Страна: Канада
мова: англійська
Джерело: Health Canada
IMMUNOGLOBULIN (HUMAN)
INSTITUTO GRIFOLS S.A.
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
50MG
SOLUTION
IMMUNOGLOBULIN (HUMAN) 50MG
INTRAVENOUS
10/50/100/200/400ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0106267002; AHFS:
APPROVED
2017-08-17
_Page 1 of 28_ PRODUCT MONOGRAPH FLEBOGAMMA ® 5% Immune Globulin Intravenous (Human) Solution for infusion, 50 mg/mL Passive immunizing agent Immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration. ATC code: J06BA02 Manufactured by: Instituto Grifols, S.A. Can Guasc, 2 - Parets del Vallès E-08150 Barcelona Spain Imported and Distributed by: Grifols Canada Ltd. 5060 Spectrum Way Suite 405 Mississauga, Ontario L4W 5N5 Date of Approval: August 17, 2017 Submission Control No: 194291 _Page 2 of 28_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION ............................................................................. 11 OVERDOSAGE ............................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 13 STORAGE AND STABILITY ......................................................................................... 15 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 15 DOSAGE FORMS, COMPOSITION AND PA Прочитайте повний документ