PMS-RAMIPRIL-HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Kup teraz

Składnik aktywny:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

C09BA05

INN (International Nazwa):

RAMIPRIL AND DIURETICS

Dawkowanie:

10.0MG; 25.0MG

Forma farmaceutyczna:

TABLET

Skład:

RAMIPRIL 10.0MG; HYDROCHLOROTHIAZIDE 25.0MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0251649005; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2010-02-02

Charakterystyka produktu

                                _pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) _
_Page 1 of 67_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-RAMIPRIL-HCTZ
Ramipril and Hydrochlorothiazide Tablets
Tablets, 10/12.5 mg, 10/25 mg, Oral
Angiotensin Converting Enzyme Inhibitor Plus Diuretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 273262
Date of Initial Approval:
January 21, 2010
Date of Revision:
June 20, 2023
_pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) _
_Page 2 of 67_
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Ophthalmologic
10/2021
7 WARNING AND PRECAUTIONS, Respiratory
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS
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4
2
CONTRAINDICATIONS
..........................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1
Dosing Considerations
......................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................................. 6
4.4
Administration
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