Crusia

Leaflet accompanying the packaging: patient information

Crusia, 12,000 IU (120 mg)/0.8 ml, solution for injection in a pre-filled syringe
Crusia, 15,000 IU (150 mg)/1 ml, solution for injection in a pre-filled syringe
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see section 4.
Enoxaparin sodium

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Crusia and what is it used for
• 2. Important information before using Crusia
• 3. How to use Crusia
• 4. Possible side effects
• 5. How to store Crusia
• 6. Contents of the packaging and other information

1. What is Crusia and what is it used for

Crusia contains the active substance enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Crusia works in two ways.

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, so they are no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

Crusia can be used for:

• Treating blood clots that are already present in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following cases: before and after surgery, during acute illness when the patient has limited mobility, if the patient has had blood clots caused by cancer to prevent the formation of new clots, in unstable angina (a condition where the heart does not receive enough blood), after a heart attack
• Preventing the formation of clots in the dialyzer tubes (used in people with severe kidney function disorders).

2. Important information before using Crusia

When not to use Crusia

• If the patient is allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction may be: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has been diagnosed with an allergy to heparin or other low molecular weight heparins, such as nadroparin, tinzaparin, or dalteparin.
• If the patient has been diagnosed with a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets) - a reaction known as heparin-induced thrombocytopenia - within the last 100 days or if the patient has antibodies against enoxaparin in their blood.
• If the patient has severe bleeding or a medical condition associated with an increased risk of bleeding (e.g., stomach ulcers, recent brain or eye surgery), including recent hemorrhagic stroke.
• If the patient is using Crusia to treat blood clots and spinal or epidural anesthesia or lumbar puncture is planned within 24 hours.

Warnings and precautions

Crusia should not be used interchangeably with other low molecular weight heparins. This is because they are not exactly the same, differ in activity, and have different instructions for use.
Before starting to use Crusia, you should discuss with your doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a significant decrease in the number of platelets
• the patient is scheduled for spinal or epidural anesthesia or lumbar puncture (see "Surgical procedures and anesthetics"): an appropriate time interval should be considered between the use of Crusia and this procedure
• the patient has a heart valve replacement
• the patient has endocarditis (infection of the membrane lining the heart)
• the patient has had stomach ulcers
• the patient has recently had a brain attack
• the patient has high blood pressure
• the patient has diabetes or has problems with blood vessels in the eyes caused by diabetes (so-called diabetic retinopathy)
• the patient has recently had eye or brain surgery
• the patient is elderly (over 65 years), especially if they are over 75 years old
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has an increased level of potassium in the blood (which can be checked with a blood test)
• the patient is currently taking medications that may cause bleeding (see the section below "Crusia and other medicines")

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets in the blood and the level of potassium.

Children and adolescents:

The safety and efficacy of enoxaparin have not been evaluated in children and adolescents.

Crusia and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• Warfarin - a medicine used to thin the blood
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3 "Change of anticoagulant medicine")
• Dextran injections - used as a blood substitute
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines 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 that increase the level of potassium in the blood, such as potassium salts, diuretics, and certain heart medicines.

Surgical procedures and anesthetics

If the patient is scheduled for a lumbar puncture or surgery under spinal or epidural anesthesia, they should inform their doctor that they are using Crusia. See the section "When not to use Crusia". Additionally, the patient should inform their doctor if they have any spinal problems or if they have had spinal surgery.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
In pregnant women with a mechanical heart valve, there may be an increased risk of blood clots. The doctor should discuss this with the patient.
Women who are breastfeeding or plan to breastfeed should consult their doctor before starting to use this medicine.

Driving and using machines

Crusia does not affect the ability to drive or use machines.
The doctor should document the trade name and batch number of the product used.

Crusia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to use Crusia

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Taking the medicine

• Crusia will usually be administered to the patient by a doctor or nurse. This is because it requires injection.
• After returning home, the patient may need to continue using Crusia and administer it themselves (see the administration instructions below).
• Crusia is usually administered by subcutaneous injection.
• Crusia may be administered intravenously in certain types of heart attack or after surgery.
• Crusia may be introduced into the dialyzer tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session. Crusia should not be administered by intramuscular injection.

Dose

• The doctor will decide what dose of Crusia the patient should take. This depends on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Crusia.
• 1. Treatment of blood clots in the patient's blood
• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• The doctor will decide how long the patient should receive Crusia.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:
• Surgery or limited mobility due to illness
• The dose depends on the patient's risk of clotting. The patient will receive Crusia at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) per day.
• In the case of planned surgery, the first injection is usually performed 2 hours or 12 hours before surgery.
• If the patient has limited mobility due to illness, they will usually receive Crusia at a dose of 4000 IU (40 mg) per day.
• The doctor will decide how long the patient should receive Crusia.
• After a heart attackCrusia can be used in two different types of heart attack: STEMI (ST-elevation myocardial infarction) and NSTEMI (non-ST-elevation myocardial infarction). The dose of Crusia will depend on the patient's age and the type of heart attack they had.

NSTEMI heart attack:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Crusia.

STEMI heart attack in patients under 75 years of age:

• The initial dose of Crusia is 3000 IU (30 mg) administered intravenously.
• At the same time, Crusia will also be administered subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Crusia.

STEMI heart attack in patients 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum amount of Crusia in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should receive Crusia.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Crusia was administered, the doctor may decide to administer an additional dose of Crusia before the PCI procedure.
Crusia will be administered intravenously.

• 3. Prevention of blood clot formation in the dialyzer tubes
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Crusia is injected into the tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session. This amount is usually sufficient for a 4-hour dialysis session. However, if necessary, the doctor may administer an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight.

Instructions for using the pre-filled syringe

Self-administration of Crusia

If the patient is able to administer Crusia themselves, the doctor or nurse will show them how to do it. You should not attempt to administer the medicine yourself until you have received instructions.
If the patient is unsure what to do, they should immediately consult their doctor or nurse. Proper administration of the injection under the skin (so-called subcutaneous injection) will help reduce pain and bruising at the injection site.

Before self-administering Crusia

• Gather the necessary items: syringe, cotton ball, or soap and water, and a container for sharp objects.
• Check the expiration date on the packaging. Do not use the medicine after the expiration date.
• Check if the syringe is damaged and if the liquid is clear. If not, use another syringe.
• Make sure what dose is to be administered.
• Examine the abdomen to check if the last injection caused redness, skin discoloration, swelling, discharge, or if it is still painful. If so, consult a doctor or nurse.

Instructions for self-administration of Crusia:

(Instructions for pre-filled syringes without a safety device)

Preparing the injection site

• 1) Choose an injection site in the right or left side of the abdomen. The injection site should be at least 5 cm away from the navel towards the sides.
• Do not inject within 5 cm of the navel or around existing scars or bruises.
• Change the injection site between the left and right side of the abdomen, depending on the site of the previous injection.

• 2) Wash your hands. Clean (do not rub) the injection site with a cotton ball soaked in alcohol or soap and water.
• 3) Sit or lie down in a comfortable position, so you are relaxed. Make sure the injection site is in your line of sight. A chair, couch, or bed with pillows for support will be suitable.

It is recommended to perform the injection with the patient sitting or lying down.

Dose selection

• 1) Carefully remove the needle cap from the syringe. Discard the cap.
• Do not press the plunger before administering the injection to remove air bubbles. This may reduce the administered dose.
• After removing the cap, do not touch the needle with anything. This will ensure the sterility of the needle.

• 2) If the amount of medicine in the syringe is consistent with the prescribed dose, there is no need to adjust the dose. You can proceed with the injection.
• 3) If the dose depends on body weight, it may be necessary to adjust the dose in the syringe according to the prescribed dose. In this case, excess medicine should be discarded by holding the syringe upside down (to keep air bubbles in the syringe) and discarding the excess medicine into a container.
• 4) A drop may appear at the tip of the needle. In this case, the drop should be removed before administering the injection by tapping the syringe with the needle facing down. You can proceed with the injection.

Injection

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently grasp the cleaned skin of the abdomen with your index finger and thumb, creating a skin fold between your fingers.
• Make sure to maintain the skin fold while performing the injection.
• 2) Hold the syringe with the needle facing down (perpendicularly at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will introduce the medicine into the abdominal fat tissue. You should inject the entire amount of medicine from the syringe.
• 4) Remove the needle from the injection site by pulling it out straight. Hold the needle away from yourself and others. Now you can release the skin fold.

After administering the injection

• 1) To avoid bruising, do not rub the injection site after administering the injection.
• 2) Dispose of the used syringe in a container for sharp objects. Close the container and store it in a place that is out of sight and reach of children. If the container is full, dispose of it according to the doctor's or pharmacist's instructions.

Any unused medicines or waste should be disposed of in accordance with local regulations.
In case of feeling that the dose is too strong (e.g., unexpected bleeding occurs) or too weak (e.g., the dose probably does not work), consult a doctor or pharmacist.

Instructions for pre-filled syringes with a safety device

Preparing the injection site

• 1) Choose an injection site in the right or left side of the abdomen. The injection site should be at least 5 cm away from the navel towards the sides.
• Do not inject within 5 cm of the navel or around existing scars or bruises.
• Change the injection site between the left and right side of the abdomen, depending on the site of the previous injection.

• 2) Wash your hands. Clean (do not rub) the injection site with a cotton ball soaked in alcohol or soap and water.
• 3) Sit or lie down in a comfortable position, so you are relaxed. Make sure the injection site is in your line of sight. A chair, couch, or bed with pillows for support will be suitable.

Dose selection

• 1) Carefully remove the needle cap from the syringe. Discard the cap.
• Do not press the plunger before administering the injection to remove air bubbles. This may reduce the administered dose.
• After removing the cap, do not touch the needle with anything. This will ensure the sterility of the needle.

• 2) If the amount of medicine in the syringe is consistent with the prescribed dose, there is no need to adjust the dose. You can proceed with the injection.
• 3) If the dose depends on body weight, it may be necessary to adjust the dose in the syringe according to the prescribed dose. In this case, excess medicine should be discarded by holding the syringe upside down (to keep air bubbles in the syringe) and discarding the excess medicine into a container.
• 4) A drop may appear at the tip of the needle. In this case, the drop should be removed before administering the injection by tapping the syringe with the needle facing down. You can proceed with the injection.

Injection

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently grasp the cleaned skin of the abdomen with your index finger and thumb, creating a skin fold between your fingers.
• Make sure to maintain the skin fold while performing the injection.
• 2) Hold the syringe with the needle facing down (perpendicularly at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will introduce the medicine into the abdominal fat tissue. You should inject the entire amount of medicine from the syringe.
• 4) Remove the needle from the injection site by pulling it out straight, while still holding the plunger. Hold the needle away from yourself and others. The safety device is activated by firmly pressing the plunger. The protective cover will automatically cover the needle, and a clicking sound will be heard, confirming the activation of the protective cover. Now you can release the skin fold.

After administering the injection

• 1) To avoid bruising, do not rub the injection site after administering the injection.
• 2) Dispose of the used syringe in a container for sharp objects. Close the container and store it in a place that is out of sight and reach of children. If the container is full, dispose of it according to the doctor's or pharmacist's instructions.

Any unused medicines or waste should be disposed of in accordance with local regulations.
In case of feeling that the dose is too strong (e.g., unexpected bleeding occurs) or too weak (e.g., the dose probably does not work), consult a doctor or pharmacist.

Change of anticoagulant medicine

• Changing from Crusia to blood-thinning medicines called vitamin K antagonists (e.g., warfarin)The doctor will recommend blood tests to determine the INR (International Normalized Ratio) and, based on this, will inform the patient when to stop taking Crusia.
• Changing from vitamin K antagonists (e.g., warfarin) to CrusiaThe patient should stop taking the vitamin K antagonist. The doctor will recommend blood tests to determine the INR and, based on this, will inform the patient when to start taking Crusia.
• Changing from Crusia to direct oral anticoagulantsThe patient should stop taking Crusia. Then, they should start taking the direct oral anticoagulant 0-2 hours before the scheduled time of the next Crusia injection; and then continue taking the medicine as usual.
• Changing from direct oral anticoagulants to CrusiaThe patient should stop taking the direct oral anticoagulant. Treatment with Crusia can be started 12 hours after the last dose of the direct oral anticoagulant.

Using more than the recommended dose of Crusia

If the patient thinks they have used too much or too little Crusia, they should immediately inform their doctor, nurse, or pharmacist, even if they do not notice any problems.
In case of accidental injection or ingestion of Crusia by a child, immediately go to the hospital emergency department.

Missing a dose of Crusia

If a dose is missed, it should be taken as soon as possible. Do not take a double dose to make up for the missed dose. Keeping a diary helps ensure that no dose is missed.

Stopping the use of Crusia

If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.
It is important to continue administering Crusia injections until the doctor recommends stopping them. If treatment is stopped, a blood clot may form, which can be very dangerous.

4. Possible side effects

Like all medicines, Crusia can cause side effects, although not everybody gets them.
As with other similar medicines (used to reduce blood clotting), Crusia may cause bleeding, which can be life-threatening. In some cases, bleeding may not be immediately visible.
If any bleeding occurs that does not stop on its own, as well as signs of excessive bleeding (severe weakness, fatigue, paleness, dizziness, headaches, or unexplained sweating), immediately consult a doctor. The doctor may decide to monitor the patient more closely or change the medicine.
If any of the following symptoms occur, stop using enoxaparin and seek medical help immediately:

• Any symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
• A red, scaly, widespread rash with thickening of the skin and blisters, accompanied by fever.

Immediately consult a doctor:

• If the patient experiences any signs of a blood clot blocking a blood vessel, such as:
• cramping pain, redness, increased warmth, or swelling in one leg - these are symptoms of deep vein thrombosis
• shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism
• If the patient experiences painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order blood tests to check the platelet count.

List of possible side effects:

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

• Bleeding.
• Increased liver enzyme activity.

Common (may affect up to 1 in 10 people)

• Increased tendency to bruise. This may be due to a decrease in platelet count.
• Pink spots on the skin. These changes are more likely to occur at the injection sites of Crusia.
• Hives (urticaria).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decreased red blood cell count.
• Increased platelet count.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden severe headache. This may be a sign of bleeding in the brain.
• Tenderness and swelling in the stomach. This may be a sign of bleeding in the stomach.
• Large, red, irregularly shaped skin changes with blisters or without blisters.
• Skin irritation (local irritation).
• The patient may notice yellowing of the skin or eyes and darker urine. This may indicate liver disease.

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

• Severe allergic reaction. Symptoms of such a reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased level of potassium in the blood. This is more likely in people with kidney disease or diabetes. The doctor can check this with a blood test.
• Increased eosinophil count in the blood. The doctor can check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine.
• Numbness, tingling, and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal anesthesia.
• Loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet).
• Hardening or a lump at the injection site.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Crusia

Store at a temperature below 25°C. Do not freeze.
Crusia pre-filled syringes are single-dose containers - any unused product should be discarded.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the month stated.
Do not use the medicine if the pre-filled syringe is damaged or if the product is not clear.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Crusia contains

• The active substance of Crusia is enoxaparin sodium

Each pre-filled syringe contains enoxaparin sodium equivalent to 12,000 IU of anti-Xa activity (which corresponds to 120 mg) in 0.8 ml of water for injections.
Each pre-filled syringe contains enoxaparin sodium equivalent to 15,000 IU of anti-Xa activity (which corresponds to 150 mg) in 1.0 ml of water for injections.

• The other ingredient is water for injections.

What Crusia looks like and contents of the pack

Crusia is a clear, colorless to pale yellow solution for injection in a pre-filled syringe made of colorless glass type I with a rubber stopper, plunger, and needle in a protective cover, with or without an automatic safety device. It is available in the following forms:
Crusia 12,000 IU (120 mg)/0.8 ml solution for injection in a 1 ml pre-filled syringe.
Packaging of 10, 30, and 50 pre-filled syringes.
Crusia 15,000 IU (150 mg)/1 ml solution for injection in a 1 ml pre-filled syringe.
Packaging of 10, 30, and 50 pre-filled syringes.
Not all pack sizes may be marketed.
In some pack sizes, the pre-filled syringes may be connected to a safety device.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
tel.: (+48) 699 711 147
Manufacturer:
ROVI Pharma Industrial Services S.A.
Julián Camarillo, 35
28037 Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, United Kingdom (Northern Ireland), Spain, Poland: Crusia
Belgium: Teuro

Date of last revision of the leaflet: 01/2023

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: http://www.urpl.gov.pl/