Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Smiths Medical ASD, Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 9 mg in 1 mL
INDICATIONS AND USAGE Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered. Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
HOW SUPPLIED 5 mL ampuls packaged in box of 50 each (NDC-65282-1505-1) 10 mL ampuls packaged in box of 50 each (NDC-65282-1510-1) 30 mL ampuls packaged in box of 30 each (NDC-65282-1530-3) Lidocaine Hydrochloride and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial 30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial 20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul 5 mL 1.5% 1:200,000 0409-1209-05 Ampul 5 mL 1.5% 1:200,000 0409-1209-65 Ampul 5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial 50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial 20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial 30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial 50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial 20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial 30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial 50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Revised: March, 2010 Printed in USA EN-2440 Hospira, Inc., Lake Forest, IL 60045 USA
Premarket Notification
A1800-17 CONTINUOUS EPIDURAL 17G TUOHY - REGIONAL ANESTHESIA KIT SMITHS MEDICAL ASD, INC. ---------- SPECTRA MEDICAL DEVICES, INC. SODIUM CHLORIDE INJECTION, USP, 0.9% DESCRIPTION Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL. Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium Chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44. CLINICAL PHARMACOLOGY Sodium chloride comprises over 90% of the inorganic constituents of the blood serum. Sodium chloride in water dissociates to provide sodium (Na+) and (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in very small infants. INDICATIONS AND USAGE Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub- cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered. WARNING Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia. Excessive amounts of sodium chloride by any route Прочитайте повний документ