FrancophonIA/ELRC3.0 huggingface dataset:
English: The provided data did not consistently show that a lower dose would be effective or that a lower dose would significantly reduce the risk of impaired driving and somnambulism, and it was considered that reducing the daily recommended dose would likely result in in-effective doses being used, in turn resulting in additional doses being taken in the middle of the night and in an increased risk of accidents the following day.
Croatian: Dostavljeni podaci nisu pružili uvjerljiv dokaz da bi manje doze bile djelotvorne ili da manje doze značajno smanjuju rizik od smanjene sposobnosti upravljanja vozilom ili somnambulizma, a smatra se da bi smanjivanje dnevne preporučene doze vrlo vjerojatno rezultiralo primjenom nedjelotvorne doze, što bi zatim opet rezultiralo unosom dodatnih doza u sred noći i povećanim rizikom od nesreća narednog dana.
English: Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant.
Croatian: Uočene su razlike vezane uz informacije o interakcijama između dva lijeka u različitim informacijama o lijeku za lijekove koji sadrže zolpidem, posebice vezano uz interakciju zolpidema s depresorom središnjeg živčanog sustava.
English: With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness.
Croatian: Vezano uz djelovanje na sposobnost upravljanja vozilom i uporabom strojevima, PRAC je preporučio da se vozači i osobe koje upravljaju strojevima upozore da jutro nakon terapije uz mogući rizik od omamljenosti, produljenog vremena reakcije i oslabljene sposobnosti upravljanja vozilom, postoji mogućnost i vrtoglavice, pospanosti, zamućenog/dvostrukog vida i smanjenje pozornosti.
English: In light of the data provided in the cumulative review performed by the MAH, and taking into consideration the recent Food and Drug Administration (FDA) approved label changes specifying new dosing recommendations for zolpidem-containing medicinal products, AIFA considered that it was in the interest of the EU to refer the matter to the PRAC for a benefit-risk review of zolpidem-containing medicinal products.
Croatian: U svjetlu dostavljenih podataka u kumulativnom pregledu kojeg je obavio nositelj odobrenja i uzimajući u obzir posljednje odobrene izmjene etikete od strane Američke agencije za hranu i lijekove (FDA) koje navode nove preporuke za doziranje za lijekove koji sadrže zolpidem, AIFA je zaključila da je u interesu EU da se ovaj predmet uputi PRAC-u na pregled omjera koristi i rizika lijekova koji sadrže zolpidem.
English: Some studies showed an association between impaired driving performance on the next morning and middle of the night intake of zolpidem.
Croatian: Pojedina su ispitivanja pokazala da postoji veza između smanjene sposobnosti upravljanja vozilom naredno jutro i unosom zolpidema usred noći.
English: Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem.
Croatian: Nakon toga, PRAC je zatražio od nositelja odobrenja za stavljanje referentnog lijeka u promet za zolpidem da dostavi kumulativni pregled spontanih prijava, kliničkih ispitivanja i objavljene literature za „smanjenju sposobnost upravljanja vozilima”, „prometne nesreće” i „somnambulizam” povezane sa zolpidemom.
English: • The PRAC considered that the above-mentioned risks of impaired driving ability and somnambulism could be mitigated by changes to the product information of zolpidem-containing medicines, in particular that zolpidem should be taken as a single intake immediately at bedtime and not exceed the recommended dose, without being re-administered during the same night, as well as highlighting the risks regarding impaired driving and somnambulism, warnings and precautions aimed at decreasing this risk and also the risks of co-administration with CNS depressants and alcohol, and/ or illicit drugs;
Croatian: • je PRAC zaključio da se prethodno spomenuti rizici oslabljene sposobnosti upravljanja vozilom i somnambulizam mogu smanjiti promjenama u informacijama o proizvodu za lijekove koji sadrže zolpidem, posebice u slučaju da se zolpidem mora uzimati u jednoj dozi neposredno prije odlaska na počinak te da se preporučena doza ne smije premašiti, bez da se drugi lijek daje tijekom iste noći, kao da se i naglašavaju rizici u vezi s oslabljenom sposobnosti upravljanja vozilom i somnambulizmom, upozorenja i mjere opreza usmjerene na smanjivanje ovog rizika kao i rizici od istovremene primjene depresora središnjeg živčanog sustava i alkohola, i/ ili nelegalnih droga;
English: Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs.
Croatian: Uzimajući u obzir da djelovanje zolpidema može trajati najmanje 8 sati te u svijetlu prethodno navedenih faktora, PRAC je također preporučio da se uključe upozorenja koja indiciraju da se rizik od smanjene sposobnosti upravljanja vozilom povećava ako se zolpidem unosi u dozama koje su veće od preporučenih, i/ili daje zajedno s drugim depresorima središnjeg živčanog sustava, i/ili alkoholom ili nelegalnim drogama.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of zolpidem containing medicinal products for which the amendments to the product information are set out in annex III.
Croatian: Nakon što je razmotrio preporuku PRAC-a od dana 6. ožujka 2014. donesenu u skladu s člankom 107.k stavkom 1 Direktive 2001/83/EZ, CMDh je donio mišljenje o izmjenama odobrenja za stavljanje lijeka u promet za lijekove koji sadrže zolpidem, a za koje su dopune za informacije o proizvodu navedene u Dodatku III.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 with regards to zolpidem-containing medicinal products, agrees with the recommendation therein as stated below:
Croatian: Nakon razmatranja preporuke PRAC-a od 6. ožujka 2014. u vezi s lijekovima koji sadrže zolpidem, CMDh je suglasan s preporukom PRAC-a kako je navedeno niže u tekstu:
English: • The PRAC considered that the data from post-marketing spontaneous case reports, clinical trials, published literature and other available information have shown that the use of zolpidemcontaining products is associated with an increased risk of impaired driving and somnambulism;
Croatian: • je PRAC zaključio da su podaci spontanih prijava nakon stavljanja lijeka u promet, kliničkih ispitivanja, objavljene literature i druge dostupne informacije dokazali da je uporaba lijekova koji sadrže zolpidem povezana s povećanim rizikom od smanjene sposobnosti upravljanja vozilom i somnambulizmom;
English: Based on the totality of the data available on the safety and the efficacy of zolpidem, and considering all the risk minimisation measures proposed during assessment, the PRAC concluded that the benefitrisk balance of zolpidem-containing medicinal products remains favourable subject to changes to the product information.
Croatian: Na temelju ukupnosti svih podatak dostupnih o sigurnoj primjeni i djelotvornosti zolpidema, te uzimajući u obzir mjere za smanjivanje rizika koje su predložene tijekom ocjene, PRAC je zaključio da omjer koristi i rizika za lijekove koji sadrže zolpidem ostaje povoljan i predmetom je promjena u informacijama o proizvodu.
English: The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem.
Croatian: PRAC je pregledao podatke o sigurnoj primjeni i djelotvornosti u vezi s rizikom od smanjene sposobnosti upravljanja vozilom i somnambulizma nakon liječenja zolpidemom.
English: Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption.
Croatian: U navedene faktore rizika za smanjenu sposobnost upravljanja vozilom i somnambulizam ubrajaju se istovremeni unos drugih depresora središnjeg živčanog sustava, nedovoljna količina sna i konzumacija alkohola ili nelegalnih droga.
English: • The PRAC reviewed all available data provided by the MAHs on the safety and efficacy of zolpidemcontaining medicines with regards the risk of impaired driving ability and somnambulism following treatment with zolpidem;
Croatian: • je PRAC pregledao sve dostupne podatke koje su dostavili nositelji odobrenja o sigurnosti i djelotvornosti lijekova koji sadrže zolpidem u vezi s rizikom od smanjene sposobnosti upravljanja vozilom i somnambulizma nakon liječenja zolpidemom;
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing zolpidem identified in Annex I remains favourable, subject to the changes to the product information set out in Annex III.
Croatian: Slijedom navedenog PRAC je zaključio da omjer koristi i rizika za lijekove koji sadrže zolpidem identificirane u Dodatku
English: This will take about one hour.
Croatian: Primjena će trajati otprilike jedan sat.
English: Date of first authorisation: 20 November 2018
Croatian: Datum prvog odobrenja: 20. studenog 2018.
English: H2 antagonists
Croatian: H2 antagonisti
English: This leaflet was last revised in
Croatian: Ova je uputa zadnji puta revidirana u
English: EXP After reconstitution: use immediately.
Croatian: EXP Nakon rekonstitucije: odmah upotrijebiti.
English: Patients 65 years and older
Croatian: Bolesnici u dobi od 65 godina i stariji
English: Do not drive or use machines if you have these symptoms.
Croatian: Nemojte upravljati vozilima ili strojevima ako imate te simptome.
English: Thus, the distribution phase is essentially complete at 2 hours after the end of infusion.
Croatian: Stoga faza distribucije u osnovi završava dva sata nakon završetka infuzije.
English: Thus, only about 1% of the paclitaxel in the body is located in plasma during the elimination phase.
Croatian: Stoga se samo otprilike 1 % paklitaksela u tijelu nalazi u plazmi tijekom faze eliminacije.
English: Post-hoc subgroup analysis by relapse
Croatian: Post-hoc analiza podskupina prema relapsu
English: The use of gloves, goggles and protective clothing is recommended.
Croatian: Preporučuje se uporaba rukavica, zaštitnih naočala i zaštitne odjeće.
English: Tel +46 18 50 54 40 e-mail: med-info@oasmia.com
Croatian: +46 18 50 54 40 e-adresa: med-info@oasmia.com
English: Steps 3 to 6 should not be more than 30 minutes.
Croatian: Koraci od 3. do 6. ne smiju trajati dulje od 30 minuta.
English: • cognitive disorder (difficulty thinking or processing thoughts, difficulty remembering)
Croatian: • kognitivni poremećaj (teškoće pri razmišljanju ili procesiranju misli, teškoće s prisjećanjem)
English: Ask your doctor or nurse about hair loss and what can be done to avoid it.
Croatian: Potražite savjet liječnika ili medicinske sestre u vezi s gubitkom kose i o tome što se može učiniti da se to izbjegne.
English: • excessive water loss (dehydration)
Croatian: • prekomjeran gubitak vode (dehidracija)
English: Total plasma levels of paclitaxel were similar after infusion of the two formulations.
Croatian: Ukupne plazmatske razine paklitaksela bile su slične nakon infuzije tih dviju formulacija.
English: Take the desired number of vials from the refrigerator.
Croatian: Izvadite željeni broj bočica iz hladnjaka.
English: Dose-linearity could not be ascertained since a large inter-individual variability was observed.
Croatian: Linearnost doze nije se mogla utvrditi jer je uočena velika interindividualna varijabilnost.
English: Range (mmol/L)
Croatian: Raspon (mmol/l)
English: The dose is based on your body surface area (worked out from your height and weight) and blood test results.
Croatian: Doza se temelji na vašoj tjelesnoj površini (izračunato na temelju visine i tjelesne težine) i nalazima krvnih pretraga.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: • The other ingredients are:
Croatian: • Drugi su sastojci:
English: The following information is intended for healthcare professionals only: Administration precautions
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: Additional experience from clinical studies
Croatian: Dodatna iskustva iz kliničkih ispitivanja
English: Uncommonly these can lead to severe allergic shock.
Croatian: U rijetkim slučajevima te nuspojave mogu dovesti do teškog alergijskog šoka.
English: • allergic reactions to other medicines, such as penicillin
Croatian: • alergijske reakcije na druge lijekove, primjerice penicilin
English: Number of deaths, n (%)
Croatian: Broj umrlih, n (%)
English: What Apealea is and what it is used for
Croatian: Što je Apealea i za što se koristi
English: • epileptic fit lasting longer than five minutes or more than one fit within five minutes
Croatian: • epileptički napadaj koji traje dulje od pet minuta ili više od jednog napadaja unutar pet minuta
English: These reactions are more common on the first infusion and may be improved by slowing the rate of infusion.
Croatian: Te su reakcije češće pri primjeni prve infuzije i mogu se poboljšati usporavanjem brzine primjene infuzije.
English: Contents of the pack and other information What Apealea contains
Croatian: Sadržaj pakiranja i druge informacije Što Apealea sadrži
English: Probability of survival
Croatian: Vjerojatnost preživljenja
English: non-inferiority margin (1.2)
Croatian: margina neinferiornosti (1.2)
English: The average time to onset was 53 days from the first dose.
Croatian: Prosječno vrijeme do pojave navedenih oblika bilo je 53 dana nakon prve doze.
English: • symptoms of allergic reaction during the infusion, such as:
Croatian: • simptomi alergijskih reakcija tijekom infuzije, kao što su:
English: • blue tinged lips or skin
Croatian: • plave usne ili koža
English: There was no marked difference in overall tolerability between the 65-74 age group and younger patients.
Croatian: Nije postojala izražena razlika u općoj podnošljivosti između dobne skupine od 65 do 74 godine i mlađih bolesnika.
English: A similar effect can be anticipated for Apealea (paclitaxel micellar).
Croatian: Sličan učinak može se očekivati i za lijek Apealea (micelarni paklitaksel).
English: The principle measures of efficacy were progression-free survival (PFS) and overall survival (OS).
Croatian: Glavna mjerila djelotvornosti bila su preživljenje bez progresije bolesti (PFS) i ukupno preživljenje (OS).
English: non-inferiority margin (1.185)
Croatian: margina neinferiornosti (1,185)
English: Your doctor may wish to delay further treatment with Apealea or reduce the dose.
Croatian: Liječnik će možda htjeti odgoditi daljnje liječenje lijekom Apealea ili smanjiti dozu.
English: • multi-organ failure which can lead to death
Croatian: • zatajenje više organa koje može dovesti do smrti
English: This is equivalent to 80% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara količini od 80 % preporučenog maksimalnog dnevnog unosa natrija u prehrani za odraslu osobu.
English: • toxicity to the nervous system
Croatian: • toksičnost za živčani sustav
English: − low blood pressure
Croatian: − nizak krvni tlak
English: Repeat dose toxicity studies have shown non-reversible, toxic effects on male reproductive organs.
Croatian: Ispitivanja toksičnosti ponovljenih doza pokazala su nepovratne, toksične učinke na muške reproduktivne organe.
English: Further it has been shown that the rate of paclitaxel elimination increased with increasing body size.
Croatian: Nadalje, dokazano je da se brzina eliminacije paklitaksela povećava s povećanjem veličine tijela.
English: Additional subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the PP and the ITT population.
Croatian: Provedene su dodatne analize podskupina da bi se ispitala djelotvorost s obzirom na relaps (prvi i drugi) u PP i ITT populaciji.
English: In the event of an overdose, the patient should be closely monitored.
Croatian: U slučaju predoziranja potrebno je pomno nadzirati bolesnika.
English: Number at risk
Croatian: Broj bolesnica pod rizikom
English: Tell your doctor before treatment if you are pregnant, think you may be pregnant or are breast-feeding.
Croatian: Prije početka liječenja obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili dojite.
English: • painful severe swelling of deep skin layers, mainly in the face
Croatian: • bolno teško oticanje dubokih slojeva kože, uglavnom na licu
English: In both groups, the majority of the serious adverse events were haematological toxicities.
Croatian: Većina ozbiljnih štetnih događaja u objema skupinama bile su pojave hematološke toksičnosti.
English: Oasmia Pharmaceutical AB Uppsala, Sweden
Croatian: Oasmia Pharmaceutical AB Uppsala, Švedska
English: The recommended dose of carboplatin is AUC = 5-6 mg/mL×min.
Croatian: Preporučena doza karboplatina jest AUC = 5 - 6 mg/ml×min.
English: During the course of the pivotal study, 46% of the peripheral neuropathies as well as the majority (78%) of the associated reactions resolved.
Croatian: Tijekom provođenja ključnog ispitivanja povuklo se 46 % perifernih neuropatija, kao i većina (78 %) povezanih reakcija.
English: Apealea is supplied as a sterile powder for reconstitution before use.
Croatian: Apealea se isporučuje kao sterilni prašak za rekonstituciju prije uporabe.
English: Steps c and to f should not be more than 30 minutes.
Croatian: Koraci od c. do f. ne smiju trajati dulje od 30 minuta.
English: What Apealea looks like and contents of the pack
Croatian: Kako Apealea izgleda i sadržaj pakiranja
English: If the solution contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako otopina dođe u dodir s kožom, kožu je potrebno odmah temeljito oprati vodom i sapunom.
English: Hazard ratio (95% CI) a Primary population in non-inferiority analysis was predefined as the PP population
Croatian: Omjer hazarda (95 % CI) a Primarna populacija u analizi neinferiornosti bila je unaprijed određena kao PP populacija.
English: Gastrointestinal symptoms
Croatian: Gastrointestinalni simptomi
English: Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Croatian: Stabilizacija ima za posljedicu inhibiciju normalne dinamičke reorganizacije mreže mikrotubula koja je ključna za vitalnu interfazu i mitotske funkcije stanice.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se lijek ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: Patients were stratified based on relapse (first or second) and CA125 values.
Croatian: Bolesnice su stratificirane na temelju relapsa (prvi ili drugi) i vrijednosti CA 125.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD01 Mechanism of action
Croatian: Farmakoterapijska skupina: antineoplastici, taksani, ATK oznaka: L01CD01 Mehanizam djelovanja
English: Stop breast-feeding while being treated, as paclitaxel passes into breast milk and may harm the child.
Croatian: Prekinite dojenje za vrijeme liječenja jer paklitaksel prelazi u majčino mlijeko i može naškoditi djetetu.
English: This amounted to a 14% decline in an 86-year-old patient compared to one aged 56.
Croatian: To je imalo za posljedicu smanjenje od 14 % u bolesnika u dobi od 86 godina, u usporedbi s bolesnikom u dobi od 56 godina.
English: Contact your doctor immediately, if during treatment you develop:
Croatian: Odmah se obratite liječniku ako se tijekom liječenja pojave:
English: Since renal elimination is a minor pathway for paclitaxel, increased plasma levels are not expected in this patient group.
Croatian: Budući da bubrežna eliminacija predstavlja manji eliminacijski put paklitaksela, u ovoj skupini bolesnika ne očekuju se povećane plazmatske razine.
English: Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Croatian: Zbog manjih simptoma kao što su crvenilo ili reakcije kože nije potrebno prekidati terapiju.
English: However, paclitaxel is potentially carcinogenic based on its mechanism of action and demonstrated genotoxic activity.
Croatian: Međutim, paklitaksel može biti kancerogen zbog svog mehanizma djelovanja i dokazanog genotoksičnog djelovanja.
English: Patients who had pre-existing neuropathy of grade ≥ 2 or serious medical risk factors involving any of the major organ systems were not allowed to enter the study.
Croatian: Bolesnice s postojećom neuropatijom ≥ 2. stupnja ili ozbiljnim medicinskim čimbenicima rizika koji su obuhvaćali bilo koji od glavnih organskih sustava bile su isključene iz ispitivanja.
English: It can have a marked impact on the patients' self-image and quality of life and patients should be counselled about the likelihood of this adverse effect and on what measures might be available to mitigate it, for example the use of cold caps.
Croatian: Ona može značajno utjecati na sliku o sebi i kvalitetu života bolesnika te je stoga bolesnike potrebno savjetovati o vjerojatnosti te nuspojave i o mogućim mjerama kojima bi se mogla ublažiti, na primjer primjenom rashladne kape.
English: Angina pectoris, tachycardia
Croatian: angina pektoris, tahikardija
English: Other medicines and Apealea
Croatian: Drugi lijekovi i Apealea
English: Patients should be observed closely during treatment, particularly those patients who previously suffered hypersensitivity reactions with any taxane formulation.
Croatian: Tijekom liječenja potrebno je pomno nadzirati bolesnike, osobito bolesnike koji su već imali reakcije preosjetljivosti na bilo koju formulaciju s taksanom.
English: In the pivotal study, about a third of the patients received granulocyte colony stimulating factor (GCSF) to treat neutropenia and clinicians should consider whether individual cases could benefit from GCSF.
Croatian: U okviru ključnog ispitivanja otprilike jedna trećina bolesnika primila je faktor stimulacije kolonije granulocita (G-CSF) za liječenje neutropenije te bi liječnici trebali razmotriti mogu li pojedinačni slučajevi imati koristi od primjene G-CSF-a.
English: There is no known antidote for paclitaxel overdose.
Croatian: Nema poznatog antidota za predoziranje paklitakselom.
English: Patients should be advised not to drive or use machines if they feel tired or dizzy.
Croatian: Bolesnike je potrebno savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako osjete umor ili omaglicu.
English: Apealea is not recommended for children and adolescents under 18 years, because it has not been studied in this age group.
Croatian: Lijek Apealea ne preporučuje se za primjenu u djece i adolescenata mlađih od 18 godina jer nisu provedena ispitivanja za tu dobnu skupinu.
English: Proportions of patients who received premedication prior to infusion of paclitaxel or carboplatin or overall (safety population)
Croatian: Udio bolesnica koje su primile premedikaciju prije infuzije paklitaksela ili karboplatina ili ukupno (populacija za procjenu sigurnosti)