NORVIR SEC CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RITONAVIR

Disponible depuis:

ABBVIE CORPORATION

Code ATC:

J05AE03

DCI (Dénomination commune internationale):

RITONAVIR

Dosage:

100MG

forme pharmaceutique:

CAPSULE

Composition:

RITONAVIR 100MG

Mode d'administration:

ORAL

Unités en paquet:

120

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2014-11-25

Résumé des caractéristiques du produit

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_NORVIR_
_®_
_, NORVIR_
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_ 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
.............................................................