JAMP-ACET-TRAMADOL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Dostępny od:

JAMP PHARMA CORPORATION

Kod ATC:

N02AJ13

INN (International Nazwa):

TRAMADOL AND PARACETAMOL

Dawkowanie:

325MG; 37.5MG

Forma farmaceutyczna:

TABLET

Skład:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

60/100

Typ recepty:

Narcotic (CDSA I)

Dziedzina terapeutyczna:

OPIATE AGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-09-04

Charakterystyka produktu

1 | P a g e
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
JAMP-ACET-TRAMADOL
Acetaminophen and Tramadol hydrochloride tablets, House Std
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Opioid Analgesic and Centrally Acting Analgesic
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Revision:
May 16, 2023
Control # 270861
2 | P a g e
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
...................................................................................................
22
DOSAGE AND ADMINISTRATION
..............................................................................
288
OVERDOSAGE
..............................................................................................................
311
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 322
STORAGE AND STABILITY
...........................................................................................
39
SPECIAL HANDLING
INSTRUCTIONS..........................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 40
PART II: SCIENTIFIC INFORMATION
........................................................................
411
PHARMACEUTICAL INFORMATION
...................................................................