PEGETRON CAPSULE
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
01-02-2017
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Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
RIBAVIRIN; PEGINTERFERON ALFA-2B
Inapatikana kutoka:
MERCK CANADA INC
ATC kanuni:
L03AB60
INN (Jina la Kimataifa):
PEGINTERFERON ALFA-2B, COMBINATIONS
Kipimo:
200MG; 100MCG
Dawa fomu:
CAPSULE
Tungo:
RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 100MCG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
2X0.675ML-56CAPS
Dawa ya aina:
Prescription
Eneo la matibabu:
INTERFERONS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0247602001; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2017-10-05
Tabia za bidhaa
PR
PEGETRON
® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH
PAGE 1 OF 70
PRODUCT MONOGRAPH
PEGETRON
®
RIBAVIRIN PLUS PEGINTERFERON ALFA-2B
RIBAVIRIN 200 MG CAPSULES
PLUS
PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN VIALS:
50 MCG/0.5 ML
150 MCG/0.5 ML
RIBAVIRIN 200 MG CAPSULES
PLUS _ _
PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN CLEARCLICK™ SINGLE DOSE
DELIVERY SYSTEM:_ _
80 MCG/0.5 ML
100 MCG/0.5 ML
120 MCG/0.5 ML
150 MCG/0.5 ML
ANTIVIRAL AGENT PLUS BIOLOGICAL RESPONSE MODIFIER
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, Quebec H9H 4M7
www.merck.ca
Submission Control No: 201233
Date of Approval:
February 1, 2017
PR
PEGETRON
® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH
PAGE 2 OF 70
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
...............................................................................................................
34
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 34
STORAGE AND STABILITY
...............................................
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