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STREPTASE INJECTION 1 500 000 IU POWDER FOR SOLUTION FOR INFUSION

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pbE8700_Streptase_28_300x270 23.07.2013 09:48 Seite 1

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Special warnings and precautions for use (continued)
• recent delivery, abortion
• diseases of the urinogenital tract with existing or potential sources of
bleeding (implanted bladder catheter)
• known septic thrombotic disease
• severe atherosclerotic vessel degeneration, cerebrovascular diseases
• cavernous pulmonary diseases, e.g. open tuberculosis
• mitral valve defects or atrial fibrillation
Antistreptokinase antibodies
Because of the increased likelihood of resistance due to antistreptokinase
antibodies, repeat treatment with Streptase or streptokinase containing
products may not be effective if administered more than 5 days, particularly
between 5 days and 12 months after initial treatment.
Likewise, the therapeutic effect may be reduced in patients with recent
streptococcal infections such as streptococcal pharyngitis, acute rheumatic
fever and acute glomerulonephritis.
Infusion rate and corticosteroid prophylaxis
At the beginning of therapy, a fall in blood pressure, tachycardia or bradycardia
(in individual cases reaching 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.

6. FURTHER INFORMATION

Pre-treatment with heparin or coumarin derivatives
If the patient is under active heparinization, it should be neutralised by the
administration of 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.
Simultaneous treatment with acetylsalicylic acid
A positive, mutually reinforcing effect of acetylsalicyclic and streptokinase on
the life expectancy of patients with suspected myocardial infarction has been
observed in the ISIS-2 study. The administration of acetylsalicyclic acid should
commence prior to the streptokinase therapy and be continued for at least
one month.
Streptase is not indicated for restoration of patency of intravenous catheters.

This leaflet was last revised in: 10/2013

What Streptase Injection contains
The active substance is:
‹ Streptokinase (1.5 M I.U.)

PATIENT INFORMATION LEAFLET

Streptase Injection
1,500,000 (1.5 M) I.U.

Other ingredients are:
‹ human albumin
‹ sodium-L-hydrogen glutamate monohydrate
‹ sodium dihydrogenphosphate dihydrate
‹ disodium hydrogenphosphate dihydrate

(Streptokinase)

Streptase Injection comes as a powder in glass containers, and will be
mixed with a liquid to make a solution before use as an infusion.
Each pack contains one vial with 1.5 million I.U. streptokinase.
Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Strasse 76,
35041 Marburg, Germany

IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

For further information contact:
CSL Behring UK Limited, Hayworth House, Market Place,
Haywards Heath, West Sussex RH16 1DB, UK.
Telephone number: 01444 447 405

What Streptase Injection is and what it is used for
Before you are given Streptase Injection
How you are given Streptase Injection
Possible side effects
Storing Streptase Injection
Further information

1. WHAT STREPTASE INJECTION IS AND WHAT IT IS USED
FOR
Streptase Injection is a type of medicine called a fibrinolytic agent. It
contains a substance called streptokinase, which helps to dissolve blood
clots.
Streptase Injection 1.5 M I.U. strength is used to limit the extent of a
heart attack, when given within 12 hours of the event occurring.

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 any drugs
which affect inhibit platelet formation or function e.g. platelet aggregation
inhibitors, dextrans.

2. BEFORE YOU ARE GIVEN STREPTASE INJECTION
You should not be given Streptase Injection if any of the
following apply to you:
• You are allergic to any of the ingredients of Streptase (see section 6
for the ingredients)
• You are pregnant
• You have recently had a stroke or a serious head injury
• You have a brain tumour or a tumour with a risk of bleeding
• You have a blood clotting disorder or you have recently had internal
bleeding
• You are taking drugs to prevent blood clotting (anticoagulants)
• You have problems with your blood vessels (e.g. weakness in an
artery)
• You have uncontrollable high blood pressure
• You have recently had a major operation, in particular on your head
(intracranial) or spine (intraspinal)
• You have inflammation of the pancreas (acute pancreatitis) or
inflammation in or around your heart (endocarditis or pericarditis)
• You have severe liver or kidney damage

Special precautions for use, handling and disposal
To ensure that the contents of the vial are rapidly and completely dissolved,
5 ml of physiological saline should be injected into the Streptase-containing
vacuum vial and the residual vacuum abolished by briefly loosening the
needle from the syringe.
Upon reconstitution with physiological saline, a colourless to yellowish, clear
solution is obtained.
For administration with an infusion pump, physiological saline, Ringer-lactate
solution, 5 % glucose solution or 5 % fructose solution can be used as a
diluent.
Once reconstituted with physiological saline, physico-chemical stability has
been demonstrated for 24 hours at +2 to +8 °C. From a microbiological point
of view and as Streptase contains no preservative, the reconstituted product
should be used immediately. If it is not administered immediately, storage
shall not exceed 24 hours at +2 to +8 °C.

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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 further questions, please ask your doctor or nurse.
• 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or nurse.

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Your doctor should consider the above points before you are
given Streptase Injection.
Taking or using other medicines
If you are taking or have recently been taking drugs which prevent blood
clotting (anticoagulants), there will be an increased risk of bleeding
(haemorrhage).
Pregnancy and breast-feeding
You should not be given Streptase Injection if you are pregnant or have
recently had a baby, miscarriage or abortion, unless there is no safer
alternative.
Breast milk should be discarded if you have received Streptase Injection
within the last 24 hours.

Common side effects (affect fewer than 1 in 10 people)
• Bleeding at the injection site, bruising of the skin, bleeding into the
gut, reproductive and urinary systems, nosebleed
• Allergic reactions e.g. skin rash, flushing, itching, blistering (may also
affect the tongue and throat), difficulty breathing, low blood pressure
(you may feel faint)
• Slow or fast heart-beat
• Feeling or being sick, diarrhoea, stomach pain
• Headache, muscle pain including back pain, feeling hot or cold,
weakness, generally feeling unwell
Uncommon effects (affect fewer than 1 in 100 people)
• Bleeding into eyes, liver, abdomen or joints, tearing of the spleen
• Stroke (cerebrovascular haemorrhage)
Rare side effects (affect fewer than 1 in 1,000 people)
• Dizziness, confusion, agitation
• Fits
• Paralysis on one or both sides of the body
Very rare side effects (affect fewer than 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 (shows as 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 in the 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
Streptase Injection, but may not be due to the medicine:
irregular heart-beat, chest pain, lack of oxygen to the heart, heart failure,
heart attack, heart shock, inflammation around the heart, fluid around
the heart, stopping of heart-beat, heart valve inefficiency, blockage of a
blood vessel.
If you receive a lot of Streptase, you may be at risk of a thrombosis (blood
clot).

3. HOW YOU ARE GIVEN STREPTASE INJECTION
• Streptase Injection is usually given to you by infusion into a vein (drip).
• It may also be infused into an artery supplying blood to your heart.
Your doctor may recommend that you also take a low dose of aspirin
for about 4 weeks to help thin your blood.
If you are given more Streptase Injection than you should have
If you are given too much Streptase Injection over a long period, you may
be at risk of another thrombosis (blood clot). Symptoms of a thrombosis
are listed in the side effects section below.

Symptoms of a thrombosis 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 have any of the side-effects listed in this section, or any
other unusual or unexpected side-effects, tell your doctor or
nurse immediately.

4. POSSIBLE SIDE EFFECTS

5. STORING STREPTASE INJECTION

Like all medicines, Streptase Injection can have side-effects, although not
everybody gets them.

You will not normally be asked to store your medicine as it will be given to
you by a doctor.

Very common side effects (affect more than 1 in 10 people)
• Development of antibodies (proteins in the blood which help to fight
disease) against streptokinase, the active ingredient of Streptase
Injection

Keep out of the reach and sight 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 to
8 ºC for up to 24 hours.
Do not use this medicine after the expiry date shown on the carton and
vial label.

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Special care should be taken with Streptase Injection if:
• you have recently had severe bleeding in your stomach (e.g. an
ulcer)
• you have recently had a severe injury and have been resuscitated
• you 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
inserted into your body)
• you have recently had a baby, miscarriage or abortion
• you have a disease of your urogenital tract (the parts of your
body used for excretion and reproduction)
• you have blood poisoning likely to cause clotting (septic thrombotic
disease)
• you have a disease of the arteries or a disease affecting the blood
vessels of your brain (cerebrovascular disease)
• you have tuberculosis (TB)
• you have an irregular heart-beat or heart murmur
• you have been treated with streptokinase before or have had a recent
infection with the streptococcus bacteria (usually a throat infection),
you may have high levels of antibodies against the active ingredient,
streptokinase. These antibodies will block the action of streptokinase in
your body and so your doctor may choose to use a different type of
fibrinolytic agent.

The following information is intended for medical or healthcare
professionals only
Therapeutic indications
Treatment of acute myocardial infarction within 12 hours of onset, with
persistent ST-segment elevation or recent left bundle-branch block.
Note: No statement on therapy outcome can be made for administration
beyond the time windows indicated above.
Posology and method of administration
The administration of Streptase may be intravenous or intracoronary.
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.
Adults
Systemic administration: A single dose of 1.5 million IU Streptase should be
infused intravenously over 60 minutes.
Local intracoronary administration: A bolus of 20,000 IU Streptase should be
followed by a maintenance infusion of 2,000 IU to 4,000 IU per minute over
30 to 90 minutes depending on the achievement of coronary artery patency.
Paediatric patients
The safety and efficacy of Streptase 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.
Adjuvant therapy
Treatment with aspirin (150 mg daily) for at least 4 weeks is recommended
for prophylaxis after streptokinase therapy for acute myocardial infarction.
The first dose should be given as soon as possible after the myocardial
infarction.
Contraindications
Streptase must not be used in case of severe allergic reactions to the product.
Because of the increased risk of haemorrhage under thrombolytic therapy,
Streptase must not be given in the following situations:
• existing or recent internal haemorrhages
• all forms of reduced blood coagulability, in particular spontaneous fibrinolysis
and extensive clotting disorders
• recent cerebrovascular insults, intracranial or intraspinal surgery
• intracranial neoplasm
• recent head trauma
• arteriovenous malformation or aneurysm
• known neoplasm with risk of haemorrhage
• acute pancreatitis
• uncontrollable hypertension with systolic values above 200 mm Hg and/or
diastolic values above 100 mm Hg or hypertensive retinal changes grades
III/IV
• recent implantation of a vessel prosthesis
• simultaneous treatment with oral anticoagulants (INR > 1.3)
• severe liver or kidney damage
• endocarditis or pericarditis. Isolated cases of pericarditis, misdiagnosed as
acute myocardial infarction and treated with Streptase, have resulted in
pericardial effusions including tamponade
• known haemorrhagic diathesis
• recent major operations (6th to 10th postoperative day, depending on the
severity of surgical intervention)
• invasive operations, e.g. recent organ biopsy, long-term (traumatic)
closed-chest cardiac massage
Special warnings and precautions for use
Individual benefit/risk assessment
The risk of therapy in case of life-threatening thromboembolic events, in
particular that of haemorrhages, must be weighed against the anticipated
benefit in cases such as:
• recent severe gastrointestinal bleeding, e.g. active peptic ulcer
• risk of severe local haemorrhage, e.g. in case of aortography by lumber route
• recent trauma and cardiopulmonary resuscitation
• invasive operations, e.g. recent intubation
• puncture of non-compressible vessels, intramuscular injections
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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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