Riik: Kanada
keel: inglise
Allikas: Health Canada
NITISINONE
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
A16AX04
NITISINONE
4MG
SUSPENSION
NITISINONE 4MG
ORAL
90ML
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0158450005; AHFS:
APPROVED
2017-11-14
_ _ _ _ _Page 1 of 31_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ORFADIN nitisinone 2 mg, 5 mg, 10 mg and 20 mg Capsules 4 mg/ml Oral suspension ATC CODE: A16AX04 Various alimentary tract and metabolism products Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden www.sobi.com Date of Preparation: October 11, 2018 Imported and distributed by: C.R.I. 4 Innovation Drive, Dundas, Ontario L9H 7P3, Canada Submission Control No: 215784 _ _ _ _ _Page 2 of 31_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 ADVERSE REACTIONS ................................................................................................... 7 DRUG INTERACTIONS ................................................................................................... 9 DOSAGE AND ADMINISTRATION ............................................................................. 11 OVERDOSAGE ............................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 13 STORAGE AND STABILITY ......................................................................................... 15 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 16 PART II: SCIENTIFIC INFORMATION ............................................................................... 17 PHARMACEUTICAL INFORMATION ......................................................................... 17 CLINICAL TRIALS ... Lugege kogu dokumenti