BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

BUPIVACAINE HYDROCHLORIDE

Pieejams no:

OMEGA LABORATORIES LIMITED

ATĶ kods:

N01BB01

SNN (starptautisko nepatentēto nosaukumu):

BUPIVACAINE

Deva:

7.5MG

Zāļu forma:

SOLUTION

Kompozīcija:

BUPIVACAINE HYDROCHLORIDE 7.5MG

Ievadīšanas:

EPIDURAL

Vienības iepakojumā:

100

Receptes veids:

Ethical

Ārstniecības joma:

LOCAL ANESTHETICS

Produktu pārskats:

Active ingredient group (AIG) number: 0108896002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-11-06

Produkta apraksts

_Page 1 of 33 _
PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE INJECTION USP
7.5 mg / mL
Sterile Solution
_ _Local Anesthetic
_ _
Omega Laboratories Limited
Date of Preparation: November 6, 2020
11 177 Hamon
Montreal, Quebec
H3M 3E4
Submission Control No: 222019
_Page 2 of 33 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
INDICATIONS AND CLINICAL USE
................................................................. 3
CONTRAINDICATIONS
......................................................................................
3
WARNINGS AND PRECAUTIONS
.....................................................................
4
ADVERSE REACTIONS
.....................................................................................
10
DRUG INTERACTIONS
.....................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................. 13
OVERDOSAGE
...................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
............................................... 20
STORAGE AND STABILITY
.............................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.......................................................... 23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 23
PART II: SCIENTIFIC INFORMATION
................................................................... 24
PHARMACEUTICAL INFORMATION
............................................................. 24
DETAILED PHARMACOLOGY
........................................................................
24
TOXICOLOGY
....................................................................................................
25
REFERENCES
..............................................................................