ZIBOR

Posology Adults Orthopaedic surgery with high risk of venous thromboembolism:

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. 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 60 kg, the dose will be 2,500 IU, whereas for patients weighing more than 60 kg, 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.

2 Posology and method of administration, renal impairment;

The most commonly reported adverse reaction is haematoma and/or ecchymosis at the injection site, occurring in approximately 15% of patients receiving Zibor. Osteoporosis has been associated with long-term heparin treatment. The undesirable effects are listed by system organ class and frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data): The frequency of adverse events (AEs) reported with bemiparin is similar to those reported with other LMWHs and is as follows: System organ class and frequency Adverse reaction Blood and lymphatic system disorders: Common Uncommon Rare Bleeding complications (skin, mucous membranes, wounds, gastro-intestinal tract, urogenital tract) which may cause haemorrhagic anaemia.

4) Hepatobiliary disorders: Common Mild and transient elevations of transaminases (ASAT, ALAT) and gamma-GT levels. 4).

General disorders and administration site conditions:

Very common Rare Ecchymosis at injection site. Haematoma and pain at injection site. Epidural and spinal haematomas following epidural or spinal anaesthesia and lumbar puncture. 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

2 Pharmacokinetic properties. 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. 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. 1. Hypersensitivity to heparin or its derivatives, including other low molecular weight heparins, or substances of porcine origin. 4). Active haemorrhage or increased risk of bleeding due to impairment of haemostasis.

Severe impairment of liver or pancreatic function. Injuries to or operations on the central nervous system, eyes and ears within the last 2 months. Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.

Acute bacterial endocarditis and slow endocarditis. : active peptic ulcer, haemorrhagic stroke, cerebral aneurysm or cerebral neoplasms). 4 Special warnings and precautions for use Do not administer by the intramuscular route. Due to the risk of haematoma during bemiparin administration, the intramuscular injection of other agents should be avoided.

The kinetics of bemiparin may be affected in patients with severe renal impairment (creatinine clearance <30 ml/min). In mild or moderate renal impairment (creatinine clearance 30-80 ml/min) no dose adjustment seems necessary, although caution should be exercised.

2 Pharmacokinetic properties). Caution should be exercised in patients with liver failure, uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis and/or urethrolithiasis, choroid and retinal vascular disease, or any other organic lesion with an increased risk of bleeding complications, or in patients undergoing spinal or epidural anaesthesia and/or lumbar puncture.

Bemiparin, like other LMWHs, can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or those taking potassium sparing drugs.

8). Serum electrolytes should be measured in patients at risk before starting bemiparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond 7 days. 8). As a general rule, no complications occur, therefore treatment can be continued.

8). This effect usually occurs within 5 to 21 days after the beginning of treatment, although in patients with a history of heparin-induced thrombocytopenia this may occur sooner. Platelet counts are recommended before administration of bemiparin, on the first day of therapy and then regularly 3 to 4 days and at the end of therapy with bemiparin.

In practice, treatment must be discontinued immediately and an alternative therapy initiated if a significantly reduced platelet count is observed (30 to 50 %), associated with positive or unknown results of in-vitro tests for anti-platelet antibody in the presence of bemiparin, other LMWHs and /or heparins.

As with other […]

1. Hypersensitivity to heparin or its derivatives, including other low molecular weight heparins, or substances of porcine origin. 4). Active haemorrhage or increased risk of bleeding due to impairment of haemostasis. Severe impairment of liver or pancreatic function.

Injuries to or operations on the central nervous system, eyes and ears within the last 2 months. Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia. Acute bacterial endocarditis and slow endocarditis.

: active peptic ulcer, haemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).