PREMPLUS KIT

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

Saadav alates:

PFIZER CANADA ULC

ATC kood:

G03FA12

INN (Rahvusvaheline Nimetus):

MEDROXYPROGESTERONE AND ESTROGEN

Annus:

0.625MG; 5MG

Ravimvorm:

KIT

Koostis:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 5MG

Manustamisviis:

ORAL

Ühikuid pakis:

56(2X28 -2DIFF TABS)

Retsepti tüüp:

Prescription

Terapeutiline ala:

ESTROGENS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0242061002; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2019-11-06

Toote omadused

_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
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