FrancophonIA/ELRC3.0 huggingface dataset:
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 DuoPlavin.
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 DuoPlavin.
English: For more information about treatment with DuoPlavin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom DuoPlavin pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Croatian: Klopidogrel je odobren od 1998. kao lijek za smanjenje agregacije trombocita i često se koristi u kombinaciji s acetilsalicilatnom kiselinom.
English: DuoPlavin clopidogrel / acetylsalicylic acid
Croatian: DuoPlavin klopidogrel/acetilsalicilatna kiselina
English: This document is a summary of the European Public Assessment Report (EPAR) for DuoPlavin.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku DuoPlavin.
English: Because the two active substances have been used together for a number of years, the company presented the results of studies showing that the active substances in DuoPlavin are absorbed in the body in the same way when taken in a single tablet as when the two medicines are taken separately.
Croatian: S obzirom na to da se te dvije djelatne tvari zajedno koriste već niz godina, tvrtka je predstavila rezultate ispitivanja koji pokazuju da se djelatne tvari u lijeku DuoPlavin apsorbiraju u tijelo na isti način kao i kada se uzimaju kao pojedinačna tableta kada se ta dva lijeka uzimaju zasebno.
English: The Committee therefore decided that DuoPlavin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je stoga odlučio da koristi od lijeka DuoPlavin nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: This means that they help to prevent blood cells called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Croatian: To znači da pomažu u sprečavanju sljepljivanja krvnih stanica koje se nazivaju trombociti i stvaranja krvnih ugrušaka, pomažući tako u sprečavanju pojave novog srčanog udara.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming.
Croatian: Time se sprečava da trombociti postanu „ljepljivi”, što smanjuje rizik od stvaranja krvnih ugrušaka.
English: DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Croatian: DuoPlavin je lijek koji sadrži dvije djelatne tvari, klopidogrel i acetilsalicilatnu kiselinu (također poznatu kao aspirin).
English: The combination of the two active substances has an additive effect, reducing the risk of blood clots forming, more than either medicine alone.
Croatian: Kombinacija ovih dviju djelatnih tvari ima zbrojni učinak tako što smanjuje rizik od stvaranja krvnih ugrušaka u većoj mjeri nego ti lijekovi pojedinačno.
English: • patients who have ‘unstable angina' (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Croatian: • u bolesnika koji imaju „nestabilnu anginu” (teži oblik boli u prsima) ili u bolesnika koji su imali srčani udar bez „elevacije ST-segmenta” (abnormalan nalaz elektrokardiograma ili EKG-a), uključujući u bolesnika koji imaju ugrađen stent (kratku cijev) u arteriji radi sprečavanja njezina zatvaranja;
English: The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Croatian: Najčešće su nuspojave lijeka DuoPlavin (zabilježene u između 1 i 10 na 100 bolesnika) hematomi (nakupljanje krvi pod kožom), epistaksa (krvarenje iz nosa), gastrointestinalno krvarenje (krvarenje u želucu ili crijevima) proljev, abdominalna bol (bol u trbuhu), dispepsija (žgaravica), pojava modrica i krvarenje na mjestu uboda na koži.
English: What is the risk associated with DuoPlavin?
Croatian: Koji su rizici povezani s lijekom DuoPlavin?
English: • patients being treated for heart attack with ST-segment elevation, when the doctor thinks that they would benefit from thrombolytic treatment (treatment to dissolve blood clots).
Croatian: • u bolesnika koji primaju terapiju za srčani udar s „elevacijom ST-segmenta” u slučaju kada liječnik smatra da će im koristiti trombolitička terapija (terapija za otapanje krvnih ugrušaka).
English: Other information about DuoPlavin:
Croatian: Ostale informacije o lijeku DuoPlavin
English: Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Croatian: Obje djelatne tvari u lijeku DuoPlavin, klopidogrel i acetilsalicilatna kiselina, jesu antitrombocitni lijekovi.
English: DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin.
Croatian: Lijek DuoPlavin ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na klopidogrel, nesteroidne protuupalne lijekove (kao što je acetilsalicilatna kiselina) ili bilo koji drugi sastojak lijeka DuoPlavin.
English: Results from the 3 studies in patients with unstable angina or who had had a heart attack showed that the combination of clopidogrel and acetylsalicylic acid taken as separate tablets was more effective at preventing events such as heart attacks than acetylsalicylic acid alone.
Croatian: Rezultati triju ispitivanja na bolesnicima s nestabilnom anginom ili bolesnicima koji su imali srčani udar pokazali su da je uzimanje kombinacije klopidogrela i acetilsalicilatne kiseline kao zasebnih tableta djelotvornije u sprečavanju stanja kao što je srčani udar od uzimanja samo acetilsalicilatne kiseline.
English: Clopidogrel stops the platelets sticking together by blocking a substance called ADP from attaching to a special receptor on their surface.
Croatian: Klopidogrel onemogućuje sljepljivanje trombocita tako što onemogućuje da se tvar koja se naziva ADP veže za poseban receptor na njihovoj površini.
English: Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Croatian: Acetilsalicilatna kiselina onemogućuje sljepljivanje trombocita onemogućivanjem djelovanja enzima koji se naziva prostaglandin ciklooksigenaza.
English: Why has DuoPlavin been approved?
Croatian: Zašto je DuoPlavin odobren?
English: It must not be used in patients who have a disease that is causing bleeding, such as stomach ulcer or bleeding in the brain or in patients with mastocytosis (high blood levels of certain white blood cells called mast cells).
Croatian: Ne smije se primjenjivati u bolesnika koji boluju od bolesti koje uzrokuju krvarenje, kao što su čir na želucu ili krvarenje u mozgu, ili u bolesnika s mastocitozom (visokim razinama određenih bijelih krvnih stanica, mastocita, u krvi).
English: What is DuoPlavin?
Croatian: Što je DuoPlavin?
English: The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets.
Croatian: CHMP je smatrao da je lijek DuoPlavin usporediv s tabletama klopidogrela i acetilsalicilatne kiseline kada se uzimaju zasebno i zaključio je da se objedinjavanjem tih dviju djelatnih tvari u jedinstveni lijek DuoPlavin pojednostavljuje liječenje za bolesnike jer će tako trebati uzimati manji broj tableta.
English: DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Croatian: Lijek DuoPlavin koristi se za sprečavanje problema uzrokovanih ugrušcima krvi i otvrdnućem arterija kao što je srčani udar, i to u odraslih osoba koje već uzimaju klopidogrel i acetilsalicilatnu kiselinu kao zasebne tablete.
English: DuoPlavin is taken as one tablet once a day in place of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Croatian: Lijek DuoPlavin uzima se u obliku jedne tablete jednom dnevno umjesto tableta klopidogrela i acetilsalicilatne kiseline koje je bolesnik prethodno zasebno uzimao.
English: What benefit has DuoPlavin shown during the studies?
Croatian: Koje su koristi lijeka DuoPlavin utvrđene u ispitivanjima?
English: DuoPlavin was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Croatian: Pokazalo se da je lijek DuoPlavin usporediv s klopidogrelom i acetilsalicilatnom kiselinom kada se te tvari uzimaju zasebno i da se stoga može koristiti umjesto tableta klopidogrela i acetilsalicilatne kiseline koje su bolesnici prethodno već uzimali.
English: For the full list of all side effects reported with DuoPlavin, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka DuoPlavin potražite u uputi o lijeku.
English: What is DuoPlavin used for?
Croatian: Za što se DuoPlavin koristi?
English: How does DuoPlavin work?
Croatian: Kako djeluje DuoPlavin?
English: How is DuoPlavin used?
Croatian: Kako se DuoPlavin koristi?
English: How has DuoPlavin been studied?
Croatian: Kako je DuoPlavin ispitivan?
English: Further information on Pelmeg can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pelmeg.
Croatian: Više informacija o lijeku Pelmeg nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/pelmeg.
English: What is Pelmeg and what is it used for?
Croatian: Što je Pelmeg i za što se primjenjuje?
English: What measures are being taken to ensure the safe and effective use of Pelmeg?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pelmeg?
English: The most common side effect with Pelmeg (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Pelmeg (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: Pelmeg is a ‘biosimilar medicine'.
Croatian: Pelmeg je „biosličan lijek”.
English: This means that Pelmeg is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Pelmeg je vrlo sličan drugom biološkom lijeku („referentnom lijeku”) koji je već odobren u EU-u.
English: Pelmeg is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Croatian: Lijek Pelmeg daje se kao pojedinačna doza od 6 mg koja se ubrizgava pod kožu najmanje 24 sata nakon završetka svakog ciklusa kemoterapije (liječenja lijekovima protiv raka).
English: What are the risks associated with Pelmeg?
Croatian: Koji su rizici povezani s lijekom Pelmeg?
English: Side effects reported with Pelmeg are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Pelmeg pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Pelmeg authorised in the EU?
Croatian: Zašto je Pelmeg odobren u EU-u?
English: Other information about Pelmeg
Croatian: Ostale informacije o lijeku Pelmeg
English: Pelmeg can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Croatian: Lijek Pelmeg izdaje se samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: An overview of Pelmeg and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Pelmeg i zašto je odobren u EU-u
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelmeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Pelmeg ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Neulasta te se u tijelu raspoređuje na isti način.
English: Because Pelmeg is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelmeg.
Croatian: Budući da je lijek Pelmeg biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Pelmeg.
English: For more information about using Pelmeg, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Pelmeg pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: The reference medicine for Pelmeg is Neulasta.
Croatian: Referentni lijek za Pelmeg je Neulasta.
English: Pelmeg is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Croatian: Pelmeg nije namijenjen za uporabu u bolesnika s rakom krvi, kroničnom mijeloičnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara velik broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: The safety of Pelmeg has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Croatian: Ocijenjena je sigurnost primjene lijeka Pelmeg i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Neulasta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelmeg 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 Pelmeg nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelmeg outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Pelmeg, kao i od lijeka Neulasta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: The active substance in Pelmeg, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Pelmeg, pegfilgrastim, oblik je filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta kolonije granulocita (G-CSF).
English: As for all medicines, data on the use of Pelmeg are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Pelmeg kontinuirano se prate.
English: What benefits of Pelmeg have been shown in studies?
Croatian: Koje su koristi od lijeka Pelmeg utvrđene u ispitivanjima?
English: Pelmeg is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Pelmeg je lijek koji se primjenjuje u bolesnika s rakom radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: Laboratory studies comparing Pelmeg with Neulasta have shown that the active substance in Pelmeg is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Croatian: Laboratorijskim ispitivanjima u kojima su uspoređivani lijekovi Pelmeg i Neulasta pokazalo se da je djelatna tvar u lijeku Pelmeg vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
English: All these data were considered sufficient to conclude that Pelmeg will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Pelmeg za odobrene indikacije djelovati na isti način kao lijek Neulasta u pogledu učinkovitosti i sigurnosti primjene.
English: In Pelmeg, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Pelmeg filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: Studies have also shown that giving Pelmeg produces similar levels of the active substance in the body to giving Neulasta.
Croatian: Ispitivanjima je također utvrđeno da se primjenom lijeka Pelmeg proizvodi slična razina djelatne tvari u tijelu kao i primjenom lijeka Neulasta.
English: How does Pelmeg work?
Croatian: Kako djeluje lijek Pelmeg?
English: How is Pelmeg used?
Croatian: Kako se Pelmeg primjenjuje?
English: For the full list of side effects and restrictions with Pelmeg, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Pelmeg potražite u uputi o lijeku.
English: You should not do both.
Croatian: Ne smijete oboje.
English: They contain white to almost white powder.
Croatian: Sadrže bijeli do gotovo bijeli prašak.
English: Time (Months)
Croatian: Vrijeme (mjeseci)
English: Patients should be carefully monitored for safety.
Croatian: Bolesnike je potrebno pažljivo motriti zbog sigurnosti.
English: It is particularly important that you mention any of the following medicines.
Croatian: Osobito je važno da spomenete sljedeće lijekove.
English: Approximate diameter: 9.1 mm.
Croatian: Približni promjer: 9,1 mm.
English: Therefore, genotoxic risk is not expected in humans.
Croatian: Stoga se u ljudi ne očekuje genotoksični rizik.
English: The median time to first dose reduction due to any reason was 8 weeks.
Croatian: Medijan vremena do prvog smanjenja doze zbog bilo kojeg razloga bio je 8 tjedana.
English: Includes cases reported within the clustered terms:
Croatian: Uključuje slučajeve prijavljene unutar objedinjenih izraza:
English: This is a long-term treatment, possibly lasting for months.
Croatian: Ovo je dugoročna terapija, koja može trajati mjesecima.
English: The purpose of these tests is to check your liver function.
Croatian: Svrha tih pretraga je da se provjeri funkcija Vaše jetre.
English: For Study X2101, OS data were not yet mature at the time of the analysis.
Croatian: Za Ispitivanje X2101, OS podaci još nisu bili zreli u vrijeme analize.
English: Medical treatment may be necessary.
Croatian: Možda će biti nužno medicinsko liječenje.
English: Do not chew or crush them.
Croatian: Nemojte ih žvakati ili drobiti.
English: Target organ effects showed partial to complete recovery.
Croatian: Učinci na ciljni organ pokazali su djelomičan do potpuni oporavak.
English: (symptomatic, may be severe and medically significant, medical intervention indicated)
Croatian: (simptomatska, može biti teška i medicinski značajna, indicirana medicinska intervencija)
English: If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti, obratite se svom liječniku za savjet.
English: (life-threatening consequences, urgent intervention indicated)
Croatian: (posljedice opasne po život, indicirana hitna intervencija)
English: You should not eat grapefruit or drink grapefruit juice during treatment.
Croatian: Ne smijete jesti grejp ili piti sok od grejpa tijekom liječenja.
English: Heart rate and blood pressure should be monitored regularly.
Croatian: Redovito treba pratiti srčanu frekvenciju i krvni tlak.
English: Your doctor will monitor your condition to see that the treatment is having the desired effect.
Croatian: Vaše stanje da bi vidio ima li liječenje željeni učinak.
English: Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the baby.
Croatian: Zykadia se ne preporučuje tijekom trudnoće, osim ako potencijalna korist ne premašuje potencijalni rizik za dijete.
English: Your doctor will tell you exactly how many tablets you need to take.
Croatian: Liječnik će Vam reći koliko točno tableta morate uzimati.
English: Effects of age, gender, and race
Croatian: Učinci dobi, spola i rase
English: Estimated using the Kaplan-Meier method.
Croatian: Procijenjeno pomoću Kaplan-Meierove metode.
English: Overall survival c
Croatian: Ukupno preživljenje c
English: Continue taking Zykadia for as long as your doctor tells you.
Croatian: Nastavite uzimati Zykadiu dokle god Vam liječnik kaže.
English: Your doctor will tell you exactly how many capsules you need to take.
Croatian: Liječnik će Vam reći koliko točno kapsula morate uzimati.
English: Talk to your doctor about the birth control methods that may be right for you.
Croatian: Razgovarajte sa svojim liječnikom o metodama kontrole začeća koje bi Vam mogle odgovarati.
English: These may be symptoms of a high level of sugar in the blood.
Croatian: To mogu biti simptomi visoke razine šećera u krvi.
English: Nausea, diarrhoea and vomiting were among the most commonly reported gastrointestinal events.
Croatian: Mučnina, proljev i povraćanje bili su među najčešće prijavljenim gastrointestinalnim događajima.
English: The micronucleus test in TK6 cells was positive.
Croatian: Mikronukleus test u TK6 stanicama bio je pozitivan.
English: Do not stop taking this medicine before talking to your doctor.
Croatian: Nemojte prestati uzimati ovaj lijek prije nego razgovarate sa svojim liječnikom.
English: Then take the next capsules at the usual time.
Croatian: Zatim uzmite sljedeće kapsule u uobičajeno vrijeme.
English: Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.
Croatian: Liječnik će s Vama razgovarati o potencijalnim rizicima uzimanja Zykadie tijekom trudnoće.
English: Based on the stratified log-rank test.
Croatian: Na temelju stratificiranog log-rang testa.
English: 92.1% of patients had adenocarcinoma.
Croatian: 92,1% bolesnika imalo je adenokarcinom.
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Croatian: Ako uzimate bilo koji od njih, liječnik će Vam možda morati propisati neki drugi lijek.
English: Cannot be sold separately.
Croatian: Nije za pojedinačnu prodaju.
English: All of the patients were treated with at least one regimen prior to enrolment into the study and 84.0% with two or more regimens.
Croatian: Svi su bolesnici bili liječeni barem jednim režimom prije uključivanja u ispitivanje, a 84,0% s dva ili više režima.
English: Treatment should continue as long as clinical benefit is observed.
Croatian: Liječenje je potrebno nastaviti dokle god se uočava klinička korist.