FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Nyxoid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Nyxoid pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: How is Nyxoid used?
Croatian: Kako se Nyxoid koristi?
English: What benefits of Nyxoid have been shown in studies?
Croatian: Koje su koristi lijeka Nyxoid utvrđene u ispitivanjima?
English: The active substance in Nyxoid, naloxone, counteracts the effects of opioid drugs.
Croatian: Djelatna tvar lijeka Nyxoid, nalokson, poništava djelovanje opioida.
English: While the reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid is given as a spray into the nose.
Croatian: Braun primjenjuje se injekcijom, a lijek Nyxoid primjenjuje se kao sprej za nos.
English: Typical opioid withdrawal syndrome is expected after Nyxoid is given to people addicted to opioids; symptoms include restlessness, agitation, feeling or being sick, a fast heart rate and sweating.
Croatian: Simptomi uključuju nemir, uzrujanost, osjećaj slabosti ili slabost, brze otkucaje srca i znojenje.
English: The full EPAR and risk management plan summary for Moventig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Moventig nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Moventig naloxegol
Croatian: Moventig naloksegol
English: This summary was last updated in 12-2014.
Croatian: Sažetak je posljednji put ažuriran u 12.2014.
English: What is Moventig and what is it used for?
Croatian: Što je Moventig i za što se koristi?
English: The recommended dose is one 25 mg tablet a day.
Croatian: Preporučena je doza jedna tableta od 25 mg na dan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Moventig on 8 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Moventig na snazi u Europskoj uniji od 8. prosinca 2014.
English: Although studies in patients with cancerrelated pain had not been conducted, based on the mechanism of action of the medicine, the benefit for these patients was not expected to be different but the safety should be closely monitored.
Croatian: Iako ispitivanja nisu provedena na bolesnicima s boli povezanom s rakom, na temelju mehanizma djelovanja lijeka nije se očekivalo da će koristi za ove bolesnike biti drugačije, ali sigurnost treba pomno nadzirati.
English: Moventig is available as tablets (12.5 and 25 mg).
Croatian: Moventig je dostupan u obliku tableta (12,5 i 25 mg).
English: The response to treatment was based on an improvement of the number of spontaneous bowel movements per week which had to be maintained for most of the duration of the study.
Croatian: Odgovor na liječenje temeljio se na poboljšanju broja spontanih pražnjenja crijeva po tjednu koji se morao održati tijekom većeg dijela trajanja ispitivanja.
English: What measures are being taken to ensure the safe and effective use of Moventig?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Moventig?
English: What are the risks associated with Moventig?
Croatian: Koji su rizici povezani s lijekom Moventig?
English: A lower starting dose of 12.5 mg may be prescribed in patients with moderately or severely reduced kidney function or who are taking certain other medicines that increase the effects of Moventig.
Croatian: Niža početna doza od 12,5 mg može se propisati kod bolesnika s umjereno ili jako smanjenom funkcijom bubrega ili koji uzimaju određene druge lijekove koji pojačavaju učinke lijeka Moventig.
English: Other information about Moventig
Croatian: Ostale informacije o lijeku Moventig
English: It is not intended to provide practical advice on how to use Moventig.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Moventig.
English: In terms of safety, the side effects were considered acceptable or manageable.
Croatian: Što se tiče sigurnosti, nuspojave se smatraju prihvatljivima ili rješivima.
English: This is a summary of the European public assessment report (EPAR) for Moventig.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Moventig.
English: Why is Moventig approved?
Croatian: Zašto je lijek Moventig odobren?
English: Before starting treatment with Moventig, treatment with laxatives should be stopped.
Croatian: Prije početka liječenja lijekom Moventig treba prekinuti liječenje laksativima.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Moventig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Moventig nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The most common side effects with Moventig (which may affect more than 5 in 100 people) are abdominal pain (stomach ache), diarrhoea, nausea (feeling sick), headache and flatulence (passing wind).
Croatian: Najčešće nuspojave pri primjeni lijeka Moventig (kod više od 5 na 100 osoba) su bol u trbuhu, proljev, mučnina, glavobolja i flatulencija (vjetrovi).
English: A risk management plan has been developed to ensure that Moventig is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Moventig.
English: When looking at the results of both main studies together, 48% (115 out of 241) of adults who previously had an inadequate response to laxatives and who took 25 mg Moventig responded to treatment compared with 30% (72 out of 239) of adults on placebo.
Croatian: Uzimajući u obzir rezultate oba glavna ispitivanja zajedno, 48 % (115 od 241) odraslih bolesnika koji su prethodno neodgovarajuće reagirali na laksative i koji su uzimali 25 mg lijeka Moventig reagiralo je na liječenje u usporedbi s 30 % (72 od 239) odraslih bolesnikakoji su uzimali placebo.
English: It must also not be used with certain medicines that affect the way Moventig is broken down in the body.
Croatian: Također se ne smije koristiti u bolesnika koji uzimaju određene druge lijekove koji utječu na način razgradnje lijeka Moventig u tijelu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Moventig, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Moventig nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For adults who took 12.5 mg Moventig and who previously had an inadequate response to laxatives, 43% (102 out of 240) responded to treatment.
Croatian: Za odrasle bolesnike koji su primili 12,5 mg lijeka Moventig, a koji prethodno nisu na odgovarajući način reagirali na laksative, 43 % (102 od 240 bolesnika) reagiralo je na liječenje.
English: The majority of side effects affecting the gut were mild to moderate, occurred early in treatment and got better during continued treatment.
Croatian: Većina nuspojava koje zahvaćaju crijeva bile su blage do umjerene, dogodile su se rano tijekom liječenja i poboljšale su se tijekom nastavka liječenja.
English: Moventig is a medicine used in adults to treat constipation caused by pain relief medicines called opioids.
Croatian: Moventig je lijek koji se koristi u odraslih osoba za liječenje konstipacije uzrokovane lijekovima za ublažavanje bolova zvanih opioidi.
English: This means that it attaches to a specific type of opioid receptor called the ‘mu-opioid receptor' and blocks opioids from binding to these receptors.
Croatian: To znači da se veže za specifični tip opioidnih receptora naziva „mi-opioidni receptor” i onemogućuje vezanje opioida na te receptore.
English: Moventig must not be used in patients who have or who are at high risk of bowel obstruction (blockage in the gut) or in patients with cancer who are at a high risk of gastro-intestinal perforation (a hole that develops in the wall of the gut).
Croatian: Lijek Moventig ne smije se koristiti u bolesnika koji imaju opstrukciju crijeva (začepljenje crijeva) ili kod kojih postoji visok rizik od opstrukcije crijeva (začepljenja crijeva) ili kod bolesnika s rakom kod kojih postoji visok rizik od gastrointestinalne perforacije (proboja koji nastaje u stijenci crijeva).
English: It is used in patients in whom treatment with laxatives has failed.
Croatian: Koristi se u bolesnika kod kojih liječenje laksativima nije uspjelo.
English: However, these receptors are also found in the gut and when opioids attach to the gut receptors, they reduce the movement of the gut and can cause constipation.
Croatian: Međutim, ti se receptori također nalaze i u crijevima pa kada se opioidi vežu na receptore na crijevima, oni smanjuju pokrete crijeva i mogu uzrokovati konstipaciju.
English: The studies involved 1,352 adults with constipation caused by opioids that were being used to treat non-cancer pain, half of whom had an inadequate response to laxatives (720).
Croatian: Ispitivanje je uključivalo 1 352 odrasle osobe s konstipacijom uzrokovanom opioidima koji se koriste za liječenje boli koja nije uzrokovana rakom, od kojih polovica nije na odgovarajući način reagirala na laksative (720).
English: People either received Moventig (at 12.5 and 25 mg) or placebo (a dummy treatment) for 12 weeks.
Croatian: Bolesnici su primali ili Moventig (u dozama od 12,5 i 25 mg) ili placebo (prividno liječenje) tijekom 12 tjedana.
English: The active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor antagonist.
Croatian: Djelatna tvar u lijeku Moventig, naloksegol, periferni je antagonist mi-opioidnih receptora.
English: The CHMP considered that Moventig had shown a clinically relevant benefit when used in adults who have not responded adequately to previous treatment with laxatives.
Croatian: CHMP je mišljenja da je Moventig dokazao klinički značajne koristi kada se koristio u odraslih osoba koje nisu na odgovarajući način reagirale na prethodno liječenje laksativima.
English: Naloxegol is less able to enter the brain than naloxone, meaning that it can block the mu-opioid receptors in the gut but less in the brain.
Croatian: Naloksegol je manje sposoban ući u mozak od naloksona što znači da može onemogućiti mi-opioidne receptore u crijevima, ali manje u mozgu.
English: What benefits of Moventig have been shown in studies?
Croatian: Koje su koristi lijeka Moventig dokazane u ispitivanjima?
English: By blocking receptors in the gut, Moventig reduces the constipation due to opioids, but does not interfere with their pain relief effects.
Croatian: Onemogućavanjem receptora u crijevima Moventig smanjuje konstipaciju zbog opioida, ali ne utječe na njihove učinke ublažavanja boli.
English: For more information about treatment with Moventig, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Moventig pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Croatian: Opioidi ublažavaju bol vezivanjem na „opioidne receptore” u mozgu i kralješničnoj moždini.
English: How is Moventig used?
Croatian: Kako se Moventig koristi?
English: For practical information about using Moventig, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Moventig pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Naloxegol is derived from naloxone, a well-known substance that is used to block the action of opioids.
Croatian: Naloksegol se dobiva od naloksona, dobro poznate tvari koja se koristi za onemogućavanje djelovanja opioida.
English: How does Moventig work?
Croatian: Kako djeluje Moventig?
English: For the full list of all side effects and restrictions reported with Moventig, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Moventig potražite u uputi o lijeku.
English: Moventig has been shown to be effective at treating constipation in adults who had an inadequate response to laxatives in two main studies.
Croatian: U dva glavna ispitivanja lijek Moventig pokazao se djelotvornim u liječenju konstipacije u odraslih bolesnika koji nisu na odgovarajući način reagirali na laksative.
English: Take 3 times per day; morning, afternoon and evening.
Croatian: Uzimati 3 puta na dan: ujutro, poslijepodne i navečer.
English: These blood tests are done for a number of reasons:
Croatian: Te se krvne pretrage obavljaju iz više razloga:
English: Ribavirin can be very damaging to an unborn baby.
Croatian: Ribavirin može biti vrlo štetan za nerođeno dijete.
English: tongue or throat - these are signs of an allergic reaction.
Croatian: jezika ili grla - to su znakovi alergijske reakcije.
English: † and ‡
Croatian: † i ‡
English: • some neuroleptics
Croatian: • neke neuroleptike
English: B-2220 Heist-op-den-Berg Belgium
Croatian: B-2220 Heist-op-den-Berg Belgija
English: 84 hard capsules.
Croatian: 84 tvrde kapsule.
English: Interaction (postulated mechanism of action, if known)
Croatian: Interakcija (pretpostavljeni mehanizam djelovanja, ako je poznat)
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Croatian: Stoga Vi i Vaš partner morate poduzeti posebne mjere opreza tijekom spolnoga odnosa ako postoji ikakva mogućnost da dođe do trudnoće:
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti niti koristiti alate i strojeve.
English: C/C C/T
Croatian: C/C C/T T/T
English: Red printing ink containing:
Croatian: Crvena tinta za označivanje koja sadrži:
English: Then continue taking your capsules as normal.
Croatian: Zatim nastavite uzimati kapsule prema uobičajenom rasporedu.
English: Take the capsules in the morning, afternoon and evening with a meal or light snack.
Croatian: Uzmite kapsule ujutro, poslije podne i navečer, uz obrok ili lagani međuobrok.
English: Component of a multipack, can't be sold separately
Croatian: Sastavni dio višestrukog pakiranja, ne može se izdavati zasebno.
English: (Refer to the stopping rule in Table 1 for all patients.)
Croatian: (Pravilo za prekid liječenja navedeno u Tablici 1 vrijedi za sve bolesnike).
English: Date of first authorisation: 18 July 2011 Date of latest renewal: 18 February 2016
Croatian: Datum posljednje obnove odobrenja: 18. veljače 2016.
English: Epiglottitis*, otitis media, sepsis
Croatian: epiglotitis*, otitis media, sepsa
English: • Do not take a double dose to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The safety and efficacy of Victrelis in children aged below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Victrelis u djece mlađe od 18 godina nisu još ustanovljene.
English: What Victrelis is and what it is used for
Croatian: Što je Victrelis i za što se koristi
English: • This medicine should be taken with a meal or light snack.
Croatian: • Ovaj lijek se mora uzimati uz obrok ili lagani međuobrok.
English: Daily doses of 3,600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
Croatian: Zdravi dobrovoljci uzimali su dnevne doze od 3600 mg tijekom 5 dana bez neželjenih simptoma.
English: Check with your doctor or pharmacist if you are not sure.
Croatian: Provjerite sa liječnikom ili ljekarnikom ako niste sigurni.
English: Neutropenia affects the body's ability to fight off infections
Croatian: Neutropenija utječe na sposobnost borbe organizma protiv infekcija
English: Stop taking Victrelis and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Prestanite uzimati Victrelis i odmah se javite liječniku ako primijetite neku od sljedećih ozbiljnih nuspojava - možda će Vam trebati hitno medicinsko liječenje:
English: Dose adjustment of the benzodiazepine should be considered.
Croatian: Treba razmotriti prilagodbu doze benzodiazepina.
English: • so your doctor knows if the treatment is working for you
Croatian: • kako bi liječnik znao je li liječenje djelotvorno
English: • The active substance is boceprevir.
Croatian: • Djelatna tvar je boceprevir.
English: • This medicine has been prescribed for you.
Croatian: - Ovaj je lijek propisan samo Vama.
English: *Please see section 5.1 clinical trial descriptions for each treatment arm.
Croatian: *Molimo vidjeti dio 5.1 za opise kliničkih ispitivanja za svaku terapijsku skupinu.
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can
Croatian: Vaš će liječnik možda trebati povećati učestalost krvnih pretraga kako bi provjerio kako se Vaša krv zgrušava.
English: SPRINT-2 (previously untreated subjects)
Croatian: SPRINT-2 (ispitanici koji prethodno nisu bili liječeni)
English: If you have any questions about what to do, talk to your doctor.
Croatian: Ako imate pitanja o tome kako postupiti, porazgovarajte sa svojim liječnikom.
English: This will lessen the possibility for ribavirin to be left in the woman's body.
Croatian: Na taj ćete način smanjiti mogućnost da ribavirin dospije u ženino tijelo.
English: Do not stop taking Victrelis unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Victrelis dok Vam to ne kaže liječnik.
English: • statins - simvastatin or lovastatin
Croatian: • statine - simvastatin ili lovastatin
English: Your doctor will have your blood tested regularly.
Croatian: Liječnik će redovito obavljati krvne pretrage.
English: The use without food could seriously compromise your chance of success of treatment.
Croatian: Uzimanje lijeka bez hrane može ozbiljno umanjiti vjerojatnost uspjeha liječenja.
English: Alpha-1 adrenoreceptor antagonists
Croatian: Antagonisti alfa-1 adrenoreceptora
English: These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Croatian: Te se preporuke temelje ili na ispitivanjima interakcija između lijekova (označeno znakom *) ili na predviđenim interakcijama zbog očekivane veličine interakcije i mogućnosti pojave ozbiljnih nuspojava ili gubitka djelotvornosti.
English: Treatment duration = 28 weeks
Croatian: Trajanje liječenja = 28 tjedana
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: Ovo uključuje i lijekove koje ste nabavili bez recepta i biljne pripravke.
English: No dose adjustment of escitalopram is anticipated, but doses may need to be adjusted based on clinical effect.
Croatian: Nije predviđeno prilagođavanje doze escitaloprama, ali možda će biti potrebno prilagoditi doze na temelju kliničkog učinka.
English: Accumulation is minimal and pharmacokinetic steady state is achieved after approximately 1 day of three times daily dosing.
Croatian: Akumulacija je minimalna i farmakokinetičko stanje dinamičke ravnoteže postiže se nakon približno jednog dana doziranja triput na dan.
English: The hepatocellular tumours are considered due to enzyme induction and therefore not relevant for humans.
Croatian: Smatra se da su hepatocelularni tumori posljedica indukcije enzima te stoga nisu relevantni za ljude.
English: • Peel back the tab to get to the capsule - do not push the capsule through the blister since pushing the capsule through the package may break the capsule.
Croatian: • Odlijepite naljepnicu kako biste izvadili kapsulu - nemojte potiskivati kapsulu kroz blister jer se potiskivanjem kapsula može slomiti.
English: What Victrelis is and what it is used for What you need to know before you take Victrelis
Croatian: Što je Victrelis i za što se koristi Što morate znati prije nego počnete uzimati Victrelis
English: (effect on P-gp transport in the
Croatian: (učinak na transport P-gp-a u
English: Treatment duration = 48 weeks
Croatian: Trajanje liječenja = 48 tjedana
English: • The duration of the administration of these medicines will depend on your response and
Croatian: • Trajanje primjene navedenih lijekova ovisi o Vašem odgovoru i planu liječenja.
English: Laboratory testing
Croatian: Laboratorijske pretrage
English: There is potential for inhibitors of these transporters to increase concentrations of boceprevir; the clinical implications of these interactions are not known.
Croatian: Inhibitori tih transportnih proteina potencijalno mogu povisiti koncentraciju boceprevira; nisu poznate kliničke implikacije tih interakcija.
English: .hr/mL, Cmax of 1,913 ng/mL, and Cmin of 90 ng/mL.
Croatian: .hr/ml, Cmax 1,913 ng/ml i Cmin 90 ng/ml.
English: Caution is warranted and clinical monitoring of patients is recommended.
Croatian: Neophodan je oprez i preporučuje se klinički nadzor bolesnika.
English: Loss of replicon RNA appears to be first-order with respect to time of treatment.
Croatian: Čini se da je gubitak RNK replikona proces prvog reda u odnosu na vrijeme liječenja.
English: Use in patients with rare hereditary disorders
Croatian: Primjena u bolesnika s rijetkim nasljednim poremećajima
English: • have a current or previous infection with the hepatitis B virus, since your doctor may want to
Croatian: • ako imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti
English: The recommended dose of Victrelis is 4 capsules three times a day (a total of 12 capsules a day).
Croatian: Preporučena doza lijeka Victrelis je 4 kapsule triput dnevno (ukupno 12 kapsula dnevno).
English: The data indicate that boceprevir is eliminated primarily by the liver.
Croatian: Podaci ukazuju na to da se boceprevir prvenstveno uklanja putem jetre.
English: Antiviral activity in cell culture
Croatian: Protuvirusno djelovanje u kulturi stanica
English: • Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • have or anyone in your family has an irregular heartbeat, especially a condition called “QT
Croatian: • ako Vi ili član Vaše obitelji patite od nepravilnog srčanog ritma, osobito stanja koje se zove
English: Decreased fertility was also observed in male rats, most likely as a consequence of testicular degeneration (no testicular degeneration has been observed in mice or monkeys).
Croatian: Smanjena plodnost opažena je i u mužjaka štakora, što je najvjerojatnije posljedica degeneracije testisa (degeneracija testisa nije opažena u miševa niti majmuna).
English: Within each system organ class, adverse reactions are listed under headings of frequency using the categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Croatian: Unutar svake klasifikacije organskog sustava, nuspojave su navedene prema sljedećim kategorijama učestalosti pojavljivanja: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Blood: low potassium levels in your blood; high calcium levels in the blood
Croatian: Krv: niska razina kalija u krvi; visoka razina kalcija u krvi
English: If you take more Victrelis than you should If you take more Victrelis than you should, talk to a doctor or go to the nearest hospital emergency
Croatian: Ako uzmete više Victrelis kapsula nego što ste trebali, odmah porazgovarajte s liječnikom ili otiđite u hitnu službu najbliže bolnice.