EMERADE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

EPINEPHRINE (EPINEPHRINE BITARTRATE)

Disponible depuis:

BAUSCH HEALTH, CANADA INC.

Code ATC:

C01CA24

DCI (Dénomination commune internationale):

EPINEPHRINE

Dosage:

0.15MG

forme pharmaceutique:

SOLUTION

Composition:

EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.15MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

0.5ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

ALPHA-AND BETA-ADRENERGIC AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2019-03-22

Résumé des caractéristiques du produit

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