RANOPTO SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

RANIBIZUMAB

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

S01LA04

INN (International ime):

RANIBIZUMAB

Doziranje:

10MG

Farmaceutski oblik:

SOLUTION

Sastav:

RANIBIZUMAB 10MG

Administracija rute:

INTRAVITREAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0152224001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2023-10-11

Svojstava lijeka

RANOPTO (_ranibizumab injection_)
_Page_ 1 _of_ 97
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RANOPTO
™
Ranibizumab injection
Single Use Vials
10 mg/mL solution for injection
Anti-Vascular Endothelial Growth Factor-A (VEGF-A inhibitor)
Distributed by:
Teva Canada Limited
30 Novopharm Court
M1B 2K9 Ontario CA
Manufactured for:
Teva Canada Innovation
1080 Cote du Beaver Hall
H2Z 1S8 Quebec CA
Date of Initial Authorization:
OCT 11, 2023
Submission Control Number: 268288
RANOPTO (_ranibizumab injection_)
_Page_ 2 _of_ 97
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS...........................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
.........................................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................................
4
RANOPTO IS CONTRAINDICATED IN:
..........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1
Dosing Considerations
....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................... 5
4.4
Administration
.........................................................................