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

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Hospira, Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

These solutions are indicated in patients requiring parenteral administration of potassium chloride and sodium chloride. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. 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 di

Resumen del producto:

Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Table: Potassium Chloride in 0.9% Sodium Chloride Inj., USP COMPOSITION Approx. Ionic Concentrations (g/L) Calculated (mEq/L) NDC No. mEq Potassium Size (mL) Sodium Chloride Potassium Chloride Osmolarity (mOsmol/L) pH (range) Sodium (Na + ) Potassium (K + ) Chloride (Cl¯) Approximate kcal/L 0409–7115–09 20 mEq 1000 9 1.49 348 4.8 (3.5 to 6.5) 154 20 174 0409–7116–09 40 mEq 1000 9 2.98 388 4.8 (3.5 to 6.5) 154 40 194 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2009  Printed in USA EN-2102 Hospira, Inc., Lake Forest, IL 60045 USA

Estat d'Autorització:

New Drug Application

Fitxa tècnica

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- SODIUM CHLORIDE AND POTASSIUM
CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
INTRAVENOUS SOLUTIONS
WITH POTASSIUM CHLORIDE
Potassium Chloride in 0.9% Sodium Chloride Injection, USP
FLEXIBLE PLASTIC CONTAINERRx only
DESCRIPTION
Intravenous solutions with potassium chloride (I.V. solutions with
KCl) are sterile and nonpyrogenic
solutions in water for injection. They are for administration by
intravenous infusion only.
See Table for summary of content and characteristics of these
solutions.
The solutions contain no bacteriostat, antimicrobial agent or added
buffer and each is intended only for
use as a single-dose injection. When smaller doses are required the
unused portion should be
discarded.
These solutions are parenteral fluid and/or electrolyte replenishers.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H 0.
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 inside the plastic container also can leach
out certain of its chemical
components in very small amounts before the expiration period is
attained. However, the safety of the
plastic has been confirmed by tests in animals according to USP
biological standards for plastic
containers.
CLINICAL PHARMACOLOGY
When administered intravenously, these solutions provide a source of
water and potassium chloride
with 0.9% sodium chloride.
Intravenous solutions containing potassium chloride are particularly
intended to provide needed
potassium cation (K ). Potassium is the chief cation of body cells
(160 mEq/liter of intracellular water).
It is found in low concentration in plasma and extracellular fluids
(3.5 to 5.0 mEq/liter in a healthy