Traleusin 750 U anti-Xa/0.6 mL solution for injection and infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Traleusin 750U anti-Xa/0.6ml solution for injection and infusion

danaparoid sodium

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Traleusin is and what it is used for
2. What you need to know before using Traleusin
3. How to use Traleusin
4. Possible side effects
5. How to store Traleusin
6. 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 for:

• Preventing blood clots in patients who can no longer receive heparin, including patients with a disease called heparin-induced thrombocytopenia (a significant decrease in platelet count due to hypersensitivity to heparin).
• Treating the formation of blood clots in blood vessels and is used in patients who require urgent prevention of blood coagulation due to the development of, or 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 hemorrhagic stroke (due to bleeding in the brain) within the last three months;
• if you have severe hypertension that cannot be controlled;
• if you have ulcer(s) in the stomach or small intestine;
• if you have diabetic eye damage;
• if you are using Traleusin to treat blood clots in your body and you are scheduled to receive spinal or epidural anesthesia or lumbar puncture within 24 hours.

The following situations do not apply if you have a condition called heparin-induced thrombocytopenia and no alternative treatment is available to prevent blood clots:

• if you are prone to serious bleeding, such as hemophilia, or have an increased risk of bleeding;
• if you have severe renal or hepatic disorders;
• if you have an infection of the inner lining of the heart and heart valves (acute bacterial endocarditis);
• if you have a bleeding condition that cannot be stopped;
• if you have damage to the central nervous system or brain, or are scheduled for spinal or eye surgery.

Tell your doctor if any of these situations apply to you.

Warnings and precautions

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

• if a previous treatment with heparins (a group of antithrombotic agents commonly used) caused a significant drop in platelet count, known as heparin-induced thrombocytopenia, and a blood test has shown that a similar reaction cannot be ruled out with Traleusin;
• kidney problems;
• liver problems;
• a gastrointestinal ulcer or another disease that may increase the risk of bleeding;
• low body weight (less than 55 kg) or overweight (more than 90 kg);
• if you are currently taking medicines that may affect bleeding (see section 2 “Other medicines and Traleusin”);
• sulfite sensitivity, as this may cause severe allergic reactions in asthmatic patients;
• if Traleusin is to be used during coronary bypass surgery;
• if you are to receive spinal or epidural anesthesia or lumbar puncture: a time interval must be observed between the administration of Traleusin and this procedure.

It is recommended that healthcare professionals record the name and batch number of the medicine being used.

Children and adolescents

Traleusin can be administered to children. Experience with this medicine in children and adolescents is limited. There is no experience with the administration of danaparoid sodium in children aged 2 to 7 years.

Other medicines and Traleusin

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. Traleusin may affect other medicines or other medicines may affect Traleusin.

Medicines that may increase the risk of bleeding when taken at the same time as Traleusin:

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

Surgery and anesthesia

If you are scheduled for a spinal puncture or surgery under epidural or spinal anesthesia, inform your doctor that you are using danaparoid sodium. See “Do not use Traleusin”. Also, inform your doctor if you have any spinal problems or have ever had spinal surgery.

Pregnancy, breastfeeding and fertility

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The limited available information does not suggest harmful effects. If another antithrombotic treatment is not medically acceptable, Traleusin may be used during pregnancy and breastfeeding.

Fertility

There is no information available on the effect of danaparoid sodium on fertility.

Driving and using machines

It is unknown whether Traleusin has any effect on the ability to drive or use machines.

Traleusin contains sodium sulfite

Rarely, this may cause severe hypersensitivity reactions and bronchospasm.

Traleusin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.6 ml; hence, it is essentially “sodium-free”.

3. How to use Traleusin

Administration will be carried out by a healthcare professional with appropriate training and experience. This person will determine the correct dose for you and the timing and method of injection administration.

A doctor or nurse will administer Traleusin to you. This medicine is given either as an injection under the skin or as an intravenous injection or infusion. This medicine must not be injected into a muscle.

Recommended dose:

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 (e.g., weight);
• whether or not you are hypersensitive to heparins.

Prevention of blood clots when heparin cannot be administered

The dose for prevention of blood clots depends on the patient's body weight. Treatment is continued for up to 14 days. Sometimes, you may receive this medicine for a longer period.

Patients who experience a sudden, significant drop in platelet count during heparin administration (thrombocytopenia, see section 1) usually 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 a bypass machine, the initial dose depends on the patient's body weight. Treatment continues for 5–7 days and is administered no sooner than 6 hours after surgery.

Cardiopulmonary procedure

Traleusin will be injected during surgery after opening the chest (thoracotomy) and will continue to be administered for as long as necessary.

Due to the risk of bleeding, Traleusin should only be used during surgical procedures in patients who do not respond satisfactorily to other blood clot prevention medicines, and whose surgery cannot be postponed.

Monitoring

Depending on your condition (e.g., if you have kidney problems or are overweight), your doctor may perform additional blood tests during treatment to adjust the dose.

Switching to oral anticoagulant therapy

Your doctor may decide to switch you to treatment with oral anticoagulants.

Switching from Traleusin to vitamin K antagonists (VKA)

Your doctor will perform a blood test called INR and will advise you when to discontinue Traleusin appropriately.

Use in children and adolescents

Traleusin may be administered to children. Your doctor will consider age and weight when determining the dose and may perform blood tests during treatment to adjust the dose. Experience with the administration of sodium danaparoid in children aged 2 to 7 years is limited.

If you use more Traleusin than you should

Since your doctor or nurse will closely monitor your condition, it is unlikely that you will be given too much Traleusin. If necessary, doses will be adjusted.

If too high a dose is administered, you may experience unusual bleeding. This may appear as:

• nosebleeds, bleeding gums;
• black stools (may indicate blood loss from the stomach or intestines);
• blood in the urine;
• unusually heavy menstrual periods.

Inform your doctor or nurse if you experience any of these symptoms or other signs of unusual blood loss.

If you forget to use Traleusin

Since your doctor or nurse will closely monitor your condition, it is unlikely that you will receive too low a dose of this medicine. If necessary, the dose will be adjusted.

If you stop using Traleusin

Your doctor will decide when to stop treatment with this medicine.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When heparin (an antithrombotic) is administered together with a spinal injection, bruising at the spine may occur. This happens very rarely (see section 2).

However, if you experience any of the following symptoms:

• back pain;
• tingling, numbness, or weakness in the legs;
• bowel or bladder problems;

inform your doctor or nurse immediately, as you may require treatment.

Traleusin may increase the risk of bleeding. Bleeding may occur after surgery, as well as bleeding or blood loss near the surgical site.

Frequent (may affect up to 1 in 10 patients):

• Significant decrease in platelet count (thrombocytopenia) in patients hypersensitive 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 (pruritus)

Rare (may affect up to 1 in 1,000 patients):

• Increased bleeding or blood-filled swelling (hematoma) at the surgical site
• Decrease in platelet count due to an autoimmune disorder (autoimmune thrombocytopenia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Traleusin

The hospital will store this medicine under appropriate storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Store in the original packaging to protect from light. Do not refrigerate or freeze.

Do not use this medicine if you notice any changes in its appearance or if the packaging is damaged.

6. Contents of the pack and other information

Composition of Traleusin

• The active substance is danaparoid sodium (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 (to adjust pH).

Appearance of the product and contents of the pack

Traleusin is a clear, colourless to pale yellow injectable and infusion solution.

It is supplied in glass ampoules (10 per pack). Each ampoule contains 0.6 ml of solution with 750 anti-factor Xa units of danaparoid sodium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Manufacturer

FAMAR Health Care Services Madrid, S.A.U

Avda. Leganés, 62,

Alcorcón 28923

Madrid,

Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Danaparoid natrium Aspen, 750 anti-Xa units/0.6 ml, solution for injection

Spain: Traleusin 750 U anti-Xa/0.6 ml solution for injection and infusion

Date of the last review of this leaflet: May/2021