FrancophonIA/ELRC3.0 huggingface dataset:
English: Intent-to-treat cohort.
Croatian: Kohorta s namjerom liječenja.
English: Following intravenous administration of palonosetron 0.25 mg once every other day for 3 doses in 11 testicular cancer patients, the mean (± SD) increase in plasma concentration from Day 1 to Day 5 was 42 ± 34 %.
Croatian: U 11 bolesnika s rakom testisa, nakon intravenske primjene palonosetrona 0,25 mg jednom svaki drugi dan kroz 3 doze, prosječna vrijednost ( SD) porasta koncentracije u plazmi od 1. dana do 5. dana iznosila je 42  34%.
English: • if you have acute bowel obstruction or a history of repeated constipation;
Croatian: - Ako imate akutnu opstrukciju crijeva ili ponavljane zatvore stolice u prošlosti.
English: In vitro metabolism studies have shown that CYP2D6 and to a lesser extent, CYP3A4 and CYP1A2 isoenzymes are involved in the metabolism of palonosetron.
Croatian: Metabolička in vitro ispitivanja pokazala su da je u metabolizam palonosetrona uključen enzim CYP2D6, a u manjoj mjeri izoenzimi CYP3A4 i CYP1A2.
English: Nervous system disorders Headache Dizziness
Croatian: Poremećaji živčanog sustava Glavobolja
English: How to store Palonosetron Hospira
Croatian: Kako čuvati Palonosetron Hospira
English: • numbness, burning, prickling or tingling sensations on the skin
Croatian: • utrnulost, osjećaj žarenja, bockanje, trnci po koži
English: • The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).
Croatian: • Pomoćne tvari su manitol, dinatrijev edetat, natrijev citrat, citratna kiselina hidrat i voda za injekcije, natrijev hidroksid i kloridna kiselina.
English: <2 y 2 to <6 y 6 to <12 y 12 to <17 y μg/kg
Croatian: < 2 god 2 do < 6 god
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17
Croatian: Nositelj odobrenja Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgija
English: Table 1: Percentage of patients a responding by treatment group and phase in the Moderately Emetogenic Chemotherapy study versus ondansetron
Croatian: Tablica 1: Postotak bolesnika a s odgovorom po skupinama liječenja i fazi u ispitivanju umjereno emetogene kemoterapije u odnosu na ondansetron
English: What Palonosetron Hospira looks like and contents of the pack Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution.
Croatian: Kako Palonosetron Hospira izgleda i sadržaj pakiranja Palonosetron Hospira otopina za injekciju bistra je bezbojna otopina, a dostupna je u pakiranju od jedne bočice stakla tip
English: For palonosetron no clinical data on exposed pregnancies are available.
Croatian: Nema kliničkih podataka o izloženosti palonosetronu u trudnoći.
English: Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
Croatian: Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonosetrona.
English: Palonosetron 250 micrograms (n= 189)
Croatian: Palonosetron 250 mikrograma (n = 189)
English: Dyspepsia, abdominal pain, abdominal pain upper, dry mouth, flatulence
Croatian: probavnog sustava gornjem dijelu trbuha, suha usta, flatulencija
English: Palonosetron 250 micrograms (n= 185)
Croatian: Palonosetron 250 mikrograma (n = 185)
English: Each ml of solution contains 50 micrograms palonosetron (as hydrochloride).
Croatian: Jedan ml otopine sadrži 50 mikrograma palonosetrona (u obliku palonosetronklorida).
English: In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥60 mg/m2, cyclophosphamide >1,500 mg/m2 and dacarbazine, palonosetron
Croatian: U randomiziranom, dvostruko slijepom ispitivanju na ukupno 667 bolesnika na visoko emetogenoj kemoterapiji koja je uključivala cisplatin ≥60 mg/m2, ciklofosfamid >1500 mg/m2 i dakarbazin, uspoređivan je palonosetron 250 mikrograma i 750 mikrograma s ondansetronom 32 mg primijenjeno intravenski na dan 1.
English: Palonosetron Hospira250 micrograms solution for injection.
Croatian: Palonosetron Hospira 250 mikrograma otopina za injekciju.
English: • nosebleed
Croatian: • omaglica
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron
Croatian: Palonosetron Hospira 250 mikrograma otopina za injekciju palonosetron
English: Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms.
Croatian: Povezano s primjenom palonosetrona u dozi od 750 mikrograma, zabilježena su dva slučaja konstipacije s fekalnom impakcijom, koja su zahtijevala hospitalizaciju.
English: Palonosetron Hospira 250 micrograms solution for injection palonosetron (as hydrochloride)
Croatian: Palonosetron Hospira 250 mikrograma otopina za injekciju Palonosetron (u obliku palonosetronklorida)
English: Each vial of 5 ml of solution contains 250 micrograms palonosetron (as hydrochloride).
Croatian: Jedna bočica otopine od 5 ml sadrži 250 mikrograma palonosetrona (u obliku palonosetronklorida).
English: Headache
Croatian: Poremećaji
English: Adults Cancer Patients
Croatian: Pedijatrijski bolesnici s karcinomom a Odrasli bolesnici s karcinomom
English: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg).
Croatian: 402 bolesnika su primila jednu dozu palonosetrona (3, 10 ili 20 mcg/kg) tijekom pedijatrijskih kliničkih ispitivanja radi sprječavanje mučnine i povraćanja povezanih s umjerenom ili visokom emetogenom kemoterapijom.
English: Table 3: Percentage of patients a responding by treatment group and phase in the Highly Emetogenic Chemotherapy study versus ondansetron
Croatian: Tablica 3: Postotak bolesnika a s odgovorom prema skupinama liječenja i fazi u ispitivanju visoko emetogene kemoterapije u odnosu na ondansetron Palonosetron 250 mikrograma (n = 223)
English: • pain at the site of infusion
Croatian: • bol na mjestu davanja infuzije.
English: This overview was last updated in 07-2018.
Croatian: Sažetak je posljednji je put ažuriran u 07-2018.
English: The medicine is available as tablets (50 mg) and the recommended dose is two tablets twice a day taken with food.
Croatian: Dostupan je u obliku tableta (50 mg), a preporučena doza su dvije tablete dvaput dnevno uzete s hranom.
English: In addition, a majority of patients who entered the main study were followed up for up to 24 months afterwards.
Croatian: Osim toga, većinu bolesnika koji su bili uključeni u glavno ispitivanje pratilo se poslije toga do 24 mjeseca.
English: Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).
Croatian: Tuberkuloza je zaraza prouzročena bakterijom Mycobacterium tuberculosis (M. tuberculosis).
English: Although the main study was of short duration and the follow-up studies had shortcomings, the Agency considered that the effects shown after the initial 2 months of treatment are likely to be sustained for the full treatment duration.
Croatian: Iako je glavno ispitivanje trajalo kratko, a nastavci ispitivanja imali su nedostatke, Agencija je zaključila da će se učinci koji su se pokazali nakon dva početna mjeseca liječenja vjerojatno nastaviti tijekom cijelog trajanja liječenja.
English: Further information on Deltyba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Deltyba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency noted that an on-going clinical study will provide confirmation on the long-term effectiveness.
Croatian: Agencija je navela da će kliničko ispitivanje koje je u tijeku pružiti potvrdu dugoročne učinkovitosti.
English: It is used together with other tuberculosis medicines and only when other standard medicine cannot be used either because the disease is resistant to them or because of their side effects.
Croatian: Primjenjuje se s ostalim lijekovima protiv tuberkuloze i to samo onda kada se standardni lijekovi ne mogu upotrebljavati jer je bolest na njih otporna ili zbog nuspojava tih lijekova.
English: What is Deltyba and what is it used for?
Croatian: Što je Deltyba i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Deltyba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Deltyba?
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Croatian: Više informacija o statusu lijeka za rijetke bolesti možete naći ovdje: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: The most common side effects with Deltyba (which may affect more than 1 patient in 10) are nausea, vomiting, headache, insomnia (sleeping problems), dizziness, tinnitus (ringing or buzzing in the ears), blood tests showing low potassium levels in the blood, gastritis (inflammation of the stomach lining), decreased appetite and weakness.
Croatian: Najčešće nuspojave lijeka Deltyba (koje se mogu javiti u više od 1 na 10 bolesnika) jesu mučnina, povraćanje, glavobolja, nesanica (teškoće sa spavanjem), omaglica, tinitus (zvonjava ili zujanje u ušima), niske razine kalija u krvi u nalazima pretraga krvi, gastritis (upala sluznice želuca), smanjeni apetit i slabost.
English: It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body.
Croatian: Također se ne smije primjenjivati u bolesnika koji uzimaju određene druge lijekove koji utječu na način na koji se Deltyba razgrađuje u tijelu.
English: Tuberculosis is rare in the EU, and Deltyba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 1 February 2008.
Croatian: Tuberkuloza je rijetka u EU-u, a Deltyba je dobio status „lijeka za rijetke bolesti” 1. veljače 2008.
English: The safety profile was considered manageable and several measures were introduced to minimise the risks, including a study to confirm the long-term safety.
Croatian: Smatra se da se sigurnosni profil može kontrolirati te je uvedeno nekoliko mjera da bi se rizici sveli na najmanju moguću mjeru, uključujući i ispitivanje koje treba potvrditi dugoročnu sigurnost primjene.
English: Deltyba has been given ‘conditional authorisation'.
Croatian: Za lijek Deltyba izdano je „uvjetno odobrenje”.
English: Deltyba is given for 6 months together with other tuberculosis medicines.
Croatian: Deltyba se uzima 6 mjeseci zajedno s drugim lijekovima protiv tuberkuloze.
English: The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Croatian: Tvrtka koja stavlja u promet lijek Deltyba osigurat će edukacijski materijal za zdravstvene radnike u kojima će objasniti kako sigurno primjenjivati lijek kako bi se izbjegli problemi kao što su razvoj otpornosti i nuspojave za srce, a također rizici u trudnoći ili u dojilja.
English: Treatment with these medicines should continue after Deltyba treatment, as recommended by official guidelines.
Croatian: Liječenje tim lijekovima treba nastaviti i nakon terapije lijekom Deltyba prema preporukama službenih smjernica.
English: Although the way it works is unclear, delamanid is known to block the production of methoxy-mycolic and ketomycolic acids, two essential components of the cell walls of M. tuberculosis, which will cause the bacteria to die.
Croatian: Iako način na koji delamanid djeluje nije jasan, zna se da blokira proizvodnju metoksi-mikolne i keto-mikolne kiseline, dviju osnovnih komponenti stanične stijenke bakterije M. tuberculosis, što prouzroči smrt bakterije.
English: Side effects reported with Deltyba are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Deltyba pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The main measure of effectiveness was the proportion of patients who no longer had the bacteria in their sputum (phlegm).
Croatian: Glavna mjera učinkovitosti bio je udio bolesnika koji u ispljuvku (sputumu) više nisu imali bakteriju.
English: Deltyba received a marketing authorisation valid throughout the European Union on 28 April 2014.
Croatian: Lijek Deltyba dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 28. travnja 2014.
English: Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
Croatian: Deltyba je lijek za liječenje odraslih osoba s tuberkulozom pluća, a otporna je na više lijekova (otporna je barem na izoniazid i rifampicin, dva standardna lijeka protiv tuberkuloze).
English: Why is Deltyba authorised in the EU?
Croatian: Zašto je lijek Deltyba odobren u EU-u?
English: The effects of Deltyba have been looked at in one main study involving 481 adults with tuberculosis resistant to standard treatments.
Croatian: Učinci lijeka Deltyba praćeni su u jednom glavnom ispitivanju koje je obuhvaćalo 481 odraslog bolesnika s tuberkulozom otpornom na standardne terapije.
English: After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
Croatian: Nakon dva mjeseca liječenja više od 40 % bolesnika koji su uzimali lijek Deltyba više nisu imali bakteriju u ispljuvku u usporedbi s 30 % bolesnika koji su uzimali placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deltyba have also 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 Deltyba nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Croatian: Budući da je lijek Deltyba dobio uvjetno odobrenje, tvrtka koja stavlja lijek Deltyba u promet provest će daljnja ispitivanja kako bi se potvrdila dugoročna učinkovitost i sigurnost primjene lijeka Deltyba.
English: Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Croatian: Promatrajući zajedno rezultate tih razdoblja praćenja, dvije godine nakon početka liječenja 75 % bolesnika koji su lijek Deltyba uzimali šest mjeseci ili dulje više nije imalo bakteriju u sputumu, za razliku od 55 % bolesnika koji su lijek Deltyba uzimali dva mjeseca ili kraće.
English: Deltyba must not be used in patients who have low levels of albumin (a blood protein).
Croatian: Lijek Deltyba ne smiju uzimati bolesnici s niskim razinama albumina (bjelančevina u krvi).
English: Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments.
Croatian: Bolesnici u ispitivanju uzimali su lijek Deltyba ili placebo (prividno liječenje) tijekom 2 mjeseca zajedno s drugim terapijama.
English: What are the risks associated with Deltyba?
Croatian: Koji su rizici povezani s lijekom Deltyba?
English: An overview of Deltyba and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Deltyba i zašto je odobren u EU-u
English: Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Croatian: Deltyba se izdaje samo na liječnički recept, a terapiju mora započeti i pratiti liječnik koji ima iskustva u liječenju tuberkuloze otporne na više lijekova.
English: For more information about using Deltyba, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Deltyba pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: As for all medicines, data on the use of Deltyba are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Deltyba kontinuirano se prate.
English: Deltyba contains the active substance delamanid.
Croatian: Deltyba sadrži djelatnu tvar delamanid.
English: The European Medicines Agency decided that Deltyba's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Deltyba nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Other information about Deltyba
Croatian: Ostale informacije o lijeku Deltyba
English: It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
Croatian: Lijek treba primjenjivati prema službenim smjernicama o liječenju tuberkuloze otporne na lijekove.
English: After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study.
Croatian: Kada je završilo glavno ispitivanje, bolesnici su mogli nastaviti terapiju lijekom Deltyba još šest mjeseci u produžetku ispitivanja.
English: What information is still awaited for Deltyba?
Croatian: Koje se još informacije očekuju o lijeku Deltyba?
English: The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
Croatian: Deltyba sadrži djelatnu tvar delamanid, antibiotik koji djeluje protiv M. tuberculosis.
English: Furthermore the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Croatian: Nadalje, istaknuta je medicinska potreba za novim lijekovima za liječenje tuberkuloze otporne na više lijekova.
English: What benefits of Deltyba have been shown in studies?
Croatian: Koje su koristi od lijeka Deltyba utvrđene u ispitivanjima?
English: How is Deltyba used?
Croatian: Kako se Deltyba koristi?
English: How does Deltyba work?
Croatian: Kako djeluje Deltyba?
English: The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Croatian: Agencija je zaključila da su koristi lijeka Deltyba utvrđene u bolesnika s tuberkulozom pluća otpornom na druge lijekove.
English: For the full list of side effects of Deltyba, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Deltyba potražite u uputi o lijeku.
English: 1 vial + 1 vial
Croatian: 3 bočice + 3 bočice
English: Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Croatian: Više informacija o lijeku Sixmo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/sixmo.
English: Sixmo (buprenorphine)
Croatian: Sixmo (buprenorfin)
English: The company will also provide an alert card which patients should carry at all times and show to other healthcare professionals before receiving any medical treatment.
Croatian: Tvrtka će također dostaviti karticu s upozorenjima koju bolesnici uvijek trebaju imati sa sobom i pokazati je zdravstvenim radnicima prije primanja bilo kakvog medicinskog liječenja.
English: Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
Croatian: Sixmo se primjenjuje u odraslih osoba koje su već stabilne prilikom uzimanja buprenorfina pod jezik (ne više od 8 mg/dan) i koji također primaju medicinsku, socijalnu i psihološku potporu.
English: What is Sixmo and what is it used for?
Croatian: Što je Sixmo i za što se koristi?
English: The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
Croatian: Najčešće nuspojave lijeka Sixmo (koje se mogu javiti u najviše 1 na 10 osoba) uključuju glavobolju, zatvor i poteškoće sa spavanjem.
English: What measures are being taken to ensure the safe and effective use of Sixmo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sixmo?
English: Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
Croatian: Sixmo se ne smije primjenjivati zajedno s drugim lijekovima zvanima „antagonisti opioida” (naltrekson i nalmefen).
English: The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
Croatian: Djelatna tvar lijeka Sixmo, buprenorfin, parcijalni je agonist opioida (to znači da djeluje poput opioida, ali manje snažno).
English: Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Croatian: Sixmo je lijek koji se koristi za liječenje ovisnosti o opioidima kao što su heroin ili morfin.
English: The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant.
Croatian: Najčešće nuspojave povezane s ugradnjom i uklanjanjem implantata jesu bol, svrbež, modrice, krvarenje, crvenilo kože i osip na mjestu implantata.
English: In addition, the company will conduct a study to investigate breakages and other complications during the insertion and removal of the implants in clinical practice.
Croatian: Osim toga, tvrtka će provesti ispitivanje u svrhu istrage o lomljenju i drugim komplikacijama tijekom ugradnje i uklanjanja implantata u kliničkoj praksi.
English: Other information about Sixmo
Croatian: Ostale informacije o lijeku Sixmo
English: It contains the active substance buprenorphine.
Croatian: Sadrži djelatnu tvar buprenorfin.
English: The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Croatian: Lijek se stoga može kontrolirano primjenjivati u cilju sprječavanja simptoma ustezanja i smanjenja potrebe za pogrešnom primjenom drugih opioida.
English: Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Croatian: Sixmo se ne smije primjenjivati u bolesnika s teškom respiratornom insuficijencijom (nesposobnost pravilnog disanja), bolesnika s teškim problemima s jetrom ni u bolesnika koji imaju intoksikaciju alkoholom ili simptome ustezanja od alkohola.
English: The European Medicines Agency therefore decided that Sixmo'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 Sixmo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Croatian: U glavnim je ispitivanjima utvrđeno da je Sixmo bio učinkovitiji od placeba i barem jednako učinkovit kao sublingvalni buprenorfin u liječenju ovisnosti o opioidima.
English: Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Sixmo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.