Zibor

Package leaflet: Information for the user

Zibor 3 500 IU anti-Xa/0.2 mL solution for injection in pre-filled syringe
Bemiparinum natricum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Zibor is and what it is 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 Zibor is and what it is used for

Zibor contains bemiparin sodium as the active substance and belongs to a group of medicines called anticoagulants, which prevent blood from clotting in blood vessels.
Zibor is used for the prophylaxis of venous thromboembolic disease (e.g. deep vein thrombosis and pulmonary embolism) in patients undergoing orthopaedic surgery (hip, knee or other bone surgery), and for the prevention of clotting in extracorporeal circulation during haemodialysis.

2. Important information before using Zibor

When not to use Zibor:

• If the patient is 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 the patient has had an allergic reaction after receiving any medicine containing heparin.
• If the patient is allergic to any substance derived from pigs.
• If the patient has heparin-induced thrombocytopenia (HIT), a condition causing a significant decrease in platelet count, or disseminated intravascular coagulation (DIC) occurring in the course of HIT, in which administration of Zibor leads to platelet aggregation.
• If the patient has a condition known as endocarditis (inflammation of the inner lining of the heart and heart valves).
• If the patient has a tendency to severe bleeding.
• If the patient has a serious liver and/or pancreatic disease.
• If the patient has any conditions with a high risk of internal bleeding (e.g. active peptic ulcer, cerebral aneurysms and angiomas [swelling of cerebral arterial walls], brain tumors).
• If the patient has experienced intracranial bleeding.
• If the patient has had trauma or surgery involving the brain, spine, eyes, and/or ears within the last two months, or if such a procedure is planned.
• During treatment with Zibor, spinal anesthesia (epidural or intrathecal anesthesia prior to surgery) must not be used, as this may be dangerous. Therefore, the doctor must be informed about treatment with Zibor before any surgical procedure.

Warnings and precautions
Before starting treatment with Zibor, discuss this with your doctor.

• If the patient has liver disease.
• In case of impaired kidney function. The doctor may decide to initiate close monitoring. If the patient suffers from severe kidney disease, the doctor may recommend special dosing instructions.
• If the patient has high blood pressure that is uncontrolled.
• If the patient has a history of gastric and/or duodenal ulcer disease, even if currently inactive.
• If the patient has thrombocytopenia—a disorder characterized by reduced platelet count (clotting cells), leading to easy bruising and bleeding.
• If the patient has kidney and/or urinary stones.
• If the patient has any other medical conditions that increase the risk of bleeding.
• If the patient has eye diseases caused by vascular disorders.
• If the patient has diabetes.
• If blood tests show elevated potassium levels in the blood.
• Ensure that the doctor is fully informed about the patient's treatment with Zibor if a lumbar puncture (spinal tap to collect cerebrospinal fluid for laboratory testing) is planned.

Zibor and other medicines
Inform the doctor if the patient is taking any of the following medicines:

• Any medicine administered intramuscularly, as intramuscular injections should be avoided during treatment with Zibor.
• Other anticoagulant medicines, such as warfarin and/or acenocoumarol (vitamin K antagonists) used in the treatment/prevention of thrombotic disorders.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, used, for example, in the treatment of arthritis.
• Steroid medicines, such as prednisolone, used in the treatment of inflammatory diseases, e.g. arthritis.
• Medicines that inhibit platelet aggregation, such as acetylsalicylic acid, ticlopidine, or clopidogrel, used to prevent thrombotic disorders.
• Medicines that increase serum potassium levels, such as diuretics (water pills) and antihypertensive medicines (used to lower blood pressure).
• Medicines that increase blood volume, such as dextran.
• Intravenous nitroglycerin, used in the treatment of heart disease.

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Laboratory tests

• Some patients may require monitoring of platelet count. The doctor will decide whether this is necessary and when (e.g. before starting treatment, on the first day of therapy, then regularly every 3 to 4 days, and at the end of treatment).
• If the patient has certain conditions (e.g. diabetes, kidney disease) or is taking potassium-sparing medicines, the doctor may decide to order a blood test to measure potassium levels.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Zibor does not affect the ability to drive or operate machinery.

3. How to use Zibor

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Recommended dose:
Surgical procedures with a high risk of venous thromboembolic disease.

• Zibor 3 500 is usually administered by a doctor or nurse as a subcutaneous injection (meaning the medicine is injected under the skin, usually into a skin fold on the patient's abdomen or upper thigh). Usually, one dose (the contents of the pre-filled syringe) is given before or after surgery. In the following days, one dose (the contents of the pre-filled syringe) is administered daily. Your doctor will inform you how long the treatment should last.

Prophylaxis of clotting in extracorporeal circulation during hemodialysis:

• For patients undergoing hemodialysis, Zibor 3 500 is usually administered as a single bolus dose (the contents of the pre-filled syringe) into the arterial line of the dialysis device.

Zibor is usually injected subcutaneously into a skin fold on the abdomen or upper thigh. In
hospital, the medicine is administered by a doctor or nurse. After discharge from hospital,
continuation of Zibor treatment at home may be necessary.

• Zibor must not be injected intramuscularly or mixed with other medicines intended for intramuscular administration.
• The medicine is usually administered once daily.
• Your doctor will inform you how long the treatment should last (usually for about 7–10 days).
• If your doctor has instructed you to self-administer the medicine, strictly follow the doctor's instructions (see below: "How to inject Zibor?").

Use in elderly patients (aged 65 years and above): no dosage adjustment is required compared
to other adult patients. In case of liver function disorders, inform your doctor, who may decide to
initiate close monitoring. In case of kidney function disorders, inform your doctor, who may
decide to initiate close monitoring. If the patient suffers from severe kidney disease, the doctor
may recommend special dosing instructions.
Use in children and adolescents (under 18 years of age): Zibor is not recommended for use in
children.
How to inject Zibor?
Zibor must never be injected intramuscularly, as this may cause bleeding into the muscles.
Before the first self-injection, the patient should receive detailed instructions on the correct
injection technique. These instructions should be provided by the doctor or qualified medical
personnel.
Follow the instructions below:

• Wash your hands thoroughly and sit or lie down in a comfortable position.
• Select a site on the front-lateral or back-lateral part of the abdomen, avoiding the area within 5 cm of the navel and any areas with scars or bruises, and clean the skin thoroughly.
• For each injection, choose a different site, e.g., alternating between the left and right side.
• Remove the cap from the Zibor pre-filled syringe.
• To maintain 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, gently pinch the cleaned area of skin with the thumb and index finger of the other hand to form a skin fold.
• Insert the entire length of the needle into the thick part of the skin fold at a 90° angle.
• Press the plunger while maintaining the skin fold throughout the injection.

• Remove the needle by pulling it straight out vertically and release the skin fold.
• Do not rub the injection site. This will help prevent bruising.
• Do not recap the pre-filled syringe. Dispose of it (needle pointing down) into a sharps container, close the container tightly, and store it out of the reach of children.
• If you feel the medicine's effect is too strong (e.g., unexpected bleeding occurs) or too weak (no improvement), inform your doctor or pharmacist.

In certain package sizes, the pre-filled syringe may be equipped with a safety system that
activates after administration to reduce the risk of needlestick injury.
For syringes with a safety system: Direct the needle away from yourself and others, then firmly
press the plunger to activate the safety mechanism. The protective sleeve will automatically
cover the needle, and a clicking sound will confirm activation. Immediately dispose of the
syringe into the nearest sharps container (needle pointing down), close the lid tightly, and
place the container out of the reach of children.
Use of more than the recommended dose of Zibor
Administering too high a dose of the medicine may cause bleeding. If bleeding occurs, inform
your doctor immediately or go to the nearest hospital with this leaflet.
Missed dose of Zibor
Do not administer a double dose to make up for a missed dose. Consult your doctor as soon as
possible.
Stopping Zibor treatment
Always consult your doctor before discontinuing Zibor.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, stop using Zibor immediately and inform your doctor or nurse (or go immediately to the nearest hospital emergency department):

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

• Bleeding complications, e.g. blood in urine and/or stool, which may lead to haemorrhagic anaemia.

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

• Significant decrease in platelet count (type II thrombocytopenia) leading to bruising, bleeding from the mouth, gums and nose, and rash.
• Dark, painful skin lesions at the injection site (skin necrosis).
• Spinal haemorrhage following epidural, intrathecal anaesthesia or lumbar puncture (back pain, sensation of loss of strength and sensation in the lower limbs, intestinal or urinary bladder dysfunction), leading to neurological damage of varying severity, including transient or long-lasting paralysis.
• Severe allergic reactions (fever, chills, shortness of breath, laryngeal oedema, feeling of losing consciousness, sweating, urticaria, itching, drop in blood pressure, hot flushes, skin eruptions, loss of consciousness, bronchospasm, laryngeal oedema).

Other adverse reactions:
Very common (may affect more than 1 in 10 patients):

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

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

• Mild and transient increase in certain liver enzymes (aminotransferases), detectable in laboratory tests.

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

• Mild and transient decrease in platelet count (type I thrombocytopenia), detectable in laboratory tests.
• Mild skin allergic reactions: rash, urticaria, skin erythema.

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

• Increased blood potassium levels, detectable in laboratory tests.

Prolonged use of Zibor or of medicines with similar properties may lead to osteoporosis. The frequency of occurrence is unknown.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zibor medication

Keep the medicine out of 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 is damaged.
• that the contents of the pre-filled syringe are cloudy.
• that it contains small particles.

After opening the package containing the pre-filled syringe, Zibor must be used immediately.
Expiry date
Do not use Zibor after the expiry date stated on the carton after "Expiry date".
The expiry date refers to the last day of the stated month.
Disposal
Single-dose container.
Used pre-filled syringes must be disposed of in a sharps container.
Do not keep used pre-filled syringes.
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 Zibor contains

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

What Zibor looks like and contents of the pack
The medicine in the pre-filled syringe is a colourless or slightly yellowish, clear solution, free from particles.
Zibor 3,500 IU is available in packs containing 2, 6, 10, 30 and 100 pre-filled syringes with 0.2 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised for marketing in 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.