KAMRAB SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

RABIES IMMUNOGLOBULIN (HUMAN)

Dostupno od:

KAMADA LTD

ATC koda:

J06BB05

INN (International ime):

RABIES IMMUNOGLOBULIN

Doziranje:

150UNIT

Farmaceutski oblik:

SOLUTION

Sastav:

RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

10 ML

Tip recepta:

Schedule D

Područje terapije:

SERUMS

Proizvod sažetak:

Active ingredient group (AIG) number: 0110666002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2018-11-07

Svojstava lijeka

_KamRAB™ - Product Monograph _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
KAMRAB
TM
RABIES IMMUNOGLOBULIN (HUMAN)
Solution for intramuscular injection (150 IU/mL)
2.0 mL vials and 10.0 mL vials
Passive, Transient Post-Exposure Agent For Prophylaxis Of Rabies
Manufactured by:
Kamada Ltd.
2 Holzman St, Science Park,
P.O. Box 4081, Rehovot 7670402, Israel
Imported by:
Imported by/Importé par:
Quality & Compliance Services Inc.,
Mississauga, ON L5N 5R1
for/pour
Valneva Canada Inc.,
Kirkland, QC H9H 5B9
Submission Control No: 211541 Date of Initial Approval: November 7,
2018
_ _
_KamRAB™ - Product Monograph _
_Page 2 of 23_
TABLE OF CONTENTS
TABLE OF CONTENTS
..................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 4
1
INDICATIONS
................................................................................................
4
1.1.
Pediatrics
.......................................................................................................
4
1.2.
Geriatrics
........................................................................................................
4
2.
CONTRAINDICATIONS
.................................................................................
4
3.
DOSAGE AND ADMINISTRATION
................................................................ 4
3.1.
Dosing Considerations
...................................................................................
4
3.2.
Recommended Dose and Dosage Adjustment
.............................................. 5
3.3.
Administration
................................................................................................
5
3.4.
Reconstitution
................................................................................................
6
3.5.
Missed Dose
..................................................................................................
6
4.
OVERDOSAGE
................