FrancophonIA/ELRC3.0 huggingface dataset:
English: Its objective was to compare the analgesic efficacy and clinical safety of Combination (paracetamol 500mg and ibuprofen 150 mg) with the other 3 treatment groups (paracetamol 500 mg; low dose ibuprofen 150 mg; high dose ibuprofen 300mg) in patients who have painful osteoarthritis of the knee.
Croatian: Njegov je cilj bio usporediti analgetičku djelotvornost i kliničku sigurnost kombinacije (paracetamol od 500 mg i ibuprofen od 150 mg) s ostalim trima ispitivanim skupinama (paracetamol od 500 mg; niska doza ibuprofena od 150 mg; visoka doza ibuprofena od 300 mg) kod bolesnika s bolnim osteoartritisom koljena.
English: The dose strengths used in the proposed fixed dose combination are well within the recommended dose range particularly with regards to the dose of ibuprofen.
Croatian: Jačine doza primijenjene u predloženoj fiksnoj kombinaciji doza nalaze se u okviru raspona preporučene doze, posebno u pogledu doze ibuprofena.
English: Clinical trials with the fixed dose combination have also not indicated any other undesirable effects other than those known for paracetamol alone or ibuprofen alone).
Croatian: Klinička ispitivanja s fiksnom kombinacijom doza također nisu utvrdila nikakve druge nuspojave osim onih prisutnih pri samostalnoj primjeni paracetamola ili ibuprofena.
English: The CHMP accepted this justification by the applicant for the need for the fixed dose combination in short term treatment of acute pain is acceptable for the several reasons.
Croatian: CHMP je prihvatio ovo opravdanje koje je podnio podnositelj zahtjeva u pogledu potrebe za fiksnom kombinacijom doza za liječenje akutne boli kao prihvatljivo iz nekoliko razloga.
English: Major issues on efficacy and safety raised by several CMS remained unresolved and were considered as a potential serious risk to public health; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29(1) of Directive 2001/83/EC.
Croatian: Stoga je postupak upućen Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), u skladu s člankom 29. stavkom 1. Direktive 2001/83/EZ.
English: Its objective was to compare the analgesic effects and safety of paracetamol and ibuprofen combined versus paracetamol alone or ibuprofen alone in adults with postoperative pain.
Croatian: Njegov je cilj bila usporedba analgetičkih učinaka i sigurnosti kombinacije paracetamola i ibuprofena u odnosu na samostalnu primjenu paracetamola ili ibuprofena u odraslih osoba s postoperativnom boli.
English: This phase III study was designed as a prospective, parallel-group, double-blind, placebo comparison of the clinical efficacy and safety of fixed dose combination (2 tablets, each tablet containing 500 mg paracetamol and 150 mg ibuprofen) versus its individual components (either 1000 mg paracetamol or 300 mg ibuprofen) and versus placebo in 300 patients suffering of moderate to severe pain due to post-arthroscopy surgery of the knee.
Croatian: faze osmišljeno je kao prospektivna, paralelna, dvostruko slijepa, usporedba kliničke djelotvornosti i sigurnosti fiksne kombinacije doza s placebom (2 tablete, svaka tableta sadržava 500 mg paracetamola i 150 mg ibuprofena) u odnosu na pojedinačne sastavnice (1 000 mg paracetamola ili 300 mg ibuprofena) i na placebo kod 300 bolesnika s umjerenom do jakom boli nakon artroskopije koljena.
English: In conclusion, the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Croatian: Kao zaključak, čini se da se poznati rizik ispitanih sigurnosnih ishoda ne mijenja kombiniranom primjenom ibuprofena i paracetamola u usporedbi sa samostalnom primjenom paracetamola ili ibuprofena.
English: (see Annex I).
Croatian: Prilog II.
English: Study AFT -MX6 was another phase III, placebo-controlled, prospective, randomised, double-blind, parallel-design trial with a safety follow-up at Day 30.
Croatian: Ispitivanje AFT -MX6 bilo je još jedno placebom kontrolirano prospektivno, randomizirano, dvostruko slijepo ispitivanje faze III. s paralelnom skupinom sa sigurnosnim praćenjem bolesnika 30. dana ispitivanja.
English: The rationale of the applicant presented the need for the fixed dose combination in short term treatment of acute pain was presented to the CHMP.
Croatian: U svom obrazloženju podnositelj zahtjeva iznio je CHMP-u potrebu za fiksnom kombinacijom doza u kratkoročnom liječenju akutne boli.
English: The CHMP was of the opinion that the benefit-risk balance of Paracetamol / ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination is considered to be favourable when used in accordance with the terms of the product information.
Croatian: Mišljenje je CHMP-a da se omjer koristi i rizika filmom obloženih tableta Paracetamol/ibuprofen 500 mg/150 mg i pridruženih imena s fiksnom kombinacijom doza može smatrati povoljnim ukoliko se upotrebljavaju u skladu s uvjetima iz informacija o lijeku.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Croatian: • Odbor je pregledao sve podatke koje je dostavio podnositelj zahtjeva u prilog djelotvornosti filmom obloženih tableta Paracetamol/ibuprofen 500 mg/150 mg i pridruženih imena s fiksnom kombinacijom doza u kratkoročnom simptomatskom liječenju blage do umjerene boli.
English: On 21 October 2016 the RMS United Kingdom therefore triggered a referral under Article 29(4) of Directive 2001/83/EC as these issues were considered to be a potential serious risk to public health.
Croatian: S obzirom na potencijalan ozbiljan rizik tih pitanja za javno zdravlje, 21. listopada 2016. referentna država članica Ujedinjena Kraljevina pokrenula je arbitražni postupak u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: Study AFT-MX-4 was a phase II exploratory study with a double-blind, randomized, parallel group comparison of the effects of Paracetamol and Ibuprofen Combined with Paracetamol, Low and High Dose Ibuprofen on Patients with Pain from Osteoarthritis of the Knee, and a 12 month open label extension.
Croatian: Ispitivanje AFT-MX-4 bilo je eksplorativno ispitivanje II. faze s paralelnom skupinom i dvostruko slijepom, randomiziranom usporedbom učinaka kombinacije paracetamola i ibuprofena s niskom dozom paracetamola i visokom dozom ibuprofena na bolesnike s boli uslijed osteoartitisa koljena i otvorenim produžetkom ispitivanja u trajanju od 12 mjeseci.
English: Study AFT-MX-1 was a phase III, pivotal study with a prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with postoperative pain.
Croatian: Ispitivanje AFT-MX-1 bilo je pivotalno ispitivanje III. faze s paralelnom skupinom i prospektivnom, dvostruko slijepom usporedbom analgetičkog učinka kombinacije paracetamola i ibuprofena, samog paracetamola ili samog ibuprofena kod bolesnika s postoperativnom boli.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Croatian: • Mišljenje je Odbora da dostupni podatci idu u prilog djelotvornosti filmom obloženih tableta Paracetamol/ibuprofen 500 mg/150 mg i pridruženih imena s fiksnom kombinacijom doza u kratkoročnom simptomatskom liječenju blage do umjerene boli.
English: The CHMP requested that specifically for the special populations of hepatic and renal impaired patients the warnings related to paracetamol use are all in line with the warnings existing in the mono-component's product information, for completeness of the safety information.
Croatian: Kako si zajamčila potpunost sigurnosnih podataka, CHMP je posebno zatražio da, za posebne populacije bolesnika s oštećenom funkcijom jetre ili bubrega, upozorenja u pogledu primjene paracetamola budu u skladu s upozorenjima navedenima u informacijama o lijeku za tu pojedinačnu sastavnicu.
English: The important safety risk associated with prolonged use of paracetamol and ibuprofen are well known and are hepatotoxicity, peptic ulceration and gastrointestinal bleeding, nephrotoxicity, cardiac, cardiovascular and cerebrovascular effects .The applicant has provided a comprehensive review of the safety data both from the submitted studies and from overall pooled study data including the exposure of the combination in elderly patients.
Croatian: Važni sigurnosni rizici povezani s produženom primjenom paracetamola i ibuprofena dobro su poznati i obuhvaćaju hepatotoksičnost, peptičke ulkuse i gastrointestinalno krvarenje, nefrotoksičnost, srčane, kardiovaskularne i cerebrovaskularne učinke.
English: Rescue medication consumption was accounted for in the primary endpoint analysis by carrying forward the pre-rescue VAS pain score.
Croatian: Uporaba lijeka s brzim djelovanjem obrađena je u analizi primarnog krajnjeg pokazatelja primjenom skale boli VAS prije primjene lijeka s brzim djelovanjem.
English: Study AFT-MX-3 was a dose response study and a double-blind, placebo-controlled, randomised, parallel group comparison of the effects of different paracetamol and ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars.
Croatian: Ispitivanje AFT-MX-3 bilo je ispitivanje odgovora na dozu s paralelnom skupinom i dvostruko slijepa, placebom kontrolirana, randomizirana usporedba učinaka različitih kombinacija doza paracetamola i ibuprofena kod sudionika s boli nakon vađenja dva do četiri treća kutnjaka.
English: Instructions in the posology section and warnings for the duration of use were provided in the product information.
Croatian: Informacije o lijeku sadržavaju upute u odjeljku o doziranju i načinu primjene i upozorenja u pogledu trajanja primjene.
English: In conclusion, the safety outcomes examined were consistent in the concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Croatian: Kao zaključak, ispitani sigurnosni ishodi nepromijenjeni su pri kombiniranoj primjeni ibuprofena i paracetamola u usporedbi sa samostalnom primjenom ibuprofena ili paracetamola.
English: Appropriately, instructions in the posology section and warnings for the duration of use were provided in the product information.
Croatian: Shodno tome, u informacije o lijeku sadržavaju upute u odjeljku o doziranju i načinu primjene i upozorenja u pogledu trajanja primjene.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: Jačina Farmaceutski oblik
English: Pack size
Croatian: Veličin a pakiran ja
English: Esmya (ulipristal acetate)
Croatian: Esmya (ulipristal acetat)
English: Treatment should always be started during the first week of the menstrual period.
Croatian: Liječenje se uvijek mora započeti tijekom prvog tjedna mjesečnog ciklusa (mjesečnice).
English: Further information on Esmya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Esmya nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A reduction in fibroid size was also observed.
Croatian: Opaženo je i smanjenje veličine fibroida.
English: 1 See outcome of safety review carried out in 2018 here.
Croatian: Ishod sigurnosnog pregleda provedenog 2018. godine pogledajte ovdje.
English: The recommended dose is one tablet a day for up to three months (one treatment course).
Croatian: Preporučena doza je jedna tableta dnevno u trajanju do tri mjeseca (jedan ciklus liječenja).
English: Esmya received a marketing authorisation valid throughout the European Union on 23 February 2012.
Croatian: Lijek Esmya dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 23. veljače 2012.
English: What measures are being taken to ensure the safe and effective use of Esmya?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Esmya?
English: It is available as tablets (5 mg) to be taken by mouth.
Croatian: Lijek Esmya dostupan je u obliku tableta (5 mg) koje se uzimaju kroz usta.
English: The three-month treatment course can be repeated in women in whom surgery is not suitable.
Croatian: Tromjesečni ciklus liječenja može se ponoviti u žena u kojih operativni zahvat nije prikladan.
English: What is Esmya and what is it used for?
Croatian: Što je Esmya i za što se koristi?
English: This overview was last updated in 07-2018.
Croatian: Sažetak je posljednji put ažuriran u 7. 2018.
English: An overview of Esmya and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Esmya i zašto je odobren u EU-u
English: Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).
Croatian: Fibroidi maternice nekancerogeni su (dobroćudni) tumori maternice.
English: A card will also be given to patients to inform them about the need for liver monitoring and to contact their doctor if they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
Croatian: Bolesnice će također primiti karticu kako bi se informirale o potrebi praćenja jetre i kontaktiranja s liječnikom ako se pojave simptomi oštećenje jetre (kao što su umor, žutilo kože, tamnjenje mokraće, mučnina i povraćanje).
English: The company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material with information about the safety of Esmya, including recommendations for monitoring liver function and endometrial changes during treatment.
Croatian: Tvrtka koja lijek Esmya stavlja na tržište osigurat će da liječnici, za koje se očekuje da će propisivati lijek, prime materijal za obuku s informacijama o sigurnosti lijeka Esmya, uključujući preporuke za praćenje funkcije jetre i promjena endometrija tijekom liječenja.
English: Other information about Esmya
Croatian: Ostale informacije o lijeku Esmya
English: 49% of women receiving 5 mg Esmya (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course.
Croatian: Od ukupnog broja žena koje su primale 5 mg lijeka Esmya, njih 49 % (95 od 195 ispitanih žena) imale su točkasto krvarenje (minimalno krvarenje iz maternice) najviše jedan dan unutar intervala od 35 dana nakon svakog ciklusa liječenja, dok je 70 % njih imalo najviše jedan dan točkastog krvarenja unutar intervala od 35 dana na kraju četvrtog ciklusa liječenja.
English: The size of the fibroids was also smaller in women treated with Esmya than in those who received placebo.
Croatian: Veličina fibroida također je bila manja u žena liječenih lijekom Esmya nego u onih koje su primale placebo.
English: Side effects reported with Esmya are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Esmya pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnica.
English: The medicine contains the active substance ulipristal acetate.
Croatian: Lijek sadrži djelatnu tvar ulipristal acetat.
English: Esmya can be given:
Croatian: Lijek Esmya može se primijeniti:
English: When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and the symptoms caused by them.
Croatian: Ako se djelovanje progesterona inhibira, prekida se dioba fibroidnih stanica i one naposljetku umiru, čime se smanjuje veličina fibroida kao i simptomi koje uzrokuju.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esmya have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnice trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Esmya nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: • as a single treatment course in women before they have surgery for their fibroids;
Croatian: • kao jedan ciklus liječenja u žena prije operativnog zahvata fibroida
English: Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause.
Croatian: Esmya je lijek koji se upotrebljava za liječenje umjerenih do ozbiljnih simptoma fibroida maternice u odraslih žena koje još nisu ušle u menopauzu.
English: The European Medicines Agency decided that the benefits of Esmya outweigh its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Esmya nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: • as intermittent treatment for women in whom surgery is not suitable.
Croatian: • kao povremeno liječenje za žene u kojih operativni zahvat nije prikladan.
English: What are the risks associated with Esmya?
Croatian: Koji su rizici povezani s lijekom Esmya?
English: Esmya can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids.
Croatian: Esmya se izdaje samo na liječnički recept, a liječenje mora započeti i nadgledati liječnik s iskustvom u dijagnosticiranju i liječenju fibroida maternice.
English: In some women, progesterone may promote the growth of fibroids, which can cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain).
Croatian: U nekih žena progesteron može potaknuti rast fibroida, što može dovesti do simptoma kao što su obilno krvarenje iz maternice (krvarenje iz maternice tijekom mjesečnog ciklusa ili izvan njega), anemija (smanjen broj eritrocita zbog krvarenja) i bol u trbuhu (kao što je bol tijekom mjesečnice).
English: As for all medicines, data on the use of Esmya are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Esmya kontinuirano se prate.
English: Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems.
Croatian: Lijek Esmya ne smije se upotrebljavati u trudnica ni dojilja, u žena s genitalnim krvarenjem nepoznatog uzroka ili s genitalnim krvarenjem uzrokovanim drugim stanjima osim fibroida maternice, u žena s karcinomom maternice, vrata maternice, jajnika ili dojke ili u žena koje imaju problema s jetrom.
English: In the first study, uterine bleeding was reduced in 92% of women taking Esmya for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment).
Croatian: U prvom je ispitivanju krvarenje iz maternice smanjeno u 92 % žena koje su uzimale lijek Esmya tijekom tri mjeseca (jedan ciklus liječenja) u usporedbi s 19 % žena koje su uzimale placebo (prividno liječenje).
English: The most common side effects with Esmya (which may affect more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb).
Croatian: Najčešće nuspojave lijeka Esmya (koje se mogu pojaviti u više od 1 na 10 osoba) su amenoreja (izostanak mjesečnice) i zadebljanje endometrija (sluznice maternice).
English: For more information about using Esmya, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Esmya pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: The active substance in Esmya, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb.
Croatian: Djelatna tvar u lijeku Esmya, ulipristal acetat, inhibira aktivnost progesterona, hormona u tijelu koji je uključen u kontrolu rasta sluznice maternice.
English: Esmya improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids.
Croatian: Lijek Esmya poboljšao je simptome fibroida maternice u dvama glavnim ispitivanjima koja su obuhvatila 549 žena koje su trebale biti podvrgnute operativnom zahvatu uklanjanja fibroida.
English: Esmya has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses).
Croatian: Lijek Esmya pokazao se učinkovitim u smanjenju veličine fibroida u žena koje su trebale biti podvrgnute operativnom zahvatu uklanjanja fibroida i kada se uz prekide upotrebljavao tijekom duljih razdoblja (do četiri ciklusa liječenja).
English: Why is Esmya authorised?
Croatian: Zašto je lijek Esmya odobren?
English: How does Esmya work?
Croatian: Kako djeluje Esmya?
English: What benefits of Esmya have been shown in studies?
Croatian: Koje su koristi od lijeka Esmya utvrđene u ispitivanjima?
English: How is Esmya used?
Croatian: Kako se Esmya koristi?
English: Rare but serious cases of liver injury have been reported with the medicine and measures have been put in place to minimise this risk.1 Although endometrial thickening was seen in some patients, it normally disappeared after stopping treatment.
Croatian: Rijetki, no ozbiljni slučajevi oštećenja jetre prijavljeni su s lijekom te su utvrđene mjere smanjenja rizika.
English: Long-term treatment with Esmya has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Esmya.
Croatian: Dugoročno liječenje lijekom Esmya ispitano je u glavnom ispitivanju kojim je obuhvaćena 451 žena.
English: For the full list of all side effects reported with Esmya, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Esmya potražite u uputi o lijeku.
English: In the second study, Esmya taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Esmya compared with 89% of women treated with leuprorelin.
Croatian: U drugom se ispitivanju lijek Esmya primjenjivao tri mjeseca te je bio učinkovit jednako kao i leuprorelin (drugi lijek za liječenje fibroida) u smanjenju obilnog materičnog krvarenja.
English: MA (EU) Number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size blister (PVC/alu)
Croatian: 15 mg / 9 mg Kapsula, tvrda blister (PVC/aluminij) 13 kapsula
English: Information for patients and healthcare professionals
Croatian: Informacije za bolesnike i zdravstvene djelatnike
English: The review of fusafungine-containing medicines was initiated on 11 September 2015 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Croatian: Ponovno ocjenjivanje lijekova koji sadrže fusafungin započeto je 11. rujna 2015. na zahtjev Italije u skladu s člankom 31. Direktive 2001/83/EZ.