APO-MIDODRINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MIDODRINE HYDROCHLORIDE

Commercializzato da:

APOTEX INC

Codice ATC:

C01CA17

INN (Nome Internazionale):

MIDODRINE

Dosaggio:

2.5MG

Forma farmaceutica:

TABLET

Composizione:

MIDODRINE HYDROCHLORIDE 2.5MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

ALPHA-ADRENERGIC AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0123066001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2006-03-13

Scheda tecnica

Page 1 of 23
PRODUCT MONOGRAPH
Pr
APO-MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS USP
2.5 MG AND 5 MG
VASOPRESSOR
APOTEX INC. DATE OF PREPARATION
150 SIGNET DRIVE OCTOBER 16, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NO. 219481
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 4
SUMMARY PRODUCT INFORMATION
.............................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................
4
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
9
DOSAGE AND ADMINISTRATION
...................................................................................
10
OVERDOSAGE
......................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 11
STORAGE AND STABILITY
...............................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 13
PART II: SCIENTIFIC INFORMATION
.............................................................................
14
PHARMACEUTICAL INFORMATION
...............................................................................
14
CLINICAL TRIALS
...............................................................................................................
16
DETAILED PHARMACOLOGY
...........................................