MYLAN-LISINOPRIL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LISINOPRIL (LISINOPRIL DIHYDRATE)

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

C09AA03

INN (Διεθνής Όνομα):

LISINOPRIL

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

LISINOPRIL (LISINOPRIL DIHYDRATE) 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0121550003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-08-02

Αρχείο Π.Χ.Π.

Page 1 of 46
PRODUCT MONOGRAPH
PR
MYLAN-LISINOPRIL
(Lisinopril Tablets, USP)
Tablets 5 mg, 10 mg and 20 mg
(Lisinopril as lisinopril dihydrate)
Angiotensin Converting Enzyme Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control number: 192608
Date of Revision:
December 19, 2016
Page 2 of 46
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
.........................................................................................................
11
DRUG
INTERACTIONS
.........................................................................................................
17
DOSAGE
AND
ADMINISTRATION
.....................................................................................
19
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL
INFORMATION
.................................................................................
27
CLINICAL
TRIALS
....................................................