UROKINASE MEDAC 10 000 I.U. POWDER FOR SOLUTION FOR INJECTION OR INFUSION - patient leaflet, side effects, dosage

Package leaflet: Information for the user

human urokinase

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

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

• 2. What you need to know before you are given Urokinase medac

• 3. How Urokinase medac is used

• 4. Possible side effects

• 5. How to store Urokinase medac

• 6. Contents of the pack and other information

1. what urokinase medac is and what it is used for

The name of your medicine is Urokinase medac. The active substance is urokinase which is a thrombolytic medicine that can help to dissolve blood clots in:

• lungs
• deep veins
• peripheral arteries (such as in the leg)
• intravascular catheters or cannulae (surgical tubes that are usually placed into a large vein in the

neck, chest, or groin in order to withdraw fluids from, or introduce fluids into the body) and haemodialysis shunts (surgically created connection between an artery and a vein that is used to filter blood)

2. what you need to know before you are given urokinase medac

Urokinase medac treatment is administered by a doctor or nurse who is experienced in this type of treatment. You will not be asked to administer Urokinase medac to yourself.

Urokinase medac will not be used

• if you are allergic to urokinase or any of the other ingredients of this medicine (listed in section 6).
• if you are currently bleeding.
• if you have abnormal blood vessels.
• if you have any cancer that has a risk of bleeding.
• if you have abnormal blood clotting, or are taking anticoagulant (blood thinning) medicines.
• if you have severe uncontrolled high blood pressure.
• if you have infection of the pancreas, heart, or any other severe infection.

if you have had a stroke in the past 2 months.

if you have recently had any major surgery or medical investigations such as lumbar puncture.

if you have a severe liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before you are given Urokinase medac

• if you have recently had bleeding from the stomach or elsewhere in the intestines.
• if you have recently had surgery.
• if you have cavities in your lungs.
• if you have problems with your urinary tract that could result in bleeding (e.g. bladder catheter).
• if you have problems with your heart, particularly the mitral valve, or have abnormal heart rhythm

e.g. atrial fibrillation.

• if you are pregnant or have recently given birth.
• if you have a severe blood vessel disease especially in the brain.
• if you are elderly, particularly if you are aged over 75 years.

In these circumstances your doctor will decide whether or not you should be given Urokinase medac. While receiving Urokinase medac, special care will also be taken if you need repeated blood tests taken or intramuscular injections or any other procedures which may be associated with a high risk of bleeding, such as any procedure performed on an artery.

Other medicines and Urokinase medac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

heparin, dipyridamole and other anticoagulants or other medicines that may affect clotting acetylsalicylic acid (aspirin)

non-steroidal anti-inflammatory drugs

dextrans

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Urokinase medac must not be used in pregnancy or immediately after delivery unless clearly necessary.

Breast-feeding

It is unknown whether urokinase is excreted in human milk. For this reason, do not breast-feed during treatment with Urokinase medac.

Driving and using machines

If your medicine makes you have side effects that may reduce your ability to concentrate, do not drive or operate machinery.

Urokinase medac contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

3. how to use urokinase medac

The amount and duration of Urokinase medac treatment will be decided by your doctor and will depend on the condition for which you are being treated. Urokinase medac must never be injected into a muscle or under the skin.

• If you are being treated for blood clots in your lungs or deep veins, Urokinase medac will be

injected into a vein (usually in the arm) during several hours and up to 3 days. Progress of the treatment may be checked by special X-rays. After the clot has been dissolved, you may be put on anticoagulant (blood thinning) therapy to prevent a recurrence.

• If you are being treated for blood clots in an artery, Urokinase medac will be injected directly into

the artery until dissolution of the clot.

• If you are being treated for a blocked intravascular catheter or cannula Urokinase medac may be

injected directly into the catheter or cannula and left for up to an hour before removing the fluid. This may be repeated several times. Urokinase medac may also be infused into the blocked tube continuously over a period of time.

• If you are being treated for a blocked haemodialysis shunt, Urokinase medac will be instilled into

both branches of the shunt. This may be repeated several times.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Urokinase medac can on rare occasions cause severe reactions.

Tell your doctor immediately :

• if you observe any spontaneous bleeding, since urokinase may increase the risk for bleeding.
• if you get symptoms of an allergic reaction/hyper­sensitivity such as

• – tightness of the chest or difficulty with breathing

• – swelling of eyelids, face or lips

• – skin rashes or lumps, itchiness

• – collapse (fall in blood pressure) or turning blue (cyanosis).

In the following, please find the other side effects that may occur:

Some patients may experience a sensation of warmth or cold (fever or chills), nausea and vomiting (feeling or being sick), back pain or shortness of breath within one hour of starting the infusion.

Very common (may affect more than 1 in 10 people)

• Unusual bleeding, particularly from recent cuts or puncture wounds.
• Blood detected in the urine after a urine test.
• Nose bleeds.
• Bleeding gums.
• Bruising.
• Changes in some blood tests.
• Blood clots: some smaller fragments of the clot may be released and pass along the blood vessel

and cause a blockage elsewhere.

Common (may affect up to 1 in 10 people)

• Bleeding (into the brain, from the stomach, in the urine, into the muscles).
• Stroke.
• Tearing of an artery wall.
• Blockage of blood vessels due to cholesterol (fat).
• Fever.

Chills.

Uncommon (may affect up to 1 in 100 people)

• Bleeding into the liver.
• Kidney failure.

Rare (may affect up to 1 in 1,000 people)

• Visible blood in the urine.
• Injury and swelling in an artery wall.

5. how to store urokinase medac

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

Do not store above 25 °C.

Store in the original container and package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Urokinase medac if the contents of the vial are discoloured.

Use reconstituted medicine immediately. Do not keep reconstituted material for later use.

After reconstitution and further dilution in sodium chloride 9 mg/mL (0.9%) solution for injection, chemical and physical stability has been demonstrated for 72 hours at room temperature.

From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.

Due to loss in activity of urokinase, the solution should be used immediately after reconstitution and further dilution in glucose 5 % or glucose 10 %.

6. contents of the pack and other information

What Urokinase medac contains

There are different strengths available and each vial contains the active substance human urokinase.

The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, human albumin.

What Urokinase medac looks like and contents of the pack

Each vial contains white powder for solution for injection or infusion.

Each pack contains one vial (small bottle). There are different strengths of Urokinase medac approved for marketing:

Urokinase medac 10,000 I.U.

Urokinase medac 50,000 I.U.

Urokinase medac 100,000 I.U.

Urokinase medac 250,000 I.U.

Urokinase medac 500,000 I.U.

Not all strengths may be marketed.

Marketing Authorisation Holder and Manufacturer

medac Gesellschaft fur klinische

Spezialpraparate mbH

Theaterstr. 6

22880 Wedel

Germany

This leaflet was last revised in 08/2020.

pal (UK) Urokinase medac

National version: 08/2020