FrancophonIA/ELRC3.0 huggingface dataset:
English: Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.
Croatian: Besilesomab je dizajniran za vezivanje na antigen naziva NCA-95, koji se nalazi na površini granulocita, tipa bijelih krvnih stanica uključenih u upalu i borbu protiv infekcije.
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 Scintimun.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima primjene lijeka Scintimun.
English: Other information about Scintimun
Croatian: Ostale informacije o lijeku Scintimun
English: Patients limbs were then scanned and the images obtained using both techniques were compared.
Croatian: Udovi bolesnika su skenirani te su uspoređene slike dobivene primjenom obiju tehnika.
English: For more information about treatment with Scintimun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Scintimun pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans.
Croatian: Budući da se veliki broj granulocita skuplja u mjestu infekcije, radioaktivnost se akumulira u područjima zahvaćenima osteomijelitisom, gdje ih se može otkriti skenovima.
English: It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.
Croatian: Koristi se za lociranje područja infekcije ili upale u odraslih osoba kod kojih postoji sumnja na osteomijelitis (koštanu infekciju) u udovima, u kombinaciji s drugim odgovarajućim metodama oslikavanja.
English: The active substance in Scintimun, besilesomab, is a monoclonal antibody.
Croatian: Djelatna tvar u setu Scintimun, besilesomab, je monoklonalno protutijelo.
English: The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies.
Croatian: Najčešće nuspojave povezane s lijekom Scintimun (kod više od 1 na 10 bolesnika) su stvaranje antimišjih protutijela.
English: In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients' own white blood cells that were radiolabelled before being injected back into the patient.
Croatian: U jednom glavnom ispitivanju provedenom na 130 bolesnika koji su imali ili za koje se sumnjalo da imaju osteomijelitis u svojim udovima, radioaktivno označeni Scintimun uspoređen je primjenom standardne dijagnostičke tehnike pomoću bijelih krvnih stanica bolesnika koje su radioaktivno označene prije ponovnog ubrizgavanja u bolesnika.
English: Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women.
Croatian: Scintimun se ne smije koristiti u bolesnika koji su bili pozitivni na ljudska anti-mišja protutijela (HAMA) i ne smije se koristiti u trudnica.
English: A risk management plan has been developed to ensure that Scintimun is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Scintimun.
English: It contains the active substance besilesomab.
Croatian: Sadrži djelatnu tvar besilesomab.
English: In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.
Croatian: Nadalje proizvođač lijeka Scintimun osigurat će da svi liječnici za koje se očekuje da će koristiti ovaj set prime dopis u kojem se pojašnjavaju rizici povezani s lijekom.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Croatian: Prilikom ubrizgavanja radioaktivno označenog lijeka u bolesnika, monoklonalno protutijelo prenosi radioaktivnost u ciljni antigen na granulocitima.
English: Scintimun is a kit for the preparation of a radioactive solution for injection.
Croatian: Scintimun je set za pripremu radioaktivne otopine za injekciju.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scintimun, 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 uputi o lijeku za lijek Scintimun nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: What is the risk associated with Scintimun?
Croatian: Koji su rizici povezani s lijekom Scintimun?
English: What is Scintimun?
Croatian: Što je Scintimun?
English: Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs.
Croatian: Scintimun je proizveo usporedive rezultate s radioaktivno označenim bijelim krvnim stanicama u slučaju kada se koristio za dijagnosticiranje i lociranje osteomijelitisa u udovima.
English: Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients.
Croatian: Scintimun se ne smije koristiti u osoba koje su preosjetljive (alergične) na besilesomab, na druga mišja protutijela ili bilo koju drugu pomoćnu tvar.
English: The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.
Croatian: Glavna mjera djelotvornosti lijeka Scintimun temeljila se na mjeri u kojoj su se slike dobivene setom Scintimun preklapale s onima dobivenim radioaktivno označenim bijelim krvnim stanicama.
English: Why has Scintimun been approved?
Croatian: Zašto je lijek Scintimun odobren?
English: Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Croatian: Scintimun se radioaktivno označava tako što se miješa s otopinom radioaktivnog tehnecija (99mTc).
English: What is Scintimun used for?
Croatian: Za što se Scintimun koristi?
English: A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc).
Croatian: Radioaktivna otopina Scintimun pripravlja se miješanjem praška i otapala koji se isporučuju u setu i zatim se radioaktivno označava tehnecijem (99mTc).
English: When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab.
Croatian: Prilikom radioaktivnog označavanja lijeka Scintimun, radioaktivni spoj tehnecij (99mTc) vezuje se na besilesomab.
English: How is Scintimun used?
Croatian: Kako se Scintimun koristi?
English: For the full list of all side effects reported with Scintimun, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Scintimun, potražite u uputi o lijeku.
English: How does Scintimun work?
Croatian: Kako djeluje Scintimun?
English: What benefit has Scintimun shown during the studies?
Croatian: Koje su koristi lijeka Scintimun utvrđene u ispitivanjima?
English: The CHMP decided that Scintimun's benefits are greater than its risks.
Croatian: Odbor za lijekove za humanu upotrebu (CHMP) odlučio je da koristi od lijeka Scintimun nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Scintimun.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 April 2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21. travnja 2017.
English: What consequences does this withdrawal have for patients in clinical trials?
Croatian: Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima?
English: It works by blocking the production of bacterial proteins, thus preventing the growth of the bacteria.
Croatian: Djeluje blokiranjem stvaranja bakterijskih proteina te tako sprečava rast bakterija.
English: The company plans to include these data in a new marketing authorisation application in the EU.
Croatian: Tvrtka namjerava uključiti te podatke u novi zahtjev za izdavanje odobrenja za stavljanje lijeka u promet u EU-u.
English: There were also concerns that solithromycin could be harmful to the liver.
Croatian: Također je postojala zabrinutost da bi solitromicin mogao imati štetan učinak na jetru.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that its decision to withdraw is based on a request from the US FDA to provide additional safety data to support approval in the US.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da je razlog za odluku o povlačenju zahtjev Uprave za hranu i lijekove Sjedinjenih Država da se dostave dodatni sigurnosni podatci kako bi se izdalo odobrenje u SAD-u.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Solithromycin Triskel EU Services.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi lijek Solithromycin Triskel EU Services.
English: The company presented data from three studies in a total of 1,855 patients with community-acquired pneumonia, in which Solithromycin Triskel EU Services was compared with other antibiotics (levofloxacin and moxifloxacin).
Croatian: Tvrtka je predstavila podatke iz triju studija provedenih na ukupno 1 855 bolesnika s izvanbolnički stečenom upalom pluća u kojima je lijek Solithromycin Triskel EU Services uspoređen s drugim antibioticima (levofloksacin i moksiﬂoksacin).
English: The active substance in Solithromycin Triskel EU Services, solithromycin, is a type of antibiotic similar to a group of antibiotics known as ‘macrolides'.
Croatian: Djelatna tvar u lijeku Solithromycin Triskel EU Services, solitromicin, vrsta je antibiotika sličnog skupini antibiotika pod nazivom „makrolidi”.
English: EMA/249992/2017
Croatian: Services (solitromicin) EMA/249992/2017
English: • community-acquired pneumonia (an infection of the lungs caught outside of hospital);
Croatian: • izvanbolnički stečene upale pluća (infekcija pluća koja je stečena izvan bolnice);
English: No studies in patients with inhaled anthrax or inhaled tularaemia have been carried out and the company presented data from laboratory studies.
Croatian: Nisu provedene studije na bolesnicima s antraksom uzrokovanim udisanjem ili tularemijom uzrokovanom udisanjem te je tvrtka predočila podatke iz laboratorijskih ispitivanja.
English: It was to be available as capsules to be taken by mouth and as a powder to be made into a solution for infusion (drip) into a vein.
Croatian: Lijek je trebao biti dostupan u obliku kapsula koje se uzimaju kroz usta i kao prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Croatian: Dana 27. ožujka 2017. tvrtka Triskel EU Services Ltd službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Solithromycin Triskel EU Services za liječenje izvanbolnički stečene upale pluća, antraksa uzrokovanog udisanjem i tularemije uzrokovane udisanjem.
English: • inhaled tularaemia (another serious disease caught by inhaling bacteria).
Croatian: • tularemije uzrokovane udisanjem (još jedna teška bolest do koje dolazi udisanjem bakterija).
English: In addition, it had concerns about the manufacturing process of the active substance, which did not exclude the presence of impurities, and the test for ensuring sterility of the product for infusion was not considered valid.
Croatian: Osim toga, CHMP je izrazio zabrinutost u vezi s postupkom proizvodnje djelatne tvari, u kojem nije isključena prisutnost nečistoća, a ispitivanje postizanja sterilnosti lijeka za infuziju ne smatra se valjanim.
English: • inhaled anthrax (the most serious form of anthrax caught by inhaling bacterial spores);
Croatian: • antraksa uzrokovanog udisanjem (najteži oblik antraksa do kojeg dolazi udisanjem bakterijskih spora);
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Solithromycin Triskel EU Services could not have been approved for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Solithromycin Triskel EU Services za liječenje izvanbolnički stečene upale pluća, antraksa uzrokovanog udisanjem i tularaemije uzrokovane udisanjem.
English: The CHMP was concerned that not enough data had been provided to support use in inhaled anthrax and inhaled tularaemia.
Croatian: CHMP je izrazio zabrinutost da nisu dostavljeni dostatni podatci koji bi potkrijepili primjenu lijeka u liječenju antraksa uzrokovanog udisanjem i tularemije uzrokovane udisanjem.
English: Solithromycin Triskel EU Services was expected to be used to treat the following bacterial infections:
Croatian: Services trebao se primjenjivati u liječenju sljedećih bakterijskih infekcija:
English: How does Solithromycin Triskel EU Services work?
Croatian: Kako djeluje Solithromycin Triskel EU Services?
English: Solithromycin Triskel EU Services is a medicine that contains the active substance solithromycin.
Croatian: Services lijek je koji sadrži djelatnu tvar solitromicin.
English: What is Solithromycin Triskel EU Services?
Croatian: Što je Solithromycin Triskel EU Services?
English: What was Solithromycin Triskel EU Services expected to be used for?
Croatian: Za što se Solithromycin Triskel EU Services trebao koristiti?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Solithromycin Triskel EU Services did not outweigh its risks.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Solithromycin Triskel EU
English: It is important that you follow this advice.
Croatian: Važno je da se pridržavate tog savjeta.
English: You need to be aware of the extra risks:
Croatian: Morate biti svjesni dodatnih rizika:
English: 200 to <350
Croatian: 200 do <350
English: • The usual dose is one tablet once a day
Croatian: • Uobičajena doza je jedna tableta jedanput na dan.
English: So it is very important to talk to your doctor about any changes in your health.
Croatian: Stoga je vrlo važno da sa svojim liječnikom razgovarate o bilo kojoj promjeni svog zdravstvenog stanja.
English: See Section 4 for more information.
Croatian: Pogledajte dio 4. za više informacija.
English: Component of a multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne smije se prodavati odvojeno.
English: To date, there is no established biological mechanism to explain a potential increase in risk.
Croatian: Do sada nije utvrđen biološki mehanizam koji bi objasnio moguće povećanje rizika.
English: 85 days
Croatian: 85 dana
English: This medicine is not for children under 12 years of age.
Croatian: Ovaj lijek nije namijenjen za djecu mlađu od 12 godina.
English: 28 days
Croatian: 28 dana
English: Push here (with Alert card attached)
Croatian: Pritisnuti ovdje (uz pričvršćenu Karticu s upozorenjima)
English: When do these reactions happen?
Croatian: Kada se te reakcije javljaju?
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete:
English: These reactions have often been transitory.
Croatian: Te su reakcije obično bile prolazne.
English: The difference in the endpoint remained statistically significant (p=0.006).
Croatian: Razlika u ishodu ostala je statistički značajna (p=0,006).
English: Discontinued for other reasons
Croatian: Prekid liječenja zbog drugih razloga
English: It also increases the number of CD4 cells in your blood.
Croatian: Uz to povećava i broj CD4 stanica u krvi.
English: You may need extra check-ups, including blood tests, while you're taking your medicine.
Croatian: Možda ćete morati dolaziti na dodatne preglede, uključujući krvne pretrage, dok uzimate ovaj lijek.
English: ATC code: J05AR13
Croatian: ATK oznaka: J05AR13
English: • hypersensitivity reaction (see ‘Hypersensitivity reactions' earlier in this section)
Croatian: • reakcije preosjetljivosti (vidjeti 'Reakcije preosjetljivosti' ranije u ovom dijelu)
English: All treatments were given open-label.
Croatian: Sve su se terapije primjenjivale otvoreno.
English: Patients were mainly white (66%) or black (28%) of male sex (87%).
Croatian: Bolesnici su uglavnom bili bijelci (66%) ili crnci (28%) muškog spola (87%).
English: • suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before)
Croatian: • suicidalne misli i ponašanja (osobito u bolesnika koji su ranije imali problema s depresijom ili s mentalnim zdravljem)
English: It is very important that you read and understand the information about this serious reaction.
Croatian: Vrlo je važno da s razumijevanjem pročitate sve informacije o toj ozbiljnoj reakciji.
English: Pol. Ind. Allendeduero Aranda de Duero Burgos, 09400
Croatian: Ind. Allendeduero Aranda de Duero Burgos, 09400
English: What Triumeq is and what it is used for
Croatian: Što je Triumeq i za što se koristi
English: The table should not be considered exhaustive but is representative of the classes studied.
Croatian: Tablica nije sveobuhvatna, ali je reprezentativna za ispitivane razrede.
English: → Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure or diabetes.
Croatian: → Obavijestite svog liječnika ako imate srčanih tegoba, ako pušite ili imate druge bolesti koje bi mogle povećati rizik od srčane bolesti, poput visokog krvnog tlaka ili šećerne bolesti.
English: Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Croatian: Triumeq ne može izliječiti HIV infekciju; on smanjuje količinu virusa u tijelu i održava je na niskoj razini.
English: This is not considered clinically significant (see Absorption).
Croatian: To se ne smatra klinički značajnim (vidjeti dio 'Apsorpcija').
English: Who gets these reactions?
Croatian: Kod koga se javljaju te reakcije?
English: (Complex binding to polyvalent ions)
Croatian: (stvaranje kompleksa s polivalentnim ionima)
English: Pharmacokinetic parameters are comparable to those reported in adults.
Croatian: Farmakokinetički parametri usporedivi su s onima prijavljenima u odraslih osoba.
English: Main prior transmission routes were homosexual (73%) or heterosexual (29%) contact.
Croatian: Glavni prethodni putovi prijenosa bili su homoseksualni (73%) ili heteroseksualni (29%) kontakt.
English: Clinically significant interaction unlikely.
Croatian: Nije vjerojatna klinički značajna interakcija.
English: The educational material includes 3 model case studies to demonstrate different clinical scenarios and their management.
Croatian: Ovaj edukacijski materijal uključuje 3 primjera prikaza slučaja, koji prikazuju različite kliničke scenarije i njihovo zbrinjavanje.
English: While the clinical relevance of these findings is unknown, these data suggest that a potential carcinogenic risk to humans is outweighed by the clinical benefit.
Croatian: Iako klinički značaj spomenutih nalaza nije poznat, ovi podaci pokazuju da klinička korist nadmašuje potencijalni kancerogeni rizik za ljude.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy, so it is important you take your medicine exactly as your doctor has told you.
Croatian: HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije, zato je važno da uzimate ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: The systemic exposures were equivalent to 7 to 21 times the expected systemic exposure in humans.
Croatian: Sistemska izloženost bila je 7 do 21 puta veća od očekivane sistemske izloženosti u ljudi.
English: HIV-1 - human immunodeficiency virus type 1
Croatian: HIV-1 - virus humane imunodeficijencije tipa 1
English: → Talk to your doctor immediately.
Croatian: Odmah razgovarajte sa svojim liječnikom.
English: • depression (feelings of deep sadness and unworthiness)
Croatian: • depresija (osjećaji duboke tuge ili bezvrijednosti)
English: Individual components have been investigated in adolescents (12 to 17 years).
Croatian: Zasebne sastavnice ispitivane su u adolescenata (u dobi od 12 do 17 godina).
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Croatian: Ako to učinite, unutar svega nekoliko sati može doći do opasnog pada krvnog tlaka koji može dovesti do smrti.
English: If you have taken Triumeq during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste uzimali Triumeq tijekom trudnoće, Vaš liječnik može zatražiti redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj Vašeg djeteta.
English: Both of these active ingredients can cause a serious allergic reaction known as a hypersensitivity reaction.
Croatian: Obje te djelatne tvari mogu uzrokovati ozbiljnu alergijsku reakciju koja se naziva reakcijom preosjetljivosti.
English: 10.5 (3.1% to 17.8%) [p=0.005].
Croatian: 10,5 (3,1% - 17,8%) [p=0,005].
English: Write your doctor's details below: Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Croatian: Liječnik:.......................…………………… Tel.:...................………… Ako Vaš liječnik nije dostupan, morate odmah potražiti liječničku pomoć negdje drugdje (npr. u hitnoj službi najbliže bolnice).
English: If you know you have this gene, tell your doctor.
Croatian: Ako znate da imate taj gen, recite to svom liječniku.
English: Do not take Triumeq:
Croatian: Nemojte uzeti Triumeq:
English: If you take more Triumeq than you should
Croatian: Ako uzmete više lijeka Triumeq nego što ste trebali
English: The exposure of lamivudine was similar with and without food.
Croatian: Izloženost lamivudinu bila je slična uz hranu i bez nje.
English: In these cases the physician should refer to the individual product information for these medicinal products.
Croatian: U tim slučajevima liječnik mora pročitati zasebne informacije o lijeku za svaki od tih lijekova.
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Notes: DTG = dolutegravir, RAL = raltegravir.
Croatian: Napomene: DTG = dolutegravir, RAL = raltegravir.