PMS-CONJUGATED ESTROGENS C.S.D. TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Osta kohe

Toote omadused Toote omadused (SPC)
04-09-2009

Toimeaine:

CONJUGATED ESTROGENS

Saadav alates:

PHARMASCIENCE INC

ATC kood:

G03CA57

INN (Rahvusvaheline Nimetus):

CONJUGATED ESTROGENS

Annus:

1.25MG

Ravimvorm:

TABLET

Koostis:

CONJUGATED ESTROGENS 1.25MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/1000

Retsepti tüüp:

Prescription

Terapeutiline ala:

ESTROGENS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0106442003; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2017-09-30

Toote omadused

                                _pms-Conjugated Estrogens CSD (tablets) _
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PRODUCT MONOGRAPH
PR
PMS-CONJUGATED ESTROGENS CSD
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, 0.9 mg, and 1.25 mg
ESTROGENIC HORMONES
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
AUGUST 28, 2009
Montreal, Quebec
H4P 2T4
CONTROL NUMBER: 120633
_pms-Conjugated Estrogens CSD (tablets) _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION……………………………...
3
SUMMARY PRODUCT
INFORMATION……………………………………….3
INDICATIONS AND CLINICAL
USE…………………………………………...3
CONTRAINDICATIONS…………………………………………………………4
WARNINGS AND
PRECAUTIONS…………………………………….……….5
ADVERSE
REACTIONS………………………………………………………...13
DRUG
INTERACTIONS………………………………………………………...18
DOSAGE AND
ADMINISTRATION…………………………………………...20
OVERDOSAGE………………………………………………………………….22
ACTION AND CLINICAL
PHARMACOLOGY……………………………….23
STORAGE AND
STABILITY…………………………………………………...26
SPECIAL HANDLING
INSTRUCTIONS………………………………………26
DOSAGE FORMS, COMPOSITION AND PACKAGING……………………..26
PART II: SCIENTIFIC
INFORMATION…………………………………………….
27
PHARMACEUTICAL
INFORMATION………………………………………...27
CLINICAL
TRIALS……………………………………………………………...27
DETAILED
PHARMACOLOGY………………………………………………..32
REFERENCES…………………………………………………………………...33
PART III: CONSUMER
INFORMATION……………………………………………………
37
_pms-Conjugated Estrogens CSD (tablets) _
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