Innohep 20 000 Iu/Ml
1. What Innohep is and what it is used for
2. What you need to know before you use Innohep
3. How to use Innohep
PACKAGE LEAFLET: INFORMATION FOR THE USER INNOHEP® SYRINGE 20,000 IU/ML
(tinzaparin sodium)
You medicine is known as the above but will be referred to as Innohep throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• In this leaflet Innohep 20,000 IU/ml syringe will be called Innohep.
What is in this leaflet
1. What Innohep is and what it is used for
2. What you need to know before you use Innohep
3. How to use Innohep
4. Possible side effects
5. How to store Innohep
6. Contents of the pack and other information
Innohep is a type of heparin - a low molecular weight heparin - and belongs to a group of medicines called anticoagulants; these medicines affect how the blood clots. Innohep prevents clotting, allowing normal blood flow through the arteries and veins.
Innohep is used in adults to treat:
• Harmful blood clots that have formed in a deep vein (deep vein thrombosis, DVT). This usually occurs in a leg.
• Clots that may travel in your bloodstream and cause a blockage (a thromboembolism).
• A clot that has travelled to the lung and caused a blockage (pulmonary embolism, PE). This can cause breathing difficulties and chest pain.
• Blood clots that have developed because of the presence of a solid tumour (a particular type of cancer).
Do not use Innohep
• If you are allergic (hypersensitive) to tinzaparin or any of the other ingredients of this medicine; you can find a list of ingredients in section 6 of this leaflet.
• If you have ever had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) - this reaction is called heparin-induced thrombocytopenia (HIT).
• If you have ever had a major bleed (for instance: in the brain, spine, eye or stomach, into a muscle or the womb, or any conditions which make you bleed severely, such as haemophilia).
• If you have a condition called septic endocarditis (an inflammation of the lining of the heart and heart valves).
Important: You must not have an epidural/spinal anaesthetic within 24 hours after your last injection of Innohep. You must wait at least 4 to 6 hours after having a spinal anaesthetic, or after the catheter has been removed, before you start using Innohep again.
You may have a blood test before you start using this medicine and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood.
Warnings and precautions
Do not inject Innohep into a muscle. See section 3, “How to use Innohep”.
This medicine may make you bleed more easily, so when you are being given other injections or having any procedures carried out, tell the doctor, nurse or dentist that you are using Innohep.
If you have a brain tumour, you will be monitored closely because medicines such as Innohep that prevent blood from forming clots, may cause bleeding into the skull.
Talk to your doctor, pharmacist or nurse before using Innohep
• If you are pregnant or think you may be pregnant. See the section “Pregnancy and breast-feeding”.
• If you have a condition which makes you more likely to bleed.
• If you are being treated with other injections into your muscles.
• If you are allergic (hypersensitive) to heparin.
• If you are allergic to other low molecular weight heparins, such as enoxaparin or dalteparin.
• If you have a medical condition such as diabetes mellitus or metabolic acidosis which may cause high levels of potassium in your blood (hyperkalaemia).
• If you have an artificial heart valve.
• If you have kidney problems.
• If you have asthma, as this medicine contains sodium metabisulphite (see “Important information about some of the ingredients of Innohep” below).
Innohep should not be interchanged with other low molecular weight heparin products. This is because they are not exactly the same and you could experience problems with your blood clotting.
Elderly people
Because kidney problems are more likely if you are elderly, you may have a blood test to check how well your kidneys are working and to monitor the activity of Innohep.
Children and adolescents
Innohep is not intended for use in children and adolescents under the age of 18 years.
Other medicines and Innohep
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines bought without a prescription.
You must tell your doctor or pharmacist if you are taking any of the following medicines as you may be likely to bleed more easily:
• Non-steroidal anti-inflammatory drugs (such as ibuprofen or diclofenac): for arthritis or aches or pains.
• Aspirin: either for reducing pain and inflammation, or the lower dose for thinning of the blood.
• Platelet aggregation inhibitors (such as clopidogrel): for stopping harmful blood clots forming.
• Thrombolytic agents (such as streptokinase): for dissolving blood clots.
• Vitamin K antagonists (such as warfarin): for stopping harmful blood clots.
• Activated protein C: for getting rid of blood clots.
• Anticoagulation, taken by mouth (such as rivaroxaban, dabigatran or apixaban) for stopping harmful blood clots.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or midwife for advice before using this medicine.
You must not have an epidural anaesthetic to help with your labour or surgery within 24 hours of your last injection of Innohep.
You must wait at least 4 to 6 hours after having a spinal anaesthetic, or after the catheter has been removed, before you start using Innohep again.
Driving and using machines
This medicine should not have any effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines.
Important information about some of the ingredients of Innohep
Innohep syringe contains:
• Sodium metabisulphite. This is a preservative and can cause an allergic reaction which may result in breathing difficulties.
See section 4.
• Sodium. This medicine is nearly “sodium free”. Your medicine contains less than 23 milligrams (mg) of sodium per dose.
Please ask your doctor or pharmacist if you are worried about any of the ingredients in this medicine.
Your doctor may decide that you or a carer may inject this medicine. You will be shown how to do the injection and should only do the injection when you have been instructed how to do so.
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with one of them if you are not sure that you understand how to do the injection or if you are unsure about anything else to do with the medicine.
How much Innohep to use
Adults, including the elderly:
The dose depends on your weight and this will be worked out by the doctor who prescribes it for you. You will be told how much you need to inject. It is possible you may not need to inject the entire contents of the syringe.
You will have one dose of Innohep each day for at least 6 days.
The treatment may be continued for up to 6 months if you have a solid tumour (a particular type of cancer).
Use in children and adolescents
There is limited experience of use in children and adolescents. Innohep is not intended for use in children and adolescents under the age of 18 years.
How to inject yourself with Innohep
You should inject yourself exactly as you have been shown and only on the parts of your body that you have been told it is safe to inject into. The type of injection you will be giving is known as a subcutaneous injection. The injection goes into a pinched up fatty layer on your abdomen or on the outer part of your thighs. Keep away from your belly button. Do NOT inject into a muscle.
Ideally you should inject at the same time every day; this helps to maintain a steady level of the medicine in your body.
When giving yourself an injection, make sure you:
1. Thoroughly wash and dry your hands.
2. Sit, stand or lie in a position so that you can see the skin where you are going to inject yourself. This can comfortably be done standing up or, if you prefer, in a lounge chair, recliner or bed propped up with pillows.
3. Decide where to inject yourself. This is usually on the right or left side of the abdomen, remembering not to inject within 5 cm (2 inches) of your belly button. You may also inject into the sides of your thigh. Do not inject near any scars or bruises. Each time you inject yourself, choose the opposite side from the site of your previous injection.
So if you injected your right thigh last time, you would inject your left thigh next time. If you are injecting in your abdomen, you would do the left side one day and right the next. You should also avoid injecting into the exact site of a previous injection.
