FrancophonIA/ELRC3.0 huggingface dataset:
English: • a meta-analysis of four clinical studies that were submitted as part of the application for marketing authorisation of ellaOne6, which suggests a possible trend for a reduced contraceptive efficacy with high bodyweight or BMI, although confidence limits overlap (pregnancy rate was 1.23% [CI: 0.78
Croatian: • meta analizu četiriju kliničkih ispitivanja koja su dostavljena kao dio zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka ellaOne6, a koja ukazuje na mogući trend smanjenja kontracepcijske djelotvornosti u slučaju povišene tjelesne težine ili ITM-a, iako se ograničenja pouzdanosti preklapaju (stopa trudnoće iznosila je 1,23% [CI: 0,78-1,84] u žena s ITM-om 18,525; 1,29% [CI: 0,59-2,43] u žena s ITM-om 25-30; i 2,57% [CI: 1,34-4,45] u žena s ITM-om
English: 90 (3 x 30 x 1) capsules (unit dose) (multipack)
Croatian: 90 (3x30x1) kapsula(jedinična doza)(višestruko pakiranje)
English: 30 x 1 capsules (unit dose)
Croatian: 30x1 kapsula (jedinična doza)
English: Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Jačina Farmaceutski oblik Put primjene Unutarnje pakiranje
English: 20 October 2015 EMA/499012/2015
Croatian: EMA/499012/2015
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da, iako postoji nedovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna i postoje dokazi o njihovoj sigurnoj primjeni na opisani način najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: While the skin preparations can be used by people of all ages, the medicines to be taken by mouth are not recommended in children and adolescent (under 18 years of age).
Croatian: Dok se pripravci za kožu mogu koristiti u osoba svih dobi, uzimanje lijekova kroz usta ne preporuča se u djece i adolescenata (mlađih od 18 godina).
English: After cooling, the essential oil separates from the water and can be collected.
Croatian: Nakon hlađenja, eterično se ulje odvaja od vode i može se sakupiti.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U trenutku ocjene HMPC-a nisu prijavljene nikakve nuspojave prilikom primjene tih lijekova.
English: Caraway oil medicines must not be used in people who are hypersensitive (allergic) to caraway oil or other plants of the same Apiaceae (Umbelliferae) family (e.g. fennel, anise, celery, coriander and dill).
Croatian: Lijekovi koji sadrže kimovo eterično ulje ne smiju se koristiti u osoba koje su preosjetljive (alergične) na kimovo eterično ulje ili druge biljke iste porodice Apiaceae (Umbelliferae) (primjerice komorač, anis, celer, korijander i kopar).
English: For further information, see the HMPC assessment report.
Croatian: Za podrobnije informacije pogledajte izvješće HMPC-a o ocjeni lijeka.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20. listopada 2015. EMA/499012/2015
English: If symptoms last for more than 2 weeks during the use of caraway oil medicines, the patient should consult a doctor or qualified healthcare practitioner.
Croatian: Ako simptomi traju dulje od 2 tjedna tijekom primjene lijekova koji sadrže kimovo eterično ulje, bolesnici se trebaju savjetovati s liječnikom ili kvalificiranim zdravstvenim djelatnikom.
English: The HMPC noted the insufficient clinical data on the effects of caraway oil in patients, but took into account the well documented use of this herbal medicine for the above-mentioned use.
Croatian: HMPC je zaključio da su klinički podaci o djelovanju kimovog eteričnog ulja u bolesnika nedostatni, no uzeo je u obzir dobro dokumentiranu uporabu ovoga biljnoga lijeka za prethodno navedenu primjenu.
English: Information on the use and licensing of caraway oil medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju lijekova koji sadrže kimovo eterično ulje u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: Any applications for the licensing of medicines containing caraway oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže kimovo eterično ulje moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the HMPC assessment of caraway oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže kimovo eterično ulje, uključujući pojedinosti zaključaka Povjerenstva, nalaze se u dokumentu u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This summary is not intended to provide practical advice on how to use medicines containing caraway oil.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže kimovo eterično ulje.
English: Further information on the risks associated with caraway oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže kimovo eterično ulje, uključujući odgovarajuće mjere opreza za sigurnu uporabu, nalazi se u monografiji u rubrici „All documents” na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway oil.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže kimovo eterično ulje.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of caraway oil.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe kimovog eteričnog ulja.
English: The HMPC conclusions on the use of caraway oil medicines in the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže kimovo eterično ulje u ublažavanju probavnih problema poput nadutosti i vjetrova temelje se na "tradicionalnoj primjeni".
English: Herbal medicines containing caraway oil preparations are usually available in liquid forms to be taken by mouth and in semi-solid forms (such as ointments) to be applied to the skin.
Croatian: Biljni lijekovi koji sadrže pripravke kimovog eteričnog ulja najčešće su dostupni u tekućim oblicima za uzimanje kroz usta te u polukrutim oblicima (poput masti) koji se primjenjuju na kožu.
English: The HMPC concluded that, on the basis of its long-standing use, caraway oil medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Croatian: HMPC je zaključio da se, na temelju dugotrajne primjene, lijekovi koji sadrže kimovo eterično ulje mogu koristiti za ublažavanje problema probavnog sustava poput nadutosti i vjetrova.
English: What is caraway oil?
Croatian: Što je kimovo eterično ulje?
English: Other information about caraway oil medicines
Croatian: Ostale informacije o lijekovima koji sadrže kimovo eterično ulje
English: Detailed instructions on how to take caraway oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu primjene lijekova koji sadrže kimovo eterično ulje kao i o tome tko ih može koristiti navedene su u uputi o lijeku priloženoj uz lijek.
English: What are the risks associated with caraway oil medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže kimovo eterično ulje?
English: Caraway oil is obtained by a current of steam through the dried fruit.
Croatian: Kimovo eterično ulje dobiva se protokom pare kroz suhi plod.
English: For more information about treatment with caraway oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže kimovo eterično ulje pročitajte u uputi o lijeku priloženoj uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: What evidence supports the use of caraway oil medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže kimovo eterično ulje?
English: For practical information about using caraway oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže kimovo eterično ulje bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svojem liječniku ili ljekarniku.
English: How are caraway oil medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže kimovo eterično ulje?
English: Caraway oil is the common name for the essential oil obtained from the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the oil for medicinal use.
Croatian: Kimovo eterično ulje je uobičajeni naziv za eterično ulje dobiveno iz ploda biljke Carum carvi L.
English: However this may not be realistic in all situations.
Croatian: Međutim, to nije realno u svim slučajevima.
English: Contraception, in press.
Croatian: Contraception, u tisku.
English: The Concerned Member States (CMS) were: Austria, Belgium, Czech Republic, Germany, Greece, Spain, France, Ireland, Iceland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal and Sweden.
Croatian: Predmetne države članice (PDČ) bile su: Austrija, Belgija, Češka Republika, Njemačka, Grčka, Španjolska, Francuska, Irska, Island, Italija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugal i Švedska.
English: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 pages
Croatian: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 stranice
English: The type II variation started on 17 September 2014.
Croatian: Izmjena tipa II započela je 17. rujna 2014. godine.
English: The CMDh 60 day procedure was initiated on 3 August 2015.
Croatian: CMDh-ov 60-dnevni postupak započeo je 3. kolovoza 2015.
English: As no agreement could be reached, the procedure was referred to the CHMP.
Croatian: Budući da nije postignut dogovor, postupak je upućen CHMP-u.
English: A relevant summary of the conclusions is presented below.
Croatian: U nastavku je predstavljen odgovarajući sažetak zaključaka.
English: Specialist clinics are not necessarily aware of the importance of the interactions and women rely on specialist clinical advice.
Croatian: Specijalističke klinike nisu nužno svjesne važnosti međudjelovanja, a žene se oslanjaju na savjet specijalističkih klinika.
English: There is a need to educate healthcare professionals and patients about the interaction concerns and the related recommendations.
Croatian: Postoji potreba za edukacijom zdravstvenih djelatnika i bolesnika o zabrinutostima u vezi s interakcijom i povezanim preporukama.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Croatian: • je Odbor razmotrio upućivanje u skladu s člankom 13. stavkom 2. Uredbe br. 1234/2008.
English: The reasons for the under-reporting are not known but may be due to an expectation of lower efficacy compared to other contraceptives.
Croatian: Nisu poznati razlozi nepotpunog izvješćivanja, no moguće je zbog očekivanja slabije učinkovitosti u usporedbi s drugim kontraceptivima.
English: All Member States (MSs) supported the existence of a clinically relevant interaction however a few remained unsure about the advice on how to manage the interaction.
Croatian: Sve države članice poduprle su postojanje klinički važne interakcije, međutim neke su ostale nejasne u vezi sa savjetom o tome kako upravljati interakcijom.
English: (iii) Management options - Dose increase / alternative treatment
Croatian: - Povećanje doze / alternativno liječenje
English: The scope of this procedure is limited to Levonelle and associated names which are authorised in the European Union (EU) as emergency hormonal contraceptives (EHC).
Croatian: Opseg ovog postupka ograničen je na Levonelle i srodne lijekove koji su na području Europske unije (EU) stavljeni u promet kao hitni hormonski kontraceptivi (EHC).
English: Moreover, to access this, a woman needs first to be aware of the risks associated with medicines interacting with LNG.
Croatian: Štoviše, u pogledu pristupačnosti, žena prvo mora biti svjesna rizika povezanih s lijekovima koji uzajamno djeluju s LNG-om.
English: For that reason the CHMP has discussed the key elements for communication to healthcare professionals and patients to facilitate the communication at national level.
Croatian: Iz tog je razloga CHMP raspravljao o ključnim elementima za komunikaciju zdravstvenom osoblju i bolesnicima kako bi se olakšala komunikacija na nacionalnoj razini
English: Secondly, AUC, the main measure of exposure, has generally been found2 to be dose-proportional.
Croatian: Kao drugo, vrijednosti AUC-a, glavnog mjerila izloženosti, uglavnom su se pokazale2 proporcionalne dozi.
English: Day 60 of the CMDh procedure was on 1 October 2015, when a final position was reached by most MSs except Italy (IT).
Croatian: Šezdeseti dan postupka CMDh-a bio je 1. listopada 2015., a tada je većina država članica, osim Italije (IT), donijela konačan stav.
English: Thus the CHMP concluded that there is a need for timely and clear advice for clinically relevant interactions.
Croatian: Stoga je CHMP zaključio da postoji potreba za pravovremenim i jasnim savjetom za interakcije od kliničke važnosti.
English: This is recognised in clinical guidance and in the product information of hormonal contraceptives which advise use of additional or alternative contraception.
Croatian: To je prepoznato u kliničkim smjernicama i informacijama o lijeku hormonskih kontraceptiva u kojima se preporučuje dodatna ili alternativna kontracepcija.
English: On 17 September 2014, Gedeon Richter Plc submitted an application for Levonelle and associated names through a mutual recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) with the United Kingdom acting as a Reference Member State (RMS).
Croatian: Tvrtka Gedeon Richter Plc 17. rujna 2014. godine dostavila je prijavu za lijek Levonelle i srodne lijekove putem postupka međusobnog priznavanja (MRP) izmjene tipa II (UK/H/0803/001/II/022) s Ujedinjenom Kraljevinom kao referentnom državom članicom (RDČ).
English: Levonelle 1500mcg and associated names consists of a single tablet.
Croatian: Levonelle 1500 μg i srodni lijekovi sastoje se od jedne tablete.
English: The currently licensed dose of 1500mcg was not included in either of the contraceptive efficacy studies, so direct comparison of efficacy is not possible.
Croatian: Trenutačna licencirana doza od 1500 μg nije bila uključena ni u jedno ispitivanje učinkovitosti kontraceptiva, stoga izravna usporedba učinkovitosti nije moguća.
English: Exposure to 400mcg LNG represented the largest group, with 2801 patients studied, 71% for >6 months and 48% for > 12 months.
Croatian: Najveću skupinu predstavljala je izloženost 400 μg LNG-a s 2801 promatranom ispitanicom, 71 % za > 6 mjeseci i 48 % za > 12 mjeseci.
English: (ii) Clinical significance of reduced plasma LNG levels
Croatian: (ii) Klinička važnost smanjenja razina LNG-a u plazmi
English: Reduction in plasma levels with efavirenz and other enzyme inducers
Croatian: (i) Smanjenje razina u plazmi uz efavirenz i ostale induktore enzima
English: Although this study was not in association with enzyme inducers, it suggests that linearity of Cmax is maintained up to 3mg LNG.
Croatian: Iako to ispitivanje nije bilo u vezi s induktorima enzima, ukazuje na to da se linearnost Cmax održava do 3 mg LNG-a.
English: The CHMP considered the possibility that a double dose may not be adequate to fully compensate the effects of strong enzyme inducers.
Croatian: CHMP je razmotrio mogućnost da dvostruka doza možda neće biti dovoljna da u potpunosti nadoknadi učinke jakih induktora enzima.
English: Finally the decision on whether a Cu-IUD is appropriate or not for a woman should be a clinical decision that considers her individual circumstances.
Croatian: Konačno, odluka o tome je li za ženu prikladan intrauterini uložak na bazi bakra (Cu-IUD) treba biti klinička odluka koja razmatra njezinu individualnu situaciju.
English: Taken together, this suggests that the magnitude of the efavirenz effect has been reliably estimated1.
Croatian: Uzimajući zajedno navedene elemente ukazuje se na to da je razmjer učinka efavirenza pouzdano procijenjen1.
English: In order to assess the effectiveness and readability of this advice in the product information, a consultation was undertaken with patient and consumer groups and relevant healthcare professionals, with responses from across the EU.
Croatian: Kako bi se ocijenila učinkovitost i čitljivost ove upute u uputi o lijeku pokrenuto je savjetovanje sa skupinama bolesnika i potrošača te odgovarajućim zdravstvenim djelatnicima uz odgovore iz cijelog EU-a.
English: (iv) Communication to healthcare professional and patients on double dosing for EHC management
Croatian: (iv) Priopćenje za zdravstvene djelatnike i bolesnike o dvostrukom doziranju za upravljanje hitnim hormonskim kontraceptivom
English: There were 75 pregnancies in the 400mcg LNG treated group, yielding a failure rate of 3.52% and a method failure rate of 1.69%.
Croatian: U skupini tretiranoj LNG-om od 400 μg bilo je 75 trudnoća, što je rezultiralo stopom neuspješnosti od 3,52 % te stopom neuspješnosti metode od 1,69 %.
English: Also, decreases in exposure of the LNG component of combined hormonal contraceptives have been noted with several enzyme inducers: LNG AUC was reduced by 36 to 47% reductions with oxcarbazepine; 40 to 46% with carbamazepine; 42% with phenytoin; 37% with eslicarbazepine; and 40% with perampanel.
Croatian: Isto su tako primijećena smanjenja izloženosti komponente LNG-a u kombiniranim hormonskim kontraceptivima uz nekoliko induktora enzima: Vrijednost AUC-a za LNG smanjena je za 36 do 47 % uz okskarbazepin; 40 do 46 % uz karbamazepin; 42 % uz fenitoin; 37 % uz eslikarbatepin te 40 % uz perampanel.
English: This is important as contraceptive efficacy of LNG EHC diminishes with time since UPSI: from 95% within 24 hours to 58% if started between 48 and 72 hours.
Croatian: To je važno iz razloga što učinkovitost hitnog hormonskog kontraceptiva LNG-a s vremenom slabi: s 95 % unutar 24 sata na 58 % ako se započne
English: Although this possibility does exist, a double dose would still result in higher plasma LNG levels than under the current posology and thus reduce the risk of contraceptive failure.
Croatian: Iako ta mogućnost postoji, dvostruka doza i dalje će dovesti do viših razina LNG-a u plazmi nego prema trenutačnom doziranju te time smanjiti rizik od neuspjeha kontraceptiva.
English: In that way the CHMP wanted to ensure that the instructions on dosing are as clear as possible on the outer carton labelling and the package leaflet, in order to maintain the non-prescription supply without increasing the risk of medication errors.
Croatian: Na taj je način CHMP htio osigurati da su upute o doziranju što je moguće jasnije na vanjskoj oznaci kutije i u uputi o lijeku kako bi se održala opskrba lijekom bez liječničkog recepta kojom se ne povećava rizik od medikacijskih pogrešaka.
English: Furthermore the Committee discussed data regarding other hepatic enzyme inducers including barbiturates and other medicines to treat epilepsy, medicines used to treat tuberculosis like rifampicin and herbal medicines containing Saint John's wort.
Croatian: Nadalje, Odbor je raspravljao o podacima koji se odnose na ostale induktore jetrenih enzima uključujući barbiturate i ostale lijekove za liječenje epilepsije, lijekove koji se primjenjuju za liječenje tuberkuloze, kao što je rifampicin te biljne lijekove koji sadržavaju gospinu travu.
English: Concerns have been raised by the CHMP of potential for medication errors related to non-prescription supply (i.e. targeted patients not using the double dosing as unaware).
Croatian: CHMP je izrazio zabrinutosti u pogledu potencijala za medikacijske pogreške povezane s nabavom lijeka bez liječničkog recepta (tj. ciljani bolesnici koji ne primjenjuju dvostruku dozu jer o tome nisu obaviješteni).
English: In addition, the CHMP considered that instructions for an amended dose for users of enzyme inducers should be part of the package leaflet and should also be highlighted on the product outer carton labelling as the information should be available prior or during the purchase of the medicinal products to get the appropriate number of packs.
Croatian: Osim toga, CHMP je smatrao da upute za izmijenjenu dozu za korisnike induktora enzima trebaju biti dijelom upute o lijeku te da trebaju biti istaknute na vanjskoj oznaci kutije lijeka jer informacije trebaju biti dostupne prije ili tijekom kupnje lijeka kako bi se dobio odgovarajući broj pakiranja.
English: However in this case, the exposure to LNG would be less than that for a woman taking a double dose (i.e. 3 mg LNG) whilst not using a concomitant enzyme inducer.
Croatian: Međutim, u tome bi slučaju izloženost LNG-u bila manja nego u žene koja uzima dvostruku dozu (tj. 3 mg LNG-a), a istodobno ne uzima induktor enzima.
English: To the extent that other 750mcg and 1500mcg LNG-containing medicinal products indicated in emergency contraception not included in this assessment but are currently authorised in the EU, or are subject to future authorisation procedures by the Member States, the CHMP recommends that the concerned member states take due consideration of these scientific conclusions.
Croatian: U mjeri u kojoj ostali lijekovi koji sadržavaju 750 μg i 1500 μg LNG-a naznačeni za hitnu kontracepciju nisu uključeni u ovu procjenu, ali su trenutačno odobreni u EU-u ili će biti predmetom budućih postupaka odobravanja država članica, CHMP dotičnim državama članicama svakako preporučuje uzimanje u obzir tih znanstvenih zaključaka.
English: For non-emergency forms of LNG-containing contraception, the decreased efficacy resulting from reduced plasma levels are considered to lead to in an increased risk of pregnancy.
Croatian: Za oblike kontracepcije koji nisu hitni, a sadržavaju LNG, smatra se da smanjena učinkovitost koja je rezultat smanjenih razina u plazmi dovodi do povećanog rizika od trudnoće.
English: It is accepted that a woman using an enzyme inducer would ideally use a method that is unaffected by the interaction; indeed such women would be unlikely to need EHC.
Croatian: Smatra se da će žena koja upotrebljava induktor enzima idealno primjenjivati metodu na koju interakcija ne utječe; takve bi žene zaista malo vjerojatno imale potrebu za primjenom hitnog hormonskog kontraceptiva.
English: The minimally effective dose of LNG for emergency contraception has not been established, but it is important to preserve efficacy margins for contraception in users of enzyme inducers.
Croatian: Nije utvrđena najmanja učinkovita doza LNG-a za hitnu kontracepciju, ali važno je očuvati granice učinkovitosti kod korisnika induktora enzima.
English: Conversely, a double dose may over compensate the effects of less strong enzyme inducers.
Croatian: S druge strane, dvostruka doza može previše nadoknaditi učinke manje jakih induktora enzima.