innohep 2,500 IU, solution for injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-11-2020
Summary of Product characteristics
(SPC)
17-03-2023
Active ingredient:
Tinzaparin sodium
Available from:
Leo Laboratories Limited
ATC code:
B01AB; B01AB10
INN (International Name):
Tinzaparin sodium
Dosage:
2,500 IU/ 0.25 ml international unit(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Heparin group; tinzaparin
Authorization status:
Marketed
Authorization date:
1997-12-11
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOHEP
® 2,500 IU
INNOHEP
® 3,500 IU
INNOHEP
® 4,500 IU
SOLUTION FOR INJECTION (10,000 IU/ML)
tinzaparin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
• In this leaflet the innohep syringe 10,000 IU/ml presentations
listed above will be called innohep.
WHAT IS IN THIS LEAFLET
1. What innohep
®
is and what it is used for
2. What you need to know before you use innohep
®
3. How to use innohep
®
4. Possible side effects
5. How to store innohep
®
6. Contents of the pack and other information
1. WHAT INNOHEP
®
IS AND WHAT IT IS USED FOR
innohep 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. innohep
prevents clotting, allowing normal blood
flow through the arteries and veins.
innohep 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 INNOHEP
®
DO NOT USE INNOHEP
• If you are allergic (hypersensitive) to tinzaparin or any of the
other ingredients of this medicine (listed in
sec
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
15 March 2023
CRN00CZX0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
innohep 2,500 IU, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tinzaparin sodium 10,000 anti-Factor Xa IU/ml
Excipients with known effect:
Sodium (in total < 23 mg/mL)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Colourless or slightly yellow aqueous solution.
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
Prophylaxisof 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.
Neuraxial anaesthesia
Caution is advised when performing neuraxial anaesthesia or lumbar
puncture in patients receiving prophylactic doses of
innohep, see
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