XYLOCAINE- lidocaine hydrochloride injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
26-09-2011

Aktiv ingrediens:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Tilgjengelig fra:

General Injectables & Vaccines, Inc

INN (International Name):

Lidocaine Hydrochloride

Sammensetning:

Lidocaine Hydrochloride 10 mg in 1 mL

Administreringsrute:

INFILTRATION

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Xylocaine (lidocaine HCl) Injections are 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 HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Autorisasjon status:

New Drug Application

Preparatomtale

                                XYLOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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XYLOCAINE 1% (10MG/ML)
DESCRIPTION
XYLOCAINE - lidocaine hydrochloride injection, solution
XYLOCAINE - lidocaine hydrochloride and epinephrine bitartrate
injection, solution
XYLOCAINE MPF - lidocaine hydrochloride injection, solution
XYLOCAINE - lidocaine hydrochloride and epinephrine bitartrate
injection, solution
XYLOCAINE MPF - lidocaine hydrochloride and epinephrine bitartrate
injection, solution
APP Pharmaceuticals, LLC
For Infiltration and Nerve Block
Rx only
DESCRIPTION
Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic,
aqueous solutions that contain a local
anesthetic agent with or without
epinephrine and are administered parenterally by injection. See
INDICATIONS for specific uses.
Xylocaine solutions contain lidocaine HCl, which is chemically
designated as acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-,
monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl
(C14H22N2O • HCl) has the
following structural formula:
Epinephrine is (-) -3, 4-Dihydroxy-a-[(methylamino) methyl] benzyl
alcohol and has the molecular wt.
183.21. Epinephrine
(C9H13NO3) has the following structural formula:
Dosage forms listed as Xylocaine-MPF indicate single dose solutions
that are Methyl Paraben Free
(MPF).
Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing
sodium chloride. Xylocaine in
multiple dose vials: Each mL
also contains 1 mg methylparaben as antiseptic preservative. The pH of
these solutions is adjusted to
approximately 6.5 (5.0 to 7.0)
with sodium hydroxide and/or hydrochloric acid.
Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic
solution containing sodium
chloride. Each mL contains
lidocaine hydrochloride and epinephrine, with 0.5 mg sodium
metabisulfite as an antioxidant and 0.2 mg
citric acid as a stabilizer.
Xylocaine with Epinephrine in multiple dose vials: Each mL also
contains 1 mg methylparaben as
antiseptic preservative. The pH of
these sol
                                
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