NTP-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
23-03-2010
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
METHYLPHENIDATE HYDROCHLORIDE
Inapatikana kutoka:
NT PHARMA CANADA LTD
ATC kanuni:
N06BA04
INN (Jina la Kimataifa):
METHYLPHENIDATE
Kipimo:
27MG
Dawa fomu:
TABLET (EXTENDED-RELEASE)
Tungo:
METHYLPHENIDATE HYDROCHLORIDE 27MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Schedule G (CDSA III)
Eneo la matibabu:
Respiratory and CNS Stimulants
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0107548007; AHFS:
Idhini hali ya:
CANCELLED PRE MARKET
Idhini ya tarehe:
2017-08-21
Tabia za bidhaa
_ _
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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