FrancophonIA/ELRC3.0 huggingface dataset:
English: However the CHMP also noted that although the findings may not pose a risk to patients, the sponge should not include any other unwanted components/contaminants and the MAH must undertake efforts to remove these and comply with the legal obligations.
Croatian: No, CHMP je također zaključio da iako nalazi možda ne predstavljaju rizik za bolesnike, spužva se ne smije uključiti u bilo koje druge neželjene komponente/kontaminante i nositelj odobrenja treba poduzeti napore da se isti uklone i da je suglasan s obvezama.
English: It was noted that alternative treatments are available, including the use of autogenous bone grafts, which are usually harvested from the iliac crest.
Croatian: Napomenuto je da su alternativne terapije dostupne, uključujući primjenu autogenih koštanih presadaka, koji se najčešće presađuju iz ilijačnog grebena.
English: - the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect;
Croatian: - posebnosti i dokumenti dostavljeni za potrebe članka 8. (3.) Direktive 2001/83/EZ netočni;
English: The CHMP noted that, following the inspection in April 2015, no batches of InductOs had been released in the EU as recommended by the inspectors.
Croatian: CHMP je napomenuo da, nakon inspekcije provedene u travnju 2015., nove serije lijeka InductOs nisu otpuštene u EU-u kao što su preporučili inspektori.
English: At that time, following a corrective action plan, restricted GMP certificate valid until January 2015 was issued.
Croatian: U isto vrijeme, nakon korektivnog plana djelovanja, izdan je ograničeni GMP certifikat valjan do siječnja 2015.
English: The CHMP also considers that no product is recommended to be recalled from the market, as the current product on the market was released under a valid GMP certificate in January 2015.
Croatian: CHMP je također zaključio da nema preporuke za povlačenjem proizvoda sa tržišta, budući da je aktualan proizvod na tržištu izdan u skladu s valjanim certifikatom GMP-a u siječnju 2015.
English: • Integra LifeSciences Corporation site is not in compliance with EU GMP for the manufacture of the absorbable collagen sponge (ACS), part of the medicinal product, InductOs;
Croatian: • lokacija tvrtke Integra LifeSciences Corporation nije u skladu s GMP-om EU-a za proizvodnju apsorbirajućih kolagenskih spužvi (ACS-a), dio lijeka, InductOs;
English: Given the findings, the CHMP considered that the quality of InductOs cannot be assured at present due to the lack of GMP compliance of the ACS issued on 23 July 2015.
Croatian: Uzimajući u obzir nalaze, CHMP je zaključio kako se kvaliteta lijeka InductOs ne može osigurati u sadašnjem trenutku zbog manjka sukladnosti s GMP-om ACS-a izdanog 23. srpnja 2015.
English: No further product was released after the GMP non-compliance certificate was issued and the latest information on stock indicates that InductOs will be available until end of December 2015.
Croatian: Daljnji lijekovi nisu izdani nakon što je izdana potvrda o nesukladnosti GMP-a, a najnovije informacije o zalihi ukazuju na to da će lijek InductOs biti dostupan do kraja prosinca 2015.
English: Standard of care in the EU consists of surgical intervention using reamed or unreamed intramedullary nailing with locking screws.
Croatian: Standardna skrb u EU-u sastoji se od kirurške intervencije uz primjenu ciljanog ili neciljanog intramedularnog sustava čavla s blokirajućim vijcima.
English: As a consequence, the CHMP recommends the suspension of the marketing authorisation for InductOs in accordance with Article 116, second paragraph of the said Directive.
Croatian: Posljedično, CHMP preporučuje suspenziju odobrenja za stavljanje u promet lijeka InductOs u skladu sa člankom 116., drugim paragrafom navedene Direktive.
English: InductOs is also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Croatian: InductOs je također indiciran za terapiju akutnih fraktura tibije u odraslih osoba, kao dodatak standardnoj skrbi primjenom smanjenja otvorene frakture i intramedularno fiksiranje čavla "koji nije naciljan".
English: USA), was inspected last in April 2015 by the Netherlands and Spain and found to be not compliant with the legal requirements and/or the principles and guidelines of GMP as provided for by Union law.
Croatian: Proizvođač ACS-a, Integra LifeSciences Corporation (ILS), nalazi se u trećoj državi (odnosno SAD-u), podvrgnut je inspekciji od strane Nizozemske i Španjolske u travnju 2015. te je utvrđeno da ne udovoljava zakonskim preduvjetima i/ili načelima i smjernicama GMP-a kako je navedeno zakonima Unije.
English: The CHMP, having considered all the data provided by the MAH, considers that there is no apparent identified safety concern nor seems to have risk to patients associated with the contamination of the ACS with particulate matter.
Croatian: Uzimajući u obzir sve podatke dostavljene od strane nositelj odobrenja, CHMP je zaključio da nema očitog identificiranog razloga za zabrinutost za sigurnu primjenu niti se čini da postoji rizik za bolesnike povezan s kontaminacijom ACS-a česticama ispod granice vidljivosti.
English: - The CHMP considers that at present the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect;
Croatian: - CHMP je zaključio da su u sadašnjem trenutku posebnosti i dokumenti dostavljeni za potrebe članka 8.(3.) Direktive 2001/83/EZ netočni:
English: For the suspension to be lifted, the marketing authorisation(s) holder(s) should have a valid GMP compliance statement for the manufacturer of the ACS, fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Croatian: Za potrebe ukidanja suspenzije, nositelji(i) odobrenja za stavljanje lijeka u promet trebaju imati valjanu izjavu o sukladnosti GMP-a za proizvođača ACS-a, ispunjavajući uvjete navedene u članku 46.
English: - The CHMP considers that the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge, part of the medicinal product precludes at present the confirmation of the benefit-risk of InductOs;
Croatian: - CHMP je zaključio kako je izostanak sukladnosti GMP-a proizvodnog mjesta za apsorbirajuću kolagensku spužvu, dio lijeka isključuje u ovom trenutku potvrdu omjera koristi i rizika za lijek InductOs;
English: The CHMP is therefore of the opinion that the marketing authorisation(s) for InductOs should be suspended in accordance with Article 116, second paragraph of the said Directive.
Croatian: CHMP je stoga mišljenja da odobrenje(a) za stavljanje lijeka u promet za lijek InductOs treba suspendirati u skladu sa člankom 116., drugim paragrafom navedene Direktive.
English: For the treatment of tibia fractures, fixation with a reamed nail instead of InductOs plus unreamed nail fixation is an alternative option.
Croatian: Za potrebe terapije fraktura tibije postoji alternativna opcija fiksiranja "ciljanim" čavlom umjesto primjene InductOs i fiksiranja čavlom "koji nije ciljan".
English: Annex I Scientific conclusions
Croatian: Dodatak I.
English: - the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge,
Croatian: - izostanak sukladnosti sa GMP-om proizvode lokacije za apsorbirajuću kolagensku spužvu isključuje potvrdu omjera koristi i rizika lijeka InductOs;
English: Medicinal product no longer authorised
Croatian: Lijeku je ukinuto odobrenje za stavljanje lijeka u promet
English: Strength Pharmaceutical Form
Croatian: Sastav (koncentracija)
English: This is because it is not known if there is a risk to your baby.
Croatian: Razlog je što nije poznato postoji li rizik za Vaše dijete.
English: • Drink the liquid straight away.
Croatian: • Odmah popijte tekućinu.
English: It may also help to reduce the size of the tumour.
Croatian: Također može pomoći smanjiti veličinu tumora.
English: Based on unconfirmed response
Croatian: Na temelju nepotvrđenog odgovora
English: Do not give this medicine to children or adolescents under the age of 18 years.
Croatian: Nemojte ovaj lijek davati djeci i adolescentima mlađima od 18 godina.
English: This is because some medicine may remain in your body, (see advice on contraception below).
Croatian: Razlog tome je što se dio lijeka može zadržati u Vašem tijelu (pogledajte savjete o kontracepciji niže).
English: • You can take this medicine with or without food.
Croatian: • Ovaj lijek možete uzimati s hranom ili bez nje.
English: Do not stop taking this medicine - talk to your doctor first.
Croatian: Nemojte prestati uzimati ovaj lijek - prvo razgovarajte sa svojim liječnikom.
English: Therefore, it is important that men also use effective contraception.
Croatian: Stoga je važno da i muškarci koriste učinkovitu kontracepciju.
English: TAGRISSO can be taken with or without food at the same time each day.
Croatian: TAGRISSO se može uzimati s ili bez hrane, u isto vrijeme svakog dana.
English: This is more likely in areas exposed to the sun.
Croatian: Vjerojatnije je da će se javiti na mjestima koja su izložena suncu.
English: The types of adverse events reported were similar regardless of age.
Croatian: Vrste prijavljenih nuspojava bile su slične bez obzira na dob.
English: These changes are small and not likely to be of clinical significance.
Croatian: Ove su promjene male i nije vjerojatno da su klinički značajne.
English: All patients received at least one prior line of therapy.
Croatian: Svi bolesnici primili su najmanje jednu prethodnu liniju liječenja.
English: If you forget a dose, take it as soon as you remember it.
Croatian: Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite.
English: Take your next normal dose at its scheduled time.
Croatian: Uzmite Vašu sljedeću uobičajenu dozu u za nju predviđeno vrijeme.
English: Interactions with transport proteins
Croatian: Interakcije s transportnim proteinima
English: However, with current available data, alternative metabolic pathways cannot be fully ruled out.
Croatian: Međutim, s obzirom na dosad dostupne podatke, ne mogu se u potpunosti isključiti alternativni metabolički putevi.
English: If you are able to become pregnant, you must use effective contraception.
Croatian: Ako možete zatrudnjeti, morate koristiti učinkovitu kontracepciju.
English: • Take TAGRISSO every day at the same time.
Croatian: • Uzmite TAGRISSO svakog dana u isto vrijeme.
English: No overall differences in efficacy were observed between these subjects and younger subjects.
Croatian: Nisu zamijećene sveukupne razlike u djelotvornosti između ovih i mlađih ispitanika.
English: Most cases can be treated but some cases have been fatal.
Croatian: U većini se slučajeva može liječiti, no u nekim je slučajevima imala smrtni ishod.
English: • To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.
Croatian: • Kako biste bili sigurni da ste uzeli sav lijek, temeljito isperite čašu s dodatnih 50 ml vode i to popijte.
English: Swallow the tablet whole with water.
Croatian: Progutajte tabletu cijelu s vodom.
English: The median duration of follow up for PFS was 12.6 months.
Croatian: Medijan trajanja praćenja za PFS bio je 12,6 mjeseci.
English: It is important to take this medicine every day, for as long as your doctor prescribes it for you.
Croatian: Važno je da uzimate ovaj lijek svaki dan, toliko dugo koliko Vam je to propisao Vaš liječnik.
English: Patients should be advised to use effective contraception for the following periods after completion of treatment with this medicinal product: at least 2 months for females and 4 months for males.
Croatian: Bolesnike treba savjetovati da koriste učinkovitu kontracepcije tijekom sljedećih razdoblja nakon dovršetka liječenja ovim lijekom: najmanje 2 mjeseca za žene i 4 mjeseca za muškarce.
English: The first analysis of OS was performed approximately 4 months after the primary analysis of PFS.
Croatian: Prva analiza OS-a provedena je približno 4 mjeseca nakon primarne analize PFS-a.
English: Do not take TAGRISSO if:
Croatian: Nemojte uzimati TAGRISSO ako:
English: Overall survival data were not mature at the time of this initial OS analysis.
Croatian: Podaci za ukupno preživljenje nisu bili zreli u trenutku provedbe ove početne analize OS-a.
English: Discuss with your doctor the most appropriate methods of contraception.
Croatian: Raspravite sa svojim liječnikom koje su najprikladnije metode kontracepcije.
English: • Stir thewater until the tablet breaks up into very small pieces -the tablet will not completely dissolve.
Croatian: • Promiješajte vodu dok se tableta ne raspadne u vrlo male dijelove - tableta se neće u potpunosti otopiti.
English: Your doctor will discuss appropriate treatment options with you.
Croatian: Vaš će liječnik s Vama raspraviti odgovarajuće mogućnosti liječenja.
English: One event (0.1%) led to discontinuation.
Croatian: Jedan je događaj (0,1%) doveo do prekida liječenja.
English: Pregnancy - information for women
Croatian: Trudnoća - informacije za žene
English: Yellow iron oxide (E 172) Red iron oxide (E 172) Black iron oxide (E 172)
Croatian: Žuti željezov oksid (E 172) Crveni željezov oksid (E 172) Crni željezov oksid (E 172)
English: See ‘Contraception - information for women and men' below.
Croatian: Pogledajte dio „Kontracepcija - informacije za žene i muškarce“ niže.
English: Tell your doctor if your skin or nail problems get worse.
Croatian: Recite svom liječniku ako se Vaši problemi s kožom ili noktima pogoršaju.
English: • you have ever had heart problems - your doctor may want to keep a close eye on you.
Croatian: • ako ste ikada imali probleme sa srcem - Vaš će Vas liječnik možda željeti pomnije pratiti
English: • TAGRISSO is taken by mouth.
Croatian: • TAGRISSO se uzima kroz usta.
English: Age and body weight
Croatian: Dob i tjelesna težina
English: Contraception - information for women and men You must use effective contraception during treatment.
Croatian: Kontracepcija - informacije za žene i muškarce Tijekom liječenja morate koristiti učinkovitu kontracepciju.
English: Your doctor will decide with you whether you should carry on taking TAGRISSO.
Croatian: Vaš će liječnik s Vama odlučiti trebate li nastaviti uzimati TAGRISSO.
English: Second PFS after start of first subsequent therapy (PFS2)
Croatian: Drugi PFS nakon uvođenja prve sljedeće terapije (PFS2)
English: • Do not use any pack that is damaged or shows signs of tampering.
Croatian: • Nemojte koristiti pakiranje koje je oštećeno ili pokazuje znakove neovlaštenog otvaranja.
English: (Findings based on test results presented as CTCAE grade shifts)
Croatian: (Nalazi temeljeni na rezultatima pretraga, prikazani kao promjene stupnja prema CTCAE)
English: This includes herbal medicines and medicines obtained without a prescription.
Croatian: To uključuje biljne lijekove i lijekove dobivene bez recepta.
English: Using moisturisers regularly on your skin and nails can help with this.
Croatian: Redovito korištenje hidratantne kreme na koži i noktima može pomoći.
English: Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016
Croatian: Datum posljednje obnove odobrenja: 12. prosinca 2016.
English: Most cases improved or resolved with interruption of treatment.
Croatian: U većini slučajeva, stanje se poboljšalo ili razriješilo uz privremeni prekid liječenja.
English: Number of patients with second progression
Croatian: Broj bolesnika s drugom progresijom bolesti
English: No other liquids should be added.
Croatian: Ne smiju se dodavati druge vrste tekućine.
English: TAGRISSO has not been studied in children or adolescents.
Croatian: TAGRISSO nije ispitan u djece i adolescenata.
English: A risk for decreased exposure of hormonal contraceptives cannot be excluded.
Croatian: Ne može se isključiti rizik od smanjene izloženosti hormonskim kontraceptivima.
English: Al/Al perforated unit dose blisters.
Croatian: Al/Al perforirani blisteri s jediničnim dozama.
English: Represents the incidence of laboratory findings, not of reported adverse events.
Croatian: Predstavlja incidenciju rezultata laboratorijskih pretraga, ne prijavljenih nuspojava.
English: Do not crush, split or chew the tablet.
Croatian: Nemojte drobiti, lomiti niti žvakati tabletu.
English: The dispersion and residues should be administered within 30 minutes of the addition of the tablets to water.
Croatian: Disperzija i preostali sadržaj trebaju se primijeniti unutar 30 minuta od dodavanja tablete u vodu.
English: • you have sudden difficulty in breathing together with a cough or fever.
Croatian: • iznenada imate poteškoće s disanjem, zajedno s kašljem ili vrućicom.
English: Most adverse reactions were Grade 1 or 2 in severity.
Croatian: Većina nuspojava bile su stupnja 1 ili 2 po težini.
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E 171) Macrogol 3350
Croatian: Ovojnica tablete Poli(vinilni alkohol) Titanijev dioksid (E 171) Makrogol 3350
English: • Oral hormonal contraceptive pill- used to prevent pregnancy.
Croatian: • Oralna hormonska kontracepcijska pilula - koristi se za sprečavanje trudnoće.
English: Further catalyzing enzymes have not been identified.
Croatian: Drugi katalitički enzimi nisu identificirani.
English: However, if it is less than 12 hours until your next dose is due, skip the missed dose.
Croatian: Međutim, ako je do Vaše sljedeće doze preostalo manje od 12 sati, preskočite propuštenu dozu.
English: The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka TAGRISSO u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Tell your doctor straight away while taking this medicine if:
Croatian: Odmah obavijestite svog liječnika tijekom uzimanja ovog lijeka ako:
English: • Digoxin - used for irregular heart beat or other heart problems.
Croatian: • Digoksin - koristi se za liječenje nepravilnih otkucaja srca ili drugih srčanih problema.
English: • TAGRISSO may pass into semen.
Croatian: • TAGRISSO može prijeći u sjeme.
English: Because of this defect, other protein kinase medicines may no longer work.
Croatian: Moguće je da zbog tog oštećenja drugi inhibitori protein kinaze više ne djeluju.
English: If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Croatian: Ako imate bilo kakvih pitanja o tome kako djeluje ovaj lijek ili zašto Vam je propisan, upitajte svog liječnika.
English: TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing.
Croatian: TAGRISSO djeluje tako da blokira EGFR i može pomoći usporiti ili zaustaviti rast raka pluća.
English: Patients with CLcr less than 15 mL/min were not included in the clinical trials.
Croatian: Bolesnici s CLcr manjim od 15 ml/min nisu bili uključeni u klinička ispitivanja.
English: • You should not become pregnant while taking this medicine.
Croatian: • Ne biste smjeli zatrudnjeti tijekom uzimanja ovog lijeka.
English: Tell your doctor straight away if you notice the serious side effects listed above.
Croatian: Odmah recite svom liječniku ako primijetite ozbiljne nuspojave navedene iznad.
English: • Modafinil -used for sleep disorders.
Croatian: • Modafinil - koristi se za poremećaje spavanja.
English: • Reduction in the number of white blood cells (leukocytes, lymphocytesor neutrophils).
Croatian: • Smanjenje broja bijelih krvnih stanica (leukocita, limfocita ili neutrofila).
English: 5 CTCAE grade 5 events (fatal) were reported.
Croatian: Prijavljeno je 5 događaja stupnja 5 (sa smrtnim ishodom) prema CTCAE.
English: • If necessary, your doctor may reduce your dose to one 40 mg tablet each day.
Croatian: • Ako je potrebno, Vaš liječnik može smanjiti Vašu dozu na jednu tabletu od 40 mg svaki dan.
English: Of 556 patients, 200 patients had available baseline brain scans.
Croatian: Od 556 bolesnika, 200 ih je na početku ispitivanja imalo nalaze oslikavanja mozga.
English: TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with osimertinib.
Croatian: TAGRISSO se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje osimertinibom.
English: The LC13 was initially administered once a week for the first 6 weeks, then every 3 weeks before and after progression.
Croatian: Upitnik LC13 najprije se ispunjavao jedanput tjedno tijekom prvih 6 tjedana, a zatim svaka 3 tjedna prije i nakon progresije.
English: Randomisation was stratified by ethnicity (Asian and non-Asian).
Croatian: Randomizacija je bila stratificirana prema etničkoj pripadnosti (Azijci i ostali).
English: • Rosuvastatin - used to lower cholesterol.
Croatian: • Rosuvastatin - koristi se za snižavanje kolesterola.
English: Compliance over the first 9 months was generally high (≥70%) and similar in both arms.
Croatian: Tijekom prvih 9 mjeseci razina pridržavanja liječenja u načelu je bila visoka (≥ 70%) i slična u obje skupine.
English: Other medicines and TAGRISSO
Croatian: Drugi lijekovi i TAGRISSO
English: Close monitoring is recommended in these patients (see section 4.8).
Croatian: Preporučuje se pažljivo praćenje tih bolesnika (vidjeti dio 4.8).
English: An additional half a glass of water should be added to ensure that no residue remains and then immediately swallowed.
Croatian: Potrebno je dodati dodatnih pola čaše vode kako bi se osiguralo da nema zaostalog sadržaja, te odmah progutati.
English: ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate
Croatian: EKG: Elektrokardiogram; QTc: QT interval korigiran prema srčanoj frekvenciji
English: These exposure changes due to body weight or baseline albumin differences are not considered clinically relevant.
Croatian: Ove promjene u izloženosti zbog razlika u tjelesnoj težini ili početnim vrijednostima albumina ne smatraju se klinički značajnima.
English: Before initiating treatment, patients should be advised of signs and symptoms of SJS.
Croatian: Prije početka liječenja bolesnike treba savjetovati o znakovima i simptomima SJS-a.
English: Tell your doctor before taking TAGRISSO if you are taking any of the following medicines:
Croatian: Recite svom liječniku prije nego uzmete TAGRISSO ako uzimate bilo koji od sljedećih lijekova:
English: • Reduction in the number of platelets in the blood.
Croatian: • Smanjenje broja trombocita u krvi.
English: If a dose of TAGRISSO is missed, the dose should be made up unless the next dose is due within 12 hours.
Croatian: Ako se propusti doza lijeka TAGRISSO, potrebno ju je nadoknaditi, osim ako je sljedeća doza predviđena za manje od 12 sati.
English: The main metabolic pathway of osimertinib was oxidation and dealkylation.
Croatian: Glavni metaboličku put osimertiniba bio je oksidacija i dealkilacija.
English: Patients were evaluated for LVEF at screening and every 12 weeks thereafter.
Croatian: Bolesnicima se ocjenjivao i LVEF, pri probiru i svakih 12 tjedana nakon toga.
English: Tell your doctor if your diarrhoea does not go away or becomes severe.
Croatian: Recite svom liječniku ako proljev ne prestaje ili postane jak.
English: Effects of osimertinib on P-gp and BCRP
Croatian: Učinci osimertiniba na P-gp i BCRP
English: What TAGRISSO is and what it is used for
Croatian: Što je TAGRISSO i za što se koristi
English: • you have a history of eye problems.
Croatian: • ako ste nekada imali problema s očima.
English: Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher.
Croatian: Stariji bolesnici (> 65 godina) ili bolesnici male tjelesne težine (< 50 kg) mogu biti izloženi povećanom riziku od razvoja štetnih događaja stupnja 3 ili višeg stupnja.
English: Intestinal inhibition of UGT1A1 is possible but the clinical impact is unknown.
Croatian: Moguća je inhibicija UGT1A1 u crijevu, ali klinički učinak je nepoznat.
English: If you do become pregnant during treatment, tell your doctor straight away.
Croatian: Ako postanete trudni tijekom liječenja, odmah recite svom liječniku.
English: Osimertinib is eliminated mainly via the liver.
Croatian: Osimertinib se pretežno eliminira putem jetre.