PMS-ESTRADIOL VALERATE INJ 10MG/ML LIQUID

国家: 加拿大

语言: 英文

来源: Health Canada

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下载 产品特点 (SPC)
12-10-2016

有效成分:

ESTRADIOL VALERATE

可用日期:

PHARMASCIENCE INC

ATC代码:

G03CA03

INN(国际名称):

ESTRADIOL

剂量:

10MG

药物剂型:

LIQUID

组成:

ESTRADIOL VALERATE 10MG

给药途径:

INTRAMUSCULAR

每包单位数:

10ML

处方类型:

Prescription

治疗领域:

ESTROGENS

產品總結:

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

授权状态:

CANCELLED POST MARKET

授权日期:

2016-10-28

产品特点

                                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
                                
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