Ivor

Package Leaflet: Information for the User

Ivor 2,500 IU/0.2 ml solution for injection in pre-filled syringe

bemiparin sodium
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ivor is and what it is used for
2. What you need to know before using Ivor
3. How to use Ivor
4. Possible side effects
5. How to store Ivor
6. Contents of the pack and other information

1. What IvOR is and what it is used for

The active substance in Ivor is bemiparin sodium, which belongs to the class of anticoagulants. These
medicines help prevent blood clotting in blood vessels.
Ivor is used to prevent the formation of dangerous blood clots, for example, in the veins of the legs
and/or lungs, which may occur if you undergo general surgery; it is also used to prevent blood clots
from forming in dialysis equipment.

2. What you need to know before using IVOR

Do not use Ivor

• If you are allergic to bemiparin sodium, heparin, or a similar product (such as enoxaparin, dalteparin, nadroparin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction after taking a medicine containing heparine.
• If you are allergic to any substance of porcine origin.
• If you have Heparin-Induced Thrombocytopenia (HIT), a condition causing a drastic reduction in clotting cells (platelets), (or, as a consequence of HIT, suffer from another condition called Disseminated Intravascular Coagulation (DIC), in which platelets would form clots if Ivor were administered).
• If you have a condition known as endocarditis (inflammation of the membrane lining the heart and heart valves).
• If you have any condition that causes a tendency to excessive bleeding.
• If you have severe liver and/or pancreatic disease.
• If you have internal organ damage that may pose a high risk of internal bleeding (e.g., active gastric ulcer, cerebral aneurysm [bulging of arterial walls in the brain], or brain tumors).
• If you have experienced cerebral hemorrhage.
• If within the last two months you have suffered trauma or have undergone or are about to undergo surgery to the brain, spinal cord, eyes and/or ears.
• If you are being treated with Ivor, you must not receive epidural or spinal anesthesia (anesthetic injected into the spine), as this may be dangerous. Therefore, make absolutely sure your doctor knows you are being treated with Ivor before undergoing any surgical procedure.

Warnings and precautions
Inform your doctor before using Ivor

• If you suffer from liver disease.
• If you suffer from kidney disease, your doctor may consider special monitoring.
• If you have high blood pressure and/or difficult to control hypertension.
• If you have previously had a gastric ulcer, currently not active.
• If you suffer from thrombocytopenia, a condition in which the number of clotting cells (platelets) is reduced, leading to easy bruising and bleeding.
• If you have kidney and/or bladder stones.
• If you suffer from conditions that may easily cause bleeding.
• If you have eye problems due to vascular causes.
• If you suffer from diabetes.
• If laboratory tests have shown high levels of potassium in your blood.
• Make absolutely certain your doctor knows you are being treated with Ivor if you are about to undergo lumbar puncture (a puncture in the lower part of the spinal cord for diagnostic purposes).

Other medicines and Ivor
Check with your doctor if you think you are taking:

• Any medicine for intramuscular injection, as this type of injection should be avoided during treatment with Ivor.
• Other anticoagulants such as warfarin and/or acenocoumarol (vitamin K antagonists) to treat and/or prevent clot formation.
• Non-steroidal anti-inflammatory drugs such as ibuprofen, for example for arthritis.
• Steroids such as prednisolone, for the treatment of inflammatory diseases such as arthritis.
• Platelet inhibitors such as aspirin, ticlopidine or clopidogrel to prevent clot formation.
• Medicines that may increase potassium levels in the blood, such as certain diuretics (to increase urine production) and antihypertensives (medicines used to reduce blood pressure).
• Medicines that increase blood volume, such as dextran.
• A medicine for injectable use to treat heart conditions, called nitroglycerin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Specific laboratory tests required

• Some patients may need to monitor platelet count. Your doctor will decide whether this is necessary and when (e.g., before treatment, on the first day of treatment, then every 3–4 days, and at the end of treatment).
• If you have certain conditions (diabetes, kidney disease) or are taking medicines that prevent potassium loss, your doctor may decide to monitor your potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivor has no effect on the ability to drive vehicles or operate machinery.

3. How to use Ivor

Always use Ivor exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dosage:

To prevent blood clots in veins during general surgery
Ivor 2,500 is usually administered by a doctor or nurse as a subcutaneous injection (i.e., injected under the skin, typically into a fold of skin on your abdomen or upper thigh). You will receive one dose of the product (the contents of the syringe) before or after surgery. In the following days, you will receive one dose (the contents of one syringe) daily. Your doctor will tell you how long you should continue taking this medicine.

Prevention of clots during hemodialysis
When used in hemodialysis, Ivor 2,500 is usually administered as a single injection (the contents of one syringe) given as a bolus into the arterial line of the dialysis equipment.

Ivor is injected subcutaneously, usually into a skin fold taken around the waist (abdomen) or upper thigh. Usually, the injection is given by a doctor or nurse in hospital, but you may need additional injections once you return home.

• This medicine must never be injected into a muscle, nor mixed with other injections.
• It is usually administered once daily.
• Your doctor will tell you how long you should use it (typically 7–10 days).
• If your doctor has instructed you to self-administer the injection, follow the instructions provided very carefully (see below “How to inject Ivor?”).

Elderly patients (65 years and older):
Elderly patients are usually treated with the same dosage as adults. If you have liver or kidney problems, discuss this with your doctor, who may wish to monitor you more closely.

Use in children (under 18 years):
Ivor is not recommended for use in children.

How to inject Ivor?
Ivor must never be injected into a muscle, as this may cause bleeding into the muscle. Before injecting yourself for the first time, you must be properly informed about the correct use of this medicine and the proper technique for self-injection. These instructions must be provided by a doctor or another qualified healthcare professional.

Follow these steps:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose an area on the abdominal waist, at least 5 centimeters away from the navel and from any scars or bruises, and clean the skin thoroughly.
• Use a different injection site each day; for example, if the first injection is given on the left side, the next should be on the right side.
• Remove the cap from the needle of the Ivor syringe.
• To maintain sterility of the needle, ensure it does not touch anything.
• This pre-filled syringe is now ready for use.
• Do not push the plunger to expel air bubbles from the syringe before injecting, as some of the medicine may be lost.

• Hold the syringe in one hand and, with the other hand, use your thumb and index finger to pinch the cleaned area of skin to form a skin fold.
• Insert the entire needle perpendicularly into the skin fold at a 90° angle.
• Press the plunger while maintaining the skin fold throughout the injection.

• Remove the needle and release the skin fold.
• Do not rub the skin at the injection site. This helps prevent bruising.
• Do not attempt to recap the needle. Dispose of the syringe (with the needle pointing downward) in a sharps container, close it securely, and store it out of the reach of children.
• If you feel the dose is too strong (e.g., sudden bleeding occurs) or too weak (e.g., you feel it is not working), speak to your doctor or pharmacist.

In some packages, the pre-filled syringe may be equipped with a safety device that must be activated after injection to reduce the risk of needle-stick injuries.
For syringes with a safety device: Orient the needle away from yourself and anyone else present, and activate the safety device by firmly pressing the syringe plunger.
The protective shield will automatically cover the needle and produce an audible click, confirming activation of the device.
Immediately after use, dispose of the syringe in the nearest sharps container (with needle attached), close the container lid tightly, and place the container out of the reach of children.

If you use more Ivor than you should
Bleeding may occur. In this case, contact your doctor immediately or go to the nearest Emergency Room, bringing this leaflet with you.

If you forget to use Ivor
Do not use a double dose to make up for the missed dose. Contact your doctor as soon as possible to find out what you should do.

If you stop using Ivor
Always consult your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, Ivor can cause side effects, although not everybody gets them.
Stop using Ivor and contact your doctor or nurse immediately (or go immediately to the nearest
Emergency Department) if you experience any of the following side effects:
Common (may affect up to 1 in 10 people)

• Unusual or unexpected bleeding, for example blood in the urine and/or faeces, which may cause haemorrhagic anaemia.

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

• Severe drop in the number of platelets in the blood (type II thrombocytopenia), which may cause bruising, bleeding from the mouth, gums or nose, rash.
• Dark, painful skin reactions at the injection site (cutaneous necrosis).
• Intraspinal haematomas following spinal or epidural anaesthesia (back pain, numbness and weakness in the legs, intestinal or bladder dysfunction). These haematomas may lead to neurological damage of varying severity, including prolonged or permanent paralysis.
• Serious allergic reactions (high temperature, chills, shortness of breath, swelling of the vocal cords, dizziness, sweating, skin irritation/hives, itching, drop in blood pressure, hot flushes, flushing, loss of consciousness, bronchospasm, swelling of the larynx).

Other side effects
Very common (affects more than 1 in 10 people)

• Bruising, skin spots, itching and pain at the injection site.

Common (may affect up to 1 in 10 people)

• Slight and temporary increase in certain liver enzymes (transaminases), detected by laboratory tests.

Uncommon (may affect up to 1 in 100 people)

• Mild and transient decrease in the number of platelets (type I thrombocytopenia), detected by laboratory tests.
• Mild skin allergic reactions: rash, irritation/hives, sores.

Not known (cannot be estimated from the available data)

• Increased blood potassium levels, detectable by blood tests.

With prolonged use of this medicine or similar medicines, bones may become more fragile (osteoporosis). The frequency of this effect is unknown.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivor

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Do not use this medicine if you notice:

• That the packaging has already been opened.
• That the packaging is damaged.
• That the medicine in the syringe is cloudy.
• That it contains small particles.

Once the blister containing the syringe has been opened, the medicine must be used
immediately.
Expiry
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month indicated.
Disposal
This medicine is supplied in a single-dose syringe.
Dispose of used syringes in a sharps container.
Never store them after use.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ivor contains

• The active substance is bemiparine sodium.
• The excipient is water for injections.

Description of the appearance of Ivor and contents of the pack
The medicinal product contained in the syringes is a clear, colourless or slightly yellow solution, free from solid particles.
Ivor 2.500 IU is available in packs of 2, 6, 10, 30 and 100 pre-filled syringes containing 0.2 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GINELADIUS, S.L.
Rufino González 50,
28037 Madrid, Spain

Manufacturer
ROVI Pharma Industrial Services, S.A.
Julián Camarillo, 35
28037 Madrid – Spain
Laboratorios Farmacéuticos ROVI, S.A.
Julián Camarillo, 35
28037 Madrid – Spain

Marketing Authorisation Holder (for sale): Rovi Biotech, S.R.L. Milano (MI) Viale Papa Achille 30 CAP 20149

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Ivor: Austria, Greece, Italy, Portugal
Zibor: Czech Republic, Estonia, Hungary, Ireland, Latvia, Lithuania, Poland, Slovakia, Slovenia, United Kingdom
Phivor: Spain

Package Leaflet: Information for the User

Ivor 3,500 IU/0.2 mL solution for injection in a pre-filled syringe

bemiparin sodium
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ivor is and what it is used for
2. What you need to know before using Ivor
3. How to use Ivor
4. Possible side effects
5. How to store Ivor
6. Contents of the pack and other information

1. What Ivor is and what it is used for

The active substance of Ivor is bemiparine sodium, which belongs to the class of anticoagulants.
These medicines help prevent blood clotting in blood vessels.
Ivor is used to prevent the formation of dangerous blood clots, for example, in the veins of the legs and/or lungs, which may occur if you undergo orthopedic surgery (hip, knee or other bone surgery). It is also used to prevent blood clots that may form in the dialysis machine.

2. What you need to know before using Ivor

Do not use Ivor

• If you are allergic to bemiparin sodium, heparin, or a similar product (such as enoxaparin, dalteparin, nadroparin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction after taking a medicine containing heparin.
• If you are allergic to any substance of porcine origin.
• If you have Heparin-Induced Thrombocytopenia (HIT), a condition causing a drastic reduction in clotting cells (platelets), (or, as a consequence of HIT, if you have another condition called Disseminated Intravascular Coagulation (DIC), in which platelets would form clots if Ivor were administered).
• If you have a condition known as endocarditis (inflammation of the membrane lining the heart and heart valves).
• If you have any condition that predisposes you to excessive bleeding.
• If you have severe liver and/or pancreatic disease.
• If you have internal organ damage that may pose a high risk of internal bleeding (for example, active gastric ulcer, cerebral aneurysm [bulging of arterial walls in the brain], or brain tumors).
• If you have experienced cerebral hemorrhage.
• If within the last two months you have suffered trauma, or have undergone or are scheduled to undergo surgery involving the brain, spinal cord, eyes, and/or ears.
• If you are being treated with Ivor, you must not receive epidural or spinal anesthesia (anesthetic injected into the spine), as this could be dangerous. Therefore, make absolutely sure your doctor knows you are being treated with Ivor before undergoing any surgical procedure.

Warnings and precautions
Inform your doctor before using Ivor

• If you suffer from liver diseases.
• If you suffer from kidney diseases. If your kidney disease is severe, your doctor may consider a specific dosage for you; however, if the condition is mild or moderate, your doctor may consider special monitoring.
• If you have high blood pressure and/or difficult-to-control hypertension.
• If you have previously had a stomach ulcer, currently inactive.
• If you suffer from thrombocytopenia, a condition in which the number of clotting cells (platelets) is reduced, leading to easy bruising and bleeding.
• If you have kidney and/or bladder stones.
• If you suffer from conditions that may easily cause bleeding.
• If you suffer from eye disorders due to vascular causes.
• If you suffer from diabetes.
• If laboratory tests have shown high levels of potassium in your blood.
• Make absolutely sure your doctor knows you are being treated with Ivor if you are scheduled to undergo a lumbar puncture (spinal tap in the lower part of the spinal cord for diagnostic testing).

Other medicines and Ivor
Check with your doctor if you think you are taking:

• Any medicine for intramuscular injection, as this type of injection should be avoided during treatment with Ivor.
• Other anticoagulants such as warfarin and/or acenocoumarol (vitamin K antagonists) used to treat and/or prevent blood clot formation.
• Non-steroidal anti-inflammatory drugs such as ibuprofen, for example for arthritis.
• Steroids such as prednisolone, used to treat inflammatory diseases such as arthritis.
• Platelet inhibitors such as aspirin, ticlopidine, or clopidogrel used to prevent blood clot formation.
• Medicines that may increase potassium levels in the blood, such as certain diuretics (to increase urine production) and antihypertensives (medicines used to reduce blood pressure).
• Medicines that increase blood volume, such as dextran.
• A medicine for injectable use to treat heart problems, called nitroglycerin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Specific laboratory tests required

• Some patients may need to monitor platelet count. Your doctor will decide whether this is necessary and when (for example, before treatment, on the first day of treatment, then every 3–4 days, and at the end of treatment).
• If you have certain conditions (diabetes, kidney disease) or are taking medicines that prevent potassium loss, your doctor may decide to monitor your potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivor has no effect on the ability to drive vehicles or operate machinery.

3. How to use Ivor

Always use Ivor exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
To prevent blood clots in veins during orthopedic surgery:
Ivor 3.500 is usually administered by a doctor or nurse as a subcutaneous injection (i.e., injected under the skin, typically into a skin fold on your abdomen or upper thigh). You will receive one dose of the product (the contents of the syringe) before or after surgery. On the following days, you will receive one dose (the contents of one syringe) daily. Your doctor will tell you how long you should continue taking this medicine.
Prevention of clots during hemodialysis
When used in hemodialysis, Ivor 3.500 is usually administered as a single dose, in the form of a bolus (the contents of one syringe) injected into the arterial line of the dialysis equipment.
Ivor is injected subcutaneously, usually into a skin fold taken at the waist (abdomen) or upper thigh. Usually, the injection is given by a doctor or nurse in hospital, but you may need additional injections once you return home.

• This medicine must never be injected into a muscle, nor mixed with other injections.
• It is usually administered once daily.
• Your doctor will tell you how long you should use it (generally 7–10 days).
• If your doctor has instructed you to self-administer the injection, follow the instructions provided by your doctor very carefully (see below “How to inject Ivor?”).

Elderly patients (65 years and older): usually treated with the same dose as adults.
If you have liver problems, discuss this with your doctor, who may wish to monitor you more closely.
If you have severe kidney disease, discuss this with your doctor, who may consider a specific dosage for you.
Use in children (under 18 years)
Ivor is not recommended for use in children.
How to inject Ivor?
Ivor must never be injected into a muscle, as this may cause bleeding into the muscle.
Before giving yourself the first injection, you must be properly informed about the correct use of this medicine and the proper technique for self-injection. These instructions must be provided by a doctor or another qualified healthcare professional.
You should follow these steps:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose an area on the abdominal waist, at least 5 centimeters away from the navel and from any scars or bruises, and clean the skin thoroughly.
• For each injection, use a different site; for example, if the first injection was on the left side, the next should be on the right.
• Remove the needle cap from the Ivor syringe.
• To maintain needle sterility, ensure the needle does not touch anything.
• This pre-filled syringe is now ready for use.
• Do not push the plunger to expel air bubbles from the syringe before injection, as some of the medicine may be lost.

• Hold the syringe in one hand and, with the other hand, use your thumb and index finger to pinch the cleaned skin area, creating a skin fold.
• Insert the entire needle perpendicularly into the skin fold, straight at a 90° angle.
• Push the plunger while maintaining the skin fold throughout the injection.

• Remove the needle and release the skin fold.
• Do not rub the skin at the injection site. This will help prevent bruising.
• Do not attempt to recap the needle. Dispose of the syringe (with the needle pointing downward) into a sharps container, close it securely, and store it out of reach of children.
• If you feel the dose was too strong (e.g., sudden bleeding occurs) or too weak (e.g., you feel it is not working), consult your doctor or pharmacist. In some packages, the pre-filled syringe may be equipped with a safety device that should be activated after injection to reduce the risk of needlestick injuries. For syringes with a safety device: Orient the needle away from yourself and anyone nearby, then activate the safety device by firmly pressing the syringe plunger. The protective sleeve will automatically cover the needle and produce an audible click, confirming activation of the device. Immediately after use, dispose of the syringe into the nearest sharps container (with needle attached), securely close the container lid, and store it out of reach of children.

If you use more Ivor than you should
Bleeding may occur. In this case, you must contact your doctor immediately or go to the nearest Emergency Room, bringing this leaflet with you.
If you forget to use Ivor
Do not use a double dose to make up for the missed dose. Consult your doctor as soon as possible for advice.
If you stop using Ivor
Always consult your doctor before stopping treatment with this medicine.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Ivor can cause side effects, although not everybody will experience them.
Stop using Ivor and speak immediately to your doctor or nurse (or go immediately to the nearest
Emergency Department) if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• Unusual or unexpected bleeding, for example blood in the urine and/or stools, which may cause hemorrhagic anemia.

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

• Severe drop in the number of platelets in the blood (type II thrombocytopenia), which may cause bruising, bleeding from the mouth, gums, or nose, and rash.
• Painful, dark skin reactions at the injection site (cutaneous necrosis).
• Intraspinal hematomas following spinal or epidural anesthesia (back pain, numbness and weakness in the legs, intestinal or bladder dysfunction). These hematomas may lead to neurological damage of varying severity, including prolonged or permanent paralysis.
• Serious allergic reactions (high temperature, chills, shortness of breath, swelling of the vocal cords, dizziness, sweating, skin irritation/hives, itching, drop in blood pressure, hot flushes, redness, loss of consciousness, bronchospasm, swelling of the larynx).

Other side effects
Very common (affects more than 1 in 10 people)

• Bruising, skin spots, itching, pain at the injection sites.

Common (may affect up to 1 in 10 people)

• Mild and temporary increase in certain liver enzymes (transaminases), detected by laboratory tests.

Uncommon (may affect up to 1 in 100 people)

• Mild and transient decrease in platelet count (type I thrombocytopenia), detected by laboratory tests.
• Mild skin allergic reactions: rash, irritation/hives, sores.

Not known (cannot be estimated from available data)

• Increased blood potassium levels detectable by blood tests.

With prolonged use of this medicine or similar medicines, bones may become more fragile (osteoporosis). The frequency of this effect is unknown.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects via:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivor

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Do not use this medicine if you notice:

• That the packaging has already been opened.
• That the packaging is damaged.
• That the medicine in the syringe is cloudy.
• That it contains small particles.

Once the blister containing the syringe has been opened, the medicine must be used
immediately.
Expiry
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month indicated.
Disposal
This medicine is supplied in a single-dose syringe.
Dispose of used syringes in a sharps container.
Never store them after use.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Ivor contains

• The active substance is bemiparin sodium.
• The excipient is water for injections.

Description of the appearance of Ivor and contents of the pack
The medicinal product contained in the syringes is a clear, colourless or slightly yellow solution, free from solid particles.
Ivor 3,500 IU is available in packs containing 2, 6, 10, 30 and 100 pre-filled syringes with 0.2 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GINELADIUS, S.L.
Rufino González 50,
28037 Madrid, Spain

Manufacturer
ROVI Pharma Industrial Services, S.A.
Julián Camarillo, 35
28037 Madrid – Spain
Laboratorios Farmacèuticos ROVI, S.A.
Julián Camarillo, 35
28037 Madrid – Spain

Distribution Authorisation Holder: Rovi Biotech, S.R.L. Milano (MI) Viale Papa Achille 30 CAP 20149

This medicinal product is authorised in the European Economic Area countries under the following names:
Ivor: Austria, Greece, Italy, Portugal
Zibor: Czech Republic, Estonia, Hungary, Ireland, Latvia, Lithuania, Poland, Slovakia, Slovenia, United Kingdom
Phivor: Spain

Package Leaflet: Information for the User

Ivor 25,000 IU/mL solution for injection in pre-filled syringe

bemiparin sodium
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ivor is and what it is used for
2. What you need to know before using Ivor
3. How to use Ivor
4. Possible side effects
5. How to store Ivor
6. Contents of the pack and other information

1. What Ivor is and what it is used for

The active substance of Ivor is bemiparin sodium, which belongs to the class of anticoagulants.
These medicines help prevent blood clotting in blood vessels.
Ivor is used to prevent the formation of dangerous blood clots, for example, in the veins of the legs and/or lungs (deep vein thrombosis and/or pulmonary embolism).

2. What you need to know before using Ivor

Do not use Ivor

• If you are allergic to bemiparin sodium, heparin, or a similar product (such as enoxaparin, dalteparin, nadroparin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction after taking a medicine containing heparin.
• If you are allergic to any substance of porcine origin.
• If you have Heparin-Induced Thrombocytopenia (HIT), a condition causing a drastic reduction in the number of clotting cells (platelets), (or, as a consequence of HIT, you have another condition called Disseminated Intravascular Coagulation (DIC), in which platelets would form clots if Ivor were administered).
• If you have a condition known as endocarditis (inflammation of the membrane lining the heart and heart valves).
• If you have any condition that predisposes you to excessive bleeding.
• If you have severe liver and/or pancreatic disease.
• If you have internal organ damage that may pose a high risk of internal bleeding (for example, active gastric ulcer, cerebral aneurysm [bulging of the arterial walls in the brain], or brain tumors).
• If you have experienced cerebral hemorrhage.
• If within the last two months you have suffered trauma or have undergone or are about to undergo surgery to the brain, spinal cord, eyes and/or ears.
• If you are being treated with Ivor, you must not receive epidural or spinal anesthesia (anesthetic injected into the spine), as this could be dangerous. Therefore, make absolutely sure your doctor knows you are being treated with Ivor before undergoing any surgical procedure.

Warnings and precautions
Inform your doctor before using Ivor

• If you suffer from liver diseases.
• If you suffer from kidney diseases. If your kidney disease is severe, your doctor may consider a specific dose for you; however, in case of mild or moderate kidney disease, your doctor may consider regular monitoring.
• If you have high blood pressure and/or blood pressure that is difficult to control.
• If you have previously had a stomach ulcer, currently inactive.
• If you suffer from thrombocytopenia, a condition in which the number of clotting cells (platelets) is reduced, leading to easy bruising and bleeding.
• If you have kidney and/or bladder stones.
• If you suffer from conditions that may easily cause bleeding.
• If you have eye problems due to vascular causes.
• If you suffer from diabetes.
• If laboratory tests have shown high levels of potassium in your blood.
• Make absolutely sure your doctor knows you are being treated with IVOR if you are about to undergo a lumbar puncture (a puncture in the lower part of the spinal cord for diagnostic purposes).

Other medicines and Ivor
Check with your doctor if you think you are taking:

• Any medicine for intramuscular injection, as this type of injection should be avoided during treatment with Ivor.
• Other anticoagulants such as warfarin and/or acenocoumarol (vitamin K antagonists) to treat and/or prevent clot formation.
• Non-steroidal anti-inflammatory drugs such as ibuprofen, for example for arthritis.
• Steroids such as prednisolone, for the treatment of inflammatory diseases such as arthritis.
• Platelet inhibitors such as aspirin, ticlopidine, or clopidogrel to prevent clot formation.
• Medicines that may increase potassium levels in the blood, such as certain diuretics (to increase urine production) and antihypertensives (medicines used to reduce blood pressure).
• Medicines that increase blood volume, such as dextran.
• A medicine for injectable use to treat heart problems, called nitroglycerin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Specific laboratory tests required

• Some patients may need to monitor platelet count. Your doctor will decide whether this is necessary and when (for example before treatment, on the first day of treatment, then every 3–4 days, and at the end of treatment).
• If you have certain conditions (diabetes, kidney diseases) or if you are taking medicines that prevent potassium loss, your doctor may decide to monitor your potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivor has no effect on the ability to drive vehicles or operate machinery.

3. How to use Ivor

Always use Ivor exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Adults (18–64 years)
Your daily injection dose depends on your body weight. If you weigh:

• Less than 50 kg: the dose is 0.2 millilitres (= 5,000 IU)
• Between 50 and 70 kg: the dose is 0.3 millilitres (= 7,500 IU)
• Between 71 and 100 kg: the dose is 0.4 millilitres (= 10,000 IU)
• More than 100 kg: the dose should be adjusted according to your exact body weight, calculating 115 IU per day for each kilogram of body weight.

IU: The potency of this medicinal product is expressed in International anti-Xa Units.
Ivor is administered by subcutaneous injection, usually into a skin fold taken at the waist (abdomen) or upper thigh. Usually, the injection is given by a doctor or nurse in hospital, but you may need additional injections once you return home.

• This medicine must never be injected into muscle, nor mixed with other injections.
• It is usually administered once daily.
• Your doctor will tell you how long you should use it (typically 5–9 days).
• If your doctor has instructed you to self-administer the injection, follow carefully the instructions provided by your doctor (see below “How to inject Ivor?”).

Elderly patients (65 years and older): usually treated with the same dosage as adults.
If you have liver problems, discuss this with your doctor, who may wish to monitor you more closely.
If you have severe kidney disease, please inform your doctor, who may consider a specific dosage.
Use in children (under 18 years)
IVOR is not recommended for use in children.

How to inject IVOR?
Ivor must never be injected into muscle, as this may cause muscle bleeding.
Before self-injecting for the first time, you must be properly informed about the correct use of this medicine and the proper technique for self-injection. This instruction must be provided by a doctor or another qualified healthcare professional.
Follow these steps:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose an area of the abdominal waist, at least 5 centimetres away from the navel, scars, or bruises, and clean the skin thoroughly.
• Use a different injection site each day; for example, if the first injection is given on the left side, the next should be on the right side.
• Remove the cap from the needle of the Ivor pre-filled syringe.
• To maintain needle sterility, ensure the needle does not touch anything.
• This pre-filled syringe is now ready for use.
• Do not push the plunger to expel any air bubbles from the syringe before injection, as some medicine may be lost.

• Hold the syringe in one hand and, with the other hand, use your thumb and index finger to pinch the cleaned area of skin to create a skin fold.
• Insert the entire needle perpendicularly into the skin fold at a 90° angle.
• Push the plunger while maintaining the skin fold throughout the injection.

• Remove the needle and release the skin fold.
• Do not rub the skin at the injection site. This helps prevent bruising.
• Do not attempt to recap the needle. Dispose of the syringe (with the needle pointing downward) into a sharps container, close it tightly, and store it out of the reach of children.
• If you feel the dose is too strong (e.g., sudden bleeding occurs) or too weak (e.g., you feel it is not working), speak to your doctor or pharmacist. In some packages, the pre-filled syringe may be equipped with a safety device that should be activated after injection to reduce the risk of needle-stick injuries. For syringes with a safety device: orient the needle away from yourself and others, then activate the safety device by firmly pressing the syringe plunger. The protective shield will automatically cover the needle and produce an audible click confirming activation. Immediately after use, dispose of the syringe in the nearest sharps container (with the needle still attached), close the container lid securely, and keep it out of children's reach.

If you use more Ivor than you should
Bleeding may occur. In this case, contact your doctor immediately or go to the nearest Emergency Department, taking this leaflet with you.

If you forget to use Ivor
Do not use a double dose to make up for the missed dose. Contact your doctor as soon as possible for advice on what to do.

If you stop using Ivor
Always consult your doctor before stopping treatment with this medicine.
If you have any doubts about how to use this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using IVOR and contact your doctor or nurse immediately (or go immediately to the nearest Emergency Department) if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• Unusual or unexpected bleeding, for example blood in the urine and/or in the stool, which may cause haemorrhagic anaemia.

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

• Severe drop in the number of platelets in the blood (type II thrombocytopenia), which may cause bruising, bleeding from the mouth, gums or nose, rash.
• Painful, dark skin reactions at the injection site (skin necrosis).
• Intraspinal haematomas following spinal or epidural anaesthesia (back pain, numbness and weakness in the legs, intestinal or bladder dysfunction). These haematomas may lead to neurological damage of varying severity, including prolonged or permanent paralysis.
• Serious allergic reactions (high temperature, chills, shortness of breath, swelling of the vocal cords, dizziness, sweating, skin irritation/urticaria, itching, drop in blood pressure, hot flushes, redness, loss of consciousness, bronchospasm, swelling of the larynx).

Other side effects
Very common (affects more than 1 in 10 people)

• Bruising, skin spots, itching and pain at the injection sites of the medicine.

Common (may affect up to 1 in 10 people)

• Slight and temporary increase in certain liver enzymes (transaminases), detected by laboratory tests.
• Pain at the injection sites of the medicine.

Uncommon (may affect up to 1 in 100 people)

• Mild and transient decrease in platelet count (type I thrombocytopenia), detected by laboratory tests.
• Mild skin allergic reactions: rash, irritation/urticaria, sores.

Not known (cannot be estimated from the available data)

• Increased levels of potassium in the blood, detectable by blood tests.

With prolonged use of this medicine or similar medicines, bones may become more fragile (osteoporosis). The frequency of this effect is unknown.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivor

Keep Ivor out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use this medicine if you notice:

• That the packaging has already been opened.
• That the packaging is damaged.
• That the solution in the syringe is cloudy.
• That it contains small particles. Once the blister containing the syringe has been opened, the medicine must be used immediately.

Expiry
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month indicated.
Disposal
This medicine is supplied in a single-dose syringe.
Dispose of used syringes in a sharps container.
Never store them after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ivor contains

• The active substance is bemiparin sodium.
• The excipient is water for injections.

Description of the appearance of Ivor and contents of the pack
The medicinal product contained in the syringes is a clear, colourless or slightly yellow solution, free from particles.
Ivor 25,000 IU is available in packs of 2, 10, 30 and 100 pre-filled syringes containing 0.2 mL, 0.3 mL or 0.4 mL of injectable solution.
Not all pack sizes may be marketed.
Each 0.2 mL syringe delivers a dose of 5,000 IU of bemiparin sodium.
Each 0.3 mL syringe delivers a dose of 7,500 IU of bemiparin sodium.
Each 0.4 mL syringe delivers a dose of 10,000 IU of bemiparin sodium.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GINELADIUS, S.L.
Rufino González 50,
28037 Madrid, Spain

Manufacturer
ROVI Pharma Industrial Services, S.A.
Julián Camarillo, 35.
28037 Madrid - Spain
Laboratorios Farmacèuticos ROVI, S.A.
Julián Camarillo, 35.
28037 Madrid – Spain

Selling Agent: Rovi Biotech, S.R.L. Milano (MI) Viale Papa Achille 30 CAP 20149

This medicinal product is authorised in the European Economic Area Member States under the following names:
Ivor: Italy, Portugal
Zibor: Czech Republic, Estonia, Ireland, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, United Kingdom.
Phivor: Spain