Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
papaverine hydrochloride, Quantity: 12 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections
Intracavernosal
5x10mL ampoules
(S4) Prescription Only Medicine
Papaverine hydrochloride injection is indicated for the treatment of erectile dysfunction.
Visual Identification: A clear colourless to pale yellow solution free from visible particulate matter.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-10-08
DBL™ PAPAVERINE HYDROCHLORIDE INJECTION D B L ™ P A P A V E R I N E H Y D R O C H L O R I D E I N J E C T I O N CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING DBL PAPAVERINE HYDROCHLORIDE INJECTION? DBL Papaverine Hydrochloride Injection contains the active ingredient papaverine hydrochloride. DBL Papaverine Hydrochloride Injection is used to produce erections in impotent men. For more information, see Section 1. Why am I using DBL Papaverine Hydrochloride Injection? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DBL PAPAVERINE HYDROCHLORIDE INJECTION? Do not use if you have ever had an allergic reaction to papaverine hydrochloride or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions and/or take any other medicines. For more information, see Section 2. What should I know before I use DBL Papaverine Hydrochloride Injection? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with DBL Papaverine Hydrochloride Injection and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS DBL PAPAVERINE HYDROCHLORIDE INJECTION GIVEN? Your doctor will decide what dose of papaverine you will receive. This depends on your medical condition and whether or not you are taking any other medicines. A doctor or trained nurse will give you the first injection. If you will be self-administering papaverine your doctor will provide you with proper training and instruction. More instructions can be found in Section 4. How is DBL Papaverine Hydrochloride Injection given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DBL PAPAVERINE HYDROCHLORIDE INJECTION? THINGS YOU MUST DO • Call your doctor straight away if the erection lasts for longer than 4 hours, or if it becomes painful. • Remind any doctor, nurse, pharmaci Прочитать полный документ
Version: pfppapai10521 Supersedes: Version: 7.0 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – DBL TM PAPAVERINE HYDROCHLORIDE INJECTION (PAPAVERINE HYDROCHLORIDE) 1. NAME OF THE MEDICINE Papaverine Hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Papaverine Hydrochloride Injection is supplied in ampoules containing 120 mg/10 mL of papaverine hydrochloride BP in water for injection BP/USP. 3. PHARMACEUTICAL FORM DBL Papaverine Hydrochloride Injection is a sterile, clear, colourless to pale-yellow solution of papaverine hydrochloride in water for injections. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Papaverine Hydrochloride Injection is indicated for the treatment of erectile dysfunction. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The lowest effective dose should be determined for each patient. In general most patients respond to doses in the range of 2.5 to 60 mg of papaverine hydrochloride. A starting dose of 15 mg is recommended for patients with erectile dysfunction due to most causes. Patients with psychogenic erectile dysfunction are likely to respond to lower doses, while those with vasculogenic erectile dysfunction are likely to require higher doses. Patients who do not respond to a dose of 60 mg should be changed to alternative therapy. A starting dose of 5 mg is recommended for men with erectile dysfunction due to spinal cord injury. Erection usually occurs within 10 minutes of injection of the drug and may persist for one to several hours. Tolerance to papaverine hydrochloride may occur during long-term use and may require an increase in dosage. The dose should be reduced if erections persist for longer than four hours. Early studies using doses of up to 80 mg papaverine hydrochloride resulted in high proportion patients requiring assisted detumescence. Version: pfppapai10521 Supersedes: Version: 7.0 Page 2 of 11 Dosage adjustment should be made carefully, based on the degree and duration of tumescence achieved with the previous dose. METHOD OF ADMINISTRATION DBL Papaverine Прочитать полный документ