NORVIR SEC CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

RITONAVIR

Disponibbli minn:

ABBVIE CORPORATION

Kodiċi ATC:

J05AE03

INN (Isem Internazzjonali):

RITONAVIR

Dożaġġ:

100MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

RITONAVIR 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

120

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HIV PROTEASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0128780001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2014-11-25

Karatteristiċi tal-prodott

_ _
_NORVIR_
_®_
_, NORVIR_
_®_
_ SEC Product Monograph _
_Page 1 of 78 _
_Date of Revision: June 13, 2014 and Control No. 173634 _
PRODUCT MONOGRAPH
PR
NORVIR
®
Ritonavir
film-coated tablets (100 mg)
PR
NORVIR
®
Ritonavir
oral solution (80 mg/mL)
PR
NORVIR
®
SEC
Ritonavir
soft elastic capsules (100 mg)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
July 21, 2014
St-Laurent, Qc H4S 1Z1
Submission Control No: 173634
_ _
_NORVIR_
_®_
_, NORVIR_
_®_
_ SEC Product Monograph _
_Page 2 of 78 _
_Date of Revision: June 13, 2014 and Control No. 173634 _
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
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................34
OVERDOSAGE
................................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................37
STORAGE AND STABILITY
..........................................................................................42
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
.............................................................