Skip to Content

SYNER-KINASE 250 000 IU POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): UROKINASE

View full screen / Print PDF » Download PDF ⇩
Transcript
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

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

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

In all these circumstances your doctor will decide
whether or not you should be given Syner-KINASE.

This leaflet answers the following questions:
1.
2.
3.
4.
5.
6.

What Syner-KINASE is and what it is used for
Before you are given Syner-KINASE
How Syner-KINASE is given
Possible side-effects
How to store Syner-KINASE
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

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.

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
Syner-Med House, 120 High Street
Purley, Surrey
CR8 2AD, UK
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
Syner-Med House, 120 High Street
Purley, Surrey, CR8 2AD, UK
Tel: +44 (0)208 655 6380
mail@syner-med.com
For further information please contact
Medical Information Department
Syner-Med (Pharmaceutical Products) Ltd
Syner-Med House, 120 High Street
Purley, Surrey, CR8 2AD, UK
Tel: +44 (0)208 655 6380
mail@syner-med.com
This leaflet was revised December 2014

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.

K164 Q10/1

Expand view ⇕

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.

Hide