FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Tandemact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Tandemact nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Tandemact
Croatian: Ostale informacije o lijeku Tandemact
English: The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Croatian: Razina HbA1c u bolesnika pala je s osnovne vrijednosti od preko 7,5 % na 1,22 % do 1,64 %.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tandemact on 8 January 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tandemact na snazi u Europskoj uniji od 8. siječnja 2007.
English: What measures are being taken to ensure the safe and effective use of Tandemact?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tandemact?
English: Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Croatian: Budući da je pioglitazon od 2000. odobren u EU-u pod nazivom Actos, a glimepirid se već koristi u odobrenim lijekovima u EU-u, tvrtka je predočila podatke iz ranijih ispitivanja i iz objavljene literature.
English: Tandemact pioglitazone and glimepiride
Croatian: Tandemact pioglitazon i glimepirid
English: It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Croatian: Dostupan je u obliku tableta (30 mg pioglitazona i 2 ili 4 mg glimepirida, ili 45 mg pioglitazona i 4 mg glimepirida).
English: This is a summary of the European public assessment report (EPAR) for Tandemact.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Tandemact.
English: The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Croatian: Tvrtka je predočila dokaze da su razine djelatnih tvari u krvi bile iste kod ljudi koji su uzimali lijek Tandemact i ljudi koji su uzimali zasebne tablete.
English: Tandemact contains two active substances, each of which has a different mode of action.
Croatian: Lijek Tandemact sadrži dvije djelatne tvari, a svaka od njih djeluje na drugačiji način.
English: The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling).
Croatian: Najčešće nuspojave pri uzimanju lijeka Tandemact (zabilježene u između 1 i 10 na 100 bolesnika) jesu infekcija gornjeg respiratornog trakta (poput prehlade), hipoestezija (smanjen osjet dodira), prijelomi kostiju, povećanje tjelesne težine, omaglica, flatulencija (nakupljanje plinova) i edem (oticanje).
English: For more information about treatment with Tandemact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tandemact pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: At least 64% of the patients treated were classified as ‘responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Croatian: Najmanje 64 % liječenih bolesnika svrstani su u skupinu koja je pozitivno odgovorila na lijek jer im je razina HbA1c tijekom ispitivanja pala s osnovne vrijednosti za najmanje 0,6 % ili im je razina HbA1c na kraju ispitivanja bila 6,1 % ili manja.
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 Tandemact.
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 Tandemact.
English: Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Croatian: Tandemact je lijek koji sadrži dvije djelatne tvari, pioglitazon i glimepirid.
English: Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Croatian: Bolesnici koji dobivaju pioglitazon zajedno s drugim lijekom istog razreda kao što je glimepirid (tj. drugom sulfonilurejom) trebali bi se prvo prebaciti s te druge sulfonilureje na glimepirid prije no što mogu početi uzimati Tandemact.
English: The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
Croatian: CHMP je zaključio da je utvrđena djelotvornost pioglitazona i glimepirida u liječenju dijabetesa tipa 2 te da lijek Tandemact pojednostavljuje liječenje i poboljšava sposobnost bolesnika da se pridržavaju liječenja kada je potrebna kombinacija tih dviju djelatnih tvari.
English: The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: Ispitivanja su trajala između četiri mjeseca i dvije godine i mjerila su koncentraciju tvari u krvi naziva glikozilirani hemoglobin (HbA1c), koja ukazuje na to koliko se uspješno kontrolira glukoza u krvi.
English: The company that markets Tandemact will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Croatian: Tvrtka koja lijek Tandemact stavlja u promet osigurat će edukativni materijal za liječnike koji propisuju taj lijek, a koji će obuhvaćati informacije o mogućem riziku od srčanog zastoja i raka mjehura u liječenjima koja sadrže pioglitazon, kriterijima za odabir bolesnika te potrebi za redovitim procjenjivanjem liječenja i njegovim prekidom ako bolesnici od njega više nemaju koristi.
English: It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated.
Croatian: Također se ne smije primjenjivati u bolesnika koji imaju ili su imali rak mjehura ili u bolesnika koji imaju krv u mokraći koja još nije ispitana.
English: What is the risk associated with Tandemact?
Croatian: Koji su rizici povezani s lijekom Tandemact?
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Croatian: Pioglitazon čini stanice (masti, mišića i jetre) osjetljivijima na inzulin što znači da tijelo u većoj mjeri koristi inzulin koji proizvodi.
English: Tandemact is used to treat adult patients who have type 2 diabetes.
Croatian: Tandemact se koristi za liječenje odraslih bolesnika koji imaju dijabetes tipa
English: The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
Croatian: U ispitivanja je bilo uključeno 1 390 bolesnika kojima je pioglitazon dodan postojećem liječenju sulfonilurejom.
English: It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride.
Croatian: Koristi se u bolesnika za koje metformin (vrsta lijeka protiv dijabetesa) nije prikladan, a koji se već liječe kombinacijom tableta koje sadrže djelatne tvari pioglitazon i glimepirid.
English: As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Croatian: Kao rezultat djelovanja obiju djelatnih tvari, smanjuje se razina glukoze u krvi što pomaže u kontroli dijabetesa tipa 2.
English: Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Croatian: Glimepirid je sulfonilureja: on potiče gušteraču da proizvodi više inzulina.
English: Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Croatian: Nakon tri do šest mjeseci liječenja potrebno je procijeniti učinke terapije lijekom Tandemact i prekinuti liječenje u bolesnika kod kojih nisu vidljive dostatne koristi.
English: It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding.
Croatian: Ne smije se primjenjivati u bolesnika koji imaju dijabetes tipa 1, bolesnika koji imaju komplikacije dijabetesa (dijabetičku ketoacidozu ili dijabetičku komu) niti u trudnica ili dojilja.
English: The Committee decided that Tandemact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi lijeka Tandemact nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Croatian: Bolesnici koji za vrijeme primjene Tandemacta dobiju hipoglikemiju (nisku razinu šećera u krvi), možda će morati smanjiti dozu lijeka ili se vratiti na primjenu zasebnih tableta.
English: Why has Tandemact been approved?
Croatian: Zašto je Tandemact odobren?
English: Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Croatian: Actos je odobren za primjenu sa sulfonilurejom u bolesnika koji imaju dijabetes tipa 2 u kojih se ne može postići zadovoljavajuća kontrola samo metforminom.
English: What is Tandemact?
Croatian: Što je Tandemact?
English: These studies used pioglitazone and sulphonylureas given as separate tablets.
Croatian: U tim su ispitivanjima pioglitazon i sulfonilureja primjenjivani u zasebnim tabletama.
English: For the full list of all side effects reported with Tandemact, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Tandemact potražite u uputi o lijeku.
English: Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Croatian: Lijek Tandemact ne smije se primjenjivati u bolesnika sa zatajenjem srca ili u bolesnika koji imaju probleme s jetrom ili teške probleme s bubrezima.
English: The company used three studies to support the use of Tandemact in the same indication.
Croatian: Kako bi dokazala korist od primjene lijeka Tandemact u istoj indikaciji, tvrtka je upotrijebila tri ispitivanja.
English: What benefit has Tandemact shown during the studies?
Croatian: Koje su koristi lijeka Tandemact utvrđene u ispitivanjima?
English: Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.
Croatian: Tandemact se ne može primjenjivati u bolesnika koji imaju teška oštećenja bubrega ili u bolesnika koji imaju probleme s jetrom.
English: What is Tandemact used for?
Croatian: Za što se Tandemact koristi?
English: In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
Croatian: U sva tri ispitivanja došlo je do poboljšanja kontrole glukoze u krvi u bolesnika koji su uzimali kombinaciju pioglitazona i sulfonilureje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tandemact have also been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku također se nalaze preporuke i mjere opreza za sigurnu i učinkovitu primjenu lijeka Glubrava kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: How is Tandemact used?
Croatian: Kako se Tandemact koristi?
English: How does Tandemact work?
Croatian: Kako djeluje Tandemact?
English: How has Tandemact been studied?
Croatian: Kako je Tandemact ispitivan?
English: This summary was last updated in 09-2017.
Croatian: Sažetak je posljednji put ažuriran u 09.2017.
English: The full EPAR for Xalkori can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Xalkori nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them.
Croatian: To se smatra pozitivnim odgovorom u usporedbi sa stopama odgovora od oko 20 % do 30 % u prethodnim terapijama kod bolesnika koji su ih primili.
English: • It is also used when the NSCLC is ‘ROS1-positive'.
Croatian: • Također se koristi kad je NSCLC „ROS1-pozitivan”.
English: If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day.
Croatian: Ako se razviju određene nuspojave, liječnik može odlučiti prekinuti terapiju ili smanjiti dozu na 200 mg dvaput dnevno, te zatim na 250 mg jedanput dnevno.
English: ALK-positive NSCLC
Croatian: ALK-pozitivan NSCLC
English: Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day.
Croatian: Lijek Xalkori dostupan je u obliku tableta (200 mg i 250 mg), a preporučena doza je 250 mg dva puta dnevno.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Xalkori u promet koje je vrijedi na prostoru Europske unije od 23. listopada 2012.
English: What is Xalkori and what is it used for?
Croatian: Što je Xalkori i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Xalkori?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xalkori?
English: ROS1-positive NSCLC
Croatian: ROS1-pozitivan NSCLC
English: Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Croatian: Doze će možda trebati odgoditi ili će terapiju trebati prekinuti ako bolesnik razvije određene ozbiljne nuspojave.
English: This is a summary of the European public assessment report (EPAR) for Xalkori.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Xalkori.
English: This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
Croatian: To znači da stanice raka sadrže promjene koje utječu na gen odgovoran za bjelančevinu ROS1.
English: Doses may need to be adjusted in patients with severely reduced kidney function.
Croatian: Možda će biti potrebno prilagoditi doze u bolesnika sa značajno smanjenom funkcijom jetre.
English: A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment.
Croatian: Ispitivanje na 53 ROS1-pozitivnih bolesnika s uznapredovalim stadijem bolesti pokazalo je da je oko 70 % bolesnika koji su uzimali Xalkori (37 od 53) djelomično ili u potpunosti odgovorilo na liječenje.
English: Other information about Xalkori
Croatian: Ostale informacije o lijeku Xalkori
English: Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Xalkori nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments.
Croatian: U bolesnika s ROS1-pozitivnim NSCLC-om za koje specifične terapije trenutno nema, Agencija je zabilježila dokaz o visokom stupnju odgovora, posebno u bolesnika koji su prethodno primili druge terapije protiv raka.
English: It is not intended to provide practical advice on how to use Xalkori.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Xalkori.
English: The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori.
Croatian: Prisutnost genetskih promjena koje utječu na ALK („ALK-pozitivan” status) ili na ROS1 („ROS1pozitivan” status) mora se potvrditi prije početka terapije lijekom Xalkori.
English: The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).
Croatian: Najozbiljnije nuspojave su oštećenje jetre, pneumonitis (upala pluća), neutropenija (niska razina neutrofila, vrste bijelih krvnih stanica, u krvi) i produljeni QT interval (problem s električnom aktivnošću srca).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori 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 Xalkori također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines.
Croatian: Terapiju lijekom Xalkori mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: The active substance in Xalkori, crizotinib, is an RTK inhibitor.
Croatian: Djelatna tvar lijeka Xalkori, krizotinib, jest inhibitor RTK-a.
English: The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness.
Croatian: Najčešće nuspojave lijeka Xalkori (zabilježene u više od 1 na 4 osoba) su problemi s vidom, mučnina (slabost), proljev, povraćanje, edem (oticanje), povišenje koncentracije jetrenih enzima u krvi, smanjeni apetit, zatvor, vrtoglavica, neuropatija (bol uslijed oštećenja živaca) i umor.
English: For the previously untreated patients, 6 out of 7 responded to treatment.
Croatian: Kod bolesnika koji prethodno nisu primili terapiju, šestero od njih sedmero reagiralo je na terapiju.
English: What is the risk associated with Xalkori?
Croatian: Koji su rizici povezani s lijekom Xalkori?
English: ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells.
Croatian: ALK i ROS1 ubrajaju se u skupinu bjelančevina naziva receptorske tirozin-kinaze (RTK-ovi) koje su uključene u rast stanica.
English: It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.
Croatian: Djeluje blokiranjem aktivnosti bjelančevina ALK ili ROS1, uključujući i kod postojanja genetske promjene, čime usporava rast i širenje raka kod ALK-pozitivnog ili ROS1-pozitivnog NSCLC-a.
English: Why is Xalkori approved?
Croatian: Zašto je lijek Xalkori odobren?
English: The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated.
Croatian: Europska agencija za lijekove zaključila je kako je terapija lijekom Xalkori produžila vrijeme u kojem su bolesnici s ALK-pozitivnim NSCLC-om živjeli bez pogoršanja bolesti, bez obzira na to jesu li prethodno primili terapiju.
English: For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Xalkori pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Xalkori crizotinib
Croatian: Xalkori krizotinib
English: Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced:
Croatian: Xalkori je lijek protiv raka koji se koristi kao monoterapija za liječenje odraslih s rakom pluća koji se naziva rak pluća nemalih stanica (NSCLC), u slučaju uznapredovale bolesti.
English: In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.
Croatian: U bolesnika koji su bilo „ALK-pozitivni” ili „ROS1-pozitivni”, bjelančevina ALK ili ROS1 abnormalno je aktivna te može pospješiti rast stanica raka i razvoj novih žila koje ih opskrbljuju krvlju.
English: The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine's summary of product characteristics and a patient alert card to be given to patients.
Croatian: Tvrtka koja stavlja u promet lijek Xalkori treba osigurati da liječnici za koje se očekuje da će propisivati ovaj lijek dobiju komplete za obuku koji sadrže sažetak opisa svojstava i karticu s upozorenjima za bolesnike.
English: What benefits of Xalkori have been shown in studies?
Croatian: Koje su koristi od lijeka Xalkori utvrđene u ispitivanjima?
English: In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.
Croatian: U drugom ispitivanju na 343 bolesnika koji nisu prethodno liječeni za NSCLC, bolesnici koji su primili Xalkori živjeli su u prosjeku gotovo 11 mjeseci bez pogoršanja bolesti u usporedbi sa sedam mjeseci u bolesnika koji su primili terapiju pemetreksedom.
English: • It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Croatian: • Koristi se ako je NSCLC pozitivan na kinazu anaplastičnog limfoma (ALK), što znači da stanice raka sadrže određene promjene koje utječu na gen odgovoran za bjelančevinu ALK.
English: For practical information about using Xalkori, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Xalkori bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How is Xalkori used?
Croatian: Kako se Xalkori koristi?