PREMPLUS CYCLE KIT

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

Saatavilla:

PFIZER CANADA ULC

ATC-koodi:

G03FA12

INN (Kansainvälinen yleisnimi):

MEDROXYPROGESTERONE AND ESTROGEN

Annos:

0.625MG; 10MG

Lääkemuoto:

KIT

Koostumus:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 10MG

Antoreitti:

ORAL

Kpl paketissa:

42

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ESTROGENS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2019-11-06

Valmisteyhteenveto

_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