Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
papaverine hydrochloride
Pfizer Australia Pty Ltd
Registered
DBL™ Papaverine cmi.doc Page 1 DBL™ PAPAVERINE HYDROCHLORIDE INJECTION Papaverine Hydrochloride (pa-PAV-er-een) CONSUMER MEDICINE INFORMATION _Date of Dispensing_ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL™ Papaverine Hydrochloride Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor weighed the risks of you using papaverine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL™ PAPAVERINE HYDROCHLORIDE INJECTION IS USED FOR This medicine is used to produce erections in impotent men. It belongs to a group of medicines called vasodilators. When papaverine is injected into the penis (called ‘intracavernosal’ injection) it works by increasing blood flow to the penis, which results in an erection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS PRODUCT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. There is not enough information to recommend the use of this medicine for children and newborn babies. BEFORE YOU USE DBL™ PAPAVERINE HYDROCHLORIDE INJECTION _WHEN YOU MUST NOT USE IT _ DO NOT USE DBL™ PAPAVERINE HYDROCHLORIDE INJECTION IF YOU HAVE AN ALLERGY TO: • any medicine containing papaverine • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT USE THIS MEDICINE IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • complete atrioventricular block (a heart condition char Lesen Sie das vollständige Dokument
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 30 mg/1 mL or 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: 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 Hydrochloride Injection should only be pres Lesen Sie das vollständige Dokument