MAGNESIUM SULFATE- magnesium sulfate heptahydrate injection, solution

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:

Fresenius Kabi USA, LLC

INN (Nama Antarabangsa):

MAGNESIUM SULFATE HEPTAHYDRATE

Komposisi:

MAGNESIUM SULFATE HEPTAHYDRATE 80 mg in 1 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 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.

Ringkasan produk:

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible containers as follows: Magnesium Sulfate* Concentration *As the heptahydrate. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. This container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. 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- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MAGNESIUM SULFATE IN WATER FOR INJECTION
FOR INTRAVENOUS USE ONLY
Rx only
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. See HOW SUPPLIED section 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 flexible container is fabricated from a specially formulated
non-plasticized, film
containing polypropylene and thermoplastic elastomers ( FREEflex
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 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
syst