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.