LUPIN-TRAMADOL/ACET TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN

Διαθέσιμο από:

LUPIN PHARMA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

N02AJ13

INN (Διεθνής Όνομα):

TRAMADOL AND PARACETAMOL

Δοσολογία:

37.50MG; 325.00MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TRAMADOL HYDROCHLORIDE 37.50MG; ACETAMINOPHEN 325.00MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/60

Τρόπος διάθεσης:

Narcotic (CDSA I)

Θεραπευτική περιοχή:

OPIATE AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0250601001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2021-11-05

Αρχείο Π.Χ.Π.

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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