Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
desmopressin acetate, Quantity: 0.1 mg/mL (Equivalent: desmopressin, Qty 0.089 mg/mL)
Ferring Pharmaceuticals Pty Ltd
Spray, solution
Excipient Ingredients: dibasic sodium phosphate dihydrate; citric acid monohydrate; sodium chloride; purified water; benzalkonium chloride
Nasal
1 x 5mL, 1x 6mL
(S4) Prescription Only Medicine
Diabetes Insipidus:The treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria.,Nocturnal Enuresis: MINIRIN Nasal Spray is indicated for the symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. MINIRIN Nasal Spray should be used only in patients who are refractory to the enuresis alarm or in patients in whom enuresis alarm is contraindicated or inappropriate, and where the oral administration of desmopressin is not feasible.,Renal Concentrating Capacity: By intranasal administration to adults and children as a diagnostic test to establish renal concentrating capacity.
Visual Identification: Clear colouless solution; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1997-04-21
MINIRIN ® _NASAL SPRAY_ _desmopressin acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MINIRIN Nasal Spray. It does not contain all the available information. It does not replace of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MINIRIN Nasal Spray against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MINIRIN NASAL SPRAY IS USED FOR The active ingredient, desmopressin acetate, in MINIRIN Nasal Spray is a synthetic version of a naturally occurring substance produced in the brain called vasopressin. It has a number of different actions on the body including an action on the kidney to reduce the amount of urine produced. This means that MINIRIN Nasal Spray can be used for several different conditions including: • primary nocturnal enuresis (bedwetting) in patients over 6 years of age, who have a normal ability to concentrate urine and who have not responded to treatment with an enuresis alarm or in patients in whom an enuresis alarm is contraindicated or inappropriate and where the oral administration of desmopressin is not feasible.. • cranial diabetes insipidus (large amounts of urine being produced day and night and constant thirst) • as a diagnostic test to establish if the kidneys have the ability to concentrate urine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. It is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU USE MINIRIN NASAL SPRAY _WHEN YOU MUST NOT USE IT_ DO NOT USE MINIRIN NASAL SPRAY IF YOU HAVE AN ALLERGY TO: • any medicine containing desmopressin or any of the ing Soma hati kamili
Page 1 of 10 #152-v18A AUSTRALIAN PRODUCT INFORMATION - MINIRIN ® (DESMOPRESSIN ACETATE) 10 MICROGRAMS/ACTUATION NASAL SPRAY 1. NAME OF THE MEDICINE Desmopressin acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MINIRIN Nasal Spray also contains sodium chloride, citric acid monohydrate, dibasic sodium phosphate- dihydrate, benzalkonium chloride solution 50% as preservative and water-purified. Desmopressin free base represents 89% of the desmopressin acetate content. This is due to the difference in molecular weight as well as the presence of acetic acid/acetate, water and impurities. 3. PHARMACEUTICAL FORM Nasal spray, solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diabetes Insipidus The treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria. Nocturnal Enuresis MINIRIN Nasal Spray is indicated for the symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. MINIRIN Nasal Spray should be used only in patients who are refractory to the enuresis alarm or in patients in whom enuresis alarm is contraindicated or inappropriate, and where the oral administration of desmopressin is not feasible. Renal Concentrating Capacity By intranasal administration to adults and children as a diagnostic test to establish renal concentrating capacity. 4.2 DOSE AND METHOD OF ADMINISTRATION Note: MINIRIN Nasal Spray is for intranasal administration only. Administration of desmopressin acetate by intravenous or intramuscular injection may be used when the intranasal route is inconvenient. Caution: The intravenous or intramuscular dose is about one tenth of the intranasal dose. A. For ADH-sensitive Cranial Diabetes Insipidus ADULT The average daily dose is 10 to 40 micrograms intranasally. PAEDIATRIC 2.5 to 20 micrograms daily. The daily dose is usually given as two divided doses. The dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Respons Soma hati kamili