Streptokinase Karma 250 000 Powder for solution for infusion

Patient Leaflet Updated 08-Jul-2024 | Tetris Pharma Ltd

Streptokinase Karma 250 000 and 750 000 Powder for solution for infusion (100068)

PATIENT INFORMATION LEAFLET

Streptokinase Karma 250 000 and 750 000

Powder for solution for infusion

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 Streptokinase Karma is and what it is used for.
2. What you need to know before you are given Streptokinase Karma.
3. How Streptokinase Karma is given to you.
4. Possible side effects.
5. How Streptokinase Karma is stored.
6. Contents of the pack and further information.

1. WHAT STREPTOKINASE KARMA IS AND WHAT IT IS USED FOR.

Streptokinase Karma 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 Streptokinase Karma to break down blood clots in blood vessels.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN STREPTOKINASE KARMA.

You should not be treated with Streptokinase Karma 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 Streptokinase Karma 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 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

CHILDREN

It is not recommended to use Streptokinase Karma in children, infants and neonates.

OTHER MEDICINES AND STREPTOKINASE KARMA

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 Streptokinase Karma if you are pregnant or have recently had a baby, miscarriage or abortion unless there is no other, safer treatment.

You should not breastfeed your child while you are being treated with Streptokinase Karma.

Breast milk should be thrown away if you have been given streptokinase within the last 24 hours.

3. HOW STREPTOKINASE KARMA IS GIVEN TO YOU.

Streptokinase Karma 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 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, so your doctor may choose to use a different type of fibrinolytic agent.

IF YOU ARE GIVEN MORE STREPTOKINASE KARMA 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, Streptokinase Karma can cause side effects, although not everybody gets them.

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.

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

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, or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW STREPTOKINASE KARMA 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.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION.
What Streptokinase Karma 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 STREPTOKINASE KARMA 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
Karma Pharmatech GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
Tel: +49 (0) 6421 395811

MANUFACTURER
Karma Pharmatech GmbH
Emil-von-Behring-Straße 76
35041 Marburg
Germany
Fax: +49 (0) 6421 395812

FOR ANY INFORMATION ABOUT THIS MEDICINE, PLEASE CONTACT OUR LOCAL DISTRIBUTOR:

Tetris Pharma Ltd.
2nd Floor
79-81 High St
Marlow
Buckinghamshire
SL7 1AB
United Kingdom
Tel: 0330 1359 433

This leaflet was last revised in 03/2024.

PL 49427/0005 PL 49427/0006

LL-SK250000_750000-UK-001

Company Contact Details
Tetris Pharma Ltd
Address

79-81 High Street, Marlow, Buckinghamshire, SL7 1AB

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01628 337579

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0330 1359 433

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