PMS-ESTRADIOL VALERATE INJ 10MG/ML LIQUID

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ESTRADIOL VALERATE

Dostupno od:

PHARMASCIENCE INC

ATC koda:

G03CA03

INN (International ime):

ESTRADIOL

Doziranje:

10MG

Farmaceutski oblik:

LIQUID

Sastav:

ESTRADIOL VALERATE 10MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

10ML

Tip recepta:

Prescription

Područje terapije:

ESTROGENS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2016-10-28

Svojstava lijeka

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