PREMPLUS KIT

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

זמין מ:

PFIZER CANADA ULC

קוד ATC:

G03FA12

INN (שם בינלאומי):

MEDROXYPROGESTERONE AND ESTROGEN

כמות:

0.625MG; 2.5MG

טופס פרצבטיות:

KIT

הרכב:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 2.5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

56(2X28 - 2DIFF TABS)

סוג מרשם:

Prescription

איזור תרפויטי:

ESTROGENS

leaflet_short:

Active ingredient group (AIG) number: 0242061001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-11-06

מאפייני מוצר

_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