MINT-ABACAVIR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ABACAVIR (ABACAVIR SULFATE)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

J05AF06

INN (Kansainvälinen yleisnimi):

ABACAVIR

Annos:

300MG

Lääkemuoto:

TABLET

Koostumus:

ABACAVIR (ABACAVIR SULFATE) 300MG

Antoreitti:

ORAL

Kpl paketissa:

60

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0137623001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-09-20

Valmisteyhteenveto

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_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ABACAVIR
Abacavir Tablets
Tablets, 300 mg abacavir (as abacavir sulfate), Oral
USP
Antiretroviral Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
September 18, 2018
Date of Revision:
November 18, 2021
Submission Control No: 253731
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
11/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
11/2021
7 WARNINGS AND PRECAUTIONS, General
11/2021
7 WARNINGS AND PRECAUTIONS, Hypersensitivity Reactions
11/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 4
1. INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics.......................................................................................................................
4
1.2
Geriatrics.......................................................................................................................
4
2. CONTRAINDICATIONS
........................................................................................................
4
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................... 5
4. DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1 Dosing Considerations
..................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.............................................................. 6
4.3 Missed
Dose.....................................