MINIRIN NASAL SPRAY 10 mcg/dose

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

SPRAY

**POSOLOGY AND METHOD OF ADMINISTRATION** General 1 dose of the spray provides 0.1 ml, which corresponds to 10 mcg desmopressin acetate. MINIRIN® nasal formulations should be used only when treatment with oral formulations is inappropriate and always start at the lowest dose (see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Fluid restriction should be observed (see indication specific instructions in section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If signs of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain and in serious cases convulsions) develop, treatment should be discontinued until the patient has recovered completely. Fluid intake should be strictly limited when treatment is reinstated (see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Indication specific _Central diabetes insipidus:_ Dosage is individual but clinical experience has shown that the normal daily dose for adults is 10–20 mcg 1–2 times daily and for children 5–10 mcg 1–2 times daily. _Renal concentrating capacity test:_ Normal adult dose is 40 mcg. For children over 12 months the dose is 20 mcg. For children under 12 months the dose is 10 mcg. After administration of MINIRIN® any urine collected within 1 hour is discarded. During the next 8 hours 2 portions of urine are collected for osmolality testing. Fluid restriction should be observed, see also under Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The reference level for normal urine osmolality after MINIRIN® administration is 800 mOsm/kg for most patients. With values under this level, the test should be repeated. A similar low result indicates an impaired ability to concentrate urine and the patient should be referred for further examination into the underlying cause of the malfunction. Special populations _Elderly:_ see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Renal Impairment:_ see section Contraindications. _Hepatic Impairment:_ see section Interaction with other medicinal products and other forms of interaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Paediatric Population:_ MINIRIN® is indicated in children with central diabetes insipidus and for testing of renal concentration capacity, see section Special warnings and precautions for use and Undesirable effects – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.