Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alprostadil
Pfizer Ltd
G04BE01
Alprostadil
10microgram
Powder and solvent for solution for injection
Intracavernous
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040500; GTIN: 5012882007997
Page 1 of 9 PATIENT INFORMATION LEAFLET Caverject® Dual Chamber 10 and 20 micrograms Powder and solvent for solution for injection Alprostadil Pfizer logo READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Caverject Dual Chamber is and what it is used for 2. Before you use Caverject Dual Chamber 3. How to use Caverject Dual Chamber 4. Possible side effects 5. How to store Caverject Dual Chamber 6. Further information 1. WHAT CAVERJECT DUAL CHAMBER IS AND WHAT IT IS USED FOR Caverject Dual Chamber contains alprostadil which is similar to the natural substance in your body called prostaglandin E1. It widens blood vessels, increasing blood flow to your penis making it easier for you to have an erection. Caverject Dual Chamber 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. 2. BEFORE YOU USE CAVERJECT DUAL CHAMBER DO NOT USE CAVERJECT DUAL CHAMBER IF YOU: are allergic (hypersensitive) to Caverject Dual Chamber, any other medicines containing alprostadil or any of the other ingredients of Caverject Dual Chamber. have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood), multiple myeloma (bone cancer) or any other problem which increases risk of getting “priapism”. This is when your erection lasts for longer than 6 hours. have an implant in your penis. have a condition (such as severe heart disease) in which sexual activity should be avoided. Page 2 of 9 have a penis which Lugege kogu dokumenti
OBJECT 1 CAVERJECT DUAL CHAMBER 10 MICROGRAMS Summary of Product Characteristics Updated 29-Mar-2017 | Pfizer Limited 1. Name of the medicinal product Caverject ® Dual Chamber 10 micrograms, Powder and solvent for solution for injection 2. Qualitative and quantitative composition Each 0.5 ml cartridge delivers a maximum dose of 10 micrograms of alprostadil. For the full list of excipients see section 6.1 3. Pharmaceutical form Powder and solvent for solution for injection Dual chamber glass cartridge containing a white lyophilised powder and diluent for reconstitution. 4. Clinical particulars 4.1 Therapeutic indications Caverject Dual Chamber is indicated for the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology. Caverject Dual Chamber may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. 4.2 Posology and method of administration No formal studies with Caverject have been performed in patients younger than 18 years and older than 75 years. General Information Caverject Dual Chamber should be administered by direct intracavernosal injection using the 1/2-inch 29 gauge needle provided. The usual site of injection is along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis and the site of injection must be altered between injections. The initial injections of Caverject Dual Chamber must be administered by medically trained personnel and after proper training, alprostadil may be injected at home. It is recommended that patients are regularly monitored (e.g. every 3 months) particularly in the initial stages of self injection therapy when dose adjustments may be needed. The dose of Caverject Dual Chamber should be individualized for each patient by careful titration under a physician's supervision. The lowest, effective dose should be used that provides the patient with an erection that is satisfactory for sexual intercourse. It is recom Lugege kogu dokumenti