Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
EPINEPHRINE
ENDO VENTURES LTD.
C01CA24
EPINEPHRINE
0.15MG
SOLUTION
EPINEPHRINE 0.15MG
INTRAMUSCULAR
0.3ML
Ethical
ALPHA-AND BETA-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0104871011; AHFS:
APPROVED
2022-01-14
_ _ Page 1 of 21 ANAPEN and ANAPEN JUNIOR Prescribing Information ANAPEN ® Sterile epinephrine injection Mfr. Std. Unidose 0.3 mg epinephrine auto-injector ANAPEN ® JUNIOR Sterile epinephrine injection Mfr. Std. Unidose 0.15 mg epinephrine auto-injector Catecholamine / Sympatomimetic Endo Ventures Ltd. Date of Revision: First Floor, Minerva House, January 14, 2022 Simmonscourt Road, Ballsbridge Dublin 4, Ireland Importer/Distributor: Paladin Labs Inc. 100 Alexis Nihon Blvd, Suite 600 St-Laurent, H4M 2P2 Quebec, Canada Submission Control No: 255336 ® Registered trademark of Bioprojet UK Ltd. _ _ Page 2 of 21 ANAPEN and ANAPEN JUNIOR _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 5 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................... 9 DOSAGE AND ADMINISTRATION ............................................................................... 9 OVERDOSAGE ............................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 11 STORAGE AND STABILITY ......................................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 12 PART II: SCIENTIFIC INFORMATION ....................................... Baca dokumen lengkap