NUWIQ KIT

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SIMOCTOCOG ALFA; WATER

Pieejams no:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

ATĶ kods:

B02BD02

SNN (starptautisko nepatentēto nosaukumu):

COAGULATION FACTOR VIII

Deva:

1500UNIT; 2.5ML

Zāļu forma:

KIT

Kompozīcija:

SIMOCTOCOG ALFA 1500UNIT; WATER 2.5ML

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100

Receptes veids:

Schedule D

Produktu pārskats:

Active ingredient group (AIG) number: 0256190008; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2022-12-29

Produkta apraksts

_ _
_Nuwiq Product Monograph _
_Page 1 of 42_
PRODUCT MONOGRAPH
Nuwiq
®
Antihemophilic
Factor (Recombinant, B-Domain deleted)
INN = simoctocog alfa
Powder and solvent for solution for intravenous injection
250 IU FVIII/vial reconstituted with 2.5 mL of solvent
500 IU FVIII/vial reconstituted with 2.5 mL of solvent
1000 IU FVIII/vial reconstituted with 2.5 mL of solvent
1500 IU FVIII/vial reconstituted with 2.5 mL of solvent
2000 IU FVIII/vial reconstituted with 2.5 mL of solvent
2500 IU FVIII/vial reconstituted with 2.5 mL of solvent
3000 IU FVIII/vial reconstituted with 2.5 mL of solvent
4000 IU FVIII/vial reconstituted with 2.5 mL of solvent
ATC code: B02BD02
Manufactured by:
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm,
SWEDEN
Manufactured for:
Octapharma Canada Inc.
308-214 King St W
Toronto, Ontario, M5H 3S6, CANADA
Date of Initial Approval:
October 23, 2014
Date of Revision:
December 29, 2022
Control #: 264181
_ _
_Nuwiq Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
DESCRIPTION
.......................................................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................
4
CONTRAINDICATIONS
........................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................
4
ADVERSE REACTIONS
........................................................................................
6
DRUG
INTERACTIONS.........................................................................................
9
DOSAGE AND
ADMINISTRATION......................................................................
9
OVERDOSAGE
.....................................................................................................15
ACTI