DEXTROSE- dextrose monohydrate injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Hospira, Inc.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

50% and 70% Dextrose Injection, USP (concentrated dextrose in water) in Pharmacy Bulk Packages are indicated for use with automated compounding devices for preparing intravenous nutritional admixtures in the pharmacy. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Descriptif du produit:

50% and 70% Dextrose Injection, USP are supplied as follows: NDC No. Container Concentration Fill 0409-7119-07 Flexible Pharmacy Bulk Package 50% 2000 mL 0409-7120-07 Flexible Pharmacy Bulk Package 70% 2000 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2010 Printed in USA                                                 EN-2527                                                              Hospira, Inc., Lake Forest, IL 60045 USA

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
50% AND 70% DEXTROSE INJECTION, USP
Concentrated Dextrose in Water
PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION.
FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
NOTE: THESE SOLUTIONS ARE HYPERTONIC – SEE _WARNINGS_ AND
_PRECAUTIONS_.
FLEXIBLE PLASTIC CONTAINERS Rx only
_DESCRIPTION_
50% and 70% Dextrose Injection, USP (concentrated dextrose in water)
are sterile, nonpyrogenic,
hypertonic solutions of Dextrose, USP in water for injection for
intravenous administration after
appropriate admixture or dilution.
The Pharmacy Bulk Package is a sterile dosage form which contains
multiple single doses for use only
in a pharmacy bulk admixture program.
The content and physical characteristics of the solutions are as
follows:
*
SOLUTION
CHARACTERIS TICS
50% DEXTROSE
INJECTION, USP
70% DEXTROSE
INJECTION, USP
pH
4.0
4.0
pH range
3.2 - 6.5
3.2 - 6.5
Osmolarity (mOsmol/L) (calc.)
2523
3532
Specific Gravity
1.170
1.236
Grams Dextrose/100 mL
50
70
kcal/100 mL
170
238
Fill volume (mL)
2000
2000
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and are intended only for use
as a single-dose injection following admixture or dilution.
This Pharmacy Bulk Package is intended only for use in the preparation
of sterile, intravenous nutrient
admixtures using automated compounding devices. The flexible plastic
container is fabricated from a
specially formulated polyvinylchloride. Water can permeate from inside
the container into the overwrap
but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic
container may leach out certain chemical components from the plastic
in very small amounts; however,
biological testing was supportive of the safety of the plastic
container materials. Exposure to
temperatures above 25°C/77°F during transport and storage will lead
to minor losses in moisture
content. Higher temperatures lead to greater losses. It is unlikely
that these minor losses will