FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Croatian: U bolesnika koji primaju dugotrajnu terapiju androgenima također je potrebno redovito pratiti sljedeće laboratorijske parametre: hemoglobin i hematokrit, testove jetrene funkcije i lipidni profil.
English: Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Croatian: Liječnici moraju prilagoditi dozu pojedinom bolesniku kako bi se osiguralo održavanje eugonadalnih razina testosterona.
English: If you are suffering from severe heart, liver or kidney disease, treatment with <name of product> may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
Croatian: Ako bolujete od teške bolesti srca, jetre ili bubrega, liječenje lijekom <naziv gotovog lijeka> može uzrokovati teške komplikacije u obliku zadržavanja tekućine u tijelu što je ponekad praćeno (kongestivnim) zatajenjem srca.
English: In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Croatian: U bolesnika koji boluju od teške srčane, jetrene ili bubrežne insuficijencije ili ishemijske bolesti srca liječenje testosteronom može uzrokovati teške komplikacije koje su karakterizirane edemom s ili bez kongestivnog zatajenja srca.
English: Testosterone may cause a rise in blood pressure and <name of product> should be used with caution in men with hypertension.
Croatian: Testosteron može uzrokovati povišenje krvnog tlaka pa se <naziv gotovog lijeka> mora primjenjivati s oprezom u muškaraca s hipertenzijom.
English: Section 4.8 Undesirable effects
Croatian: Dio 4.8 Nuspojave
English: Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Croatian: Nadomjesno liječenje testosteronom kod hipogonadizma u muškaraca kada je manjak testosterona potvrđen kliničkom slikom i biokemijskim testovima.
English: Currently, there is no consensus about age specific testosterone reference values.
Croatian: Trenutno nema usuglašenog mišljenja o referentnim vrijednostima testosterona za određenu dob.
English: Frequency common: Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
Croatian: Učestalost česta: Povišenje broja crvenih krvnih stanica, vrijednosti hematokrita (postotak crvenih krvnih stanica u krvi) i hemoglobina (sastavni dio crvenih krvnih stanica koji prenosi kisik), koji se utvrđuje povremenim krvnim pretragama.
English: What <name of product> is and what it is used for <name of product> is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism).
Croatian: <Naziv gotovog lijeka> se primjenjuje u odraslih muškaraca kao nadomjestak testosterona kako bi se liječili različiti zdravstveni problemi uzrokovani manjkom testosterona (muški hipogonadizam).
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i upute o lijeku rezultat su arbitražnog postupka.
English: Haematocrit increased, Red blood cell count increased, Haemoglobin increased Frequency common.
Croatian: Povišen hematokrit, povišen broj crvenih krvnih stanica, povišen hemoglobin Učestalost česta.
English: Testosterone level should be monitored at baseline and at regular intervals during treatment.
Croatian: Razine testosterona moraju se odrediti prije početka i pratiti u redovitim vremenskim razmacima tijekom liječenja.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjena odgovarajućih dijelova sažetka opisa svojstava lijeka i upute o lijeku
English: Package Leaflet
Croatian: Dodatak III
English: A potential serious risk to public health was raised by the Netherlands.
Croatian: Nizozemska je istaknula potencijalan ozbiljan rizik za javno zdravlje.
English: The relevant authorities of the concerned marketing authorisations are: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
Croatian: Relevantna tijela za predmetna odobrenja za stavljanje lijeka u promet su: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
English: The reference authority for the worksharing procedure is Sweden.
Croatian: Referentno tijelo za postupak podjele rada je Švedska.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008;
Croatian: • Odbor je razmotrio arbitražni postupak prema članku 13. Uredbe (EZ) br. 1234/2008;
English: The worksharing procedure SE/H/xxxx/WS/190 started on 20 January 2018.
Croatian: Postupak podjele rada SE/H/xxxx/WS/190 započeo je 20. siječnja 2018.
English: 1 Mohamed 2004 n7 Mohamed MI. Optimisation of chlorphenesin emulgel formulation AAPS Journal 6 (2004) 3;81
Croatian: Optimisation of chlorphenesin emulgel formulation AAPS Journal 6 (2004) 3;81
English: As per the Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents (EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
Croatian: U skladu s Uputama za smjernice o kliničkim zahtjevima za lijekove s lokalnim djelovanjem koji se primjenjuju lokalno i sadrže poznate sastojke (EMA CPMP/EWP/239/95), za utvrđivanje terapijske ekvivalencije između dva lijeka u načelu su potrebni klinički podatci.
English: The Committee, as a consequence, recommends the refusal of the variation to the terms of the marketing authorisation application for the medicinal products referred to in Annex I of the CHMP opinion.
Croatian: Odbor slijedom toga preporučuje da se odbije zahtjev za izmjenu uvjeta odobrenja za stavljanje u promet za lijekove navedene u Prilogu I. mišljenju CHMP-a.
English: Furthermore, the CHMP considered that the submitted in-vitro studies had several methodological limitations including the absence of a positive control, the duration, and the high heterogeneity among the donors.
Croatian: Nadalje, CHMP je smatrao da dostavljena in vitro ispitivanja imaju nekoliko metodoloških ograničenja, uključujući izostanak pozitivne kontrole, trajanje te visoku heterogenost donora.
English: In the clinical studies performed in support of the Epiduo gel, approximately 2500 subjects above 9 years of age were exposed to Simulgel 600 PHA.
Croatian: U kliničkim ispitivanjima koja su provedena kao potpora za gel Epiduo, otprilike 2500 osoba starijih od devet godina bilo je izloženo sredstvu Simulgel 600 PHA.
English: The clinical relevance of the test results therefore could not be determined;
Croatian: Stoga se nije mogla utvrditi klinička relevantnost rezultata ispitivanja;
English: As documented in the scientific literature1 changes in the qualitative composition of semi-solid topical formulation can have an impact on drug release and efficacy of the topical products.
Croatian: Kao što je dokumentirano u znanstvenoj literaturi1, promjene u kvalitativnom sastavu polukrute topikalne formulacije mogu utjecati na oslobađanje lijeka i učinkovitost topikalnih lijekova.
English: Day 60 of the CMDh procedure was on 25 October 2018 and as no agreement amongst member states could be reached, Sweden notified the European Medicines Agency on 26 October 2018 of a referral under Article 13 of Regulation EC No 1234/2008.
Croatian: Šezdeseti dan postupka pri CMDh-u bio je 25. listopada 2018. i s obzirom na to da nije bilo moguće postići sporazum među državama članicama, Švedska je 26. listopada 2018. obavijestila Europsku agenciju za lijekove o arbitražnom postupku u skladu s člankom 13. Uredbe EZ br. 1234/2008.
English: In absence of clinical data, non-clinical validated models can be accepted.
Croatian: U nedostatku kliničkih podataka mogu se prihvatiti neklinički provjereni modeli.
English: The MAH conducted two in-vitro studies which showed that there were differences in the absorbed dose (35% lower absorbed dose) and less significant differences in the penetrated doses.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet proveo je dva in vitro ispitivanja koja su pokazala da postoje razlike u apsorbiranoj dozi (35 % niža apsorbirana doza) i manje značajne razlike u dozama koje su prodrle u tijelo.
English: However, since the tests have not been validated for the therapeutic situation, the clinical relevance of the test results is unclear.
Croatian: Međutim, s obzirom na to da ispitivanja nisu potvrđena u terapiji, klinička relevantnost rezultata ispitivanja nije jasna.
English: The clinical significance of the observed differences cannot be determined, since the criteria for the selected non-inferiority margins have not been adequately justified, and therefore these results cannot support the efficacy and safety of the new formulation.
Croatian: Klinički značaj uočenih razlika nije moguće utvrditi jer kriteriji za odabrane granice neinferiornosti nisu obrazloženi na odgovarajući način te stoga navedeni rezultati ne mogu potkrijepiti učinkovitost i sigurnost nove formulacije.
English: However, in support of this application neither clinical data nor validated non-clinical data have been submitted.
Croatian: Međutim, u prilog ovom zahtjevu nisu dostavljeni ni klinički podatci ni provjereni neklinički podatci.
English: The reformulation was focused on the gelling agent to improve physical stability in order to extend the shelf-life of the products in Zone IV countries where viscosity value tends to decrease due to higher temperature.
Croatian: Promjena formulacije odnosila se na sredstvo za želiranje kako bi se poboljšala fizička stabilnost i time produljio rok trajanja lijeka u zemljama zone IV. u kojima vrijednost viskoznosti ima tendenciju smanjenja zbog više temperature.
English: Safety data of the new gelling agent Simulgel 600 PHA has been evaluated in 2008 for Epiduo 0.1%, which contains adapalene 0.1% and benzoyl peroxide 2.5%, in a vehicle containing Simulgel 600 PHA.
Croatian: Podatci o sigurnosti novoga sredstva za želiranje Simulgel 600 PHA procijenjeni su 2008. za gel Epiduo 0,1 %, koji sadrži 0,1 % adapalena i 2,5 % benzoil peroksida u nosaču koji sadrži Simulgel 600 PHA.
English: Moreover the Committee noted that the in-vitro tests used were not validated for the therapeutic situation and that they had several methodological limitations.
Croatian: Nadalje, Odbor je uočio da navedena in vitro ispitivanja nisu potvrđena u terapiji te da imaju nekoliko metodoloških ograničenja.
English: This variation relates to a change of formulation for Basiron in order to replace the gelling agent Carbomer 940 with Simulgel 600 PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Croatian: Ova izmjena odnosi se na promjenu formulacije za gel Basiron kako bi se sredstvo za želiranje Carbomer 940 zamijenilo sredstvom Simulgel 600 PHA (akrilamid - natrijev akrilodimetiltaurat kopolimer, izoheksadekan, polisorbat 80, sorbitan oleat i voda).
English: The change in composition due to the replacement of the gelling agent cannot be considered minor per se, and the available data from in-vitro tests are not considered suitable to fully elucidate the clinical impact of this reformulation.
Croatian: Promjena sastava zbog zamjene sredstva za želiranje ne može se sama po sebi smatrati malom, a dostupni podatci iz in vitro ispitivanja ne smatraju se prikladnima da bi u potpunosti razjasnili klinički učinak ove promjene formulacije.
English: On 1 December 2017, a Quality type II variation application was submitted by Galderma Nordic AB in line with Article 10(1) of Commission Regulation (EC) No 1234/2008 under the worksharing procedure in accordance with Article 20 of Commission Regulation (EC) No 1234/2008 (SE/H/xxxx/WS/190) for the marketing authorisations for Basiron AC 5% w/w gel and 10% w/w gel to change the formulation by replacing the gelling agent excipient Carbomer 940 with Simulgel 600 PHA (acrylamide sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Croatian: Dana 1. prosinca 2017. tvrtka Galderma Nordic AB podnijela je zahtjev za kvalitativnom izmjenom tipa II u skladu s člankom 10. stavkom 1. Uredbe Komisije (EZ) br. 1234/2008 u okviru postupka podjele rada u skladu s člankom 20. Uredbe Komisije (EZ) 1234/2008 (SE/H/xxxx/WS/190) za odobrenja za stavljanje u promet gelova Basiron AC s 5 % masenog udjela i Basiron AC s 10 % masenog udjela radi promjene formulacije na način da se sredstvo za želiranje, pomoćna tvar Carbomer 940 zamijeni sredstvom za želiranje Simulgel 600 PHA (akrilamid - natrijev akrilodimetiltaurat kopolimer, izoheksadekan, polisorbat 80, sorbitan oleat i voda).
English: The CHMP concluded that the submitted data are not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Croatian: CHMP je zaključio da dostavljeni podatci nisu dostatni kako bi se dokazala terapijska ekvivalencija nove formulacije i formulacije koja je trenutačno dostupna na tržištu.
English: Taking into consideration the qualitative and quantitative differences between Epiduo gel and the re-formulated Basiron, it cannot be concluded based on the data provided that the data from Epiduo gel can be extrapolated to the new formulation of Basiron AC
Croatian: Uzimajući u obzir kvalitativne i kvantitativne razlike između gela Epiduo i gela Basiron promijenjene formulacije, na temelju dostavljenih podataka ne može se zaključiti da se podatci u vezi s gelom Epiduo mogu ekstrapolirati na novu formulaciju gela Basiron AC.
English: The CHMP noted that according to the ICH Quality Guidelines, none of the Member States of the EU is considered a Zone IV region.
Croatian: Razlog za promjenu formulacije bio je produljenje roka trajanja lijeka u zemljama zone IV. CHMP je napomenuo da se prema smjernicama ICH-a o kvaliteti nijedna država članica EU-a ne smatra područjem u zoni IV.
English: • The Committee considered the supportive clinical data of another medicinal product containing benzoyl peroxide 2.5% in combination with adapalene 0.1%, in a vehicle containing Simulgel 600 PHA, and concluded that data of the reformulated Basiron AC gels 5% w/w and 10% w/w could not be extrapolated from the dossier of another product in view of qualitative and quantitative differences between Basiron AC gels 5% w/w and 10% w/w and the other medicinal product;
Croatian: • Odbor je razmotrio potporne kliničke podatke za drugi lijek koji sadrži 2,5 % benzoil peroksida u kombinaciji s 0,1 % adapalena u nosaču koji sadrži Simulgel 600 PHA te je zaključio da se podatci za gelove promijenjene formulacije Basiron AC s 5 % masenog udjela i Basiron AC s 10 % masenog udjela ne mogu ekstrapolirati iz dokumentacije o drugom lijeku s obzirom na kvalitativne i kvantitativne razlike između gelova Basiron AC s 5 % masenog udjela i Basiron AC s 10 % masenog udjela i drugoga lijeka;
English: There may be differences in absorption and stability of the active substance between the Epiduo and the new Basiron formulation, which cannot be determined in the absence of relevant data for Basiron.
Croatian: Moguće su razlike u apsorpciji i stabilnosti djelatne tvari između gela Epiduo i nove formulacije gela Basiron koje se ne mogu utvrditi bez relevantnih podataka za gel Basiron.
English: • The Committee noted that the in-vitro tests indicated differences between the marketed formulation and the new proposed formulation containing the new gelling agent Simulgel 600 PHA.
Croatian: • Odbor je uočio da in vitro ispitivanja upućuju na razlike između formulacije na tržištu i nove predložene formulacije koja sadrži novo sredstvo za želiranje Simulgel 600 PHA.
English: The procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by Sweden on 21 August 2018.
Croatian: Švedska je 21. kolovoza 2018. uputila postupak Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), u skladu s člankom 13. stavkom 1. Uredbe EZ br. 1234/2008.
English: • The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
Croatian: • Odbor je pregledao dostupne podatke dostavljene u prilog novoj formulaciji gela Basiron koja sadrži novu pomoćnu tvar, sredstvo za želiranje Simulgel 600 PHA;
English: • The Committee considered the totality of the data submitted by the MAH in support of the type II quality variation for Basiron AC gels 5% w/w and 10% w/w;
Croatian: • Odbor je razmotrio cjelokupne podatke koje je nositelj odobrenja za stavljanje lijeka u promet dostavio u prilog kvalitativnoj izmjeni tipa II za gelove Basiron AC s 5 % masenog udjela i Basiron AC s 10 % masenog udjela;
English: Therefore, the safety and the efficacy of the re-formulated product cannot be
Croatian: Stoga se sigurnost i djelotvornost lijeka promijenjene formulacije ne mogu smatratiutvrđenima.
English: • The Committee noted the absence of clinical data generated with the reformulated product containing the gelling agent excipient Simulgel 600 PHA for Basiron and associated names;
Croatian: • Odbor je uočio izostanak kliničkih podataka za lijek promijenjene formulacije koji sadrži pomoćnu tvar sredstvo za želiranje Simulgel 600 PHA za gel Basiron i pridružena imena;
English: Therefore the benefit/risk balance of the reformulated medicinal product isconsidered unfavourable.
Croatian: Stoga se smatra da je omjer koristi i rizika lijeka promijenjene formulacije nepovoljan.
English: considered established.
Croatian: tržištu.
English: Therefore, the safety and the efficacy of the reformulated product cannot be considered established.
Croatian: Stoga se sigurnost i djelotvornost lijeka promijenjene formulacije ne mogu smatrati utvrđenima.
English: • Having assessed the totality of the data, the Committee was of the view that the available data were not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Croatian: Odbor je smatrao da dostupni podatci nisu dostatni kako bi se dokazala terapijska ekvivalencija nove formulacije i formulacije koja je trenutačno dostupna na
English: The main measure of effectiveness was how long the patients lived.
Croatian: Glavna mjera djelotvornosti bila je koliko su dugo bolesnici preživjeli.
English: These enzymes promote the development and progression of cancer.
Croatian: Ti enzimi promiču razvoj i progresiju raka.
English: Dacogen decitabine
Croatian: Dacogen decitabin
English: The dose is calculated using the patient's height and weight.
Croatian: Doza se izračunava na temelju bolesnikove tjelesne težine i visine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Dacogen vrijedi na prostoru Europske unije od 20. rujna 2012.
English: In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Croatian: Ciklus liječenja traje četiri tjedna, pri čemu se Dacogen primjenjuje svaki dan tijekom prvih pet dana.
English: At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Croatian: Preporučuje se provesti najmanje četiri ciklusa liječenja, koje je moguće nastaviti sve dok je AML pod kontrolom.
English: What measures are being taken to ensure the safe and effective use of Dacogen?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Dacogen?
English: Other information about Dacogen
Croatian: Ostale informacije o lijeku Dacogen
English: If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Croatian: Ako bolesnik razvije određene ozbiljne nuspojave, liječnik može donijeti odluku o odgodi ili prestanku liječenja Dacogenom.
English: Dacogen is given as an infusion into a vein over one hour.
Croatian: Dacogen se infuzijom ubrizgava u venu u trajanju od jednog sata.
English: Treatment was given for as long as patients benefited from it.
Croatian: Liječenje je trajalo sve dok je bolesnik imao koristi od liječenja.
English: It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Croatian: Namijenjen je bolesnicima koji nisu kandidati za standardnu indukcijsku kemoterapiju (početno liječenje lijekovima za liječenje raka).
English: Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Croatian: Bolesnici koji su primali Dacogen živjeli su u prosjeku 7,7 mjeseci, za razliku od 5,0 mjeseci koliko su u prosjeku živjeli bolesnici koji su primali potpornu skrb ili liječenje citarabinom.
English: The full EPAR for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Dacogen nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Dacogen.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Dacogen.
English: Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Croatian: Liječenje Dacogenom treba započeti pod nadzorom liječnika koji ima iskustva u primjeni kemoterapije.
English: For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Dacogen pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Dacogen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have 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 Dacogen nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Dacogen dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Croatian: Dacogen je uspoređivan s potpornom skrbi (bilo kojim lijekom ili metodom kojima se pomaže bolesnicima, osim lijekova za liječenje raka ili operativnog zahvata) ili niskom dozom citarabina (drugog lijeka za liječenje raka).