OCTIM Nasal spray Ref.[27954] Active ingredients: Desmopressin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

4.1. Therapeutic indications

OCTIM Nasal Spray is indicated as follows:

  1. To increase Factor VIIIC and Factor VIII:Ag (vWf) in patients with mild to moderate haemophilia or von Willebrand’s disease undergoing surgery, following trauma or with other bleeding episodes such as menorrhagia and epistaxis.
  2. To test for fibrinolytic response.

4.2. Posology and method of administration

Mild to moderate haemophilia and von Willebrand’s disease

Adults (including the elderly) should take 300 micrograms (one spray into each nostril) half an hour before surgery or at bleeding.

Under direct medical supervision, 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, Factor VIII levels should continue to be monitored.

Unless specifically directed by the doctor, when OCTIM Nasal Spray is self-administered by the patient, there should be an interval of at least three days between doses.

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 60 minutes post-dose for assay of Factor VIII levels in order to monitor response.

Fibrinolytic response testing

Adults (including the elderly) should take 300 micrograms (one spray in each nostril). A sample of venous blood should be taken 60 minutes later.

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

4.9. Overdose

Overdose of OCTIM Nasal Spray can lead to hyponatraemia and convulsions.

Treatment

Overdosage increases the risk of fluid retention and hyponatraemia. If hyponatraemia occurs, desmopressin treatment should immediately be discontinued and fluid intake restricted until serum sodium is normalised.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Do not store above 25°C. Keep vial in the outer carton.

Do not freeze.

6.5. Nature and contents of container

Multidose container, Type I glass vial with a pre-compression pump set comprising of a spray pump with a metering valve, nasal applicator and protection cap.

Pack size: 2.5ml (25 sprays).

6.6. Special precautions for disposal and other handling

None.

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