PREMPLUS CYCLE KIT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

Available from:

PFIZER CANADA ULC

ATC code:

G03FA12

INN (International Name):

MEDROXYPROGESTERONE AND ESTROGEN

Dosage:

0.625MG; 10MG

Pharmaceutical form:

KIT

Composition:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 10MG

Administration route:

ORAL

Units in package:

42

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0242061003; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-11-06

Summary of Product characteristics

_Premplus _
®
_ and Premplus Cycle_
®
_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
PREMPLUS
®
conjugated estrogens tablets CSD 0.625 mg and
medroxyprogesterone acetate tablets USP 2.5 mg, 5.0 mg
(Continuous therapy)
Pr
PREMPLUS CYCLE
®
conjugated estrogens tablets CSD 0.625 mg and
medroxyprogesterone acetate tablets USP 10.0 mg
(Cyclic therapy)
Estrogenic Hormones/Progestin
® Wyeth LLC
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
DECEMBER 8, 2010
Submission Control No: 141329
_Premplus _
®
_ and Premplus Cycle_
®
_ _
_Page 2 of 49_
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
....................................................................................................14
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
................................................................................23
OVERDOSAGE...................................................................................................................24
ACTION AND CLINICAL
PHARMACOLOGY...............................................................25
STORAGE AND STABILITY
............................................................................................30
SPECIAL HANDLING
INSTRUCTIONS..........................................................................30
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................30
P