Fraxiparine 0,2 ml Solution

FRAXIPARINE is called an antithrombotic medicine. FRAXIPARINE is a medicine that helps to prevent blood clots from forming in the blood vessels (thromboses), which may lead to blood clots in the chest (pulmonary embolism) in patients undergoing hip or knee replacement surgery or abdominal surgery, or treats blood clots if they have already formed. FRAXIPARINE is used in medical patients that are at high risk (lung failure and/or lung infection and/or heart failure), immobilised due to being very ill or hospitalised in an intensive care unit (ICU).

Do not use FRAXIPARINE:

• if you are hypersensitive (allergic) to nadroparin calcium, unfractionated heparin, any other low molecular heparin or to any of the other ingredients of FRAXIPARINE (see section 6) especially when a severe decrease in the number of your blood platelets (cells that help blood to clot) has occurred in recent months.
• if you are bleeding or have any illness which reduces the ability of your blood to clot normally.
• if you have an infection of the heart valves (acute infective endocarditis).
• if you have a condition that is likely to cause bleeding, such as:
• a stomach ulcer.
• threatened abortion.
• recent childbirth.
• severe or uncontrolled high blood pressure.
• a bulging blood vessel in the brain or heart (cerebral or aortic aneurysm).
• during or after eye, brain or spinal cord surgery or trauma.
• prior to lumbar puncture or regional anaesthetic block.
• surgical or traumatic wounds resulting in large open surfaces.
• severe inflammation of the blood vessels (vasculitis).
• active, cavitating tuberculosis.
• carcinoma (type of cancer) of the internal organs of the body (especially chest or abdomen).
• primary or secondary brain tumour.
• inflammation of the lining around the heart (pericarditis).
• if you are being treated for a blood clotting condition and have severe kidney disease.
• if you have an artificial heart valve (mechanical heart valve prosthesis).
• if you have severe liver impairment.
• if you are pregnant or breastfeeding.
• if you are under 18 years of age.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection:

• if you have a history of allergic reactions with heparins or low molecular weight heparins (medication that has been prescribed for you to prevent the formation of blood clots or to treat clots that have already formed).
• if you have any delayed reactions as cross-reactivity may occur, and a delayed hypersensitivity can present.
• if you have a skin reaction at injection site.
• if you have a risk of uncontrolled bleeding (haemorrhage) including:
• history of stomach ulcers.
• if you have kidney or liver disease.
• if you are elderly, especially women over 60 years old.
• if you are taking other medications that affect blood clotting e.g. aspirin, ibuprofen for inflammation and pain.

You will need regular blood tests:

• FRAXIPARINE can cause a reduction in the number of platelets in your blood.
• FRAXIPARINE can increase the potassium levels in your blood. You will need to have blood tests, if you have diabetes, serious kidney disease or if you are taking other medicines that affect potassium levels.

You should go for frequent checks with regards to signs and symptoms of neurological deficits such as back pain, sensory and motor deficits (numbness and weakness of the lower limbs), disturbances of rectal and/or bladder functions. If a neurological disorder is determined, treatment should be started immediately. You should notify your doctor immediately if you experience one of these symptoms.

You will be monitored closely if you are going to have a spinal anaesthetic or fluid removed from the spine area (spinal lumbar puncture) as FRAXIPARINE may cause bleeding into the spine at the injection site.

Do not share medicines prescribed for you with any other person. Always use FRAXIPARINE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you the dose and volume of FRAXIPARINE you need to use, and for how long you need to use it. Your doctor will tell you how long your treatment with FRAXIPARINE will last. Do not stop treatment early. If you have the impression that the effect of FRAXIPARINE is too strong or too weak, tell your doctor or pharmacist.

How to use FRAXIPARINE:

FRAXIPARINE is given by an injection under the skin (subcutaneously) into a skin fold of the lower abdominal area. While usually a healthcare provider will administer this injection, some patients may be taught how to do this themselves. If you are taught to self administer, you should follow carefully the step-by-step instructions.

Don’t inject FRAXIPARINE into muscle.

For FRAXIPARINE pre-filled syringes: The pre-filled syringes are available in different doses. Your doctor will select the correct syringe dose for you. Some people may need to adjust the volume in the syringe. Your doctor will let you know if this applies to you.

Step-by-step instructions

Parts of the syringe:

1. Needle shield
2. Plunger
3. Finger-grip
4. Security sleeve

Instructions for use

1. Wash your hands thoroughly with soap and water and dry them with a towel.
2. Remove the syringe from the carton and check that:
• the expiry date has not passed
• the syringe has not been opened or damaged.
3. Sit or lie down in a comfortable position. Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A). Alternate the left and right side of the lower abdominal area at each injection. This will help to reduce the discomfort at the injection site. If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice. Picture A
4. Clean the injection area with an alcohol wipe.
5. Remove the needle shield, by first twisting it and then pulling it in a straight line away from the body of the syringe (picture B). Discard the needle shield. If the volume in the syringe is more than you need, you must remove the excess before you inject yourself.
6. Hold the syringe with the needle pointing straight down.
7. Push the syringe plunger gently down until the bottom of the bubble sits on the line marked with the volume your doctor has prescribed for you.
8. Drip the fluid that comes out of the needle on to a tissue, and discard.
9. The syringe is now ready to use.
10. Important note: Don’t touch the needle or allow it to touch any surface before the injection. It is normal to see a small air bubble in this syringe. Don’t try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
11. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger during the entire injection (picture C). Picture C
12. Hold the syringe firmly by the finger grip. Insert the full length of the needle at right angles into the skin fold (picture D). Picture D
13. Inject ALL the contents of the syringe by pressing down on the plunger as far as it goes (picture E). Then gently remove the needle from the skin. Picture E
14. After the injection, hold the syringe in one hand by gripping the security sleeve, use the other hand to hold the finger grip and pull firmly back. This unlocks the sleeve. Slide the sleeve up the body of the syringe until it locks into position over the needle (picture F). Picture F

Do not dispose of the used syringe in household waste. Dispose of it as your doctor or pharmacist has instructed.

If you administer more FRAXIPARINE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take FRAXIPARINE

Do not take a double dose to make up for forgotten individual doses.

If you stop using FRAXIPARINE

Use FRAXIPARINE for as long as your doctor recommends. Don’t stop unless your doctor advises you to. If you stop the treatment before your doctor tells you to, the blood clot may not be treated properly or you may be at higher risk of developing a new blood clot in a vein of your leg or lung. If you want to stop taking FRAXIPARINE speak to your doctor or pharmacist first.

FRAXIPARINE can have side effects. Not all side effects reported for FRAXIPARINE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FRAXIPARINE, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking FRAXIPARINE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FRAXIPARINE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Bleeding (most common complication),
• bruising easily and feeling extremely tired due to low platelet levels in the blood (thrombocytopenia),
• chest pain, racing heart or irregular heart beat, muscle weakness or numbness in your limbs; this may be a sign of high potassium levels in your blood (hyperkalaemia),
• severe pain, swelling and discoloration due to tissue cell death at the site of injection.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Collection of blood outside the blood vessels, usually in liquid form within the tissue at the injection site,
• reduced liver function (increase in the amount of liver enzymes in the blood, as seen from a blood test).

Less frequent side effects:

• Increase in the number of platelets (blood cells necessary for blood clotting),
• increase in white blood cells (as seen on a blood test result),
• persistent painful erection of the penis,
• risk of thinning of bones (osteoporosis) as well as breaking (fractures),
• hardening of tissue or other material by the deposition of or conversion into calcium compounds at the injection site,
• reddness of the skin (erythema),
• high levels of fat in the blood (rebound hyperlipidemia) after stopping treatment with FRAXIPARINE.

Side effects with unknown frequency:

• Headache,
• severe headaches (migraines).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA: via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/ +27 (0)11 239 - 6200. By reporting side effects, you can help provide more information on the safety of FRAXIPARINE.

Store all medicines out of reach of children.

Pre-filled syringes and graduated pre-filled syringes: Store at or below 25 °C. Do not freeze. Discard any unused portion of each syringe. Do not refrigerate, as the injection of cold injections may be painful. Do not mix with other preparations. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).