PMS-CONJUGATED ESTROGENS C.S.D. TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

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Prenos Lastnosti izdelka (SPC)
04-09-2009

Aktivna sestavina:

CONJUGATED ESTROGENS

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

G03CA57

INN (mednarodno ime):

CONJUGATED ESTROGENS

Odmerek:

0.625MG

Farmacevtska oblika:

TABLET

Sestava:

CONJUGATED ESTROGENS 0.625MG

Pot uporabe:

ORAL

Enote v paketu:

500

Tip zastaranja:

Prescription

Terapevtsko območje:

ESTROGENS

Povzetek izdelek:

Active ingredient group (AIG) number: 0106442006; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2017-09-30

Lastnosti izdelka

                                _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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_ page 2 of 42 _
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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