VOLUVEN SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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17-02-2020

有效成分:

HYDROXYETHYL STARCH 130/0.4

可用日期:

FRESENIUS KABI CANADA LTD

ATC代码:

B05AA07

INN(国际名称):

HYDROXYETHYLSTARCH

剂量:

6%

药物剂型:

SOLUTION

组成:

HYDROXYETHYL STARCH 130/0.4 6%

给药途径:

INTRAVENOUS

每包单位数:

250ML/500ML

处方类型:

Prescription

治疗领域:

REPLACEMENT PREPARATIONS

產品總結:

Active ingredient group (AIG) number: 0147581001; AHFS:

授权状态:

APPROVED

授权日期:

2006-03-10

产品特点

                                PRODUCT MONOGRAPH
VOLUVEN
®
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection
Plasma Volume Expander
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C84
Date of Revision:
February 17, 2020_ _
Submission Control No: 222938
_Product Monograph: VOLUVEN_
_® _
_(v 3.6) Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
................................................................................
4
ADVERSE REACTIONS
..................................................................................................
6
DRUG INTERACTIONS
..................................................................................................
7
DOSAGE AND ADMINISTRATION
..............................................................................
7
OVERDOSAGE
................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 8
STORAGE AND STABILITY
........................................................................................
10
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
........................................................................
15
CLINICAL TRIALS
.........................................................................
                                
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