Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
Bimeda, Inc.
INTRAVENOUS
OTC
INDICATIONS: For use as an aid in the treatment of uncomplicated ketosis in cattle.
unapproved drug other
DEXTROSE- DEXTROSE MONOHYDRATE INJECTION BIMEDA, INC. _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._ ---------- INDICATIONS: For use as an aid in the treatment of uncomplicated ketosis in cattle. DOSAGE AND ADMINISTRATION: CATTLE: 100 to 500 mL depending on size and condition of animal. For intravenous use only. Solution should be warmed to body temperature and administered slowly. This product is sterile in unopened container. Contains no preservative. If entire contents are not used, discard unused portion. Handle under strict aseptic conditions. COMPOSITION: Each 100 mL contains: Dextrose Monohydrate ...............50 g Water for Injection.....................q.s. May contain hydrochloric acid or sodium hydroxide for pH adjustment. 2525 m0smol/liter (Calculated) Caloric Value per liter: 1700 Hypertonic pH 3.5-6.5 STORAGE: STORE BETWEEN 15°C-30°C (59°F-86°F). DEXTROSE dextrose monohydrate injection PRODUCT INFORMATION PRODUCT TYPE OTC ANIMAL DRUG ITEM CODE (SOURCE) NDC:61133-0295 ROUTE OF ADMINISTRATION INTRAVENOUS ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE 50 g in 100 mL PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:61133-0295-5 500 mL in 1 VIAL MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE unapproved drug other 10/28/2016 Bimeda, Inc. LABELER - Bimeda, Inc. (060492923) REGISTRANT - Bimeda, Inc. (060492923) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Bimeda-MTC Animal Health 256232216 manufacture Revised: 12/2021 Izlasiet visu dokumentu