EVICEL SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FIBRINOGEN (HUMAN); THROMBIN (HUMAN)

Verfügbar ab:

OMRIX BIOPHARMACEUTICALS LTD

ATC-Code:

B02BC30

INN (Internationale Bezeichnung):

COMBINATIONS

Dosierung:

90MG; 1200UNIT

Darreichungsform:

SOLUTION

Zusammensetzung:

FIBRINOGEN (HUMAN) 90MG; THROMBIN (HUMAN) 1200UNIT

Verabreichungsweg:

TOPICAL

Einheiten im Paket:

2X1ML/2X2ML/2X5ML

Verschreibungstyp:

Schedule D

Therapiebereich:

HEMOSTATICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0252708001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2023-06-06

Fachinformation

1
PRODUCT MONOGRAPH
EVICEL
®
2 x 1 mL, 2 x 2 mL & 2 x 5 mL Kits
Fibrin Sealant Kit Ph. Eur.
Haemostatic Agent
COMPONENT
HUMAN CLOTTABLE PROTEIN:
HUMAN THROMBIN:
STRENGTH
FACTOR XIII
50- 90 mg/mL
2-15 IU/mL
800-1200 IU/mL
DOSAGE FORM
Single use kits consisting of one vial each of frozen sterile
solutions of Human Clottable Protein and Thrombin
EVICEL
®
is a registered trademark of Johnson & Johnson.
Sponsor Name:
Omrix Biopharmaceuticals Ltd.
Sponsor Address:
MDA Blood Bank,
Sheba Hospital, Ramat-Gan
POB 888, Kiryat Ono 5510801
ISRAEL
Importer/Distributor:
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham, Ontario
L3R 0T5
CANADA
Submission Control No: 208336 Date of Approval: October 13, 2017
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................ 3
SUMMARY PRODUCT INFORMATION
............................................................... 3
DESCRIPTION
..........................................................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................
5
CONTRAINDICATIONS
..........................................................................................
6
WARNINGS AND PRECAUTIONS
........................................................................
6
ADVERSE REACTIONS
..........................................................................................
9
DRUG INTERACTIONS
.........................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................
13
OVERDOSAGE
.......................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................... 17
STORAGE AND STABILITY
................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................