FOSAPREPITANT POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE)

Dostupné z:

APOTEX INC

ATC kód:

A04AD

INN (Medzinárodný Name):

OTHER ANTIEMETICS

Dávkovanie:

150MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) 150MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTIEMETICS

Prehľad produktov:

Active ingredient group (AIG) number: 0152547002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2015-08-25

Súhrn charakteristických

_FOSAPREPITANT Product Monograph_
Page 1 of 33
PRODUCT MONOGRAPH
PR
FOSAPREPITANT
FOSAPREPITANT FOR INJECTION
150 MG FOSAPREPITANT / VIAL
(AS FOSAPREPITANT DIMEGLUMINE)
NEUROKININ 1 (NK
1
) RECEPTOR ANTAGONIST
APOTEX INC.
Date of Revision:
150 SIGNET DRIVE June 13, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 227022
_FOSAPREPITANT Product Monograph_
Page 2 of 33
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
......................................................................................................
5
DRUG INTERACTIONS
.......................................................................................................
9
DOSAGE AND ADMINISTRATION
.....................................................................................13
OVERDOSAGE
...................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
......................................................................16
STORAGE AND
STABILITY................................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................19
PART II: SCIENTIFIC INFORMATION
....................................................................................20
PHARMACEUTICAL INFORMATION
..................................................................................20
CLINICAL TRIALS
..........................