Land: Canada
Språk: engelsk
Kilde: Health Canada
EPINEPHRINE (EPINEPHRINE BITARTRATE)
BAUSCH HEALTH, CANADA INC.
C01CA24
EPINEPHRINE
0.15MG
SOLUTION
EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.15MG
INTRAMUSCULAR
0.5ML
Ethical
ALPHA-AND BETA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0104871002; AHFS:
APPROVED
2019-03-22
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 Les hele dokumentet