Package leaflet: Information for the user

Orgaran, 750 anti-Xa units, injectable solution
Danaparoid sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

What Traleusin is and what it is used for
What you need to know before using Traleusin
How to use Traleusin
Possible side effects
How to store Traleusin
Contents of the pack and other information

1. What Traleusin is and what it is used for

Traleusin contains danaparoid sodium and belongs to a group of medicines called antithrombotics.
Traleusin can be used to

Prevent the formation of blood clots in patients who can no longer take heparin, including patients with a condition called heparin-induced thrombocytopenia (a significant decrease in platelet count due to hypersensitivity to heparin).
Treat blood clots in blood vessels, and is used in patients who require urgent prevention of blood clotting due to the development or clinical history of heparin-induced thrombocytopenia.

2. What you need to know before using Traleusin

Do not use Traleusin

If you are allergic to danaparoid sodium or to any of the other ingredients of this medicine (listed in section 6)
if you have had a haemorrhagic stroke (caused by bleeding in the brain) within the last three months
if you have very high blood pressure that cannot be controlled
if you have ulcers in your stomach or small intestine
if you have eye damage due to diabetes
if you are using Traleusin to treat blood clots in the body and need to receive spinal or epidural anaesthesia or a lumbar puncture within 24 hours. The following situations do not apply to you if you have a condition called heparin-induced thrombocytopenia and no alternative treatment is available to prevent blood clots.
if you have a tendency to bleed severely, for example, if you have haemophilia or an increased risk of bleeding
if you have liver or kidney disorders
if you have an infection of the inner lining of the heart and heart valves ( acute bacterial endocarditis )
if you have bleeding that cannot be stopped
if you have damage to the central nervous system or brain, or if you need to undergo spinal or eye surgery. Inform your doctor if any of these conditions apply to you.

Warnings and precautions
Talk to your doctor before using Traleusin if you have or have ever had any of the following conditions:

if a previous treatment with heparins (a group of anticoagulants frequently used) caused a marked decrease in the number of blood clotting cells (platelets) – this reaction is called heparin-induced thrombocytopenia – and a blood test has shown that a similar effect cannot be ruled out if Traleusin is used
hypersensitivity to sulphite, as this may cause severe allergic reactions in patients with asthma
if Traleusin is to be used during heart bypass surgery
if you need to undergo spinal or epidural anaesthesia or lumbar puncture: a time interval must be respected between the use of Traleusin and such procedures.

Children and adolescents
Experience with Traleusin in children and adolescents is limited.
Other medicines and Traleusin
Inform your doctor if you are taking, have recently taken, or might take any other medicines. Traleusin may affect other medicines or may be affected by them.
Medicines that may increase the risk of bleeding when taken together with Traleusin:

medicines used to prevent blood clots such as vitamin K antagonists, for example, warfarin
medicines used to dissolve blood clots, for example, alteplase
medicines used as anti-inflammatory agents (e.g. NSAIDs and aspirin), for example, for the treatment of rheumatic disorders
medicines that may cause ulcers (e.g. corticosteroids).

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. The limited information available does not indicate harmful effects. If alternative anticoagulant treatment is not acceptable for clinical reasons, Traleusin may be used during pregnancy and breastfeeding.
Fertility
There is no available information on the effect of danaparoid sodium on fertility.
Driving and using machines
Traleusin does not affect the ability to drive or operate machinery.
Traleusin contains sodium sulphite
It may rarely cause severe hypersensitivity reactions and bronchospasm.
Traleusin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) in 0.6 ml, i.e. essentially ‘sodium-free’.

3. How to use Traleusin

Administration will be performed by a healthcare professional with adequate training and appropriate experience, who will determine the correct dosage for you and when and how the injection should be administered.
The recommended dose is:
Your doctor will calculate the dose of Traleusin you need based on:

your underlying medical condition
your risk of blood clots
your risk of bleeding
your general health and physical characteristics (such as body weight)
whether or not you have hypersensitivity to heparins

Prevention of blood clots
Prevention of blood clots in situations where heparin cannot be used
The dose for prevention of blood clots depends on the patient's body weight. Treatment continues for up to 14 days. Sometimes, Traleusin may be administered to you for a longer period.
Patients with a significant and acute reduction in platelet count during heparin administration ( thrombocytopenia , see section 1) generally require higher doses.
Treatment of blood clots in patients with heparin-induced thrombocytopenia
In patients with heparin-induced thrombocytopenia, the initial injected dose depends on the patient's body weight. After the initial dose, the dose is gradually reduced.
Vascular surgery or invasive vascular procedures
For vascular surgeries that do not require bypass, the initial dose depends on the patient's body weight. Treatment is started no less than 6 hours after surgery and continued for 5–7 days.
Cardiopulmonary procedure
Traleusin will be administered during surgery after opening of the chest (thoracotomy) and subsequently continued for as long as necessary.
Monitoring
Depending on your condition, your doctor may perform additional tests during treatment to adjust the dose.
Use in children and adolescents
Traleusin may be administered to children. The doctor will take into account age and weight when determining the dose. There is no experience with administration of danaparoid sodium in children aged between 2 and 7 years.
Switching to oral anticoagulant therapy
Your doctor may decide to switch you to oral anticoagulant therapy.
Switching from Traleusin to vitamin K antagonist (VKA) oral anticoagulants
Your doctor will perform a blood test called INR and, based on the result, will advise you when to discontinue Traleusin.
How Traleusin is administered
Traleusin will be administered by your doctor or nurse. Traleusin is given either as a subcutaneous injection or as an intravenous injection or infusion. Traleusin must not be injected into a muscle.
If you use more Traleusin than you should
Since your doctor or nurse will closely monitor your condition, it is unlikely that you will receive too much Traleusin, and doses will be adjusted as necessary.
If an overdose is administered, you may experience unusual bleeding. This may present as:

nosebleeds or bleeding gums
dark-coloured stools (may indicate bleeding from the stomach or intestine)
blood in the urine
unusually heavy menstrual bleeding

Inform your doctor or nurse immediately if you notice any of these symptoms or other signs of unusual bleeding.
If you forget to use Traleusin
Since your doctor and nurse will closely monitor your clinical condition, it is unlikely that you will receive too low a dose of Traleusin. If necessary, they will adjust the dose.
If you stop using Traleusin
Your doctor will decide when to stop treatment with Traleusin.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When heparin (an antithrombotic) is used at the same time as a spinal injection, spinal haematoma may occur. This is rare (see section 2).
However, if you notice any of the following symptoms:

back pain
tingling, numbness or weakness in the legs
problems with the bowel or bladder contact your doctor or nurse immediately, as treatment may be necessary.

Traleusin may potentially increase the risk of bleeding. Bleeding after surgery and bleeding or discharge near the surgical site may occur.

Common: may affect up to 1 in 10 people

significantly reduced platelet count in the blood (thrombocytopenia) in patients with hypersensitivity to heparin
skin rash
increased bleeding after surgery

Uncommon: may affect up to 1 in 100 people

bruising, pain or bleeding at the injection site
allergic reactions (hypersensitivity)
itching

Rare: may affect up to 1 in 1,000 people

increased bleeding or blood-filled swelling at the surgical site (haematoma)
reduced platelet count in the blood due to an autoimmune disorder (autoimmune thrombocytopenia)

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Traleusin

The hospital will store Traleusin according to the correct storage conditions.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light. Do not refrigerate or
freeze.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.

6. Pack contents and other information

What Traleusin contains

The active substance is sodium danaparoid (750 anti-factor Xa units in 0.6 ml of solution).
The other components are sodium sulfite, sodium chloride, water for injections, and hydrochloric acid (for pH adjustment).

Description of the appearance of Traleusin and pack contents
Traleusin is a clear, colourless to pale yellow injectable solution.
It is available in glass vials (10 per pack). Each vial contains 0.6 ml of solution with 750 anti-factor Xa units of sodium danaparoid.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lakedrive
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
FAMAR Health Care Services Madrid, S.A.U
Avda. Leganés, 62,
Alcorcón 28923
Madrid,
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Danaparoid natrium Aspen 750 anti-Xa units/0.6 ml solution for injection
Denmark Orgaran
Italy Traleusin