HOLKIRA PAK KIT

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

OMBITASVIR; RITONAVIR; PARITAPREVIR; DASABUVIR (DASABUVIR SODIUM MONOHYDRATE)

Доступна з:

ABBVIE CORPORATION

Код атс:

J05AP52

ІПН (Міжнародна Ім'я):

DASABUVIR, OMBITASVIR, PARITAPREVIR AND RITONAVIR

Дозування:

12.5MG; 50MG; 75MG; 250MG

Фармацевтична форма:

KIT

Склад:

OMBITASVIR 12.5MG; RITONAVIR 50MG; PARITAPREVIR 75MG; DASABUVIR (DASABUVIR SODIUM MONOHYDRATE) 250MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

56 PINK & 56 BEIGE

Тип рецепту:

Prescription

Терапевтична области:

HCV Polymerase Inhibitors

Огляд продуктів:

Active ingredient group (AIG) number: 0456390001; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2018-08-15

Характеристики продукта

_HOLKIRA PAK Product Monograph _
_Page 1 of 90 _
_Date of Revision: February 13, 2018 and Control No. 211536 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
HOLKIRA
® PAK
ombitasvir/paritaprevir/ritonavir
film-coated tablets (12.5/75/50 mg)
and
dasabuvir (as dasabuvir sodium monohydrate)
film-coated tablets (250 mg)
Antiviral Agent
_ _
Date of Preparation:
December 22, 2014
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: 211536
_HOLKIRA PAK Product Monograph _
_Page 2 of 90 _
_Date of Revision: February 13, 2018 and Control No. 211536 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................38
OVERDOSAGE
................................................................................................................40
ACTION AND CLINICAL PHARMACOLOGY
............................................................41
STORAGE AND STABILITY
..........................................................................................47
SPECIAL HANDLING INSTRUCTIONS
.......................................................................47
DOSAGE FORMS, COMPOSITI