innohep 10,000 IU in 0.5 ml, solution for injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Tinzaparin sodium

Dostupné z:

Leo Laboratories Limited

ATC kód:

B01AB; B01AB10

INN (Medzinárodný Name):

Tinzaparin sodium

Dávkovanie:

10,000 IU/0.5 ml international unit(s)/millilitre

Forma lieku:

Solution for injection

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Heparin group; tinzaparin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1997-01-24

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOHEP
® 8,000 IU IN 0.4 ML
INNOHEP
® 10,000 IU IN 0.5 ML
INNOHEP
® 12,000 IU IN 0.6 ML
INNOHEP
® 14,000 IU IN 0.7 ML
INNOHEP
® 16,000 IU IN 0.8 ML
INNOHEP
® 18,000 IU IN 0.9 ML
SOLUTION FOR INJECTION (20,000 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 20,000 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 in adults to treat:

Harmful blood clots that have formed in a deep vein (deep vein
thrombosis, DVT). This usually
occurs in a leg.

Clots that may travel in your bloodstream and cause a blockage (a
thromboembolism).

A clot that has travelled to your lung and caused a blockage
(pulmonary embolism, PE). This can
cause breathing difficulties and chest pain.

Blood clots that have developed because of cancer and to prevent
further clots from forming.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE INNOHEP
®
DO NOT USE INNOH

Súhrn charakteristických

Health Products Regulatory Authority
15 March 2023
CRN00CZX0
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
innohep 10,000 IU in 0.5 ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tinzaparin sodium 20,000 anti-Factor Xa IU/ml
Excipients with known effect:
Sodium metabisulfite (1.83 mg/mL) and sodium (up to 40 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
Treatment of venous thrombosis and thromboembolic disease including
deep vein thrombosis and pulmonary embolus in
adults.
Extended treatment of venous thromboembolism and prevention of
recurrences in adult patients with active cancer.
For some patients with pulmonary embolism (e.g. those with severe
haemodynamic instability) alternative treatment, such as
surgery or thrombolysis, may be indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treatment in adults_
175 anti-Xa IU/kg body weight given subcutaneously once daily for at
least 6 days and until adequate oral anticoagulation is
established.
_Extended treatment in adult patients with active cancer_
175 anti-Xa IU/kg body weight given subcutaneously once daily for a
recommended treatment period of 6 months. The benefit
of continued anticoagulation treatment beyond 6 months should be
evaluated.
_Neuraxial anaesthesia_
Treatment doses of innohep (175 IU/kg) are contraindicated in patients
who receive neuraxial anaesthesia, see section 4.3. If
neuraxial anaesthesia is planned, innohep should be discontinued at
least 24 hours before the procedure is performed.
innohep should not be resumed until at least 4-6 hours after the use
of spinal anaesthesia or after the catheter has been
removed.
_Interchangeability_
For interchangeability with other LMWHs, see section 4.4.
_Paediatric population_
The safety and efficacy of innohep in children below 18 years have not
yet been established. Currently availa