FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC (see Annex A).
Croatian: Uredbe (EZ) br. 726/2004, nakon što je razmotrio preporuku PRAC-a od 5. prosinca 2013., mišljenje je CHMP-a da se odobrenja za stavljanje u promet lijekova Kogenate Bayer i Helixate NexGen trebaju izmijeniti sukladno preporuci PRAC-a (vidi Dodatak A).
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Croatian: Bayer/Helixate NexGen u bolesnika koji boluju od hemofilije A, uključujući ispitivanja 200021EU i 100074US u PUP-ova i minimalno liječenih bolesnika (MTP-ova).
English: In support of the above mentioned clinical data, the MAH provided information with regards to the manufacturing process (i.e. growth condition, purification) of Kogenate Bayer /Helixate Nexgen and discussed any change which took place since the studies 200021EU and 100074US.
Croatian: Kogenate Bayer /Helixate Nexgen, te je raspravio sve izmjene koje su primijenjene nakon ispitivanja 200021EU i 100074US.
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Croatian: Članak 13. Uredbe komisije (EZ) br. 1234/2008
English: The reference Member State (RMS) is the United Kingdom and 12 concerned Member States (CMS) are involved: Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain.
Croatian: Referentna država članica je Ujedinjena Kraljevina, a 12 država članica uključenih u postupak su: Austrija, Republika Češka, Estonija, Finska, Francuska, Njemačka, Grčka, Italija, Latvija, Nizozemska, Slovačka i Španjolska.
English: International non-proprietary name (INN): doxycycline hyclate
Croatian: Međunarodni nezaštićeni naziv (INN): doksiciklin hiklat
English: The opinion was converted into a Decision by the European Commission on 12 August 2013.
Croatian: Europska Komisija pretvorila je mišljenje u odluku 12. kolovoza 2013.
English: Potential serious risks were identified during the decentralised procedure by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal.
Croatian: Mogući ozbiljni rizici identificirani su tijekom decentraliziranog postupka od strane Nizozemske, a odnosili su se na odgovarajuću karenciju za meso i iznutrice pilića.
English: The Committee appointed Mr J. Schefferlie as rapporteur and Ms H. Jukes as co-rapporteur.
Croatian: Povjerenstvo je imenovalo gospodina J. Schefferliea kao procjenitelja i gospođu H.
English: The re-examination procedure started on 27 April 2013.
Croatian: Postupak ponovnog pregleda počeo je 27. travnja 2013. godine.
English: The detailed grounds for the re-examination request were submitted by Eurovet Animal Health BV on 26 April 2013.
Croatian: Detaljniji razlozi za zahtjev za ponovnim pregledom predani su od strane tvrtke Eurovet Animal Health BV 26. travnja 2013.
English: Day 60 of the CMD(v) procedure was on 18 October 2012, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Croatian: Dan 60. postupka CMD(v)-a bio je 18. listopada 2012. i s obzirom da dotične države članice nisu uspjele postići dogovor, postupak je proslijeđen CVMP-u.
English: On 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a reexamination of the CVMP opinion of 7 March 2013.
Croatian: Dana 22. ožujka 2013., tvrtka Eurovet Animal Health BV obavijestila je Agenciju o svojoj namjeri za zahtjevom za ponovnom procjenom mišljenja CVMP-a 7.ožujka 2013.
English: It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Croatian: Indiciran je za redukciju mortaliteta i morbiditeta u pilića te kliničkih znakova kao i za redukciju lezija uzrokovanih pasterelozom koju izaziva Pasteurella multocida ili za smanjenje morbiditeta i lezija kod respiratornih infekcija koju uzrokuje Ornithobacterium rhinotracheale (ORT).
English: The referral procedure started on 7 November 2012.
Croatian: Postupak procjene počeo je 7. studenog 2012.
English: Oral explanations were given on 5 March 2013.
Croatian: Usmena objašnjenja dana su 5. ožujka 2013.
English: On 30 October 2012, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Croatian: Dana 30. listopada 2012. referenta država članica, Ujedinjena Kraljevina obavijestila je Europsku agenciju za lijekove da CMD(v) nije uspio donijeti odluku i proslijedio je predmet CVMP-u u skladu s člankom 13. stavkom 2. Uredbe Komisije (EZ) br. 1234/2008.
English: Written explanations were provided by the marketing authorisation holder on 8 January 2013.
Croatian: Nositelj odobrenja podnio je pisana objašnjenja 8. siječnja 2013.
English: There are two authorised dosages: 10 mg/kg bw for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg bw for 4 consecutive days for which the withdrawal period is 12 days.
Croatian: Odobrene su dvije doze: Deset mg/kg tjelesne težine tijekom 4 uzastopna dana za koja je karencija 3 dana i 20 mg/kg tjelesne težine za 4 uzastopna dana za koja je karencija 12 dana.
English: The CVMP concluded a withdrawal period of 9 days is appropriate for chickens for the dose of 20 mg/kg bw for 4 consecutive days.
Croatian: CVMP je zaključio da je karencija od 9 dana odgovarajuća za piliće za dozu od 20 mg/kg tjelesne težine tijekom 4 uzastopna dana.
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 August 2012.
Croatian: Na 90. dan ova pitanja ostaju neriješena i stoga je počela procjena u skladu s člankom 13. stavkom 1. Uredbe Komisije (EZ) br. 1234/2008 od strane Koordinacijske skupine za međusobno priznavanje i
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens contains doxycycline hyclate as active ingredient.
Croatian: Soludox 500 mg/g prašak za upotrebu u vodi za piće za svinje i piliće sadrži doksiciklin hiklat kao djelatnu tvar.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Croatian: Znanstveni zaključci nalaze se u Prilogu II. skupa sa Sažetkom opisa svojstava i uputi o VMP u Prilogu III.
English: During its meeting of 9-11 April 2013 the CVMP appointed Prof. C. Friis as the rapporteur and Dr M. Holzhauser-Alberti as the co-rapporteur for the re-examination procedure.
Croatian: Friis kao procjenitelja i dr. M. Holzhauser-Alberti kao pomoćnog procjenitelja u postupku ponovnog pregleda.
English: The marketing authorisation holder, Eurovet Animal Health BV submitted an application for a type II variation to shorten the withdrawal period in chickens to 6 days for Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names, which has been subject to a worksharing procedure by the CMDv according to Article 20 of Commission Regulation (EC) No 1234/2008.
Croatian: Nositelj odobrenja, tvrtka Eurovet Animal Health BV predala je zahtjev za izmjenom tipa II kako bi se skratila karencija u pilića na 6 dana za Soludox 500 mg/g praška za upotrebu u vodi za piće za svinje i piliće te pridružena imena koja su podložna zajedničkom radnom postupku od strane CMDv-a u skladu s člankom 20. Uredbe Komisije (EZ) br. 1234/2008.
English: The worksharing procedure (UK/V/xxxx/WS/006) involving Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) started on 6 January 2012.
Croatian: Zajednički radni postupak (UK/V/xxxx/WS/006) koji uključuje Soludox 500 mg/g prašak za upotrebu u vodi za piće za svinje i piliće (NL/V/0141/001/WS/002) i Soludox 500 mg/g prašak za upotrebu u vodi za piće za svinje i piliće (UK/V/0349/001/WS/002) počeo je 6. siječnja 2012.
English: Opinion following an Article 131 referral for Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names
Croatian: Mišljenje nakon Članka 13.0F procjene za Soludox 500 mg/g prašak za upotrebu u pitkoj vodi za svinje i piliće i pridružene nazive
English: Based on the evaluation of the available data the CVMP adopted, on 7 March 2013, an opinion recommending the granting of the variation of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002).
Croatian: Na temelju procjene dostupnih podataka, CVMP je objavio 7. ožujka 2013. godine mišljenje koje preporučuje odobrenje izmjene odobrenja za stavljanje u promet Soludox 500 mg/g praška za upotrebu u vodi za piće za svinje i piliće (NL/V/0141/001/WS/002) i Soludox 500 mg/g praška za upotrebu u vodi za piće za svinje i piliće (UK/V/0349/001/WS/002).
English: On 12 June 2013 the CVMP adopted a final opinion confirming the recommendation included in its opinion of 7 March 2013, that the variation of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) can be granted and a withdrawal period of 9 days is appropriate for chickens for the dose of 20 mg/kg bw for 4 consecutive days.
Croatian: Dana 12. lipnja 2013. godine CVMP je usvojio konačno mišljenje koje potvrđuje preporuku uključenu u svom mišljenju od 7. ožujka 2013. godine da se može odobriti izmjena odobrenja za stavljanje u promet za lijek Soludox 500 mg/g prašak za upotrebu u vodi za piće za svinje i piliće (NL/V/0141/001/WS/002) i Soludox 100 mg/g prašak za upotrebu u vodi za piće za svinje i piliće (UK/V/0349/001/WS/002) te je karencija od 9 dana odgovarajuća za piliće za dozu od 20 mg/kg tjelesne težine za 4 uzastopna dana.
English: Gabapentin - Dysphagia (EPITT no 19296)
Croatian: Gabapentin - disfagija (EPITT br. 19296)
English: Your doctor may ask you to stop taking [Product name] before performing laboratory tests.
Croatian: Vaš liječnik od Vas može zatražiti da prestane uzimati [naziv lijeka] prije provođenja laboratorijskih pretraga.
English: Interference with clinical laboratory tests
Croatian: Interferencija s kliničkim laboratorijskim pretragama
English: The risk of interference is higher in children and patients with renal impairment and increases with higher doses.
Croatian: Rizik od interferencije veći je u djece i bolesnika s oštećenjem bubrega, te raste s višim dozama.
English: [Product name] contains <quantity> biotin per <dose unit>.
Croatian: [Naziv lijeka] sadrži <količinu> biotina po <doznoj jedinici>.
English: Adopted at the 14-17 January 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a 14. - 17. siječnja 2019.
English: Biotin - Interference with clinical laboratory tests (EPITT no 19156)
Croatian: Biotin - Interferencija s kliničkim laboratorijskim pretragama (EPITT br. 19156)
English: You should also be aware that other products that you may take, such as multivitamins or supplements for hair, skin, and nails could also contain biotin and affect the results of laboratory tests.
Croatian: Imajte na umu da i drugi proizvodi koje možda uzimate, kao što su multivitamini ili dodaci prehrani za kosu, kožu i nokte, također mogu sadržavati biotin te tako utjecati na rezultate laboratorijskih pretraga.
English: If you are about to undergo laboratory testing you must tell your doctor or the laboratory personnel that you are taking or have recently taken [Product name], because biotin may affect results of such tests.
Croatian: Ako ćete biti podvrgnuti laboratorijskim pretragama, morate reći svojem liječniku ili laboratorijskom osoblju da uzimate ili ste nedavno uzeli [naziv lijeka], jer biotin može utjecati na rezultate tih pretraga.
English: For medicinal products for oral use containing ≥150 microgram biotin per dose unit and medicinal products for parenteral use containing ≥60 microgram biotin per dose unit
Croatian: Za lijekove za peroralnu primjenu koji sadrže ≥150 mikrograma biotina po doznoj jedinici i lijekove za parenteralnu primjenu koji sadrže ≥60 mikrograma biotina po doznoj jedinici
English: When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin).
Croatian: Pri tumačenju rezultata laboratorijskih pretraga mora se uzeti u obzir moguća interferencija biotina, osobito ako je uočen manjak dosljednosti u kliničkoj slici (npr. rezultati pretraga štitnjače koji oponašaju Gravesovu bolest u asimptomatskih bolesnika koji uzimaju biotin ili lažno negativni rezultati pretraga troponina u bolesnika s infarktom miokarda koji uzimaju biotin).
English: Depending on the test, the results may be falsely elevated or falsely low due to biotin.
Croatian: Ovisno o pretrazi, rezultati mogu biti lažno povišeni ili lažno sniženi zbog biotina.
English: Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay.
Croatian: Biotin može interferirati s laboratorijskim pretragama koje se temelje na interakciji biotin/streptavidin, što dovodi do lažno smanjenih ili lažno povišenih rezultata pretrage, ovisno o testu.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/905277/2019
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/36993/2019
English: Undesirable effects Gastrointestinal disorders Uncommon: dysphagia
Croatian: Poremećaji probavnog sustava Manje često: disfagija
English: • Difficulty swallowing
Croatian: • Otežano gutanje
English: Please inform your doctor or the laboratory personnel, if you are taking such products.
Croatian: Ako uzimate te proizvode, obavijestite svog liječnika ili laboratorijsko osoblje o tome.
English: Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected.
Croatian: U slučaju sumnje na interferenciju potrebno je koristiti zamjenske pretrage koje nisu osjetljive na interferenciju biotina, ako su dostupne.
English: The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Croatian: Kada se bolesnik koji uzima biotin upućuje na laboratorijske pretrage, potrebno je savjetovati se s laboratorijskim osobljem.
English: Strength
Croatian: EU
English: Invented name
Croatian: Ime
English: The tablet should be swallowed whole with water.
Croatian: Tableta se treba progutati cijela s vodom.
English: This summary was last updated in 02-2015.
Croatian: Sažetak je posljednji put ažuriran: 02.2015.
English: The patient should take one tablet once a day with a light meal, preferably at the same time each day.
Croatian: Bolesnik treba uzimati jednu tabletu na dan uz lagani obrok, po mogućnosti u isto vrijeme svaki dan.
English: Rasilamlo is for use in adults only; it must not be used in children aged less than 2 years and is not recommended for older children.
Croatian: Rasilamlo se primjenjuje samo u odraslih; ne smije se primjenjivati u djece mlađe od dvije godine, a ne preporučuje se u starije djece.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Croatian: Blokira posebne kanale na površini stanica naziva kalcijevi kanali, kroz koje normalno ulaze ioni kalcija.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilamlo on 14 April 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Rasilamlo na snazi u Europskoj uniji od 14. travnja 2011.
English: What measures are being taken to ensure the safe and effective use of Rasilamlo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rasilamlo?
English: It should not be taken together with fruit juice or drinks containing plant extracts such as herbal teas.
Croatian: Lijek se ne smije uzimati s voćnim sokom ili pićima koja sadrže biljne ekstrakte poput biljnih čajeva.
English: Rasilamlo aliskiren / amlodipine
Croatian: Rasilamlo aliskiren / amlodipin
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Croatian: Kad ioni kalcija uđu u stanice u mišićima stijenki krvnih žila, to uzrokuje kontrakciju.
English: Other information about Rasilamlo
Croatian: Ostale informacije o lijeku Rasilamlo
English: This is a summary of the European public assessment report (EPAR) for Rasilamlo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Rasilamlo.
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 Rasilamlo.
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 i svoje preporuke za uporabu lijeka Rasilamlo.
English: The main measure of effectiveness was the change in the average diastolic blood pressure (blood pressure measured between two heartbeats) measured when the patients were seated.
Croatian: Glavna mjera djelotvornosti bila je promjena u prosječnom dijastoličkom krvnom tlaku (krvnom tlaku izmjerenom između dva otkucaja srca) izmjerenom nakon što bolesnik sjedne.
English: What is the risk associated with Rasilamlo?
Croatian: Koji su rizici povezani s lijekom Rasilamlo?
English: In three main studies involving 2,212 patients Rasilamlo was compared with aliskiren or amlodipine taken alone for eight or six weeks.
Croatian: U tri glavna ispitivanja koja su obuhvatila 2 212 bolesnika, Rasilamlo je uspoređen s aliskirenom ili amlodipinom koji su uzimani samostalno tijekom osam ili šest tjedana.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Croatian: Angiotenzin I konvertira se u hormonski angiotenzin II, koji je snažan vazokonstriktor (tvar koja sužava krvne žile).
English: It must also not be used in women who are more than three months pregnant or in patients taking medicines containing ciclosporin, itraconazole or other medicines known as ‘potent Pglycoprotein inhibitors' (such as quinidine).
Croatian: Također se ne smije koristiti u žena koje su trudne dulje od tri mjeseca ili u bolesnika koji uzimaju lijekove koji sadrže ciklosporin, itrakonazol ili druge lijekove poznate kao „potentni inhibitori P-glikoproteina” (poput kinidina).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasilamlo, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Rasilamlo nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: A risk management plan has been developed to ensure that Rasilamlo is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rasilamlo.
English: The CHMP decided that Rasilamlo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Rasilamlo nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The most common side effects with Rasilamlo are hypotension (low blood pressure) and peripheral oedema (swelling, especially of the ankles and feet).
Croatian: Najčešće nuspojave pri primjeni lijeka Rasilamlo su hipotenzija (niski krvni tlak) i periferni edem (oticanje, posebice gležnjeva i stopala).
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Croatian: Inhibira djelovanje ljudskog enzima naziva renin, koji je uključen u stvaranje tvari naziva angiotenzin I u tijelu.
English: The strength of the tablet the patient takes depends on the doses of aliskiren or amlodipine that they received previously.
Croatian: Jačina tablete koju će bolesnik uzimati ovisi o dozama aliskirena ili amlodipina koje su prethodno uzimali.
English: By reducing the flow of calcium into the cells, amlodipine prevents the blood vessel walls from contracting, thus lowering the blood pressure.
Croatian: Smanjivanjem dotoka kalcija u stanice amlodipin sprječava kontrakciju stijenki krvnih žila, te tako snižava krvni tlak.
English: Rasilamlo was more effective at controlling essential hypertension than placebo, aliskiren or amlodipine used alone.
Croatian: Rasilamlo je bio učinkovitiji u kontroliranju esencijalne hipertenzije od placeba, aliskirena ili amlodipina korištenih samostalno.
English: Rasilamlo can be used with other antihypertensive medicines, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Croatian: Rasilamlo se može koristiti zajedno s drugim antihipertenzicima, uz iznimku „inhibitora angiotenzin konvertirajućeg enzima (ACE)” ili „blokatora receptora angiotenzina” (ARB-ova) u bolesnika sa šećernom bolešću ili umjerenim do ozbiljnim oštećenjem bubrežne funkcije.
English: The dose may be adjusted based on the side effects the patient experienced with their previous treatment with aliskiren or amlodipine and also on how the patient responds to treatment with Rasilamlo.
Croatian: Doza će se možda morati prilagoditi na temelju nuspojava koje je bolesnik imao pri prethodnom liječenju aliskirenom ili amlodipinom, te načina na koji bolesnik odgovara na liječenje lijekom Rasilamlo.
English: The full EPAR for Rasilamlo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Rasilamlo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Rasilamlo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Rasilamlo must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine).
Croatian: Rasilamlo se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na aliskiren, amlodipin, bilo koju pomoćnu tvar ili drugu tvar dobivenu iz dihidropiridina (grupe koja uključuje amlodipin).
English: Why has Rasilamlo been approved?
Croatian: Zašto je lijek Rasilamlo odobren?