JAMP TOLTERODINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TOLTERODINE TARTRATE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

G04BD07

INN (Nama Internasional):

TOLTERODINE

Dosis:

2MG

Bentuk farmasi:

TABLET

Komposisi:

TOLTERODINE TARTRATE 2MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

Antimuscarinics

Ringkasan produk:

Active ingredient group (AIG) number: 0135202002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-03-05

Karakteristik produk

_JAMP TOLTERODINE (tolterodine L-tartrate) Product Monograph_
_Page 1 of 33_
PRODUCT MONOGRAPH
PR
JAMP TOLTERODINE
TOLTERODINE TARTRATE TABLETS
1 MG AND 2 MG TOLTERODINE TARTRATE
HOUSE STANDARD
ANTICHOLINERGIC - ANTISPASMODIC AGENT
JAMP PHARMA CORPORATION
1310 RUE NOBEL
BOUCHERVILLE, QUÉBEC
J4B 5H3
DATE OF APPROVAL:
MARCH 05, 2020
CONTROL NO: 217606
_JAMP TOLTERODINE (tolterodine L-tartrate) Product Monograph_
_Page 2 of 33_
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
....................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND ADMINISTRATION
..............................................................................
11
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 12
STORAGE AND STABILITY
..........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
........................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 14
PART II: SCIENTIFIC INFORMATION
...............................................................................
15
PHARMACEUTICAL INFORMATION
.........................