国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
DESMOPRESSIN ACETATE
Ferring Ireland Ltd
H01BA; H01BA02
DESMOPRESSIN ACETATE
4 microgram(s)/millilitre
Solution for injection
Product subject to Restricted Prescription (C)
Vasopressin and analogues; desmopressin
Marketed
1977-02-17
5009000660 • • • • What is in this leaflet: • • • DDAVP/Desmopressin Injection will not be given if you: Package Leaflet: Information for the User DDAVP ® /Desmopressin 4 micrograms/ml Solution for Injection Desmopressin acetate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. 1. What DDAVP/Desmopressin Injection is and what it is used for 2. Before DDAVP/Desmopressin Injection is given 3. How DDAVP/Desmopressin Injection will be given 4. Possible side effects 5. How to store DDAVP/Desmopressin Injection 6. Contents of the pack and other information 1. What DDAVP/Desmopressin Injection is and what it is used for DDAVP/Desmopressin Injection is a clear, colourless solution. It contains desmopressin acetate, an antidiuretic (reduces urine production). It is used: to diagnosis and treat cranial diabetes insipidus (a condition which causes extreme thirst and the continuous production of large volumes of dilute urine). _IMPORTANT: This should not be confused with _ _diabetes mellitus (sugar diabetes)._ during surgery or following trauma in patients with mild to moderate haemophilia (blood condition) or von Willebrand’s disease (blood clotting condition) to increase blood clotting factors _(Note: _ _DDAVP/Desmopressin Injection is not suitable for _ _every patient or for the treatment of all types of _ _haemophilia or von Willebrand’s disease)._ as a test to check if the kidneys are functioning properly (renal concentration capacity test). 2. Before DDAVP/Desmopressin Injection is given • are allergic to des 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DDAVP/Desmopressin 4 micrograms/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml DDAVP/Desmopressin solution for injection contains 4 microgram desmopressin acetate equivalent to 3.56 microgram desmopressin. Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. (Injection) Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DDAVP/Desmopressin Injection is indicated for: 1. For the diagnosis and treatment of cranial diabetes insipidus. 2. In the control of bleeding in patients with mild to moderate haemophilia and von Willebrand’s disease type I and IIA undergoing surgery or following trauma. 3. To establish renal concentration capacity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY TREATMENT OF CRANIAL DIABETES INSIPIDUS: By subcutaneous, intramuscular or intravenous injection. The injection may be used when the intranasal or oral administration is considered unsuitable. Individualise dosage after testing of the effect on urine osmolality and diuresis at different dose levels. Adults: The usual dose is 1 to 4 micrograms given once daily. Children: Doses from 0.4 micrograms (0.1ml) may be used. DIAGNOSIS OF CRANIAL DIABETES INSIPIDUS: The diagnostic dose in adults and children is 2 micrograms given by subcutaneous or intramuscular injection. Failure to elaborate a concentrated urine after water deprivation, followed by the ability to do so after the administration of desmopressin confirms a diagnosis of cranial diabetes insipidus. Failure to concentrate after the administration suggests nephrogenic diabetes insipidus. When used for diagnostic purposes the fluid intake must be limited to a maximum of 0.5 litres to quench thirst from 1 hour before until 8 hours after administration. MILD TO MODERATE HAEMOPHILIA AND VON WILLEBRAND’S DISEASE By intrave 阅读完整的文件