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BIOFACTOR STREPTOKINASE 750 000

Active substance(s): STREPTOKINASE

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Read all of this leaflet carefully before you
are given 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 nurse.
- If you get any side effects, talk to your doctor
or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet?
1. What Biofactor Streptokinase is and what it is
used for.
2. What you need to know before you are given
Biofactor Streptokinase.
3. How Biofactor Streptokinase is given to you.
4. Possible side effects.
5. How Biofactor Streptokinase is stored.
6. Contents of the pack and further information.

1. What Biofactor Streptokinase is and what it is
used for.
Biofactor Streptokinase contains a number of
ingredients. The active substance is a protein
called streptokinase, an antithrombotic agent which
dissolves blood clots.
You are being treated with Biofactor Streptokinase
to break down blood clots in blood vessels.
2. What you need to know before you are given
Biofactor Streptokinase.
You should not be treated with Biofactor
Streptokinase if you:

- are allergic to streptokinase or any of the other
ingredients in this medicine (listed in section 6)
- are pregnant
- are suffering from or have recently had internal
bleeding
- have recently suffered a stroke or a serious
head injury
- have recently had surgery, especially on your
head (intracranial) or spine (intraspinal)
- have a brain tumour or a tumour with a risk of
bleeding
- have uncontrollable high blood pressure
- have problems with your blood vessels
(e.g. weakness in an artery)
- have a clotting disorder or are taking drugs to
prevent blood clotting (anticoagulants)
- have an unusual susceptibility to bleeding
- have inflammation of the pancreas (acute
pancreatitis) or inflammation in or around your
heart (endocarditis or pericarditis)
- have severe liver or kidney damage.

Warnings and precautions
Talk to your doctor or nurse before you are given
Biofactor Streptokinase if you:
- have recently had severe bleeding in your
stomach (e.g. an ulcer) or any other stomach or
intestinal disorder that causes bleeding
- have recently had a severe injury and have
been resuscitated
- are at risk of severe local bleeding for example
if you have recently had an invasive operation
(e.g. where you have had a tube or drip
inserted into your body)
- have recently given birth or had a miscarriage
or an abortion
- have any problems in the genital area or urinary
tract, especially those with bleeding
- have had blood poisoning that could cause
clotting (septic thrombotic disease)
- have a disease of the arteries or a disease

-

-

The following information is intended for the healthcare
professionals only.
Biofactor Streptokinase 250 000 and 750 000
Powder for solution for infusion

This is an extract from the Summary of Product
Characteristics to assist in the administration of Biofactor
Streptokinase 250 000 and 750 000. When determining
appropriateness of use in a particular patient, the
prescriber should be familiar with the Summary of Product
Characteristics for the product.
QUALITATIVE AND QUANTITATIVE COMPOSITION

Biofactor Streptokinase 250 000 and 750 000 are
presented as powder for solution in vials containing
250 000 and 750 000 International Units (IU) of purified
streptokinase as the active ingredient.

Children
It is not recommended to use Biofactor
Streptokinase in children, infants and neonates. If
streptokinase is to be given to your child,
a streptokinase resistance test should be
performed before treatment. This test will help the
doctor to decide whether or not your child can be
treated with streptokinase and which dose should
be used.

POSOLOGY AND METHOD OF ADMINISTRATION

This product is for use in adults. The safety and efficacy
of Biofactor Streptokinase in children, infants and
neonates have not been established. The benefit of
treatment has to be evaluated against the potential risks,
which may aggravate an acute life-threatening condition.
Method of Administration

Other medicines and Biofactor Streptokinase
Tell your doctor or nurse if you are taking or have
recently taken any other medicines, including
those obtained without a prescription.
In particular tell the doctor or nurse if you have
been treated with any drugs that prevent blood
clotting (anticoagulants). Examples of such drugs
are heparins, coumarin derivatives, dipyridamole
and dextrans.
Pregnancy and breast-feeding
You should not be given Biofactor Streptokinase
if you are pregnant or have recently had a baby,
miscarriage or abortion unless there is no other,
safer treatment.

The administration of streptokinase may be by systemic
intravenous infusion or by local intra-arterial catheterdirected infusion.

The contents should be dissolved in 4-5 ml of
physiological saline or water for injection. The solution
should be swirled gently to facilitate quick reconstitution,
but care should be taken to avoid foaming.
Physiological saline, 5% glucose solution, 5% fructose
solution, or Ringer-lactate solution can be used as a
diluent for administration with an infusion pump. Upon
reconstitution with physiological saline a clear solution,
colourless to yellowish, is obtained.

You should not breastfeed your child while you are
being treated with Biofactor Streptokinase.
Breast milk should be thrown away if you have
been given streptokinase within the last 24 hours.
3. How Biofactor Streptokinase is given to you.
Biofactor Streptokinase will be given to you by
a doctor or nurse. Your doctor will decide how
much will be given and for how long.
- It will usually be infused into one of your veins
with a drip.
- It may also be infused by a drip into an artery
supplying blood to a limb, for example.

If you are given more Biofactor Streptokinase
than you should have been
If this medicine is given for too long, bleeding
problems may occur. You may be at risk of
another blood clot (thrombosis). The symptoms
are listed in section 4 under possible side effects.
Tell your doctor or nurse if you think you have
been given too much.
4. Possible side effects.
Like all medicines, Biofactor Streptokinase can
cause side effects, although not everybody gets
them.

Note: When thrombolytic therapy is necessary and a high
antibody concentration against streptokinase is present
or when recent streptokinase therapy has been given
(more than 5 days and less than one year previously),
homologous fibrinolytics should be used.
Children

In children it is always recommended to estimate
possibility of treatment and the initial dose by performing
a streptokinase resistance test. The recommended
maintenance dose is 20 IU/ml blood volume per hour.
Adults

Deep vein thrombosis
An initial dose of 250 000 IU streptokinase should be
infused into a peripheral vein over 30 minutes.
A maintenance infusion of 100 000 IU/hour for
72 hours should follow.
Pulmonary embolism
Infuse 1 500 000 IU streptokinase into a peripheral
vein preferably over a short time of 1-2 hours.

As an alternative, an initial dose of 250 000 IU
streptokinase should be infused into a peripheral vein
over 30 minutes. A maintenance infusion of
100 000 IU/hour for 24 hours should follow.

Occlusive peripheral arterial diseases
Administer streptokinase with a local intra-arterial
catheter-directed infusion using one of the following
regimes:

- Gradual infusion: 1000 to 2500 IU streptokinase at
an interval of 3 to 5 minutes for a maximum of
10 hours and a total maximum dose of 250 000 IU

Immediately report allergic reactions such as
skin rash, flushing, itching, blistering, swelling
(may also affect the tongue or throat), or
shortness of breath, low blood pressure (may feel
light headed) to your doctor or nurse.

If you receive a lot of streptokinase, you may be
at risk of a blood clot (thrombosis).
Symptoms of a blood clot include:
- unusual pain or swelling in your legs
- sudden sharp pain in your chest
- sudden difficulty breathing
- an unusual, severe, or long-lasting headache
- dizziness or fainting.
If you experience any of these side effects tell
your doctor or nurse immediately.

- Prolonged continuous low-dose infusion
(using an infusion pump):
5000 to 10,000 IU streptokinase per hour for up to
5 days maximum.

A percutaneous transluminal angioplasty can be
performed simultaneously, if necessary.

As an alternative for difficult arterial access or multiple
occlusions, an initial dose of 250 000 IU streptokinase
should be infused over 30 minutes. A maintenance
infusion of 100 000 IU/hour for a maximum of 5 days
should follow.

Central retinal vessel occlusion
An initial dose of 250 000 IU streptokinase should be
infused into a peripheral vein over 30 minutes.
A maintenance infusion of 100 000 IU/hour for
12 hours should follow.



Biofactor Streptokinase 250 000 and 750 000
Powder for solution for infusion

affecting the blood vessels of your brain
(cerebrovascular disease)
have tuberculosis or similar lung diseases or
severe bronchitis
have any heart or circulation problems or high
blood pressure
have received any drug containing streptokinase
or have had an infection caused by
streptococcal bacteria such as rheumatic fever
or a throat infection
have damage to the eye caused by diabetes.



PATIENT INFORMATION LEAFLET

RS

In patients previously treated with coumarin derivatives,
the INR (international normalised ratio) should be
below 1.3 before starting therapy with streptokinase.

Systemic Administration
During the infusion, decreases in the plasminogen
and fibrinogen levels and an increase in the level of
fibrin degradation product (FDP) (the latter two serving
to prolong the clotting time of coagulation tests) will
generally confirm the existence of a thrombolytic state.
Therefore, therapy can be monitored by performing the
TT or aPTT approximately 4 hours after initiation of
therapy.
A 2 to 4-fold prolongation of the TT should be aimed
for and is considered a sufficient anticoagulation
protection. If the thrombin time or any other
parameter of lysis after 4 hours of therapy is less
than approximately 1.5 times the normal control value,
discontinue Biofactor Streptokinase as excessive
resistance to streptokinase is present.

Local administration
As is usual with angiographies, heparin is
administered, if necessary, prior to the angiography
as a safeguard against catheter-induced thromboses.
The success of therapy can be determined by the
angiography. With a sufficient blood flow of more than
15 minutes the therapy can be considered successful
and then stopped.

Follow-up treatment
After every course of streptokinase therapy, follow-up
treatment with anticoagulants or platelet aggregation
inhibitors can be instituted as prevention of
rethromboses. With heparin therapy, in particularly, an
increased risk of haemorrhage must be considered.
Infusion rate and corticosteroid prophylaxis
At the beginning of therapy, a fall in blood pressure,
tachycardia or bradycardia (in individual cases going
as far as shock) are commonly observed.
Therefore, at the beginning of therapy the infusion
should be performed slowly.
Corticosteroids can be administered prophylactically
to reduce the likelihood of infusion-related allergic
reactions.

Pre-treatment with heparin or coumarin derivatives
If the patient is under active heparinization, it should
be neutralised by administering protamine sulphate
before the start of the thrombolytic therapy.
The thrombin time should not be more than twice the
normal control value before thrombolytic therapy is
started. In patients previously treated with coumarin
derivatives, the INR (International Normalized Ratio)
must be less than 1.3 before starting the streptokinase
infusion.
INTERACTION WITH OTHER MEDICINAL PRODUCTS
AND OTHER FORMS OF INTERACTION

There is an increased risk of haemorrhage in patients
who are receiving or who have recently been treated with
anticoagulants, e.g. heparin or drugs which inhibit platelet
formation or function, e.g. platelet aggregation inhibitors,
dextrans.
The effects of drugs which act upon platelet formation
or function should be allowed to subside before starting
long-term lysis of deep vein thromboses and arterial
occlusions with streptokinase.
PHARMACEUTICAL INFORMATION

Excipients: Human albumin, Aminoacetic acid (glycine),
Mannitol

Incompatibilities: No incompatibilities have been reported
when Biofactor Streptokinase is used as recommended.
This medicinal product must not be mixed with other
medicinal products.

Very common side effects
(may affect more than 1 in 10 people)
- development of antibodies
(proteins in the blood that help fight disease)
against the active ingredient streptokinase



Control of Therapy
Before commencing thrombolytic therapy, it is desirable
to obtain a thrombin time (TT), activated partial
thromboplastin time (aPTT), haematocrit and platelet
count to obtain the haemostatic status of the patient.
If heparin has been given it should be discontinued,
and the TT or aPTT should be less than twice the
normal control value before the thrombolytic therapy is
started.

Common side effects
(may affect up to 1 in 10 people)
- bleeding, especially at the injection site,
bruising of the skin, bleeding into the stomach,
reproductive and urinary systems, nosebleed
- slow or fast heartbeat
- feeling or being sick, diarrhoea, stomach pain
- headache, muscle pain including back pain,
fever, chills, weakness, generally feeling unwell
Uncommon side effects
(may affect up to 1 in 100 people)
- bleeding into eyes, liver, abdomen or joints,
tearing of the spleen
- stroke (cerebrovascular haemorrhage)

Rare side effects
(may affect up to 1 in 1,000 people)
- dizziness, confusion, agitation
- seizures
- weakness or paralysis on one or both sides of
the body

Very rare side effects
(may affect up to 1 in 10,000 people)
- bleeding into the space around the heart,
including tearing of the heart muscle
- delayed allergic reactions, e.g. serum sickness
(pain and swelling in joints and lymph nodes,
rash, fall in blood pressure and shock), arthritis,
inflammation of blood vessels and kidneys,
numbness or pins and needles feeling in arms
or legs
- blockage of blood vessels caused by cholesterol
crystals
- fluid in the lungs (not caused by heart failure)
- inflammation in the eyes

The following events have been reported in
patients being treated with streptokinase, but
they may not have been caused by the medicine:
irregular heartbeat, chest pain, lack of oxygen
to the heart, heart failure, heart attack, heart
shock, inflammation around the heart, fluid around
the heart, stopping of heartbeat, heart valve
insufficiency, blockage of a blood vessel.

Reporting of side effects
If you get any side effects, talk to your doctor or
nurse immediately. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How Biofactor Streptokinase is stored.
Your medicine will be given to you by your doctor.
Normally, you will not need to store this medicine.
Keep this medicine out of the sight and reach of
children.
Do not store above +25°C. Do not freeze.
After the injection has been prepared it may be
kept in a fridge at +2°C to +8°C for up to
24 hours.
Do not use this medicine after the expiry date
which is stated on the carton and vial label.

DATE OF REVISION OF THE TEXT
01/2014



Do not store the reconstituted solution for more than
24 hours in a refrigerator at +2°C to +8°C.

6. Contents of the pack and further information.
What Biofactor Streptokinase contains.
- The active substance is streptokinase
250 000 IU or 750 000 IU
(International Units).
- The other ingredients are human albumin,
glycine and mannitol.
What Biofactor Streptokinase looks like and
contents of the pack
The medicine comes in glass vials as a white to
slightly yellow powder. It is mixed with a liquid to
make a solution to be used for infusion.
Each pack contains one vial with 250 000 IU or
750 000 IU of streptokinase.
Marketing Authorisation Holder and
Manufacturer
Biofactor GmbH
Rudolf-Huch-Str. 14,
38667 Bad Harzburg, Germany
Fax: +49 5322-30 17 Email: info@biofactor.de

For any information about this medicine, please
contact the local representative:
Beacon Pharmaceuticals Ltd
The Regent, The Broadway
Crowborough, TN6 1DA, UK
Tel: +44 (0) 1892 600930
Email: info@beaconpharma.co.uk
This leaflet was last revised in 01/2014.

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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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