Label:information for the user

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

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

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

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

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

urokinase

Read this label carefullybefore starting to use thismedicine,because it contains important informationfor you

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

• Ifyou experience any adverse effects, consult your doctor,even if they are not listed in this label. See section 4.

1.What isUrokinase Syner Medicaand how it is used

2.What you need to knowbeforestarting touseUrokinase Syner Medica

3.How to useUrokinase Syner Medica

4.Possible adverse effects

5Storage ofUrokinase Syner Medica

6. Contents of the package and additional information

This medication is calledUroquinasa Syner Medica. The active ingredient is urokinase, an enzyme extracted from human urine that can act as a thrombolytic. This means that it can help to dissolve blood clots that may 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).

No useUroquinasa 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 in the 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 recently suffered a trauma, such as cardiopulmonary resuscitation or thoracic or cerebral surgery (for example, 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, for example, a dilation (aneurysm).
• If you have a severe infection in the pancreas or heart, or any other severe infection.
• If you have severe liver or kidney failure.
• If you have given birth recently.

Warnings and precautions

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

-You have a severe vascular disease, especially in the brain.

-You have a high risk of forming blood clots in the heart cavities, for example, in the case of abnormal heart rhythm (atrial fibrillation).

-You have blood clotting abnormalities, including those due to severe nephropathy or hepatopathy.

-You have cavities in the lungs.

-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 to administer or not Uroquinasa Syner Medica.

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

Uroquinasa 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 made from human urine, the possibility of transmission of an infection cannot be completely ruled out.

Use of Uroquinasa Syner Medica with other medications

Inform your doctor if you are takingor have recently taken any of the following medications, as the probability of bleeding may be increased by medications that counteract blood clotting, such as:

• Heparin or other anticoagulants.
• Acid acetilsalicilico (aspirin), anti-inflammatory non-steroidal drugs.
• Dipiridamol, dextranos (used to treat a decrease in the circulating plasma blood volume).

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

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

Use in children

Uroquinasa Syner Medica may be used in children to dissolve blood clots in intravenous catheters or cannulas.

Pregnancy and breastfeeding

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

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

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

Excipients

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

Uroquinasa Syner Medica will be administered by a doctor or a nurse.

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

If you are being treated for:

A blocked catheter or intravascular cannula

You may be injected with urokinase 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 may be repeated several times if necessary. You may also be infused with a maximum of 250,000 U.I. of Uroquinasa Syner Medica via a solution with 1,000-2,500 units per ml in the blocked tube over a period of 90 to 180 minutes.

Clots that block deep veins in the limbs

You may be initially administered 4,400 U.I. of urokinase per kg of body weight in 15 ml of solvent via an injection into a vein over a period of 10 minutes. You will then be administered 4,400 UI/kg/hour for 12-24 hours.

Clots that block blood vessels in the lungs

You may be initially administered 4,400 U.I. of urokinase per kg of body weight in 15 ml of solvent via an injection into a vein over a period of 10 minutes. You will then be administered 4,400 UI/kg/hour for 12 hours. Alternatively, the doctor may choose to administer 3 injections into the pulmonary artery at 24-hour intervals.

Clots that block an artery

You may be initially administered 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 for obstruction and may repeat this treatment up to 4 times until the clot is dissolved.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience:

-any bleeding

-any sign of allergic reaction, such as difficulty breathing, swelling of the face, lips, or throat, skin rash, or blisters

-collapse (drop in 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 lack of air when breathing, starting from one hour after the infusion has begun.

Other side effects include:

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

-unusual bleeding, particularly from puncture wounds or nosebleeds

-blood in urine after a urine test

-blood clot: small fragments of the blood clot may break off and pass into the blood vessels and cause a blockage in another area, such as the lungs, heart, or extremities

-decrease in hematocrit (blood test of red blood cells) and a temporary increase in certain liver enzymes

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

-bleeding in the stomach or in/around the brain or at puncture sites, in the urine, in muscles

-stroke

-tear in the wall of an artery

-blockage of blood vessels due to cholesterol (fat)

-fever, chills, and/or tremors

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

-visible blood in urine

-damage or swelling of the arterial wall

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

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

From a microbiological point of view, the product must be used immediately. If not used immediately, storage times in use conditions and pre-use conditions will be the responsibility of the user and generally will not be more than 24 hours at 2-8°C, except when 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 appearing on the label, after the CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and of the medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofUroquinasa Syner Medica

• The active principle is urokinase
• The other componentsare mannitol, disodium edetate, dodecahydrate disodium phosphate, sodium hydroxide.

Appearance of the product and contents of the packaging

Each package contains a vial (small bottle). The content of the white powder isUroquinasa Syner Medica.There are different available doses:

Uroquinasa Syner Medica 10,000 U.I.

Uroquinasa Syner Medica 25,000 U.I.

Uroquinasa Syner Medica 100,000 U.I.

Uroquinasa Syner Medica 250,000 U.I.

Uroquinasa Syner Medica 500,000 IU U.I.

Holder of the marketing authorization

Syner-Medica BV

Laanzichtweg 60

4847SJ Teteringen

Netherlands

Responsible for manufacturing

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 holder of the marketing authorization

MANA PHARMA S.L.

Carretera Fuencarral 22

28108 Alcobendas, Madrid

Spain

This leaflet was last reviewed in September 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)