UROQUINASE SYNER MEDICA 500,000 IU POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Leaflet:information for the user

Urokinase SYNER MEDICA 10,000U.I.powder for injectable solution and perfusion

Urokinase SYNER MEDICA 25,000U.I.powder for injectable solution and perfusion

Urokinase SYNER MEDICA 100,000U.I.powder for injectable solution and perfusion

Urokinase SYNER MEDICA 250,000U.I.powder for injectable solution and perfusion

Urokinase SYNER MEDICA 500,000U.I.powder for injectable solution and perfusion

urokinase

Read the entire leaflet carefullybefore starting to use thismedication,as it contains important informationfor you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• If you experience side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Urokinase Syner Medica and what is it used for
2. What you need to know before starting to use Urokinase Syner Medica
3. How to use Urokinase Syner Medica
4. Possible side effects

5 Conservation of Urokinase Syner Medica

1. Package contents and additional information

1. What is Urokinase Syner Medica and what is it used for

This medication is called Urokinase Syner Medica. The active ingredient is urokinase, an enzyme extracted from human urine that can act as a thrombolytic. This means it can help dissolve blood clots that can form in:

• Catheters or intravenous cannulas (surgical tubes used to remove fluids or introduce fluids into the body)
• Lungs
• Deep veins

• Peripheral arteries (blood vessels away from the heart, such as in the legs).

2. What you need to know before starting to use Urokinase Syner Medica

Do not useUrokinase Syner Medica

• if you are allergic (hypersensitive) to urokinase or any of the other components of this medication (listed in section 6).
• if you have a bleeding stomach or intestines, or have had one recently
• if you have any type of cancer with a risk of bleeding
• if you have undergone major surgery or have had a stroke recently
• if you have suffered a recent trauma, such as cardiopulmonary resuscitation or thoracic or cerebral surgery (e.g., in the last 2 months)
• if you have very high blood pressure
• if you have abnormal blood clotting or a very low platelet count
• if you have vascular malformations, such as an aneurysm
• if you have a pancreatic or heart infection, or any other severe infection
• if you have severe liver or kidney failure
• if you have recently given birth.

Warnings and precautions

Due to the increased risk of bleeding, special precautions will be taken with Urokinase Syner Medica if:

• you have a severe vascular disease, especially in the brain
• you have a high risk of blood clot formation in the heart cavities, for example, in the case of abnormal heart rhythm (atrial fibrillation)
• you have blood clotting disorders, including those due to severe nephropathy or hepatopathy
• you have lung cavities
• you have urinary tract problems that could lead to bleeding (e.g., a urinary catheter)
• you have obstructed and infected blood vessels.
• you are elderly, especially if you are over 75 years old.

In all these circumstances, your doctor will decide whether or not to administer Urokinase Syner Medica.

If a severe bleeding occurs during treatment, Urokinase Syner Medica will be discontinued and you will be given medications to control the bleeding.

Urokinase Syner Medica is manufactured from human urine; certain measures are taken to prevent the transmission of infections to patients. However, despite these measures, when administering medications manufactured from human urine, the possibility of transmitting an infection cannot be completely ruled out.

Use ofUrokinase Syner Medicawithother medications

Tell your doctor if you are taking or have recently taken any of the following medications, as the likelihood of bleeding may be increased by medications that counteract blood clotting, such as:

• heparin or other anticoagulants
• acetylsalicylic acid (aspirin), non-steroidal anti-inflammatory drugs
• dipyridamole, dextran (used to treat decreased plasma blood volume)

Tell your doctor if you are taking an angiotensin-converting enzyme (ACE) inhibitor (used to treat high blood pressure), as it may increase the likelihood of an allergic reaction.

Tell your doctor if you are using, have recently used, or may need to use any other medication.

Use in children

Urokinase Syner Medica can be used in children to dissolve blood clots in intravenous catheters or cannulas.

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 medication.

Urokinase Syner Medica should not be used during pregnancy or immediately after childbirth unless your doctor recommends otherwise.

You should not breastfeed your child while being treated with Urokinase Syner Medica.

Excipients

This medication contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".

3. How to use Urokinase Syner Medica

Urokinase Syner Medica will be administered to you by a doctor or nurse.

Before administering Urokinase Syner Medica, it will be dissolved in a saline solution (salt and water solution). It should never be injected into a muscle or under the skin. The doctor will decide the amount and duration of treatment with Urokinase Syner Medica.

If you are being treated for:

A blocked intravascular catheter or cannula

Urokinase may be injected at a concentration of 5,000 to 25,000 U.I. per ml directly into the catheter or cannula and wait between 20 and 60 minutes before removing the liquid. This can be repeated several times if necessary. Up to 250,000 U.I. of Urokinase Syner Medica may also be infused through a solution with 1,000-2,500 units per ml in the blocked tube over a period of 90 to 180 minutes.

Blood clots that block deep veins in the limbs

Initially, you may be given 4,400 U.I. of urokinase per kg of body weight in 15 ml of solvent through an intravenous injection over a period of 10 minutes. Then, you will be given 4,400 U.I./kg/hour for 12-24 hours.

Blood clots that block lung vessels

Initially, you may be given 4,400 U.I. of urokinase per kg of body weight in 15 ml of solvent through an intravenous injection over a period of 10 minutes. Then, you will be given 4,400 U.I./kg/hour for 12 hours. Alternatively, your doctor may choose to administer three injections into the pulmonary artery at 24-hour intervals.

Blood clots that block an artery

Initially, you may be given a solution of 2,000 U.I. per ml directly into the clot at a rate of 4,000 U.I. per minute for 2 hours. The doctor will check the obstruction and may repeat this treatment up to 4 times until the clot is dissolved.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor immediately if you experience:

• any bleeding
• any signs of an allergic reaction, such as difficulty breathing, swelling of the face, lips, or throat, skin rash, or blisters
• collapse (low blood pressure) or turning blue (cyanosis).

Some patients may experience a feeling of heat or cold (fever or chills), nausea, and vomiting (feeling of dizziness), back pain, or a feeling of shortness of breath from one hour after starting the infusion.

Other side effects include:

Very common side effects (affect more than 1 in 10 users)

• unusual bleeding, in particular from puncture wounds or nosebleeds
• blood in the urine after a urine test
• blood clot: small fragments of the blood clot can break off and travel to the blood vessels and cause a blockage in another area, such as the lungs, heart, or limbs
• a decrease in hematocrit (red blood cell test) and a temporary increase in certain liver enzymes

Common side effects (affect 1 to 10 users in 100)

• bleeding in the stomach or around the brain or at puncture sites, in the urine, in the muscles
• stroke
• tear in the artery wall
• blockage of blood vessels due to cholesterol (fat)
• fever, chills, and/or tremors

Uncommon side effects (affect 1 to 10 users in 1,000)

• kidney failure
• bleeding in the liver

Rare side effects (affect 1 to 10 users in 10,000)

• visible blood in the urine
• damage or swelling of the arterial wall

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Urokinase Syner Medica

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

Do not store above 25°C.

Stability studies have shown stable biological activity in a 2000 UI/ml dilution for 10 hours at room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use will be the responsibility of the user and will generally not exceed 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions. Do not store the reconstituted material for later use.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown on the label, after the EXP. The expiration date is the last day of the month indicated.

Do not use this medication if you notice discoloration of the contents.

Medications should not be disposed of through wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofUrokinase Syner Medica

• The active ingredient is urokinase
• The other components are mannitol, disodium edetate, disodium phosphate dodecahydrate, sodium hydroxide.

Appearance of the product and package contents

Each package contains a vial (small bottle). The contents of the white powder are Urokinase Syner Medica. Different doses are available:

Urokinase Syner Medica 10,000 U.I.

Urokinase Syner Medica 25,000 U.I.

Urokinase Syner Medica 100,000 U.I.

Urokinase Syner Medica 250,000 U.I.

Urokinase Syner Medica 500,000 U.I.

Marketing authorization holder

Syner-Medica BV

Laanzichtweg 60

4847SJ Teteringen

Netherlands

Manufacturer

Sirton Pharmaceuticals SpA

Piazza XX Settembre, 2

22079 Villa Guardia (CO)

Italy

GiPharma SRL

Via Crescentino

13040 Saluggia (VC)

Italy

Lyocontract GmbH (only for 100,000 IU, 250,000 IU, and 500,000 IU)

Pulverwiese 1

38871 Ilsenburg

Germany

Local representative of the marketing authorization holder

MANA PHARMA S.L.

Carretera Fuencarral 22

28108 Alcobendas, Madrid

Spain

This leaflet was last revised in September 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)