Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
Baxter Healthcare Corporation
INTRAVENOUS
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
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 Izlasiet visu dokumentu