EMERADE SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EPINEPHRINE (EPINEPHRINE BITARTRATE)

Disponibil de la:

BAUSCH HEALTH, CANADA INC.

Codul ATC:

C01CA24

INN (nume internaţional):

EPINEPHRINE

Dozare:

0.3MG

Forma farmaceutică:

SOLUTION

Compoziție:

EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.3MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

0.5ML

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

ALPHA-AND BETA-ADRENERGIC AGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0104871002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-10-19

Caracteristicilor produsului

PRESCRIBING INFORMATION
EMERADE
™
Sterile epinephrine injection
Unidose 0.15 mg epinephrine (as epinephrine hydrogen tartrate)
auto-injector
Unidose 0.3 mg epinephrine (as epinephrine hydrogen tartrate)
auto-injector and
Unidose 0.5 mg epinephrine (as epinephrine hydrogen tartrate)
auto-injector
CATECHOLAMINE / SYMPATHOMIMETIC
ATC Code: C01CA24
BAUSCH HEALTH, CANADA INC.
2150 St. Elzéar West
Laval, Quebec
H7L 4A8
DATE OF REVISION:
November 28, 2022
Submission
Control No: 265364
EMERADE
TM
is a trademark of Medeca Pharma AB used under licence by Bausch
Health, Canada Inc.
_ _
_EMERADE_
_TM_
_ Prescribing Information _
_Page 2 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL USE
.........................................................................3
CONTRAINDICATIONS
.............................................................................................6
WARNINGS AND PRECAUTIONS
.............................................................................6
ADVERSE
REACTIONS..............................................................................................9
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
12
OVERDOSAGE
.........................................................................................................
16
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
16
STORAGE AND STABILITY
....................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 18
PART II: SCIENTIFIC INFORMATION
.........................................................................
19
PHARMACEUTICAL INFORMATI