MARCAINE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BUPIVACAINE HYDROCHLORIDE

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

N01BB01

INN (Διεθνής Όνομα):

BUPIVACAINE

Δοσολογία:

125MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

BUPIVACAINE HYDROCHLORIDE 125MG

Οδός χορήγησης:

BLOCK/INFILTRATION

Μονάδες σε πακέτο:

50ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

LOCAL ANESTHETICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108896001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2004-05-04

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
MARCAINE
®
(Bupivacaine Hydrochloride Injection USP)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
MARCAINE
® SPINAL
(Bupivacaine Hydrochloride in Dextrose Injection USP)
7.5 mg/mL
MARCAINE
® E
(Bupivacaine Hydrochloride and Epinephrine Injection USP)
Bupivacaine Hydrochloride 2.5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Bupivacaine Hydrochloride 5 mg/mL and Epinephrine Bitartrate 9.1
mcg/mL
Sterile Solution
Local Anesthetic
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 208287
Date of Revision:
September 6, 2017
_Product Monograph – Marcaine_
_®_
_, Marcaine_
_®_
_ Spinal, Marcaine_
_®_
_ E _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION