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SYNER-KINASE 1 000 000 IU POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): UROKINASE

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PACKAGE LEAFLET

Syner-KINASE®
INFORMATION FOR THE USER
Syner-KINASE® 10,000 IU
Syner-KINASE® 25,000 IU
Syner-KINASE® 100,000 IU
Syner-KINASE® 250,000 IU
Syner-KINASE® 500,000 IU
Syner-KINASE® 1,000,000 IU
Powder for solution for injection or infusion.
Read all of this leaflet carefully before you start
taking/using this medicine. It contains a summary
of the information available on Syner-KINASE.
The information in this leaflet applies only to your
medicine.

keep this leaflet. You may need to read it again

if you have further questions, please ask your
doctor or your 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 become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor
This leaflet answers the following questions:
1. What Syner-KINASE is and what it is used for
2. Before you are given Syner-KINASE
3. How Syner-KINASE is given
4. Possible side-effects
5. How to store Syner-KINASE
6. Further information
1. What Syner-KINASE is and what it is used for:
The name of your medicine is Syner-KINASE. The
active ingredient is urokinase, a thrombolytic that
can help to dissolve blood clots that may form in:

intravenous catheters or cannulae (surgical
tubes used to withdraw fluids from, or introduce
fluids into the body)

lungs

deep veins

peripheral arteries (blood vessels away from the
heart, such as in the leg)
2. Before you are given Syner-KINASE:
Syner-KINASE will not be given to you if you:

are allergic (hypersensitive) to urokinase or any
of the other ingredients of Syner-KINASE
(See Section 6)

are currently bleeding

had a major surgical operation or a stroke
recently (in the past 2 months)

have severe high blood pressure

have abnormal blood clotting

have abnormal blood vessels

have cancer of the brain

have infection of the pancreas or heart

have severe liver or kidney disease

Special care will be taken with Syner-KINASE
if you:

have been recently bleeding from the stomach
or intestines
had surgery or have given birth recently


have severe blood vessel disease in your brain

have problems with your heart
are elderly, particularly if you are aged over 75 years

In all these circumstances your doctor will decide
whether or not you should be given Syner-KINASE.
Taking or using other medicines:
Please inform your doctor if you are taking, or have
recently taken any of the following medicines, or any
other medicines, including medicines obtained
without a prescription:

heparin or other anticoagulants

acetylsalicylic acid (aspirin)

non-steroidal anti-inflammatory agents

dipyridamole

dextrans
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before
taking any medicine.
Syner-KINASE must not be used in pregnancy or
immediately after delivery unless otherwise
recommended by your doctor.
Do not breast-feed during treatment with
Syner-KINASE.
3. How Syner-KINASE is given:
Syner-KINASE will be given to you by a doctor or
nurse. You will not be asked to administer
Syner-KINASE to yourself.
Before you are given Syner-KINASE it will be
dissolved in saline (solution of salt and water). It
should never be injected into a muscle or under the
skin. The amount and duration of Syner-KINASE
treatment will be decided by your doctor.

if you are being treated for a blocked
intravascular catheter or cannulae, Syner-KINASE
may be injected directly into the catheter or
cannulae and left for a while before removing the
fluid. This may be repeated several times.
Syner-KINASE may also be injected into the
blocked tube over a period of time.

if you are being treated for blood clots in your
lungs, deep veins or peripheral arteries,
Syner-KINASE may be injected into a vein
(usually in the arm) or directly into the blocked
vessel. Progress of the treatment may be
checked by special X-rays. After the clot has
been dissolved, you may be put on anticoagulant
therapy (blood thinning) to prevent a recurrence.

Use in children:
Syner-KINASE can be used in children to dissolve
blood clots in intravenous catheters or cannulae.
4. Possible side-effects:
Like all medicines, Syner-KINASE can have
side-effects but not everybody will get them.
Tell your doctor immediately if you notice:
any bleeding


any sign of an allergic reaction, such as difficulty
with breathing, swelling of face, lips or throat,
skin rash or hives
Other side effects include:
Very common side effects (affects more than
1 user in 10)

unusual bleeding, particularly from puncture
wounds or nose bleeds

blood detected in the urine after a urine test

blood clots: small fragments of a blood clot may
be released and pass along the blood vessel
and cause blockage elsewhere, such as in the
lungs, heart or limbs

a decrease in haematocrit (a red blood cell test)
and a temporary increase in certain liver enzymes
Common side effects (affects 1 to 10 users in 100)

bleeding in the stomach or into/around the brain
or at puncture sites

stroke

tearing of an artery wall

blockage of blood vessels due to cholesterol (fat)

fever, chills and/or shivering
Uncommon side effects (affects 1 to 10 users
in 1000)

kidney failure
Rare side effects (affects 1 to 10 users in 10,000)

visible blood in the urine

injury and swelling in an artery wall
If you experience any of the above side effects, or if
you notice anything else which is unusual, and not
mentioned in this leaflet, please inform your doctor
or pharmacist immediately.
5. How to store Syner-KINASE:

keep out of the reach and sight of children

do not store above 25˚C

do not keep reconstituted material for later use

store in the original container and package in
order to protect from light

do not use after the expiry date stated on the
label. The expiry date refers to the last day of
the month

do not use if the contents of the vial are
discoloured

medicines should not be disposed of via waste
water or household waste
6. Further information:
The active ingredient is urokinase.
The other ingredients are: Mannitol, Disodium
Edetate, Disodium Phosphate Dodecahydrate,
Sodium Hydroxide.

What Syner-KINASE looks like and contents
of the pack:
Each pack contains one vial (small bottle). The white
powder contents are Syner-KINASE.
There are different strengths available:
Syner-KINASE® 10,000 IU
Syner-KINASE® 25,000 IU
Syner-KINASE® 100,000 IU
Syner-KINASE® 250,000 IU
Syner-KINASE® 500,000 IU
Syner-KINASE® 1,000,000 IU
Marketing Authorisation Holder (MAH)
Syner-Medica Ltd
Beech House
840 Brighton Road
Purley, Surrey
UK CR8 2BH
Manufacturers
Sirton Pharmaceuticals SpA
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
GiPharma SRL
Via Crescentino
13040 Saluggia (VC)
Italy
Sales & Distribution
Syner-Med (Pharmaceutical Products) Ltd
2nd Floor
Beech House
840 Brighton Road
Purley, Surrey
UK
CR8 2BH
+44 (0) 208 655 6380
mail@syner-med.com
For further information please contact
Medical Information Department
Syner-Med (Pharmaceutical Products) Ltd
2nd Floor
Beech House
840 Brighton Road
Purley, Surrey
UK
CR8 2BH
+44 (0) 208 655 6380
mail@syner-med.com
This leaflet was revised May 2011

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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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