MAGNESIUM SULFATE IN WATER- magnesium sulfate injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)

Boleh didapati daripada:

WG Critical Care, LLC

INN (Nama Antarabangsa):

MAGNESIUM SULFATE HEPTAHYDRATE

Komposisi:

MAGNESIUM SULFATE HEPTAHYDRATE 4 g in 100 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose. Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

Ringkasan produk:

Magnesium Sulfate in Water for Injection is supplied in single-dose bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex. Magnesium Sulfate in Water for Injection is available as follows: NDC No. Packaging Configuration Total Magnesium Sulfate** Total Magnesium Ion Magnesium Sulfate** Concentration Magnesium Ion Concentration 44567-421-24 1 single-dose bag 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 44567-421-24 24 bags per carton 44567-422-24 1 single-dose bag 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 44567-422-24 24 bags per carton 44567-423-10 1 single-dose bag 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 44567-423-10 10 bags per carton 44567-420-24 1 single-dose bag 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/100 mL 44567-420-24 24 bags per carton 44567-424-24 1 single-dose bag 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/100 mL 44567-424-24 24 bags per carton * Partial fill container 50 mL volume in 100 mL container. ** As the heptahydrate. 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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MAGNESIUM SULFATE IN WATER- MAGNESIUM SULFATE INJECTION
WG CRITICAL CARE, LLC
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MAGNESIUM SULFATE IN WATER FOR INJECTION
DESCRIPTION
Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic
solution of
magnesium sulfate heptahydrate in water for injection. May contain
sulfuric acid and/or
sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is
available in 4% and
8% concentrations. SeeHOW SUPPLIEDsection for the content and
characteristics of
available dosage forms and sizes.
Magnesium Sulfate, USP heptahydrate is chemically designated MgSO •
7H O, colorless
crystals or white powder freely soluble in water.
Water for Injection, USP is chemically designated H O.
The single port bag is made of Nexcel M312A material, a 5-layer,
polyolefin based on co-
extrude film. Water can permeate from inside the container into the
overwrap but not in
amounts sufficient to affect the solution significantly. Solutions in
contact with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the plastic
container materials.
Exposure to temperatures above 25°C/77°F during transport and
storage will lead to
minor losses in moisture content. Higher temperatures lead to greater
losses. It is
unlikely that these minor losses will lead to clinically significant
changes within the
expiration period.
CLINICAL PHARMACOLOGY
Magnesium (Mg
) is an important cofactor for enzymatic reactions and plays an
important role in neurochemical transmission and muscular
excitability.
Magnesium prevents or controls convulsions by blocking neuromuscular
transmission
and decreasing the amount of acetylcholine liberated at the end plate
by the motor
nerve impulse. Magnesium is said to have a depressant effect on the
central nervous
system, but it does not adversely affect the mother, fetus or neonate
when used as
directed in eclampsia or pre-eclampsia. Normal serum magnesium levels
range from 1.3
to 2.1 mEq/liter.
As