P-CARE 100MX- bupivacaine hydrochloride, lidocaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO)

Commercializzato da:

RX PHARMA-PACK, INC.

INN (Nome Internazionale):

BUPIVACAINE HYDROCHLORIDE

Composizione:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients. MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS . The routes of administration and indicated MARCAINE concentrations are: - local infiltration - peripheral nerve block - retrobulbar block - sympathetic block - lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) - caudal - epidural test dose - dental blocks (See DOSAGE AND ADMINISTRATION for additional information). Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARC

Dettagli prodotto:

These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. 25 mg/10 mL (2.5 mg/mL) NDC 0409-1559-19 Single-dose vial MARCAINE with epinephrine 1:200,000 (as bitartrate)―Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. 0.25% with epinephrine 1:200,000 Contains 2.5 mg bupivacaine hydrochloride per mL. NDC 0409-1746-10 Carton of 10   25 mg/10 mL (2.5 mg/mL) NDC 0409-1746-70 Single-dose vial NDC 0409-1746-30 Carton of 10   75 mg/30 mL (2.5 mg/mL) NDC 0409-1746-71 Single-dose vial NDC 0409-1752-50 Carton of 1  125 mg/50 mL (2.5 mg/mL) NDC 0409-1752-50 Multiple-dose vial 0.5% with epinephrine 1:200,000 Contains 5 mg bupivacaine hydrochloride per mL.  NDC 0409-1749-10 Carton of 10  50 mg/10 mL (5 mg/mL) NDC 0409-1749-70 Single-dose vial NDC 0409-1749-29 Carton of 10  150 mg/30 mL (5 mg/mL) NDC 0409-1749-71 Single-dose vial NDC 0409-1755-50 Carton of 1 250 mg/50 mL (5 mg/mL)  NDC 0409-1755-50 Multiple-dose vial For single-dose vials: Discard unused portion. Distributed by Hospira , Inc., Lake Forest , IL 60045 USA Revised: 11/2018 Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® -MPF (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000  0.5% (250 mg per 50 mL) (5 mg per mL) Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows:  Preservative Free. Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

P-CARE 100MX- BUPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE,
SODIUM CHLORIDE,
POVIDONE-IODINE, ISOPROPYL ALCOHOL
RX PHARMA-PACK, INC.
----------
P-CARE 100MX
MARCAINE - BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
MARCAINE
Bupivacaine Hydrochloride Injection, USP
MARCAINE
With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride
and Epinephrine Injection, USP
HOSPIRA, INC.
Rx only
DESCRIPTION
Bupivacaine hydrochloride is 2-Piperidinecarboxamide,
1-butyl-N-(2,6-dimethylphenyl)-
,monohydrochloride, monohydrate, a white crystalline powder that is
freely soluble in 95 percent
ethanol, soluble in water, and slightly soluble in chloroform or
acetone. It has the following structural
formula:
MARCAINE STRUCTURAL FORMULA
Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl
alcohol. It has the following
structural formula:
EPINEPHRINE STRUCTURAL FORMULA
MARCAINE is available in sterile isotonic solutions with and without
epinephrine (as bitartrate)
1:200,000 for injection via local infiltration, peripheral nerve
block, and caudal and lumbar epidural
blocks. Solutions of MARCAINE may be autoclaved if they do not contain
epinephrine. Solutions are
TM
TM
clear and colorless.
Bupivacaine is related chemically and pharmacologically to the
aminoacyl local anesthetics. It is a
homologue of mepivacaine and is chemically related to lidocaine. All
three of these anesthetics contain
an amide linkage between the aromatic nucleus and the amino, or
piperidine group. They differ in this
respect from the procaine-type local anesthetics, which have an ester
linkage.
_MARCAINE_—Sterile isotonic solutions containing sodium chloride. In
multiple-dose vials, each mL
also contains 1 mg methylparaben as antiseptic preservative. The pH of
these solutions is adjusted to
between 4 and 6.5 with sodium hydroxide or hydrochloric acid.
_MARCAINEwith epinephrine _1:200,000 (as bitartrate)—Sterile
isotonic solutions containing sodium
chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg
epinephrine bitartrate