FrancophonIA/ELRC3.0 huggingface dataset:
English: It acts on different receptors for serotonin in the brain, blocking the action of some receptors and having some stimulant action on others.
Croatian: Djeluje na različite receptore serotonina u mozgu, blokirajući djelovanje pojedinih receptora te djelujući stimulativno na druge.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brintellix'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 Brintellix nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Brintellix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Brintellix?
English: Brintellix has been studied in 12 main short-term studies involving more than 6,700 patients with major depression (including one study in patients aged 65 and over), in which it was compared with placebo (a dummy treatment) for 6 or 8 weeks.
Croatian: Brintellix se ispitivao u 12 glavnih kratkoročnih ispitivanja koja su obuhvatila više od 6 700 bolesnika s velikim depresivnim poremećajem (uključujući jedno ispitivanje u bolesnika u dobi od 65 godina i starijih), u kojima je Brintellix uspoređen s placebom (lažnim liječenjem) tijekom 6 do 8 tjedana.
English: Studies have shown a clinically relevant improvement in major depressive episodes, and the types of side effects seen were similar to those with other antidepressants that act through serotonin.
Croatian: Ispitivanja su dokazala klinički značajno poboljšanje u velikim depresivnim epizodama, a tipovi nuspojava slični su drugim antidepresivima koji djeluju putem serotonina.
English: What is Brintellix and what is it used for?
Croatian: Što je Brintellix i za što se koristi?
English: The most common side effect with Brintellix, seen in more than 1 in 10 people is nausea (feeling sick).
Croatian: Najčešća nuspojava lijeka Brintellix, primijećena kod više od 1 na 10 osoba, je mučnina (osjećaj slabosti).
English: In addition, vortioxetine blocks the action of the serotonin transporter, which is responsible for clearing serotonin from its sites of activity in the brain, thus increasing the activity of serotonin.
Croatian: vortioksetin blokira djelovanje serotoninskog prijenosnika koji je odgovoran za uklanjanje serotonina s mjesta njegovog djelovanja u mozgu, čime se povećava djelovanje serotonina.
English: The main measure of effectiveness in each study was the change in a standard score for symptoms of depression; the studies showed that doses of Brintellix ranging from 5 to 20 mg were generally more effective than placebo in improving depression and resulted in a clinically relevant decrease of the depression scores.
Croatian: Glavna mjera djelotvornosti u svakom ispitivanju bila je promjena u standardnom pokazatelju simptoma depresije; ispitivanjima je utvrđeno da su doze lijeka Brintellix u rasponu od 5 do 20 mg bile načelno djelotvornije od placeba u ublažavanju depresije te su rezultirale klinički relevantnim smanjivanjem pokazatelja depresije.
English: Other information about Brintellix
Croatian: Ostale informacije o lijeku Brintellix
English: A risk management plan has been developed to ensure that Brintellix is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Brintellix.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Brintellix, 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 Brintellix uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza koje zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: In a 12-week comparison of Brintellix with another antidepressant, agomelatine, Brintellix was more effective than agomelatine in improving the symptom score.
Croatian: U 12-tjednoj usporedbi lijeka Brintellix s drugim antidepresivom, agomelatinom, Brintellix je bio djelotvorniji od agomelatina u ublažavanju simptoma.
English: Why is Brintellix approved?
Croatian: Zašto je lijek Brintellix odobren?
English: A 24-week study comparing the effect of Brintellix with placebo in preventing relapses of depression found that the proportion of patients given Brintellix who relapsed during the study was 13%, compared with 26% in the placebo group.
Croatian: Tijekom 24-tjednog ispitivanja, koje je usporedilo djelovanje lijeka Brintellix s placebom u sprječavanju ponovne pojave depresije, utvrđeno je da je dio bolesnika koji su primili lijek Brintellix, a kod kojih je uočena remisija tijekom ispitivanja bio 13%, u usporedbi s 26% u grupi koja je primala placebo.
English: What are the risks associated with Brintellix?
Croatian: Koji su rizici povezani s lijekom Brintellix?
English: For more information about treatment with Brintellix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Brintellix pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Brintellix is an antidepressant medicine containing the active substance vortioxetine.
Croatian: Brintellix je antidepresiv koji sadrži djelatnu tvar vortioksetin.
English: The active substance in Brintellix, vortioxetine, is an antidepressant.
Croatian: Djelatna tvar u lijeku Brintellix, vortioksetin, je antidepresiv.
English: What benefits of Brintellix have been shown in studies?
Croatian: Koje su koristi lijeka Brintellix dokazane u ispitivanjima?
English: For practical information about using Brintellix, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Brintellix pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Brintellix used?
Croatian: Kako se Brintellix koristi?
English: How does Brintellix work?
Croatian: Kako djeluje Brintellix?
English: Treatment with Brintellix should continue for at least 6 months after the depressive symptoms have resolved.
Croatian: Nakon što se depresivni simptomi povuku, preporučuje se nastavak liječenja lijekom Brintellix u trajanju od najmanje 6 mjeseci.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu304186.
Croatian: Više informacija o statusu lijeka za rijetku bolest možete naći ovdje: ema.europa.eu/medicines/human/orphan-designations/eu304186.
English: Further information on Trecondi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/trecondi.
Croatian: Više informacija o lijeku Trecondi nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/trecondi.
English: What measures are being taken to ensure the safe and effective use of Trecondi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trecondi?
English: What is Trecondi and what is it used for?
Croatian: Što je Trecondi i za što se primjenjuje?
English: There is also sufficient data to show that Trecondi is effective in adults (but not enough data are available in children) with non-cancerous blood disorders.
Croatian: Postoji i dovoljno podataka koji pokazuju da je Trecondi učinkovit u odraslih (no nije dostupno dovoljno podataka za djecu) s poremećajima krvi koji nisu zloćudni.
English: Like busulfan, Trecondi is considered as a conditioning treatment of ‘reduced-intensity': this means that it is less toxic than standard conditioning treatments which are based on chemotherapy with or without radiation.
Croatian: Kao i busulfan, Trecondi se smatra kondicioniranom (pripremnom) terapijom „smanjena intenziteta”, što znači da je manje toksična od uobičajenih kondicioniranih terapija koje se temelje na kemoterapiji u kombinaciji sa zračenjem ili bez zračenja.
English: Fludarabine is given once a day for 5 days before transplantation.
Croatian: Fludarabin se daje jednom dnevno tijekom pet dana prije presađivanja.
English: Trecondi is given as a two-hour infusion (drip) into a vein.
Croatian: Trecondi se daje intravenskom infuzijom (ukapavanjem) u trajanju od dva sata.
English: Side effects reported with Trecondi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Trecondi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The dose of Trecondi depends on the condition for which transplantation is needed, whether the patient is an adult or a child and on the patient's weight and height.
Croatian: Doza lijeka Trecondi ovisi o stanju zbog kojeg je potrebno presađivanje, o tomu je li bolesnik odrasla osoba ili dijete te o bolesnikovoj težini i visini.
English: Other information about Trecondi
Croatian: Ostale informacije o lijeku Trecondi
English: The European Medicines Agency therefore decided that Trecondi'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 Trecondi 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 Trecondi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Trecondi kontinuirano se prate.
English: In an additional study in 70 children with blood cancers, 99% of children given Trecondi (with fludarabine) were alive 3 months after their transplant.
Croatian: U dodatnom ispitivanju kojim je bilo obuhvaćeno 70 djece s rakom krvi, 99 % djece koja su primala lijek Trecondi (s fludarabinom) bilo je živo tri mjeseca nakon presađivanja.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trecondi 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 Trecondi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Trecondi authorised in the EU?
Croatian: Zašto je Trecondi odobren u EU-u?
English: What are the risks associated with Trecondi?
Croatian: Koji su rizici povezani s lijekom Trecondi?
English: Pregnant women must not use Trecondi and live vaccines must not be given to patients receiving Trecondi.
Croatian: Trudnice ne smiju upotrebljavati lijek Trecondi, a bolesnici koji uzimaju lijek Trecondi ne smiju primati živa cjepiva.
English: An overview of Trecondi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Trecondi i zašto je odobren u EU-u
English: Haematopoietic stem cell transplantation is rare, and Trecondi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2004.
Croatian: Transplantacija krvotvornih matičnih stanica je rijetka, a lijek Trecondi dobio je status „lijeka za rijetku bolest” 23. veljače 2004.
English: The patient receives Trecondi once a day for 3 days before the transplantation.
Croatian: Bolesnik prima lijek Trecondi jednom dnevno tri dana prije presađivanja.
English: The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents.
Croatian: Djelatna tvar u lijeku Trecondi, treosulfan, pripada skupini lijekova poznatih pod nazivom alkilirajući agensi.
English: Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung, liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders.
Croatian: Lijek Trecondi ne smije se upotrebljavati u bolesnika s aktivnom infekcijom koja nije pod kontrolom, u bolesnika s teškim problemima sa srcem, plućima, jetrom ili bubrezima, kao i u bolesnika s Fanconijevom anemijom i drugim poremećajima popravka DNK-a.
English: Tiredness, febrile neutropenia (low white blood cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are also seen in more than 1 in 10 adults, and rash also affects more than 1 in 10 children.
Croatian: Umor, febrilna neutropenija (niska razina bijelih krvnih stanica s vrućicom) i visoka razina bilirubina (proizvoda razgradnje crvenih krvnih stanica) u krvi također su zabilježeni u više od 1 na 10 odraslih osoba, dok se osip pojavljuje u više od 1 na 10 djece.
English: Two main studies showed that Trecondi is at least as effective as busulfan, another medicine used to prepare patients for haematopoietic stem cell transplantation.
Croatian: U dvama glavnim ispitivanjima utvrđeno je da je lijek Trecondi barem jednako učinkovit kao busulfan, drugi lijek koji se upotrebljava za pripremu bolesnika za presađivanje krvotvornih matičnih stanica.
English: The most common side effects in adults and children with Trecondi (which may affect more than 1 in 10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), vomiting, diarrhoea and abdominal pain (belly ache).
Croatian: Najčešće nuspojave lijeka Trecondi u odraslih i djece (koje se mogu pojaviti u više od 1 na 10 osoba) su infekcije, mučnina, stomatitis (upala sluznice usne šupljine), povraćanje, proljev i abdominalna bol (bol u trbuhu).
English: In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced), 64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).
Croatian: U jednom ispitivanju, u kojem je sudjelovalo 570 odraslih osoba s akutnom mijeloičnom leukemijom (rak krvi) ili mijelodisplastičnim sindromima (stanja u kojima se proizvodi veliki broj abnormalnih krvnih stanica), u 64 % bolesnika koji su uzimali lijek Trecondi (s fludarabinom) presađivanje je bilo uspješno te su bili živi i bez simptoma bolesti nakon dvije godine, u usporedbi s 51 % bolesnika koji su primali busulfan (s fludarabinom).
English: For more information about using Trecondi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Trecondi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Trecondi can therefore kill cells in the patient's bone marrow and make room for the new cells from a donor.
Croatian: Trecondi tako može ubiti stanice u koštanoj srži bolesnika i napraviti mjesta za nove stanice donora.
English: In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells, by attaching to their DNA while they are dividing.
Croatian: U tijelu se treosulfan pretvara u druge spojeve pod nazivom epoksidi koji ubijaju stanice, a posebno stanice koje se brzo razvijaju, kao što su stanice koštane srži, tako što se prilikom dijeljenja stanica vežu na njihov DNK.
English: It is used as a ‘conditioning' treatment to clear the patient's bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells.
Croatian: Primjenjuje se kao (pripremna) terapija kodicioniranja kako bi se očistila koštana srž bolesnika i napravilo mjesta za presađene stanice koštane srži koje potom mogu proizvoditi zdrave krvne stanice.
English: Trecondi is used together with another medicine called fludarabine in adults and children from 1 month of age with blood cancers as well as in adults with other severe disorders requiring a bone marrow transplant.
Croatian: Trecondi se primjenjuje zajedno s drugim lijekom pod nazivom fludarabin u odraslih i djece starije od mjesec dana koji boluju od raka krvi, kao i u odraslih s teškim poremećajima koji zahtijevaju presađivanje koštane srži.
English: Trecondi is effective at preparing adults and children with blood cancers for haematopoietic stem cell transplantation.
Croatian: Trecondi je učinkovit u pripremi odraslih i djece oboljelih od raka krvi za presađivanje krvotvornih matičnih stanica.
English: The medicine can only be obtained with a prescription and use of Trecondi must be supervised by a doctor experienced in conditioning treatment before allogeneic haematopoietic stem cell transplantation.
Croatian: Lijek se izdaje samo na liječnički recept, a uporabu lijeka Trecondi mora nadzirati liječnik s iskustvom u pripremnoj terapiji prije alogene transplantacije krvotvornih matičnih stanica.
English: The active substance in Trecondi is treosulfan.
Croatian: Djelatna tvar lijeka Trecondi je treosulfan.
English: Trecondi is a medicine given to patients before they have a bone marrow transplant from a donor known as ‘allogeneic haematopoietic stem cell transplantation'.
Croatian: Trecondi je lijek koji se daje bolesnicima prije presađivanja koštane srži od donora, što je poznato pod nazivom „alogena transplantacija krvotvornih matičnih stanica”.
English: Side effects with Trecondi are manageable and comparable to those seen with busulfan.
Croatian: Nuspojave lijeka Trecondi mogu se kontrolirati i usporedive su s onima zabilježenima pri primjeni busulfana.
English: What benefits of Trecondi have been shown in studies?
Croatian: Koje su koristi od lijeka Trecondi utvrđene u ispitivanjima?
English: How is Trecondi used?
Croatian: Kako se Trecondi primjenjuje?
English: How does Trecondi work?
Croatian: Kako djeluje Trecondi?
English: Take it as soon as you remember then carry on as before.
Croatian: Uzmite ju čim se sjetite, a zatim nastavite kao prije.
English: Try to take the tablet at the same time each day.
Croatian: Pokušajte uzimati tabletu u isto vrijeme svaki dan.
English: If you forget to take a dose, do not worry.
Croatian: Ako ste zaboravili uzeti dozu, ne brinite.
English: Ethnic differences
Croatian: Etničke razlike
English: If you do not take your tablet on one day, take your normal dose on the next day.
Croatian: Ako ne uzmete svoju tabletu jedan dan, uzmite uobičajenu dozu sljedeći dan.
English: The mean duration of follow up was 4 years and 8 months.
Croatian: Prosječno trajanje praćenja iznosilo je 4 godine i 8 mjeseci.
English: The binding is long-lasting.
Croatian: Vezanje je dugotrajno.
English: The change was dose dependent.
Croatian: Promjena je bila ovisna o dozi.
English: • Alcohol
Croatian: • Alkohol
English: The manufacturer is:
Croatian: Proizvođač je:
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 ali ne može se doći do preporuka za doziranje.
English: Cumulative urinary excretion is <1 % of dose.
Croatian: Kumulativna urinarna ekskrecija je <1 % doze.
English: In some cases you may have to stop taking one of the medicines.
Croatian: U nekim slučajevima, možda ćete morati prestati uzimati jedan od tih lijekova.
English: Do not take a double dose to make up for forgotten individual doses.
Croatian: Ne uzimajte dvostruku dozu kako biste nadoknadili pojedinačnu zaboravljenu dozu.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Croatian: Stoga se kombinacija mora oprezno primjenjivati, osobito u starijih osoba.
English: You can take Telmisartan Teva with or without food.
Croatian: Možete uzimati Telmisartan Teva sa ili bez hrane.
English: The risk is increased in case of the above-mentioned treatment combinations.
Croatian: Rizik se povećava u slučaju gore spomenutih kombinacija liječenja.
English: These measures will help protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša
English: Activated charcoal may be useful in the treatment of overdosage.
Croatian: Aktivni ugljen može biti koristan u liječenju predoziranja.
English: It is important that you take Telmisartan Teva every day until your doctor tells you otherwise.
Croatian: Važno je uzimati Telmisartan Teva svaki dan, dok Vam liječnik ne kaže drugačije.
English: Push the tablet through the exposed foil
Croatian: Gurnite tabletu kroz izloženu foliju
English: • if you are taking digoxin.
Croatian: • ako uzimate digoksin.
English: Insomnia, depression
Croatian: Nesanica, depresija
English: ‘Essential' means that the high blood pressure is not caused by any other condition.
Croatian: ‘Esencijalna' znači da visoki krvni tlak nije izazvan niti jednim drugim uzrokom.
English: Its clinical significance and relevance is unknown.
Croatian: Njegov klinički značaj i relevantnost nisu poznati.
English: You must tell your doctor if you think you are (or might become) pregnant.
Croatian: Morate obavijestiti svog liječnika ako mislite da ste (ili biste mogli ostati) trudni.
English: If these effects are not treated they could be fatal.
Croatian: Ako se ove nuspojave ne liječe mogu imati smrtni ishod.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Croatian: Bolesnika se mora pažljivo pratiti, a liječenje mora biti simptomatsko i suportivno.
English: <1/1,000); very rare (<1/10,000).
Croatian: <1/1000), vrlo rijetko (<1/10 000).
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Croatian: Ne očekuje se da malo smanjenje AUC izaziva smanjenje terapijske djelotvornosti.
English: Cardiovascular prevention
Croatian: Kardiovaskularna prevencija
English: • Pharmacovigilance system
Croatian: • Farmakovigilancijski sustav
English: Elderly The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Croatian: Farmakokinetika telmisartana se ne razlikuje između starijih i onih mlađih od 65 godina.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne informacije.
English: Always take Telmisartan Teva exactly as your doctor has told you.
Croatian: Uvijek uzimajte Telmisartan Teva točno onako kako Vam je rekao Vaš liječnik.
English: Contents of the pack and other information
Croatian: Sadržaj pakovanja i druge informacije
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Croatian: U ovom pogledu podaci koji se tiču dijastoličkog krvnog tlaka (DKT) nisu konzistentni.
English: These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.
Croatian: Ovi klinički podaci ne dozvoljavaju donošenje zaključaka o djelotvornosti i sigurnosti telmisartana u hipertenzivnoj pedijatrijskoj populaciji.
English: No pharmacological activity has been shown for the conjugate.
Croatian: Nije pokazana farmakološka aktivnost za konjugat.
English: Your doctor can tell you if you are at high risk for such events.
Croatian: Liječnik će Vam reći da li spadate u rizičnu skupinu za takve događaje.
English: There is limited information available with regard to overdose in humans.
Croatian: Postoje ograničeni dostupni podaci u vezi predoziranja u ljudi.
English: The event may be a chance finding or related to a mechanism currently not known (see also section
Croatian: Taj događaj može biti slučajan ili povezan s trenutno nepoznatim mehanizmom (također vidjeti dio
English: 1, 2, 3, 4: for further descriptions, please see sub-section “Description of selected adverse reactions”.
Croatian: 1, 2, 3, 4: za daljnje opise, molimo vidjeti pod “Opis odabranih nuspojava”.
English: By inclusion the presence of secondary hypertension was not investigated.
Croatian: Uključivanjem prisustvo sekundarne hipertenzije nije ispitivano.
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Croatian: Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza.