POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- potassium chloride, sodium chloride, calcium chloride, sodium lactate, and

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
18-11-2019

Aktiv ingrediens:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0

Tilgjengelig fra:

Hospira, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Sammensetning:

POTASSIUM CHLORIDE 1.79 g in 1000 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

These solutions are indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS. 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 need

Produkt oppsummering:

Intravenous solutions with potassium chloride (I.V. solution with KCl) are supplied in single-dose flexible plastic containers. See Table: Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP   List No. mEq Potassium Added Size (mL) COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 7111   7113 20 mEq   40 mEq 1000   1000 50   50 1.79   3.28 6   6 3.1   3.1 0.2   0.2 563   604 Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP        (Continued) pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na+ ) Potassium (K+ ) Chloride (Cl¯) Lactate 4.9 (3.5 to 6.5)   4.9 (3.5 to 6.5) 2.7     2.7 130     130 24     44 129     149 28     28 179     179 May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2006   EN-1319                            Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

Autorisasjon status:

New Drug Application

Preparatomtale

                                POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE- POTASSIUM
CHLORIDE,
SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE
MONOHYDRATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
_POTASSIUM CHLORIDE IN LACTATED RINGER’S AND 5% DEXTROSE INJECTION,
USP_
INTRAVENOUS SOLUTIONS WITH POTASSIUM CHLORIDE
FLEXIBLE PLASTIC CONTAINER
R 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, nutrient and/or electrolyte
replenishers.
Dextrose, USP is chemically designated D-glucose, monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
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.
Calcium Chloride, USP is chemically designated calcium chloride
dihydrate (CaCl
• 2H O), white
fragments or granules freely soluble in water.
Sodium Lactate, USP is chemically designated monosodium lactate [CH
CH(OH)COONa], a 60%
aqueous solution miscible in water. It has the following structural
formula:
Water for Injection, USP is chemically designated H 0.
x
6
12
6
2
2
2
3
2
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 in contact with the plastic container may
leach out certain chemical components
from the plastic in very small amounts; however, biological testing
w
                                
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