DEXTROSE AND SODIUM CHLORIDE injection solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Baxter Healthcare Corporation

INN (Διεθνής Όνομα):

DEXTROSE MONOHYDRATE

Σύνθεση:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

DEXTROSE AND SODIUM CHLORIDE- DEXTROSE AND SODIUM CHLORIDE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
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DEXTROSE AND SODIUM CHLORIDE INJECTION, USP
IN AVIVA PLASTIC CONTAINER
DESCRIPTION
Dextrose and Sodium Chloride Injection, USP is a sterile, nonpyrogenic
solution for fluid and
electrolyte replenishment and caloric supply in single dose containers
for intravenous administration. It
contains no antimicrobial agents. Composition, osmolarity, pH, ionic
concentration and caloric content
are shown in Table 1.
TABLE 1
Size
(mL)
Composition (g/L)
Osmolarity
(mOsmol/L)
(calc.)
pH
nominal
(range)
Ionic Concentration
(mEq/L)
Caloric
Content
(kcal/L)
Dextrose
Hydrous,
USP
Sodium
Chloride,
USP (NaCl)
Sodium
Chloride
2.5%
Dextrose
and 0.45%
Sodium
Chloride
Injection,
USP
500
1000
25
4.5
280
4.5
(3.2 to 6.5)
77
77
85
5%
Dextrose
and 0.2%
Sodium
Chloride
Injection,
USP
250
500
1000
50
2
321
4.0
(3.2 to 6.5)
34
34
170
5%
Dextrose
and 0.33%
Sodium
Chloride
Injection,
USP
250
500
1000
50
3.3
365
4.0
(3.2 to 6.5)
56
56
170
5%
Dextrose
and 0.45%
Sodium
Chloride
Injection,
USP
250
500
1000
50
4.5
406
4.0
(3.2 to 6.5)
77
77
170
5%
Dextrose
*
†
*
†
and 0.9%
Sodium
Chloride
Injection,
USP
250
500
1000
50
9
560
4.0
(3.2 to 6.5)
154
154
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)
t