FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Croatian: Ako se u bolesnika razvije takva reakcija, infuziju je potrebno usporiti ili prekinuti.
English: What is Polivy and what is it used for?
Croatian: Što je Polivy i za što se koristi?
English: Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Croatian: Moguće su ozbiljne nuspojave, ali one se mogu kontrolirati primjenom odgovarajućih mjera.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
English: Polivy is for infusion (drip) into a vein over 90 minutes.
Croatian: Polivy se daje intravenskom infuzijom (ukapavanjem) u trajanju od 90 minuta.
English: Although the study included a limited number of patients and more data are needed to confirm the results, the European Medicines Agency considered that Polivy meets an unmet medical need.
Croatian: Iako je ispitivanjem bio obuhvaćen ograničen broj bolesnika i potrebni su dodatni podatci kako bi se potvrdili njegovi rezultati, Europska agencija za lijekove smatra da Polivy zadovoljava nezadovoljenu medicinsku potrebu.
English: Why is Polivy authorised in the EU?
Croatian: Zašto je lijek Polivy odobren u EU-u?
English: Other information about Polivy
Croatian: Ostale informacije o lijeku Polivy
English: The Agency therefore decided that Polivy's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Polivy nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: What are the risks associated with Polivy?
Croatian: Koji su rizici povezani s lijekom Polivy?
English: Polivy can affect the production of blood cells.
Croatian: Polivy može utjecati na proces stvaranja krvnih stanica.
English: The main study showed that Polivy is effective at treating patients whose disease was not responding to previous treatment or had returned and who could not have a transplant.
Croatian: U glavnom ispitivanju lijek Polivy pokazao se učinkovitim za liječenje onih bolesnika čija bolest nije odgovorila na prethodnu terapiju ili se vratila te koji nisu bili kandidati za presađivanje.
English: An overview of Polivy and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Polivy i zašto je odobren u EU-u
English: Patients with DLBCL have cancerous B cells, which are a type of white blood cell.
Croatian: Osobe oboljele od DLBCL-a imaju kancerogene B-stanice, koje su vrsta bijelih krvnih stanica.
English: Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Croatian: Budući da je za lijek Polivy izdano uvjetno odobrenje, tvrtka koja stavlja lijek Polivy u promet dostavit će dodatne podatke o njegovim učincima kako bi se potvrdila sigurna primjena lijeka i njegova učinkovitost kada se primjenjuje u kombinaciji s drugim lijekovima protiv raka u bolesnika s DLBCL-om.
English: Side effects reported with Polivy are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Polivy pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The dose of Polivy depends on the patient's bodyweight and is given for 6 cycles.
Croatian: Doza lijeka Polivy ovisi o tjelesnoj težini bolesnika, a terapija se sastoji od šest ciklusa.
English: It is used in combination with two other medicines, bendamustine and rituximab.
Croatian: Koristi se u kombinaciji s dva druga lijeka, bendamustinom i rituksimabom.
English: As for all medicines, data on the use of Polivy are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Polivy kontinuirano se prate.
English: After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Croatian: Nakon šest do osam tjedana terapije nije bilo nikakvih znakova raka (potpuni odgovor) u 40 % bolesnika koji su primali lijek Polivy u kombinaciji s rituksimabom i bendamustinom, u usporedbi s 18 % bolesnika koji su primali samo kombinaciju rituksimaba i bendamustina.
English: It is given in 21-day cycles with rituximab and bendamustine.
Croatian: Daje se u ciklusima od 21 dana zajedno s rituksimabom i bendamustinom.
English: DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Croatian: DLBCL je rijetka bolest, a lijek Polivy dobio je status „lijeka za rijetku bolest” 16. travnja 2018.
English: Polivy was investigated in a study involving 80 patients with DLBCL.
Croatian: Ispitivanje lijeka Polivy provedeno je na 80 bolesnika s DLBCL-om.
English: Polivy can only be obtained with a prescription, and treatment must be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer.
Croatian: Polivy se izdaje samo na recept i mora se primjenjivati pod nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju raka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Polivy 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 Polivy nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: How does Polivy work?
Croatian: Kako djeluje Polivy?
English: Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Croatian: Ozbiljne nuspojave (koje se u mogu javiti u najviše 1 na 10 osoba) uključuju febrilnu neutropeniju (nizak broj bijelih krvnih stanica popraćen groznicom), groznicu i pneumoniju (upalu pluća).
English: Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Croatian: Polivy je lijek protiv raka koji se koristi za liječenje odraslih osoba oboljelih od difuznog B-velikostaničnog limfoma (engl. diffuse large B cell lymphoma - DLBCL) u kojih se rak vratio ili je prestao odgovarati na druge terapije i koji nisu kandidati za presađivanje matičnih stanica.
English: MMAE then stops the B cells from dividing and causes them to die.
Croatian: MMAE zaustavlja diobu B-stanica i dovodi do njihova odumiranja.
English: Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Croatian: Prije nego što prime lijek Polivy, bolesnicima se daje paracetamol i antihistaminik kako bi se smanjio rizik od reakcija na infuziju.
English: What information is still awaited for Polivy?
Croatian: Koje se još informacije očekuju o lijeku Polivy?
English: Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Croatian: Više informacija o lijeku Polivy dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/polivy.
English: Half of the patients received Polivy added to the standard regimen of bendamustine plus rituximab whereas the other half received bendamustine plus rituximab alone.
Croatian: Polovica bolesnika primala je lijek Polivy kao dodatak standardnom terapijskom režimu bendamustina i rituksimaba, a druga polovica primala je samo kombinaciju bendamustina i rituksimaba.
English: The doctor may reduce or stop the dose of Polivy if the patient develops side effects affecting blood cells.
Croatian: Liječnik može smanjiti dozu ili obustaviti terapiju lijekom Polivy ako se u bolesnika razviju nuspojave koje zahvaćaju krvne stanice.
English: For more information about using Polivy, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Polivy pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Croatian: Najčešće nuspojave lijeka Polivy u kombinaciji s bendamustinom i rituksimabom (koje se mogu javiti u više od 3 na 10 osoba) bile su anemija (nizak broj crvenih krvnih stanica), trombocitopenija (nizak broj krvnih pločica, trombocita), neutropenija (nizak broj bijelih krvnih stanica), umor, proljev, mučnina i groznica.
English: The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Croatian: Djelatna tvar lijeka Polivy, polatuzumab vedotin, sadrži monoklonsko protutijelo (vrstu bjelančevina) i tvar naziva monometilauristatin E (MMAE).
English: What benefits of Polivy have been shown in studies?
Croatian: Koje su koristi od lijeka Polivy utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Polivy, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Polivy potražite u uputi o lijeku.
English: How is Polivy used?
Croatian: Kako se Polivy primjenjuje?
English: The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Croatian: Monoklonsko protutijelo veže se na bjelančevinu CD79b na B
English: Polivy contains the active substance polatuzumab vedotin.
Croatian: Polivy sadrži djelatnu tvar polatuzumab vedotin.
English: This summary was last updated in 06-2013.
Croatian: Sažetak je posljednji put obnovljen 06-2013.
English: What is MACI and what is it used for?
Croatian: Što je MACI i za što se koristi?
English: EMA/282918/2013
Croatian: EMA/414375/2013 EMEA/H/C/002522
English: How does MACI work?
Croatian: Kako MACI djeluje?
English: A risk management plan has been developed to ensure that MACI is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se implantat MACI koristi što je sigurnije moguće.
English: What measures are being taken to ensure the safe and effective use of MACI?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena implantata MACI?
English: It is not intended to provide practical advice on how to use MACI.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja implantata MACI.
English: The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
Croatian: U ispitivanju su sudjelovale 144 odrasle osobe s oštećenjem površine od 3 do 20 cm2.
English: The CHMP's recommendation is based on an initial assessment by the CAT.
Croatian: Preporuka CHMP-a bazira se na prvobitnoj procjeni CAT-a.
English: The other important risks are those related to the surgical procedure itself, including infection, inflammation, haemoarthrosis (blood in the joints), arthrofibrosis (scar tissue in the joints), and thromboembolic events (blood clots).
Croatian: Ostali važni rizici su rizici povezani sa samim kirurškim zahvatom, uključujući infekciju, upalu, hemoartrozu (krv u zglobovima), artrofibrozu (ožiljkasto tkivo u zglobovima) i tromboembolijske događaje (krvni ugrušci).
English: As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Croatian: MACI je proizvod za naprednu terapiju, te je prvotno procijenjen od strane Odbora za napredne terapije (CAT).
English: Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Croatian: Prekomjeran rast hrskavice i odvajanje implantata mogu nastupiti kod 1 do 10 bolesnika na 1.000 bolesnika liječenih implantatom MACI.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
Croatian: Riječ je o vrsti lijeka koja sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za popravljanje, regeneraciju ili zamjenu tkiva.
English: What are the risks associated with MACI?
Croatian: Koji su rizici povezani s implantatom MACI?
English: What benefits of MACI have been shown in studies?
Croatian: Koje koristi implantata MACI su dokazane u ispitivanjima?
English: MACI was evaluated to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the EMA in order to obtain an EU-wide marketing authorisation.
Croatian: Ocijenjeno je da implantat MACI udovoljava propisima EU-a o naprednim terapijama, koji zahtijevaju da se sve napredne terapije u državama članicama EU-a podvrgnu ocjenjivanju od strane EMA-e kako bi se pribavilo odobrenje za stavljanje lijeka u promet valjano širom Europske unije.
English: In the first stage of treatment, a sample of cartilage cells is taken from the patient's joint and grown in a laboratory.
Croatian: U prvom stadiju liječenja uzima se uzorak stanica hrskavice iz zgloba bolesnika i uzgaja se u laboratoriju.
English: Growth plates close (or harden) when a child has become skeletally mature and their bones have stopped growing.
Croatian: Ploča rasta se zatvara (ili otvrdne) nakon što sjete postigne koštanu zrelost i kosti prestanu rasti.
English: This is a summary of the European public assessment report (EPAR) for MACI.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za implantat MACI.
English: In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Croatian: Nadalje, kirurzi i zdravstveni djelatnici koji će biti uključeni u liječenje bolesnika implantatom MACI zaprimit će edukacijske materijale s detaljnim uputama o korištenju implantata MACI kao i informacije o rizicima te potrebi za naknadno praćenje bolesnika liječenih implantatom MACI.
English: The study showed that MACI is more effective than microfracture surgery at relieving pain and improving knee function: two years after surgery, patients treated with MACI had an average score of 82 for pain and 61 for knee function, compared with 71 and 49 respectively for patients treated with microfracture surgery.
Croatian: Ispitivanje je pokazalo da je implantat MACI djelotvorniji od kirurškog zahvata mikrofraktura s obzirom na ublažavanje boli i poboljšanje funkcije koljena: dvije godine nakon kirurškog zahvata, bolesnici liječeni implantatom MACI imali su prosječan rezultat 82 za bol i 61 za funkciju koljena, u usporedbi sa 71, odnosno 49 u slučaju bolesnika liječenih kirurškim zahvatom mikrofraktura.
English: A standard scale, known as the ‘knee injury and osteoarthritis outcome score' (KOOS), was used to measure pain and knee function, where 0 reflects extreme problems and 100 reflects an absence of problems.
Croatian: Standardna ljestvica poznata pod nazivom „rezultat za ozljedu koljena i ishod osteoartritisa (engl. knee injury and osteoarthritis outcome score - KOOS)” primijenjena je za mjerenje boli i funkcije koljena, pri čemu 0 označava ekstremne probleme, a 100 označava izostanak problema.
English: The full EPAR for MACI can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za implantat MACI može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports . Više informacija o liječenju implantatom MACI pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: MACI is used to repair full-thickness defects with a surface area of between 3 to 20 cm2 in adults who are experiencing symptoms (such as pain and problems moving the knee).
Croatian: MACI se koristi za popravak oštećenja čitave debljine hrskavice površine od 3 do 20 m2 u odraslih bolesnika, koji osjećaju simptome (poput boli i problema prilikom pokretanja koljena).
English: In addition, patients treated with MACI had fewer side effects compared with microfracture
Croatian: Nadalje, bolesnici liječeni implantatom MACI imali su manji broj nuspojava u usporedbi s bolesnicima podvrgnutima metodi mikrofraktura.
English: Around 6 weeks later, the surgeon shapes the membrane to fit the damaged area in the knee cartilage and then implants it using a surgical procedure.
Croatian: Nakon otprilike 6 tjedana, kirurg oblikuje membranu kako bi je prilagodio oštećenom području u hrskavici koljena te je zatim implantira tijekom drugog kirurškog zahvata.
English: matrix applied characterised autologous cultured chondrocytes
Croatian: kultivirani karakterizirani autologni hondrociti aplicirani na matriks
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MACI, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za implantat MACI uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: MACI is an advanced therapy product called a ‘tissue engineered product'.
Croatian: Implantat MACI je vrsta lijeka za naprednu terapiju koji se naziva „lijek dobiven tkivnim inženjerstvom”.
English: The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in
Croatian: Odbor je zaključio da su liječenja implantatima poput MACI ustaljena klinička praksa te da se rezultati glavne studije poklapaju s rezultatima dostupnima u znanstvenoj literaturi.
English: A type of glue known as a fibrin sealant, which is made from blood clotting proteins, is used to hold the implant in place on the cartilage.
Croatian: Tip lijepila poznat pod nazivom fibrinsko tkivno lijepilo, koje se izrađuje od ljudskih proteina koji zgrušavaju krv, koristi se za pričvršćivanje implantata za hrskavicu.
English: MACI must not be used in patients with severe osteoarthritis (swelling and pain) of the knee, inflammatory joint disease, or uncorrected inborn blood clotting disorders.
Croatian: MACI se ne smije koristiti u bolesnika s teškim osteoartritisom (oticanje i bol) koljena, upalnom bolesti zglobova i nekorigiranim prirođenim poremećajima koagulacije krvi.
English: For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
Croatian: S obzirom na bol i funkciju, poboljšanja od otprilike 45 boda zabilježena su kod bolesnika s usađenim implantatom MACI u usporedbi s otprilike 35 boda u bolesnika podvrgnutih metodi mikrofraktura.
English: The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
Croatian: Stoga je CHMP zaključio da koristi implantata MACI nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da je glavna studija pokazala da je u liječenju bolesnika s oštećenjem hrskavice koljena implantat MACI bio superioran u odnosu na liječenje mikrofrakturama.
English: The cells are used to fill in the space where the cartilage has been damaged, thereby regenerating the damaged areas and helping to resolve the patient's symptoms such as pain and problems moving the knee.
Croatian: Ove se stanice koriste za prekrivanje oštećenog područja hrskavice, te stoga regeneriraju oštećena područja i pomažu pri rješavanju simptoma bolesnika, poput boli i problema prilikom pomicanja koljena.
English: MACI was compared with microfracture surgery (a surgical procedure commonly used to treat cartilage defects) in a main study which looked at pain relief and improvements in knee function in patients with full thickness cartilage defects in the knee.
Croatian: Implantat MACI uspoređen je s kirurškim zahvatom mikrofraktura (kirurškim zahvatom koji se obično koristi za liječenje oštećenja hrskavice) u glavnom ispitivanju, u kojem se promatralo ublažavanje boli i poboljšanje funkcije koljena u bolesnika s oštećenjem pune debljine hrskavice koljena.
English: MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Croatian: MACI je implantat koji se koristi za popravak oštećenja hrskavice u završecima kosti zgloba koljena.
English: It consists of the patient's own cartilage cells on 14.5 cm2 collagen membranes, which are used by a surgeon to fill in the spaces where cartilage is damaged.
Croatian: Implantat se sastoji od bolesnikovih vlastitih stanica hrskavice na membrani od kolagena površine 14,5 cm2, koju kirurg koristi za popunjavanje oštećenog područja hrskavice.
English: The cells are then placed onto the collagen membrane.
Croatian: Stanice se zatim premjeste na membranu od kolagena.
English: MACI should only be used by a surgeon specifically trained and qualified to use it and the product can
Croatian: Implantat MACI smije koristiti isključivo kirurg koji je posebno obučen i kvalificiran za primjenu implantata.
English: For practical information about using MACI, patients should read the package leaflet or contact their
Croatian: Praktične informacije o korištenju implantata MACI bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Croatian: Djelatna tvar u implantatu MACI sastoji se od bolesnikovih vlastitih stanica hrskavice, koje se usađuju u oštećenu hrskavicu koljena.
English: MACI must also not be used in patients whose growth plates in the thigh bone have not fully closed.
Croatian: MACI se ne smije koristiti u bolesnika s nepotpuno zatvorenom femoralnom epifiznom pločom rasta.
English: For the full list of all side effects reported with MACI,
Croatian: Cjelokupan popis svih nuspojava prijavljenih za implantat MACI dostupan je u uputi o lijeku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za implantat MACI vrijedi na prostoru Europske unije od 27. lipnja 2013. godine.
English: • major depression;
Croatian: • većom depresijom;
English: A response is usually seen in two to four weeks.
Croatian: Odgovor se najčešće uoči u roku dva do četiri tjedna.
English: The response to treatment should be assessed regularly.
Croatian: Potrebno je redoviti ocjenjivati odgovor na liječenje.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Croatian: • generaliziranim poremećajem anksioznosti (dugoročna anksioznost ili nervoza vezana uz svakodnevnicu).
English: Most patients will need to take 60 mg per day.
Croatian: Većina bolesnika mora uzimati 60 mg na dan.