JAMP-KETOTIFEN SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

KETOTIFEN (KETOTIFEN FUMARATE)

Dostępny od:

JAMP PHARMA CORPORATION

Kod ATC:

S01GX08

INN (International Nazwa):

KETOTIFEN

Dawkowanie:

0.25MG

Forma farmaceutyczna:

SOLUTION

Skład:

KETOTIFEN (KETOTIFEN FUMARATE) 0.25MG

Droga podania:

OPHTHALMIC

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTIALLERGIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0115676003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-06-27

Charakterystyka produktu

_Page 1 of 11_
PRODUCT MONOGRAPH
Pr
JAMP-KETOTIFEN
Ketotifen Fumarate Ophthalmic Solution
(0.25 mg
/
mL as ketotifen)
Anti-allergy Agent
Jamp Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3
Date of Preparation:
June 17, 2019
Submission Control No: 212300
_Page 2 of 11_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................4
DRUG INTERACTIONS
....................................................................................................4
DOSAGE AND ADMINISTRATION
................................................................................4
OVERDOSAGE
..................................................................................................................
4
ACTION AND CLINICAL PHARMACOLOGY
...............................................................5
STORAGE AND STABILITY
............................................................................................5
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 5
PART II: SCIENTIFIC INFORMATION
..................................................................................6
PHARMACEUTICAL INFORMATION
...........................................................................
6
DETAILED PHARMACOLOGY
.......................................................................................7
TOXICOLOGY
.................................................................................