emove plastic tab covering center of stopper.
Sterilize top of stopper with a suitable germicide.
Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.
STORAGE CONDITIONS
Protect from light.
Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Store solution at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Use solution within 48 hours after mixing.
HOW SUPPLIED
SOLU-MEDROL Sterile Powder is available in the following packages:
40 mg Act-O-Vial System (Single-Dose Vial) 1 gram Act-O-Vial System (Single-Dose Vial)
25 x1 mL NDC 0009-0039-28 8 mL NDC 0009-0018-20
125 mg Act-O-Vial System (Single-Dose Vial) 500 mg (Multi-Dose Vial)
25 x 2 mL NDC 0009-0047-22 8 mL NDC 0009-0758-01
500 mg Act-O-Vial System (Single-Dose Vial) 1 gram (Multi-Dose Vial)
4 mL NDC 0009-0003-02 16 mL NDC 0009-0698-01
REFERENCES
1Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050–1.
2Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63.
Rx only
LAB-0420-1.0
October 2009
PRINCIPAL DISPLAY PANEL - 40 mg Bag
Solu-Medrol® 40 mg*
Methyprednisolone Sodium Succinate
for Injection, USP
5 x 1 ml Act-O-Vial® Systems
PRINCIPAL DISPLAY PANEL - 125 mg Bag
Solu-Medrol® 125 mg*
Methyprednisolone Sodium Succinate
for Injection, USP
125 mg
5 x 2 ml Act-O-Vial® Systems
Solu-MedrolR 40 mg*
Methylprednisolone Sodium Succinate
for Injection, USP
1 x 1 mL Act-O-VialR System
Solu-MedrolR 125 mg*
Methylprednisolone Sodium Succinate
for Injection, USP
1 x 2 mL Act-O-VialR System
SOLU-MEDROL
methylprednisolone sodium succinate injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3941(NDC:0009-0047)
Route of Administration INTRAVENOUS,INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylprednisolone sodium succinate (methylprednisolone) methylprednisolone 125mg in1mL
Inactive Ingredients
Ingredient Name Strength
sodium phosphate, monobasic anhydrous 1.6mg in1mL
sodium phosphate, dibasic 17.4mg in1mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-3941-5 5 VIAL, PATENT DELIVERY SYSTEM in 1 BAG contains a VIAL, PATENT DELIVERY SYSTEM
1 2 mL in 1 VIAL, PATENT DELIVERY SYSTEM This package is contained within the BAG(55154-3941-5)
2 NDC:55154-3941-8 1 VIAL, PATENT DELIVERY SYSTEM in 1 BAG contains a VIAL, PATENT DELIVERY SYSTEM
2 2 mL in 1 VIAL, PATENT DELIVERY SYSTEM This package is contained within the BAG(55154-3941-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA01
