Страна: Канада
Язык: английский
Источник: Health Canada
FLUDEOXYGLUCOSE 18F
SYLVIA FEDORUK CANADIAN CENTRE FOR NUCLEAR INNOVATION
V09IX04
FLUDEOXYGLUCOSE (18F)
441GBQ
SOLUTION
FLUDEOXYGLUCOSE 18F 441GBQ
INTRAVENOUS
10ML/30ML
Schedule C
RADIOACTIVE AGENTS
Active ingredient group (AIG) number: 0152591022; AHFS:
APPROVED
2019-10-08
_ _ _[F-18]-Fludeoxyglucose (FDG) Injection _ _Page 1 of 20_ PRODUCT MONOGRAPH [F-18] Fludeoxyglucose Injection ([F-18]-FDG Injection) 1 - 441 GBq per batch at EOS DIAGNOSTIC RADIOPHARMACEUTICAL Sylvia Fedoruk Canadian Centre for Nuclear Innovation 303-111 Research Drive Saskatoon SK S7N 3R2 www.fedorukcentre.ca _ _ Submission Control No: 194866 Date of Approval: TBD Date of Revision: January 17, 2019 _ _ _[F-18]-Fludeoxyglucose (FDG) Injection _ _Page 2 of 20_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 4 CONTRAINDICATIONS .................................................................................................. 5 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................... 7 DRUG INTERACTIONS ................................................................................................... 8 DOSAGE AND ADMINISTRATION ............................................................................... 8 RADIATION DOSIMETRY ............................................................................................ 10 OVERDOSAGE ............................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 11 STORAGE AND STABILITY ......................................................................................... 12 SPECIAL HANDLING INSTRUCTIONS ................................................................. Прочитать полный документ