देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DESMOPRESSIN ACETATE
Ferring Ireland Ltd
H01BA; H01BA02
DESMOPRESSIN ACETATE
15 microgram(s)/millilitre
Solution for injection
Product subject to prescription which may be renewed (B)
Vasopressin and analogues; desmopressin
Not marketed
2006-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER OCTOSTIM ® 15 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Octostim Injection is and what it is used for 2. What you need to know before Octostim Injection is given 3. How Octostim Injection will be given 4. Possible side effects 5. How to store Octostim Injection 6. Contents of the pack and other information 1. WHAT OCTOSTIM INJECTION IS AND WHAT IT IS USED FOR Octostim Injection is a clear, colourless solution. It contains desmopressin acetate, an antidiuretic (reduces urine production). It is used: • 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: Octostim Injection is not suitable for every patient or for the treatment of all types of haemophilia or von Willebrand’s disease. • to test for fibrinolytic response (a test to measure the capacity of the body to dissolve blood clots once they have formed). 2. WHAT YOU NEED TO KNOW BEFORE OCTOSTIM INJECTION IS GIVEN OCTOSTIM INJECTION WILL NOT BE GIVEN: • if you are allergic to desmopressin or any of the ingredients listed in section 6 • if you drink unusually large quantities of fluids, or if you experience excessive thirst • if you are taking diuretics (water tablets) • if you suffer from angina or have heart problems • if you have type IIB von Willebrand’s disease • if you have low bl पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Octostim 15 micrograms/ml Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 15 micrograms desmopressin acetate equivalent to 13.4 micrograms desmopressin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Uncoloured glass ampoule containing a clear aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OCTOSTIM ® solution for subcutaneous injection or as intravenous infusion as follows: For short-term use to increase factor eight levels in patients with mild to moderate haemophilia or von Willebrand's disease under going surgery or following trauma, and who respond positively to a test dose. To test for Fibrinolytic response. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 0.3 micrograms/kg body weight subcutaneously or diluted in physiological saline to 50-100 ml and given as an intravenous infusion over 15-30 minutes. If a positive effect is obtained, the initial OCTOSTIM dose may be repeated 1-2 times with intervals of 6-12 hours. Further repetition of the dose may result in a reduced effect. In patients with haemophilia A the desired increase of VIII:C is appraised by the same criterion as in the treatment with Factor VIII-concentrate. If the OCTOSTIM infusion does not lead to the desired increase of the concentration of VIII:C in plasma, the treatment may be complemented with administration of factor VIII concentrate. Treatment of haemophilia patients should be conducted in consultation with each patient’s coagulation laboratory. Determination of coagulation factors and bleeding time before OCTOSTIM-treatment: Plasma levels of VIII:C and vWF:Ag increase substantially after the desmopressin administration. However it has not been possible to establish any correlation between the plasma concentration of these factors and the bleeding time, either before or after desmopressin. The effect of Desmopressin on the bleeding time should therefore पूरा दस्तावेज़ पढ़ें