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 Gardasil.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Gardasil.
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers.
Croatian: Tipovi HPV-a 16 i 18 uzrokuju otprilike 70% rakova grlića maternice, te između 75% i 80% rakova anusa.
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Croatian: Nakon što bolesnik primi cjepivo, imunosni sustav proizvodi protutijela protiv L1 proteina.
English: HPV types 6 and 11 cause approximately 90% of genital warts.
Croatian: Tipovi HPV-a 6 i 11 uzrokuju otprilike 90% genitalnih bradavica.
English: Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Croatian: Gardasil sadrži pročišćene L1 proteine za tipove HPV-a 6, 11, 16 i 18, koji se proizvode metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvode se od stanica kvasca u koje se ugradio gen (DNK), što im omogućuje proizvodnju L1 proteina.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
Croatian: U ispitivanju nisu zabilježeni slučajevi raka anusa, ali očekuje se da prevencija premalignih lezija anusa predstavlja i prevenciju raka.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.
Croatian: Glavna mjera djelotvornosti bio je razvoj protutijela protiv tipova HPV-a 6, 11, 16 i 18 mjesec dana nakon posljednje doze.
English: For more information about treatment with Gardasil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Gardasil pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Croatian: Najčešće nuspojave lijeka Gardasil u ispitivanjima (kod više od 1 na 10 osoba) su glavobolja i reakcija u mjestu injekcije (crvenilo, bol i oticanje).
English: In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Croatian: Za usporedbu, ukupno 189 slučajeva vanjskih genitalnih lezija zabilježeno je u skupini u gotovo 8 000 žena koje su primile placebo.
English: A risk management plan has been developed to ensure that Gardasil is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Gardasil.
English: The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
Croatian: Ispitivanja su istražila u koliko su se žena razvile genitalne lezije ili bradavice uslijed infekcije HPV-om.
English: The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Croatian: Ispitivanja su također pokazala da je Gardasil pružio određenu zaštitu od lezija na grliću maternice uzrokovanih drugim tipovima HPV-a koji uzrokuju rak, uključujući tip 31.
English: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Croatian: Gardasil cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: What is the risk associated with Gardasil?
Croatian: Koji su rizici povezani s lijekom Gardasil?
English: The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Croatian: Ispitivanja su također pokazala da cjepivo potiče proizvodnju dostatnih količina protutijela protiv HPV-a u djevojčica i dječaka u dobi između devet i 15 godina.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil, 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 lijek Gardasil uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Croatian: Ispitivanje kojim je testiran Gardasil primijenjen u 2 doze u djevojčica u dobi od 9 do 13 godina pokazalo je da dvije doze primijenjene u razmaku od šest mjeseci nisu bile manje učinkovite od cijepljenja s tri doze: svi su subjekti razvili dovoljne količine protutijela protiv HPV-a mjesec dana nakon posljednje doze.
English: With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Croatian: S obzirom na premaligne lezije anusa, u cijepljenoj skupini (koja je obuhvaćala oko 200 bolesnika) zabilježeno je pet slučajeva, dok su u skupini koja je primila placebo (koja je također obuhvaćala oko 200 bolesnika) zabilježena 24 slučaja.
English: For the full list of all restrictions, see the package leaflet.
Croatian: Potpuni popis svih ograničenja potražite u uputi o lijeku.
English: In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Croatian: U četiri glavna ispitivanja lijeka Gardasil primjenjivanog u tri doze, Gardasil je uspoređen s placebom (lažnim cjepivom) u gotovo 21 000 žena u dobi od 16 do 26 godina.
English: The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP odlučilo je da koristi od lijeka Gardasil nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: • cervical and anal cancers;
Croatian: • raka grlića maternice i anusa
English: Other information about Gardasil:
Croatian: Ostale informacije o lijeku Gardasil
English: For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second.
Croatian: Za osobe u dobi od četrnaest godina ili starije, Gardasil se obično primjenjuje u tri doze, pri čemu se druga doza daje dva mjeseca nakon prve doze, a treća četiri mjeseca nakon druge.
English: In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women.
Croatian: Osim toga, ova su ispitivanja potvrdila sposobnost zaštite lijeka Gardasil od lezija i infekcija HPV-om u žena u dobi od 24 do 45 godina.
English: Why has Gardasil been approved?
Croatian: Zašto je lijek Gardasil odobren?
English: For people aged nine to thirteen years, Gardasil can be given as two doses six months apart.
Croatian: Za osobe u dobi od devet do trinaest godina, Gardasil se primjenjuje kao dvije doze u razmaku od šest mjeseci.
English: In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
Croatian: U ispitivanju provedenom u mladića i muškaraca, zabilježena su tri slučaja genitalnih lezija među otprilike 1 400 bolesnika koji su primili cjepivo u usporedbi s 32 slučaja među otprilike 1 400 bolesnika koji su primili placebo.
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Croatian: U četiri ispitivanja provedena u 21 000 žena, od preko 8 000 žena cijepljenih lijekom Gardasil koje nikad nisu bile zaražene tipovima HPV-a 6, 11, 16 ili 18, jedna je žena razvila premaligne lezije grlića maternice koje su mogle biti uzrokovane tipom HPV-a 16 ili 18.
English: Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
Croatian: Drugo ispitivanje provedeno na otprilike 800 djevojaka i žena usporedilo je djelovanje dvije doze lijeka Gardasil u djevojčica u dobi od devet do 13 godina s djelovanjem tri doze u djevojaka i mladih žena u dobi od 16 do 24 godine.
English: Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Croatian: Naposljetku, u glavnom ispitivanju koje je obuhvatilo oko 4 000 mladića i muškaraca u dobi od 16 do 26 godina cjepivo je uspoređeno s placebom kako bi se ispitalo djelovanje cjepiva u sprječavanju genitalnih bradavica, premalignih lezija i raka anusa.
English: Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Croatian: Tri ispitivanja lijeka Gardasil primijenjenog u tri doze istražila su sposobnost lijeka Gardasil za sprječavanje infekcija uzrokovanih tipovima HPV-a 6, 11, 16 i 18, te genitalnih bradavica uzrokovanih tim tipovima HPV-a u gotovo 4 000 žena u dobi između 24 i 45 godina, te razvoj protutijela protiv tih tipova HPV-a u otprilike 1 700 djevojčica i dječaka u dobi od devet do 15 godina.
English: It is available in vials or prefilled syringes.
Croatian: Dostupno je u bočicama i napunjenim špricama.
English: What is Gardasil?
Croatian: Što je Gardasil?
English: In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Croatian: U tri ispitivanja genitalnih bradavica, genitalne bradavice razvile su se u dvije žene od gotovo 8 000 u skupini koja je primala lijek Gardasil, te nije bilo slučaja premalignih lezija vulve ili vagine.
English: What benefit has Gardasil shown during the studies?
Croatian: Koje su koristi lijeka Gardasil dokazane u ispitivanjima?
English: How does Gardasil work?
Croatian: Kako djeluje Gardasil?
English: What is Gardasil used for?
Croatian: Za što se Gardasil koristi?
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Croatian: Nasuprot tome, 85 od više od 8 000 žena koje su primile placebo cjepivo razvile su lezije koje su uzrokovala ova dva tipa virusa HPV-a Slično djelovanje lijeka Gardasil uočeno je prilikom analize koja je uključivala lezije grlića maternice uzrokovane s druga dva tipa HPV-a (tipovi 6 i 11).
English: For the full list of all side effects reported with Gardasil, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Gardasil potražite u uputi o lijeku.
English: How is Gardasil used?
Croatian: Kako se Gardasil koristi?
English: Pain in muscles is also common.
Croatian: Bol u mišićima također je česta nuspojava.
English: Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
Croatian: Više informacija o lijeku Pegfilgrastim Mundipharma dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).
Croatian: Posebno se daje za skraćivanje trajanja neutropenije i sprječavanje febrilne neutropenije (kad je neutropenija popraćena vrućicom zbog infekcije).
English: Filgrastim has been available in other medicines in the EU for a number of years.
Croatian: Filgrastim je godinama dostupan u drugim lijekovima u Europskoj uniji.
English: The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Pegfilgrastim Mundipharma (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: Pegfilgrastim Mundipharma 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.
Croatian: Pegfilgrastim Mundipharma daje se kao jedna doza od 6 mg koja se ubrizgava pod kožu najmanje 24 sata nakon završetka svakog ciklusa kemoterapije.
English: This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: To znači da je lijek Pegfilgrastim Mundipharma vrlo sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u EU-u.
English: Pegfilgrastim Mundipharma 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: Pegfilgrastim Mundipharma izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Pegfilgrastim Mundipharma pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pegfilgrastim Mundipharma?
English: Because Pegfilgrastim Mundipharma is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pegfilgrastim Mundipharma.
Croatian: Budući da je lijek Pegfilgrastim Mundipharma biosličan lijek, ispitivanja učinkovitosti i sigurnosti primjene pegfilgrastima provedena za lijek Neulasta nije potrebno ponavljati za lijek Pegfilgrastim Mundipharma.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pegfilgrastim Mundipharma 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 kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, utvrđeno da Pegfilgrastim Mundipharma ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i Neulasta te se u tijelu raspoređuje na isti način.
English: What is Pegfilgrastim Mundipharma and what is it used for?
Croatian: Što je Pegfilgrastim Mundipharma i za što se koristi?
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Croatian: Lijek je dostupan u obliku napunjene štrcaljke koja sadrži otopinu za supkutanu injekciju.
English: Filgrastim works by encouraging the bone marrow to produce more white blood cells, increasing white blood cell counts and so treating neutropenia.
Croatian: Filgrastim potiče koštanu srž na stvaranje više bijelih krvnih stanica, što dovodi do povećanja broja bijelih krvnih stanica i liječenja neutropenije.
English: An overview of Pegfilgrastim Mundipharma and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Pegfilgrastim Mundipharma i zašto je odobren u EU-u
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pegfilgrastim Mundipharma 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 Pegfilgrastim Mundipharma nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Pegfilgrastim Mundipharma outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod lijeka Neulasta, koristi od lijeka Pegfilgrastim Mundipharma nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Pegfilgrastim Mundipharma 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: Lijek Pegfilgrastim Mundipharma nije namijenjen za primjenu u osoba oboljelih od raka krvi, kronične mijeloične leukemije ili mijelodisplastičnih sindroma (stanja kod kojih se stvara velik broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: The safety of Pegfilgrastim Mundipharma 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 Pegfilgrastim Mundipharma i na temelju svih provedenih ispitivanja nuspojave lijeka smatraju se usporedivima s onima za referentni lijek Neulasta.
English: For more information about using Pegfilgrastim Mundipharma, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Pegfilgrastim Mundipharma pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: All these data were considered sufficient to conclude that Pegfilgrastim Mundipharma 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 Pegfilgrastim Mundipharma za odobrene indikacije djelovati jednako kao Neulasta u pogledu učinkovitosti i sigurnosti primjene.
English: Pegfilgrastim Mundipharma 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 chemotherapy and can leave patients vulnerable to infections.
Croatian: Pegfilgrastim Mundipharma je lijek koji se primjenjuje u osoba oboljelih od raka radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava kemoterapije protiv raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: The active substance in Pegfilgrastim Mundipharma, 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 Pegfilgrastim Mundipharma, pegfilgrastim, oblik je filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta kolonije granulocita (G-CSF).
English: Laboratory studies comparing Pegfilgrastim Mundipharma with Neulasta have shown that the active substance in Pegfilgrastim Mundipharma is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Pegfilgrastim Mundipharma i Neulasta pokazala su da je djelatna tvar u lijeku Pegfilgrastim Mundipharma vrlo slična djelatnoj tvari u lijeku Neulasta u pogledu strukture, čistoće i biološke aktivnosti.
English: Why is Pegfilgrastim Mundipharma authorised in the EU?
Croatian: Zašto je lijek Pegfilgrastim Mundipharma odobren u EU-u?
English: As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Pegfilgrastim Mundipharma kontinuirano se prate.
English: Other information about Pegfilgrastim Mundipharma
Croatian: Ostale informacije o lijeku Pegfilgrastim Mundipharma
English: The reference medicine for Pegfilgrastim Mundipharma is Neulasta.
Croatian: Referentni lijek za Pegfilgrastim Mundipharma je Neulasta.
English: Studies have also shown that giving Pegfilgrastim Mundipharma produces similar levels of the active substance in the body to giving Neulasta.
Croatian: Ispitivanja su pokazala i da se primjenom lijeka Pegfilgrastim Mundipharma stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Neulasta.
English: Pegfilgrastim Mundipharma is a ‘biosimilar medicine'.
Croatian: Pegfilgrastim Mundipharma je „biosličan lijek”.
English: What are the risks associated with Pegfilgrastim Mundipharma?
Croatian: Koji su rizici povezani s lijekomPegfilgrastim Mundipharma?
English: For the full list of side effects and restrictions with Pegfilgrastim Mundipharma, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Pegfilgrastim Mundipharma potražite u uputi o lijeku.
English: How does Pegfilgrastim Mundipharma work?
Croatian: Kako djeluje Pegfilgrastim Mundipharma?
English: Pegfilgrastim Mundipharma contains the active substance pegfilgrastim.
Croatian: Pegfilgrastim Mundipharma sadrži djelatnu tvar pegfilgrastim.
English: What benefits of Pegfilgrastim Mundipharma have been shown in studies?
Croatian: Koje su koristi od lijeka Pegfilgrastim Mundipharma utvrđene u ispitivanjima?
English: How is Pegfilgrastim Mundipharma used?
Croatian: Kako se Pegfilgrastim Mundipharma primjenjuje?
English: Mundipharma, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Pegfilgrastim Mundipharma filgrastim je pegiliran (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: Registration of a manufacturing site for the active substance, finished product and batch release.
Croatian: Registraciju proizvodne lokacije za djelatnu tvar, gotovi proizvod i izdavanje serije.
English: For the suspension to be lifted, the marketing authorisation holder for MACI shall provide the following:
Croatian: Za potrebe ukidanja suspenzije, nositelj odobrenja za stavljanje lijeka u promet za lijek MACI dostavlja sljedeće:
English: Therefore, the conclusions of the PRAC are not affected.
Croatian: Stoga to ne utječe na zaključke PRAC-a.
English: The PRAC adopted a recommendation on 16 May 2019 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Croatian: PRAC je 16. svibnja 2019. donio preporuku koju je zatim razmatrao CMDh u skladu s člankom 107.k Direktive 2001/83/EZ.
English: No other appropriate measure was identified that would reduce the risk of QT prolongation to an acceptable level.
Croatian: Nije utvrđena nijedna druga odgovarajuća mjera kojom bi se rizik od produljenja QT intervala smanjio na prihvatljivu razinu.
English: In conclusion, no feasible and effective measures could be identified which would minimise this risk to an acceptable level.
Croatian: Zaključno, nisu se mogle utvrditi izvedive i učinkovite mjere kojima bi se taj rizik sveo na prihvatljivu razinu.