DEXTROSE- dextrose monohydrate injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Baxter Healthcare Corporation

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Dextrose Injection, USP is indicated as a source of water and calories. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Product samenvatting:

Dextrose Injection, USP in AVIVA plastic container is available as follows: Code Size (mL) NDC Product Name 6E0062 250 0338-6346-02 5% Dextrose Injection, USP 6E0063 500 0338-6346-03   Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C/ 77° F); brief exposure up to 40° C/ 104° F does not adversely affect the product.

Autorisatie-status:

New Drug Application

Productkenmerken

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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DEXTROSE INJECTION, USP
IN AVIVA PLASTIC CONTAINER
DESCRIPTION
Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid
replenishment and caloric supply in
single dose containers for intravenous administration. It contains no
antimicrobial agents. Composition,
osmolarity, pH, and caloric content are shown in Table 1.
TABLE 1
Size
(mL)
*Dextrose
Hydrous,
USP
(g/L)
Osmolarity
(mOsmol/L)
(calc.)
pH nominal
(range)
Caloric Content
(kcal/L)
5% Dextrose
Injection, USP
250
500
50
252
4.5
(3.2 to 6.5)
170
The flexible container is made with non-latex plastic materials
specially designed for a wide range of
parenteral drugs including those requiring delivery in containers made
of polyolefins or polypropylene.
For example, the AVIVA container system is compatible with and
appropriate for use in the admixture
and administration of paclitaxel. In addition, the AVIVA container
system is compatible with and
appropriate for use in the admixture and administration of all drugs
deemed compatible with existing
polyvinyl chloride container systems. The solution contact materials
do not contain PVC, DEHP, or
other plasticizers.
The suitability of the container materials has been established
through biological evaluations, which
have shown the container passes Class VI U.S. Pharmacopeia (USP)
testing for plastic containers.
These tests confirm the biological safety of the container system.
The flexible container is a closed system, and air is prefilled in the
container to facilitate drainage. The
container does not require entry of external air during
administration.
The container has two ports: one is the administration outlet port for
attachment of an intravenous
administration set and the other port has a medication site for
addition of supplemental medication (see
DIRECTIONS FOR USE). The primary function of the overwrap is to
protect the container from the
physical environment.
CLINICAL PHARMACOLOGY
Dextrose Injection, USP ha