Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838)
Baxter Healthcare Corporation
INTRAVENOUS
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
MAGNESIUM SULFATE- MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- 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 Preberite celoten dokument