:

SELENIOUS ACID 65.4 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Selenium Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

Product summary:

Selenium Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental selenium 40 mcg/mL). NDC 0517-6510-25           10 mL Single Dose Vial           Packaged in boxes of 25 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). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN6510 Rev. 8/18

Authorization status:

unapproved drug other

Summary of Product characteristics

SELENIUM- SELENIUM INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SELENIUM INJECTION
RX ONLY
TRACE ELEMENT ADDITIVE FOR IV USE AFTER DILUTION
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
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/100 ML) (A)
WHOLE BLOOD
BLOOD CELLS
PLASMA/
SERUM
(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.
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)
—