Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
HYDROXYETHYL STARCH 130/0.4
FRESENIUS KABI CANADA LTD
B05AA07
HYDROXYETHYLSTARCH
6%
SOLUTION
HYDROXYETHYL STARCH 130/0.4 6%
INTRAVENOUS
30X250ML/20X500ML
Prescription
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0147581001; AHFS:
APPROVED
2015-03-09
PRODUCT MONOGRAPH VOLULYTE ® 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte injection Plasma Volume Expander FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Preparation: February 17, 2020 Canada Submission Control No: 223031 Volulyte - Product Monograph (v 4.1) 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 ................................................................................................................ 7 DRUG INTERACTIONS ................................................................................................................. 8 DOSAGE AND ADMINISTRATION ............................................................................................. 8 OVERDOSAGE ............................................................................................................................... 9 ACTION AND CLINICAL PHARMACOLOGY ........................................................................... 9 STORAGE AND STABILITY ...................................................................................................... 11 SPECIAL HANDLING INSTRUCTIONS .................................................................................... 12 WARNINGS ................................................................................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ Đọc toàn bộ tài liệu