Страна: Канада
Език: английски
Източник: Health Canada
ATENOLOL
IVAX PHARMACEUTICALS INCORPORATED
C07AB03
ATENOLOL
50MG
TABLET
ATENOLOL 50MG
ORAL
100
Prescription
BETA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0113847002; AHFS:
CANCELLED PRE MARKET
2018-07-24
_1_ PRODUCT MONOGRAPH _Pr _ ATENOLOL TABLETS Atenolol Tablets 50 mg and 100 mg USP Beta Adrenergic-receptor Blocking Agent IVAX Pharmaceuticals, Inc. 140 Legrand Avenue Northvale, New Jersey 07647 Control #: 099059 Canadian Distributor: IVAX Pharmaceuticals Canada Inc. 1 Place Ville-Marie Suite 3900 Montreal, Quebec H3B 4M7 Date of Revision: November 02, 2005 _2_ Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SUMMARY PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 SPECIAL HANDLING INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . . . . . . . . . 18 PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . Прочетете целия документ