Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
ALPROSTADIL
UCB (Pharma) Ireland Limited
G04BE01
ALPROSTADIL
40 Microgram/ML
Pdr+Solv for Soln for Inj
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction
Authorised
2010-08-13
CIA76833D_MU1 4020019 10/462 1485 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIRIDAL DUO ® 10/20/40 MICROGRAMS/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ALPROSTADIL FIG 10: The injection site must be within the area shown in figure 10. FIG 11: Hold the injector in your fingers as shown. Always HOLD IT LEVEL with the penis and insert the needle ALMOST COMPLETELY STRAIGHT, into the penis. The place where you inject should be within the area shown on the picture. Use a DIFFERENT SIDE of the penis than you used the last time. Pushing your thumb gently on the plunger, INJECT the solution slowly over a period of 5 TO 10 SECONDS. FIG 12: After injection, remove the injector and needle from your penis and put it down. If BLEEDING occurs, APPLY PRESSURE to the injection site with a clean pad for 3 minutes to stop the bleeding. If it continues to occur, carry on APPLYING PRESSURE UNTIL IT STOPS. It will take between 5–15 minutes for your erection to develop. Your erection should last for about one hour. If it lasts for between 2-4 hours, discuss this with your doctor. If it lasts for LONGER THAN 4 HOURS, CONTACT YOUR DOCTOR IMMEDIATELY. DISPOSING OF THE USED PACK: • Cut the needle with a needle cutter (available from your doctor, pharmacist or the Marketing Authori- sation holder) • Unscrew the needle base and put it into a contain- er for needles (called a sharps bin) (also available from your doctor or pharmacist) • Remove the cartridge by unscrewing the plunger from the injector body and sliding out the car- tridge. • Wash the Easy-Duo ® injector with warm water and a mild detergent. Once dry, store it in original carton for your next injection. • DO NOT THROW THE INJECTOR AWAY. Not all packs contain injectors so you will need to use this again for your next injection. However, do not use a damaged injector. Replacements are available from the company. • Place the cartridge in a plastic bag and tie it careful- ly. This can be thrown away with normal household rubbish. • IT IS IMPORTANT TO DISC Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Viridal Duo 40 micrograms/mL, Powder and Solvent for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alprostadil 40 micrograms (used as a 1:1 clathrate complex with alfadex). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Double chamber glass cartridge containing lyophilised powder and solvent for reconstitution (isotonic sodium chloride solution). The powder is white and the isotonic sodium chloride solution is clear, colourless liquid without a special odour. The powder is freely soluble within 60 seconds when dissolved in isotonic sodium chloride solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Viridal Duo is indicated in adult males: as an adjunct to the diagnostic evaluation of erectile dysfunction. for treatment of erectile dysfunction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Treatment initiation and dose titration Injections for treatment initiation, diagnostic evaluation and dose titration must be performed by the treating physician. He will determine an individual dose suitable to produce an erectile response for diagnostic purposes. For erectile dysfunction of neurological origin, the starting dose is 1.25mcg. For all other patients, the recommended starting dose is 2.5 mcg. Dose adjustments may be performed in increments of about 2.5 mcg to 5 mcg Viridal Duo. Most of the patients require between 10 and 20 mcg per injection. Some patients may need to be titrated to higher doses. Doses exceeding 20 mcg should be prescribed with particular care in-patients with cardiovascular risk factors. The dose per injection should never exceed 40 mcg. Dosage for self-injection therapy at home Before starting treatment at home, each patient or the patient’s partner has to be taught by a physician how to prepare the drug and perform the injection. In no cases should the injection therapy be started without precise instructions by Прочетете целия документ