APO-MIDODRINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MIDODRINE HYDROCHLORIDE

Tersedia dari:

APOTEX INC

Kode ATC:

C01CA17

INN (Nama Internasional):

MIDODRINE

Dosis:

2.5MG

Bentuk farmasi:

TABLET

Komposisi:

MIDODRINE HYDROCHLORIDE 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ALPHA-ADRENERGIC AGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-03-13

Karakteristik produk

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
...........................................