- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Treatment of Cranial Diabetes Insipidus:By subcutaneous, intramuscular or intravenous injection.Adults:The usual dose is 1 to 4 micrograms given once daily.Children and infants:Doses from 0.4 micrograms (0.1ml) may be used.
Diagnosis of Cranial Diabetes Insipidus:The diagnostic dose in adults and children is 2 micrograms given by subcutaneous or intramuscular injection. Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of Desmopressin confirms a diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus.
Mild to moderate haemophilia and von Willebrand's disease:By intravenous administration.The dose for adults, children and infants is 0.4 micrograms per kilogram body weight administered by 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. The dose should be diluted in 50ml of 0.9% 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.
Renal Function Testing:By subcutaneous or intramuscular injection.Adults and children can be expected to achieve urine concentrations above 700mOsm/kg in the period of 5 to 9 hours following a dose of 2 micrograms DDAVP®/Desmopressin Injection. It is recommended that the bladder should be emptied at the time of administration.In normal infants, a urine concentration of 600mOsm/kg should be achieved in the five hour period following a dose of 0.4 micrograms DDAVP®/Desmopressin Injection. The fluid intake at the two meals following the administration should be restricted to 50% of the ordinary intake to avoid water overload.
Post Lumbar Puncture Headache:By subcutaneous or intramuscular injection.Where a headache is thought to be due to a lumbar puncture, an adult patient can be given a dose of 4 micrograms DDAVP®/Desmopressin Injection which may be repeated 24 hours later if necessary. Alternatively, a prophylactic dose of 4 micrograms can be given immediately prior to the lumbar puncture and repeated 24 hours later.
Fibrinolytic Response Testing:By intravenous administration.The dose for adults and children is 0.4 micrograms per kilogram body weight administered by intravenous infusion. The dose should be diluted in 50ml of 0.9% sodium chloride for injection and given over 20 minutes.A sample of venous blood should be taken 20 minutes after the infusion. In patients with a normal response the sample should show fibrinolytic activity of euglobulin clot precipitate on fibrin plates of at least 240mm2.
Pregnancy:Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.
Lactation:Results from analyses of milk from nursing mothers receiving high dose Desmopressin (300 micrograms intranasally) indicate that the amounts of Desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis or haemostasis.
Treatment:Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given. Hyponatraemia is treated by discontinuing the desmopressin treatment, fluid restriction and symptomatic treatment if needed.
Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
+44 (0)844 931 0051
+44 (0)844 931 0050