FrancophonIA/ELRC3.0 huggingface dataset:
English: Although patients with Still's disease had a higher risk of liver problems, this risk was considered to be outweighed by the medicine's benefits.
Croatian: Iako su bolesnici sa Stillovom bolesti imali viši rizik od problema s jetrom, smatra se da koristi lijeka nadmašuju taj rizik.
English: The active substance in Kineret, anakinra, is an immunosuppressive medicine (a medicine that reduces the activity of the immune system).
Croatian: Djelatna tvar u lijeku Kineret, anakinra, imunosupresivni je lijek (lijek koji smanjuje aktivnost imunosnog sustava).
English: The European Medicines Agency decided that Kineret's benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
Croatian: Europska agencija za lijekove zaključila je da je koristi lijeka Kineret nadmašuju njegove rizike za liječenje znakova i simptoma reumatoidnog artritisa u kombinaciji s metotreksatom u bolesnika s neodgovarajućim odgovorom na liječenje samo metotreksatom.
English: How is Kineret used?
Croatian: Kako se Kineret koristi?
English: In patients with severely reduced kidney function the doctor should consider giving Kineret every other day
Croatian: U bolesnika s ozbiljno smanjenom funkcijom bubrega liječnik treba razmotriti primjenu lijeka Kineret svakog drugog dana.
English: Kineret should be used with caution in patients who have severely reduced liver function or moderately reduced kidney function.
Croatian: Lijek Kineret treba se pažljivo primjenjivati u bolesnika s ozbiljno smanjenom funkcijom jetre ili umjereno smanjenom funkcijom bubrega.
English: This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness.
Croatian: To dovodi to upale u mnogim dijelovima tijela, sa simptomima poput vrućice, osipa, bola u zglobovima i umora.
English: Kineret must not be used in people who are hypersensitive (allergic) to anakinra, to any of the other ingredients, or to proteins produced by Escherichia coli (a type of bacterium).
Croatian: Lijek Kineret ne smiju uzimati osobe preosjetljive (alergične) na tvar anakinru, na bilo koji drugi sastojak lijeka ili na proteine koje proizvodi Escherichia coli (vrsta bakterije).
English: The most common side effects with Kineret (which may affect more than 1 patient in 10) are headache, injection site reactions (redness, bruising, pain and inflammation), and increase in blood cholesterol.
Croatian: Najčešće nuspojave lijeka Kineret (mogu se javiti u više od 1 na 10 osoba) su glavobolja, reakcije na mjestu ubrizgavanja (crvenilo, modrice, bol i upala) te povećanje kolesterola u krvi.
English: Kineret can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of rheumatoid arthritis, CAPS or Still's disease as appropriate.
Croatian: Kineret se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik koji ima iskustva u liječenju reumatoidnog artritisa, CAPS-a ili Stillove bolesti.
English: An overview of Kineret and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Kineret i razlozima njegova odobrenja u EU-u
English: Kineret is a medicine that is used to treat:
Croatian: Kineret je lijek za liječenje raka koji se primjenjuje za liječenje:
English: A second study in 24 children showed similar results: 67 % had at least a 30% reduction in symptoms after one month compared with 8 % given placebo.
Croatian: U drugom je ispitivanju 24 djece pokazalo slične rezultate: u 67 % njih simptomi su ublaženi za najmanje 30 % nakon jednog mjeseca u usporedbi s 8 % onih koji su primili placebo.
English: For more information about using Kineret, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Kineret pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
Croatian: Primjenjuje se u kombinaciji s metotreksatom (lijekom za ublažavanje upale) u bolesnika koji na liječenje samo metotreksatom nisu odgovorili na odgovarajući način.
English: This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage, and is also involved in the inflammation associated with CAPS and Still's disease.
Croatian: Taj se glasnik proizvodi u visokim razinama u bolesnika s reumatoidnim artritisom, uzrokujući upalu i oštećenje zglobova te je također uključen u upalu povezanu s CAPS-om i Stillovom bolesti.
English: In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
Croatian: U ispitivanju u kojem je primijenjena fiksna doza lijeka Kineret, u 38 % bolesnika kojima je dodan lijek Kineret simptomi su ublaženi za najmanje 20 % nakon šest mjeseci, u usporedbi s 22 % bolesnika kojima je dodan placebo.
English: For CAPS and Still's disease, the dose depends on body weight and for CAPS, on the severity of the condition.
Croatian: Doza za CAPS i Stillovu bolest ovisi o tjelesnoj težini te o ozbiljnosti stanja za CAPS.
English: Kineret must not be started in patients who have neutropenia (low levels neutrophils, a type of blood cell that fights infection).
Croatian: Lijek Kineret ne smije se uvoditi u bolesnika koji imaju neutropeniju (niske razine neutrofila, vrste krvnih stanica koje se bore protiv infekcije).
English: All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment).
Croatian: U tim trima ispitivanjima uspoređene su djelotvornosti lijeka Kineret i placeba (prividnog liječenja).
English: In the first study, 11 of 15 children with Still's disease (73 %) had at least a 30% reduction in symptoms after three months treatment with Kineret.
Croatian: U prvom su ispitivanju u 11 od 15 djece sa Stillovom bolesti (73 %) simptomi ublaženi za najmanje 30 % nakon tri mjeseca liječenja lijekom Kineret.
English: What benefits of Kineret have been shown in studies?
Croatian: Koje su koristi lijeka Kineret utvrđene u ispitivanjima?
English: adult patients who also received corticosteroids for their disease.
Croatian: Treće je ispitivanje obuhvatilo 22 odrasla bolesnika koji si primali kortikosteroide za svoju bolest.
English: Kineret is available as a solution for injection under the skin.
Croatian: Kineret je otopina za potkožnu injekciju.
English: • Still's disease, a disease causing inflammation of joints as well as rash and fever.
Croatian: • Stillove bolesti, odnosno bolesti koja uzrokuje upalu zglobova kao i osip i vrućicu.
English: How does Kineret work?
Croatian: Kako djeluje Kineret?
English: Patients either received Kineret or another type of medicine, called a DMARD.
Croatian: Bolesnici su primali lijek Kineret ili drugu vrstu lijeka, tzv. lijek koji mijenja tijek upalne reumatske bolesti (DMARD).
English: For the full list of side effects of Kineret, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Kineret potražite u uputi o lijeku.
English: For CAPS and Still's disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg. Kineret contains the active substance anakinra.
Croatian: Lijek Kineret se, za CAPS i Stillovu bolest, primjenjuje u bolesnika u dobi od osam mjeseci i starijih te tjelesne težine od najmanje 10 kg.
English: Children and Adolescents:
Croatian: Djeca i adolescenti:
English: Date of first authorisation: 08 April 2016
Croatian: Datum prvog odobrenja: 08. travnja 2016.
English: Volume of distribution c, d,
Croatian: Volumen distribucije c, d
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
Croatian: Obavijestite svoga liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući:
English: • if you have other heart problems;
Croatian: - Ako imate druge teškoće sa srcem.
English: Approximately 62 % of palonosetron is bound to plasma proteins.
Croatian: Približno 62% palonosetrona vezano je za proteine plazme.
English: • high or low blood pressure
Croatian: • visoki ili niski krvni tlak
English: • sleepiness or trouble sleeping
Croatian: • pospanost ili poteškoće sa spavanjem
English: • decrease or loss of appetite
Croatian: • smanjenje ili gubitak apetita
English: 10 μg/kg
Croatian: 10 g/kg
English: The safety and efficacy of palonosetron in children aged less than 1 month have not been established.
Croatian: Sigurnost primjene i djelotvornost palonosetrona u djece mlađe od 1 mjeseca nisu ustanovljene.
English: Ten percent of patients have a mean terminal elimination halflife greater than 100 hours.
Croatian: Deset posto bolesnika ima terminalni poluvijek eliminacije dulji od 100 sati.
English: Children and Adolescents (aged 1 month to 17 years) The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms.
Croatian: Djeca i adolescenti (u dobi od 1 mjeseca do 17 godina) Liječnik će odrediti dozu ovisno o tjelesnoj težini, ali najveća doza je 1500 mikrograma.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo ovaj lijek.
English: • At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1).
Croatian: Temeljito ispitivanje upravo QT/QTc intervala, provedeno je u zdravih dobrovoljaca kako bi se dobili definitivni podaci o učinku palonosetrona na QT/QTc (vidjeti dio 5.1).
English: Palonosetron is not mutagenic.
Croatian: Palonosetron nije mutagen.
English: • if you have an imbalance of certain minerals in your blood such as potassium and magnesium which has not been treated.
Croatian: - Ako imate neravnotežu nekih minerala u krvi kao npr. kalija i magnezija, a to nije bilo liječeno.
English: This leaflet was last revised in month YYYY.
Croatian: Ova uputa je zadnji puta revidirana u mjesec/GGGG.
English: Clearance c, L/h/kg
Croatian: Klirens c, l/h/kg
English: Palonosetron Hospira should be injected over 30 seconds.
Croatian: Palonosetron Hospira treba ubrizgati tijekom 30 sekundi.
English: Manufacturer Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Croatian: Proizvođač Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, Ujedinjeno Kraljevstvo
English: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italy
Croatian: Via Fosse Ardeatine, 2, 20060, Liscate (MI) Italija
English: It is not known whether Palonosetron Hospira will cause any harmful effects when used during pregnancy.
Croatian: Nije poznato hoće li Palonosetron Hospira prouzročiti bilo kakve štetne učinke ako se primjenjuje tijekom trudnoće.
English: Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3 -antagonist administration.
Croatian: Hipokalijemiju i hipomagnezijemiju treba ukloniti prije primjene antagonista 5-HT3.
English: Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician.
Croatian: Stoga palonosetron ne smiju uzimati trudnice, osim ako liječnik smatra da je to prijeko potrebno.
English: • high levels of the pigment bilirubin in the blood
Croatian: • visoke razine pigmenta bilirubina u krvi
English: Package leaflet: Information for the patient
Croatian: Uputa o lijeku: Informacija za korisnika
English: A lower bound greater than -15 % demonstrates non-inferiority between palonosetron and comparator.
Croatian: Donja granica veća od -15% pokazuje neinferiornost između palonosetrona i usporednog lijeka.
English: As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.
Croatian: S obzirom da ne postoje podaci o izlučivanju palonosetrona u majčino mlijeko, za vrijeme terapije treba prekinuti dojenje.
English: The effect of palonosetron on QTc interval was evaluated in a double blind, randomised, parallel, placebo and positive (moxifloxacin) controlled trial in adult men and women.
Croatian: Učinak palonosetrona na QTc interval procijenjen je u dvostruko slijepom, randomiziranom, usporednom, placebom i pozitivno (moksifloksacin) kontroliranom ispitivanju u odraslih muškaraca i žena.
English: Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists.
Croatian: Palonosetron Hospira pripada skupini lijekova poznatih kao antagonisti serotonina (5HT3).
English: • change in the colour of the vein and/or veins becoming larger
Croatian: • promjene boje vene i/ili proširenje vena
English: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium
Croatian: Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgija
English: In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %).
Croatian: U kliničkim ispitivanjima u odraslih s dozom od 250 mikrograma (ukupno 633 bolesnika) najčešće opažene nuspojave, barem moguće povezane s primjenom palonosetrona, bile su glavobolja (9%) i konstipacija. (5%).
English: However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.
Croatian: Međutim, kao i za druge antagoniste 5-HT3, potreban je oprez pri primjeni palonosetrona u bolesnika koji imaju produljenje QT intervala ili je vjerojatno da će se ono u njih pojaviti.
English: • if you have a personal or family history of alterations in heart rhythm (QT prolongation);
Croatian: - Ako imate osobnu ili obiteljsku anamnezu promjena srčanog ritma (produljenje QT intervala).
English: Palonosetron is a selective high-affinity receptor antagonist of the 5HT3 receptor.
Croatian: Palonosetron je selektivni antagonist visokog afiniteta za 5HT3 receptor.
English: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy
Croatian: Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italija
English: L/kg
Croatian: g/kg
English: While this study demonstrated that paediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults (see section 4.8).
Croatian: Iako je ovo ispitivanje pokazalo da je za sprječavanje mučnine i povraćanja izazvanih kemoterapijom pedijatrijskim bolesnicima potrebna veća doza palonosetrona nego odraslim bolesnicima, profil sigurnosti podudara se s profilom ustanovljenim u odraslih (vidjeti dio 4.8).
English: Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.
Croatian: Nuspojave su procijenjene u pedijatrijskih bolesnika koji su primali palonosetron do 4 kemoterapijska ciklusa.
English: Palonosetron was non-inferior versus the comparators in the acute phase of emesis both in moderately and highly emetogenic setting.
Croatian: Palonosetron nije bio inferioran u usporedbi s usporednim lijekovima u akutnoj fazi emeze u umjereno i visoko emetogenim okolnostima.
English: Although comparative efficacy of palonosetron in multiple cycles has not been demonstrated in controlled clinical studies, 875 patients enrolled in the three phase 3 trials continued in an open label safety study and were treated with palonosetron 750 micrograms for up to 9 additional cycles of chemotherapy.
Croatian: Iako se u kontroliranim kliničkim ispitivanjima nije pokazala usporedna djelotvornost palonosetrona u više ciklusa, 875 bolesnika uključena u tri ispitivanja faze 3 nastavila su sudjelovati u otvorenom ispitivanju sigurnosti i liječeni su palonosetronom 750 mikrograma do 9 dodatnih ciklusa kemoterapije.
English: Palonosetron is eliminated by dual route, about 40 % eliminated through the kidney and with approximately 50 % metabolised to form two primary metabolites, which have less than 1 % of the 5HT3 receptor antagonist activity of palonosetron.
Croatian: Palonosetron se izlučuje dvojnim putem; oko 40% uklanja se bubregom a približno 50% metaboliziranog lijeka tvori dva primarna metabolita, koji imaju manje od 1% djelovanja palonosetrona kao antagonista 5HT3 receptora.
English: The underlying mechanisms are not fully understood, but because of the high doses employed and since Palonosetron Hospira is intended for single application in humans, these findings are not considered relevant for clinical use.
Croatian: Osnovni mehanizmi nisu potpuno poznati, ali budući da se radi o visokim dozama lijeka Palonosetron Hospira je namijenjen za jednokratnu primjenu u ljudi, ti se nalazi ne smatraju značajnima za kliničku uporabu.
English: It is not known if Palonosetron Hospira is found in breast milk.
Croatian: Nije poznato može li se Palonosetron Hospira naći u majčinu mlijeku.
English: Given the pre-specified noninferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was [-10.5, 1.7%], therefore non-inferiority was not demonstrated.
Croatian: Uz prethodno određenu granicu neinferiornosti od -10%, prema Mantel-Haenszelovom statističkom intervalu pouzdanosti za neinferiornost prilagođenom za slojeve za razliku u primarnom ishodu, potpuni odgovor (CR), bio je [-10,5, 1,7%]; dakle, neinferiornost nije dokazana.
English: In clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron.
Croatian: U kliničkim ispitivanjima opažene su sljedeće nuspojave koje su možda ili vjerojatno bile povezane s primjenom palonosetrona.
English: The proportion of patients without emesis during 0-72 hours post-operatively was similar after palonosetron 1 μg/kg or 3 μg/kg (88% vs 84%).
Croatian: Udio bolesnika bez emeze u trajanju od 0-72 sata poslije operacije bio je sličan nakon primjene palonosetrona 1 µg/kg ili 3 µg/kg (88% naspram 84%).
English: High doses of palonosetron (each dose causing at least 30 times the human therapeutic exposure) applied daily for two years caused an increased rate of liver tumours, endocrine neoplasms (in thyroid, pituitary, pancreas, adrenal medulla) and skin tumours in rats but not in mice.
Croatian: Visoke doze palonosetrona (jedna doza najmanje 30 puta veća od doze primijenjene u terapijske svrhe u čovjeka) primijenjene svakodnevno tijekom dvije godine prouzročile su povećanu učestalost tumora jetre, neoplazme endokrinog sustava (u štitnjači, hipofizi, gušterači, nadbubrežnoj žlijezdi) i tumore kože u štakora ali ne u miševa.
English: Noninferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%.
Croatian: Kriteriji neinferiornosti bili su ispunjeni ako je donja granica intervala pouzdanosti od 97,5%, za razliku u stopama potpunog odgovora za intravenski palonosetron minus intravenski ondansetron, bila veća od -15%.
English: There are limited data on the use of palonosetron in the prevention of nausea and vomiting in children under 2 years of age.
Croatian: Postoje ograničeni podaci o primjeni palonosetrona za sprječavanje mučnine i povraćanja u djece mlađe od 2 godine.
English: A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy.
Croatian: Liječnik ili medicinska sestra će Vam ubrizgati Palonosetron Hospira otprilike 30 minuta prije početka kemoterapije.
English: Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for Palonosetron Hospira overdose.
Croatian: Ispitivanja dijalize nisu bila provedena, međutim, zbog velikog volumena distribucije, dijaliza se ne čini djelotvornim liječenjem za predoziranje lijekom Palonosetron Hospira.
English: Palonosetron Hospira is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
Croatian: Palonosetron Hospira se koristi za sprječavanje mučnine i povraćanja povezanih s kemoterapijom raka u odraslih bolesnika, adolescenata i djece starije od mjesec dana.
English: CYP2D6 inducers and inhibitors.
Croatian: Induktori i inhibitori CYP2D6
English: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, The Netherlands
Croatian: HOSPIRA Enterprises B.V., Randstad 22-11, 1316 BN Almere, Nizozemska
English: Efficacy after palonosetron 10 μg/kg compared to palonosetron 3 μg/kg was 54.1% and 37.1% respectively.
Croatian: Djelotvornost nakon palonosetrona 10 µg/kg u usporedbi s palonosetronom 3 µg/kg bila je 54,1% odnosno 37,1%.
English: It is not recommended to receive Palonosetron Hospira in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Croatian: Ne preporučuje se primjenjivati Palonosetron Hospira u dane nakon kemoterapije, osim ako primate sljedeći ciklus kemoterapije.
English: When the dose was increased from 10 μg/kg to 20 μg/kg a dose-proportional increase in mean AUC was observed.
Croatian: Kada je doza povećana s 10 µg/kg na 20 µg/kg opažen je porast srednje vrijednosti AUC-a proporcionalan dozi.
English: Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Croatian: Djelotvornost se temeljila na dokazivanju neinferiornosti intravenski primijenjenog palonosetrona u usporedbi s intravenskim ondansetronom.
English: Allergic reactions to Palonosetron Hospira.
Croatian: Alergijske reakcije na Palonosetron Hospira.
English: Fertility There are no data concerning the effect of palonosetron on fertility.
Croatian: Plodnost Nema podataka o učinku palonosetrona na plodnost.
English: The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group.
Croatian: Primarni ishod djelotvornosti, potpuni odgovor (CR: izostanak povraćanja, dizanja želuca i bez primjene antiemetičkog simptomatskog lijeka) tijekom prva 24 sata poslije operacije bilo je postignuto u 78,2% bolesnika u skupini koja je primala palonosetron i 82,7% u skupini koja je primala ondansetron.
English: Dolasetron 100 milligrams (n= 191)
Croatian: Dolasetron 100 miligrama (n = 191)
English: There is no experience of palonosetron in human pregnancy.
Croatian: Nema iskustva s palonosetronom u trudnoći u ljudi.
English: The objective was to evaluate the ECG effects of IV administered palonosetron at single doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects.
Croatian: Cilj je bio procijeniti učinke i.v. primijenjenog palonosetrona u jednostrukim dozama od 0,25, 0,75 ili 2,25 mg na EKG 221 zdravog ispitanika.