BUPIVACAINE HYDROCHLORIDE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BUPIVACAINE HYDROCHLORIDE

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

N01BB01

INN (Διεθνής Όνομα):

BUPIVACAINE

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

BUPIVACAINE HYDROCHLORIDE 5MG

Οδός χορήγησης:

BLOCK/INFILTRATION

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

LOCAL ANESTHETICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0108896004; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2022-01-27

Αρχείο Π.Χ.Π.

_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 1 of 34 _
PRODUCT MONOGRAPH
Bupivacaine Hydrochloride Injection USP
2.5 mg/mL, 5 mg/mL and 7.5mg/mL Bupivacaine Hydrochloride
(as bupivacaine hydrochloride monohydrate)
Sterile Solution
Local Anesthetic
MYLAN PHARMACEUTICALS ULC
Date of Preparation: September 08, 2014
85 Advance Rd.
Etobicoke, ON
M8Z 2S6
Canada
Control No: 165243
_Product Monograph - Bupivacaine Hydrochloride Injection USP _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND STABILITY
.........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INF