P-CARE MG- bupivacaine hydrochloride, sodium chloride, povidone-iodine, isopropyl alcohol kit

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

RX PHARMA-PACK, INC.

INN (International Name):

BUPIVACAINE HYDROCHLORIDE

রচনা:

BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 MAR

পণ্য সারাংশ:

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.  0.5% Contains 5 mg bupivacaine hydrochloride per mL.   0.75% Contains 7.5 mg bupivacaine hydrochloride per mL.  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.  0.5% with epinephrine 1:200,000—Contains 5 mg bupivacaine hydrochloride per mL.  For single-dose vials: Discard unused portion. Distributed by Hospira, Inc ., Lake Forest, IL 60045 USA Revised: 11/2018 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: 63323-186-02 Trays of 25 0.9% (18 mg per 2 mL) (9 mg per mL) NDC 63323-186-04 2 mL, fill, in a 3mL Single-Dose vial 63323-186-10 Trays of 25 0.9% (90 mg per 10 mL) (9 mg per mL) NDC 63323-186-10 10 mL Single-Dose vial 63323-186-20 Trays of 25 0.9% (180 mg per 20 mL) (9 mg per mL) NDC 63323-186-03 20 mL Single-Dose vial 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 45764E Revised: October 2018 Aerosol Can Pain Ease 3.9 fl. oz. in Medium Stream P/N 0386-0008-03 Pain Ease 1.0 fl. oz. in Medium Stream P/N 0386-0008-04 Pain Ease 3.9 fl. oz. in Mist P/N 0386-0008-02 Pain Ease 1.0 fl. oz. in Mist P/N 0386-0008-01 Manufactured by: Gebauer Company Cleveland, OH 44128 1-800-321-9348 www.Gebauer.com ©2018 Gebauer Company

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

P-CARE MG- BUPIVACAINE HYDROCHLORIDE, SODIUM CHLORIDE,
POVIDONE-IODINE, ISOPROPYL ALCOHOL
RX PHARMA-PACK, INC.
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P-CARE MG
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
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
TM
TM
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.
_MARCAINE with epinephrine 1:200,000 _(as bitartrate)—Sterile
isotonic solutions containing sodium
chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg
epinephrine bitartrate, with 0.5
mg sodium metabis