TECHNIVIE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

OMBITASVIR; PARITAPREVIR; RITONAVIR

Tersedia dari:

ABBVIE CORPORATION

Kode ATC:

J05AP53

INN (Nama Internasional):

OMBITASVIR, PARITAPREVIR AND RITONAVIR

Dosis:

12.5MG; 75MG; 50MG

Bentuk farmasi:

TABLET

Komposisi:

OMBITASVIR 12.5MG; PARITAPREVIR 75MG; RITONAVIR 50MG

Rute administrasi :

ORAL

Unit dalam paket:

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

Jenis Resep:

Prescription

Area terapi:

HCV Protease Inhibitors

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-07-30

Karakteristik produk

_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