INNOHEP SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TINZAPARIN SODIUM

Disponível em:

LEO PHARMA INC

Código ATC:

B01AB10

DCI (Denominação Comum Internacional):

TINZAPARIN

Dosagem:

20000UNIT

Forma farmacêutica:

SOLUTION

Composição:

TINZAPARIN SODIUM 20000UNIT

Via de administração:

SUBCUTANEOUS

Unidades em pacote:

0.5ML

Tipo de prescrição:

Prescription

Área terapêutica:

HEPARINS

Resumo do produto:

Active ingredient group (AIG) number: 0124929003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2010-10-14

Características técnicas

_ _
_innohep® (tinzaparin sodium) Product Monograph, version 8.0 _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
INNOHEP®
tinzaparin sodium
Sterile solution for SC injection
MULTI-DOSE VIAL
10,000 anti-Xa IU/mL
20,000 anti-Xa IU/mL
PRE-FILLED SYRINGE WITH SAFETY NEEDLE DEVICE
2,500 anti-Xa IU/0.25 mL
3,500 anti-Xa IU/0.35 mL
4,500 anti-Xa IU/0.45 mL
8,000 anti-Xa IU/0.4 mL
10,000 anti-Xa IU/0.5 mL
12,000 anti-Xa IU/0.6 mL
14,000 anti-Xa IU/0.7 mL
16,000 anti-Xa IU/0.8 mL
18,000 anti-Xa IU/0.9 mL
Ph. Eur.
Anticoagulant / Antithrombotic
LEO Pharma Inc
Thornhill, ON
L3T 7W8
www.leo-pharma.com/canada
Date of Revision:
Date of Approval:
MAY 26, 2017
Submission Control No:
202366
® Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
eDoc-000592317 - Version 5.0
_ _
_innohep® (tinzaparin sodium) Product Monograph, version 8.0 _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
.....................