Posology : מינונים

4.2   Posology and method of administration

Dosage
Heparin sodium must be individually dosed.
The dosage depends on the coagulation parameters (see section 4.4), the nature and course of the disease, the patient's response, adverse reactions, and the patient's weight and age.
Differences in sensitivity to heparin and a possible change in heparin tolerance during the course of treatment need to be considered.


Prophylaxis of thromboembolism (low-dose treatment)
Subcutaneous injection is recommended for the prophylaxis of thromboembolism. Pre-filled syringes with an appropriate dosage are available for this.

General dosage recommendation for the prophylaxis of thromboembolism: - Pre- and postoperative prophylaxis of thromboembolism
Preoperatively 5000-7500 IU subcutaneously approximately 2 hours before the operation.
Postoperatively, depending on the risk of thrombosis, usually 5000 IU subcutaneously every 8-12 hours or 7500 IU subcutaneously every 12 hours until the patient is mobilised or until vitamin K antagonists have an adequate effect. Laboratory monitoring (coagulation parameters) for dose adjustment may be required in individual cases.

- Prophylaxis in non-surgical medicine
(e.g. prolonged bed rest, increased thrombotic tendency in the patient, diseases with an increased risk of thrombosis.)
Depending on the risk of thrombosis, generally 5000 IU subcutaneously every 8-12 hours or 7500 IU subcutaneously every 12 hours.
The dosage must be adapted to the risk of thrombosis and the level of activity of the coagulation system and can be determined by monitoring coagulation parameters.

As part of the treatment of venous or arterial thromboembolic disorders Continuous intravenous administration is recommended if there are clots in blood vessels.

Dosage in adults
Generally start with 5000 IU heparin sodium as an intravenous bolus, followed by a continuous infusion of 1000 IU heparin sodium per hour using an infusion pump.

Dosage in children
Initially 50 IU/kg body weight, then 20 IU/kg body weight per hour.

If a continuous intravenous infusion is not possible, subcutaneous therapy (in 2-3 separate doses) may be used as an alternative, with close monitoring of therapy (e.g. 10,000-12,500 IU of heparin sodium every 12 hours).

Close monitoring of therapy accompanied by assay of coagulation parameters is absolutely essential in all cases. Monitoring of therapy and dose adjustment are generally based on activated partial thromboplastin time (aPTT), which should be around 1.5-2.5 times the normal value. It is recommended that the aPTT be checked 1-2 hours, 6 hours, 12 hours and 24 hours after the start of treatment in the case of continuous intravenous heparin administration, and 6 hours after administration of the second dose in the case of subcutaneous administration.

- Treatment of venous thromboembolism
Initially, 5000 IU heparin sodium should be administered intravenously as a bolus, followed by an intravenous infusion of generally 1000 IU heparin sodium per hour. The dosage should be adjusted according to the aPTT values, aiming to prolong the aPTT to 1.5-2.5 times the initial value (within the first 24 hours if possible).
The treatment should take place for at least 4 days or continued until adequate oral anticoagulation has been achieved.

- As part of the treatment of unstable angina and non–Q-wave myocardial infarction In general, 5000 IU heparin sodium as an intravenous bolus, followed by a continuous infusion of 1000 IU per hour. The dose is based on the aPTT, which should be prolonged to 1.5-2.5 times the normal value.
Heparin sodium should be administered for at least 48 hours.

- As concomitant therapy in thrombolysis with fibrin-specific thrombolytics (e.g. r-tPA) for the treatment of acute myocardial infarction
Initially, 5000 IU heparin sodium as an intravenous bolus, followed by an intravenous infusion of 1000 IU per hour.
The infusion should be adjusted according to aPTT values to prolong them to about 1.5-2.5 times the initial value. Heparin sodium should be given for 48 hours.

In the case of thrombolysis with non-fibrin-specific thrombolytics (e.g. streptokinase), a subcutaneous injection of 12,500 IU heparin sodium may also be administered every 12 hours, starting 4 hours after thrombolysis.

The exact dosage of the concomitant heparin therapy depends on the type of thrombolytic and should be undertaken according to the data on the individual thrombolytic agents.
It is important to ensure accurate monitoring of the coagulation status in all cases.

Anticoagulation in treatment or surgery with an extracorporeal circulation Haemodialysis
Individual dosage depending on the results of the coagulation tests and type of machine.

Heart/lung machine
The dosage depends on the type of heart/lung machine and the length of the operation and should be managed individually.

Method of administration
Subcutaneous and intravenous injection or intravenous infusion after dilution.

Administration of the subcutaneous injection
The injection should be administered with a fine injection needle held perpendicular to the body axis, into a raised fold of abdominal skin or on the anterior aspect of the thigh; the injection must be strictly subcutaneous. Any drops adhering to the injection needle should be removed before the injection, as introducing heparin sodium into the injection channel can result in superficial bruising and in rare cases local allergic irritation.

Notes:
To minimise disruption of lymph drainage, Heparin Sodium Teva 25,000 IU/5ml should be administered into the upper arm in patients with surgical clearance of lymph nodes in the abdominal/urogenital regions.


As heparin is bound by platelet components (PF4), as a result of which the effect is neutralised, blood taken for coagulation tests and mixed with citrate should be centrifuged and decanted as soon as possible after sampling in order to separate blood cells and blood plasma.

The treating physician decides on the duration of administration.
Regular monitoring of the activated partial thromboplastin time (aPTT) and platelet count are necessary with heparin therapy.