CSL Behring
Streptase Injection 1,500,000 (1.5 M) I.U.
(Streptokinase)
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.
In This Leaflet:
- 1. What Streptase Injection is and what it is used for
- 2. Before you are given Streptase Injection
- 3. How you are given Streptase Injection
- 4. Possible side effects
- 5. Storing Streptase Injection
- 6. Further information
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 IU strength is used to limit the extent of a heart attack, within 12 hours of the event occurring.
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 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.
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.
How You Are Given Streptase Injection
- Streptase Injection will usually be 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.
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
Common side effects (affect less 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 less than 1 in 100 people)
- Bleeding into eyes, liver, abdomen or joints, tearing of the spleen
- Stroke (cerebrovascular haemorrhage)
Rare side effects (affect less than 1 in 1,000 people)
- Dizziness, confusion, agitation
- Fits
- Paralysis on one or both sides of the body
Very rare side effects (affect less 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 have been 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).
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.
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.
Further Information
What Streptase Injection contains
The active substance is:
- Streptokinase (1.5 Million International Units (IU))
Other ingredients are:
- human albumin
- sodium-L-hydrogen glutamate monohydrate
- polygeline
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 IU streptokinase.
Marketing Authorisation Holder
Manufacturer
This leaflet was last approved on: 04/2008
For further information contact
This leaflet was last approved on: 05/2009
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