LUPIN-TRAMADOL/ACET TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
19-07-2018
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Aktiva substanser:
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Tillgänglig från:
LUPIN PHARMA CANADA LIMITED
ATC-kod:
N02AJ13
INN (International namn):
TRAMADOL AND PARACETAMOL
Dos:
37.50MG; 325.00MG
Läkemedelsform:
TABLET
Sammansättning:
TRAMADOL HYDROCHLORIDE 37.50MG; ACETAMINOPHEN 325.00MG
Administreringssätt:
ORAL
Enheter i paketet:
10/60
Receptbelagda typ:
Narcotic (CDSA I)
Terapiområde:
OPIATE AGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0250601001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2021-11-05
Produktens egenskaper
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_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPIN-TRAMADOL/ACET
House Standard
acetaminophen and tramadol hydrochloride tablets
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
Lupin Pharma Canada Limited
1155 René-Lévesque West Blvd.
Suite 2500
Montreal QC
H3B 2K4
Date of Revision:
July 19, 2018
SUBMISSION CONTROL NO: 216388
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_Page 2 of 64_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
3
CONTRAINDICATIONS
......................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................
4
ADVERSE REACTIONS
.....................................................................................................
17
DRUG INTERACTIONS
.....................................................................................................
21
DOSAGE AND ADMINISTRATION
.................................................................................
24
OVERDOSAGE
...................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 28
STORAGE AND STABILITY
.............................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 35
PART II: SCIENTIFIC INFORMATION
...............................................................................
37
PHARMACEUTICAL INFORMA
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