FrancophonIA/ELRC3.0 huggingface dataset:
English: (Invented) Name
Croatian: (Zaštićeno) ime
English: MA EU Number
Croatian: Broj (EU) odobrenja
English: Content Pack Size
Croatian: 12 napunjenih štrcaljki + 12 igala
English: Responses were maintained on average for around 14 months.
Croatian: Odgovori su se zadržali prosječno oko 14 mjeseci.
English: Further information on Alunbrig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Alunbrig.
Croatian: Više informacija o lijeku Alunbrig nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Alunbrig.
English: The recommended starting dose is 90 mg taken once a day for the first 7 days and then increased to 180 mg once a day afterwards.
Croatian: Preporučena početna doza je 90 mg koja se uzima jedanput dnevno tijekom prvih sedam dana, koju je nakon toga potrebno povećati na 180 mg jedanput dnevno.
English: The medicine is available as tablets (30 mg, 90 mg and 180 mg).
Croatian: Lijek je dostupan u obliku tableta (od 30, 90 i 180 mg).
English: Out of patients who received 90 mg Alunbrig a day and increased to 180 mg after 7 days, around 56% showed a complete or partial response to the medicine.
Croatian: Od bolesnika koji su primali 90 mg lijeka Alunbrig dnevno, a zatim 180 mg nakon sedam dana, približno 56 % njih imali su potpuni ili djelomični odgovor na lijek.
English: The most common side effects with Alunbrig (which may affect more than 1 in 4 people) are hyperglycaemia (high blood sugar levels), hyperinsulinaemia (high blood insulin levels), anaemia (low red blood cell counts), nausea (feeling sick), low white blood cell counts including decreased levels of the white blood cells called lymphocytes, diarrhoea, tiredness, cough, headache, hypophosphataemia (low blood levels of phosphates), rash, vomiting, dyspnoea (difficulty breathing), hypertension (high blood pressure), myalgia (muscle pain), peripheral neuropathy (damage to the nerves in the extremities) and blood test results indicating abnormalities of liver (increased levels of ALT and AST and alkaline phosphatase), pancreas (increased lipase and amylase), muscle function (increased CPK) or blood clotting (increased APTT).
Croatian: Najčešće nuspojave na lijek Alunbrig (koje se mogu pojaviti u više od 1 na 4 osobe) su hiperglikemija (visoke razine šećera u krvi), hiperinzulinemija (visoke razine inzulina u krvi), anemija (smanjen broj crvenih krvnih zrnaca), mučnina (slabost), smanjen broj bijelih krvnih zrnaca uključujući smanjene razine bijelih krvnih zrnaca koji se zovu limfociti, proljev, umor, kašalj, glavobolja, hipofosfatemija (niska razina fosfata u krvi), osip, povraćanje, dispneja (otežano disanje), hipertenzija (visok krvni tlak), mijalgija (bol u mišićima), periferna neuropatija (oštećenje živaca u udovima) te rezultati krvnih pretraga koji ukazuju na abnormalnosti jetre (povišene razine ALT-a i AST-a te alkalne fosfataze), gušterače (povišene lipaza i amilaza), mišićne funkcije (povišen CPK) ili na grušanje krvi (povišen APTT).
English: The most common serious side effects (which may affect more than 1 in 50 people) are pneumonitis (inflammation in the lungs), pneumonia (infection of the lungs) and dyspnoea.
Croatian: Najčešće ozbiljne nuspojave (koje se mogu pojaviti u više od 1 na 50 osoba) su pneumonitis (upala pluća), pneumonija (infekcija pluća) i dispneja.
English: Treatment can continue for as long as the patient benefits from it.
Croatian: Liječenje može trajati onoliko dugo koliko bolesnik ima koristi od liječenja.
English: Patients with severely reduced kidney function should be closely monitored especially during the first week of treatment for symptoms of lung disease such as cough or difficulty breathing.
Croatian: Bolesnike s teškim oblikom smanjene funkcije bubrega potrebno je pažljivo pratiti, posebice tijekom prvog tjedna liječenja, radi simptoma bolesti pluća kao što su kašalj ili otežano disanje.
English: Once appropriate measures are taken to manage the potentially serious side effect of lung disease, the safety profile of Alunbrig is considered manageable.
Croatian: Nakon što su poduzete prikladne mjere radi upravljanja potencijalno ozbiljnom nuspojavom bolesti pluća, sigurnosni profil lijeka Alunbrig smatra se prihvatljivim.
English: What measures are being taken to ensure the safe and effective use of Alunbrig?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Alunbrig?
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Croatian: Odgovor na liječenje ocijenjen je s pomoću snimanja tijela i standardiziranih kriterija koji se upotrebljavaju za solidne tumore, pri čemu je potpuni odgovor definiran kao nedostatak preostalih znakova raka u bolesnika.
English: As for all medicines, data on the use of Alunbrig are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Alunbrig kontinuirano se prate.
English: ALK belongs to a family of enzymes called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Croatian: ALK pripada obitelji enzima zvanima receptorske tirozin kinaze (RTK), koji su uključeni u rast stanica i razvoj novih krvnih žila koje ih opskrbljuju.
English: For more information about using Alunbrig, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Alunbrig pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Other information about Alunbrig
Croatian: Ostale informacije o lijeku Alunbrig
English: It will also provide an alert card for patients summarising key safety information about the risk of lung disease with the medicine and what to do in case of signs and symptoms.
Croatian: Tvrtka će također dostaviti karticu s upozorenjima namijenjenu bolesnicima na kojoj su, u sažetom obliku, navedene ključne informacije o sigurnosti primjene koje se odnose na rizik od plućne bolesti povezan s ovim lijekom kao i upute što činiti u slučaju znakova i simptoma.
English: Reduced doses are recommended in patients with severely reduced liver or kidney function.
Croatian: Smanjene se doze preporučuje u bolesnika s teškim oblikom smanjene funkcije rada jetre ili bubrega.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alunbrig have also 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 Alunbrig nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Side effects reported with Alunbrig are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Alunbrig pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The patient's cancer should be tested before starting treatment to confirm it has the gene changes affecting ALK (‘ALK-positive' status).
Croatian: Rak bolesnika potrebno je ispitati prije početka liječenja kako bi se potvrdilo da ima promjene gena koje utječu na ALK (odnosno, da je pozitivan na ALK).
English: Alunbrig was not compared with any other treatment or placebo (a dummy treatment).
Croatian: Lijek Alunbrig nije uspoređen s nekim drugim liječenjem ni s placebom (prividnim liječenjem).
English: What is Alunbrig and what is it used for?
Croatian: Što je Alunbrig i za što se primjenjuje?
English: An overview of Alunbrig and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Alunbrig i zašto je odobren u EU-u
English: Why is Alunbrig authorised in the EU?
Croatian: Zašto je Alunbrig odobren u EU-u?
English: Alunbrig can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Croatian: Lijek Alunbrig izdaje se samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: The European Medicines Agency decided that Alunbrig's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Alunbrig nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What are the risks associated with Alunbrig?
Croatian: Koji su rizici povezani s lijekom Alunbrig?
English: Alunbrig is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Croatian: Lijek Alunbrig upotrebljava se samo ako je NSCLC pozitivan na ALK, što znači da stanice raka imaju određene promjene koje utječu na gen koji stvara protein kinaza anaplastičnog limfoma (engl. anaplastic lymphoma kinase, ALK).
English: Alunbrig has been shown to be effective in treating ALK-positive NSCLC in one main study involving 222 patients in whom the disease progressed despite previous treatment with crizotinib.
Croatian: Lijek Alunbrig pokazao se djelotvornim u liječenju NSCLC-a pozitivnog na ALK u jednom glavnom ispitivanju u kojem su sudjelovala 222 bolesnika u kojih je bolest napredovala unatoč prethodnom liječenju krizotinibom.
English: The doctor may reduce the dose or stop treatment temporarily if side effects occur.
Croatian: Ako se pojave nuspojave, liječnik može smanjiti dozu ili privremeno prekinuti liječenje.
English: The company that markets Alunbrig will submit the results of an ongoing study on the effectiveness and safety of Alunbrig in patients with ALK-positive NSCLC who have not received previous treatment targeted to ALK.
Croatian: Tvrtka koja na tržište stavlja lijek Alunbrig dostavit će rezultate ispitivanja koje je trenutačno u tijeku o djelotvornosti i sigurnosti lijeka Alunbrig u bolesnika s NSCLC-om pozitivnim na ALK koji prethodno nisu primili liječenje usmjereno na ALK.
English: The active substance in Alunbrig, brigatinib, works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Croatian: Djelatna tvar lijeka Alunbrig, brigatinib, inhibira djelovanje ALK-a te tako smanjuje rast i širenje raka.
English: How does Alunbrig work?
Croatian: Kako djeluje Alunbrig?
English: Alunbrig is a cancer medicine that is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC) who have been treated before with a cancer medicine called crizotinib.
Croatian: Alunbrig je lijek za liječenje raka, namijenjen odraslim osobama koji su oboljeli od raka pluća koji se naziva rak pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) i koji su ranije liječeni lijekom krizotinibom.
English: Alunbrig contains the active substance brigatinib.
Croatian: Lijek Alunbrig sadrži djelatnu tvar brigatinib.
English: What benefits of Alunbrig have been shown in studies?
Croatian: Koje su koristi od lijeka Alunbrig utvrđene u ispitivanjima?
English: positive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Croatian: U bolesnika s NSCLC-om pozitivnim na ALK stvara se abnormalni oblik ALK-a koji stimulira diobu i nekontrolirani rast stanica raka.
English: How is Alunbrig used?
Croatian: Kako se Alunbrig primjenjuje?
English: For the full list of side effects and restrictions with Alunbrig, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Alunbrig potražite u uputi o lijeku.
English: Alunbrig was effective in treating patients with ALK-positive NSCLC previously treated with crizotinib.
Croatian: Lijek Alunbrig bio je učinkovit u liječenju bolesnika s NSCLC-om pozitivnim na ALK koju su prethodno liječeni krizotinibom.
English: 1 For more information, see here.
Croatian: 1 Za više informacija, pogledajte ovdje.
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Kontaktirajte naše djelatnike za medije Monika Benstetter ili Martin Harvey
English: 19 August 2014 EMA/515780/2014
Croatian: 19. kolovoza 2014. EMA/515780/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Croatian: +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
English: • If you have any questions about your treatment, you should contact your doctor or pharmacist.
Croatian: • Ako imate bilo kakvih pitanja vezanih uz liječenje, trebate kontaktirati liječnika ili ljekarnika.
English: The CHMP issued an opinion in December 2013.
Croatian: CHMP je izdao mišljenje u prosincu 2013.
English: Both medicines have been authorised in the EU through national procedures for over 40 years.
Croatian: Oba su lijeka odobrena u EU-u na temelju nacionalnih postupaka od prije 40 godina.
English: Patients using these creams should be aware of the following:
Croatian: Bolesnici koji koriste kreme moraju biti svjesni sljedećeg:
English: • Both creams should not be used for more than 4 weeks.
Croatian: • Obje se kreme ne smiju koristiti dulje od 4 tjedna.
English: Treatment with both creams should be limited to a maximum duration of 4 weeks.
Croatian: Liječenje s obje kreme treba ograničiti na maksimalno trajanje od 4 tjedna.
English: Linoladiol N is marketed in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia, while Linoladiol HN is marketed in Estonia, Germany, Latvia and Lithuania.
Croatian: Linoladiol N nalazi se na tržištu u Bugarskoj, Češkoj, Estoniji, Njemačkoj, Mađarskoj, Latviji, Litvi i Slovačkoj, dok se Linoladiol HN nalazi na tržištu u Estoniji, Njemačkoj, Latviji i Litvi.
English: The product information for both creams will be updated with the following recommendations:
Croatian: Informacije o proizvodu za obje kreme ažurirat će se kako slijedi:
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP) responsible for questions concerning medicines for human use.
Croatian: Pregled je proveo Odbor za lijekove za primjenu kod ljudi (CHMP) odgovoran za pitanja vezana uz primjenu lijeka u ljudi.
English: A limit to the duration of use and other measures put in place to manage potential risk of side effects
Croatian: Ograničeno trajanje primjene i druge mjere postavljene sa ciljem upravljanja potencijalnim rizikom od nuspojava
English: The review of the topical estradiol-containing medicines Linoladiol N and Linoladiol HN was triggered on 24 May 2012 by Germany, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled lijekova koji sadrže estradiol za primjenu na koži, Linoladiol N i Linoladiol HN, pokrenula je 24. svibnja 2012. godine Njemačka u skladu s člankom 31. Direktive 2001/83/EZ.
English: The German medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of these medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Croatian: Njemačka agencija za lijekove zatražila je od CHMP-a provedbu potpune procjene omjera koristi i rizika ovih lijekova te izdavanje mišljenja o tome trebaju li se odobrenja za stavljanje lijeka u promet zadržati, izmijeniti, suspendirati ili povući iz Europske unije.
English: The Linoladiol N cream (0.01 %w/w) contains 100 microgram of estradiol per gram, while Linoladiol HN (0.005 %w/w, 0.4 %w/w) contains 50 microgram of estradiol and 4 mg of the corticosteroid prednisolone per gram.
Croatian: Krema Linoladiol N (0.01 %w/w) sadrži 100 mikrograma estradiola po gramu, dok Linoladiol HN (0.005 %w/w, 0.4 %w/w) sadrži 50 mikrograma estradiola i 4 mg kortikosteroidnog prednizolona po gramu.
English: If you have been using Linoladiol HN for this condition, contact your doctor to discuss alternative treatments.
Croatian: Ako ste koristili Linoladiol HN za ovo stanje, kontaktirajte svojeg liječnika i raspitajte se za alternativnu terapiju.
English: The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.
Croatian: Informacije o proizvodu za kreme Linoladiol N i Linoladiol HN ažurirane su kako bi se bolesnike i zdravstvene djelatnike obavijestilo o ovim potencijalnim rizicima.
English: In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.
Croatian: Nadalje, u slučaju kreme Linoladiol N, koja ima veću koncentraciju estradiola, CHMP je od tvrtke zatražio ograničavanje količine kreme koja je dostupna u pakiranjima kako bi se bolesnike spriječilo da koriste kreme dulje nego što je preporučeno.
English: The CHMP's recommendations were sent to the European Commission which endorsed them and issued a final, legally binding decision valid throughout the EU on 19 August 2014.
Croatian: Preporuke CHMP-a poslane su Europskoj komisiji koja ih je potvrdila i izdala je konačnu pravno obvezujuću odluku valjanju na razini EU-a dana 19. kolovoza 2014.
English: Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer.
Croatian: Sistemska apsorpcija estradiola može se povezati s rizicima sličnima onima uočenima u sistemskoj hormonskoj zamjenskoj terapiji (HRT), uključujući krvne ugruške, moždani udar i endometrijalni rak (maternice).
English: Following a request from the company, a reexamination of the opinion for Linoladiol N was carried out and concluded in April 2014.
Croatian: Postupajući po zahtjevu kojeg je izdala tvrtka, proveden je ponovni pregled mišljenja za lijek Linoladiol N te je isti zaključen u travnju 2014.
English: The final CHMP opinion was forwarded to the European Commission, which issued a final decision on 19 August 2014.
Croatian: Konačno mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je izdala odluku dana 19. kolovoza 2014.
English: The CHMP reiterated the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body).
Croatian: CHMP je ponovno propisao potrebu ograničenja liječenja s obje kreme na 4 tjedna zbog relativno velike koncentracije estradiola i potencijalnih rizika od nuspojava izazvanih sistemskom apsorpcijom estradiola (kroz tijelo).
English: • Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.
Croatian: • Linoladiol N i Linoladiol HN ne smiju se koristiti dulje od četiri tjedna zbog rizika povezanih s mogućim sistemskim izlaganjem estradiolu.
English: Linoladiol HN also contains low-dose prednisolone, which acts as an anti-inflammatory agent.
Croatian: Linoladiol HN također sadrži malu dozu prednizolona, koja djeluje kao protuupalno sredstvo.
English: This is because the creams contain the hormone estradiol which can be absorbed into the bloodstream and may increase your risks of side effects such as blood clots and strokes if the creams are used for extended periods.
Croatian: Razlog tomu je što kreme sadrže hormon estradiol koji se može apsorbirati u krvotok i povećati rizike od nuspojava poput krvnih ugrušaka i moždanog udara ako se kreme koriste tijekom duljih razdoblja.
English: Linoladiol N and Linoladiol HN are a type of local ‘hormone replacement therapy': they contain a female hormone, estradiol, used to replace the estradiol hormone the body no longer makes after menopause.
Croatian: Linoladiol N i Linoladiol HN su tip „hormonske zamjenske terapije“: sadrže ženski hormon estradiol koji se koristi kao zamjena za hormon estradiol kojeg tijelo više ne proizvodi nakon menopauze.
English: In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.
Croatian: Nadalje, Linoladiol HN više se ne koristi za liječenje Lichenove skleroze, stanja kože koje najčešće zahvaća genitalno područje, budući da nema dokaza o koristima kod ovog stanja.
English: • Linoladiol N should be applied into the vagina while Linoladiol HN should be applied to the external genital area.
Croatian: • Linoladiol N treba primjenjivati u vagini, a Linoladiol HN treba primjenjivati na vanjsko genitalno područje.
English: The European Medicines Agency has updated advice on how to use Linoladiol N and Linoladiol HN creams.
Croatian: Europska agencija za lijekove ažurirala je način primjene krema Linoladiol N i Linoladiol HN.
English: The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area.
Croatian: Krema Linoladiol N indicirana je samo za primjenu unutar vagine za liječenje žena u postmenopauzi s vaginalnom atrofijom uslijed nedostatka hormona estrogena, dok se krema Linoladiol HN koristi u žena u postmenopauzi s blagim, upalnim stanjima kože genitalnog područja.
English: On 25 April 2014, the EMA's Committee for Medicinal Products for Human Use (CHMP) updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) pri EMA-i ažurirao je preporuke za primjenu dvije kreme koji sadrže visoke koncentracije estradiola: Linoladiol N i Linoladiol HN.
English: • Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.
Croatian: • Linoladiol HN je indiciran za kratkoročno liječenje akutne, blage upalne kožne bolesti vanjskog genitalnog područja u žena u postmenopauzi.
English: • Linoladiol HN should no longer be prescribed for lichen sclerosus.
Croatian: • Linoladiol HN se ne smije više propisivati za liječenje Lichenove skleroze.
English: • Linoladiol HN was previously being used to treat a condition called lichen sclerosus.
Croatian: • Linoladiol HN se prethodno koristio za liječenje Lichenove skleroze.
English: • Linoladiol N is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of estrogen.
Croatian: • Linoladiol N se koristi samo unutar vagine za liječenje žena u postmenopauzi s vaginalnom atrofijom uslijed nedostatka hormona estrogena.
English: • Linoladiol N is indicated for the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women.
Croatian: • Linoladiol N indiciran je za liječenje vaginalne atrofije uslijed manjka estrogena u žena u postmenopauzi.
English: In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use.1 Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have been updated, taking into account new measures to manage the potential risk of side effects.
Croatian: Nastavno na zahtjev tvrtke za ponovni pregled kreme Linoladiol N, preporuke za ovu kremu su ažurirane, uzimajući u obzir nove mjere za upravljanje potencijalnim rizikom od nuspojava.
English: The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use.
Croatian: EMA je završila pregled dvije kreme koji sadrže visoke koncentracije estradiola, Linoladiol N i Linoladiol HN te je ažurirala preporuke za njihovu primjenu.
English: • Linoladiol HN should only be used for treating postmenopausal women with mild, inflammatory skin conditions affecting the external genital area.
Croatian: • Linoladiol HN smije se koristiti u žena u postmenopauzi s blagim, upalnim stanjima kože genitalnog područja.
English: You will also need:
Croatian: Osim toga, trebat ćete: