FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the patient Picato 500 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacija za bolesnika Picato 500 mikrograma/gram gel ingenol mebutat (ingenoli mebutas)
English: Tel.: +48 22 244 18 40
Croatian: LEO Pharma Sp. z o.o. Tel: +48 22 244 18 40
English: Package leaflet: Information for the patient Picato 150 micrograms/gram gel ingenol mebutate This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacija za bolesnika Picato 150 mikrograma/gram gel ingenol mebutat (ingenoli mebutas)
English: Trunk and extremities
Croatian: Trup i udovi
English: Each gram of gel contains 150 mcg of ingenol mebutate.
Croatian: Jedan gram gela sadrži 150 µg ingenol mebutata (ingenoli mebutas).
English: Chest
Croatian: OBLIK
English: Pregnancy
Croatian: Dojenje
English: - Treatment of actinic keratosis on the body, arms, hands and legs is one tube of Picato 500 micrograms/g gel (containing 235 micrograms of ingenol mebutate) once a day for 2 days in a row.
Croatian: 500 mikrograma/g gela (koji sadrži 235 mikrograma ingenol mebutata) jedanput na dan 2 dana zaredom.
English: Clear colourless gel.
Croatian: Bistar, bezbojan gel.
English: Each gram of gel contains 500 mcg of ingenol mebutate.
Croatian: Jedan gram gela sadrži 500 µg ingenol mebutata (ingenoli mebutas).
English: 29 August 2014
Croatian: 29. kolovoza 2014.
English: Final study report by:
Croatian: Konačno izvješće o ispitivanju do:
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna nacionalna tijela zemlje članice ili referentne zemlje članice ako je primjenjivo, osigurat će da nositelj odobrenja ispuni sljedeće uvjete:
English: Outline of the education materials within 3 months after EC decision
Croatian: Kratki prikaz edukacijskih materijala unutar 3 mjeseca nakon odluke etičkog povjerenstva.
English: This will be included in the risk management plan, highlighting the risks and warnings of thromboembolism (by e.g. a checklist, to be implemented at national level).
Croatian: To će biti uključeno u plan upravljanja rizikom, naglašavajući rizik e i upozorenja za tromboemboliju (npr. popisom koji će se primjenjivati na nacionalnoj razini).
English: Within 3 months after EC decision
Croatian: U roku od 3 mjeseca od odluke etičkog povjerenstva.
English: The MAH(s) should submit the next PSUR by:
Croatian: Nositelj odobrenja trebaju podnijeti sljedeći PSUR do:
English: The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format.
Croatian: Nositelj odobrenja treba podnijeti osnovne elemente (uključujući pregled DUS, PASS i edukacijske materijale) plana upravljanja rizikom u EU formatu.
English: Annex IV Conditions to the marketing authorisations
Croatian: Dodatak IV Uvjeti davanja odobrenja za stavljanje lijeka u promet
English: The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities.
Croatian: Nositelj odobrenja treba podnijeti protokol za PASS u sklopu podnošenja plana upravljanja rizikom kako bi se procijenila učinkovitost aktivnosti za minimizaciju rizika.
English: The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Croatian: Nositelj odobrenja treba u okviru podnošenja plana upravljanja rizikom podnijeti protokol za ispitivanje iskoristivosti lijeka, kako bi se opisale prakse propisivanja lijekova u uobičajenoj kliničkoj upotrebi u reprezentativnoj skupini liječnika koji propisuju lijek te radi procjene glavnih razloga propisivanja.
English: Conditions to the marketing authorisations
Croatian: Uvjeti davanja odobrenja za stavljanje lijeka u promet
English: The MAH(s) should provide within the risk management plan Educational material for prescribers and patients.
Croatian: Nositelj odobrenja treba u okviru plana upravljanja rizikom podnijeti edukacijske materijale za liječnike koji propisuju lijek i za bolesnike.
English: It is given for a total of 5 courses.
Croatian: Daje se u ukupno 5 ciklusa.
English: However, more data are needed to fully understand the medicine's effectiveness.
Croatian: Međutim, potrebno je više podataka kako bi se u potpunosti utvrdila djelotvornost lijeka.
English: In addition, the company will report on the 5-year survival rates of patients who took part in studies.
Croatian: Nadalje, tvrtka će izvijestiti o 5-godišnjim stopama preživljenja bolesnika koji su sudjelovali u ispitivanjima.
English: What is Qarziba and what is it used for?
Croatian: Što je Qarziba i za što se koristi?
English: The recommended dose depends on the patient's weight and height.
Croatian: Preporučena doza ovisi o tjelesnoj težini i visini bolesnika.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove pregledava sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
English: Each course of treatment with the medicine is given for 5 or 10 days every 35 days.
Croatian: U svakom ciklusu liječenja koji traje 35 dana, lijek se daje 5 ili 10 dana.
English: The company will also perform tests to obtain more information on how the medicine is processed by the body and how the immune system responds to the medicine.
Croatian: Također, tvrtka će provoditi testove kako bi dobila više podataka o tome kako se lijek razgrađuje u tijelu te kako imunosni sustav odgovara na lijek.
English: Qarziba has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Qarziba odobren je u „iznimnim okolnostima”.
English: This is because it has not been possible to obtain complete information about Qarziba for ethical reasons.
Croatian: Razlog tome je nemogućnost dobivanja potpunih informacija o lijeku Qarziba iz etičkih razloga.
English: It is used in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back):
Croatian: Primjenjuje se u 2 skupine bolesnika koji imaju neuroblastom visokog rizika (za koji postoji velika vjerojatnost da će se vratiti):
English: This summary was last updated on 12-2017.
Croatian: Sažetak je posljednji put ažuriran u 12. 2017.
English: • patients who have had some improvement with previous treatments, which included blood stem cell transplantation (a transplant of blood-producing cells);
Croatian: • bolesnika u kojih je prethodnim liječenjima ostvareno određeno poboljšanje, a ta su liječenja uključila transplantaciju matičnih krvnih stanica (transplantacija krvotvornih stanica);
English: At the start of treatment some of these patients had no sign of neuroblastoma and some still had some sign of the disease.
Croatian: Na početku liječenja neki od tih bolesnika nisu imali nikakav znak neuroblastoma, a neki su još imali neke simptome bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji uočio je manjak opcija liječenja kojima bi se spriječio recidiv neuroblastoma visokog rizika.
English: If the neuroblastoma has come back after previous treatment, it should be stabilised (stopped from getting worse) before treatment with Qarziba is started.
Croatian: Ako se nakon prethodnih liječenja neuroblastom vratio, treba ga stabilizirati (zaustaviti pogoršanje) prije početka terapije lijekom Qarziba.
English: It must be given in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if needed.
Croatian: Lijek se mora davati u bolnici, a daju ga liječnik ili medicinska sestra osposobljeni za liječenje teških alergijskih reakcija, kojima je u svakom trenutku dostupna oprema za oživljavanje ako to bude potrebno.
English: What measures are being taken to ensure the safe and effective use of Qarziba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Qarziba?
English: As dinutuximab is a recommended treatment for high-risk neuroblastoma, it would not be ethical to carry out a trial in which some patients were given placebo (a dummy treatment).
Croatian: Budući da se dinituksimab preporučuje za liječenje visokorizičnog neuroblastoma, ne bi bilo etično provoditi ispitivanje u kojemu bi neki bolesnici primali placebo (prividno liječenje).
English: Treatment must be supervised by a doctor experienced in the treatment of cancer.
Croatian: Liječenje lijekom Qarziba mora se provoditi pod nadzorom liječnika s iskustvom u liječenju raka.
English: Although treatment with Qarziba can cause serious side effects, the safety of the medicine is considered acceptable.
Croatian: Iako liječenje lijekom Qarziba može prouzročiti ozbiljne nuspojave, sigurnost lijeka smatra se prihvatljivom.
English: The full EPAR for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Qarziba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The name of the product was changed to Dinutuximab beta EUSA on 4 August 2017 and to Qarziba on 27 November 2017.
Croatian: Naziv lijeka promijenjen je u Dinutuximab beta EUSA 4. kolovoza 2017. i u Qarziba 27. studenoga 2017.
English: Previously known as Dinutuximab beta Apeiron and Dinutuximab beta EUSA.
Croatian: Prethodno poznat pod nazivima Dinutuximab beta Apeiron i Dinutuximab beta EUSA.
English: The most common side effects with Qarziba (which may affect more than 7 in 10 people) are pyrexia (fever) and pain.
Croatian: Najčešće nuspojave lijeka Qarziba (koje se mogu javiti u više od 7 na 10 osoba) su vrućica (pireksija) i bol.
English: Therefore the CHMP decided that Qarziba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Qarziba nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Qarziba.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Qarziba.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qarziba 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 Qarziba nalaze se u sažetku opisa svojstava u uputi o lijeku.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Qarzibadostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Qarziba must not be used in patients with severe or widespread graft-versus-host disease (when transplanted cells attack the body).
Croatian: Qarziba se ne smije upotrebljavati u bolesnika s teškom ili opsežnom reakcijom presatka protiv primatelja (kada transplantirane stanice napadnu tijelo).
English: When Qarziba attaches to the neuroblastoma cells, it makes them a target for the body's immune system (the body's natural defences), which then kills the cancer cells.
Croatian: Kada se Qarziba veže na stanice neuroblastoma, one postaju ciljno mjesto djelovanja imunosnog sustava (prirodna obrana tijela), koje tada ubija stanice raka.
English: Treatment with Qarziba should not be started unless the patient has satisfactory results in certain blood tests of liver, lung, kidney and bone marrow function.
Croatian: Liječenje lijekom Qarziba ne smije se započeti ako bolesnik nema zadovoljavajuće rezultate krvnih pretraga za funkciju jetre, pluća, bubrega i koštane srži.
English: Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Qarziba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Croatian: Budući da je broj bolesnika s neuroblastomom nizak, dotična se bolest smatra „rijetkom” te se Qarziba označava kao lijek za liječenje rijetkih bolesti od 8. studenog 2012.
English: Qarziba is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a structure called GD2 that is present in high amounts on the surface of neuroblastoma cells, but not normal cells.
Croatian: Qarziba je monoklonsko protutijelo (vrsta proteina) proizvedeno kako bi prepoznalo strukturu pod nazivom GD2 koja je u velikim količinama prisutna na stanicama neuroblastoma, ali ne i na normalnim stanicama i vezalo se za nju.
English: (allergy), vomiting, diarrhoea, capillary leak syndrome (leakage of fluid from blood vessels that can cause swelling and a drop in blood pressure) and hypotension (low blood pressure).
Croatian: Druge nuspojave (koje se mogu javiti u više od 3 na 10 osoba) su preosjetljivost (alergija), povraćanje, proljev, sindrom kapilarnog curenja (curenje tekućine iz krvnih žila što može prouzročiti oticanje i pad krvnog tlaka) i hipotenzija (nizak krvni tlak).
English: Since Qarziba has been approved under exceptional circumstances, the company that markets Qarziba will monitor the safety of the medicine using a patient registry and provide yearly updates.
Croatian: Budući da je lijek Qarziba odobren u iznimnim okolnostima, tvrtka koja lijek Qarziba stavlja na tržište nadzirat će sigurnost lijeka na temelju registra bolesnika i svake godine ažurirati podatke.
English: Other information about Qarziba
Croatian: Ostale informacije o lijeku Qarziba
English: Taken together, data on outcomes with Qarziba show that the medicine is effective.
Croatian: Sveukupni podatci o ishodima lijeka Qarziba pokazuju da je lijek učinkovit.
English: What are the risks associated with Qarziba?
Croatian: Koji su rizici povezani s lijekom Qarziba?
English: Studies have shown that Qarziba is effective at increasing survival in patients with neuroblastoma.
Croatian: Ispitivanja su pokazala da Qarziba učinkovito produljuje preživljenje bolesnika s neuroblastomom.
English: Qarziba is a cancer medicine used to treat neuroblastoma, a cancer of nerve cells, in patients over 1 year of age.
Croatian: Qarzibalijek je protiv raka namijenjen za liječenje neuroblastoma, raka živčanih stanica, u bolesnika starijih od 1 godine.
English: dinutuximab beta
Croatian: Qarziba dinutuksimab beta
English: Two studies analysed data from 88 children and adults with neuroblastoma that had not improved with other cancer treatments or had come back.
Croatian: U dva ispitivanja analizirani su podatci za 88 djece i odraslih s neuroblastomom, koji se uz druge terapije protiv raka nije poboljšao ili se vratio.
English: In these studies, 70% and 78% of the patients whose neuroblastoma had not improved with other treatments were still alive 2 years after treatment.
Croatian: U tim ispitivanjima, 70 % i 78 % bolesnika u kojih drugim terapijama nije došlo do poboljšanja neuroblastoma, živjelo je 2 godine nakon liječenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dinutuximab beta Apeiron on 8 May 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet lijeka Dinutuximab beta Apeiron koje vrijedi na prostoru Europske unije od 8. svibnja 2017.
English: • patients whose neuroblastoma has not improved with other cancer treatments or has come back.
Croatian: • bolesnika u kojih drugim liječenjima protiv raka nije došlo do poboljšanja neuroblastoma ili se on vratio (recidiv).
English: The doctor may need to reduce or delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Croatian: Ako se pojave određene nuspojave, liječnik će možda trebati smanjiti ili odgoditi primjenu doza, a ako su nuspojave teške, potpuno prekinuti liječenje.
English: In a third study, 370 children with high-risk neuroblastoma that had improved after other treatments were given Qarziba and isotretinoin with or without interleukin-2.
Croatian: U trećem ispitivanju, 370 djece s neuroblastomom visokog rizika koji se poboljšao nakon drugih terapija primalo je lijek Qarziba i izotretinoin s interleukinom-2 ili bez njega.
English: Of the patients with neuroblastoma that had come back, 42% and 69% were still alive 2 years after treatment.
Croatian: Od bolesnika s recidivom neuroblastoma, 42 % i 69 % bolesnika živjelo je 2 godine nakon liječenja.
English: The medicine contains the active substance dinutuximab beta.
Croatian: Ovaj lijek sadrži djelatnu tvar dinutuksimab beta.
English: Of the patients who had no sign of neuroblastoma, 71% were still alive 3 years after treatment and the results were similar whether the treatment included interleukin-2 or not.
Croatian: Od bolesnika koji nisu imali nikakav znak neuroblastoma, postotak bolesnika koji su bili živi tri godine nakon liječenja iznosio je 71%, a rezultati su bili slični bez obzira je li liječenje uključivalo interleukin-2 ili ne.
English: It is not intended to provide practical advice on how to use Qarziba.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Qarziba.
English: Patients were treated with Qarziba plus interleukin-2 and another medicine called isotretinoin.
Croatian: Bolesnici su bili liječeni lijekom Qarzibaplus interleukin-2 i još jednim lijekom pod nazivom izotretinoin.
English: How is Qarziba used?
Croatian: Kako se Qarziba koristi?
English: Qarziba is given as an infusion (drip) into a vein.
Croatian: Qarzibadaje se putem intravenske infuzije (drip).
English: What benefits of Qarziba have been shown in studies?
Croatian: Koje su koristi lijeka Qarziba dokazane u ispitivanjima?
English: For practical information about using Qarziba, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Qarziba bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Of the patients who had some sign of neuroblastoma, 63% of those given interleukin-2 were still alive 3 years after treatment compared with 54% of patients who did not receive interleukin-2.
Croatian: Među bolesnicima koji su imali neki simptom neuroblastoma, 3 godine nakon liječenja bilo je živo 63 % bolesnika koji su primali interleukin-2 u usporedbi s 54 % onih koji nisu primali interleukin-2.
English: For more information about treatment with Qarziba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Qarzibapročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: What information is still awaited for Qarziba?
Croatian: Koje se još informacije očekuju o lijeku Qarziba?
English: In these studies, outcomes with Qarziba compared favourably with those previously seen in patients treated for neuroblastoma without Qarziba.
Croatian: Ishodi s lijekom Qarziba bili su u tim ispitivanjima povoljniji od onih ranije opaženih u bolesnika u kojih je neuroblastom liječen bez lijeka Qarziba.
English: How does Qarziba work?
Croatian: Kako djeluje Qarziba?
English: Results of a study looking at the effect of giving Qarziba together with interleukin-2 will be provided by the company.
Croatian: Tvrtka će prikazati rezultate ispitivanja kojim se prati učinak lijeka Qarziba zajedno s interleukinom-2.
English: For the full list of all side effects and restrictions with Qarziba, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Qarziba potražite u uputi o lijeku.
English: Why is Qarziba approved?
Croatian: Zašto je lijek Qarzibaodobren?
English: Qarziba is used together with another medicine called interleukin-2 (aldesleukin) in some cases where previous treatments have not worked well enough.
Croatian: U nekim slučajevima u kojima prethodna liječenja nisu bila dovoljno djelotvorna, Qarziba kombinira se s još jednim lijekom zvanim interleukin-2 (aldesleukin).
English: This overview was last updated in May 2018.
Croatian: Pregled je posljednji put ažuriran u svibnju 2018.
English: The full course should be repeated with each pregnancy.
Croatian: Cjelovit program imunizacije mora se ponoviti kod svakog graviditeta.
English: Further information on Ubac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Ubac nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This will help protect the cattle against the infection and reduce the risk of mastitis.
Croatian: To će pomoći u zaštiti goveda od infekcije i smanjiti rizik od mastitisa.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Croatian: Ako bol potraje više od 12 sati nakon liječničkog pregleda, treba ponovo potražiti pomoć liječnika.
English: What is Ubac and what is it used for?
Croatian: Što je Ubac i za što se koristi?
English: The whole herd should be vaccinated.
Croatian: Potrebno je cijepiti cijelo stado.
English: If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected.
Croatian: Ako se netko slučajno injicira ovim VMP-om, mora potražiti hitnu medicinsku pomoć čak i ako je injicirana vrlo mala količina.
English: The vaccine also contains ‘adjuvants' (Montanide ISA and MPLA) to stimulate a better reaction by the immune system.
Croatian: Cjepivo također sadržava „adjuvanse” (Montanide ISA i MPLA) kako bi se potaknula bolja reakcija imunosnog sustava.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or fingerthis could result in the loss of the finger if prompt medical attention is not given.
Croatian: Slučajno injiciranje može prouzročiti jaku bol i oticanje, naročito ako se cjepivo injicira u zglob ili prst, što može rezultirati gubitkom zahvaćenog prsta ako se ne pruži hitna medicinska pomoć.
English: The third injection is given about 15 days after calving.
Croatian: Treća injekcija daje se oko 15 dana nakon teljenja.
English: What are the risks associated with Ubac?
Croatian: Koji su rizici povezani s VMP-om Ubac?
English: In the future, if the animals are exposed to disease-causing S. uberis bacteria, the immune system will be able to respond more quickly.
Croatian: Ako životinje ubuduće budu izložene bakteriji S. uberis koja uzrokuje bolest, imunosni sustav moći će brže reagirati.
English: Ubac (Streptococcus uberis vaccine, inactivated)
Croatian: Ubac (cjepivo protiv Streptococcus uberis, inaktivirano)
English: Other information about Ubac
Croatian: Ostale informacije o VMP-u Ubac
English: The injection site swelling usually disappears or reduces in size by 17 days after vaccination but in some cases the swelling may last for up to 4 weeks.
Croatian: Oteklina na mjestu injekcije najčešće nestaje ili se smanjuje u roku od 17 dana nakon cijepljenja, ali u nekim slučajevima oteklina može trajati do četiri tjedna.
English: The withdrawal period for meat and milk from cattle treated with Ubac is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso i mlijeko goveda liječenih VMP-om Ubac iznosi „nula” dana, odnosno nema obveznog razdoblja čekanja.