SUGAMMADEX- sugammadex injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Download Productkenmerken (SPC)
11-08-2015

Werkstoffen:

Sugammadex (UNII: 361LPM2T56) (Sugammadex Sodium - UNII:ERJ6X2MXV7)

Beschikbaar vanaf:

Patheon Manufacturing Services LLC

INN (Algemene Internationale Benaming):

Sugammadex

Samenstelling:

Sugammadex 500 mg in 5 mL

Toedieningsweg:

NOT APPLICABLE

Autorisatie-status:

Export only

Productkenmerken

                                SUGAMMADEX- SUGAMMADEX INJECTION
PATHEON MANUFACTURING SERVICES LLC
----------
SUGAMMADEX INJECTION 100 MG/ML (5 ML)
PRINCIPAL DISPLAY PANEL - SHIPPING LABEL
LOT NUMBER: ???????
MFG. DATE: DD/MMM/YYYY
OSS PO: ?????????
MERCK PRODUCT CODE: 2006792
QU: 864 UNLABELED VIALS
SUGAMMADEX INJECTION 100 MG/ML (5 ML)
PRODUCT CODE: 011331
STORE AT 2°-30°C (36°-86°F).
CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING. RX ONLY
FOR EXPORT
MANUFACTURED BY:
PATHEON MANUFACTURING SERVICES, LLC
GREENVILLE, NC 27834, USA
FOR:
MERCK SHARP & DOHME CORP - MSD PRODUCTION
MOLENWEG 50
5342 CC OSS, THE NETHERLANDS
MADE IN U.S.A.
LABEL NO: 512044
SUGAMMADEX
sugammadex injection
PRODUCT INFORMATION
PRODUCT T YPE
BULK INGREDIENT
ITE M CODE (SOURCE )
NDC:6 3552-0 0 4
ROUTE OF ADMINISTRATION
NOT APPLICABLE
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
SUG A MMA DEX (UNII: 36 1LPM2T56 ) (Sugammadex So dium - UNII:ERJ6
X2MXV7)
Sugammadex
50 0 mg in 5 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WA TER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 3552-0 0 4-0 1
8 6 4 in 1 CASE
1
5 mL in 1 VIAL, GLASS
Patheon Manufacturing Services LLC
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
EXPORT ONLY
0 1/18 /20 16
LABELER -
Patheon Manufacturing Services LLC (079415560)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Patheo n Manufacturing Services
LLC
0 79 41556 0
MANUFACTURE(6 3552-0 0 4) , ANALYSIS(6 3552-0 0 4) , PACK(6 3552-
0 0 4)
Revised: 8/2015
                                
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