ALTACE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

RAMIPRIL

Dostopno od:

BAUSCH HEALTH, CANADA INC.

Koda artikla:

C09AA05

INN (mednarodno ime):

RAMIPRIL

Odmerek:

1.25MG

Farmacevtska oblika:

TABLET

Sestava:

RAMIPRIL 1.25MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Povzetek izdelek:

Active ingredient group (AIG) number: 0122858001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-01-11

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
ALTACE
®
Ramipril Capsules, USP
Capsules 1.25 mg, 2.5 mg, 5.0 mg, 10.0 mg, and 15 mg
Ramipril Tablets, USP
Tablets 1.25 mg, 2.5 mg, 5.0 mg and 10.0 mg
ATC CODE: C09AA05
ANGIOTENSIN CONVERTING ENZYME INHIBITOR
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
January 8, 2021
Laval, Quebec
H7L 4A8
Control #: 239641
_Pr_
_ALTACE_
_®_
_ Product Monograph _
_Page 2 of 42_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY
PRODUCT
INFORMATION
..................................................................................
3
INDICATIONS
AND
CLINICAL
USE
........................................................................................
4
CONTRAINDICATIONS
.............................................................................................................
5
WARNINGS
AND
PRECAUTIONS
............................................................................................
6
ADVERSE
REACTIONS
............................................................................................................
13
DRUG
INTERACTIONS
............................................................................................................
18
DOSAGE
AND
ADMINISTRATION
........................................................................................
21
OVERDOSAGE
..........................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
24
STORAGE
AND
STABILITY
....................................................................................................
27
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
30
PHARMACEUTICAL
INFORMATION
................................