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UROKINASE MEDAC 100 000 I.U. POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): UROKINASE

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Urokinase medac · 82100-VP1GB · BA · 04.15 · Pharma-Code: 266
Format: 296 x 132 mm · HKS 44 · Corrective action: KV01_osc_10.03.15

PACKAGE LEAFLET: INFORMATION FOR THE USER

Urokinase medac 10,000 I.U.
powder for solution for injection or infusion

Urokinase medac 50,000 I.U.
powder for solution for injection or infusion

Urokinase medac 100,000 I.U.
powder for solution for injection or infusion

Urokinase medac 250,000 I.U.
powder for solution for injection or infusion

Urokinase medac 500,000 I.U.
powder for solution for injection or infusion
Human urokinase
Read all of this leaflet carefully before you start
using this medicine.
• Keep this 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Urokinase medac is and what it is used for
2. Before you are given Urokinase medac
3. How Urokinase medac is used
4. Possible side effects
5. How to store Urokinase medac
6. Further 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)
• intravenous central catheters (catheter placed
into a large vein in the neck, chest, or groin)
and haemodialysis shunts (surgically created
connection between an artery and a vein that is
used to filter blood)
2. 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 (hypersensitive) to urokinase or any
of the other ingredients of Urokinase medac
• are currently bleeding
• have any abnormal blood vessel
• have any cancer that has a risk of bleeding
• have abnormal blood clotting, or are taking
anticoagulant (blood thinning) medicines
• have severe uncontrolled high blood pressure

• have infection of the pancreas, heart, or any
other severe infection
• have had a stroke in the past 2 months
• have recently had any major surgery or medical
investigations such as lumbar puncture
Special care will be taken with Urokinase medac
if you
• have recently had bleeding from the stomach or
elsewhere in the intestines
• have recently had surgery
• have cavities in your lungs
• have problems with your urinary tract that could
result in bleeding (e.g. bladder catheter)
• have problems with your heart, particularly the
mitral valve, or have abnormal heart rhythm
e.g. atrial fibrillation
• have a severe liver or kidney disease
• are pregnant or have recently given birth
• have a severe blood vessel disease especially in
the brain
• 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.
Whilst 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.

Taking or using other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any of the following
medicines, or any other medicines, even those
obtained without a prescription:
• heparin, dipyridamole and other anticoagulants
or other medicines that may affect clotting
• acetylsalicylic acid (aspirin)
• non-steroidal anti-inflammatory drugs
• dextrans
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Urokinase medac must not be used in pregnancy or
immediately after delivery unless clearly necessary.
It is unknown whether urokinase is excreted into
human breast milk. For this reason, do not breastfeed 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.
3. HOW UROKINASE MEDAC IS USED
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.

Urokinase medac · 82100-VP1GB · BA · 04.15 · Pharma-Code: 266
Format: 296 x 132 mm · HKS 44 · Corrective action: KV01_osc_10.03.15

• 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 central
venous catheter Urokinase medac may be
injected directly into the catheter and left for up
to an hour before removing the fluid. This may be
repeated several times.
• 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, Urokinase medac 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.
• 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)
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 side effects (occur in more than
1 in 10 people)
• bleeding
- unusual bleeding, particularly from recent cuts
or puncture wounds
- small amounts of blood in the urine
- nose bleeds
- bleeding gums
- bruising
• changes in some blood tests
Common side effects (occur in between
1 in 10 and 1 in 100 people)
• fever
• chills
• bleeding (into the brain, from the stomach, in the
urine, into the muscles)
• some smaller fragments of the clot or even
cholesterol crystals may be released and pass
along the blood vessel and cause a blockage
elsewhere.
Uncommon side effects (occur in between
1 in 100 people and 1 in 1000 people)
• bleeding into the liver

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE UROKINASE MEDAC
Keep out of the reach and sight of children.
Do not store above 25 °C.
Store in the original container and package in order
to protect from light.
Do not use 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.

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. 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 für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Phone: +49 (0)4103 8006-0
Fax:
+49 (0)4103 8006-100

6. FURTHER INFORMATION
This leaflet was last revised in 04/2015.
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.

82100-VP1GB
BA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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