MAGNESIUM SULFATE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

HF Acquisition Co LLC, DBA HealthFirst

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows: NDC 51662-1352-1 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG NDC 51662-1352-2 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG IN A POUCH NDC 51662-1352-3 MAGNESIUM SULFATE IN WATER FOR INJECTION 2g/50mL (40mg/mL) 50mL BAG IN A POUCH, 24 POUCHES IN A CASE HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275 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.

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

MAGNESIUM SULFATE- MAGNESIUM SULFATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 MEQ MG"/ML)
40MG/ML 2G TOTAL 50ML BAG
SPL UNCLASSIFIED
Flexible Plastic Container
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 MgSO4 •
7H2O,
colorless crystals or white powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.
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, fe