Zibor

Package Leaflet: Information for the User

Zibor 2 500 IU anti-Xa/0.2 mL solution for injection in a pre-filled syringe

Bemiparin sodium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Zibor and what is it used for

Zibor contains bemiparin sodium as the active substance and belongs to a group of anticoagulant medicines that prevent blood clotting in blood vessels. Zibor is used to prevent thromboembolic disease (e.g., deep vein thrombosis and pulmonary embolism) in patients undergoing surgical procedures and to prevent clotting in extracorporeal circulation during hemodialysis.

2. Important information before using Zibor

When not to use Zibor:

• If you are allergic to bemiparin sodium, heparin, or similar products (such as enoxaparin, dalteparin, nadroparin) or any of the other ingredients of this medicine (listed in section 6).
• If you have had an allergic reaction after administration of any heparin-containing medicine.
• If you are allergic to any substance derived from pigs.
• If you have heparin-induced thrombocytopenia (HIT), a condition that causes a significant decrease in platelet count or the occurrence of disseminated intravascular coagulation (DIC) syndrome during HIT, in which platelet aggregation occurs after administration of Zibor.
• If you have a condition known as endocarditis (inflammation of the heart lining and heart valves).
• If you have a tendency to bleed excessively.
• If you have severe liver and/or pancreatic disease.
• If you have any internal organ damage that may increase the risk of internal bleeding (e.g., active gastric ulcer, brain arteriovenous malformations, brain tumors).
• If you have had intracranial bleeding.
• If you have had a spinal or eye surgery, or if such surgery is planned within the last two months.

of the spine, eyes, and/or ears, or if such surgery is planned.

• During treatment with Zibor, do not use spinal or epidural anesthesia, as this may be hazardous. Therefore, inform your doctor about treatment with Zibor before undergoing surgery.

Warnings and precautions

Before starting treatment with Zibor, discuss it with your doctor.

• If you have liver disease.
• In case of kidney function disorders, your doctor may decide to monitor you closely.
• If you have high blood pressure or uncontrolled hypertension.
• If you have had gastric or duodenal ulcer, and it is no longer present.
• If you have thrombocytopenia, a disorder characterized by a decrease in platelet count, which makes it easy to develop bruises and bleeding.
• If you have kidney or urinary stones.
• If you have any other conditions that increase the risk of bleeding.
• If you have eye diseases caused by vascular disease.
• If you have diabetes.
• If your blood tests show an increased potassium level in the blood.
• Make sure your doctor is informed about your use of Zibor if you are scheduled for a lumbar puncture (a procedure that involves inserting a needle into the lower spine to collect cerebrospinal fluid for laboratory tests).

Zibor and other medicines

Inform your doctor if you are taking any of the following medicines:

• any medicine administered intramuscularly, as you should avoid using intramuscularly administered medicines during treatment with Zibor,
• other anticoagulant medicines, such as warfarin and/or acenocoumarol (vitamin K antagonists) used to treat and/or prevent thrombotic disorders,
• non-steroidal anti-inflammatory medicines, such as ibuprofen, used to treat arthritis,
• corticosteroid medicines, such as prednisolone, used to treat inflammatory diseases, such as arthritis,
• platelet aggregation inhibitors, such as acetylsalicylic acid, ticlopidine, or clopidogrel, used to prevent thrombotic disorders,
• medicines that increase potassium levels in the blood, such as diuretics (urinary medicines) and antihypertensive medicines (used to lower blood pressure),
• medicines that increase blood volume, such as dextran,
• intravenous nitroglycerin used to treat heart diseases.

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Lab tests

• In some patients, it may be necessary to determine the platelet count. Your doctor will decide whether this is necessary and when (e.g., before starting treatment, on the first day of therapy, and then regularly every 3 to 4 days, as well as at the end of treatment).
• In case of certain diseases (diabetes, kidney disease) or if you are taking potassium-sparing medicines, your doctor may decide to have your blood potassium levels checked.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Zibor does not affect your ability to drive or use machines.

3. How to use Zibor

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose:
Surgical procedures with a high risk of venous thromboembolic disease.

• Zibor 2 500 is usually administered by a doctor or nurse, subcutaneously (this means that the medicine is injected under the skin, usually into the fatty tissue of the abdomen or the top of the thigh). Usually, one dose of the medicine (the contents of the pre-filled syringe) is administered before or after the surgical procedure. In subsequent days, one dose of the medicine (the contents of the pre-filled syringe) is administered daily. Your doctor will inform you about the duration of treatment.

Prevention of clotting in extracorporeal circulation during hemodialysis:

• In patients undergoing hemodialysis, Zibor 2 500 is usually administered as a single bolus dose (the contents of the pre-filled syringe) into the arterial line of the dialysis equipment.

Zibor is usually injected under the skin, into the fatty tissue of the abdomen or the top of the thigh. In the hospital, the medicine is administered by a doctor or nurse. After discharge from the hospital, it may be necessary to continue treatment with Zibor at home.

• Zibor must not be administered intramuscularly or mixed with other intramuscularly administered medicines.
• The medicine is usually administered once a day.
• Your doctor will inform you about the duration of treatment (usually for about 7-10 days).
• If your doctor has instructed you to administer the medicine yourself, follow the doctor's instructions carefully (see below: "How to inject Zibor?").

Use in elderly patients (65 years and older):usually, there is no need to change the dose. In case of liver or kidney function disorders, inform your doctor, who may decide to monitor you closely.
Use in children and adolescents (under 18 years):Zibor is not recommended for use in children.

How to inject Zibor?

Zibor must never be administered intramuscularly, as this may cause muscle bleeding.
Before the first self-administration of the injection, the patient should receive detailed instructions on the proper injection technique. The instructions should be provided to the patient by a doctor or qualified medical staff.
Follow the instructions below:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Choose a place on the anterior or posterior abdominal wall, avoiding the area around the navel and areas with scars or bruising, and clean the skin thoroughly.
• For each injection, choose a different place, e.g., alternating between the left and right sides.
• Remove the cap from the Zibor pre-filled syringe.
• To maintain the sterility of the needle, do not touch it to any surface.
• The pre-filled syringe is ready for use.
• Before injection, do not press the plunger to remove air bubbles, as this may result in loss of medicine.

• Holding the pre-filled syringe in one hand, use your thumb and index finger of the other hand to gently hold the cleaned skin area, creating a skin fold.
• Insert the entire length of the needle into the thick part of the skin fold at a 90-degree angle.
• Press the plunger while holding the skin fold throughout the injection.

• Remove the needle by pulling it straight up and release the skin fold.
• Do not rub the injection site. This will help avoid bruising.
• Do not replace the cap on the pre-filled syringe. Dispose of it (with the needle down) in a sharps container, close it tightly, and keep it out of the reach of children.
• If you feel that the effect of the medicine is too strong (e.g., if unexpected bleeding occurs) or too weak (lack of improvement), inform your doctor or pharmacist.

In some pack sizes, the pre-filled syringe may be connected to a safety system, which is designed to be activated after administration to reduce the risk of needlestick injury.
For the pre-filled syringe with a safety system: Point the needle away from yourself and others, and activate the safety system by pressing the plunger firmly. The protective sleeve will automatically cover the needle, and a clicking sound will confirm the activation of the device.
Immediately dispose of the pre-filled syringe in the nearest sharps container (with the needle down), close it tightly, and keep it out of the reach of children.

Overdose of Zibor

Administration of too high a dose of the medicine may cause bleeding. If bleeding occurs, immediately inform your doctor or go to the nearest hospital with this package leaflet.

Missed dose of Zibor

Do not take a double dose to make up for a missed dose. Consult your doctor as soon as possible.

Stopping treatment with Zibor

Before stopping treatment with Zibor, always consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

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

If you experience any of the following side effects, stop using Zibor and inform your doctor or nurse (or go to the nearest hospital emergency department) immediately:

Common (may affect up to 1 in 10 people):

• Bleeding complications, e.g., blood in urine and/or stool, which may cause hemorrhagic anemia.

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

• Significant decrease in platelet count (type II thrombocytopenia) leading to bruising, bleeding in the mouth, from the gums, and nose, as well as rash.
• Dark, painful changes at the injection site (skin necrosis).
• Hematomas in the spine after spinal or epidural anesthesia, or lumbar puncture (back pain, feeling of strength and sensation loss in the lower limbs, bowel or bladder function disorders), leading to neurological damage of varying severity, including transient or long-term paralysis.
• Severe allergic reactions (fever, chills, shortness of breath, laryngeal edema, feeling of loss of consciousness, sweating, urticaria, itching, hypotension, flushing, rash, loss of consciousness, bronchospasm, laryngeal edema).

Other side effects:

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

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

Common (may affect up to 1 in 10 people):

• Mild and transient increase in certain enzymes (aminotransferases) visible in laboratory tests.

Uncommon (may affect up to 1 in 100 people):

• Mild and transient decrease in platelet count (type I thrombocytopenia) visible in laboratory tests.
• Mild skin allergic reactions: rash, urticaria, streaks on the skin.

Frequency not known (cannot be estimated from the available data):

• Increased potassium levels in the blood visible in laboratory tests.

Long-term use of Zibor or similar medicines may cause osteoporosis. The frequency is not known.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zibor

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 protective packaging has been opened.
• that the protective packaging has been damaged.
• that the contents of the pre-filled syringe are cloudy.
• that it contains small particles.

After opening the packaging containing the Zibor pre-filled syringe, use it immediately.

Expiration date

Do not use this medicine after the expiration date stated on the carton. The expiration date refers to the last day of the month.

Disposal

Single-dose container.
Dispose of used pre-filled syringes in a sharps container.
Do not keep used pre-filled syringes.
Do not throw away medicines 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 pack and other information

What Zibor contains

• The active substance is bemiparin sodium.
• The other ingredient is water for injections.

What Zibor looks like and contents of the pack

Zibor is a colorless or slightly yellowish, clear solution, without solid particles.
Zibor 2 500 IU is available in packs containing 2, 6, 10, 30, and 100 pre-filled syringes, each containing 0.2 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GINELADIUS, S.L.
Rufino González 50,
28037 Madrid, Spain
+(34) 91 375 62 30

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Phivor:Spain.
Ivor:Austria, Greece, Italy, Portugal.
Zibor:Czech Republic, Estonia, Hungary, Ireland, Latvia, Lithuania, Poland, Slovakia, Slovenia, United Kingdom.

Date of last revision of the package leaflet: