PROVERA 100MG TABLETS

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MEDROXYPROGESTERONE ACETATE

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

G03DA02

INN (Διεθνής Όνομα):

MEDROXYPROGESTERONE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

MEDROXYPROGESTERONE ACETATE 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PROGESTINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0106339007; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2012-02-13

Αρχείο Π.Χ.Π.

_ _
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 1 of 42_
PRODUCT MONOGRAPH
PR
PROVERA*
(medroxyprogesterone acetate USP)
2.5 mg, 5 mg, 10 mg and 100 mg tablets
and
PR
PROVERA-PAK*
(medroxyprogesterone acetate USP)
5 mg and 10 mg tablets
PROGESTIN
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
DATE OF REVISION:
December 9, 2009
SUBMISSION CONTROL NO: 133050
* TM Pharmacia & Upjohn Company LLC
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2009
_PROVERA / PROVERA-PAK (medroxyprogesterone acetate) Product Monograph
_
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................14
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND
ADMINISTRATION..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND
STABILITY..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL
INFORMATION..........................................................................27
CLINICAL
TRIAL