国: マルタ
言語: 英語
ソース: Medicines Authority
DESMOPRESSIN ACETATE
Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland
H01BA02
DESMOPRESSIN ACETATE 10 µg
NASAL SPRAY
DESMOPRESSIN ACETATE 10 µg
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Authorised
2006-04-17
2009053964 Package Leaflet: Information for the User Desmospray is a solution for nasal use only. It contains desmopressin acetate, an antidiuretic (reduces urine production). • if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6) • if you are over 65 years old • if you are taking medication for high blood pressure or have been told that your blood pressure is abnormal • if you have an illness causing fluid and/or electrolyte imbalance e.g. vomiting, diarrhoea, infections or fever • 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 have cystic fibrosis • 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) Do not use Desmospray: Other medicines and Desmospray Desmospray with food and drink Pregnancy and breast feeding Desmospray contains benzalkonium chloride When used for nocturia associated with multiple sclerosis, do not use Desmospray: Warnings and Precautions Talk to your doctor or pharmacist before using Desmospray. Take special care with Desmospray: • 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 • For nocturia associated with multiple sclerosis: STOP using Desmospray when suffering from vomiting and diarrhoea until you are better Desmospray should be used with caution in very young and older patients. If any of these apply to you, or if you are not sure, contact your doctor or pharmacist before taking Desmospray. • For nocturia associated with multiple sclero 完全なドキュメントを読む
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Desmospray, Desmopressin Nasal Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Desmospray contains 10 micrograms of desmopressin acetate per actuation (0.1ml) equivalent to 8.9 micrograms desmopressin. Excipients: 1 ml Desmospray contains 0.1 mg benzalkonium chloride. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Nasal Spray, Solution. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Desmospray is indicated for: i) The treatment of nocturia associated with multiple sclerosis. ii) The diagnosis and treatment of vasopressin sensitive cranial diabetes insipidus. iii) Establishing renal concentration capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ GENERAL One dose of the spray provides 0.1 ml which corresponds to 10 μg desmopressin acetate. Method of administration: see instructions in sections 6.5 and 6.6. Only use Desmospray in patients where oral formulations are not feasible and always start at the lowest dose (see section 4.4). 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 Page 2 of 10 _TREATMENT OF NOCTURIA ASSOCIATED WITH MULTIPLE SCLEROSIS _ 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. Fluid restriction should be observed, please see section _4.4 Special Warnings and Precautions for _ _Use. _In the event of signs of fluid retention/hyponatraemia, tre 完全なドキュメントを読む