PREMARIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
10-01-2012
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Aktivna sestavina:
CONJUGATED ESTROGENS
Dostopno od:
PFIZER CANADA ULC
Koda artikla:
G03CA57
INN (mednarodno ime):
CONJUGATED ESTROGENS
Odmerek:
1.25MG
Farmacevtska oblika:
TABLET
Sestava:
CONJUGATED ESTROGENS 1.25MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
ESTROGENS
Povzetek izdelek:
Active ingredient group (AIG) number: 0106442003; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2017-08-02
Lastnosti izdelka
_Premarin_
_ (conjugated_
_ _
_estrogens tablets, CSD) _
_Page 1 of 42_
COMPLETE PRESCRIBING INFORMATION
Pr
PREMARIN
®
(conjugated estrogens tablets, CSD)
0.3 mg, 0.625 mg, and 1.25 mg
ESTROGENIC HORMONES
® Wyeth Canada
Pfizer Canada Inc., Licensee
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Revision:
January 10, 2012
Submission Control No: 148504
_Premarin_
_ (conjugated_
_ _
_estrogens tablets, CSD) _
_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
....................................................................................4
ADVERSE REACTIONS
....................................................................................................14
DRUG INTERACTIONS
....................................................................................................19
DOSAGE AND ADMINISTRATION
................................................................................22
OVERDOSAGE...................................................................................................................25
ACTION AND CLINICAL
PHARMACOLOGY...............................................................25
STORAGE AND STABILITY
............................................................................................28
SPECIAL HANDLING
INSTRUCTIONS..........................................................................28
DOSAGE FORMS, COMPOSITION AND
PACKAGING................................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
....
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