TECHNIVIE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

OMBITASVIR; PARITAPREVIR; RITONAVIR

זמין מ:

ABBVIE CORPORATION

קוד ATC:

J05AP53

INN (שם בינלאומי):

OMBITASVIR, PARITAPREVIR AND RITONAVIR

כמות:

12.5MG; 75MG; 50MG

טופס פרצבטיות:

TABLET

הרכב:

OMBITASVIR 12.5MG; PARITAPREVIR 75MG; RITONAVIR 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

56 (1 MONTH CARTON, 28 PACKS, 2 TABLETS PER PACK)

סוג מרשם:

Prescription

איזור תרפויטי:

HCV Protease Inhibitors

leaflet_short:

Active ingredient group (AIG) number: 0357510001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-07-30

מאפייני מוצר

_TECHNIVIE Product Monograph _
_ _
_Page 1 of 67 _
_Date of Revision: February 13, 2018 and Control No. 211480 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TECHNIVIE
™
ombitasvir/paritaprevir/ritonavir
film-coated tablets (12.5/75/50 mg)
Antiviral Agent
Date of Preparation:
October 20, 2015
Date of Previous Revision:
August 10, 2017
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
February 22, 2018
St-Laurent, Qc H4S 1Z1
Submission Control No: 211480
_TECHNIVIE Product Monograph _
_ _
_Page 2 of 67 _
_Date of Revision: February 13, 2018 and Control No. 211480 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................35
OVERDOSAGE
................................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................37
STORAGE AND STABILITY
..........................................................................................43
SPECIAL HANDLING INSTRUCTIONS
.......................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIEN