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th Anniversary 15 Congress of Nice, France, 24-26 March 2010 ABSTRACT BOOK “Focus on pharmacotherapy - hospital pharmacists advancing patient care” The European Association of Hospital Pharmacists (EAHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education I]Vc`ndjid:6=EÉheVgicZgh[dg EAHP Platinum Partner EAHP Gold Partners i]Z^ghjeedgiVcYXdaaVWdgVi^dc# ©2010 Amgen Inc. All rights reserved. NP-AMG-602-2009 TABLE OF CONTENTS AND INFORMATION GENERAL INFORMATION............................................................................................. 1 CALL FOR ABSTRACTS - Vienna Congress from 30 March – 1 April 2011.................. 3 Format......................................................................................................................................... 3 PosterAward................................................................................................................................. 5 EAHP-EPSA Award..................................................................................................................... 7 ORAL PRESENTATIONS............................................................................................... 9 POSTER AWARD NOMINEE PRESENTATIONS............................................................. 12 POSTER PRESENTATION.............................................................................................. 14 GROUP A: HOSPITAL PHARMACY............................................................................... 14 GROUP B: MANAGEMENT AND STRATEGY................................................................. 34 GROUP C: PHARMACOECONOMICS............................................................................ 38 GROUP D: PHARMACEUTICAL TECHNOLOGY............................................................. 42 GROUP E: CLINICAL PHARMACY................................................................................. 44 GROUP F: DRUG INFORMATION.................................................................................. 60 GROUP G: DRUG SAFETY........................................................................................... 67 GROUP H: INFECTIOUS DISEASES.............................................................................. 76 GROUP I: ONCOLOGY............................................................................................... 83 GROUP J: PHARMACOKINETICS................................................................................. 88 GROUP K: CASE REPORT............................................................................................ 91 GROUP L: HOSPITAL PHARMACY PRACTICE............................................................. 100 GENERAL INFORMATION The poster judging will take place on Thursday, 25 March 2010. Poster presenters must check in with the hostesses in the poster area (level 3 of congress centre) on Wednesday, 24 March, and they will assist participants with hanging their posters in the proper area. The poster prize winners must be present at the closing ceremony on Friday, 26 March in order to win. DISCLAIMER EAHP makes no representations or warantees of any kind expressed or implied about the completeness, accuracy, reliability, suitability or availability with respect to the content of the abstracts and related graphics and tables. Any reliance you place on such information is therefore at your own risk. In no event will EAHP be reliable for any loss or dammage arrising from or in connection with the content of these abstracts. 15th Anniversary Congress of EAHP 1 ® Xarelto®MGnTAB¬` ORAL, once-daily Xarelto : Public Price Belgium Reshaping the future of clot prevention New Hip, New Level of Protection from VTE SUPERIOR EFFICACY in elective hip replacement surgery1 Total VTE risk reduction 70% in head to head comparison with enoxaparin1* REASSURING SAFETY Similar safety profile compared with enoxaparin1,2 222#) TO0 INMODIlED)44POPULATION total VTE: any DVT, non-fatal PE, and all-cause mortality. 1. %RIKSSON")ETALN Engl J Med. n 2. Kakkar AK et al. Lancet. Xarelto® 10 mg film-coated tablets Qualitative and quantitative composition: Each film-coated tablet contains 10 mg rivaroxaban. Excipients: Each headache or unexplained swelling. Therefore, the possibility of haemorrhage is to be considered in evaluating the condition film-coated tablet contains 27.9 mg lactose monohydrate. Pharmaceutical form: Film-coated tablet (tablet). Therapeutic INANYANTICOAGULATEDPATIENT!DVERSEREACTIONSINTHETHREEPHASE)))STUDIESARELISTEDBELOWBYSYSTEMORGANCLASS indications: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement (in MedDRA) and by frequency. Frequencies are defined as: Common: rTO 5NCOMMONr TO surgery. Posology and method of administration: The recommended dose is 10 mg rivaroxaban taken orally 2AREr TO 6ERYRARE .OTKNOWNCANNOTBEESTIMATEDFROMTHEAVAILABLEDATA once daily. The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established. The ■ Investigations: ◆#OMMON)NCREASED''4 INCREASEINTRANSAMINASESINCL!,4INCREASE !34INCREASE ◆ Uncommon: duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the )NCREASED LIPASE INCREASED AMYLASE BLOOD BILIRUBIN INCREASED INCREASED ,$( INCREASED ALKALINE PHOSPHATASE ◆ Rare: TYPEOFORTHOPAEDICSURGERYs&ORPATIENTSUNDERGOINGMAJORHIPSURGERY ATREATMENTDURATIONOFWEEKSISRECOMMENDED "ILIRUBINCONJUGATEDINCREASEDWITHORWITHOUTCONCOMITANTINCREASEOF!,4 ■ Cardiac disorders: ◆ Uncommon: s&ORPATIENTSUNDERGOINGMAJORKNEESURGERY ATREATMENTDURATIONOFWEEKSISRECOMMENDED)FADOSEISMISSEDTHEPATIENT Tachycardia ■ Blood and lymphatic system disorders: ◆ Common: Anaemia (incl. respective laboratory should take Xarelto immediately and then continue the following day with once daily intake as before. Xarelto can be taken with parameter) ◆ Uncommon: Thrombocythaemia (incl. platelet count increased) ■ Nervous system disorders: ◆ Uncommon: ORWITHOUTFOOD2ENALIMPAIRMENT.ODOSEADJUSTMENTISNECESSARYINPATIENTSWITHMILDRENALIMPAIRMENTCREATININECLEARANCE 3YNCOPE INCL LOSS OF CONSCIOUSNESS DIZZINESS HEADACHE ■ Gastrointestinal disorders: ◆ Common: Nausea MLMIN ORMODERATERENALIMPAIRMENTCREATININECLEARANCE MLMIN SEESECTION ,IMITEDCLINICAL ◆ Uncommon: Constipation, diarrhoea, abdominal and gastrointestinal pain (incl. upper abdominal pain, stomach DATAFORPATIENTSWITHSEVERERENALIMPAIRMENTCREATININECLEARANCE MLMIN INDICATETHATRIVAROXABANPLASMA discomfort), dyspepsia (incl. epigastric discomfort), dry mouth, vomiting ■ Renal and urinary disorders: concentrations are significantly increased in this patient population, therefore, Xarelto is to be used with caution ◆ Uncommon: Renal impairment (incl. blood creatinine increased, blood urea increased) ■ Skin and subcutaneous IN THESE PATIENTS 5SE IS NOT RECOMMENDED IN PATIENTS WITH CREATININE CLEARANCE MLMIN (EPATIC IMPAIRMENT tissue disorders: ◆ Uncommon: Pruritus (incl. rare cases of generalised pruritus), rash, urticaria (incl. rare cases of Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant generalised urticaria), contusion ■ Musculoskeletal and connective tissue disorders: ◆ Uncommon: BLEEDINGRISKSEESECTIONSAND 8ARELTOMAYBEUSEDWITHCAUTIONINCIRRHOTICPATIENTSWITHMODERATEHEPATIC Pain in extremity ■ )NJURY POISONING AND PROCEDURAL COMPLICATIONS ◆ Uncommon: Wound secretion ■ Vascular IMPAIRMENT#HILD0UGH" IFITISNOTASSOCIATEDWITHCOAGULOPATHY.ODOSEADJUSTMENTISNECESSARYINPATIENTSWITH disorders: ◆ Common: Post-procedural haemorrhage (incl. post-operative anaemia, and wound haemorrhage) OTHERHEPATICDISEASES0ATIENTSABOVEYEARS.ODOSEADJUSTMENT"ODYWEIGHT.ODOSEADJUSTMENT'ENDER.O ◆ 5NCOMMON (AEMORRHAGE INCL HAEMATOMA AND RARE CASES OF MUSCLE HAEMORRHAGE GASTROINTESTINAL TRACT DOSE ADJUSTMENT #HILDREN AND ADOLESCENTS 8ARELTO IS NOT RECOMMENDED FOR USE IN CHILDREN OR ADOLESCENTS BELOW haemorrhage (incl. gingival bleeding, rectal haemorrhage, haememesis), haematuria (incl. blood urine present), genital YEARSOFAGEDUETOALACKOFDATAONSAFETYANDEFlCACYContraindications:(YPERSENSITIVITYTOTHEACTIVESUBSTANCE tract haemorrhage (incl. menorrhagia), hypotension (incl. blood pressure decreased, procedural hypotension), nose bleed ORTOANYOFTHEEXCIPIENTS#LINICALLYSIGNIlCANTACTIVEBLEEDING(EPATICDISEASEASSOCIATEDWITHCOAGULOPATHYANDCLINICALLY ◆.OTKNOWN "LEEDINGINTOACRITICALORGANEGBRAIN ADRENALHAEMORRHAGE CONJUNCTIVALHAEMORRHAGE HAEMOPTYSIS relevant bleeding risk. Pregnancy and lactation. Undesirable effects: The safety of rivaroxaban 10 mg has been ■ General disorders and administration site conditions: ◆ 5NCOMMON ,OCALISED OEDEMA PERIPHERAL EVALUATEDINTHREEPHASE)))STUDIESINCLUDING PATIENTSEXPOSEDTORIVAROXABANUNDERGOINGMAJORORTHOPAEDICSURGERY oedema, feeling unwell (incl. fatigue, asthenia), fever ■ Immune system disorders: ◆ Rare: Dermatitis allergic OFTHELOWERLIMBSTOTALHIPREPLACEMENTORTOTALKNEEREPLACEMENT TREATEDFORUPTODAYS)NTOTAL ABOUTOF ◆.OTKNOWN (YPERSENSITIVITY■ Hepatobiliary disorders: ◆2ARE(EPATICFUNCTIONABNORMAL◆ Not known*: Jaundice. THETREATEDPATIENTSEXPERIENCEDADVERSEREACTIONS"LEEDINGSORANAEMIAOCCURREDINAPPROXIMATELYANDOF !DVERSEEVENTSHAVEBEENREPORTEDINOTHERCLINICALSTUDIESTHANTHETHREEPHASE)))STUDIESINPATIENTSUNDERGOINGMAJOR PATIENTS RESPECTIVELY/THERCOMMONADVERSEREACTIONSWERENAUSEA INCREASED''4ANDANINCREASEINTRANSAMINASES4HE orthopaedic surgery of the lower limbs. Nature and contents of container:00!LUMINIUMFOILBLISTERSOR06#
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  • TRANSPARENCY COMMITTEE OPINION 4 February 2009 KUVAN

    TRANSPARENCY COMMITTEE OPINION 4 February 2009 KUVAN

    The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 4 February 2009 KUVAN 100 mg, soluble tablet Box of 30 tablets (CIP: 390 462-4) Box of 120 tablets (CIP: 390 463-0) Applicant: MERCK LIPHA SANTE sapropterin dihydrochloride List I Medicinal product for hospital prescription only Orphan drug ATC Code: A16AX07 Date of Marketing Authorisation (centralised procedure): 2 December 2008 Reason for request : inclusion on the list of medicinal products approved for use by hospitals. Medical, Economic and Public Health Assessment Division 1 1 CHARACTERISTICS OF THE MEDICINAL PRODUCT 1.1. Active ingredient sapropterin dihydrochloride 1 1.2. Indications "KUVAN is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and children aged four or over suffering from phenylketonuria (PKU) who have been shown to be responsive to such treatment. KUVAN is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and children aged four or over with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment." N.B.: Hyperphenylalaninaemia (HPA), which is an abnormal elevation of blood phenylalanine levels, is normally caused by autosomal recessive mutations of the genes coding for phenylalanine hydroxylase (in the case of PKU) or for the enzymes involved in the biosynthesis or regeneration of 6R-tetrahydrobiopterin (6R-BH4) (in the case of BH4 deficiency). The aim of administering KUVAN to patients suffering from PKU who are responsive to BH4 is to boost the activity of the defective phenylalanine hydroxylase and, as a consequence, to increase or sufficiently restore the oxidative metabolism of phenylalanine in order to reduce or maintain blood phenylalanine levels, to prevent or reduce the build-up of phenylalanine and to increase tolerance of dietary phenylalanine.