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.

DCI (Dénomination commune internationale):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 50 mg in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient. In this dosage form, 5% Dextrose Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTORTM . 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:

5% Dextrose Injection, USP is supplied in single-dose flexible plastic ADD-VantageTM diluent containers. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] INSTRUCTIONS FOR USE WITH ADD-VANTAGE VIAL   These instructions for use should be made available to the individuals who perform the reconstitution steps.  To Open:  Peel overwrap at corner and remove solution container. Use unit within 30 days of opening overwrap, as long as the use date does not exceed the printed expiration date. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Assemble Vial and Flexible Diluent Container: (Use Aseptic Technique)                                                                                                                         Fig. 1                                                                      Fig. 2                                                                                                                       Fig. 3                                                                    Fig. 4 To Reconstitute the Drug: If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.           Fig. 5         Fig. 6           Fig. 7 Preparation for Administration: (Use Aseptic Technique) WARNING: Do not use flexible container in series connections.   INSTRUCTIONS FOR USE WITH ADD-VANTAGE ADDAPTORTM   The instructions for use provided with the ADD-Vantage ADDAPTORTM should be made available to the individuals who perform the reconstitution steps.    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                       LAB-1143-3.0 Revised: 09/2021

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
5% DEXTROSE Injection, USP
ADD-VANTAGE DILUENT
FLEXIBLE PLASTIC
CONTAINER Rx
only
DESCRIPTION
5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is
a parenteral
solution containing 50 mg/mL of dextrose, hydrous in water for
injection and is intended
for intravenous administration after admixing with an ADD-Vantage
vial, or single-dose
powdered drug vials with 20 mm closure using the ADD-Vantage ADDAPTOR
(WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS).
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only as a single-dose injection. When smaller doses are
required the unused
portion should be discarded.
The solution is slightly hypotonic (253 mOsmol/liter; calc.) in
relation to the extracellular
fluid (approx. 280 mOsmol/liter). The pH of the solution is 4.3 (3.2 -
6.5).
The solution is a parenteral fluid and nutrient replenisher.
Dextrose, USP is chemically designated D-glucose, monohydrate (C H
O • H O), a
hexose sugar freely soluble in water. It has the following structural
formula:
Water for Injection, USP is chemically designated H O.
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 lead to
clinically significant
changes within the expiration period.
CLINICAL PHARMACOLOGY
When administered intravenously, this solution provides a source of
water and
carbohydrate.
TM
TM
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