PREMPLUS CYCLE KIT

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

Beschikbaar vanaf:

PFIZER CANADA ULC

ATC-code:

G03FA12

INN (Algemene Internationale Benaming):

MEDROXYPROGESTERONE AND ESTROGEN

Dosering:

0.625MG; 10MG

farmaceutische vorm:

KIT

Samenstelling:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 10MG

Toedieningsweg:

ORAL

Eenheden in pakket:

42

Prescription-type:

Prescription

Therapeutisch gebied:

ESTROGENS

Product samenvatting:

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

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2019-11-06

Productkenmerken

_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