LACTATED RINGERS sodium chloride potassium calcium injection solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Διαθέσιμο από:

Baxter Healthcare Corporation

INN (Διεθνής Όνομα):

SODIUM CHLORIDE

Σύνθεση:

SODIUM CHLORIDE 600 mg in 100 mL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE,
CALCIUM
CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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LACTATED RINGER’S INJECTION, USP
IN AVIVA PLASTIC CONTAINER
DESCRIPTION
Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution
for fluid and electrolyte
replenishment 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)
Sodium
Chloride,
USP,
(NaCl)
Sodium
Lactate,
(C H NaO )
Potassium
Chloride,
USP,
(KCl)
Calcium
Chloride,
USP
(CaCl
·2H O)
SodiumPOTAS S IUM CalciumChloride Lactate
Lactated
Ringer’s
Injection,
USP
250
6
3.1
0.3
0.2
273
6.5
(6.0 to
7.5)
130
4
2.7
109
28
9
500
1000
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