PROPOFOL EMULSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
03-10-2017

Viambatanisho vya kazi:

PROPOFOL

Inapatikana kutoka:

BAXTER CORPORATION

ATC kanuni:

N01AX10

INN (Jina la Kimataifa):

PROPOFOL

Kipimo:

10MG

Dawa fomu:

EMULSION

Tungo:

PROPOFOL 10MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

20ML/50ML/100ML

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS GENERAL ANESTHETICS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0121833001; AHFS:

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2024-01-30

Tabia za bidhaa

                                _PROPOFOL Product Monograph _
_Page 1 of 48_
_ _
PRODUCT MONOGRAPH
PR
PROPOFOL
Propofol Injectable Emulsion, BP
1% w/v
10 mg/mL
Intravenous Emulsion – Anaesthetic - Sedative
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Date of Revision:
September 29, 2017
Submission Control No: 207653
_PROPOFOL Product Monograph _
_Page 2 of 48_
_ _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
.....................................................................................27
TOXICOLOGY
..................
                                
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