FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Croatian: Tijekom antiretrovirusne terapije mogu se povećati tjelesna težina i razine lipida i glukoze u krvi (vidjeti dio 4.4)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/055/002
English: Uncommon (may affect up to 1 in 100 people): - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - decreased numbers of red blood cells (anaemia) - yellow skin (jaundice) - severe and life-threatening skin rashes (Stevens-Johnson syndrome/ toxic epidermal necrolysis) - hives (urticaria) - fluid under the skin (angioedema) - joint pain (arthralgia) - muscle pain (myalgia) - decreased blood phosphorus - increased blood pressure
Croatian: ili anafilaktički šok - smanjen broj crvenih krvnih stanica (anemija) - žuta koža (žutica) - teški i po život opasni osipi kože (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) - koprivnjača (urtikarija) - tekućina ispod kože (angioedem) - bol u zglobovima (artralgija) - bol u mišićima (mijalgija) - snižena razina fosfora u krvi - povišeni krvni tlak
English: Microcrystalline cellulose
Croatian: Metabolit 14-OH klaritromicin AUC
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - decreased numbers of red blood cells (anaemia) - decreased numbers of white blood cells (granulocytopenia) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - muscle pain (myalgia) - joint pain (arthralgia) - decreased blood phosphorus - increased blood pressure
Croatian: ili anafilaktički šok - reakcija na lijek sa sistemskim simptomima (reakcija na lijek uz eozinofiliju i sistemskim simptomima) - iznenadna i intenzivna upala jetre (fulminantni hepatitis) - teški i po život opasni osipi kože (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) - smanjen broj crvenih krvnih stanica (anemija) - smanjeni broj bijelih krvnih stanica (granulocitopenija) - žuta koža (žutica) - koprivnjača (urtikarija) - tekućina ispod kože (angioneurotski edem) - bol u mišićima (mijalgija) - bol u zglobovima (artralgija) - snižena razina fosfora u krvi - povišeni krvni tlak
English: Viramune.
Croatian: NNRTI-i
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - vomiting - muscle pain (myalgia) - joint pain (arthralgia) - decreased numbers of white blood cells (granulocytopenia) - abnormal liver function tests - decreased blood phosphorus - increased blood pressure
Croatian: ili anafilaktički šok - reakcija na lijek s općim simptomima (reakcija na lijek s eozinofilijom i općim simptomima) - iznenadna i intenzivna upala jetre (fulminantni hepatitis) - teški i po život opasni osipi kože (Stevens-Johnsonov sindrom/toksična epidermalna nekroliza) - žuta koža (žutica) - koprivnjača (urtikarija) - tekućina ispod kože (angioneurotski edem) - povraćanje - bol u mišićima (mijalgija) - bol u zglobovima (artralgija) - smanjeni broj bijelih krvnih stanica (granulocitopenija) - abnormalni nalazi jetrenih testova - snižena razina fosfora u krvi - povišeni krvni tlak
English: The once daily dosing regimen of Viramune immediate-release should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Croatian: Režim doziranja jednom dnevno Viramune tableta s produljenim oslobađanjem ne smije trajati dulje od 28 dana te je tada potrebno odrediti alternativno liječenje zbog mogućeg rizika od nedostatne izloženosti lijeku i razvoja rezistencije virusa.
English: Genotypic analysis of isolates from antiretroviral naïve patients experiencing virologic failure (n=71) receiving nevirapine once daily (n=25) or twice daily (n=46) in combination with lamivudine and stavudine for 48 weeks showed that isolates from 8/25 and 23/46 patients, respectively, contained one or more of the following NNRTI resistance-associated substitutions: Y181C, K101E, G190A/S, K103N, V106A/M, V108I, Y188C/L, A98G, F227L and M230L.
Croatian: Genotipska analiza izolata dobivenih od bolesnika prethodno neliječenih, a dobili su virološki neuspjeh (n=71) liječenja nevirapinom jednom dnevno (n=25) ili dvaput dnevno (n=46) u kombinaciji s lamivudinom i stavudinom tijekom 48 tjedana, pokazala je da su izolati iz 8/25 i 23/46 bolesnika saadržavali jednu ili više od sljedećih supstitucija združenih s rezistencijom NNRTI:
English: Do not use this medicine after the expiry date which is stated on the carton and on bottle after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „EXP”.
English: Renal impairment: The single-dose pharmacokinetics of nevirapine has been compared in 23 patients with either mild (50  CLcr  80 ml/min), moderate (30  CLcr  50 ml/min) or severe renal dysfunction (CLcr  30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr  80 ml/min).
Croatian: Oštećenje bubrega: U odnosu na bolesnike s normalnom bubrežnom funkcijom (klirens kreatinina, CLcr, >80 ml/min) (n=8), bolesnici s blagom (50≤ CLcr <80ml/min), umjerenom (30 ≤ CLcr <50ml/min), teškom (CLcr <30ml/min) ili terminalnom bubrežnom disfunkcijom (dijalizirani) (n=23) nisu se razlikovali u pogledu farmakokinetike nevirapina.
English: Investigations Common liver function test abnormal (alanine aminotransferase increased; transaminases increased; aspartate aminotransferase increased; gamma-glutamyltransferase increased; hepatic enzyme increased; hypertransaminasaemia), blood phosphorus decreased, blood pressure increased
Croatian: Često abnormalni testovi jetrene funkcije (povišena alanin-aminotransferaza, povišene transaminaze; povišena aspartat-aminotransferaza; povišena gamaglutamiltransferaza; povišeni jetreni enzimi; hipertransaminazemija)
English: Entecavir and Viramune may be coadministered without dose adjustments.
Croatian: Entekavir i Viramune se mogu istodobno primjenjivati bez prilagodbe doze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/055/004
English: 90 prolonged-release tablets
Croatian: Tableta s produljenim oslobađanjem
English: Hypersensitivity reactions can also occur as rash with other side effects such as: - fever - blistering of your skin - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - a reduction in the numbers of your white blood cells (granulocytopenia) - general feelings of illness - severe problems with liver or kidneys (liver or kidney failure).
Croatian: - oticanje lica - opće oticanje - nedostatak zraka - bol u mišićima ili zglobovima - smanjenje broja bijelih krvnih stanica (granulocitopenija) - opći osjećaj bolesti - teški problemi s jetrom ili bubrezima (zatajenje jetre ili bubrega).
English: The dose of Viramune may need adjusting.
Croatian: Nakon prekida uzimanja gospine trave razine nevirapina mogu se povisiti pa može biti potrebna prilagodbe doze Viramunea.
English: Viramune has been evaluated in both treatment-naïve and treatment-experienced patients.
Croatian: Viramune je ispitivan i u liječenju prethodno neliječenih bolesnika i u liječenju bolesnika prethodno liječenih drugim anti-HIV lijekovima.
English: Enfuvirtide and Viramune can be coadministered without dose adjustments.
Croatian: DMPA i Viramune mogu se istodobno primjenjivati bez prilagodbe doze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/97/055/007
English: Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Croatian: Boehringer Ingelheim Sp. z o.o. Tel.: +48 22 699 0 699
English: Maraviroc
Croatian: Efavirenz
English: Dose:
Croatian: Tel.:
English: Baseline (mean) n=505
Croatian: Početne vrijednosti (srednja vrijednost) N=503
English: 3 for women and <400 cells/mm
Croatian: 3, muškarci s više od 400 stanica/mm
English: Tabulated summary of adverse reactions
Croatian: “Rebound”/povratni učinak
English: Magnesium stearate
Croatian: Jetra i žuč
English: 24 July 2014 EMA/444346/2014
Croatian: EMA/444346/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Croatian: +44 (0)20 7418 8427 E-mail: 19TUpress@ema.europa.euU1
English: Oral solutions have been authorised in Denmark, Finland, Malta, Norway, Sweden and the United Kingdom; oral tablets have been authorised in Denmark, Finland, Hungary, Iceland, Norway, Romania, Spain and Sweden.
Croatian: Oralne otopine odobrene su u Danskoj, Finskoj, Malti, Norveškoj, Švedskoj i Ujedinjenom Kraljevstvu; oralne tablete odobrene su u Danskoj, Finskoj, Mađarskoj, Islandu, Norveškoj, Rumunjskoj, Španjolskoj i Švedskoj.
English: Information to healthcare professionals
Croatian: Informacije zdravstvenim djelatnicima
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled je prvo proveo Odbor za procjenu rizika na području farmakovigilancije (PRAC).
English: • Patients who have questions or concerns should consult their doctor or another healthcare professional.
Croatian: • Bolesnici koji imaju pitanja ili razloge za zabrinutost trebaju se savjetovati sa svojim liječnikom ili drugim zdravstvenim djelatnikom.
English: Methadone is also used in the treatment of severe pain.
Croatian: Metadon se također koristi za liječenje teške boli.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Croatian: CMDh je regulatorno tijelo za lijekove koje predstavlja države članice Europske unije (EU).
English: Therefore, these products will remain on the
Croatian: Stoga, ovi lijekovi ostaju u prometu, a
English: The review of oral methadone medicines containing povidone was initiated on 10 April 2014 under Article 107i of Directive 2001/83/EC, also known as the ‘urgent Union procedure'.
Croatian: Pregled oralnih lijekova metadona koji sadrže povidon započet je dana 10. travnja 2014. sukladno članku 107 i Direktive 2001/83/EZ, poznatim pod nazivom „hitan postupak Unije”.
English: They will need to be appropriately reformulated before being reintroduced on the European market.
Croatian: Bit će potrebna primjerena preformulacija prije ponovnog uvođenja na Europsko tržište.
English: Treatment with methadone should be given in the context of a wider rehabilitation program.
Croatian: Liječenje metadonom treba davati u kontekstu šireg rehabilitacijskog programa.
English: Methadone is a synthetic opioid (a morphine-like substance).
Croatian: Metadon je sintetički opioid (tvar slična morfiju).
English: • While these medicines are suspended, healthcare professionals should switch their patients to alternative methadone products.
Croatian: • Budući da su ovi lijekovi suspendirani, zdravstveni djelatnici trebaju prepisati svojim bolesnicima na alternativne proizvode metadona.
English: Methadone medicines containing povidone have been authorised via national procedures in several European countries.
Croatian: Lijekovi metadona koji sadrže povidon odobreni su putem nacionalnih postupaka u nekoliko Europskih država.
English: These products will remain suspended until they have been reformulated.
Croatian: Ovi lijekovi ostaju suspendirani sve do njihove ponovne formulacije.
English: The PRAC recommendation was sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Preporuka PRAC-a dostavljena je Koordinacijskoj grupi za međusobno priznavanje i decentralizirani postupak za humane lijekove (CMDh), koja je usvojena kao završno mišljenje.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU, odgovorno je za utvrđivanje usklađenih sigurnosnih standarda za lijekove odobrene putem nacionalnih postupaka diljem EU.
English: Additionally, the CMDh agreed that methadone tablets that contain low molecular weight povidone should remain on the market with changes to the product information.
Croatian: Nadalje, CMDh je suglasan da tablete metadona koje sadrže providon niske molekulske mase trebaju ostati na tržištu s izmjenama u informacijama o proizvodu.
English: Povidone is available in different molecular weights.
Croatian: Povidon je dostupan u različitim molekulskim masama.
English: • Cases of povidone deposits and serious adverse reactions (e.g. anaemia and pathological fractures) have been reported in intravenous drug abusers.
Croatian: • Slučajevi taloženja povidona i ozbiljnih nuspojava (primjerice anemije i patološke frakture) prijavljeni su u osoba koje su zloupotrebljavale intravenozne lijekove.
English: While these medicines are intended for oral use only, some patients may misuse oral methadone formulations by injecting them into a vein.
Croatian: Iako su ovi lijekovi predviđeni samo za oralnu primjenu, određeni bolesnici mogu zlouporabiti formulacije oralnog metadona ubrizgavajući ih u venu.
English: • Because of the potential harm that could derive from such a misuse (injection into a vein), methadone solutions containing povidone K90 will be suspended.
Croatian: • Zbog mogućih oštećenja koja mogu rezultirati iz takve zlouporabe (ubrizgavanje u venu), otopine metadona koje sadrže povidon K90 bit će suspendirane.
English: Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights.
Croatian: Određene oralne formulacije metadona sadrže također dodani povidon, koji je dostupan u različitim molekulskim masama.
English: The efficacy of methadone in opioid substitution therapy was acknowledged and was not questioned in this review.
Croatian: Potvrđena je djelotvornost metadona u zamjenskoj terapiji za opioide te ista nije ispitana u ovoj procjeni.
English: • Patients taking methadone oral solutions with povidone K90 as part of their rehabilitation program will be switched to other methadone medicines, which do not pose the same risk of povidone accumulating inside vital organs.
Croatian: • Bolesnici koji uzimaju oralne otopine metadona s povidonom K90 kao sastavni dio svojeg rehabilitacijskog programa prijeći će na druge lijekove metadona, koji ne predstavljaju isti rizik od akumuliranja povidona unutar vitalnih organa.
English: The source of povidone could not be confirmed, but is likely to be methadone oral solution containing high molecular weight povidone following misuse by injection.
Croatian: Izvor povidona se ne može potvrditi, no vjerojatno je to oralna otopina metadona koja sadrži povidon visoke molekulske mase uslijed zlouporabe injekcijom.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented in all EU Member States where these medicines are marketed, according to an agreed timetable.
Croatian: Budući da je preporuka PRAC-a potvrđena konsenzusom CMDh-a, ista će biti primijenjena u svim državama članicama EU-a u kojima se ovi lijekovi stavljaju u promet, u skladu s dogovorenim rasporedom.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus the recommendation to suspend the marketing authorisation of methadone oral (by mouth) solutions containing high molecular weight povidone.
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh)P0F1P konsenzusom je potvrdila preporuku za suspenziju odobrenja za stavljanje lijeka u promet za oralne otopine (uzimaju se peroralno) metadona koje sadrže povidon visoke molekulske mase.
English: • Methadone tablets containing povidone of lower molecular weight can continue to be used, but patients are reminded that they should only be taken by mouth.
Croatian: • Tablete metadona koje sadrže povidon niže molekulske mase mogu se i dalje koristiti, no bolesnike se podsjeća da se iste trebaju uzimati samo peroralno.
English: • Some methadone oral solutions contain an additive, povidone.
Croatian: • Određene oralne otopine metadona sadrže aditiv, povidon.
English: • The risk of harm is reduced with low molecular weight povidone since it is expected to be readily excreted and not to accumulate inside cells.
Croatian: • Rizik od oštećenja se smanjuje povidonom niske molekulske mase budući da se od istog očekuje da se naknadno izluči i da se ne akumulira unutar stanica.
English: • Methadone is used to treat drug addiction in patients depending on opioids (such as heroin).
Croatian: • Metadon se koristi za liječenje ovisnosti o drogama u bolesnika koji su ovisni o opioidima (poput heroina).
English: The povidone contained in oral methadone solutions has a high molecular weight (known as K90), while the povidone used in methadone tablets has a low molecular weight (e.g. K25 and K30).
Croatian: Povidon sadržan u oralnim otopinama metadona ima visoku molekulsku masu (poznatu kao K90), dok povidon korišten u tabletama metadona ima vrlo nisku molekulsku masu (primjerice K25 i K30).
English: • Since no measures could be identified to minimise the potential harm with methadone oral solutions containing high molecular weight povidone, these solutions will be suspended.
Croatian: • Budući da nije bilo moguće utvrditi mjere za minimiziranje potencijalnog oštećenja oralnim otopinama metadona koje sadrže povidon visoke molekularne mase, ove će otopine biti suspendirane.
English: Povidone is used in oral solutions as a suspending and dispersing agent, or as a binding agent for tablets.
Croatian: Povidon se koristi u oralnim otopinama kao sredstvo za suspenziju i disperziju ili kao sredstvo za vezivanje za tablete.
English: Different types of povidone are available, which vary in their molecular weight (a measure of the size of the molecule).
Croatian: Dostupni su različiti tipovi povidona, koji se mogu razlikovati u molekulskoj masi (mjera veličine molekule).
English: Methadone is used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids such as heroin.
Croatian: Metadon se koristi u rehabilitacijskim programima za sprječavanje ili smanjivanje simptoma ustezanja u bolesnika ovisnima o opiodima poput heroina.
English: Methadone-containing medicines are used to treat drug addiction in patients dependent on opioids (such as heroin); methadone prevents or reduces opiate withdrawal symptoms.
Croatian: Lijekovi koji sadrže metadon koriste se za liječenje ovisnosti o drogama u bolesnika koji su ovisni o opiodima (poput heroina); metadon sprječava ili smanjuje simptome ustezanja opijata.
English: Oral methadone medicines are available as solutions or tablets, and should only be taken by mouth.
Croatian: Oralni lijekovi metadona dostupni su kao otopine ili tablete, i treba ih uzimati samo oralno.
English: Because the CMDh reached an agreement by consensus, it will be implemented by the Member States where the medicines are authorised according to an agreed timetable.
Croatian: Budući da je odluka CMDh-a usvojena konsenzusom, provodit će se u svim državama članicama u kojima su lijekovi odobreni u skladu s dogovorenim rasporedom.
English: Methadone tablets containing low molecular weight povidone remain on the market, but their product information will be amended to reinforce the recommendation that these medicines are for oral administration only and must not be used in any other way.
Croatian: Tablete metadona koje sadrže povidon niske molekulske mase ostaju u prometu, no informacije o proizvodu trebaju biti dopunjene kako bi se naglasila preporuka da su ovi lijekovi samo za oralnu primjenu re da se ne smiju koristiti ni na koji drugi način.
English: It followed the decision of NOMA, the Norwegian medicines agency, to suspend the only methadone-containing oral solution that contains high molecular weight povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Croatian: Ovaj je postupak slijedio nakon odluke NOMA-e, Norveške agencije za lijekove, vezane uz suspenziju samo oralnih otopina metadona koje sadrže povidon visoke molekularne mase prisutne na nacionalnom tržištu, na temelju izvještaja o ozbiljnim nuspojavama u bivših ili aktualnih ovisnika u Norveškoj.
English: The above recommendations are based on available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone.
Croatian: Gorenavedene preporuke temelje se na dostupnim podacima o sigurnoj primjeni vezanima uz rizike povezane s zlouporabom injekcije lijeka metadona koji sadrži povidon.
English: The safety of oral methadone medicines containing povidone was reviewed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
Croatian: Odbor za ocjenu rizika na području farmakovigilancije (PRAC) pri EMA-i ocijenilo je sigurnu primjenu oralnih lijekova metadona koji sadrže povidon, nakon izvještaja o ozbiljnim nuspojavama u izliječenih ili aktualnih ovisnika o drogama u Norveškoj, što je rezultiralo suspenzijom oralne otopine metadona koja sadrži povidon K90 na norveškom tržištu.
English: Oral methadone medicines are available as solutions or tablets; only oral methadone products containing povidone were concerned by this review.
Croatian: Oralni lijekovi metadona dostupni su kao otopine ili tablete; ovim pregledom obuhvaćeni su samo oralni lijekovi metadona koji sadrže povidon.
English: • Some oral methadone solutions contain high molecular weight povidone (K90), which can be harmful if injected as it is retained in the body and may cause tissue damage.
Croatian: • Određene oralne otopine metadona sadrže povidon visoke molekularne mase (K90), koji može biti štetan ako se zadržava u tijelu te može uzrokovati oštećenje tkiva.
English: The risk of harm is reduced with low molecular weight povidone (e.g. K25 and K30) as this type of povidone is excreted from the body and is not expected to accumulate inside the cells as high molecular weight povidone does.
Croatian: Rizik od oštećenja smanjen je povidonom niže molekulske mase (primjerice K25 i K30) s obzirom da se ova vrsta povidona izlučuje iz tijela te se očekuje da se ne akumulira unutar stanica kao što je to u slučaju povidona visoke molekularne mase.
English: If a medicine containing high molecular weight povidone (known as K90) is misused in this way, the povidone is not excreted from the body and accumulates inside the cells of vital organs, which may cause serious harm.
Croatian: Ako se lijek koji sadrži povidon visoke molekularne mase (poznat pod nazivom K90) zlouporabi na ovaj način, povidon se ne izlučuje iz tijela i akumulira se unutar stanica vitalnih organa što može uzrokovati ozbiljna oštećenja.
English: They will need to be reformulated before being reintroduced on the market.
Croatian: Potrebna je nova formulacija lijeka prije ponovnog stavljanja u promet.