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STREPTASE INJECTION 750 000 IU POWDER AND SOLUTION FOR INFUSION

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pbE8703_Streptase_28_300x270 23.07.2013 09:50 Seite 1

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Contraindications (continued)
• 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
• endocarditits 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
• 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 infusionrelated allergic reactions.
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.
Arterial puncture
Should an arterial puncture be necessary during intravenous therapy, upper extremity vessels
are preferable. After the puncture, pressure should be applied for at least 30 minutes by a
compression bandage and the puncture site should be checked frequently for evidence of
bleeding.
Streptase is not indicated for restoration of patency of intravenous catheters.

6. FURTHER INFORMATION
What Streptase Injection contains
The active substance is:
‹ Streptokinase 250,000 or 750,000 I.U.

PATIENT INFORMATION LEAFLET

Streptase Injection
250,000 & 750,000 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 either 250,000 or 750,000 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.

This leaflet was last revised in: 10/2013
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 250,000 & 750,000 I.U. strengths are used to
disperse blockages in blood vessels.

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

Interaction with other medicinal products and other forms of interaction
There is an increased risk of haemorrhage in patients who are receiving or 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
Streptase.
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 given intra-arterially e.g. into an artery supplying blood
to a limb.
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
Like all medicines, Streptase Injection can have side-effects, although not
everybody gets them.
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

5. STORING STREPTASE INJECTION
You will not normally be asked to store your medicine as it will be given to
you by a doctor.
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
Intravascular dissolution of thrombi and emboli:
– massive deep vein thrombosis with risk of gangrene
– acute massive pulmonary embolism
– acute, sub-acute and chronic (not older than 6 weeks) occlusive arterial diseases with limb
threatening ischaemia
– central retinal artery or vein occlusion (arterial occlusions not older than 8 hours, venous
occlusion not older than 10 days)
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 by systemic intravenous infusion or by local intraarterial catheter-directed infusion during arteriography.
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
Deep vein thrombosis
Streptase should be administered by intravenous infusion into a peripheral vein using the
following standard dose regimen: an initial dose of 250,000 IU Streptase infused over
30 minutes, followed by a maintenance dose of 100,000 IU per hour for 72 hours.
Pulmonary embolism
Streptase should be administered by intravenous infusion into a peripheral vein using
preferably a short infusion of 1,500,000 IU Streptase over 1 – 2 hours.
Alternatively, the standard dose regimen can be used: an initial dose of 250,000 IU Streptase
infused over 30 minutes, followed by a maintenance dose of 100,000 IU per hour for
24 hours.
Occlusive peripheral arterial diseases
Streptase should be administered by local intra-arterial catheter-directed infusion using one
of the following dose regimens:
• Stepwise infusion: 1,000 to 2,500 IU Streptase in intervals of 3 to 5 minutes for a maximum
duration of 10 hours and a total maximum dose of 250,000 IU.
• Prolonged continuous low-dose infusion (using an infusion pump): 5,000 to 10,000 IU
Streptase per hour for a maximum of 5 days.
A percutaneous transluminal angioplasty can be performed simultaneously, if necessary.
Alternatively, in case of difficult arterial access or multiple occlusions, the standard
intravenous dose regimen can be used: an initial dose of 250,000 IU Streptase infused over
30 minutes, followed by a maintenance dose of 100,000 IU per hour for a maximum of
5 days.
Occlusion of central retinal vessels
Streptase should be administered by intravenous infusion into a peripheral vein using the
standard dose regimen: an initial dose of 250,000 IU Streptase infused over 30 minutes,
followed by a maintenance dose of 100,000 IU per hour for 12 hours.
Paediatric patients
The safety and efficacy of Streptase have not been sufficiently established in children. Due to
low levels of plasminogen in newborns and in children with acquired plasminogen
deficiency and due to the potential of streptokinase for allergic/anaphylactic reactions, its use
is not recommended in neonates, infants and children.
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 thrombolytic therapy is started. In patients previously
treated with coumarin derivatives, the INR (International Normalised Ratio) should be below
1.7 before starting therapy with streptokinase.
Systemic administration
During the infusion, decreases in the plasminogen and fibrinogen level and an increase in the
level of fibrin degradation products (FDP) (the latter two serving to prolong the clotting times
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 is considered as a sufficient anticoagulation protection
that should be aimed for. If the TT or any other parameter of lysis after 4 hours of therapy is
less than approximately 1.5 times the normal control value, Streptase should be discontinued
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 terminated.
Follow-up treatment
After every course of streptokinase therapy a follow-up treatment with anticoagulants or
platelet aggregation inhibitors can be instituted as a prevention of rethromboses. With
heparin therapy, in particular, an increased risk of haemorrhage must be considered.
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

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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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