PREMPLUS KIT

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CONJUGATED ESTROGENS; MEDROXYPROGESTERONE ACETATE

Disponible des:

PFIZER CANADA ULC

Codi ATC:

G03FA12

Designació comuna internacional (DCI):

MEDROXYPROGESTERONE AND ESTROGEN

Dosis:

0.625MG; 5MG

formulario farmacéutico:

KIT

Composición:

CONJUGATED ESTROGENS 0.625MG; MEDROXYPROGESTERONE ACETATE 5MG

Vía de administración:

ORAL

Unidades en paquete:

56(2X28 -2DIFF TABS)

tipo de receta:

Prescription

Área terapéutica:

ESTROGENS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2019-11-06

Fitxa tècnica

_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