PMS-CONJUGATED ESTROGENS C.S.D. TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

CONJUGATED ESTROGENS

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

G03CA57

SNN (starptautisko nepatentēto nosaukumu):

CONJUGATED ESTROGENS

Deva:

0.3MG

Zāļu forma:

TABLET

Kompozīcija:

CONJUGATED ESTROGENS 0.3MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

ESTROGENS

Produktu pārskats:

Active ingredient group (AIG) number: 0106442002; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2017-09-30

Produkta apraksts

_pms-Conjugated Estrogens CSD (tablets) _
_ _
_ _
_ _
_ page 1 of 42 _
_ _
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) _
_ _
_ _
_ _
_ 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) _
_ _
_