Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Alprostadil
Pfizer Healthcare Ireland
G04BE; G04BE01
Alprostadil
20 microgram(s)
Powder and solvent for solution for injection
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction; alprostadil
Marketed
1995-03-13
Package leaflet: Information for the user Caverject ® 10 OR 20 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Alprostadil 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Caverject is and what it is used for 2. What you need to know before you use Caverject 3. How to use Caverject 4. Possible side effects 5. How to store Caverject 6. Contents of the pack and other information 1. What Caverject is and what it is used for Caverject contains alprostadil which is similar to the natural substance in your body called prostaglandin E1. It widens blood vessels so that blood can flow in your penis more easily. This makes it easier for you to have an erection. Caverject is used for “erectile dysfunction” including weak erections or impotence. Your doctor may also use it to help find the exact cause of your erectile dysfunction along with other tests. Caverject is not suitable for children under 18 years of age. 2. What you need to know before you use Caverject Do not use Caverject: • if you are allergic (hypersensitive) to Caverject or any other medicines containing alprostadil or any of the other ingredients of Caverject (listed in section 6). • if you have sickle cell anaemia (a blood disease), leukaemia (cancer of the blood), multiple myeloma (bone cancer) or any other problem which increases the risk of getting “priapism”. This is a painful condition when your penis continues to remain erect. • if you have a penis which is scarred or not straight which may sometim Baca dokumen lengkap
Health Products Regulatory Authority 08 January 2021 CRN009ZCR Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caverject 20 micrograms Powder and Solvent for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alprostadil 20 micrograms. When reconstituted, each 1ml delivers a dose of 20 micrograms of alprostadil. Excipient with known effect: Each 1ml of reconstituted solution contains 8.4 mg benzyl alcohol, equivalent to 8.4 mg/ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: A white to off-white lyophilised powder. Solvent: A clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed aetiology. Caverject may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. Caverject is not indicated for paediatric use (see section 4.4 Benzyl alcohol). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Caverject is administered by direct intracavernous injection.A 1/2-inch, 27 to 30 gauge needle is generally recommended.The dose of Caverject should be individualised for each patient by careful titration under supervision by a physician. The intracavernosal injection must be done under sterile conditions.The site of injection is usually along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided.Both the side of the penis that is injected and the site of injection should be alternated; prior to the injection, the injection site must be cleansed with an alcohol swab. To reconstitute Caverject using the prefilled diluent syringe: flip off the plastic cap from the vial, and use one of the swabs to wipe the rubber cap.Fit the 22 gauge needle to the syringe. Inject the 1 ml of diluent into the vial, and shake to dissolve the powder entirely.Withdraw slightly more than the required dose of Caverj Baca dokumen lengkap