International Congress on Head and Neck Tumors 1st Congress of Croatian Head and Neck Society 20 - 22 October 2011 Zagreb, Croatia High Definition – When detail is everything KARL STORZ FULL HD KARL STORZ – FULL HD platform In medicine, precision and focus are key terms. In order to continue developing and enhancing quality standards KARL STORZ has developed a new tool – the FULL HD platform – which guarantees the user a new visual dimension. The highest resolution possible – 5 times greater than the standard – combined with the 16:9 format guarantees brilliant picture quality and larger display details. Now, with an upgrade of the IMAGE1™ CCU, HD quality is becoming ever more accessible to the field of medicine: from the HD camera head right up to the HD WideView™ monitor. DOK 30.1/E/06/07/A All this is perfectly in line with the KARL STORZ philosophy that all previous IMAGE1™ systems as well as their numerous functions are fully compatible and can therefore be used with the FULL HD platform too. KARL STORZ GmbH & Co. KG, Mittelstraße 8, D-78532 Tuttlingen/Germany, Phone: +49 (0)7461 708-0, Fax: +49 (0)7461 708-105, E-Mail: info@karlstorz.de KARL STORZ Endoscopy America, Inc, 2151 E. Grand Avenue, El Segundo, CA 90245-5017, USA, Phone: +1-424-218-8100, Fax: +1-800-321-1304, E-Mail: info@ksea.com KARL STORZ Endoscopia Latino-America, 815 N. W. 57 Av., Suite No. 480, Miami, FL 33126-2042, USA, Phone: +1 305 262-8980, Fax: +1 305 262-89 86, E-Mail: info@ksela.com KARL STORZ Endoscopy Canada Ltd., 2345 Argentia Road, Suite 100, Mississauga, Ontario L5N 8K4, Phone: +1 905 816-8100, Fax: +1 905 858-0933, E-Mail: info@karlstorz.ca www.karlstorz.com Message from the organizer Dear friends and colleagues, it is my great honour and pleasure to invite you to participate in the International Congress on Head and Neck Tumors organized by Croatian Head and Neck Society that will be held in Zagreb, Croatia on October 20-22, 2011. The Croatian Head and Neck Society founded in March 2010 has been established to actively participate in increasing public awareness of Head and Neck Tumors as well as to highlight the importance of both early diagnosis and treatment of these tumors. The major purpose of this Congress is to exchange scientific knowledge and progress made in the field of research and education in Head and Neck oncology. It is also our intent to point out the necessity of multidisciplinary team approach to the management of patients suffering from Head and Neck Tumors. Covering main scientific topics such as New Horizons in Chemoradiotherapy for Head and Neck Tumors, Oral Cavity Cancer, Thyroid Cancer and Laryngeal Cancer this Congress will certainly be of your interest and provide you with the opportunity to learn from the experiences of the world experts in all of these fields. I wish you a very pleasant and fruitful stay in Zagreb. Looking forward to welcoming you all in Zagreb, Kindest regards, Drago Prgomet, MD, PhD Congress President Scientific Committee Jasminka ALAGIĆ SMAILBEGOVIĆ, Bosnia and Herzegovina Naranđa ALJINOVIĆ RATKOVIĆ, Croatia Karine AUBRY, France Vladimir BEDEKOVIĆ, Croatia Woong Youn CHUNG, South Korea Peter G. CORDEIRO, USA Bogdan ČIZMAREVIČ, Slovenia Andreas DIETZ, Germany Damir DODIG, Croatia Danijel DOŠEN, Croatia Davorin ĐANIĆ, Croatia Hans ECKEL, Austria Dan FLISS, Israel Wojciech GOLUSINSKI, Poland Mirko IVKIĆ, Croatia Rajko JOVIĆ, Serbia Mario JURIĆ, Bosnia and Herzegovina Sang Wook KANG, South Korea Jan KLOZAR, Czech Republic Zvonko KUSIĆ, Croatia Dinko LEOVIĆ, Croatia Sonja LEVANAT, Croatia Adem LIMANI, Kosovo Ivica LUKŠIĆ, Croatia Spomenka MANOJLOVIĆ, Croatia Anton MIKIĆ, Serbia Nikola NIKOLOVSKI, Macedonia Jan OLOFFSON, Norway Krešimir PAVELIĆ, Croatia Valdi PEŠUTIĆ, Croatia Cesare PIAZZA, Italy Zoran RAKUŠIĆ, Croatia Marc REMACLE, Belgium Sven SEIWERTH, Croatia Jatin P. SHAH, USA Ricard SIMO, UK Radan STARČEVIĆ, Croatia Vedran UGLEŠIĆ, Croatia Mišo VIRAG, Croatia Croatian Head and Neck Society Committe President Drago PRGOMET Vice Presidents Mirko IVKIĆ Zoran RAKUŠIĆ Secretary Ivica LUKŠIĆ Organizing Comittee Mario BILIĆ Vesna BIŠOF Zaviša ČOLOVIĆ Zdenka HUTINEC Renato JANUŠIĆ Saša JANJANIN Željko KOTROMANOVIĆ Lana KOVAČ BILIĆ Robert TIĆAC Davor VAGIĆ Program Thursday, October 20, 2011 08.30 – 09.15 Opening ceremony Olofsson J European specialization in head and neck oncology 09.15– 10.00 Welcome cocktail 10.00 – 11.30 Head and Neck Cancer – General Session I Moderator: Golusinski W, Grce M Pavelić K High-throughput personalized medicine to bring forward head and neck oncology Klozar J Clinical implications of HPV in head and neck tumors Zvrko E, Mikić A, Jančić S Relationship of E-cadherin with cervical lymph node metastasis in laryngeal cancer Fočo F, Bilalović N, Vranić S, Serdarević F, Ramović I, Imamović E Is there a correlation between peritumoral expression of protein p53 in oral carcinoma and its relapse? Rogan SA, Balenović A, Anić P, Ivkić M, Lukšić I Usefulness and limitations of FDG/PET in the detection of malignancy in treated head and neck squamos cell carcinoma 12.00 – 13.30 Head and Neck Cancer – General Session II Moderator: Klozar J, Ivkić M Golusinski W Young adults in head and neck cancer Program Milisavljević D, Stanković M, Živić M, Petrović D, Stanković P Head and neck cancer surgery in elderly Limani A Locoregionally advanced head and neck cancer, possibilities and challenges Petrović D, Stanković M, Vučković I, Pešić Z, Milisavljević D, Petrović S, Djokić I, Stanković P The influence of different treatment modalities on the functional outcome and survival rate for oral and oropharyngeal carcinoma Alajbeg I, Pastorčić Grgić M, Gršić K, Andabak-Rogulj A, Stubljar B, Tomičević T Strategies for prevention and treatment of head and neck radiotherapy complications - our experiences Beketić-Orešković L Use of enteral nutrition in patient with head and neck malignancies 13.30 – 14.30 Lunch Sponsored by Medtronic 14.30 – 16.00 Laryngeal Cancer Moderator: Simo R, Starčević R Olofsson J Laryngeal cancer. Diagnosis and therapy in past, present and future Piazza C Hypopharyngeal reconstruction by fascio-cutaneous free flaps Jović MR, Čanji K, Dragičević D, Gašić J Near total laryngectomy in management of selected patients with advanced laryngeal and pharyngolaryngeal carcinomas Program Stanković M, Milisavljević D, Stojanov D, Živić M, Živaljević S, Stanković I Influential factors, complications, and survival rate of primary and salvage total laryngectomy for advanced laryngeal cancer Znaor T, Večerina-Volić S, Trotić R, Ivanković D, Papeš V, Lajtman Z The role of mucosal wave in the early detection of glottic cancer Đanić Hadžibegović A, Đanić D, Tičac R, Kozmar A Analysis of pepsin in patients with tracheoesophageal fistula and voice prosthesis complications Mikić A, Zvrko E, Trivić A, Stefanović D, Golubović M Small Cell Neuroendocrine Tumor of the Larynx – A Small Case Series 16.00 – 16.30 Coffee break 16.30 – 18.30 Head and Neck Cancer Moderator: Piazza C, Lukšić I Ostović KT The importance of team work of cytologist and surgeon in preoperative diagnosis of intraoral minor salivary gland tumors Petrović A, Petrović D, Stanković M, Vučković I Update on imaging of head and neck paragangliomas Vuong H, Awada T, Ringenbach P, Andreoletti JB, Saez P, Beck M Thin skin grafted forehead flap with poached cartilage graft Pastorčić Grgić M, Perše P, Tomičević T, Gršić K, Šmalcelj J, Došen D The place of modified radical neck dissection in head and neck squamous cell cancer treatment Solter D, Vagić D, Zurak K, Ivkić M, Bedeković V Gastric tube reconstruction in advanced tumors of the hypopharynx and cervical esophagus Program Vidjak V, Novačić K, Matijević F, Slavica M, Leder NI, Grubelić Crnčević M, Kavur L Postirradiation carotid artery stenosis - Endovascular treatment with carotid artery stenting Znaor T, Kuliš T, Pastorčić-Grgić M, Znaor A Incidence and mortality trends of head and neck cancer in Croatia, 1988-2008 Paštar Z, Lipozenčić J Dermoscopy of the melanocytic and non-melanocytic lesion of the face and scalp Bödeker L SinuFIT / LaryngoFIT – the new concept of ENT instruments from KARL STORZ Friday, October 21, 2011 08.15 – 09.00 Instructional Courses Uglešić V Principles of Midface Reconstruction Piazza C Early laryngeal cancer diagnosis Simo R Treatment of advanced thyroid cancer Ilić D Basics in the surgical navigation 09.00 – 10.00 Modern Technologies Moderator: Remacle M, Bilić M Aubry K Transoral robotic surgery for the treatment of head and neck cancer Program Kang SW Robotic neck dissection for the management of thyroid Janjanin S Harmonic scalpel in head and neck surgery 10.00 – 10.30 Coffee break 10.30 – 12.30 Oral Cancer, panel discussion Moderator: Virag M Panelists: Cordeiro P, Shah J, Tachezy R, Bišof V Shah J Factors affecting treatment of cancer of the oral cavity Tachezy R HPV in the etiology of oral and oropharyngeal cancer Cordeiro P Reconstruction of the mandible with free tissue transfer – outcomes and algorithm for flap selection Virag M Treatment of recurrent oral cancer 12.30 – 13.30 Lunch Sponsored by Medtronic 13.30 – 15.00 Halder R Autofluorescence Diagnostic in ENT Head and Neck Surgery Moderator: Eckel H, Leović D Fliss D Orbital tumors: Resection and reconstruction Program Jurlina M Surgery of skull base tumors Vagić D, Ivkić M, Zurak K, Solter D, Pegan A, Rašić I A transmandibular approach for tumors of the parapharyngeal space Čizmarevič B, Lanišnik B, Dinevski D Cervical lymph node metastasis of squamous cell carcinoma from unknown primary tumor Leović D, Zubčić V, Dinjar K Distant metastases after the treatment of oral and oropharyngeal sqaumous cell cancer 15.00 – 15.30 Coffee break 15.30 – 17.30 Laryngeal cancer, round table Moderator: Prgomet D Panelists: Dietz A, Eckel H, Ivkić M, Remacle M, Rakušić Z Dietz A Nonsurgical larynx preservation therapy – what have we learned until today? Eckel H Surgical treatment of early-stage laryngeal carcinoma Remacle M Transoral robotic surgery for the management of laryngeal cancer Program Saturday, October 22, 2011 09.30 – 10.30 Thyroid surgery I Moderator: Fliss D, Janušić R Shah J Changing epidemiology, management and outcomes in thyroid cancer Chung WY Robotic Thyroid Surgery: technique and outcomes Radović D PET/CT in management of thyroid malignancy - current status 10.30 – 11.00 Coffee break 11.00 – 12.30 Thyroid surgery II Moderator: Jović MR, Vagić D Simo R Management of retrosternal goiters - To split or not to split! Džepina D, Bedeković V, Čupić H, Krušlin B Papillary thyroid microcarcinoma: clinical and pathological study of 321 cases. Salkić A, Brkić F, Čičkušić A, Čičkušić E, Altumbabić H Thyroid cancer in Tuzla region of Bosnia and Herzegovina: a 10-year study (1999-2008) Pastorčić Grgić M, Stublja B, Gršić K, Janušić R, Šmalcelj J, Došen D Indications for reoperation in patients treated for well differentiated thyroid cancer Alagić–Smailbegović J, Kucukalić–Selimović E, Šetić I, Bećirović M, Begović L Importance of measurement of thyroglobulin and anti- thyroglobulin antibodies in differentiated thyroid cancer Poster session Moderator: Đanić D, Čolović Z • Thursday, October 20, 2011, 14.00 – 15.00 Markov-Glavaš D, Makovac I, Jakovčević A Acinic cell carcinoma of the parotid gland in a child Džepina D, Kalogjera L, Baudoin T Recurrent sinonasal melanoma – Report of five surgical cases Boščić D, Vlašić, Frančeski D, Piskac-Živković N, Ožegović I, Kovačić J Synovial sarcoma of the pharynx Carić T, Bilić M, Kovač Bilić L, Kovačić J, Topić Grahovac I, Hutinec Z Neuroendocrine tumors of larynx – two case reports and literature review Roglić A, Šeronja Kuhar M, Markešić J Chondroma of the larynx - case report Bernić A, Novosel I, Križanac Š The Dąbska tumor: a case report Vukasović A, Kusačić Kuna S, Trutin Ostović K, Prgomet D, Banek T Diffuse sclerosing variant of thyroid carcinoma presenting as Hashimoto thyroiditis: a case report Jakovčević A, Hutinec Z, Žarković K, Duška Markov-Glavaš Alveolar rhabdomyosarcoma of the parotid gland: a case report Čandrlić B, Pušić M, Kukuljan M, Matana Z, Cvjetković N Patient with lingual thyroid and squamous cell carcinoma of the tongue base: a case report Boci B Amyloidosis of the larynx Boci B, Thomai K Non-Hodgkin’s lymphomas of the parotid gland Boci B, Zaharia K, Thomai K Neurilemomas of the neck: case report Pauzar B, Karner I, Glavaš-Obrovac Lj, Štefanić M, Dmitrović B Pax8-pparγ oncogene in follicular thyroid tumors: rt-pcr and immunohistochemical analyses Bumber B, Bilić M, Bura M, Prgomet D Supracricoid partial laryngectomy - our experience Filipović B, Pirkl I, Goranović T, Brkić I, Kovačić M, Šimunjak B Paraneoplastic neurological syndrome with demyelinating polyradiculoneuropathy in tonsillar carcinoma patient Poster session Marev D An unusual cause of dysphonia: laryngeal verruca vulgaris Marev D Definitive radiotherapy for carcinoma in situ of the true vocal cords Marev D Nondiagnostic conjunctival map biopsies for sebaceous carcinoma Sauerborn D, Pajić-Penavić I, Stojadinović T Eosinophilic granuloma of the temporal bone in an adult: controversy in management Müller D, Manojlović S, Lukšić I, Grgurević J Calcifying epithelial odontogenic tumor of the maxilla Đanić D, Đanić Hadžibegović A, Stojadinović T, Damjanović D, Gudelj A, Mahovne I Harmonic scalpel surgical treatment of the tongue angioleomyoma - case report and review of the literature Pedisić D, Tićac R, Čandrlić B, Marijić B, Malvić G, Velepič M, Starčević R The use of neck ultrasound to determine the length of a Provox II voice prosthesis Leović D, Levanat S, Sabol M, Ozretić P, Sikora M Hedgehog signaling pathway in oral and oropharyngeal squamous cell carcinomas Klišeska E, Makovac I Skip metastases in thyroid cancer Košlabová E, Klozar J , Hamšíková E, Rotnáglová E, Saláková M, Tachezy R Markers of HPV infection and their clinical relevance Fustar-Preradović Lj, Đanic D, Kardum-Skelin I Morphometry in differential diagnosis of pathologically altered parathyroid glands Malvić G, Manestar D, Krstulja M, Čorak D, Čandrlić B, Kujundžić M, Velepič M, Starčević R Juvenile angiofibroma of the maxillary sinus Gršić K, Šitić S, Pastorčić Grgić M, Stubljar B, Perše P, Došen D Merkel cell carcinoma of oral mucosa - case report Vučinić I, Stojadinović T, Borić Mikez Z, Đanić D, Coha B Apocrine carcinoma of the scalp with agressive clinical course – a case report and review of the literature Lukšić I, Suton P, Manojlović S, Macan D, Dediol E Pleomorphic adenoma in ectopic salivary gland tissue in the neck Lukinović J, Bilić M, Raguž I, Živković T, Kovač Bilić L, Prgomet D Overview of 100 patients with voice prosthesis after total laryngectomy – experience of single institutions Poster session Karadža- Lapić Lj, Karađole Č Benign tracheal tumor: a case report Širić Lj, Šoš D, Rosso M, Stevanović S Objective assessment of tracheoesophageal and esophageal speech using acoustic analysis of voice Marjanović Kavanagh M, Janjanin S, Hutinec Z Cardiac metastases and a sudden death as a complication of advanced stage of head and neck squamous cell carcinoma Moderator: Stanković M, Znaor T • Friday, October 21, 2011, 13.00 – 14.00 Perić M, Miličić V, Pajter M, Marjanović K, Zubčić V Potential value and disadvantages of fine needle aspiration cytology in diagnosis of ameloblastoma Rosso M, Širić Lj, Tićac R, Starčević R, Šegec I, Kraljik N Perceptual evaluation of alaryngeal speech Rosso M, Kraljik N, Mihaljević I, Širić Lj, Šoš D, Vranješ Ž Epidemiology of laryngeal cancer in Osijek - Baranja County (Eastern Croatia) Snovak N, Bilić M, Žarković K Merkel cell carcinoma: Report of three cases Drviš P, Ries M, Zurak K, Trotić R, Ajduk J, Stevanović S Hidradenoma of external auditory canal: Clinical presentation and surgical treatment Slipac J, Janjanin S, Ljepava D, Hutinec Z, Bence-Žigman Z Thyroid metastasis from breast carcinoma resembling medullary thyroid carcinoma. A case report Starčević R, Marijić B, Manestar D, Pedisić D, Bonifačić D Rare tumour of the epipharynx – case report Tićac R, Čandrlić B, Juranić J, Pavelić G, Pedisić D, Pušić M, Starčević R Videofluoroscopy and ultrasound role in assessment of laryngoesophageal muscle tonus after laryngectomy Tićac R, Živković Ivanović T, Kirinić Papeš V, Starčević R, Pedisić D, Vukelić J, Marijić B, Velepič M, Čandrlić B, Comparative acoustic analysis of Provox 2 and Provox Vega voice prosthesis Rudeš M, Bilić M, Jurlina M, Prgomet D Pectoralis major myofascial flap in reconstructive surgery of the head and neck – our experience Ristić S Holistic stimulating method in patients with total laryngectomy Poster session Grabovac S , Đanić Hadžibegović A , Markešić J Inferior turbinate osteoma as a cause of unilateral nose obstruction – case report Grabovac S, Cikoja I, Maličić Dalipi V, Čujić Lj, Planinić I Minimally invasive surgery as a possibility of an atypical larynx carcinoid treatment. Braut T, Kujundžić M, Vukelić J, Manestar D, Krstulja M, Starčević R, Grahovac B Gene amplification of epidermal growth factor receptor in atypical glottic hyperplasia Goranović T, Pirkl I, Filipović B, Parazajder D, Gudelj G, Šimunjak B Diabetes mellitus, wound healing and wound infection in neck dissection Bauer V, Alerić Z Rare tumors of the head and neck found in the practice of Karlovac county hospital otorhinolaringologysts Orovčanec G Lipoma sinus piriformis Dediol E, Manojlović S, Tomasović Lončarić Č, Biočić J, Hat J Inflammatory pseudotumor presenting as a facial swelling Bišof V ERCC1 expression in head and neck carcinoma treated with radiotherapy alone or cisplatin-based concurrent chemoradiotherapy Kukić Brusić S, Pušić M, Cvjetković N, Karnjuš R, Čandrlić B, Kukuljan, Matana Kaštelan Z, Miletić D Osteosarcoma of the mastoid process following radiation therapy of mucoepidermoid carcinoma of the parotid gland – a case report Makaruha K, Plaščak J, Lajtman Z, Kavur L, Bačić A Giant parapharyngeal space lipoma: radiological findings and surgical approach Birtić D, Včeva A, Kotromanović Ž, Zubčić Ž, Mihalj H, Jovanović S Significance pepsin from saliva in diagnosis and treatment laryngopharyngeal reflux disease Kotromanović Ž, Birtić D, Včeva A, Medić D, Zubčić Ž, Mihalj H, Kotromanović Z, Erić S, Dmitrović B, Štefanić M Non – functional parathyroid carcinoma – rare malignant tumor of the head and neck Kotromanović Ž, Mihalj H, Zubčić Ž, Včeva A, Birtić D, Kotromanović Z, Rajc J Angiosarcoma of the hypopharynx – a case report General Information Date & venue October 20 – 22, 2011 Hotel Antunović, Zagrebačka avenija 100A Zagreb, Croatia Congress Language The official language of the Congress is English Thursday, October 20, 2011 Lecture Hall Schedule Friday, October 21, 2011 Instructional Courses HALL BEETHOVEN 1 HALL BEETHOVEN 1 3 sections of HALL TOMISLAV Oral cancer, panel discussion HALL BEETHOVEN 1 Head and Neck Surgery HALL BEETHOVEN 1 Laryngeal cancer, round table HALL TOMISLAV Saturday, October 22, 2011 HALL BEETHOVEN 1 Poster Session (Thursday and Friday) HALL BEETHOVEN 3 CME Accreditation Congress will be accredited by Croatian Medical Chamber Registration fee includes Admission to all Congress sessions, posters, instructional courses and exhibition areas, Certificate of Attendance, Welcome cocktail, Congress coffee breaks and lunches, Congress bag and material All papers accepted after a review process will be published in issue of Collegium Antropologicum as abstracts or full text articles. Oral presentation will be 8 minutes and invited lectures 20 and 30 minutes long. The poster session will be guided, meaning that the poster presenting authors will have to present the content of their poster to the Chairpersons. Registration desk will be open every day from 7.30 am. You can apply for Instructional courses at the registration desk. There is a limitation of maximum 15 participants per Course Website www.tumoriglave.com Tehnical Organizer FILIDA TRAVEL AGENCY Selska 92 b, 10 000 Zagreb Office hours: monday – friday 09 -17 850.00 KN per persone per night in 1/1 room 530.00 KN per persone per night in 1/2 room Phone: +385 1 4616 520/522 Fax: +385 1 4616 521 e-mail: info@filidatravel.hr web: www. filidatravel.hr RAIFFEISEN BANK: 2484008-1101947031 IBAN: HR0524840081101947031 SWIFT: RZBHHR2X * registration fee can be paid to the bank account of the Technical Organizer **in the field payment purpose please write „registration fee for Head and Neck Congress“ For each individual accommodation we recommend you to contact FILIDA TRAVEL AGENCY. ENDOSCOPY DEVICES Ultrasound system The special ultrasound scissors for thyroid surgery Minimally-invasive procedures compete with conventional routes of access in virtually every indication in visceral surgery; in many diseases (such as cholecystolithiasis), they themselves have become the standard procedure. In thyroid surgery, various minimallyinvasive access routes have been developed over the past decade. The cosmetic benefits and reduced post-operative strain on the patient lead to the increasing importance of minimally-invasive procedures of the thyroid glands. Rješenje za oči i nos AVYS-11/05/2011-ADV CRO/FF/0006/11 Iz bilo kojeg razloga U bilo kojoj sezoni Sastavni dio ovog materijala predstavlja odobreni Sažetak opisa svojstava lijeka, sukladno Pravilniku o načinu oglašavanja o lijekovima i homeopatskim proizvodima, Narodne novine br. 118/09. Prije propisivanja lijeka, molimo pročitajte zadnji odobreni Sažetak opisa svojstava lijeka i Uputu o lijeku. Samo za zdravstvene radnike. AVAMYS SKRAĆENI SAŽETAK OPISA SVOJSTAVA LIJEKA. NAZIV LIJEKA AVAMYS 27,5 mikrograma/ potisnoj dozi Sprej za nos, suspenzija KVALITATIVNI I KVANTITATIVNI SASTAV Jedna potisna doza spreja sadrži 27,5 mikrograma flutikazonfuroata. Terapijske indikacije Odrasli, adolescenti (12 i više godina) i djeca (6-11 godina) Avamys se primjenjuje u liječenju simptoma alergijskog rinitisa. Doziranje i način primjene Odrasli i adolescenti (12 i više godina): Preporučena početna doza je dvije inhalacije spreja jednom na dan (27,5 mikrograma flutikazonfuroata po svakoj inhalaciji spreja) u svaku nosnicu (ukupna dnevna doza 110 mikrograma). Djeca (6 do 11 godina): Preporučena početna doza je jedna inhalacija spreja (27,5 mikrograma flutikazonfuroata po svakoj inhalaciji spreja) u svaku nosnicu jednom na dan (ukupna dnevna doza 55 mikrograma). Djeca ispod 6 godina starosti: Iskustvo primjene lijeka u djece ispod 6 godina starosti je ograničeno (vidi poglavlje 5.1 i 5.2). Sigurnost i učinkovitost primjene lijeka u ovoj skupini nisu dobro utvrđene. Kontraindikacije Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari lijeka Avamys. Posebna upozorenja i mjere opreza Flutikazonfuroat prolazi ekstenzivni metabolizam prvog prolaza te je stoga vjerojatno povećanje sistemske izloženosti intranazalnom flutikazonfuroatu kod bolesnika s teškim oboljenjem jetre, što može rezultirati većom učestalošću sistemskih nuspojava (vidi poglavlje 4.2 i 5.2). Savjetuje se oprez u liječenju spomenutih bolesnika. Može doći do pojave sistemskih učinaka nazalno primjenjenih kortikosteroida, osobito pri visokim dozama propisanima u produljenom razdoblju. Ovi učinci variraju među bolesnicima i različitim kortikosteroidima (vidi poglavlje 5.2). Liječenje višim dozama nazalno primjenjenih kortikosteroida od preporučenih može imati za posljedicu klinički značajnu adrenalnu supresiju. Ako postoji dokaz o primjeni viših doza od preporučenih, potrebno je razmotriti dodatnu zaštitu od sistemskih kortikosteroida tijekom stresnih razdoblja ili elektivnih kirurških zahvata. Flutikazonfuroat 110 mikrograma jednom na dan nije bio povezan sa supresijom osovine hipotalamus-hipofiza-nadbubrežna žlijezda (HPA) kod subjekata odrasle, adolescentske i dječje dobi. Međutim, potrebno je smanjiti intranazalnu dozu flutikazonfuroata na najnižu dozu kojom se učinkovito održava kontrola simptoma rinitisa. Avamys sadrži benzalkonij klorid, koji može izazvati iritaciju sluznice nosa. Nuspojave Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često: epistaksa. Često: ulceracija nosa. Epistaksa je općenito bila blagog do umjerenog intenziteta. Kod odraslih i adolescenata, stopa incidencije epistakse bila je viša u dugotrajnoj primjeni (dulje od 6 tjedana) nego u kratkotrajnoj primjeni (do 6 tjedana). U pedijatrijskim kliničkim ispitivanjima, u trajanju do 12 tjedana, stopa incidencije epistakse bila je slična između bolesnika koji su primali flutikazonfuroat i bolesnika koji su primali placebo. Sadržaj pakiranja Avamys sprej za nos je plastična naprava žućkastobijele boje, s otvorom dozirnog indikatora, svijetloplavom bočnom ručicom za aktivaciju i poklopcem koji sadrži čep. Plastična naprava sadržava sprej za nos u obliku suspenzije u smeđoj (staklenoj) bočici tipa I, s odmjernom pumpicom raspršivača. Lijek je dostupan u veličini pakiranja: 120 doza. NOSITELJ ODOBRENJA GlaxoSmithKline d.o.o., Livadarski put 7, 10 000 Zagreb. KLASA RJEŠENJA O ODOBRENJU ZA STAVLJANJE GOTOVOG LIJEKA U PROMET UP/I-530-09/08-01/344. NAČIN IZDAVANJA Samo na liječnički recept. DATUM PRVOG ODOBRENJA/OBNOVE ODOBRENJA 04. lipnja 2009. (ALMP-06/2009). Sastavni dio ovog promotivnog materijala predstavljaju i cjelokupni odobreni Sažetak opisa svojstava lijeka sukladno pravilniku o načinu oglašavanja o lijekovima i homeopatskim proizvodima, Narodne novine br. 118/09. Prije propisivanja lijeka, molimo pročitajte zadnji odobreni Sažetak opisa svojstava lijeka i Uputu o lijeku. PLATINUM SPONSORS GOLDEN SPONSOR iga d.o.o.
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