ARTISS SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

SEALER PROTEIN (HUMAN); APROTININ (SYNTHETIC); THROMBIN (HUMAN); CALCIUM CHLORIDE

Pieejams no:

BAXTER CORPORATION

ATĶ kods:

B02BC30

SNN (starptautisko nepatentēto nosaukumu):

COMBINATIONS

Deva:

125MG; 3000KIU; 4UNIT; 40MCMOL

Zāļu forma:

SOLUTION

Kompozīcija:

SEALER PROTEIN (HUMAN) 125MG; APROTININ (SYNTHETIC) 3000KIU; THROMBIN (HUMAN) 4UNIT; CALCIUM CHLORIDE 40MCMOL

Ievadīšanas:

TOPICAL

Vienības iepakojumā:

2ML/4ML/10ML (TOTAL VOLUME)

Receptes veids:

Schedule D

Ārstniecības joma:

HEMOSTATICS

Produktu pārskats:

Active ingredient group (AIG) number: 0452577004; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2010-08-11

Produkta apraksts

_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
ARTISS
Fibrin Sealant (Human), Slow Set
Frozen Solutions for Thawing for Topical Application
4 IU/mL (Total Volumes: 2mL, 4mL, 10mL)
Haemostatic and Tissue Adhesive Agent, ATC code: B02BC30
Baxter Corporation
Mississauga, ON
Canada L5N 0C2
DATE OF INITIAL AUTHORIZATION:
DEC 18, 2011
DATE OF REVISION:
JAN 28, 2022
Submission Control Number: 251204
Baxter, Artiss, Duplocath. Duploject, Duplospray, Easyspray, and
Tisseel are
trademarks of Baxter International Inc.
_ _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
Update to 2020 Product Monograph Template and Addition of
DUPLOJECT COMBI (for PRIMA syringe) container closure,
All sections
[02/2021]
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ................................................................................
2
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. SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................................... 5
4. DOSAGE AND ADMINISTRATION ................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
......................................................... 5
4.4 Administration
................................................................................................