LYOPHILIZED PEGASPARGASE- pegaspargase injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGASPARGASE (UNII: 7D96IR0PPM) (PEGASPARGASE - UNII:7D96IR0PPM)

Available from:

Servier Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Export only

Summary of Product characteristics

LYOPHILIZED PEGASPARGASE- PEGASPARGASE INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
SERVIER PHARMACEUTICALS
----------
LYOPHILIZED PEGASPARGASE (750 U/ML) EXPORT ONLY
PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
Manufactured By:
Exelead, Inc.
Indianapolis, IN 46268, USA
Distributed By:
Les Laboratoires Servier
92284 Suresnes, France
Store Between 2°C and 8°C (36°F to 46°F)
Do not freeze
Lyophilized Pegaspargase (750 U/mL) Export Only
U/M:Vial
Code:305-21-AR
PC 07795384010495
EXP: 07 2025
LOT: 1234F
Pallet
PLS-305-21-AR-B
Manufactured By: Exelead, Inc.
Indianapolis, IN 46268, USA
Distributed By: Les Laboratoires Servier
92284 Suresnes, France
Store Between 2°C and 8°C (36°F to 46°F)
Do not freeze
Lyophilized Pegaspargase (750 U/mL) Export Only
U/M:Vial
Code:305-21-AR
PC 07795384010495
EXP: 07 2025
LOT: 1234F
QTY: 60
Case
ALS-305-21-AR-B
Servier Pharmaceuticals
LYOPHILIZED PEGASPARGASE
pegaspargase injection, powder, lyophilized, for solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:726 9 4-313
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PEGASPARGASE (UNII: 7D9 6 IR0 PPM) (PEGASPARGASE - UNII:7D9 6 IR0 PPM)
PEGASPARGASE
750 [iU] in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM PHO SPHATE, DIBASIC, UNSPECIFIED FO RM (UNII: GR6 8 6 LBA74)
SO DIUM PHO SPHATE, MO NO BASIC, DIHYDRATE (UNII: 5QWK6 6 59 56 )
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
SUCRO SE (UNII: C151H8 M554)
SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)
HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:726 9 4-313-
0 1
1 in 1 CARTON
0 8 /0 3/20 20
1
5 mL in 1 VIAL, SINGLE-USE; Type 0 : No t a Co mbinatio n
Pro duc t
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
EXPORT ONLY
0 8 /0 3/20 20
LABELER -
Servier Pharmaceuticals (116608503)
Revised: 8/2020