PMS-ESTRADIOL VALERATE INJ 10MG/ML LIQUID

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ESTRADIOL VALERATE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

G03CA03

INN (nume internaţional):

ESTRADIOL

Dozare:

10MG

Forma farmaceutică:

LIQUID

Compoziție:

ESTRADIOL VALERATE 10MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ESTROGENS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2016-10-28

Caracteristicilor produsului

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