Држава: Канада
Језик: Енглески
Извор: Health Canada
METHYLPHENIDATE HYDROCHLORIDE
NT PHARMA CANADA LTD
N06BA04
METHYLPHENIDATE
18MG
TABLET (EXTENDED-RELEASE)
METHYLPHENIDATE HYDROCHLORIDE 18MG
ORAL
100
Schedule G (CDSA III)
Respiratory and CNS Stimulants
Active ingredient group (AIG) number: 0107548004; AHFS:
CANCELLED PRE MARKET
2017-08-21
_ _ PRODUCT MONOGRAPH NTP-METHYLPHENIDATE ER-C (Methylphenidate Hydrochloride) Extended-release Tablets 18 mg, 27 mg, 36 mg, and 54 mg NT Pharma Standard CNS Stimulant NT Pharma Canada Limited Date of Preparation: 5691 Main Street March 18, 2010 Stouffville, Ontario Canada, L4A 1H5 Submission Control No: 136744 C _Page 2 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS......................................................................................... 5 ADVERSE REACTIONS........................................................................................................... 9 DRUG INTERACTIONS ......................................................................................................... 15 DOSAGE AND ADMINISTRATION..................................................................................... 16 OVERDOSAGE ....................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 19 STORAGE AND STABILITY................................................................................................. 23 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 24 PART II: SCIENTIFIC INFORMATION.................................................................................... 25 PHARMACEUTICAL INFORMATION................................................................................. 25 CLINICAL TRIALS.............................................................. Прочитајте комплетан документ