NTP-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
23-03-2010
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
METHYLPHENIDATE HYDROCHLORIDE
Fáanlegur frá:
NT PHARMA CANADA LTD
ATC númer:
N06BA04
INN (Alþjóðlegt nafn):
METHYLPHENIDATE
Skammtar:
36MG
Lyfjaform:
TABLET (EXTENDED-RELEASE)
Samsetning:
METHYLPHENIDATE HYDROCHLORIDE 36MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Schedule G (CDSA III)
Lækningarsvæði:
Respiratory and CNS Stimulants
Vörulýsing:
Active ingredient group (AIG) number: 0107548005; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2017-08-21
Vara einkenni
_ _
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..............................................................
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