Thorinane - patient leaflet, side effects, dosage

1. What Thorinane is and what it is used for

Thorinane contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).

Thorinane works in two ways.

• 1) Stopping existing blood clots from g etting any bigger. This helps your body to break them down and stops them from causing you harm.

• 2) Stopping blood clots from forming in your blood.

Thorinane can be used to:

• Treat blood clots that are in your blood
• Stop blood clots from forming in your blood in the following situations:

o Before and after an operation

o When you have an acute illness and face period of limited mobility

o When you have unstable angina (a condition when not enough blood gets to your heart)

o After a heart attack

• Stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).

2. What you need to know before you use Thorinane

Do not use Thorinane

• If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
• If you have 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 – within the last 100 days or if you have antibodies against enoxaparin in your blood.

• If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach

ulcer, recent surgery of the brain or eyes), including recent bleeding stroke.

• If you are using Thorinane to treat blood clots in your body and going to receive spinal or

epidural anaesthesia or lumbar puncture within 24 hours.

Warnings and precautions

Thorinane should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins. This is because they are not exactly the same and do not have the same activity and instructions for use.

Talk to your doctor or pharmacist before using Thorinane if:

you have ever had a reaction to heparin that caused a severe drop in the number ets

you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and Anaesthetics): a delay should be respected between Thorinane use and this procedure you have had a heart valve fitted

you have endocarditis (an infection of the inner lining of the heart)

you have history of gastric ulcer

you have had a recent stroke

you have high blood pressure

you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)

you have had an operation recently on your eyes or brain

you are elderly (over 65 years old) and especially if you are over 75 years old

you have kidney problems

you have liver problems

you are underweight or overweight

you have high level of potassium in your blood (this may be checked with a blood test) are currently using medicines which affect bleeding (see section below – Other medicines).

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 cell s (platelets) and potassium in your blood.

Other medicines and Thorin^ne

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

• Warfarin – used for thinning the blood
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see also in section 3, “Changing of anticoagulant medicine”)
• Dextran injection – used as a blood replacer
• Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents which are used to treat pain and swelling in arthritis and other conditions
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• Medicines which increase potassium level in your blood such as potassium salts, water pills, some medicines for heart problems.

Operations and anesthetics

If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell you doctor that you are using Thorinane. See “Do not use Thorinane”. Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots. Your doctor should discuss this with you.

If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.

Driving and using machines

Thorinane does not affect the ability to drive and operate machinery.

It is advised that the trade name and batch number of the product you are using are recorded by your healthcare professional.

Thorinane contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘soi

3. How to use Thorinane

Always use this medicine exactly as your doctor or pharmacist has to] pharmacist if you are not sure.

Having this medicine

Your doctor or nurse will normally give you Thorinane. This is because it needs to be given as an injection.

When you go home, you may need to continue to use Thorinane and give it yourself (see instructions below on how to do this).

Thorinane is usually given by injection underneath the skin (subcutaneous).

Thorinane can be given by injection into your vein (intravenous) after certain types of heart attack or operation.

Thorinane can be added to the tube leaving the body (arterial line) at the start of the dialysis session.

Do not inject Thorinane into a muscle.

How much will be given to you

• Your doctor will decide how much Thorinane to give you. The amount will depend on the reason it is

being used.

• If you have problems with your kidneys you may be given a smaller amount of Thorinane.

• 1. Treating blood clots that are in your blood

• The usual dose is 150 IU (1.5 mg) for every kilogram of your weight each day or 100 IU (1 mg) for every kilogram of your weight twice a day.
• Your doctor will decide how long you should receive Thorinane.

• 2. Stopping blood clots forming in your blood in the following situations:

• ❖ Operation or periods of limited mobility due to an illness

• The dose will depend on how likely you are to develop a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Thorinane each day.
• If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
• If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of Thorinane each day.
• Your doctor will decide how long you should receive Thorinane.

• ❖ After you have had a heart attack

Thorinane can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI). The amount of Thorinane given to you will depend on your age and the kind of heart attack you have had.

NSTEMI type of heart attack:

• The usual dose is 100 IU (1 mg) for every kilogram of weight every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Thorinane.

STEMI type of heart attack if you are under 75 years old:

• An initial dose of 3,000 IU (30 mg) of Thorinane will be given as injection into your vein.
• At the same time you will also be given Thorinane as an injection underneath your skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for every kilogram of your weight, every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Thorinane.

STEMI type of heart attack if you are 75 years old or older:

The usual dose is 75 IU (0.75 mg) for every kilogram of your weight, every 12 hours.

The maximum amount of Thorinane given for the first two injections is 7,500 IU (75 mg).

Your doctor will decide how long you should receive Thorinane.

For patients have an operation called percutaneous coronary intervention (PCI):

Depending on when you were last given Thorinane, your doctor may decide to give an additional dose of Thorinane before a PCI operation. This is by injection into your vein.

• 3. Stopping blood clots from forming in the tubes of your dialysis machine

• The usual dose is 100 IU (1 mg) for every kilogram of your weight.
• Thorinane is added to the tube leaving the body (arterial line) at the start of the dialysis session. This amount is usually enough for a 4-hour session. However, your doctor may give you a futher dose of 50 IU to 100 IU (0.5 to 1 mg) for every k ilogram of your weight, if necessary.

How to give yourself an injection of Th orinane^

If you are able to give this medicine to y ourself, your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained how to do so. If you are not sure what to do, talk to your doctor or nurse immediately.

Before injecting yourself with Thorinane

• – Check the expiry dai ^ on the medicine. Do not use if the date has passed.

• – Check the syringe is not damaged and the medicine in it is a clear solution. If not, use another syringe.

• – Do not use this medicine if you notice any change in the appearance of the product.

• – Make sure you know how much you are going to inject.

• – Check your abdomen to see if the last injection caused any redness, change in skin colour, swelling,

oozing or is still painful, if so talk to your doctor or nurse.

• – Dec;de where you are going to inject the medicine. Change the place where you inject each time from

the right to the left side of your stomach. This medicine should be injected just under the skin on your stomach, but not too near the belly button or any scar tissue (at least 5 cm away from these).

• – The pre-filled syringe is intended for single use only.

Instructions on injecting yourself with Thorinane

• 1) Wash your hands and the area that you will inject with soap and water. Dry them.

• 2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place you are going

to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.

• 3) Choose an area on the right or left side of your stomach. This should be at least 5 cm away from your belly button and out towards your sides.

Remember: Do not inject yourself within 5 cm of your belly button or around existing scars or bruises. Change the place where you inject between the left and right sides of your stomach, depending on the area you were last injected.

• 4) Carefully pull off the needle cap from the syringe. Throw away the cap. The syringe is pre-filled and ready to use.

• 7) Press down on the plunger with y our finger. This will send the medicine into the fatty tissue of the stomach. Make sure you hold the skin fold throughout the injection.

• 8) Remove the needle by pulling it straight out.

To avoid bruising, do not rub the injection site after you have injected yourself.

• 9) Drop the used syringe with its protective sleeve into the sharps bin provided. Close the container lid tightly and place the container out of reach of children.

When the container is full, give it to your doctor or home care nurse for disposal. Do not put it in the household rubbish.

Changing of anticoagulant treatment

4.      Possible side effects

Like other similar medicines (medicines to reduce blood clotting), Thorinane may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious.

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), consult your doctor immediately.

Your doctor may decide to keep you under closer observation or change your medicine.

Thorinane and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction ifficulty breathing, swelling of the lips, mouth, throat or eyes).

You should tell your doctor straight away

• If you have any sign of blockage of a blood vessel by a blood clot such as:

• – cramping pain, redness, warmth, or swelling in one of your legs – these are thrombosis

• – or- these are

• If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

Your doctor may request you perform a blood test to check your platelet count.

Overall list of possible side effects:

Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increases in liver enzymes.

Common (may affect up to 1 in 10 people)

• You bruise more easily than usual. This could be because of a blood problem with low platelet counts.
• Pink patches on your skin. These are more likely to appear in the area you have been injected with Thorinane.
• Skin rash (hives, urticaria).
• Itchy red skin.
• Bruising or pain at the injection site.
• Decreased red blood cell count.
• High platelet counts in the blood. Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden severe headache. This could be a sign of bleeding in the brain.
• A feeling of tenderness and swelling in your stomach. You may have bleeding in your stomach.
• Large red irregularly shaped skin lesions with or without blisters.
• Skin irritation (local irritation).
• You notice yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem.

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Increased potassium in your blood. This is more likely to happen in people with kidney problems or diabetes. Your doctor will be able to check this by carrying out a blood test.

An increase in the number of eosinophils in your blood. Your doctor will be able to check this by carrying out a blood test.

Hair loss.

Osteoporosis (a condition where your bones are more likely to break) after long term use.

Tingling, numbness and muscular weakness (particularly in the lower part of your body) when you have had a spinal puncture or a spinal anaesthetic.

Lost of control over your bladder or bowel (so you cannot control when you go to the toilet).

Hard mass or lump at the ini ection site.

Reporting of side effe<cts

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 25 °C. Do not freeze.

After dilution the solution should be used within 8 hours.

Do not use this medicine if you notice any visible change in the appearance of the solution.

The Thorinane pre-filled syringes are for single dose use only. Discard any unused medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.     Contents of the pack and other information

What Thorinane contains

• – The active substance is enoxaparin sodium.

Each mL contains 100 mg enoxaparin sodium.

Each pre-filled syringe of 0.2 mL contains 2,000 IU (20 mg) of enoxaparin sodium.

• – The other ingredient is water for injections.

What Thorinane looks like and contents of the pack

0.2 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod.

Marketing Authorisation Holder

National and Kapodistrian University of Athens,

Department of Chemistry, Service Laboratory „Chemical Analysis – Quality Control“

Panepistimiopolis Zografou,

Athens, Attiki 15771

Greece

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: