FrancophonIA/ELRC3.0 huggingface dataset:
English: Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤400 copies/ml; intention to treat analysis (ITT), 47% versus 49%; as treated analysis (AT), 86% versus 94% for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (>100,000 copies/ml at baseline; ITT, 46% versus 55%; AT, 84% versus 93% for abacavir and indinavir respectively).
Croatian: za kombinacije s indinavirom u analizi bolesnika s namjerom liječenja (ITT, engl. intention to treat); 86% za kombinacije s abakavirom naspram 94% za kombinacije s indinavirom u analizi liječenih bolesnika (AT, engl. as treated)), rezultati su pokazali da je kombinacija s indinavirom učinkovitija, osobito u podskupini bolesnika s visokim virusnim opterećenjem (>100 000 kopija/ml na početku;
English: Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Croatian: Nakon dvogodišnje primjene abakavira, primijećena je blaga degeneracija miokarda u miševa i štakora.
English: These were primarily asymptomatic HIV infected patients - Centre for Disease Control and Prevention (CDC) stage A. They were randomised to receive either abacavir 600 mg once daily or 300 mg twice daily, in combination with efavirenz and lamivudine given once daily.
Croatian: Oni su bili randomizirani u dvije skupine koje su primale ili abakavir (600 mg jedanput na dan ili abakavir 300 mg dvaput na dan, u kombinaciji s efavirenzom i lamivudinom jedanput na dan.
English: These may affect up to 1 in 1,000 people: • inflammation of the pancreas (pancreatitis)
Croatian: Mogu se pojaviti u manje od 1 na 10 osoba: • reakcija preosjetljivosti
English: However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).
Croatian: Međutim, treba izbjegavati primjenu lijeka Ziagen u bolesnika s krajnjim stadijem bubrežne bolesti (vidjeti dio 5.2).
English: (e.g. Triumeq,Trizivir or Kivexa).
Croatian: Trizivir, Triumeq ili Kivexa).
English: After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
Croatian: 32 tjedna pokazalo se da je liječenje s tri nukleozida ZDV/3TC/ABC virološki manje uspješno nego liječenje u druge dvije skupine, bez obzira na početno virusno opterećenje (< ili > 100 000 kopija/ml).
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Croatian: Glaxo Operations UK Ltd, (posluje kao Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co.
English: • feeling sick (nausea)
Croatian: • upala gušterače (pankreatitis)
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when abacavir was combined with tenofovir disoproxil fumarate and lamivudine as a once daily regimen.
Croatian: Pri kombiniranoj primjeni abakavira s tenofovir dizoproksilfumaratom i lamivudinom jedanput na dan zabilježen je visok postotak izostanka virološkog odgovora te nastup rezistencije u ranoj fazi liječenja.
English: Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies.
Croatian: Bolesnicima u kliničkim ispitivanjima primijenjene su pojedinačne doze do 1200 mg i dnevne doze do
English: Manufacturer: Glaxo Operations UK Ltd, (trading as GlaxoWellcome Operations) Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom or ViiV Healthcare Trading Services UK Limited, 12 Riverwalk,
Croatian: Durham DL12 8DT, Ujedinjeno Kraljevstvo ili ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Saccharin sodium
Croatian: Oralna otopina
English: Tell your doctor or pharmacist if any of the side effects get severe or troublesome, or if you notice any side effects not listed in this leaflet.
Croatian: Ako bilo koja od navedenih nuspojava postane teška ili zabrinjavajuća ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj Uputi, potrebno je obavijestiti liječnika ili ljekarnika.
English: 2 to 12 years (N=14) PENTA 15 3 to 36 months (N=18)
Croatian: 3-36 mjeseci (N=18)
English: In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either the fixed-dose combination of abacavir/lamivudine (FDC) once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
Croatian: randomizirani su tako da su tijekom 48 tjedana dobivali ili fiksnu kombinaciju abakavira i lamivudina jedanput na dan ili abakavir u dozi od 300 mg dvaput na dan uz lamivudin 300 mg jedanput na dan, u oba slučaja u kombinaciji s tenofovirom i nekim inhibitorom proteaze ili nekim nenukleozidnim inhibitorom reverzne transkriptaze.
English: Ziagen 300 mg tablets.
Croatian: Ziagen 300 mg tablete abakavir
English: Musculoskeletal
Croatian: Bolest bubrega
English: Ziagen contains abacavir (which is also an active substance in Trizivir , Triumeq and Kivexa).
Croatian: Ziagen sadržava abakavir (koji je isto djelatna tvar u lijekovima Trizivir, Triumeq i Kivexa).
English: INSTRUCTIONS ON USE 16.
Croatian: u dijelu 4 ove upute.
English: A randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
Croatian: U sklopu randomiziranog, multicentričnog, kontroliranog ispitivanja s pedijatrijskim bolesnicima zaraženima HIV-om provedena je randomizirana usporedba režima primjene abakavira i lamivudina jedanput na dan u odnosu na režim primjene dvaput na dan.
English: Remove the bottle cap. Keep it safely.
Croatian: Izvadite štrcaljku iz boce i operite je u čistoj vodi.
English: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Croatian: GlaxoSmithKline d.o.o. Tel:++385 1 6051 999
English: Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa, Triumeq and Trizivir).
Croatian: Ziagen sadrži abakavir (koji je također djelatna tvar u lijekovima kao što su Kivexa, Triumeq i
English: Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa,Triumeq and Trizivir).
Croatian: Ziagen sadrži abakavir(koji je također djelatna tvar u lijekovima kao što su Kivexa, Triumeq i
English: • if you have severe kidney disease Talk to your doctor if any of these apply to you.
Croatian: Obavijestite liječnika ako se išta od navedenog odnosi na Vas.
English: Clinical description of abacavir HSR
Croatian: Klinički opis reakcije preosjetljivosti na abakavir
English: Tablet Coating
Croatian: Česte nuspojave
English: • Ziagen should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.
Croatian: • Liječenje lijekom Ziagen ne smije se nikada započeti u bolesnika s pozitivnim HLA-B*5701
English: Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl)
Croatian: Usporedba primjene jedanput naspram dvaput na dan -omjer geometrijskih srednjih vrijednosti dobivenih metodom najmanjih kvadrata (90% Cl)
English: Description of Selected Adverse Reactions
Croatian: Opis odabranih nuspojava Reakcije preosjetljivosti na abakavir
English: Age Group
Croatian: Starije osobe
English: Do not stop taking Ziagen unless your doctor advises you to do so.
Croatian: osim ako Vam to nije savjetovao liječnik.
English: Based on limited experience Ziagen should be avoided in patients with end-stage renal disease.
Croatian: Ziagen u bolesnika s krajnjim stadijem bubrežne bolesti.
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Ziagen or other medicines you are taking, or an effect of the HIV disease itself.
Croatian: Ziagen, drugim istodobno primijenjenim lijekovima ili su posljedica same bolesti.
English: B. PACKAGE LEAFLET
Croatian: Rijetko: pankreatitis
English: Respiratory tract
Croatian: Oštećenje jetre
English: What Ziagen is and what it is used for What you need to know before you take Ziagen How to take Ziagen
Croatian: Što je Ziagen i za što se koristi
English: The other dosages and pharmaceutical forms are only available in Germany.
Croatian: Druge doze i farmaceutski oblici dostupni su samo u Njemačkoj.
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovakia.
Croatian: Lijekovi koji sadrže flupirtin odobreni su od 1980. godine i trenutačno su dostupni u sljedećim državama članicama EU-a: Bugarska, Estonija, Njemačka, Mađarska, Italija, Latvija, Litva, Poljska, Portugal, Rumunjska i Slovačka.
English: A review of these data was first conducted by the PRAC.
Croatian: Pregled tih podataka prvo je proveden od strane PRAC-a.
English: Subsequently, multiple other actions such as muscle relaxation were identified.
Croatian: Naknadno su identificirane i mnoge druge akcije poput relaksacije mišića.
English: The opening of these channels reduces the excessive electrical activity that leads to many pain states.
Croatian: Otvaranja tih kanala smanjuje prekomjernu električnu aktivnost koja vodi u mnoga bolna stanja.
English: In particular, there was a lack of efficacy data on the use of flupirtine for longer than 8 weeks.
Croatian: Posebice, postojao je manjak podataka o djelotvornosti o upotrebi flupirtina na dulje od 8 tjedana.
English: It followed the procedural steps laid out in Article 107i of Directive 2001/83, also known as the urgent Union procedure.
Croatian: Sijedi korake postupka iznesene u članku 107.i Direktive 2001/83 koji je također poznat kao hitni postupak Unije.
English: The review of flupirtine-containing medicines was initiated in March 2013 at the request of Germany, under Article 107i of Directive 2001/83/EC.
Croatian: Pregled lijekova koji sadrže flupirtin pokrenut je u ožujku 2013. na zahtjev Njemačke, u skladu s člankom 107.i Direktive 2001/83/EZ.
English: Based on the findings of this review, healthcare professionals in the EU are advised of the following updated recommendations:
Croatian: Na temelju nalaza ovog pregleda, zdravstvenim djelatnicima u EU savjetuju se sljedeće ažurirane preporuke.
English: The 100-mg immediate-release capsules are available in the 11 EU Member States listed above.
Croatian: Kapsule s neposrednim oslobađanjem od 100 mg dostupne su u 11 prethodno navedenih država članica EU-a.
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-a odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima širom EU.
English: This means that it opens specific pores on the surface of nerve cells called potassium channels.
Croatian: To znači da otvara specifične pore na površini živčanih stanica zvanih kalijev kanal.
English: Flupirtine is available as 100-mg immediate-release capsules, 400-mg extended-release tablets, 75mg and 150-mg suppositories and as a solution for injection (100 mg).
Croatian: Flupirtin je dostupan kao kapsule s trenutačnim oslobađanjem od 100 mg, tablete s produljenim oslobađanjem od 400 mg te supozitoriji od 75 i 150 mg kao i otopina za injekciju (100 mg).
English: If you are taking flupirtine, your treatment should not last longer than 2 weeks.
Croatian: Ako uzimate flupirtin, vaš liječenje ne smije trajati dulje od 2 tjedna.
English: Doctors using the injectable flupirtine should also follow relevant advice to minimise risk to patients.
Croatian: Liječnici koji koriste injektabilni flupirtin trebaju se također pridržavati odgovarajućeg savjeta kako bi se smanjio rizik za bolesnike.
English: • You should not take flupiritine as a long-term treatment for chronic pain.
Croatian: • Ne smijete uzimati flupirtin kao dugotrajnu terapiju za kroničnu bol.
English: 28 June 2013 EMA/384191/2013
Croatian: 13. rujna 2013. EMA/563900/2013
English: • The duration of treatment with flupirtine should not exceed 2 weeks and patients' liver function should be checked after each full week of treatment.
Croatian: • Trajanje liječenja flupirtinom ne smije premašiti dva tjedna i jetrene funkcije bolesnika treba provjeravati nakon svakog punog tjedna liječenja.
English: • Healthcare professionals should review the treatment of patients taking flupirtine taking into account the recommendations above.
Croatian: • Zdravstveni djelatnici trebaju pregledati terapije bolesnika koji uzimaju flupirtin uzimajući u obzir prethodne preporuke.
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Croatian: Preporuke PRAC-a poslane su CMDh koji su usvojili konačni položaj.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority new recommendations to restrict the use of oral flupirtine medicines and suppositories.
Croatian: Skupina za koordinaciju za međusobno priznavanje i decentralizirane postupke za humane lijekove (CMDh) 26. lipnja 2013. preporučila je većinu novih preporuka za ograničavanje upotrebe oralnih lijekova koji sadrže flupirtin i supozitorije.
English: Flupirtine is a non-opioid painkiller that has been used to treat pain, such as pain associated with muscle tension, cancer pain, menstrual pain and pain following orthopaedic surgery or injuries.
Croatian: Flupirtin je neopiodni analgetik koji je korišten za liječenje boli poput boli povezane s napetosti u mišićima, boli od karcinoma, menstrualne boli i boli nakon ortopedskih kirurških zahvata ili ozljeda.
English: Flupirtine works as a ‘selective neuronal-potassium-channel opener'.
Croatian: Flupirtin djeluje kao „selektivan neuronski otvarač kalijevih kanala”.
English: The CMDh agreed with the PRAC's conclusions and has endorsed the PRAC's recommendations on the use of flupirtine-containing medicines.
Croatian: CMDh također se složio sa zaključcima PRAC-a i preporučio preporuke PRAC-a o upotrebi lijekova koji sadrže flupirtin.
English: With regard to the evidence of efficacy, the review highlighted a lack of sufficient data on the benefits of flupirtine in chronic pain.
Croatian: S obzirom na dokaz djelotvornosti, pregled je istaknuo manjak dostatnih podataka o koristima flupirtina kod kronične boli.
English: A review of the safety data from the EU adverse reaction database revealed 330 cases of adverse liver events suspected to be linked to flupirtine.
Croatian: Pregled sigurnosnih podataka iz baze nuspojava EU-a koja je otkrila 330 slučajeva jetrenih nuspojava za koje se sumnja da su povezane s flupirtinom.
English: The PRAC also reviewed the available data on the benefits of flupirtine and concluded that, while there were data from studies in the treatment of acute pain, there were insufficient data to support its use in the treatment of long-term pain.
Croatian: PRAC je također pregledao dostupne podatke o koristima flupirtina i zaključio da dok postoje podaci iz ispitivanja u liječenju akutne boli, nema dovoljno podataka koji bi podržali njegovu upotrebu u liječenju dugotrajne boli.
English: The PRAC concluded that the benefits of injectable flupirtine continue to outweigh their risks when used in this way.
Croatian: PRAC je zaključio da koristi od injektabilnog flupirtina nastavljaju premašivati njegove rizike kad se lijek koristi na ovaj način.
English: In addition to oral medicines and suppositories, this review also covered injectable flupirtine medicines which were being given as a single injection for pain following surgery.
Croatian: Pored lijekova za oralnu primjenu i supozitorija, ovaj pregled također je pokrio injektabilne lijekove koji se daju kao pojedinačna injekcija za bol nakon kirurškog zahvata.
English: • Because flupirtine may have effects on the liver in some patients, your doctor will test your liver function during treatment and stop treatment if there are any signs of liver problems.
Croatian: • S obzirom da flupirtin može imati učinke na jetru kod nekih bolesnika, vaš liječnik će ispitati funkciju vaše jetre tijekom liječenja te prekinuti liječenje ako postoje znakovi problema s jetrom.
English: If you have been taking flupirtine for longer than 2 weeks you will need to get your treatment reviewed by your doctor or pharmacists.
Croatian: Ako ste uzimali flupirtin dulje od 2 tjedna liječnik ili ljekarnik moraju preispitati vašu terapiju.
English: The recommendations follow a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked into reported liver problems with flupirtine, ranging from high liver-enzyme levels to liver failure.
Croatian: Preporuke nakon pregleda od strane EMA-inog Povjerenstva za procjenu rizika u farmakovigilanciji (PRAC) koje su se bavile prijavljenim problemima s jetrom uz uzimanje lijeka flupirtina u rasponu od povišenih razina jetrenih enzima do zatajenja jetre.
English: In addition, patients' liver function should be checked after each full week of treatment and treatment should be stopped if the patient has any signs of liver problems.
Croatian: Pored toga, funkciju bolesnikove jetre treba provjeravati nakon svakog punog tjedna liječenja te liječenje treba prekinuti, ako bolesnik iskazuje znakove problema s jetrom.
English: • Treatment must be stopped in any patient with abnormal liver function tests results or symptoms of liver disease.
Croatian: • Liječenje treba prekinuti kod svakog bolesnika s nenormalnim testovima jetrene funkcije ili simptomima jetrene bolesti.
English: Flupirtine was first introduced as an alternative painkiller to opioids and NSAIDs.
Croatian: Flupirtin je prvo uveden kao alternativni analgetik naspram opioida i nesteroidnih protuupalnih lijekova.
English: No cases of liver failure or liver transplantation were reported in patients who took the medicine for 2 weeks or less.
Croatian: Nema slučajeva zatajenja jetre ili transplantacije jetre koji su bili prijavljeni kod bolesnika koji su uzimali lijekove dva tjedna ili manje.
English: The events ranged from asymptomatic increases in liver enzymes to liver failure.
Croatian: Slučajevi variraju u rasponu od asimptomatskih porasta u razini jetrenih enzima do zatajenja jetre.
English: The PRAC evaluated the available data on liver safety, noting that there were no cases of liver failure or liver transplantation reported in patients who took the medicine for 2 weeks or less.
Croatian: PRAC je procijenio dostupne podatke o jetrenoj sigurnosti, vodeći računa da nema slučajeva zatajenja jetre ili prijavljenih slučajeva transplantacije jetre kod bolesnika koji su uzimali lijek tijekom 2 tjedna ili manje.
English: These medicines should now only be used for treating acute (short-term) pain in adults who cannot use other painkillers, such as non-steroidal anti-inflammatory drug (NSAIDs) and weak opioids, and treatment should not last longer than 2 weeks.
Croatian: Ove lijekove treba koristiti samo za liječenje akutne (kratkoročne) boli u odraslih bolesnika koji ne mogu uzimati druge analgetike poput nesteroidnih protuupalnih lijekova (NSAIDs) i slabih opioida te čije liječenje ne smije trajati dulje od 2 tjedna.
English: • Oral flupirtine medicines and suppositories should only be used to treat adults with acute pain and only if treatment with other painkillers (such as NSAIDs and weak opioids) is contraindicated.
Croatian: • Oralni lijekovi koji sadrže flupirtin i supozitoriji smiju se koristiti samo za liječenje odraslih s akutnom boli i samo ako je liječenje drugim analgeticima kontraindicirano (poput NSAIDs i slabih opioida).
English: As the CMDh position was adopted by majority it will be sent to the European Commission, which will take a legally binding position throughout the EU.
Croatian: S obzirom da je većina usvojila stajalište CMDh, isto je poslano Europskoj komisiji koja ga je preporučila i usvojila kao konačnu pravno obvezujuću odluku koja vrijedi kroz EU.
English: • If you are being treated with flupirtine and have any questions or concerns about your treatment,
Croatian: • Ako se liječite flupirtinom i imate pitanja ili bojazni oko vašeg liječenja, razgovarajte s liječnikom ili ljekarnikom.
English: Flupirtine must also not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Croatian: Flupirtin također ne smiju koristiti bolesnici s postojećom bolesti jetre ili problemima s alkoholom ili bolesnici koji uzimaju druge lijekove za koje se zna da uzrokuju probleme s jetrom.
English: • Flupirtine must not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems.
Croatian: • Flupirtin ne smiju koristiti bolesnici s postojećom bolesti jetre ili problemima s alkoholom ili bolesnici koji uzimaju druge lijekove za koje se zna da uzrokuju probleme s jetrom.
English: The CMDh position will now be sent to the European Commission, which will take a legally binding decision to be valid throughout the EU.
Croatian: Stajalište CMDh poslano je Europskoj komisiji koja ga je 5. rujna 2013. godine preporučila i usvojila konačnu pravnu obvezujuću odluku koja vrijedi širom EU-a.
English: • Oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as NSAIDs and weak opioids).
Croatian: (kratkotrajne) boli kod odraslih osoba koje ne mogu koristiti druge analgetike (poput NSAIDs i slabih opioida).
English: 1 tablet bottle (glass) + syringe (plastic)
Croatian: Kroz usta boca (staklo) + štrcaljka (plastika)
English: 31 October 2013
Croatian: 31. listopada 2013.
English: The European Commission issued a decision on 31 October 2013.
Croatian: Europska komisija usvojila je Odluku dana 31. listopada 2013.
English: In addition, the capsules and oral solutions may also be used to treat the following autoimmune diseases:
Croatian: Nadalje, kapsule i oralne otopine mogu se također koristiti za liječenje sljedećih autoimunih bolesti:
English: The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding).
Croatian: Povjerenstvo je također uskladilo druge odjeljke sažetka opisa svojstava lijekova, uključujući i odjeljke 4.4. (Posebna upozorenja i mjere opreza za uporabu), 4.5. (Interakcije s drugim lijekovima) i 4.6. (Primjena tijekom trudnoće i dojenja).
English: Both medicines contain the active substance ciclosporin.
Croatian: Oba lijeka sadrže djelatnu tvar ciklosporin.
English: The companies that market these medicines are Novartis group of companies and associated companies.
Croatian: Farmaceutske tvrtke koje stavljaju ove lijekove u promet su društva i pridružena društva Novartis grupacije.
English: The CHMP agreed on specific dose ranges for the various indications, which should serve as guidelines only, and recommended that these medicines should be given in two divided doses equally distributed throughout the day.
Croatian: CHMP je suglasan sa specifičnim rasponima doziranja za različite indikacije, koji trebaju poslužiti samo kao smjernice, te je preporučio da se ovi lijekovi trebaju primjenjivati u dvije podijeljene doze koje su ravnomjerno raspodijeljene tijekom dana.