RETISERT IMPLANT

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FLUOCINOLONE ACETONIDE

Dostupno od:

BAUSCH & LOMB INC

ATC koda:

S01BA15

INN (International ime):

FLUOCINOLONE ACETONIDE

Doziranje:

0.59MG

Farmaceutski oblik:

IMPLANT

Sastav:

FLUOCINOLONE ACETONIDE 0.59MG

Administracija rute:

INTRAVITREAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

CORTICOSTEROIDS

Proizvod sažetak:

Active ingredient group (AIG) number: 0106314003; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2008-03-13

Svojstava lijeka

_0.59 mg Retisert Product Monograph _
_Page 1 of 36 _
PRODUCT MONOGRAPH
PR
RETISERT
TM
Fluocinolone acetonide
0.59 mg
Intravitreal Implant
ATC Code: S01BA15
Bausch & Lomb Incorporated
1400 N Goodman Street
Rochester, NY 14609
USA
Imported by:
Bausch & Lomb Canada Inc.
520 Applewood Crescent
Vaughan, Ontario
L4K 4B4
Date of Preparation:
March 12, 2013
Control No.: 156472
_0.59 mg Retisert Product Monograph _
_Page 2 of 36 _
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
............................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................
20
DOSAGE AND ADMINISTRATION
......................................................................................
21
OVERDOSAGE
.........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
..................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 23
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMA