TEVA-AMBRISENTAN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

AMBRISENTAN

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

C02KX02

INN (nemzetközi neve):

AMBRISENTAN

Adagolás:

5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

AMBRISENTAN 5MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0152452001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-03-16

Termékjellemzők

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_Teva-Ambrisentan _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-AMBRISENTAN
Ambrisentan tablets
Tablets, 5 mg and 10 mg, Oral
Endothelin Receptor Antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
March 15, 2023
Submission Control Number: 260243
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_Teva-Ambrisentan _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
......................................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
INDICATIONS
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4
1.1 Pediatrics (<18 years of age)
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4
1.2 Geriatrics (≥ 65 years of age)
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4
CONTRAINDICATIONS
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4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
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5
4.5 Missed Dose
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5
OVERDOSAGE
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