MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
27-07-2020
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Inapatikana kutoka:
MYLAN PHARMACEUTICALS ULC
ATC kanuni:
J05AR06
INN (Jina la Kimataifa):
EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ
Kipimo:
600MG; 200MG; 300MG
Dawa fomu:
TABLET
Tungo:
EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30
Dawa ya aina:
Prescription
Eneo la matibabu:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0352327001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2017-07-26
Tabia za bidhaa
PAGE 1 OF 75
PRODUCT MONOGRAPH
PR MYLAN-EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
MYLAN STD.
ANTIRETROVIRAL AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: July 27, 2020
Submission Control No: 241548
PAGE 2 OF 75
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................
5
ADVERSE
REACTIONS
.......................................................................................................................................
15
DRUG
INTERACTIONS
.......................................................................................................................................
24
DOSAGE
AND
ADMINISTRATION....................................................................................................................
40
OVERDOSAGE
.....................................................................................................................................................
41
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
42
STORAGE
AND
STABILITY
.......................................................................................................................
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