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:

Baxter Healthcare Corporation

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 flexible plastic containers as follows: Product Code NDC No. Size Container Total Magnesium Sulfate* Total Magnesium Ion Magnesium Sulfate* Concentration Magnesium Ion Concentration Osmolarity (calc.) EZPE8001 0338-1708-40 50 mL 2g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter EZPE8003 0338-1715-40 100 mL 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter EZPE8002 0338-1719-40 50 mL 4g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 mOsmol/Liter *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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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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 a 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.
VIAFLO container is a flexible plastic container fabricated from a
multilayer sheeting
composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE).
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 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 ne