PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – Made in Spain

Container Label

100 mL
NDC 0338-1709-40

Magnesium Sulfate
in5% Dextrose Injection, USP

1 g/ 100 mL (10 mg/mL)

1 g
TOTAL

Each 100 mL of sterile, nonpyrogenic solution contains:
Magnesium Sulfate Heptahydrate** 1** g (equivalent to8.1 mEq
magnesium) and dextrose, hydrous5 g in water for injection. May
contain sulfuric acid and/or sodium hydroxide for pH adjustment.

pH4.5 (3.5 to6.5)333mOsmol/Liter (calc.)

Single-Dose Container – Discard unused portion. For Intravenous Use.
Recommended dosage: See prescribing information. Use only if
solution is clear and container is undamaged. Must not be used
in series connections. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

Rx Only
Number 07 plastics symbol 0

Bar code
(01) 00303381709402

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Spain

UE8501
UN-35-04-602

DO NOT USE
THIS PORT symbol

Lot
Exp

Overpouch Label

100 mL
TO OPEN – TEAR AT NOTCH
NDC 0338-1709-40

Magnesium Sulfate
in 5% Dextrose Injection, USP

1 g/100 mL (10 mg/mL)

1g
Total

Each 100 mL of sterile, nonpyrogenic solution contains:
Magnesium Sulfate Heptahydrate 1 g (equivalent to 8.1 mEq magnesium) and
dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or
sodium hydroxide for pH adjustment.

333 mOsmol/Liter (calc.) pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE
CENTRAL ROUTE.

Single-Dose Container – Discard unused portion. For Intravenous Use.
Recommended dosage: See prescribing information. Use only if solution is
clear and container is undamaged. After removing the overwrap, check for
minute leaks by squeezing container firmly. If leaks are found, discard unit as
sterility may be impaired. Must not be used in series connections.

The overwrap is a moisture barrier. Do not remove unit from overwrap until
ready for use. Use unit promptly when pouch is opened.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Protect from freezing. VIAFLO container is not made with natural rubber latex,
DEHP, or PVC.

2D Barcode
(91)SA1001003

Rx Only
UN8501
SA-10-01-003

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in Spain
(See Solution Container for Lot and Exp)

Barcode
(01) 00303381709402

11 DESCRIPTION

Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection for intravenous use. Each 100 mL contains 1 gram of magnesium sulfate heptahydrate and dextrose, hydrous 5 grams in water for injection [see How Supplied/Storage and Handling (16)]. Magnesium Sulfate in 5% Dextrose Injection, USP may contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5).

Magnesium Sulfate, USP heptahydrate is chemically known as sulfuric acid magnesium salt (1:1), heptahydrate and chemically designated MgSO4 • 7H2O, with a molecular weight of 246.47. It occurs as colorless crystals or white powder freely soluble in water.

Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. The molecular formula is C6H12O6 • H2O and the molecular weight is 198.17. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

Water can permeate from inside the Baxter VIAFLO flexible plastic container [composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE)] into the overwrap [see Dosage and Administration (2.1)] 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Magnesium Sulfate in 5% Dextrose Injection, USP is a clear solution supplied in VIAFLO single-dose flexible plastic containers (see Table 2).

Table 2 : How Supplied Information

Magnesium Sulfate Concentration*	NDC Number	Container Size	Total Magnesium Sulfate*	Total Magnesium Ion	Magnesium Ion Concentration	Osmolarity**
0.01 grams/mL (1%)	0338-1709-40	100 mL	1 gram	8.1 mEq	8.1 mEq/100 mL	333 mOsmol/liter

VIAFLO container is not made with natural rubber latex, DEHP, or PVC.

Storage

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

17 PATIENT COUNSELING INFORMATION

Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnant women in emergent situations. When feasible, advise the patient and family of the following:

Fetal-Neonatal Toxicity Reported With Prolonged Use
Continuous administration of Magnesium Sulfate in 5% Dextrose Injection in pregnant women beyond 5 to 7 days can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported [see Warnings and Precautions (5.1)].

Risk of Magnesium Toxicity
Pregnant women receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity, including facial edema, diminished strength of deep tendon reflexes, and respiratory depression [see Warnings and Precautions (5.2)].

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in Spain

Baxter and Viaflo are trademarks of Baxter International Inc. or its subsidiaries.

SA-30-02-892