CALMYLIN ACE SYRUP

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GUAIFENESIN; PHENIRAMINE MALEATE; CODEINE PHOSPHATE

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

R05FA02

INN (nume internaţional):

OPIUM DERIVATIVES AND EXPECTORANTS

Dozare:

100MG; 7.5MG; 10MG

Forma farmaceutică:

SYRUP

Compoziție:

GUAIFENESIN 100MG; PHENIRAMINE MALEATE 7.5MG; CODEINE PHOSPHATE 10MG

Calea de administrare:

ORAL

Unități în pachet:

500ML/1L

Tip de prescriptie medicala:

Narcotic (CDSA I)

Zonă Terapeutică:

ANTITUSSIVES

Rezumat produs:

Active ingredient group (AIG) number: 0303191001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2002-10-10

Caracteristicilor produsului

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CALMYLIN ACE
GUAIFENESIN, CODEINE PHOSPHATE AND PHENIRAMINE MALEATE SYRUP
Guaifenesin 100 mg/5 mL - Codeine Phosphate 10 mg/5 mL –
Pheniramine Maleate 7.5 mg/5 mL
EXPECTORANT/ ANTITUSSIVE/ ANTIHISTAMINE
TEVA CANADA LIMITED
DATE OF REVISION:
30 NOVOPHARM COURT
September 02, 2020
TORONTO, ONTARIO
CANADA M1B 2K9
WWW.TEVACANADA.COM
CONTROL #: 242347
_______________________________________________________________________________
_Product Monograph – CALMYLIN ACE_ Page 2 of 29
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
.........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
......................................................................................
14
OVERDOSAGE
.......................................................................................................................
15
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
16
STORAGE
AND
STABILITY
.................................................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 16
PART II: SCIENTIFIC INFORMATION
......................................................