REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

N01AH06

INN (International Adı):

REMIFENTANIL

Doz:

1MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 1MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

1ML

Reçete türü:

Narcotic (CDSA I)

Terapötik alanı:

OPIATE AGONISTS

Ürün özeti:

Active ingredient group (AIG) number: 0133098001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2021-07-30

Ürün özellikleri

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_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
REMIFENTANIL FOR INJECTION
1 mg/vial, 2 mg/vial of remifentanil
Lyophilized Powder for Injection
Sterile
Opioid Component to Anesthesia
Teva Canada Limited
Date of Revision:
30 Novopharm Court
January 2, 2019
Toronto, Ontario
M1B 2K9
Control Number: 221336
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_Page 2 of 42_
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
.............................................................................................................
14
DRUG INTERACTIONS
.............................................................................................................
16
DOSAGE AND ADMINISTRATION
.........................................................................................
17
OVERDOSAGE
...........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
24
STORAGE AND STABILITY
.....................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 28
PART II: SCIENTIFIC INFORMATION
...............................................................................
29
PHARMACEUTICAL INFORMATION
...................................................................................