Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)
Hospira, Inc.
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 10 meq in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance. Potassium Chloride Injection is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.
Potassium Chloride Injection in flexible plastic containers is available as follows: NDC No. Potassium per container 0409–7074–26 10 mEq/100 mL 0409–7075–14 10 mEq/50 mL 0409–7075–26 20 mEq/100 mL 0409–7076–26 30 mEq/100 mL 0409–7077–14 20 mEq/50 mL 0409–7077–26 40 mEq/100 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Printed in USA Revised: April, 2009 EN-2079 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
POTASSIUM CHLORIDE- POTASSIUM CHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- POTASSIUM CHLORIDE INJECTION For Use Only With A Calibrated Infusion Device HIGHLY CONCENTRATED Flexible Plastic Container Ready To Use R only DESCRIPTION This Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Potassium Chloride Injection mEq Potassium/ Container COMPOS ITION (g/L) Potassium Chloride, USP (KCl) OS MOLARITY* (MOS MOL/L) (CALC) PH IONIC CONCENTRATION (mEq/L) POTAS S IUM Chloride 10 mEq/100 mL 7.45 200 5.8 (4.0 to 8.0) 100 100 10 mEq/50 mL 20 mEq/100 mL 14.9 400 5.8 (4.0 to 8.0) 200 200 30 mEq/100 mL 22.4 601 5.8 (4.0 to 8.0) 300 300 20 mEq/50 mL 40 mEq/100 mL 29.8 799 5.8 (4.0 to 8.0) 400 400 *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. This flexible plastic container is fabricated from a specially formulated polyvinylchloride. Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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 may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. CLINICAL PHARMACOLOGY Potassium is the major cation of body cells (160 mEq/liter of intracellular water) and is concerned with x the maintenance of body fluid composition and electrolyte balance. Potassium partic Lugege kogu dokumenti