MAGNESIUM SULFATE IN 5% DEXTROSE- magnesium sulfate heptahydrate injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Fresenius Kabi USA, LLC

INN (International Name):

MAGNESIUM SULFATE HEPTAHYDRATE

Sammensetning:

MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 100 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Magnesium sulfate in 5% dextrose injection, USP is indicated for the prevention and control of seizures in pre-eclampsia 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.

Produkt oppsummering:

Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose flexible plastic container as follows: *As the heptahydrate. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MAGNESIUM SULFATE IN 5% DEXTROSE- MAGNESIUM SULFATE
HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP
_FOR INTRAVENOUS USE ONLY_
Rx only
DESCRIPTION
Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution of
magnesium sulfate heptahydrate and dextrose in water for injection.
Each 100 mL
contains 1 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g
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 a 1% concentration. See HOW
SUPPLIED section for
the content and characteristics of available dosage form and size.
Magnesium sulfate, USP heptahydrate is chemically designated MgSO
• 7H
O,
colorless crystals or white powder freely soluble in water.
Dextrose, USP is chemically designated D-glucose, monohydrate, a
hexose sugar freely
soluble in water. It has the following structural formula:
C
H
O
• H
O M.W. 198.17
Water for injection, USP is chemically designated H
O.
The flexible container is fabricated from a specially formulated
non-plasticized, film
containing polypropylene and thermoplastic elastomers ( FREE_flex_
bag). The amount of
water that can permeate from the container into the overwrap is
insufficient to affect
the solution significantly. Solutions in contact with the flexible
container can leach out
certain of the container’s chemical components in very small amounts
within the
expiration period. The suitability of the container material has been
confirmed by tests in
animals according to USP biological tests for plastic containers.
Exposure to
temperatures above 25ºC/77ºF 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 r