TINZAPARIN SODIUM SYRINGE 10 000 IU/ML, INNOHEP SYRINGE 10 000 IU/ML - patient leaflet, side effects, dosage

Patient leaflet - TINZAPARIN SODIUM SYRINGE 10 000 IU/ML, INNOHEP SYRINGE 10 000 IU/ML

Package leaflet: Information for the user

(10,000 anti-Xa IU/ml) tinzaparin sodium

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.

– In this leaflet the innohep syringe 10,000 anti-Xa IU/mL presentations listed above 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

1. what innohep is and what it is used for

innohep is a blood thinning drug that inhibits the natural ability of the blood to clot (coagulate). innohep

10,000 anti-Xa IU/mL is used to:

– prevent blood clots in adults before and after an operation.
– prevent blood clots in adults that have an increased risk of blood clots e.g. due to an acute illness with

limited mobility.

– prevent blood clots being formed in haemodialysis equipment in patients undergoing haemodialysis or

haemofiltration. In haemodialysis, wastes and fluids from the blood are removed by a dialysis machine and a dialysis filter, which acts as a kind of artificial kidney.

2. what you need to know before you use innohep

Do not use innohep:

– if you are allergic to tinzaparin sodium or any of the other ingredients of this medicine (listed in

section 6).

– if you have or have had heparin-induced thrombocytopenia (HIT).
– if you have a major bleeding (e.g. in the brain, spine, eye or stomach).
– if you have an infection in the heart membranes (septic endocarditis).

Warnings and precautions

Talk to your doctor or nurse before using innohep

– if you are planned to undergo spinal or epidural anaesthesia or lumbar puncture.
– if you know you have a tendency to bleed.
– if you are treated with other medicines by intramuscular injection.
– if you have a decreased level of blood platelets.

(00279336 v.12.0)

– if you have an increased level of potassium in your blood (hyperkalaemia).
– if you have an artificial heart valve.
– if you are suffering from kidney problems.

Children and adolescents

innohep is not intended for use in children and adolescents.

Other medicines and innohep

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some medicines can interact with the effect of innohep.

Talk to your doctor if you are using any of the following medicines as you may be likely to bleed more easily:

– Medicines for treatment of inflammation and pain, especially non-steroidal anti-inflammatory drugs

(NSAIDs), such as acetylsalicylic acid

– Medicines used for dissolving blood clots (thrombolytic agents)
– Medicines that block the action of vitamin K (vitamin K antagonists)
– Activated protein C
– Direct factor Xa and IIa inhibitors

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 or pharmacist for advice before taking this medicine.

innohep in pre-filled syringes can be used in all trimesters of pregnancy.

If epidural anaesthesia is needed you must tell your doctor that you are using innohep.

Talk to your doctor of nurse if you have an artificial heart valve.

Driving and using machines

innohep does not affect the ability to drive and use machines.

innohep contains sodium

- This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-free’.

3. how to use innohep

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure.

Your doctor may perform routine blood analyses in order to be able to evaluate the effects of innohep.

To prevent blood clots forming in your veins

innohep must be injected under the skin (subcutaneous injection). The dose and the length of your treatment will depend on the type of operation or illness you are having. Your doctor will prescribe the right dose for you and tell you how long your treatment with innohep will last.

To prevent blood clots forming in connection with haemodialysis or haemofiltration

innohep will be given either into the tubes of the haemodialysis machine or into your vein. The dose will depend on the duration of dialysis.

How to inject innohep – instructions:

1. Thoroughly wash your hands before you inject this medicine. Wipe clean the skin around the injection site with a surgical alcohol pad and let it dry – do not rub.
2. Open the tube by bending the coloured lid all the way back and take out the syringe.

Inspect the content of the syringe before you use it. If you observe cloudiness or precipitate in the medicine, do not use it but take another syringe. The medicine may turn yellow during storage but can still be used if the solution is clear and expiry date is not overdue. Each syringe is intended to be used only once.

3. Bend the safety device down away from the protective cap on the needle.
4. Remove the protective needle cap without bending the needle. Do not pull back the plunger and do not press out the air bubble. If the air bubble is not placed right by the plunger, then tap lightly on the syringe until the air bubble is in place.
5. Hold a skin fold loosely between thumb and index finger of one hand and with the other hand slowly insert the needle vertically at the skin fold, i.e. at the right angle to the skin.
6. Slowly inject the required dose into the fatty tissue of e.g. the abdominal skin, the extensor sides of the thigh, lower back or upper arm. Wait a few seconds to give the solution time to distribute before you remove the needle and release the skin fold.
7. Wipe off any blood with a tissue. Choose a different injection site next time (for instance, move from the left to the right of the abdomen).
8. Bend the safety device back to its original position so it is now underneath the needle. Then, with the safety device flat against a hard surface, push downwards until the needle locks into the device.
9. You can either place the used syringe in the tube with the needle downwards or you can put the used syringe into a sharps container. The syringe is now secured, and the tube or sharps container can be handed over for destruction at the hospital or by the pharmacist.

If you use more innohep than you should

Bleedings can appear if you have received more innohep than you should. Tell your doctor or nurse immediately if you feel unwell or think you have used too much innohep.

If you forget to use innohep

Do not inject a double dose to make up for a forgotten dose. If you missed more than one dose, contact your doctor as soon as possible.

If you stop using innohep

The blood thinning effect will stop if you discontinue the use of innohep. Do not discontinue the treatment with innohep without consulting your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Serious side effects:

Serious side effects that need immediate medical help are rarely seen during treatment with innohep. If you experience any of the following symptoms you should immediately contact your doctor or local hospital for emergency help.

- Serious allergic reaction. Symptoms include sudden onset of severe rash, swelling of the throat, face, lips or mouth, difficulty in breathing.
- Severe bleeding. Symptoms include red or brown urine, black tarry stools, unusual bruising (very painful, large or dark bruises) and any bleeding that will not stop.

The following side effects have been observed with the administration of innohep:

Common: may affect up to 1 in 10 people

– Bleeding. This could result in complications such as anaemia (a low blood cell count) or haematoma (bruising)
– Injection site reaction (incl. bruising, bleeding, pain, itching, redness, swelling and a hard lump at the injection site)

Uncommon: may affect up to 1 in 100 people

– Thrombocytopenia (decrease in the number of blood platelets)
– Hypersensitivity (allergic reaction)
– Bruising and discolorations of the skin
– Elevated liver enzymes
– Dermatitis (inflammation of the skin)
– Rash and itching

Rare: may affect up to 1 in 1,000 people

– Heparin-induced thrombocytopenia (decrease in the number of blood platelets due to heparin treatment).
– Thrombocytosis (increase in the number of blood platelets)
– Angioedema (swelling of the face, lips and tongue)
– Anaphylactic reaction (see “Serious allergic reaction” above)
– Hyperkalaemia (increased levels of potassium in the blood)
– Toxic skin eruption
– Skin necrosis (tissue death)
– Hives
– Osteoporosis, seen in connection with long-term treatment
– Priapism (persistent erection, usually painful, without sexual desire)

Paediatric population

Limited information derived from one study and postmarketing data indicates that the pattern of adverse reactions in children and adolescents is comparable to that in adults.

Reporting of side effects

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

5. how to store innohep

– 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 carton. The expiry date refers to

the last day of that month.

– This medicinal product does not require any special storage conditions.
– Do not use this medicine if you notice cloudiness or precipitate in the syringe.
– The liquid may turn yellow in storage, but this does not affect the product quality, and the product is

still safe to use.

– 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 innohep contains

– The active substance is tinzaparin sodium. Each mL of solution for injection contains 10,000 anti-Xa

IU of tinzaparin sodium.

– The other ingredients are sodium acetate trihydrate, sodium hydroxide and water for injections.

What innohep looks like and contents of the pack

Solution for injection.

Colourless glass syringes filled with a colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing.

Pack sizes:

– 0.25 mL (2,500 anti-Xa IU), pack size of 10 syringes
– 0.35 mL (3,500 anti-Xa IU), pack size of 10 syringes
– 0.45 mL (4,500 anti-Xa IU), pack size of 10 syringes