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FINAL PROGRAM www.essm.org 10th Congress of the European ...

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INVICORP ABBREVIATED PRESCRIBINGINFORMATION Prescribing Information(please refer to full SPC before prescribing)INVICORP solution for injectionInvicorp 25 micrograms/1mg, each dosecontaining 25 micrograms aviptadil and 1mgphentolamine mesylate in 0.35ml; Invicorp 25micrograms/2mg, each dose containing 25micrograms aviptadil and 2mg phentolaminemesylate in 0.35ml Presentation: Amber glassampoule containing 0.35ml solution forintraca ernous injection. Indication: Erectiledysfunction. Posology and method <strong>of</strong>administration: For men only. Initial dose is 25micrograms/1mg, administered by intracavernousinjection. Dosage can subsequently be increasedto 25 micrograms/2mg if response is inadequate.Treatment should not exceed more than oncedaily or 3 times/week with ei<strong>the</strong>r dose. No formalstudies have been performed in elderlypatients or those with renal or hepaticimpairment. Contraindications: In men forwhom sexual activity is inadvisable orcontraindicated due to <strong>org</strong>anic disease. Diseaseswhich predispose priapism (e.g. sickle cellanaemia, bone cancer, leukaemia), treatmentwith anticoagulants, hypersensitivity to activesubstances or excipients. Warnings/Precautions: Prolonged or painful erectionsmay rarely occur, particularly with anatomicaldeformities <strong>of</strong> <strong>the</strong> penis, cavernous fibrosis,Peyronie’s disease or plaque. Patients with anypainful/uncomfortable erection persisting beyond4 hours should seek urgent medical attention.Patients should be instructed in correct injectiontechnique before attempting self injection.Invicorp must be used with caution in severecardiovascular and cerebrovascular conditions.Potential risks related to intercourse in patients onmulti-drug treatment for cardiovascular symptomsmay be increased by <strong>the</strong> treatment and underlyingheart disease. Treatment should be discontinued iftachycardia occurs. Invicorp is unsuitable forconcomitant use with o<strong>the</strong>r treatments forerectile dysfunction. Interactions: No clinicalinteractions have been observed withantihypertensives or o<strong>the</strong>r cardiovascularmedicines.Undesirable effects (per injection):Common: Flushing, bruising at injection site.Uncommon: Haematoma, headache, dizziness,tachycardia, palpitations. Rare: Priapism,prolonged erections; penile nodules/fibrosis(after multiple injections), pain post injection.Very rare: Myocardial infarction, angina pectoris.Overdose: Long-term erections or priapism mayresult and require urgent medical treatment. Referto SPC for fur<strong>the</strong>r details. D.Sp.No.9797Dispensing/supply classification: B. Price (inclVAT): To be confirmed. Reimbursement: Notavailable MA Holder: Ardana Bioscience Ltd, 38Melville Street, Edinburgh EH3 7HA, UK. MTnr:19049 and 19050 Ardana Bioscience is aregistered Trade Mark. Code: ARDINV 002. Date<strong>of</strong> Preparation: November 2006. Aviptadil is <strong>the</strong>INN for Vasoactive Intestinal Polypeptide (VIP)Challenges in<strong>the</strong> ED clinic:Invicorp anew choiceDr. John Dean, UKPr<strong>of</strong>. Francesco Montorsi, ItalyDr. Ge<strong>of</strong>f Hackett, UKPlease join us18.00-19.00Tuesday 27th November 2007Auditorium IWithin <strong>the</strong> EU, marketingauthorisations for Invicorp are currently only availablein DenmarkARD INV 024For when oral <strong>the</strong>rapy doesn’t suitSatellite symposium - supported by

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