Urokinase medac

Package Leaflet: Information for the User

Urokinase medac, 10,000 IU, powder for solution for injection or infusion
Urokinase medac, 50,000 IU, powder for solution for injection or infusion
Urokinase medac, 100,000 IU, powder for solution for injection or infusion
Urokinase medac, 250,000 IU, powder for solution for injection or infusion
Urokinase medac, 500,000 IU, powder for solution for injection or infusion
Urokinasum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Urokinase medac and what is it used for
• 2. Important information before using Urokinase medac
• 3. How to use Urokinase medac
• 4. Possible side effects
• 5. How to store Urokinase medac
• 6. Package contents and other information

1. What is Urokinase medac and what is it used for

The name of the medicine is Urokinase medac. The active substance is urokinase, which helps to dissolve blood clots in:

• lungs
• deep veins
• peripheral arteries (e.g. in the legs)
• central venous catheters (catheters placed in large veins in the neck, chest, or groin) and arteriovenous fistulas for hemodialysis (surgically created connections between an artery and a vein used for blood filtration)

2. Important information before using Urokinase medac

Urokinase medac is administered by a doctor or nurse with experience in this type of therapy. The patient will not be asked to use the medicine on their own.

When not to use Urokinase medac

• if the patient is allergic to urokinase or any of the other ingredients of this medicine (listed in section 6)
• if the patient is currently bleeding
• if the patient has blood vessel deformities
• if the patient has a tumor with a risk of bleeding
• if the patient has blood coagulation problems or is taking anticoagulant medications (blood thinners)
• if the patient has uncontrolled high blood pressure
• if the patient has pancreatitis, pericarditis, or other acute infections
• if the patient has had a stroke in the last 2 months
• if the patient has recently undergone major surgery or a procedure such as a lumbar puncture

Warnings and precautions

Particular caution should be exercised when using Urokinase medac

• if the patient has recently experienced gastrointestinal bleeding
• if the patient has recently undergone surgery other than chest or neurosurgery, recently given birth, or had a puncture of a non-compressible vessel
• if the patient has cavernous lung disease
• if the patient has urinary tract diseases that may cause bleeding (e.g. catheterization of the urinary tract)
• if the patient has heart problems, especially mitral valve problems, or irregular heart rhythm, such as atrial fibrillation
• if the patient has severe liver or kidney disease
• if the patient is pregnant or breastfeeding
• if the patient has severe vascular disease, especially cerebral
• if the patient is elderly, especially over 75 years of age.

In such cases, the doctor will decide whether to use Urokinase medac. During treatment with Urokinase medac, the doctor will exercise particular caution if the patient is undergoing blood tests, intramuscular injections, or other medical procedures that carry a high risk of bleeding, such as arterial procedures.

Children

There is very limited experience with the use of urokinase in dissolving blood clots in peripheral arteries (e.g. in the legs) in children. Therefore, urokinase should not be used in such cases.

Urokinase medac and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription, especially if you are taking any of the following medicines:

• heparin, dipyridamole, and other anticoagulant or antiplatelet medicines
• acetylsalicylic acid (aspirin)
• non-steroidal anti-inflammatory drugs (NSAIDs)
• dextran
• contrast agents

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Urokinase medac should not be used during pregnancy or immediately after childbirth, unless it is clearly necessary. It is not known whether urokinase passes into breast milk. Therefore, breastfeeding should be avoided during treatment with Urokinase medac.

Driving and using machines

Using Urokinase medac has no significant effect on the ability to drive or use machines.

3. How to use Urokinase medac

This medicine should always be used as directed by your doctor. The doctor will determine the dose and duration of treatment with Urokinase medac, depending on the indication. Urokinase medac should never be injected into muscles or under the skin.

• If the patient has blood clots in the lungs or deep veins, Urokinase medac should be injected into a vein (usually in the arm) for several hours to 3 days. After the blood clots have dissolved, the patient may start anticoagulant therapy (blood thinning) to prevent recurrence.
• If the patient has blood clots in an artery, Urokinase medac should be injected directly into the artery until the blood clot has dissolved.
• If the patient has a central venous catheter blocked by a blood clot, Urokinase medac should be injected directly into the catheter and left for one hour before removing the fluid. This procedure can be repeated several times if necessary.
• If the patient has an arteriovenous fistula for hemodialysis blocked by a blood clot, Urokinase medac should be injected into both branches of the fistula. This procedure can be repeated several times if necessary.

Use in children

Urokinase medac can be used in children of any age to treat blocked central venous catheters, using the same procedures as for adult patients. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Urokinase medac can cause side effects, although not everybody gets them. Urokinase medac may rarely cause serious side effects. You should immediately inform your doctor if you experience:

• any spontaneous bleeding, as urokinase increases the risk of bleeding.
• symptoms of an allergic reaction or hypersensitivity, such as
• chest tightness or breathing difficulties
• swelling of the eyelids, face, or lips
• rash or hives on the skin, itching
• fainting (drop in blood pressure) or cyanosis (blue discoloration)

Other side effects may occur: Some patients may experience fever or chills, nausea and vomiting, back pain, or shortness of breath within an hour of starting the infusion.

Very common (occurred in more than 1 in 10 patients)

• bleeding
• unusual bleeding, especially from injection sites or wounds
• small amounts of blood in the urine
• nosebleeds
• gum bleeding
• bruising
• changes in blood test results

Common (occurred in less than 1 in 10 patients and more than 1 in 100)

• fever
• chills
• bleeding (in the brain, from the stomach, in the urine, in the muscles)
• small blood clots or cholesterol crystals may break loose and travel through the bloodstream, causing blockages in other areas.

Uncommon (occurred in less than 1 in 100 patients and more than 1 in 1000)

• liver bleeding

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Urokinase medac

Keep this medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original package to protect from light. Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month stated. Do not use Urokinase medac if the powder in the vial is not white. The chemical and physical stability, both at room temperature and at 5°C ± 3°C, after reconstitution and further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection is 72 hours. From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, the responsibility for the storage conditions and duration before use lies with the user, and normally should not exceed 24 hours at 2°C to 8°C, unless reconstitution and dilution are performed under controlled and validated aseptic conditions. Due to the loss of urokinase activity, the solution should be used immediately after reconstitution and further dilution with 5% or 10% glucose solution.

6. Package contents and other information

What Urokinase medac contains

The active substance is human urokinase. The other ingredients are disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, human albumin.

What Urokinase medac looks like and contents of the package

Each vial contains a white powder for solution for injection or infusion. Each package contains one vial. Urokinase medac is available in different strengths: 10,000 IU, 50,000 IU, 100,000 IU, 250,000 IU, 500,000 IU. Not all strengths may be available.

Marketing authorization holder and manufacturer

Pharma-Zentrale GmbH
Loerfeldstraße 20
58313 Herdecke
Germany

Date of last revision of the package leaflet: