SUFENTANIL CITRATE INJECTION SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SUFENTANIL (SUFENTANIL CITRATE)

Mevcut itibaren:

HIKMA CANADA LIMITED

ATC kodu:

N01AH03

INN (International Adı):

SUFENTANIL

Doz:

50MCG

Farmasötik formu:

SOLUTION

Kompozisyon:

SUFENTANIL (SUFENTANIL CITRATE) 50MCG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

100

Reçete türü:

Narcotic (CDSA I)

Terapötik alanı:

OPIATE AGONISTS

Ürün özeti:

Active ingredient group (AIG) number: 0144821001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-06-07

Ürün özellikleri

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
SUFENTANIL CITRATE INJECTION
50 mcg/mL sufentanil
(as sufentanil citrate)
Preservative free sterile aqueous solution
For Intravenous and Epidural use
Hikma Standard
Opioid Analgesic
Adjunct to Anesthesia
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
SUBMISSION CONTROL NO.: 264335
Date of
Preparation:
June 6, 2022
_Sufentanil Citrate Injection _
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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
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
.........................