País: Canadà
Idioma: anglès
Font: Health Canada
HYDROXYETHYL STARCH 130/0.4
FRESENIUS KABI CANADA LTD
B05AA07
HYDROXYETHYLSTARCH
6%
SOLUTION
HYDROXYETHYL STARCH 130/0.4 6%
INTRAVENOUS
250ML/500ML
Prescription
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0147581001; AHFS:
APPROVED
2006-03-10
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 ......................................................................... Llegiu el document complet