A4119-25 SPINAL 25G QUINCKE - regional anesthesia kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Available from:

Smiths Medical ASD, Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Therapeutic indications:

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. INDICATIONS AND USAGE 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. CONTRAINDICATIONS Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. INDICATIONS AND USAGE MARCAINE Spinal is indic

Product summary:

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) HOW SUPPLIED 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 HOW SUPPLIED Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE Spinal solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. Do not administer any solution which is discolored or contains particulate matter. Revised: 08/2013 EN-3326 Hospira, Inc., Lake Forest, IL 60045 USA HOW SUPPLIED 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

Authorization status:

Premarket Notification

Summary of Product characteristics

A4119-25 SPINAL 25G QUINCKE - 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 may cause
h