DEXTROSE- dextrose monohydrate injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
01-04-2018

Aktīvā sastāvdaļa:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Pieejams no:

Baxter Healthcare Corporation

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Unapproved drug for use in drug shortage

Produkta apraksts

                                DEXTROSE- DEXTROSE MONOHYDRATE INJECTION
BAXTER HEALTHCARE CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
5% DEXTROSE INJECTION
HEALTH CARE PROVIDER LETTER
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
BATCH
EXP
5% DEXTROSE INJECTION
100ML
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE EACH 100ML CONTAINS
DEXTROSE HYDROUS 5G WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML
pH APPROX 4.0 OSMOLARITY APPROX 252 mOsml/L
INTRAVENOUS ADMINISTRATION STERILE NONPYROGENIC
SOLUTION DO NOT USE IF TURBIDITY IS PRESENT SINGLE USE
DISCARD AFTER USE INFORMATION TO THE HEALTHCARE
PROFESSIONAL INDICATIONS CONTRAINDICATIONS AND
PRECAUTIONS REFER TO PACKAGE INSERT ALL MEDICINES
SHOULD BE KEPT OUT OF THE REACH OF CHILDREN
REMOVE THE OVERPOUCH FOR USE LATEX FREE PRODUCT
RESTRICTED USE FOR HOSPITALS SALE UNDER MEDICAL
PRESCRIPTION
_BAXTER_
BAXTER HOSPITALAR LTDA
HENRI DUNANT STREET 1383 12º FLOOR TOWER B
CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300700282
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
PRINTED IN BRAZIL
25
50
75
28 25 01 499
FZB0087
DEXTROSE
dextrose monohydrate injection
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:0 338 -9 523
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G) (ANHYDROUS DEXTROSE -
UNII:5SL0 G7R0 OK)
DEXTROSE
MONOHYDRATE
5 g
in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:0 338 -9 523-72
72 in 1 CARTON
0 1/15/20 18
1
10 0 mL in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATI
                                
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