Innohep 3,500units/0.35ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tinzaparin sodium

Available from:

LEO Pharma

ATC code:

B01AB10

INN (International Name):

Tinzaparin sodium

Dosage:

10000unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100; GTIN: 5702191004830

Patient Information leaflet

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Page 1 of
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ARTWORK
Please return to:
LEO Pharma A/S
Internal Market Access
Industriparken 55 – DK-2750 – Ballerup
Scale
Get-up
Material No.
Rev. No.
Sent by e-mail
Subject
Date
Date
Date
Colour
Sign.
Sign.
Sign.
100%
GB
051520
Preparation
Supplier / Place of production
Strength
Comments:
INS 410 x 315 mm (
205 x 315 mm with 2 foils
) 02/03/17
XX
Black
OMA
tinzaparin sodium (INNOHEP
®
) syringe 10,000 IU/ml
France
Page 1 of 2 font 9 pt and lines space 3,35 mm Only for 10 syringes
Mock-up for reg. purpose
▲
051520-XX
WHAT IS IN THIS LEAFLET
1. What tinzaparin sodium is and what it is used for
2. What you need to know before you use tinzaparin sodium
3. How to use tinzaparin sodium
4. Possible side effects
5. How to store tinzaparin sodium
6. Contents of pack and other information
1. WHAT TINZAPARIN SODIUM IS AND WHAT IT IS USED FOR
Tinzaparin is a type of heparin – a low molecular weight heparin –
and belongs to a group of medicines called anticoagulants;
these medicines affect how your blood clots.
Tinzaparin prevents clotting, allowing normal blood flow
through the arteries and veins.
Tinzaparin is used to:
• Prevent blood clots in adults before and after an operation.
• Prevent blood clots in adults who have an increased risk of
blood clots e.g. due to an acute illness with limited mobility.
• Prevent blood clots being formed in haemodialysis
equipment in patients undergoing haemodialysis or
haemofiltration. In haemodialysis, wastes and fluids from the
blood are removed by a dialysis machine and a dialysis filter,
which acts as a kind of artificial kidney.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TINZAPARIN
SODIUM
DO NOT USE TINZAPARIN
• If you are allergic (hypersensitive) to tinzaparin or any of the
other ingredients of this medicine; you can find a list of
ingredients in section 6 of this leaflet.
• If you have ever had a reaction to heparin that caused a
severe drop in the number of your clotting cells (platelets) -
this reaction is called heparin-induced thrombocytopenia (HI

Summary of Product characteristics

OBJECT 1
INNOHEP SYRINGE 10,000 IU/ML
Summary of Product Characteristics Updated 30-Mar-2017 | Leo
Laboratories Limited
1. Name of the medicinal product
innohep Syringe 10,000 IU/ml
or
tinzaparin sodium Syringe 10,000 IU/ml
2. Qualitative and quantitative composition
Tinzaparin sodium 10,000 anti-Factor Xa IU/ml
Excipients with known effect:
Sodium (in total <23 mg/dose).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe.
0.5 ml syringe holding a colourless to straw coloured liquid, free
from turbidity and from matter that
deposits on standing.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis of venous thromboembolism in adult patients undergoing
surgery, particularly orthopaedic,
general or oncological surgery.
Prophylaxis of venous thromboembolism in non-surgical adult patients
immobilised due to acute medical
illness including: acute heart failure, acute respiratory failure,
severe infections, active cancer, as well as
exacerbation of rheumatic diseases.
Prevention of clotting in extracorporeal circuits during haemodialysis
and haemofiltration in adults.
4.2 Posology and method of administration
Posology
Prophylaxis of thromboembolic events in adults:
Administration is by subcutaneous injection.
_Surgical patients at moderate risk of thromboembolic events:_
3,500 anti-Xa IU given SC 2 hours before surgery and then once daily
for as long as the patient is
considered to be at risk of VTE.
_Surgical patients at high risk of thromboembolic events e.g.
undergoing orthopaedic or cancer surgery:_
4,500 anti-Xa IU given SC 12 hours before surgery and then once daily
for as long as the patient is
considered to be at risk of VTE.
_Non-surgical patients immobilised due to acute medical illness:_
3,500 anti-Xa IU given SC once daily in patients at moderate risk of
VTE, or 4,500 anti-Xa IU given SC
once daily in patients at high risk of VTE. Administration should
continue for as long as the patient is
considered to be at risk of VTE.
Neuraxi