TEVA-COTRIDIN EXPECTORANT SYRUP

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; GUAIFENESIN; CODEINE PHOSPHATE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

R05FA02

INN (International Name):

OPIUM DERIVATIVES AND EXPECTORANTS

Dosering :

2MG; 30MG; 100MG; 10MG

Legemiddelform:

SYRUP

Sammensetning:

TRIPROLIDINE HYDROCHLORIDE 2MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; GUAIFENESIN 100MG; CODEINE PHOSPHATE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

500ML/2L

Resept typen:

Narcotic (CDSA I)

Terapeutisk område:

ANTITUSSIVES

Produkt oppsummering:

Active ingredient group (AIG) number: 0403192001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-03-05

Preparatomtale

PRESCRIBING INFORMATION
N
TEVA-COTRIDIN
Triprolidine hydrochloride 2 mg / 5 mL –
Pseudoephedrine hydrochloride 30 mg / 5 mL – Codeine phosphate 10 mg
/ 5 mL
_ _
N
TEVA-COTRIDIN EXPECTORANT
Triprolidine hydrochloride 2 mg / 5 mL – Pseudoephedrine
hydrochloride
30 mg / 5 mL – Guaifenesin 100 mg / 5 mL – Codeine phosphate 10 mg
/ 5 mL
ANTIHISTAMINE
– ANTITUSSIVE DECONGESTANT
SYRUPS
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada
M1B 2K9
www.tevacanada.com
Control No.: 220037, 220038
Date of Revision:
October 29, 2018
Page 2 or 35
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
..................................................................................................
13
DOSAGE AND ADMINISTRATION
..............................................................................
15
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
................