OCTIM

Mild to Moderate Haemophilia and von Willebrand's Disease:

By subcutaneous or intravenous administration. 3 micrograms per kilogram body weight, administered by subcutaneous injection or intravenous infusion. Further doses may be administered at 12 hourly intervals so long as cover is required.

As some patients have shown a diminishing response to successive doses, it is recommended that monitoring of factor VIII levels should continue. 9% sodium chloride for injection and given over 20 minutes. This dose should be given immediately prior to surgery or following trauma.

During administration of intravenous Desmopressin, vasodilation may occur resulting in decreased blood pressure and tachycardia with facial flushing in some patients. Increase of Factor VIII levels are dependent on basal levels and are normally between 2 and 5 times the pre-treatment levels.

If results from a previous administration of Desmopressin are not available then blood should be taken pre-dose and 20 minutes post-dose for assay of factor VIII levels in order to monitor response. Unless contraindicated, when surgery is undertaken tranexamic acid may be given orally at the recommended dose from 24 hours beforehand until healing is complete.

Fibrinolytic Response Testing:

By subcutaneous or intraveonus administration. 3 micrograms per kilogram body weight, administered by subcutaneous injection or intravenous infusion. 9% sodium chloride for injection and given over 20 minutes. A sample of venous blood should be taken 20 minutes after the administration.

In patients with a normal response the sample should show fibrinolytic activity of euglobulin clot precipitate on fibrin plates of at least 240mm2.

Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported.

Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

During intravenous infusion of OCTIM Injection, vasodilation may occur, resulting in decreased blood pressure and tachycardia with facial flushing. This side effect is normally avoided by infusing the product over 20 minutes.

4. Special Warnings and Special Precautions for Use Precautions to prevent fluid overload must be taken in : - conditions characterised by fluid and/or electrolyte imbalance - patients at risk for increased intracranial pressure Care should be taken with patients who have reduced renal function and/or cardiovascular disease.

When repeated doses are used to control bleeding in haemophilia or von Willebrand's disease, care should be taken to prevent fluid overload. Fluid should not be forced, orally or parenterally, and patients should only take as much fluid as they require to satisfy thirst.

Intravenous infusions should not be left up as a routine after surgery. Fluid accumulation can be readily monitored by weighing the patient or by determining plasma sodium or osmolality. Measures to prevent fluid overload must be taken in patients with conditions requiring treatment with diuretic agents.

Special attention must be paid to the risk of water retention. The fluid intake should be restricted to the least possible and the body weight should be checked regularly. If there is a gradual increase of the body weight, decrease of serum sodium to below 130mmol/l or plasma osmolality to below 270mOsm/kg, the fluid intake must be reduced drastically and the administration of Octim® Injection interrupted.

During administration of Octim® Injection, it is recommended that the patient's blood pressure is monitored continuously. Octim® Injection does not reduce prolonged bleeding time in thrombocytopenia.

3. Contra-Indications Octim® Injection is contraindicated in cases of: - habitual and psychogenic polydipsia - unstable angina pectoris - decompensated cardiac insufficiency - von Willebrand's Disease Type IIB where the administration of Desmopressin may result in pseudothrombocytopenia due to the release of abnormal clotting factors which cause platelet aggregation.

Fibrinolytic Response Testing should not be carried out in patients with hypertension, heart disease, cardiac insufficiency and other conditions requiring treatment with diuretic agents.