PDP-AMANTADINE HYDROCHLORIDE CAPSULES

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AMANTADINE HYDROCHLORIDE

Saatavilla:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC-koodi:

N04BB01

INN (Kansainvälinen yleisnimi):

AMANTADINE

Annos:

100MG

Lääkemuoto:

CAPSULE

Koostumus:

AMANTADINE HYDROCHLORIDE 100MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ADAMANTANES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0109101001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-03-13

Valmisteyhteenveto

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pdp-AMANTADINE HYDROCHLORIDE
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_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PDP-AMANTADINE HYDROCHLORIDE CAPSULES
amantadine hydrochloride capsules
100 mg
House Standard
PR
PDP-AMANTADINE HYDROCHLORIDE SYRUP
amantadine hydrochloride oral solution
10 mg/mL
USP
Antiparkinsonian Agent
Antiviral Agent
PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Initial Authorization:
Jun 27, 1992
Date of Revision:
Jun 13, 2022
Submission Control Number: 261229
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_pdp-AMANTADINE HYDROCHLORIDE_
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_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
2 Contraindications
06/2022
4 Dosage and Administration
12/2021
4.2 Recommended Dose and Dosage Adjustment
06/2022
7 Warnings and Precautions
12/2021
7 Warnings and Precautions, Cardiovascular
06/2022
7 Warnings and Precautions, Neurologic
06/2022
7 Warnings and Precautions, Ophthalmologic
06/2022
7 Warnings and Precautions, Psychiatric
06/2022
7 Warnings and Precautions, Renal
06/2022
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
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND
ADMINISTRATION