POTASSIUM CHLORIDE IN SODIUM CHLORIDE- sodium chloride and potassium chloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Hospira, Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 4.5 g in 1000 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. None known. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. 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 Add Medication - Prepare additive port. Prepare additive port. - Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. - The additive port may be protected by covering with an a

Product summary:

20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP is supplied in 1000 mL single-dose flexible plastic containers (NDC 0409-9257-39). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2008   Printed in USA                            EN-1811 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- SODIUM CHLORIDE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
POTASSIUM CHLORIDE IN SODIUM CHLORIDE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Potassium Chloride in Sodium Chloride Injection, USP is a sterile,
nonpyrogenic, solution for fluid and
electrolyte replenishment in a single dose container for intravenous
administration. It contains no
antimicrobial agents. Composition, osmolarity, pH and ionic
concentration are shown in Table 1.
TABLE 1:
20 MEQ/ L POTASSIUM
CHLORIDE IN 0.45%
SODIUM CHLORIDE INJ.,
USP
COMPOS ITION
(G/L)
CALCULATED
OS MOLARITY
(MOS MOL/L)
PH
(RANGE)
IONIC
CONCENTRATIONS
(MEQ/L)
NDC
NO.
SIZE
(ML)
SODIUM
CHLORIDE
(NACL)
POTAS S IUM
CHLORIDE
(KCL)
SODIUM
(NA )
POTAS S IUM
(K )
CHLORIDE
(CL )
0409-9257-39
1000
4.5
1.49
194
4.8
(3.5 to 6.5)
77
20
97
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146
Plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period. However, the
safety of the plastic has been confirmed in tests in animals according
to USP biological tests for plastic
containers.
CLINICAL PHARMACOLOGY
Potassium Chloride in Sodium Chloride Injection, USP has value as a
source of water and electrolytes.
It is capable of inducing diuresis depending on the clinical condition
of the patient.
INDICATIONS AND USAGE
Potassium Chloride in Sodium Chloride Injection, USP is indicated as a
source of water and
electrolytes.
CONTRAINDICATIONS
None known.
WARNINGS
x
+
+
-
Potassium Chloride in Sodium Chloride Injection, USP should be used
with great care, if at all, in
patients with congestive heart failure, severe renal insufficiency and
in clinical states in which there
exists edema with sodium retention.
Potassium Chloride in Sodium Chloride