ial
INTRAVENTRICULAR ELETROLYTES INJECTION VIAL
NDC 68135-495-04
Intraventricular Electrolytes
Injection
Use after BrineuraTM (cerliponase alfa)
5 mL
For Intraventricular Infusion Only
Intraventricular Electrolytes Injection Vial
ADMINISTRATION KIT
Administration Kit for use with BrineuraTM (cerliponase alfa)
Intraventricular infusion only
Dosage and Administration: see package insert enclosed.
Contents of Administration Kit:
Two single-use 20-mL syringes
Two single-use syringe needles, 21 G, 25.4 mm
One single-use extension line
One single-use infusion set with 0.2 micron inline filter
One single-use port needle, 22 G, 16 mm
Admin Kit
CLOSE
INGREDIENTS AND APPEARANCE
BRINEURA
cerliponase alfa kit
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68135-811
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-811-02 1 in 1 CARTON; Type 6: Drug/Biologic Combination 04/27/2017
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL, GLASS 10 mL
Part 2 1 VIAL, GLASS 5 mL
Part 1 of 2
BRINEURA
cerlinponase alfa injection, solution
PRODUCT INFORMATION
Item Code (Source) NDC:68135-500
Route of Administration INTRAVENTRICULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
CERLIPONASE ALFA (UNII: X8R2D92QP1) (CERLIPONASE ALFA - UNII:X8R2D92QP1) CERLIPONASE ALFA 150 mg in 5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) 0.55 mg in 5 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) 0.40 mg in 5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 43.85 mg in 5 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) 1.10 mg in 5 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.80 mg in 5 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 1.05 mg in 5 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68135-500-00 5 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761052 04/27/2017
Part 2 of 2
INTRAVENTRICULAR ELECTROLYTES
intraventricular electrolytes injection, solution
PRODUCT INFORMATION
Item Code (Source) NDC:68135-495
Route of Administration INTRAVENTRICULAR
INACTIVE INGREDIENTS
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) 0.55 mg in 5 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) 0.40 mg in 5 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 43.85 mg in 5 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) 1.10 mg in 5 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.80 mg in 5 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 1.05 mg in 5 mL
WATER (UNII: 059QF0KO0R) |
