DEXTROSE- dextrose monohydrate injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
22-12-2021

Aktīvā sastāvdaļa:

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

Pieejams no:

Bimeda, Inc.

Ievadīšanas:

INTRAVENOUS

Receptes veids:

OTC

Ārstēšanas norādes:

INDICATIONS: For use as an aid in the treatment of uncomplicated ketosis in cattle.

Autorizācija statuss:

unapproved drug other

Produkta apraksts

                                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
                                
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