देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
DESMOPRESSIN ACETATE
Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland
H01BA02
DESMOPRESSIN ACETATE 100 µg/ml
NASAL DROPS, SOLUTION
DESMOPRESSIN ACETATE 100 µg/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Withdrawn
2016-08-01
2009053366_s1-1.pdf 1 12/05/14 19.16 DDAVP ® / Desmopressin 100 micrograms/ml Nasal Drops, Solution Desmopressin acetate DDAVP/Desmopressin Nasal Drops, Solution is for nasal use only. It contains desmopressin acetate, an antidiuretic (reduces urine production). if you have a serious heart or kidney disease Do not use DDAVP/Desmopressin Nasal Drops, Solution: if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6) if you are taking diuretics (water tablets) if you drink unusually large quantities of fluids, including alcohol if you have known hyponatraemia (serum sodium levels below normal range) If you have syndrome of inappropriate secretion of anti-diuretic hormone, a hormone regulating urine production (SIADH) Please consult your doctor before you use DDAVP/Desmopressin Nasal Drops, Solution: Use with caution in very young and older patients. Renal function testing in children below 1 year old should only be performed under carefully supervised conditions in hospital. if you have an illness causing fluid and/or electrolyte imbalance e.g. vomiting, diarrhoea, infections, fever or gastroenteritis if you have a medical condition that could be made worse by fluid and/or electrolyte disturbance (conditions where your blood sodium levels are too low or you are likely to build up too much water in your body, e.g. hyponatraemia) if you suffer from heart disease or reduced kidney function if you have cystic fibrosis if you have difficulty or problems passing urine if you suffer from bladder problems e.g. incontinence (inability to hold in urine), hesitance in starting urination, frequent urination and/or urgent urination if you have been warned that you are at risk of increased intracranial pressure • if you have high blood pressure If any of these apply to you, or if you are not sure, contact your doctor before taking DDAVP/Desmopressin Nasal Drops, Solution. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Plea पूरा दस्तावेज़ पढ़ें
Page 1 of 9 1. NAME OF THE MEDICINAL PRODUCT DDAVP Desmopressin 100 micrograms/ml Nasal drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 micrograms desmopressin acetate equivalent to 89 microgram desmopressin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal drops, solution. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. For the diagnosis and treatment of cranial diabetes insipidus including post-hypophysectomy polyuria/polydipsia. 2. For the measurement of the urine concentration capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL The rhinyle tube has a graduated scale corresponding to 2.5 µg, 5 µg, 10 µg, 15 µg and 20 µg desmopressin acetate. Method of administration: see instruction in sections 6.5 and 6.6. Fluid restriction should be observed (see indication specific instructions in section 4.4). In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see section 4.4). INDICATION SPECIFIC _TREATMENT OF DIABETES INSIPIDUS: _ Adults Dosage is individual. The dose is usually 10 to 20 micrograms once or twice daily (equivalent to 0.1ml to 0.2ml once or twice daily). Children Dosage is individual. The dose is usually 5 to 10 micrograms once or twice daily (equivalent to 0.05ml to 0.1ml once or twice daily). A lower dose may be required for infants. _DIAGNOSIS OF DIABETES INSIPIDUS: _ Adults and children : Page 2 of 9 A single dose of 20 micrograms (0.2ml). _RENAL FUNCTION TESTING: _ To establish renal concentration capacity, the following single doses are recommended: Adults: 40 micrograms (0.4ml). Children > 1 year: 20 micrograms (0.2ml). Children < 1 year: 10 micrograms (0.1ml). After administration of DDAVP/Desmopressin Nasal drops solution any urine collected withi पूरा दस्तावेज़ पढ़ें