TRAMADOL/ACET TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Commercializzato da:

SANIS HEALTH INC

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:

100

Tipo di ricetta:

Narcotic (CDSA I)

Area terapeutica:

OPIATE AGONISTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2020-12-16

Scheda tecnica

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRAMADOL/ACET
tramadol hydrochloride and acetaminophen tablets, USP
37.5 mg tramadol hydrochloride/325 mg acetaminophen
Centrally Acting Analgesic
SANIS HEALTH INC.
Date of Revision:
1 President’s Choice Circle November 27, 2018
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NUMBER: 221806
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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
................................................................ 25
OVERDOSAGE
.............................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
................................................ 29
STORAGE AND STABILITY
..........................................................................
35
SPECIAL HANDLING INSTRUCTIONS
....................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 36
PART II: SCIENTIFIC INFORMATION
................................................................. 37
PHARMACEUTICAL INFORMATION
............................................................ 37
CLINICAL TRIALS
........................................................................................
38
DETAILED PHARMACOLOGY
......................................................................
42
TOXICOLOGY................