BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
27-03-2023
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Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
BUPIVACAINE HYDROCHLORIDE
Fáanlegur frá:
FORMATIVE PHARMA INC.
ATC númer:
N01BB01
INN (Alþjóðlegt nafn):
BUPIVACAINE
Skammtar:
7.5MG
Lyfjaform:
SOLUTION
Samsetning:
BUPIVACAINE HYDROCHLORIDE 7.5MG
Stjórnsýsluleið:
INTRASPINAL
Einingar í pakka:
100
Gerð lyfseðils:
Ethical
Vörulýsing:
Active ingredient group (AIG) number: 0108896002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-03-29
Vara einkenni
Bupivacaine Hydrochloride in Dextrose Injection USP
Page 1 of 29
PRODUCT MONOGRAPH
BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP
7.5 mg bupivacaine hydrochloride / mL
Sterile Hyperbaric Solution
Local Anesthetic for Spinal Use Only
FORMATIVE PHARMA INC.
4145 North Service Road, Suite 200,
Burlington, Ontario, L7L 6A3
DATE OF PREPARATION:
March 27, 2023
CONTROL NO.: 263877
Bupivacaine Hydrochloride in Dextrose Injection USP
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
10
DOSAGE AND ADMINISTRATION
...................................................................................
12
OVERDOSAGE
......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 17
STORAGE AND STABILITY
...............................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 20
PART II: SCIENTIFIC INFORMATION
......................................................................
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