FrancophonIA/ELRC3.0 huggingface dataset:
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
Croatian: Icandra 50 mg/850 mg filmom obložene tablete Icandra 50 mg/1000 mg filmom obložene tablete
English: Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Croatian: Dostupno u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
English: How to store Icandra
Croatian: Kako Čuvati Icandru
English: Aluminium/Aluminium (PA/Alu/PVC/Alu) blister Available in packs containing 10, 30, 60, 120,180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Croatian: Dostupno u pakiranjima koja sadrže 10, 30, 60, 120,180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima koja sadrže 120 (2 pakiranja od 60), 180 (3 pakiranja od 60) ili 360 (6 pakiranja od 60) filmom obloženih tableta.
English: Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Icandra 50 mg/850 mg filmom obložene tablete vildagliptin/metforminklorid
English: Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Icandra 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Croatian: Icandra 50 mg/850 mg filmom obložene tablete Icandra 50 mg/1000 mg filmom obložene tablete vildagliptin/metforminklorid
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru..
English: EU/1/08/484/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/030 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/08/484/007 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/008 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/009 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/010 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/011 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/012 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/025 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/026 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/027 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/028 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/029 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/030 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: EU/1/08/484/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/024 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/08/484/001 10 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/002 30 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/003 60 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/004 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/005 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/006 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/019 10 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/020 30 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/021 60 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/022 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/023 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/024 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: - For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Icandra should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Croatian: Uobičajena početna doza Icandre mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) plus dosadašnja doza metformina.
English: EU/1/08/484/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/036 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/08/484/016 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/017 180 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/018 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/034 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/035 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/036 360 filmom obloženih tablet (PCTFE/PVC/Al)
English: EU/1/08/484/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/033 360 film-coated tablets (PCTFE/PVC/Alu)
Croatian: EU/1/08/484/013 120 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/014 180 filmom obloženih tableta (PA/Al/PVC/Alu) EU/1/08/484/015 360 filmom obloženih tableta (PA/Al/PVC/Al) EU/1/08/484/031 120 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/032 180 filmom obloženih tableta (PCTFE/PVC/Al) EU/1/08/484/033 360 filmom obloženih tableta (PCTFE/PVC/Al)
English: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Croatian: Mylan Pharmaceuticals, S.L. Tel: +34 93 378 64 00
English: Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
Croatian: Intanza sadrži 15 mikrograma svakog od tri soja (vrste) virusa gripe (podvrsta H1N1, A/California/7/2009, NYMC X-179A, podvrsta H3N2, A/Hong Kong/4801/2014, NYMC X-263B i tip B, B/Brisbane/60/2008, divlji soj).
English: Influenza vaccine (split virion, inactivated)
Croatian: Cjepivo protiv influence (fragmentirani virion, inaktivirano)
English: What measures are being taken to ensure the safe and effective use of Intanza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Intanza?
English: Two other studies looked at use of a lower strength in people under the age of 60.
Croatian: U drugim dvama ispitivanjima proučavane su primjene manjih doza u ljudi mlađih od 60 godina.
English: This is a summary of the European public assessment report (EPAR) for Intanza.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Intanza.
English: Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Intanza before the
Croatian: Fragmenti sojeva virusa za koje se očekuje da će prouzročiti gripu u nadolazećoj sezoni, u skladu s preporukama SZO-a za sjevernu hemisferu kao i preporukama Europske unije (EU), moraju biti dodani cjepivu Intanza prije korištenja.
English: Intanza is a vaccine.
Croatian: Intanza je cjepivo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Intanza.
English: The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Croatian: Najčešće nuspojave cjepiva Intanza (zabilježene u više od 1 na 10 osoba) su glavobolja, bol u mišićima, i lokalne reakcije na mjestu cijepljenja (crvenilo, oteklina, otvrdnuće kože, bol i svrbež).
English: Intanza contains fragments from three different strains of flu virus.
Croatian: Intanza sadrži fragmente iz triju različitih sojeva virusa gripe.
English: Intanza is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Croatian: Intanza se koristi za cijepljenje osoba od 60 godina i starijih protiv gripe, posebice onih koji su izloženi većem riziku od razvijanja komplikacija bolesti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intanza have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Intanza nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The ability of Intanza to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Croatian: Sposobnost lijeka Intanza da potakne stvaranje protutijela (imunogenost) ocijenjena je u pet glavnih ispitivanja koja su obuhvatila gotovo 9 000 bolesnika.
English: Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
Croatian: Intanza se ne smije primjenjivati u osoba koje se preosjetljive (alergične) na djelatne tvari ili na bilo koji drugi sastojak, odnosno na bilo koju komponentu koja može biti prisutna u vrlo malim količinama poput jaja (ovalbumin, pileći protein), neomicina, formaldehida ili octoksinola 9. Osobe koje imaju vrućicu ili akutnu (kratkoročnu) upalu ne smiju primiti cjepivo sve dok se ne oporave.
English: Intanza is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Croatian: Intanza se primjenjuje „intradermalnom” injekcijom u gornji sloj kože uz pomoć posebnog sustava mikroinjekcije.
English: The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.
Croatian: Ispitivanjima je uspoređena sposobnost cjepiva da aktivira stvaranje protutijela (imunogenost), uspoređujući razine protutijela prije injekcije i tri tjedna nakon injekcije.
English: Intanza is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Croatian: Intanza je cjepivo koje je dostupno kao suspenzija za injekciju u prethodno napunjenoj štrcaljki.
English: Other information about Intanza
Croatian: Ostale informacije o lijeku Intanza
English: The CHMP decided that Intanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Intanza nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
Croatian: U jednom ispitivanju u osoba u dobi od 60 godina i starijih Intanza je uspoređena s cjepivom protiv gripe koje sadrži adjuvans (spoj koji se dodaje za pojačanje imunosnog odgovora).
English: Why has Intanza been approved?
Croatian: Zašto je lijek Intanza odobren?
English: In the five original studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Croatian: U pet prvotnih ispitivanja Intanza i usporedno cjepivo doveli su do primjerenih razina protutijela za zaštitu protiv sva tri soja gripe.
English: What is the risk associated with Intanza?
Croatian: Koji su rizici povezani s lijekom Intanza?
English: In all studies, Intanza was compared with another flu vaccine given by injection into a muscle.
Croatian: U svim je ispitivanjima Intanza uspoređena s drugim cjepivom protiv gripe koje se primjenjuje injekcijom u mišić.
English: Later seasonal formulations of Intanza have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Croatian: Kasnije sezonske formulacije lijeka Intanza potaknule su slične odgovore protutijela protiv sva tri soja gripe uključena u cjepivo kao u glavnim ispitivanjima.
English: The full EPAR for Intanza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Intanza nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Intanza pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: How does Intanza work?
Croatian: Kako djeluje Intanza ?
English: The European Commission granted a marketing authorisation valid throughout the EU for Intanza on
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Intanza na snazi u Europskoj uniji od 24. veljače 2009.
English: What benefit has Intanza shown during the studies?
Croatian: Koje su koristi lijeka Intanza utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Intanza, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni cjepiva Intanza potražite u uputi o lijeku.
English: Ameluz (5-aminolaevulinic acid)
Croatian: Ameluz (5-aminolevulinatna kiselina)
English: What is Ameluz and what is it used for?
Croatian: Što je Ameluz i za što se koristi?
English: This method of treatment involves applying a source of light to activate the medicine.
Croatian: Taj način liječenja obuhvaća izlaganje izvoru svjetlosti radi aktiviranja lijeka.
English: Ameluz is available as a gel (78 mg/g) to be applied to the skin.
Croatian: Ameluz je dostupan u obliku gela (78 mg/g) koji se nanosi na kožu.
English: Ameluz received a marketing authorisation valid throughout the EU on 14 December 2011.
Croatian: Lijek Ameluz dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 14. prosinca 2011.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom svjetlosti, aktivira se fotosenzitivni agens koji reagira s kisikom u stanicama i stvara vrlo reaktivnu i toksičnu vrstu kisika.
English: What measures are being taken to ensure the safe and effective use of Ameluz?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ameluz?
English: Other information about Ameluz
Croatian: Ostale informacije o lijeku Ameluz
English: An overview of Ameluz and why it is authorised in the EU
Croatian: Pregled informacija o proizvodu Ameluz i zašto je odobren u EU-u
English: It can only be obtained with a prescription and should only be given under the supervision of a healthcare professional experienced in using photodynamic therapy.
Croatian: Lijek se izdaje samo na liječnički recept i smije se davati samo pod nadzorom zdravstvenog radnika s iskustvom u primjeni fotodinamičke terapije.
English: The state of the growths or lesions should be monitored three months after treatment, and any remaining growths or lesions should be retreated.
Croatian: Stanje izraslina ili lezija potrebno je pratiti sljedeća tri mjeseca nakon liječenja, a preostale izrasline ili lezije potrebno je ponovno liječiti.
English: It must not be used in people who have porphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases caused by exposure to light.
Croatian: Ne smije se primjenjivati u osoba koje imaju porfiriju (nemogućnost razgradnje kemikalija zvanih porfirini) ili u osoba koje imaju određene kožne bolesti uzrokovane izlaganjem svjetlosti.
English: The main measure of effectiveness in all studies was the total number of patients whose actinic keratoses or cancer lesions had all cleared up three months after the last treatment.
Croatian: Glavno mjerilo učinkovitosti u svim ispitivanjima bio je ukupan broj bolesnika u kojih su se aktinička keratoza ili lezije raka povukle nakon tri mjeseca od zadnje terapije.
English: Why is Ameluz authorised in the EU?
Croatian: Zašto je lijek Ameluz odobren u EU-u?
English: The European Medicines Agency concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative.
Croatian: Europska agencija za lijekove zaključila je da su koristi od liječenja lijekom Ameluz veće od nekoliko uglavnom blagih nuspojava te da je Ameluz učinkovitiji i donekle sigurniji od standardnih alternativnih načina liječenja.
English: Ameluz can also be used in adults to treat certain types of basal cell carcinoma (a type of skin cancer) when it cannot be treated by surgery.
Croatian: Ameluz se također može koristiti u odraslih osoba za liječenje određenih vrsta raka bazalnih stanica (vrste raka kože) kad ga se ne može liječiti kirurškim zahvatom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ameluz have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ameluz nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Side effects reported with Ameluz are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ameluz pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Ameluz are continuously monitored.
Croatian: Kao i za sve lijekove, podaci o primjeni lijeka Ameluz kontinuirano se prate.
English: What are the risks associated with Ameluz?
Croatian: Koji su rizici povezani s lijekom Ameluz?
English: This kills the cells by reacting with and destroying their components, such as proteins and DNA.
Croatian: Stanice se uništavaju reaktivnim djelovanjem u stanicama i uništavanjem njihovih sastavnica, kao što su bjelančevine i DNK.
English: Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins, soybeans or peanuts, or any of the ingredients.
Croatian: Lijek Ameluz ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na 5-aminolevulinatnu kiselinu, porfirine, soju, kikiriki ili bilo koji drugi sastojak lijeka.
English: The most common side effects with Ameluz (seen in more than 1 patient in 10) are reactions at the site of application, including erythema (reddening of the skin), pain (including burning pain), irritation, itching, oedema (swelling), scab formation, exfoliation (skin peeling), hardening of the skin and paraesthesia (sensations like numbness, tingling, pins and needles).
Croatian: Najčešće nuspojave lijeka Ameluz (koje se mogu javiti u više od 1 na 10 bolesnika) jesu reakcije na mjestu primjene, koje uključuju eritem (crvenilo kože), bol (uključujući žareću bol), nadraženost, svrbež, edem (oticanje), stvaranje krasta, eksfolijaciju (ljuštenje kože), otvrdnuće kože i paresteziju (osjećaji poput utrnulosti, trnaca i probadanja).
English: Actinic keratoses are skin growths caused by exposure to sunlight, which can lead to skin cancer.
Croatian: Aktiničke keratoze izrasline su na koži nastale zbog izlaganja sunčevoj svjetlosti, koje mogu prerasti u rak kože.
English: Single or multiple actinic keratosis growths may be treated in one session, while basal cell carcinoma lesions will need two treatment sessions about one week apart.
Croatian: Izrasline jednostruke ili višestruke aktiničke keratoze može se liječiti jednokratno, dok je lezije raka bazalnih stanica potrebno liječiti dvjema terapijama, s razmakom od otprilike jednog tjedna.
English: Ameluz was more effective than placebo (a dummy treatment) or a comparator medicine when used in photodynamic therapy to treat actinic keratosis or basal cell carcinoma.
Croatian: Lijek Ameluz pokazao se učinkovitijim od placeba (prividno liječenje) ili usporednog lijeka pri primjeni u fotodinamičkoj terapiji za liječenje aktiničke keratoze ili raka bazalnih stanica.
English: For more information about using Ameluz, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ameluz pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: When Ameluz is applied to the abnormal skin growths or lesions, the active substance in the medicine, 5-aminolaevulinic acid, is absorbed by cells where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength).
Croatian: Nakon što se Ameluz nanese na abnormalne izrasline ili lezije na koži, djelatnu tvar u lijeku, 5aminolevulinatnu kiselinu, apsorbiraju njihove stanice u kojima djeluje kao fotosenzitivni agens (tvar koja se mijenja pri izlaganju svjetlosti određene valne dužine).
English: Ameluz contains the active substance 5-aminolaevulinic acid.
Croatian: Ameluz sadrži djelatnu tvar 5-aminolevulinatnu kiselinu.
English: For basal cell carcinoma that cannot be treated surgically, Ameluz was investigated in a study involving 281 patients, in which it was compared with Metvix.
Croatian: U slučaju raka bazalnih stanica koji nije moguće kirurški liječiti Ameluz je ispitan u ispitivanju koje je uključivalo 281 bolesnika, u kojem je uspoređen s lijekom Metvix.
English: Ameluz is applied directly to the skin growths or lesions or to the entire area affected and a red light source is then shone onto the skin.
Croatian: Lijek Ameluz nanosi se izravno na izrasline na koži, na lezije ili na cijelo zahvaćeno područje te se koža zatim ozračuje izvorom crvene svjetlosti.
English: The Agency therefore concluded that the benefits of Ameluz are greater than its risks and it can be authorised.
Croatian: Stoga je Agencija odlučila da koristi od lijeka Ameluz nadmašuju s njim povezane rizike te da lijek može biti odobren.
English: The effects of Ameluz were examined in four main studies in patients with actinic keratosis, and in one main study in patients with basal cell carcinoma.
Croatian: Učinci lijeka Ameluz ispitani su u četirima glavnim ispitivanjima u bolesnika s aktiničkom keratozom te u jednom glavnom ispitivanju u bolesnika s rakom bazalnih stanica.