TARO-FAMPRIDINE TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FAMPRIDINE

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

N07XX07

SNN (starptautisko nepatentēto nosaukumu):

FAMPRIDINE

Deva:

10MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

FAMPRIDINE 10MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

(2X14)/(4X14)/28/56

Receptes veids:

Prescription

Ārstniecības joma:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0153090001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2020-05-15

Produkta apraksts

_Page 1 of 31_
PRODUCT MONOGRAPH
Pr
Taro-Fampridine
Fampridine Sustained Release Tablet
10 mg
Potassium Channel Blocker
Taro Pharmaceuticals Inc.
Date of Preparation: November 05, 2018
130 East Drive, Brampton
Ontario L6T 1C1
Submission Control No: 212539
_Page 2 of 31_
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................................................................................................................9
DRUG INTERACTIONS
..............................................................................................................14
DOSAGE AND ADMINISTRATION
..........................................................................................15
OVERDOSAGE
............................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
........................................................................17
STORAGE AND STABILITY
......................................................................................................19
SPECIAL HANDLING INSTRUCTIONS
...................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................19
PART II: SCIENTIFIC INFORMATION
....................................................................................20
PHARMACEUTICAL
INFORMATION....................................................