Traleusin 750 u anti-xa/0,6 ml solucion inyectable y para perfusion

Product Information for the User

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

Danaparoid sodium

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

1. What isTraleusinand for what it is used

2. What you need to know before starting to useTraleusin

3. How to useTraleusin

4. Possible adverse effects

5. Storage ofTraleusin

6. Contents of the package and additional information

Traleusin contains danaparoid sodium and belongs to a group of medications called antithrombotics.

Traleusin may be used for:

• Preventing blood clots in patients who can no longer receive heparin, including patients with a condition calledheparin-induced thrombocytopeniaa 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 or history ofheparin-induced thrombocytopenia.

Do not use Traleusin

• if you areallergicto sodium danaparoid or any of the other components of this medication (listed in section6);
• if you have had ahemorrhagic strokein the last three months;
• if you havesevere uncontrolled hypertension;
• if you haveulcersin the stomach or small intestine;
• if you haveeye damagecaused by diabetes;
• if you are using Traleusin to treat blood clots in your body and are to receivespinalorepidural anesthesiaor lumbar puncture within 24hours.

The following situations do not apply if you have a condition calledheparin-induced thrombocytopeniaand there is no alternative treatment available to prevent the formation of blood clots:

• if you areprone to severe bleedingsuch as hemophilia, or have a higher risk of bleeding;
• if you havesevere kidney or liver disease;
• if you have aninfectionof the heart lining and heart valves(acute bacterial endocarditis);
• if you have ahemorrhagethat cannot be stopped.
• if you have damage to thecentral nervous systemorbrain, or are to undergo surgery on the spine or eye.

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

Warnings and precautions

Consult your doctor before starting to use Traleusin if you have or have had any of the following conditions:

• if aprevious treatmentwith heparins (a group of antithrombotic medications administered frequently) caused a significant decrease in platelet count, known as heparin-induced thrombocytopenia, and a blood test determined that it cannot be ruled out that a similar effect may occur if Traleusin is administered;
• kidney problems;
• liver problems;
• an ulcer in the digestive tract or another condition that may increase the risk of bleeding;
• low body weight (less than 55kg) or obesity (more than 90kg);
• if you are currently taking medications that may affect bleeding (see section2 “Other medications and Traleusin”);

• hypersensitivity tosodium sulfite, as this may cause severe allergic reactions in asthmatic patients;
• if Traleusin is to be used during acoronary artery bypassoperation;
• if you are to receivespinal or epidural anesthesia or lumbar puncture: a period of delay should be respected between the administration of Traleusin and this procedure.

It is recommended that the healthcare professional record the name and batch number of the medication being used.

Children and adolescents

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

Other medications and Traleusin

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. Traleusin may affect other medications or vice versa.

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

• medications toprevent blood clotssuch asvitamin K antagonists(e.g., warfarin);
• medications todissolve blood clots(e.g., alteplase);
• medications used asanti-inflammatoryagents (such asNSAIDs and aspirin) for the treatment of rheumatic disorders, among others;
• medications that may causeulcers(e.g., corticosteroids).

Operations and anesthetics

If you are to undergo a spinal puncture or a surgical procedure with epidural or spinal anesthesia, inform your doctor that you are using sodium danaparoid. Also, inform your doctor if you have had any problems with your spine or if you have ever undergone spinal surgery.

Pregnancy, breastfeeding, and fertility

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

The limited available information does not suggest any harmful effects.If another antithrombotic treatment is not acceptable for medical reasons, Traleusin can be administered during pregnancy and breastfeeding.

Fertility

No information is available on the effect of sodium danaparoid on fertility.

Driving and operating machinery

The effect of Traleusin on the ability to drive or operate machinery is unknown.

Traleusin contains sodium sulfite

Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

Traleusin contains sodium

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

The administration will be handled by a healthcare professional with the necessary training and experience. They will determine the correct dose for you and the timing and method of injection administration.

A doctor or nurse will administer Traleusin. This medication is administered by injection under the skin or as an injection or infusion into a vein. This medication should not be injected into a muscle.

The recommended dose is:

Your doctor will calculate the dose of Traleusin you need based on:

• the underlying disease you have;
• the risk of blood clots;
• the risk of bleeding;
• your overall health and physical characteristics (e.g., weight);
• whether you are hypersensitive to heparins.

Prevention of blood clots when heparin cannot be administered

The dose for the prevention of blood clots depends on the patient's body weight. Treatment is continued for a maximum of 14days. In some cases, this medication may be administered for a longer period of time.

Patients with a significant acute decrease in platelet count during heparin administration (thrombocytopenia, see section1) usually require higher doses.

Treatment of blood clots in patients withheparin-induced thrombocytopenia

In patients with heparin-induced thrombocytopenia, the initial dose injected 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 abypass machine,the initial dosedepends on the patient's body weight.The treatment continues for 5-7days and is administered no less than 6 hours after the operation.

Cardiopulmonary procedure

Traleusin will be injected during the operation after the chest is opened (thoracotomy) and will continue to be administered as long as necessary.

Due to the risk of bleeding, Traleusin should only be administered for surgical procedures in patients who do not respond satisfactorily to other medications for blood clot prevention and whose operation cannot be postponed.

Monitoring

Depending on your situation (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 anticoagulants

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

Switching from Traleusin to anticoagulants called vitamin K antagonists (AVK)

Your doctor will perform a blood test called INR and will indicate when to properly discontinue Traleusin.

Use in children and adolescents

Traleusin can be administered to children. Your doctor will take into account the age and weight to determine the dose and may perform blood tests during treatment to adjust the dose. There is no experience with the administration of danaparoid sodium in children 2 to 7years old.

If you take 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 and, when necessary, they will adjust the doses.

If an excessive dose is administered, you may experience unusual bleeding. This may be observed as:

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

Inform your doctor or nurse if you experience any of these symptoms or other symptoms of unusual bleeding.

If you forget to take Traleusin

Since your doctor or nurse will closely monitor your condition, it is unlikely that you will receive a low dose of this medication. If necessary, they will adjust the dose.

If you interrupt treatment with Traleusin

Your doctor will decide when to discontinue treatment with this medication.

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

When heparin (an anticoagulant) is administered with a spinal injection, bruising may appear on the spine. This occurs in very rare instances (see section2).

However, if you experience any of the following symptoms:

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

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

Traleusin may increase the risk of bleeding. Bleeding may occur after the operation and bleeding or blood loss near the site of the operation.

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

• Significant decrease in platelet count (thrombocytopenia) in patients hypersensitive to heparin
• skin rash
• Increased bleeding after the operation

Infrequent (may affect up to 1 in 100people):

• bruising, pain, or bleeding near the injection site
• allergic reactions (hypersensitivity)
• itching (pruritus)

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is apossible adverse effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

The hospital will conserve this medication following the appropriate conservation conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F.

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

Do not use this medication if you observe a change in its visual appearance or if the packaging is damaged.

Composition ofTraleusin

• The active principle is danaparoid sodium (750U anti-factor Xa in 0.6mlof solution).
• The other components are sodium sulfite, sodium chloride, water for injection preparations, and hydrochloric acid (to adjust the pH).

Appearance of the product and contents of the packaging

Traleusin is a clear and colorless to pale yellow injectable and perfusion solution.

It is presented in glass ampoules (10per box). Each ampoule contains 0.6mlof solution with 750U anti-factor Xa of danaparoid sodium.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Responsible for manufacturing

FAMAR Health Care Services Madrid, S.A.U

Avda. Leganés, 62,

Alcorcón 28923

Madrid,

Spain

For further information about this medication, please contact the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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 injectable and perfusion solution

Last review date of this leaflet:May/2021