REMIFENTANIL FOR INJECTION POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)

Commercializzato da:

SANDOZ CANADA INCORPORATED

Codice ATC:

N01AH06

INN (Nome Internazionale):

REMIFENTANIL

Dosaggio:

2MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 2MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0133098002; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2021-03-22

Scheda tecnica

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_Remifentanil for Injection _
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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
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC J4B 1E6
Date of Revision:
November 27, 2018
Submission Control No: 221334
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_Remifentanil for 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
..............................................................................................................
15
DRUG INTERACTIONS
..............................................................................................................
17
DOSAGE AND ADMINISTRATION
..........................................................................................
18
OVERDOSAGE
............................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
25
STORAGE AND STABILITY
......................................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 30
PART II: SCIENTIFIC INFORMATION
............................................................................................
32
PHARMACEUTICAL