FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that the PET scans were able to correctly identify as positive 77.4% of the cases where patients had significant amounts of plaques, and that almost all patients without significant plaques were correctly rated as negative.
Croatian: Ovo znači da su PET skenovi mogli točno identificirati 77,4% slučajeva kao pozitivne kada su bolesnici imali značajne količine plakova, te da su skoro svi bolesnici bez značajnih plakova bili ispravno ocijenjeni kao negativni.
English: Patients should discuss the results of their PET scan with their doctor.
Croatian: Bolesnici trebaju razgovarati o rezultatima svojih PET skenova sa svojim liječnicima.
English: What measures are being taken to ensure the safe and effective use of Neuraceq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Neuraceq?
English: What is Neuraceq and what is it used for?
Croatian: Što je Neuraceq i za što se koristi?
English: The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Croatian: Lijek se primjenjuje demencijom u venu otprilike 90 minuta prije dobivanja slike iz PET skenera.
English: This is a summary of the European public assessment report (EPAR) for Neuraceq.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Neuraceq.
English: Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Croatian: Neuraceq isporučuje vrlo malu količinu zračenja s minimalnim rizikom od raka ili nasljednih bolesti.
English: The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Croatian: No, CHMP je uočio da zbog ograničenog djelovanja trenutno dostupnih terapija Alzheimerove bolesti, ne postoje snažni dokazi da bi rana dijagnoza nakon PET skenova provedenih s lijekom Neuraceq i rano upravljanje liječenjem moglo poboljšati ishode bolesnika.
English: The type of scan used with Neuraceq is called positronemission tomography (PET).
Croatian: Tip skena koji se koristi s lijekom Neuraceq naziva se pozitronska emisijska tomografija (PET).
English: This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Croatian: Ovo se smatra značajnim poboljšanjem u dijagnozi bolesnika s problemima u pamćenju koje testira na Alzheimerovu bolest i druge demencije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Neuraceq nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Croatian: Neuraceq je otopina za injekciju koja sadrži djelatnu tvar florbetaben (18F); koristi se samo za dijagnostičke potrebe.
English: It is not intended to provide practical advice on how to use Neuraceq.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Neuraceq.
English: The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Croatian: Najčešće nuspojave lijeka Neuraceq (koje se mogu pojaviti kod 1 od 10 bolesnika) uključuju bolove, iritaciju i crvenilo kože na mjestu injektiranja.
English: What are the risks associated with Neuraceq?
Croatian: Koji su rizici povezani s lijekom Neuraceq?
English: If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Croatian: Ako je nekoliko beta-amiloidnih plakova uočeno u PET skenu ili nema uočenih beta-amiloidnih plakova (negativan sken), nije izgledno da bolesnik boluje od Alzheimerove bolesti.
English: In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Croatian: Nadalje, nije utvrđena primjenjivost lijeka Neuraceq u predviđanju razvoja Alzheimerove bolesti u bolesnika s problemima s pamćenjem ili u praćenju odgovora bolesnika na liječenje.
English: The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
Croatian: Ispitivanje je istražilo osjetljivost i posebnost PET skenova (koliko su dobro identificirali bolesnike s plakovima u mozgu i koliko su ih točno razlikovali od onih osoba koje nisu imali plakove u mozgu).
English: Neuraceq can only be obtained with a prescription, and PET scans with Neuraceq should only be requested by doctors experienced in the management of patients with diseases such as Alzheimer's and other dementias.
Croatian: Neuraceq se izdaje samo na liječnički recept, a PET pretragu s lijekom Neuraceq treba zatražiti samo liječnik s iskustvom u upravljanju s bolesnicima oboljelima od bolesti poput Alzheimerove bolesti i demencija.
English: A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Neuraceq.
English: Neuraceq florbetaben (
Croatian: Neuraceq florbetaben (18F)
English: Why is Neuraceq approved?
Croatian: Zašto je lijek Neuraceq odobren?
English: However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen with several types of dementia and also in some elderly people with no symptoms.
Croatian: No, samo pozitivan sken nije dostatan za iznošenje dijagnoze u bolesnika s problemima s pamćenjem, s obzirom da su plakovi uočeni u nekoliko tipova demencije i u određenih starijih osoba bez simptoma.
English: After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Croatian: Nakon spajanja na plakove, zračenje koje emitira može se detektirati PET skenerom, što dozvoljava liječnicima da uoče je li prisutna značajna količina plakova.
English: The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Croatian: Djelatna tvar u lijeku Neuraceq, florbetaben (18F), je tip lijeka koji je poznat kao radiofarmaceutik koji emitira vrlo male količine zračenja i djeluje tako što cilja i vezuje se na beta-amiloidne plakove u mozgu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, 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 Neuraceq uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Croatian: Nakon što se slika snimi, trebaju pročitati liječnik koji je posebno obučen za tumačenje PET pretraga provedenih s lijekom Neuraceq.
English: For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Neuraceq pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
Croatian: Po završetku ispitivanja, 31 bolesnik je umro i na njima su provedene autopsije kako bi se dokazalo jesu li imali ili neznačajne količine beta-amiloidnih plakova u mozgu.
English: What benefits of Neuraceq have been shown in studies?
Croatian: Koje su koristi lijeka Neuraceq dokazane u ispitivanjima?
English: With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Croatian: Sigurnosni profil lijeka Neuraceq smatra se potvrdnim, pri čemu je većina nuspojava povezana s reakcijama u mjestu injekcije.
English: For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Neuraceq pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Croatian: Neuraceq se koristi tijekom skeniranja mozga u bolesnika s problemima s pamćenjem kako bi liječnici mogli vidjeti imaju li bolesnici značajne količine beta-amiloidnih plakova u mozgu.
English: Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Croatian: Rezultati glavnih ispitivanja pokazali su da PET skenovi s lijekom Neuraceq imaju veliki stupanj osjetljivosti i specifičnosti za otkrivanje beta-amiloidnih plakova u mozgu, što rezultira skenovima koji precizno reflektiraju ono što se vidi na autopsiji.
English: How does Neuraceq work?
Croatian: Kako djeluje Neuraceq?
English: PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Croatian: Dokazano je da PET skenovi s lijekom Neuraceq imaju visoku razinu specifičnosti i osjetljivosti kada se koriste za identificiranje osoba sa značajnim količinama beta-amiloidnih plakova u mozgu.
English: How is Neuraceq used?
Croatian: Kako se Neuraceq koristi?
English: For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Neuraceq, potražite u uputi o lijeku.
English: The full European Public Assessment Report for Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o procijeni lijeka Xgeva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Xgeva?
Croatian: Što je Xgeva?
English: EMEA/H/C/002173/II/0045
Croatian: EMA/47097/2017 EMEA/H/C/002173/II/0045
English: What is happening with Xgeva for the prevention and treatment of other diseases?
Croatian: Što se događa s lijekom Xgeva kada je riječ o prevenciji i liječenju drugih bolesti?
English: Xgeva has been authorised since July 2011.
Croatian: Lijek Xgeva odobren je u srpnju 2011. godine.
English: It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Croatian: Primjenjuje se za bolesnike koji se ne mogu operirati ili u kojih bi operacija uzrokovala teške komplikacije.
English: The company presented the results of a study involving 33 patients with hypercalcaemia.
Croatian: Tvrtka je predstavila rezultate ispitivanja koje je obuhvatilo 33 bolesnika oboljelih od hiperkalcemije.
English: These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Croatian: Te komplikacije uključuju frakture (prijelome kostiju), kompresiju leđne moždine (kada kost pritišće leđnu moždinu) ili komplikacije koje zahtijevaju radioterapiju (liječenje zračenjem) ili kirurški zahvat.
English: High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Croatian: Visoke razine kalcija uzrokuju teške komplikacije koje mogu utjecati na bolesnike oboljele od raka u posljednjem stadiju bolesti.
English: There are no consequences for the use of Xgeva in its authorised indications.
Croatian: Nema posljedica za primjenu lijeka Xgeva u njegovim odobrenim indikacijama.
English: The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Croatian: Osnovna mjera djelotvornosti temeljila se na broju bolesnika na koje je liječenje djelovalo, s obzirom na to da su im se razine kalcija u krvi snizile na 2,9 mmol/l ili niže unutar 10 dana od prve doze.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Croatian: Vezujući se na i blokirajući RANKL, denosumab smanjuje stvaranje i djelovanje osteoklasta.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
Croatian: Ovime se smanjuje gubitak kostiju, čime se smanjuju izgledi za frakture i druge ozbiljne koštane komplikacije te smanjuju razine kalcija u krvi.
English: It contains the active substance denosumab and is available as a solution to be injected under the skin.
Croatian: Sadrži djelatnu tvar denosumab i dostupan je kao otopina za ubrizgavanje pod kožu.
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Croatian: RANKL sudjeluje u aktivaciji osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Croatian: Tvrtka Amgen Europe BV 13. siječnja 2017. godine službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za primjenu lijeka Xgeva za liječenje maligne hiperkalcemije (visoke razine kalcija u krvi koju uzrokuje rak).
English: The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Croatian: Djelatna tvar lijeka Xgeva, denosumab, monoklonsko je protutijelo, protein koji je namijenjen prepoznavanju i vezivanju za protein pod nazivom RANKL.
English: Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments.
Croatian: Nadalje, budući da su bolesnici bili podvrgnuti drugom načinu liječenja hiperkalcemije ili su nedavno prekinuli liječenje bisfosfonatima, nije bilo moguće odrediti opseg učinka ni činjenicu proizlaze li koristi navedene u ispitivanju iz djelovanja lijeka Xgeva ili učinaka tih drugih načina liječenja.
English: The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Croatian: Tvrtka je obavijestila CHMP da trenutačno nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka Xgeva koji su u tijeku.
English: What was Xgeva expected to be used for?
Croatian: Za što se lijek Xgeva trebao koristiti?
English: How does Xgeva work?
Croatian: Kako djeluje Xgeva?
English: Xgeva was also expected to be used to reduce hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer) that did not respond to previous treatment with medicines called bisphosphonates.
Croatian: Lijek Xgeva trebao se primjenjivati i za smanjenje maligne hiperkalcemije (visoke razine kalcija u krvi koju uzrokuje rak) na koju nije djelovalo prethodno liječenje lijekovima pod nazivom bisfosfonati.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako se rezultati ispitivanja ne mogu smatrati dostatnima te je zaključio da lijek nije moguće odobriti na temelju podataka koje je tvrtka dostavila.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application because the CHMP considered the data provided insufficient to conclude that the benefits of Xgeva outweighed its risks in the treatment of hypercalcaemia caused by cancer.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev jer CHMP smatra da dostavljeni podatci nisu dostatni da bi se zaključilo da koristi lijeka Xgeva nadmašuju s njim povezane rizike u liječenju hiperkalcemije koju uzrokuje rak.
English: Xgeva was not compared with any other treatment in this study.
Croatian: U tom ispitivanju lijek Xgeva nije uspoređen ni s jednim drugim načinom liječenja.
English: The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Croatian: CHMP je smatrao da u glavnom ispitivanju postoji nekoliko problema zbog kojih Odbor nije mogao donijeti odluku o učinkovitosti lijeka Xgeva: u ispitivanju je sudjelovao mali broj bolesnika i lijek Xgeva nije uspoređen ni s jednim drugim načinom liječenja; nejasno je jesu li bisfosfonati djelovali na zdravstveno stanje bolesnika s obzirom na to da nisu dostupne prethodne razine kalcija u bolesnika.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.
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 Xgeva za liječenje hiperkalcemije koju uzrokuje rak i koja nije reagirala na liječenje bisfosfonatima.
English: Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Croatian: Xgeva je lijek koji se primjenjuje za sprječavanje koštanih komplikacija u odraslih bolesnika s uznapredovalim rakom koji je zahvatio kosti.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Croatian: Xgeva se također primjenjuje za liječenje gigantocelularnog tumora kosti u odraslih bolesnika i koštano sazrelih adolescenata.
English: It has been available in the EU since the 1950s.
Croatian: Dostupan je u EU-u od 1950-ih.
English: It is given as 2 tablets of the appropriate strength once a day with food.
Croatian: Uzimaju se dvije tablete odgovarajuće jačine jedanput na dan s hranom.
English: Further information on Qtrilmet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/qtrilmet.
Croatian: Više informacija o lijeku Qtrilmet dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/qtrilmet.
English: It is used to treat type 2 diabetes in:
Croatian: Koristi se za liječenje šećerne bolesti tipa 2 u:
English: Qtrilmet contains three active substances which all work in different ways.
Croatian: Qtrilmet sadrži tri djelatne tvari od kojih svaka djeluje na različite načine.
English: What is Qtrilmet and what is it used for?
Croatian: Što je Qtrilmet i za što se koristi?
English: Having all three active ingredients in one tablet reduces the number of tablets the patient needs to take and may improve adherence to treatment, which can improve overall management of the disease.
Croatian: Sva tri djelatna sastojka u jednoj tableti smanjuju broj tableta koje bolesnik treba uzimati i mogu doprinijeti pridržavanju terapije što može poboljšati sveukupno liječenje bolesti.
English: What measures are being taken to ensure the safe and effective use of Qtrilmet?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Qtrilmet?
English: Dapagliflozin has been authorised in the EU as Forxiga since 2012
Croatian: Dapagliflozin je od 2012. odobren u EU-u pod nazivom Forxiga.
English: However, reducing doses or interrupting treatment with Qtrilmet is more complicated than using the active ingredients separately.
Croatian: Međutim, smanjenje doza ili prekid liječenja lijekom Qtrilmet složenije je od uporabe djelatnih sastojaka zasebno.
English: Saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, has been authorised in the EU as Onglyza since 2009.
Croatian: Saksagliptin, inhibitor dipeptidil peptidaze 4 (DPP 4), odobren je u EU-u od 2009. pod nazivom Onglyza.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin or when the body cannot use insulin effectively.
Croatian: Šećerna bolest tipa 2 bolest je pri kojoj gušterača ne proizvodi dovoljno inzulina ili tijelo ne može učinkovito iskoristiti inzulin.
English: These studies measured the change in HbA1c levels after 24 weeks of treatment.
Croatian: U tim se ispitivanjima mjerila razlika u vrijednostima glikoziliranog hemoglobina (HbA1c) nakon 24 tjedna liječenja.
English: Other information about Qtrilmet
Croatian: Ostale informacije o lijeku Qtrilmet
English: Qtrilmet (metformin / saxagliptin / dapagliflozin)
Croatian: Qtrilmet (metformin / saksagliptin / dapagliflozin)
English: Side effects reported with Qtrilmet are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Qtrilmet pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Qtrilmet?
Croatian: Koji su rizici povezani s lijekom Qtrilmet?
English: The HbA1c levels of patients in the studies were at least 8% and treatment was aimed at reducing HbA1c levels to 7% or less.
Croatian: Razine glikoziliranog hemoglobina u bolesnika u ispitivanjima bile su najmanje 8 %, a cilj liječenja bio je smanjiti njegovu razinu na 7 % ili niže.
English: The Agency decided that Qtrilmet's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Qtrilmet nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Why is Qtrilmet authorised in the EU?
Croatian: Zašto je lijek Qtrilmet odobren u EU-u?
English: An overview of Qtrilmet and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Qtrilmet i zašto je odobren u EU-u
English: HbA1c (glycosylated haemoglobin) is an indicator of glucose levels in the blood over the previous 2 to 3 months.
Croatian: HbA1c (glikozilirani hemoglobin) pokazatelj je razina glukoze u krvi tijekom zadnjih 2 do 3 mjeseca.