Zibor

Package leaflet: Information for the user

Zibor 25,000 IU anti-Xa/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, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, 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 25,000 IU anti-Xa/mL containing bemiparin sodium (Bemiparinum natricum) as the active substance, belongs to a group of anticoagulant medicines known as low molecular weight heparins, which prevent blood from clotting in blood vessels.
Zibor is used to treat blood clots in the veins of the legs and (or) lungs (deep vein thrombosis (or) pulmonary embolism).

2. Important information before using Zibor

When not to use Zibor:

• If the patient is allergic to sodium bemiparin, 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 in which the number of blood platelets decreases and platelets clump together after administration of Zibor, or disseminated intravascular coagulation (DIC) associated with reduced platelet count.
• If the patient has a known condition called 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 severe liver and/or pancreatic insufficiency.
• If the patient has any lesions with a high risk of bleeding (e.g. active peptic ulcer, cerebral aneurysms or arteriovenous malformations [swelling of cerebral artery walls], brain tumors).
• If the patient has experienced intracranial bleeding.
• If the patient has suffered trauma or surgery involving the brain, spine, eyes,

and/or ears.

• During treatment with Zibor, spinal or epidural anaesthesia must not be used, as this may be dangerous. Therefore, inform your doctor about Zibor treatment before undergoing any surgical procedure.

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

• If the patient has liver insufficiency.
• If the patient has impaired kidney function. The doctor may decide to carry out 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 not controlled by treatment.
• If the patient has a history of gastric or duodenal ulcer disease, even if currently inactive.
• If the patient has thrombocytopenia – a disorder in which there is a low number of blood platelets (clotting cells), leading to easy bruising and bleeding.
• If the patient has kidney and/or urinary stones.
• If the patient has any other organic disorders associated with an increased risk of hemorrhagic complications.
• If the patient has eye diseases (affecting blood vessels).
• If the patient has diabetes.
• If blood tests show elevated potassium levels in the blood.
• Ensure that the doctor is adequately informed about any planned lumbar puncture (spinal tap in the lower spine to collect cerebrospinal fluid for laboratory testing).

Zibor and other medicines
Inform your doctor if you are 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 or prevention of thrombotic disorders.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, used, for example, in treating joint inflammation.
• Steroid medicines, such as prednisolone, used in treating inflammatory diseases, e.g. joint inflammation.
• 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 tablets) and antihypertensive medicines (used to lower blood pressure).
• Medicines that increase blood volume, such as dextran.
• Intravenous nitroglycerin, used in the treatment of heart diseases.

Tell your 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 if this is necessary (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 recommend monitoring blood potassium levels.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose:
Adults (18 – 64 years of age)
The daily dose of the medicine will be determined based on the patient's body weight.

• For patients with body weight below 50 kg, the dose is 0.2 mL (5000 IU anti-Xa).
• For patients with body weight from 50 kg to 70 kg, the dose is 0.3 mL (7500 IU anti-Xa).
• For patients with body weight from 71 kg to 100 kg, the dose is 0.4 mL (10,000 IU anti-Xa).
• For patients with body weight above 100 kg, the daily dose is determined based on body weight using a conversion factor: 115 IU anti-Xa/kg body weight/day.

Activity is expressed in international units of anti-factor Xa activity (IU) according to the
First International Standard for Low Molecular Weight Heparin.
Zibor is usually administered by subcutaneous injection, typically into a skin fold on the abdomen or upper thigh. In hospital, the medicine is given by a doctor or nurse. After discharge from hospital,
continuation of treatment with Zibor 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 of the duration of treatment (usually for approximately 5–9 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): dose adjustment is usually not 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 impairment, inform your doctor, who may decide to initiate close monitoring. If you suffer from severe kidney disease, your 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 performing 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 an injection site on the front-lateral or back-lateral area of the abdomen, avoiding the area within 5 cm around the navel, as well as scarred or bruised areas, and clean the skin thoroughly.
• For each injection, choose a different site, e.g., alternating between left and right sides.
• 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 expel air bubbles, as this may result in loss of medicine.

• Holding the pre-filled syringe in one hand, gently grasp the cleaned area of skin with the thumb and index finger of the other hand to form a skin fold.
• Insert the full 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 upward and release the skin fold.
• Do not rub the injection site. This helps prevent bruising.
• Do not recap the needle. Dispose of it (starting with the needle) in a sharps container, close the container tightly, and place it out of children's reach.
• 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.

Use of a higher than recommended dose of Zibor
Taking too high a dose of the medicine may cause bleeding. If bleeding occurs, inform your doctor immediately or go to the nearest hospital, taking this leaflet with you.
Missed dose of Zibor
Do not use a double dose to make up for a missed dose. Contact your doctor as soon as possible to obtain advice on the recommended course of action.
Stopping Zibor treatment
Always consult your doctor before stopping Zibor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine Zibor can cause adverse reactions, although they do not occur in all patients.
If any of the adverse reactions listed below occur, stop using Zibor immediately and contact 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) in stool, which may lead to haemorrhagic anaemia.

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

• Severe decrease in platelet count (severe type II thrombocytopenia) leading to bruising, bleeding from the oral cavity, gums and nose, rash.
• Spinal haematomas following epidural, intrathecal anaesthesia or lumbar puncture (back pain, feeling of loss of strength and sensation in the lower limbs, disturbances in bowel or bladder function), leading to neurological damage of varying severity, including transient or long-lasting paralysis.
• Severe allergic reactions (increased body temperature, chills, shortness of breath, laryngeal oedema, feeling of loss of consciousness, sweating, urticaria, itching, drop in blood pressure, hot flushes, 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 aminotransferase activity observed in laboratory tests.

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

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

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

• Increased blood potassium concentration observed in laboratory tests.

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

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zibor medication

Keep this medication out of sight and reach of children.
Do not store at temperatures above 25°C. Do not freeze.
Do not use this medication if you notice:

• that the protective packaging has been opened.
• that the protective packaging has been damaged.
• that the contents of the ampoule-syringe are cloudy.
• that the contents contain small particles.

After opening the package containing the ampoule-syringe, Zibor medication must be used immediately.
Expiry date
Do not use Zibor medication 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 ampoule-syringes must be discarded into a sharps container.
Do not keep used ampoule-syringes.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Following this advice helps protect the environment.

6. Contents of the Package 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 Package
Zibor is a colourless or slightly yellowish, clear solution free from visible particles.
Zibor 25,000 IU is available in packages containing 2, 10, 30 and 100 pre-filled syringes containing 0.2 mL, 0.3 mL or 0.4 mL of solution for injection.
Not all pack sizes may be marketed.
Each 0.2 mL pre-filled syringe contains a dose of 5,000 IU anti-Xa of bemiparin sodium.
Each 0.3 mL pre-filled syringe contains a dose of 7,500 IU anti-Xa of bemiparin sodium.
Each 0.4 mL pre-filled syringe contains a dose of 10,000 IU anti-Xa of bemiparin sodium.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GINELADIUS, S.L.
Rufino González 50,
28037 Madrid, Spain
+(34) 91 375 62 30

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

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