Țară: Canada
Limbă: engleză
Sursă: Health Canada
CLONIDINE HYDROCHLORIDE
SANDOZ CANADA INCORPORATED
C02AC01
CLONIDINE
0.2MG
TABLET
CLONIDINE HYDROCHLORIDE 0.2MG
ORAL
15G/50G
Prescription
CENTRAL ALPHA-AGONISTS
Active ingredient group (AIG) number: 0108891002; AHFS:
APPROVED
2021-05-13
_ _ _Sandoz Clonidine _ _Page 1 of 29_ PRODUCT MONOGRAPH Pr SANDOZ ® CLONIDINE Clonidine Hydrochloride 0.1 mg and 0.2 mg Tablets USP Antihypertensive Sandoz Canada Inc. 110 de Lauzon Street Boucherville, Quebec J4B 1E6 Date of Preparation: 11 May, 2021 Submission Control No: 240149 _ _ _Sandoz Clonidine _ _Page 2 of 29_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................7 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................12 ACTION AND CLINICAL PHARMACOLOGY ............................................................13 STORAGE AND STABILITY ..........................................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................16 PHARMACEUTICAL INFORMATION ..........................................................................16 CLINICAL TRIALS ..........................................................................................................17 DETAILED PHARMACOLOGY ................................ Citiți documentul complet