BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BUPIVACAINE HYDROCHLORIDE

Commercializzato da:

OMEGA LABORATORIES LIMITED

Codice ATC:

N01BB01

INN (Nome Internazionale):

BUPIVACAINE

Dosaggio:

7.5MG

Forma farmaceutica:

SOLUTION

Composizione:

BUPIVACAINE HYDROCHLORIDE 7.5MG

Via di somministrazione:

EPIDURAL

Confezione:

100

Tipo di ricetta:

Ethical

Area terapeutica:

LOCAL ANESTHETICS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2020-11-06

Scheda tecnica

_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
..............................................................................