FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hexyon's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Hexyon nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: What is Hexyon and what is it used for?
Croatian: Što je Hexyon i za što se koristi?
English: Vaccination with Hexyon should be postponed if a child has a moderate to severe fever.
Croatian: Cijepljenje lijekom Hexyon treba odgoditi ako dijete ima umjerenu do ozbiljnu groznicu.
English: Hexyon has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Croatian: Hexyon je ispitivan u nekoliko država diljem svijeta u 12 glavnih ispitivanja koja su obuhvatila više od 3 400 djece u dobi između šest tjedana i dvije godine starosti koja su primila tri doze cjepiva tijekom prvih šest tjedana života u skladu s različitim lokalnim rasporedima cijepljenja.
English: Hexyon contains small amounts of materials derived from the bacteria and viruses it protects against.
Croatian: Hexyon sadrži male količine materijala koji potječu iz virusa i bakterija od kojih taj lijek štiti.
English: The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.
Croatian: Glavna mjera djelotvornosti bilo je stvaranje koncentracija protutijela za koje je poznato da štite protiv tih bolesti.
English: The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexyon.
Croatian: Djelovanje je uspoređeno s kombinacijom zasebnih cjepiva osmišljenih za zaštitu protiv bolesti uključenih u Hexyon.
English: What are the risks associated with Hexyon?
Croatian: Koji su rizici povezani s lijekom Hexyon?
English: Hexyon is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Croatian: Hexyon se primjenjuje dubokom injekcijom u mišić, najčešće u gornji dio bedra ili ramena.
English: The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexyon; protection was maintained or improved when a booster dose was given.
Croatian: Ispitivanjima je utvrđeno da su se zaštitne koncentracije protutijela protiv različitih bolesti razvile u između 90 % i 100 % djece nakon prve tri doze cjepiva Hexyon, a zaštita se održala ili poboljšala nakon davanja dodatne doze.
English: The recommended initial vaccination schedule is either two doses, given two months apart or three doses, given at least one month apart.
Croatian: Preporučeni početni raspored cijepljenja jest ili dvije doze, koje se daju u razmaku od dva mjeseca, ili tri doze koje se primjenjuju u razmaku od najmanje mjesec dana.
English: Regarding safety, the CHMP considered that Hexyon's overall safety profile is similar to other vaccines, although vaccination with Hexyon is more likely than similar vaccines to cause reactions (mainly at the injection site).
Croatian: U pogledu sigurnosti, CHMP smatra da je opći sigurnosni profil cjepiva Hexyon sličan drugim cjepivima, premda je izglednije da će cijepljenje cjepivom Hexyon u odnosu na slična cjepiva uzrokovati reakcije (uglavnom na mjestu injekcije).
English: Hexyon must not be used in children who have ever had an allergic reaction to Hexyon or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Croatian: Hexyon se ne smije primjenjivati u djece koja su imala alergijske reakcije na cjepivo Hexyon ili na cjepivo koje sadrži iste sastavne dijelove, uključujući tvari koje se koriste u proizvodnji cjepiva i koje se mogu naći u vrlo niskim razinama (kao što su antibiotici neomicin i streptomicin).
English: The most common side effects with Hexyon include pain and redness at the site of injection, irritability and crying.
Croatian: Najčešće nuspojave povezane s lijekom Hexyon uključuju bol i crvenilo na mjestu injekcije, nadraženost i plač.
English: A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexyon, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
Croatian: U idućem ispitivanju obuhvaćeno je 455 djece te je istražena dugoročna prisutnost zaštitnih protutijela do 3 godine nakon dodatne doze cjepiva Hexyon, a u drugom je ispitivanju provedenom na 1 336 djece procijenjen odgovor na različite serije cjepiva te rezultat njegova davanja s cjepivima za infekcije uzrokovane bakterijom Streptococcus pneumoniae (Prevenar) i rotavirusom (Rotarix).
English: For more information about treatment with Hexyon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Hexyon pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: These studies showed that Hexyon produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.
Croatian: Ova su ispitivanja pokazala da cjepivo Hexyon proizvodi slične profile protutijela tijekom vremena u odnosu na usporediva cjepiva te da se cjepivo može primjenjivati istovremeno s lijekovima Prevenar i Rotarix.
English: Hexyon is available as a suspension for injection in vials and prefilled syringes.
Croatian: Lijek Hexyon dostupan je kao suspenzija za injekciju u bočicama i prethodno napunjenim štrcaljkama.
English: In the study, children who either received Hexyon produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Croatian: U tom su ispitivanju djeca koja su primila cjepivo Hexacima proizvela sličan odgovor protutijelima kao i ona koja su primila usporedno cjepivo (Infanrix hexa) ako su primili cjepivo u dvije doze prema rasporedu te dodatnu dozu nakon 6 mjeseci.
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Croatian: Hexyon se ne smije primjenjivati u djece koja su u prošlosti oboljela od encefalopatije (bolesti mozga) s nepoznatim uzrokom u roku od sedam dana nakon primanja cjepiva koje sadrži sastavne dijelove hripavca.
English: How does Hexyon work?
Croatian: Kako djeluje Hexyon?
English: For practical information about using Hexyon, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Hexyon pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Hexyon is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Croatian: Hexyon je cjepivo koje sadrži djelatne tvari dobivene iz difterije, tetanusa, hripavca i bakterije Haemophilus influenzae tipa b, virusa hepatitisa B i inaktiviranog poliovirusa.
English: What benefits of Hexyon have been shown in studies?
Croatian: Koje su koristi lijeka Hexyon utvrđene u ispitivanjima?
English: How is Hexyon used?
Croatian: Kako se Hexyon koristi?
English: The CHMP noted that Hexyon has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Croatian: CHMP smatra da lijek Hexyon stvara zaštitne koncentracije protutijela protiv difterije, tetanusa, hripavca, hepatitisa B, poliomijelitisa i infekcije H. influenzae tipa B u djece između šest tjedana i dvije godine starosti, neovisno o etničkoj pripadnosti.
English: For the full list of all side effects reported with Hexyon, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni cjepiva Hexyon potražite u uputi o lijeku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hexyon have been included in the summary of product characteristics and the package leaflet.
Croatian: U sažetku opisa svojstava lijeka i uputi o lijeku nalaze se preporuke i mjere opreza za sigurnu i učinkovitu primjenu cjepiva Hexyon kojih se zdravstveni radnici i bolesnici trebaju pridržavati.
English: Furthermore, while tablets can be taken with food or between meals, the patient should take the capsules at least 1 hour after food and not eat for up to 2 hours afterwards.
Croatian: Nadalje, iako se tablete mogu uzimati s hranom ili između obroka, bolesnice trebaju uzimati kapsule najmanje jedan sat nakon jela i ne jesti do dva sata nakon toga.
English: Further information on Lynparza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lynparza.
Croatian: Više informacija o lijeku Lynparza dostupno je na internetskim stranicama Agencije:ema.europa.eu/medicines/human/EPAR/lynparza.
English: The doses in milligrams are different for the tablets and capsules.
Croatian: Doze lijeka izražene u miligramima razlikuju se za tablete i kapsule.
English: Lynparza is available as tablets (100 and 150 mg) and capsules (50 mg) which the patient takes twice a day.
Croatian: Lijek Lynparza dostupan je u obliku tableta (100 mg i 150 mg) i kapsula (50 mg) koje se uzimaju dvaput na dan.
English: Treatment is continued for as long as the disease is not getting worse.
Croatian: Terapija se nastavlja sve dok nema pogoršanja bolesti.
English: Lynparza received a marketing authorisation valid throughout the EU on 16 December 2014.
Croatian: Lijek Lynparza dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 16. prosinca 2014.
English: Women must not breastfeed during treatment with Lynparza and for a month after stopping treatment.
Croatian: Žene ne smiju dojiti tijekom liječenja lijekom Lynparza i mjesec dana nakon prestanka liječenja.
English: What measures are being taken to ensure the safe and effective use of Lynparza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lynparza?
English: What is Lynparza and what is it used for?
Croatian: Što je Lynparza i za što se koristi?
English: The most common side effects with Lynparza (which may affect more than 1 in 10 people) are tiredness, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), cough, headache, dysgeusia (taste disturbances), decreased appetite, dizziness, upper abdominal pain (stomach ache), dyspnoea (difficulty breathing), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and thrombocytopenia (low blood platelet counts).
Croatian: Najčešće nuspojave lijeka Lynparza (koje se mogu javiti u više od 1 na 10 osoba) jesu umor, mučnina (slabost), povraćanje, proljev, dispepsija (žgaravica), kašalj, glavobolja, disgeuzija (poremećaj okusa), smanjen tek, omaglica, bol u gornjem dijelu abdomena (bol u želudcu), dispneja (otežano disanje), anemija (nizak broj crvenih krvnih stanica), leukopenija (nizak broj bijelih krvnih stanica), neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcija) i trombocitopenija (nizak broj krvnih pločica u krvi).
English: Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Croatian: Stoga se nakon blokiranja proteina PARP oštećeni DNK u stanicama raka ne može popraviti, što uzrokuje odumiranje stanica raka.
English: In advanced ovarian cancer, the doctor may stop treatment after 2 years if X-rays show no signs of the cancer.
Croatian: U liječenju uznapredovalog raka jajnika liječnik može prekinuti terapiju nakon dvije godine ako na rendgenskim snimkama nema znakova raka.
English: Other information about Lynparza
Croatian: Ostale informacije o lijeku Lynparza
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynparza 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 Lynparza nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: Lynparza can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Lynparza se izdaje samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: The European Medicines Agency therefore decided that Lynparza's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Lynparza nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Lynparza are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Lynparza kontinuirano se prate.
English: Side effects reported with Lynparza are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lynparza pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer.
Croatian: Tvrtka koja stavlja lijek Lynparza u promet provest će ispitivanja kako bi se dodatno potvrdila korist lijeka, uključujući dugoročnu korist, u bolesnica s rakom jajnika.
English: Lynparza contains the active substance olaparib.
Croatian: Lynparza sadrži djelatnu tvar olaparib.
English: The side effects with Lynparza were mostly mild or moderate and were generally manageable.
Croatian: Nuspojave pri primjeni lijeka Lynparza većinom su blage ili umjerene i uglavnom se mogu kontrolirati.
English: An overview of Lynparza and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Lynparza i zašto je odobren u EU-u
English: The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Croatian: Djelatna tvar lijeka Lynparza, olaparib, inhibira djelovanje enzima pod nazivom humana poli (ADP riboza) polimeraza (PARP), koji tijekom diobe stanica pomažu u popravljanju oštećenja DNK u stanicama (u normalnim stanicama i u stanicama raka).
English: Treatment may be interrupted or stopped or the dose reduced if certain side effects develop.
Croatian: Ako nastupe određene nuspojave, liječenje se može prekinuti, obustaviti ili se doza može smanjiti.
English: For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Lynparza pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Lynparza?
Croatian: Koji su rizici povezani s lijekom Lynparza?
English: The dose and the choice between capsules and tablets of Lynparza depends on what disease it is being used for.
Croatian: Doza i odabir kapsula ili tableta lijeka Lynparza ovise o bolesti koja se liječi.
English: Lynparza is a cancer medicine used on its own for:
Croatian: Lynparza je lijek protiv raka koji se primjenjuje kao monoterapija u:
English: Why is Lynparza authorised in the EU?
Croatian: Zašto je lijek Lynparza odobren u EU-u?
English: Studies show that Lynparza increases the time patients live without their disease getting worse after treatment with platinum-based chemotherapy has reduced or cleared the cancer:
Croatian: Ispitivanja pokazuju da lijek Lynparza produljuje razdoblje tijekom kojeg bolesnice žive bez pogoršanja bolesti nakon što se liječenjem kemoterapijom na bazi platine tumor smanjio ili u cijelosti povukao:
English: • continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
Croatian: • kontinuiranoj terapiji raka (brzorastućeg) visokog stupnja, i to raka jajnika, jajovoda (koji povezuju jajnike s maternicom) i peritoneuma (membranske ovojnice koja obavija abdomen) u:
English: • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
Croatian: • liječenju HER2-negativnog raka dojke koji se proširio izvan područja prvotnog tumora u bolesnica s mutacijama gena BRCA1 ili BRCA2 koje su liječene određenim lijekovima protiv raka dojke (osim ako ti lijekovi nisu bili prikladni).
English: Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.
Croatian: Bolesnice liječene lijekom Lynparza u prosjeku su živjele sedam mjeseci bez pogoršanja bolesti, u usporedbi s 4,2 mjeseca u bolesnica koje su primale drugi lijek za liječenje raka po izboru liječnika.
English: Lynparza can increase the time these patients live without their disease getting worse.
Croatian: Terapija lijekom Lynparza može produljiti razdoblje tijekom kojeg bolesnice žive bez pogoršanja bolesti.
English: How does Lynparza work?
Croatian: Kako djeluje Lynparza?
English: In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the next cycle of platinum chemotherapy.
Croatian: Lynparza u bolesnica s rakom jajnika, jajovoda ili peritoneuma također može odgoditi sljedeći ciklus kemoterapije na bazi platine.
English: − in newly diagnosed women with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has reduced or cleared the cancer;
Croatian: − u žena s novodijagnosticiranim, uznapredovalim rakom s mutacijama (promjenama) na jednom ili oba gena pod nazivom BRCA1 i BRCA2 koje su liječene kemoterapijom na bazi platine i u kojih je ovom terapijom rak smanjen ili se u cijelosti povukao;
English: − women whose cancer had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
Croatian: − žena u kojih se rak vratio (recidiv) nakon prijašnjeg liječenja i u kojih se uz pomoć kemoterapije na bazi platine rak smanjio ili se u cijelosti povukao;
English: • In a third study involving 391 patients with advanced cancer who had BRCA1/2 mutations, the disease had not got worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.
Croatian: • U trećem ispitivanju koje je obuhvatilo 391 bolesnicu s uznapredovalim rakom koje su imale mutacije gena BRCA1/2, u otprilike 74 % bolesnica koje su primale lijek Lynparza tijekom dvije godine nije bilo pogoršanja bolesti, u usporedbi s 35 % bolesnica koje su primale placebo.
English: Generally the outcome is poor for patients with ovarian, fallopian tube or peritoneal cancers and for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Croatian: Uglavnom je slab ishod liječenja za bolesnice s rakom jajnika, jajovoda ili peritoneuma i bolesnica s HER2-negativnim rakom dojke s mutacijama gena BRCA koji se proširio.
English: Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 mutations whose cancer had spread.
Croatian: Učinkovitost lijeka Lynparza utvrđena je u ispitivanju kojim su bile obuhvaćene 302 bolesnice oboljele od HER2-negativnog raka dojke s mutacijama gena BRCA1/2 koji se proširio.
English: • A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).
Croatian: • Ispitivanje kojim je bilo obuhvaćeno 295 bolesnica s recidivom raka jajnika, jajovoda i peritoneuma pokazalo je da su bolesnice liječene lijekom Lynparza živjele u prosjeku 19,1 mjesec bez pogoršanja bolesti, u usporedbi s 5,5 mjeseci u slučaju bolesnica koje su primale placebo (prividno liječenje).
English: What benefits of Lynparza have been shown in studies?
Croatian: Koje su koristi od lijeka Lynparza utvrđene u ispitivanjima?
English: • In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.
Croatian: • U drugom ispitivanju kojim je bilo obuhvaćeno 265 bolesnica s recidivom raka, bolesnice koje su uzimale lijek Lynparza živjele su u prosjeku 8,4 mjeseca bez pogoršanja bolesti, u usporedbi s 4,8 mjeseci u slučaju bolesnica koje su primale placebo.
English: For the full list of side effects and restrictions with Lynparza, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Lynparza potražite u uputi o lijeku.
English: How is Lynparza used?
Croatian: Kako se Lynparza primjenjuje?
English: What is Vimpat and what is it used for?
Croatian: Što je Vimpat i za što se koristi?
English: The full EPAR for Vimpat can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Vimpat nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Vimpat u promet koje je vrijedi na prostoru Europske unije od 29. kolovoza 2008.
English: It can also be used in patients who are temporarily unable to take the tablets or syrup.
Croatian: Može se davati bolesnicima koji trenutačno ne mogu uzimati tablete ili sirup.
English: What are the risks associated with Vimpat?
Croatian: Koji su rizici povezani s lijekom Vimpat?
English: What measures are being taken to ensure the safe and effective use of Vimpat?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vimpat?
English: Vimpat infusion can be used to begin treatment.
Croatian: Infuzija lijekom Vimpat može se koristiti za početak liječenja.
English: Why is Vimpat approved?
Croatian: Zašto je lijek Vimpat odobren?
English: Vimpat must not be used in people who have second or third degree AV block (a type of heart rhythm disorder).
Croatian: Vimpat ne smiju uzimati osobe koje imaju AV-blok drugog ili trećeg stupnja (vrsta poremećaja srčanog ritma).
English: If treatment with Vimpat has to be stopped, the dose should be gradually reduced.
Croatian: Ako se terapiju lijekom Vimpat treba prekinuti, dozu valja postupno smanjivati.
English: This action may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Croatian: Ta aktivnost može smanjiti abnormalnu električnu aktivnost koja se širi kroz mozak, smanjujući time mogućnost epileptičkog napadaja.