PMS-ESTRADIOL VALERATE INJ 10MG/ML LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL VALERATE

Available from:

PHARMASCIENCE INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

10MG

Pharmaceutical form:

LIQUID

Composition:

ESTRADIOL VALERATE 10MG

Administration route:

INTRAMUSCULAR

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106456001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-10-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-ESTRADIOL VALERATE INJECTION
Estradiol Valerate
10 mg/mL
ESTROGEN
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
JUNE 30, 2009
Montreal, Quebec
H4P 2T4
CONTROL NUMBER: 120632
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………………………………………………………...15
DOSAGE AND
ADMINISTRATION…………………………………………...17
OVERDOSAGE………………………………………………………………….19
ACTION AND CLINICAL
PHARMACOLOGY……………………………….19
STORAGE AND
STABILITY…………………………………………………...22
DOSAGE FORMS, COMPOSITION AND PACKAGING……………………..22
PART II: SCIENTIFIC
INFORMATION…………………………………………….
23
PHARMACEUTICAL
INFORMATION………………………………………...23
CLINICAL
TRIALS……………………………………………………………...24
DETAILED
PHARMACOLOGY………………………………………………..24
REFERENCES…………………………………………………………………...25
PART III: CONSUMER
INFORMATION……………………………………………………
27
2
PRODUCT MONOGRAPH
PR
PMS- ESTRADIOL VALERATE INJECTION
(Estradiol Valerate)
10 mg/mL
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
CLINICALLY RELEVANT NONMEDICINAL
INGREDIENTS
Intramuscular
Injection / 10 mg/mL
Sesame Oil
_For a complete listing see Dosa