JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
19-05-2021
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Aktiva substanser:
TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
Tillgänglig från:
JAMP PHARMA CORPORATION
ATC-kod:
J05AR03
INN (International namn):
TENOFOVIR DISOPROXIL AND EMTRICITABINE
Dos:
300MG; 200MG
Läkemedelsform:
TABLET
Sammansättning:
TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0251568001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2019-05-21
Produktens egenskaper
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 1 of 67
PRODUCT MONOGRAPH
Pr
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate
Emtricitabine and Tenofovir Tablets
200 mg / 300 mg
(Emtricitabine / Tenofovir disoproxil fumarate)
House Standard
Antiretroviral Agent
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville,
Québec
J4B 5H3, Canada
Submission Control No.: 248455
Date of Revision: May 19, 2021
JAMP Emtricitabine / Tenofovir Disoproxil Fumarate (Emtricitabine and
Tenofovir Tablets) Page 2 of 67
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
.............................................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................................
3
CONTRAINDICATIONS
.......................................................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................................................
5
ADVERSE
REACTIONS......................................................................................................................................
14
DRUG INTERACTIONS
......................................................................................................................................
22
DOSAGE AND ADMINISTRATION
.................................................................................................................
34
OVERDOSAGE
.....................................................................................................................................................
36
ACTION AND CLINICAL
PHARMACOLOGY................................................................................................
37
STORAGE
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