JAMP-ACET-TRAMADOL TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Commercializzato da:

JAMP PHARMA CORPORATION

Codice ATC:

N02AJ13

INN (Nome Internazionale):

TRAMADOL AND PARACETAMOL

Dosaggio:

325MG; 37.5MG

Forma farmaceutica:

TABLET

Composizione:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Via di somministrazione:

ORAL

Confezione:

60/100

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-09-04

Scheda tecnica

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
...................................................................