Nazione: Malta
Lingua: inglese
Fonte: Malta Medicines Authority
DESMOPRESSIN ACETATE
Ferring Pharmaceuticals Limited
H01BA02
DESMOPRESSIN ACETATE
NASAL SPRAY, SOLUTION
DESMOPRESSIN ACETATE 0.1 mg/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Authorised
Desmospray ® 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: • Desmospray 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) - 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 Desmospray, 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 DESMOSPRAY. 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. In this leaflet: 1. What Desmospray is and what it is used for 2. Before you use Desmospray 3. How to use Desmospray 4. Possible side effects 5. How to store Desmospray 6. Further information 1. WHAT DESMOSPRAY IS AND WHAT IT IS USED FOR Desmospray is a solution for nasal use only. It contains Desmopressin acetate, an antidiuretic (reduces urine production). It is used: • to treat patie Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DESMOSPRAY ® , Desmopressin Nasal Spray. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DESMOSPRAY contains 10 micrograms of Demopressin acetate per actuation. 3 PHARMACEUTICAL FORM Nasal spray. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DESMOSPRAY is indicated for: i) The treatment of nocturia associated with multiple sclerosis where other treatments have failed. ii) The diagnosis and treatment of vasopressin-sensitive cranial diabetes insipidus. iii) Establishing renal concentration capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT OF NOCTURIA: When DESMOSPRAY is used for the treatment of nocturia associated with multiple sclerosis, fluid intake must be limited to a minimum from 1 hour before using the spray at bedtime until the next morning and in any case for a minimum of 8 hours after administration. For multiple sclerosis patients up to 65 years of age with normal renal function suffering from nocturia the dose is one or two sprays intranasally (10 to 20 micrograms) at bedtime. Not more than one dose should be used in any 24 hour period. If a dose of two sprays is required, this should be as one spray into each nostril. Page 1 of 8 TREATMENT OF DIABETES INSIPIDUS: Dosage is individual but clinical experience has shown that the average maintenance dose in adults and children is one or two sprays (10 to 20 micrograms) once or twice daily. If a dose of two sprays is required, this should be as one spray into each nostril. DIAGNOSIS OF DIABETES INSIPIDUS: The diagnostic dose in adults and children is two sprays (20 micrograms). Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of DESMOSPRAY confirms the diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus. RENAL FUNCTION TESTING: Recommended doses for the renal concentration capacity test: Adults: Two sprays into each nostril (a t Leggi il documento completo