A3038 PORTEX NERVE BLOCK - regional anesthesia kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

Prieinama:

Smiths Medical ASD, Inc.

INN (Tarptautinis Pavadinimas):

SODIUM CHLORIDE

Sudėtis:

SODIUM CHLORIDE 9 mg in 1 mL

Terapinės indikacijos:

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, 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 Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia 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.

Produkto santrauka:

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 Injection, USP is supplied as follows: NDC Container Concentration Size Total (mg) Single-dose: 0409-4278-01 Glass Teartop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4713-01 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 400 units) 20 0409-4713-02 Glass Ampul 1% (10 mg/mL) 5 mL 50 0409-4713-05 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 400 units) 50 0409-4713-20 Glass Ampul 1% (10 mg/mL) 20 mL 200 0409-4713-32 Glass Ampul 1% (10 mg/mL) 2 mL 20 0409-4713-62 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 800 units) 20 0409-4713-65 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 800 units) 50 0409-4279-02 Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4270-01 Sterile Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4776-01 Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4056-01 Sterile Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4282-01 Glass Ampul 2% (20 mg/mL) 2 mL 40 0409-4282-02 Glass Ampul 2% (20 mg/mL) 10 mL 200 Multiple-dose: 0409-4275-01 Plastic Fliptop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4276-01 Plastic Fliptop Vial 1% (10 mg/mL) 20 mL 200 0409-4276-02 Plastic Fliptop Vial 1% (10 mg/mL) 50 mL 500 0409-4277-01 Plastic Fliptop Vial 2% (20 mg/mL) 20 mL 400 0409-4277-02 Plastic Fliptop Vial 2% (20 mg/mL) 50 mL 1000 Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: February, 2010 Printed in USA                            EN-2421 Hospira, Inc., Lake Forest, IL 60045 USA

Autorizacija statusas:

Premarket Notification

Prekės savybės

A3038 PORTEX NERVE BLOCK - 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%
(9 mg/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 miliosmols 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 emprirical 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 chloride
(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, 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 may