Maa: Kanada
Kieli: englanti
Lähde: Health Canada
REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE)
ABBVIE CORPORATION
N01AH06
REMIFENTANIL
5MG
POWDER FOR SOLUTION
REMIFENTANIL (REMIFENTANIL HYDROCHLORIDE) 5MG
INTRAVENOUS
3ML
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0133098003; AHFS:
CANCELLED POST MARKET
2013-10-02
_ _ _ULTIVA_ _®_ _ Product Monograph _ _Page 1 of 30 _ PRODUCT MONOGRAPH N ULTIVA ® (Remifentanil Hydrochloride) 1 mg/vial, 2 mg/vial, 5 mg/vial Injection Opioid Component to Anesthesia AbbVie Corporation 8401 Trans Canada Highway St-Laurent (QC) CANADA H4S 1Z1 Date of Preparation: November 2, 2012 Date of the Previous Revision: Date of Revision: Submission Control No: 158347 NOTE: ULTIVA is a trademark of the Glaxo group of companies, AbbVie Corporation licensed use _ _ _ULTIVA_ _®_ _ Product Monograph _ _Page 2 of 30 _ 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 ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................10 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................22 DETAILED PHARMACOLOGY ....................................................... Lue koko asiakirja