15926-20 SPINAL 22G/25G WHITACRE- anesthesia conduction kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Smiths Medical ASD, Inc.

INN (שם בינלאומי):

LIDOCAINE HYDROCHLORIDE

הרכב:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

סממני תרפויטית:

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. MARCAINE Spinal is indicated for the production of subarachnoid block (spinal anesthesia). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia. MARCAINE Spinal is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type. The following conditions preclude the use of spinal anesthesia: 1. Severe hemorrhage, severe hy

leaflet_short:

Lidocaine Hydrochloride Injection, USP is supplied as follows: Unit of Sale Concentration Each Single-dose NDC 0409-4278-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4278-16 Glass Teartop Vial NDC 0409-4713-02 Carton of 25 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-12 Glass Ampul NDC 0409-4713-32 Carton of 50 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-42 Glass Ampul NDC 0409-4713-62 Case of 800 1% 20 mg/2 mL (10 mg/mL) NDC 0409-4713-72 Glass Ampul NDC 0409-4713-65 Case of 800 1% 50 mg/5 mL (10 mg/mL) NDC 0409-4713-75 Glass Ampul NDC 0409-4279-02 Carton of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4279-16 Glass Teartop Vial NDC 0409-4270-01 Case of 25 1% 300 mg/30 mL (10 mg/mL) NDC 0409-4270-11 Sterile Glass Teartop Vial NDC 0409-4776-01 Carton of 25 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4776-10 Glass Ampul NDC 0409-4056-01 Carton of 5 1.5% 300 mg/20 mL (15 mg/mL) NDC 0409-4056-11 Sterile Glass Ampul NDC 0409-4282-01 Bundle of 25 2% 40 mg/2 mL (20mg/mL) NDC 0409-4282-11 Glass Ampul NDC 0409-4282-02 Carton of 25 2% 200 mg/10 mL (20 mg/mL) NDC 0409-4282-12 Glass Ampul Unit of Sale Concentration Each Multiple-dose: NDC 0409-4275-01 Tray of 25 0.5% 250 mg/50 mL (5 mg/mL) NDC 0409-4275-16 Plastic Fliptop Vial NDC 0409-4276-01 Tray of 25 1% 200 mg/20 mL (10 mg/mL) NDC 0409-4276-16 Plastic Fliptop Vial NDC 0409-4276-02 Tray of 25 1% 500 mg/50 mL (10 mg/mL) NDC 0409-4276-17 Plastic Fliptop Vial NDC 0409-4277-01 Tray of 25 2% 400 mg/20 mL (20 mg/mL) NDC 0409-4277-16 Plastic Fliptop bottle NDC 0409-4277-02 Tray of 25 2% 1000 mg/50 mL (20 mg/mL) NDC 0409-4277-17 Plastic Fliptop Vial 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: 1/2015                                                                               EN-3679 Hospira, Inc., Lake Forest, IL 60045 USA                       Single-dose ampuls of 2 mL (15 mg bupivacaine hydrochloride with 165 mg dextrose), is supplied as follows: Unit of Sale Concentration Each NDC 0409-1761-02 Package of 10 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-19 Uni-Amp™ NDC 0409-1761-62  Bulk package of 800 15 mg/2 mL (7.5 mg/mL) NDC 0409-1761-18 Uni-Amp™ 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: 8/2015                                                                                  EN-3993 Hospira, Inc., Lake Forest, IL 60045 USA    

מצב אישור:

Premarket Notification

מאפייני מוצר

15926-20 SPINAL 22G/25G WHITACRE- ANESTHESIA CONDUCTION KIT
SMITHS MEDICAL ASD, INC.
----------
Lidocaine Rx only
Hydrochloride
Injection, USP
AQUEOUS SOLUTIONS FOR
INFILTRATION AND NERVE BLOCK
Ampul
Plastic Multiple-dose Fliptop Vial
Glass Teartop Vial
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic
solution of lidocaine hydrochloride
in water for injection for parenteral administration in various
concentrations with characteristics as
follows:
Concentration
0.5%
1%
1.5%
2%
mg/mL lidocaine HCl
(anhyd.)
5
10
15
20
mg/mL sodium chloride
8
7
6.5
6
Multiple-dose vials contain 0.1% of methylparaben added as
preservative. May contain sodium
hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5
(5.0 to 7.0). See HOW
SUPPLIEDsection for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethylamino)-N-(2,6-dimethylphenyl)-
acetamide monohydrochloride monohydrate, a white powder freely soluble
in water. The molecular
weight is 288.82. It has the following structural formula:
The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated polyolefin. It is a
copolymer of ethylene and propylene. The safety of the plastic has
been confirmed by tests in animals
according to USP biological standards for plastic containers. The
container requires no vapor barrier to
maintain the proper drug concentration.
Mechanism of action: Lidocaine stabilizes the neuronal membrane by
inhibiting the ionic fluxes required
for the initiation and conduction of impulses, thereby effecting local
anesthetic action.
Hemodynamics: Excessive blood levels may cause changes in cardiac
output, total peripheral
resistance, and mean arterial pressure. With central neural blockade
these changes may be attributable to
block of autonomic fibers, a direct depressant effect of the local
anesthetic agent on various
components of the cardiovascular system and/or the beta-adrenergic
receptor stimulating action of
epineph