ZIBOR 3.500 IU Solution for injection Ref.[10842] Active ingredients: Bemiparin

WARNING: The different low molecular weight heparins are not necessarily equivalent. Therefore compliance with the dosage regimen and the specific method of use for each of these medicinal products is required.

Posology

Adults

Orthopaedic surgery with high risk of venous thromboembolism

On the day of the surgical procedure, 3,500 IU anti-Xa is to be administered by subcutaneous route (sc), 2 hours before or 6 hours after surgery. On subsequent days, 3,500 IU anti-Xa sc is to be administered every 24 hours.

Prophylactic treatment must be followed in accordance with the physician’s opinion during the period of risk or until the patient is mobilised. As a general rule, it is considered necessary to maintain prophylactic treatment for at least 7-10 days after the surgical procedure and until the risk of thromboembolic disease has decreased.

Prevention of clotting in the extracorporeal circuit during haemodialysis

For patients undergoing repeated haemodialysis of no longer than 4 hours in duration and with no risk of bleeding, the prevention of clotting in the extracorporeal circuit during haemodialysis is obtained by injecting a single dose in the form of bolus into the arterial line at the beginning of the dialysis session. For patients weighing less than 60kg, the dose will be 2,500 IU, whereas for patients weighing more than 60kg, the dose will be 3,500 IU.

Paediatric population

The safety and efficacy of Zibor in children has not been established due to a lack of data.

Older people

No dose adjustment required if the renal function is impaired see section: 4.2 Posology and method of administration, renal impairment; 4.4 Special warnings and precautions for use; 5.2 Pharmacokinetic properties.

Renal impairment

(See section: 4.4 Special warnings and precautions for use; 5.2 Pharmacokinetic properties)

Prevention of thromboembolic disease in patients undergoing orthopaedic surgery.

• In mild or moderate renal insufficiency (creatinine clearance 30-80 ml/min): no dose adjustment is necessary. However, a close monitoring is recommended
• Severe renal insufficiency (creatinine clearance <30 mL/min) could influence the pharmacokinetics of bemiparin. Physicians should assess the individual bleeding and thrombotic risks in these patients. In some cases, the dose may be necessary to be adjusted. Based on limited pharmacokinetic data (See Section 5.2), a dose reduction up to 2,500 IU anti-Xa s.c. once daily could be recommended. A close monitoring is recommended. Measurement of peak anti-Xa levels at about 4 hours post-dose should be considered.

Hepatic impairment

There are insufficient data to recommend a dose adjustment of bemiparin in this group of patients.

Method of administration

Subcutaneous injection technique

The pre-filled syringes are ready for immediate use and must not be purged before the subcutaneous injection. When Zibor is administered subcutaneously, the injection should be given in the subcutaneous cell tissue of the anterolateral or posterolateral abdominal waist, alternately on the left and right sides. The needle should be fully inserted, perpendicularly and not tangentially, into the thick part of a skin fold held between the thumb and the forefinger, the skin fold should be held throughout the whole injection. Do not rub the injection site.

In some package sizes, the prefilled syringe may be combined to a safety device system.

For syringes with safety device system the needle must be oriented away from the user and anyone else who is present. The safety system is activated by pressing firmly on the plunger rod. The protective sleeve will automatically cover the needle and will produce an audible click which confirms the activation of the device.

Immediately, the syringe must be discarded by throwing it into the nearest sharps bin (the needle in). The container lid must be closed tightly and the container placed out of the reach of children.

Bleeding is the main symptom of overdosage. If bleeding occurs bemiparin should be discontinued depending on the severity of the haemorrhage and the risk of thrombosis.

Minor haemorrhages rarely need specific treatment. In case of major haemorrhages, administration of protamine sulphate may be needed.

The neutralisation of bemiparin with protamine sulphate has been studied in-vitro and in-vivo systems, with the aim of observing the reduction of anti-Xa activity and the effect on the Activated Partial Thromboplastin Time (APTT). Protamine sulphate exerts a partial decrease on anti-Xa activity for 2 hours after its intravenous administration, at a dose of 1.4 mg of protamine sulphate each 100 IU anti-Xa administered.

2 years.

After first opening, Zibor should be used immediately.

Do not store above 30°C. Do not freeze.

0.2 ml solution in pre-filled syringe (Type I glass) with a plunger rod (polypropylene), rubber plunger stopper (chlorobutyl) and injection needle (stainless steel). Packs of 2, 6, 10, 30 and 100 syringes.

In some package sizes, the prefilled syringe may be combined to a safety device system. For syringes with safety device system the needle must be oriented away from the user and anyone else who is present. The safety system is activated by pressing firmly on the plunger rod. The protective sleeve will automatically cover the needle and will produce an audible click which confirms the activation of the device.

Immediately, the syringe must be discarded by throwing it into the nearest sharps bin (the needle in). The container lid must be closed tightly and the container placed out of the reach of children.

Not all pack sizes may be marketed.

Single-dose container. Discard any unused content. Do not use if the protective package is opened or damaged. Only clear colourless or slightly yellowish solutions, free of visible particles, should be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.