Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
DESMOPRESSIN ACETATE
Ferring Pharmaceuticals Limited
H01BA02
DESMOPRESSIN ACETATE
NASAL DROPS, SOLUTION
DESMOPRESSIN ACETATE 100 µg/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Authorised
No text in this field No text in this field DDAVP / Desmopressin ® Intranasal Solution desmopressin acetate PATIENT INFORMATION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet, you may need to read it again • If you have further questions, please ask your doctor or pharmacist • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IMPORTANT THINGS THAT YOU NEED TO KNOW: • DDAVP/Desmopressin Intranasal Solution is used - to treat patients with multiple sclerosis suffering from nocturia (the need to get up at night to pass urine), when other treatments have failed - to diagnose and treat cranial diabetes insipidus (a condition that causes extreme thirst and the continuous production of large volumes of dilute urine, when other treatments have failed) - as a test to check if the kidneys are functioning properly (renal function test) • You should avoid drinking large amounts of fluid while you are being treated with DDAVP/Desmopressin Intranasal Solution, as this could lead to a build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions. • If you experience unusually bad or prolonged headache, confusion, unexplained weight gain, ankle swelling, nausea or vomiting STOP USING DDAVP/DESMOPRESSIN INTRANASAL SOLUTION. You should tell your doctor immediately or go to the casualty department at your nearest hospital. Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you. This leaflet was last updated on 29/11/08 In this leaflet: 1. What DDAVP/Desmopressin Intranasal Solution is and what it is used for 2. Before you use DDAVP/Desmopressin Intranasal Solution 3. How t Lue koko asiakirja
Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT DDAVP ® /Desmopressin Intranasal Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Desmopressin acetate 0.01% w/v 3. PHARMACEUTICAL FORM Aqueous solution for intranasal administration 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DDAVP ® /Desmopressin Intranasal Solution is indicated for: 1) The diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus. 2) The treatment of nocturia associated with multiple sclerosis where other treatments have failed. 3) Establishing renal concentration capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT OF DIABETES INSIPIDUS: Dosage is individual but clinical experience has shown that the average maintenance doses are as follows: _Adults_: 10 to 20 micrograms once or twice daily. _Elderly_: 10 to 20 micrograms once or twice daily. _Children_: 5 to 20 micrograms daily, (a lower dose may be required for infants). DIAGNOSIS OF DIABETES INSIPIDUS: The diagnostic dose in adults and children is 20 micrograms. Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of Desmopressin confirms the diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus. TREATMENT OF NOCTURIA: Page 2 of 6 For multiple sclerosis patients up to 65 years of age with normal renal function suffering from nocturia the dose is 10 to 20 micrograms at bed time. Not more than one dose should be used in any 24 hour period. RENAL FUNCTION TESTING: To establish renal concentration capacity, the following single doses are recommended: Adults: 40 micrograms Elderly: 40 micrograms Children (1 - 15 years): 20 micrograms Infants (to 1 year): 10 micrograms Adults and children with normal renal function can be expected to achieve concentrations above 700mOsm/kg in the period of 5-9 hours following administration of DDAVP ® /Desmopressin Intranasal Solution. It is recommended that the bladder should be em Lue koko asiakirja