PAL-PRAVASTATIN-ASA TABLET (DELAYED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PRAVASTATIN SODIUM; ACETYLSALICYLIC ACID

Διαθέσιμο από:

PALADIN LABS INC.

Φαρμακολογική κατηγορία (ATC):

C10BX02

INN (Διεθνής Όνομα):

PRAVASTATIN AND ACETYLSALICYLIC ACID

Δοσολογία:

10MG; 81MG

Φαρμακοτεχνική μορφή:

TABLET (DELAYED-RELEASE)

Σύνθεση:

PRAVASTATIN SODIUM 10MG; ACETYLSALICYLIC ACID 81MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10+10

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HMG-COA REDUCTASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0251548001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-07-31

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PR PAL-PRAVASTATIN-ASA
Acetylsalicylic acid delayed-release tablets/caplets USP
81 mg,162 mg and 325 mg
and
Pravastatin sodium tablets
10 mg, 20 mg and 40 mg
PLATELET AGGREGATION INHIBITOR
AND
LIPID METABOLISM REGULATOR
Paladin Labs Inc.
Date of Revision:
6111 Royalmount Ave. Suite #102
September 19, 2012
Montreal, Quebec
H4P 2T4
Control No. 158368
_ _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
4
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
12
DRUG INTERACTIONS
..........................................................................................................
17
DOSAGE AND ADMINISTRATION
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
..................................................................................
26
CLINICAL TRIALS
.