FrancophonIA/ELRC3.0 huggingface dataset:
English: • to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
Croatian: • povećanje količine krvi koja se može uzeti u odraslih bolesnika s umjerenom anemijom i normalnom razinom željeza u krvi, koji će ići na operaciju i donirati vlastitu krv prije zahvata (autologna transfuzija krvi);
English: Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Croatian: Epoetin alfa koristi se i prije operacije za povećanje broja crvenih krvnih stanica te za smanjenje posljedica gubitka krvi.
English: In these cases, epoetin alfa is used to increase red blood cell counts.
Croatian: U tim se slučajevima koristi epoetin alfa za povećanje broja crvenih krvnih stanica.
English: The active substance in Binocrit, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Croatian: Djelatna tvar lijeka Binocrit, epoetin alfa, kopija je hormona pod nazivom eritropoetin, i djeluje na potpuno isti način kao prirodni hormon za stimulaciju proizvodnje crvenih krvnih stanica u koštanoj srži.
English: Binocrit can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Binocrit is used for.
Croatian: Binocrit se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika sa stanjima za koje se Binocrit primjenjuje.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin.
Croatian: U bolesnika koji primaju kemoterapiju ili imaju problema s bubrezima, anemiju može uzrokovati manjak eritropoetina ili loš odgovor tijela na prirodni eritropoetin.
English: The reference medicine for Binocrit is Eprex/Erypo.
Croatian: Referentni lijek za lijek Binocrit je Eprex/Erypo.
English: What are the risks associated with Binocrit?
Croatian: Koji su rizici povezani s lijekom Binocrit?
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Binocrit outweighs the identified risk and it can be authorised.
Croatian: Stoga je stav Agencije da korist od lijeka Eprex/Erypo, kao i od lijeka Binocrit, nadmašuje identificirani rizik te da lijek može biti odobren.
English: All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Binocrit or remained on Eprex/Erypo.
Croatian: Svi bolesnici primali su Eprex/Erypo u venu najmanje 8 tjedana prije nego što su počeli uzimati Binocrit ili nastavili uzimati Eprex/Erypo.
English: The dose, the frequency of injection and how long it is used for also depend on why Binocrit is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Croatian: Doza, učestalost injektiranja i vrijeme korištenja ovisi i o razlogu zbog kojeg se Binocrit primjenjuje te o tjelesnoj težini bolesnika, a prilagođavaju se ovisno o djelovanju lijeka.
English: Binocrit contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Croatian: Binocrit sadrži djelatnu tvar epoetin alfa te je „biosličan lijek”.
English: The iron levels of all patients should be checked to make sure that they are not too low, and iron supplements given if necessary.
Croatian: U svih bolesnika treba provjeriti razinu željeza koja ne smije biti preniska.
English: Why is Binocrit authorised in the EU?
Croatian: Zašto je lijek Binocrit odobren u EU-u?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Binocrit has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Binocrit ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek Eprex/Erypo te se u tijelu raspoređuje na isti način.
English: Binocrit is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Croatian: Lijek Binocrit primjenjuje se u bolesnika s malim ili umjerenim rizikom od razvoja akutne mijeloidne leukemije koji imaju nisku razinu prirodnog hormona eritropoetina.
English: • to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Croatian: • smanjenje potrebe za transfuzijom krvi u odraslih bolesnika s umjerenom anemijom koji se trebaju podvrgnuti velikoj ortopedskoj (na kostima) operaciji, na primjer operaciji kuka.
English: In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Croatian: Osim toga, ispitivanja su pokazala da su učinci lijeka jednaki učincima lijeka Eprex/Erypo na povećanje i održavanje broja krvnih stanica u bolesnika s kroničnim zatajenjem bubrega ili u bolesnika koji primaju kemoterapiju.
English: Another study showed that Binocrit injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Croatian: Drugo ispitivanje pokazalo je da Binocrit ubrizgan pod kožu bio jednako učinkovit u održavanju razina hemoglobina kao i Eprex/Erypo u 114 bolesnika koji boluju od raka i primaju kemoterapiju.
English: Laboratory studies comparing Binocrit with the reference medicine Eprex/Erypo have shown that the active substance in Binocrit is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Binocrit i referentni lijek Eprex/Erypo pokazala su da je djelatna tvar u lijeku Binocrit vrlo slična djelatnoj tvari u lijeku Eprex/Erypo u pogledu strukture, čistoće i biološke aktivnosti.
English: Erythropoietin is produced by the kidneys.
Croatian: Bubrezi proizvode eritropoetin.
English: What benefits of Binocrit have been shown in studies?
Croatian: Koje su koristi od lijeka Binocrit utvrđene u ispitivanjima?
English: Patients switching to Binocrit maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Croatian: Bolesnici koji su počeli primjenjivati Binocrit održavali su razinu hemoglobina u istoj mjeri kao bolesnici koji su nastavili koristiti Eprex/Erypo.
English: In addition, Binocrit was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Croatian: Nadalje, u nekoliko je ispitivanja utvrđeno da je Binocrit učinkovit kao i Eprex/Erypo za povećanje i održavanje broja crvenih krvnih stranica.
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
Croatian: • kod bolesnika koji su razvili čistu aplaziju krvnih stanica (smanjena proizvodnja crvenih krvnih stanica ili prestanak njihove proizvodnje) nakon terapije eritropoetinom;
English: How does Binocrit work?
Croatian: Kako djeluje Binocrit?
English: Studies have also shown that giving Binocrit produces similar levels of the active substance in the body to giving Eprex/Erypo.
Croatian: Ispitivanja su pokazala i da primjena lijeka Binocrit dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Eprex/Erypo.
English: How is Binocrit used?
Croatian: Kako se Binocrit primjenjuje?
English: For the full list of side effects of Binocrit, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Binocrit potražite u uputi o lijeku.
English: • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Croatian: (srčane i krvne žile), uključujući nedavni srčani ili moždani udar.
English: Binocrit, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Croatian: U jednom glavnom ispitivanju u kojem je sudjelovalo 479 bolesnika s anemijom uzrokovanom problemima s bubrezima uspoređen je lijek Binocrit ubrizgan u venu s referentnim lijekom.
English: Let it dry completely before you use it again.
Croatian: Neka se potpuno osuši prije nego je koristite ponovno.
English: Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Croatian: Ponovite korake 3-7 na isti način dok ne uzmete cijelu dozu.
English: You need to keep taking it every day to stop your illness getting worse.
Croatian: Morate ga uzimati svaki dan da biste spriječili pogoršanje bolesti.
English: • if you are seriously overweight (especially if you are a woman)
Croatian: • ako ste izrazito pretili (a posebno ako ste žena)
English: If you notice any of these symptoms:
Croatian: Ako primijetite neki od tih simptoma:
English: You may have problems with your bones
Croatian: Možete imati probleme s kostima
English: Sucrose may be harmful to the teeth.
Croatian: Saharoza može biti opasna za zube.
English: See Section 4 for more information.
Croatian: Pogledajte dio 4. za dodatne informacije.
English: Look out for important symptoms
Croatian: Pazite na pojavu važnih simptoma
English: Take the syringe out of the bottle and wash it thoroughly in clean water.
Croatian: Izvadite štrcaljku iz boce i operite je u čistoj vodi.
English: So it is very important to talk to your doctor about any changes in your health.
Croatian: Zato je vrlo važno s liječnikom razgovarati o svim promjenama u zdravstvenom stanju.
English: • difficulty in sleeping (insomnia)
Croatian: • teškoće sa spavanjem (nesanica)
English: You may need extra check-ups, including blood tests, while you are taking your medicine.
Croatian: Možda ćete trebati dodatne preglede, uključujući i krvne pretrage, dok uzimate ovaj lijek.
English: For example, if your dose is 15 ml, you need to take one and a half syringe-fulls of medicine.
Croatian: Na primjer, ako Vaša doza iznosi 15 ml, morate uzeti 1 i pol štrcaljku punu lijeka.
English: It should be taken into account that data for the once daily regimen are very limited in this population (see sections 4.4, 5.1 and 5.2).
Croatian: Treba uzeti u obzir činjenicu da su podaci o režimu primjene jedanput na dan u ovoj populaciji vrlo ograničeni (vidjeti dijelove 4.4, 5.1 i 5.2).
English: It also increases the CD4 cell count in your blood.
Croatian: Istodobno povećava broj CD4 stanica u Vašoj krvi.
English: Signs of osteonecrosis include:
Croatian: Simptomi osteonekroze uključuju:
English: Your doctor will monitor the effectiveness of your treatment.
Croatian: Liječnik će nadzirati učinkovitost liječenja.
English: Do not push too hard and squirt the liquid into the back of your throat or you may choke.
Croatian: Nemojte gurati prejako niti špricati otopinu u stražnju stranu grla jer bi moglo doći do gušenja.
English: What Epivir is and what it is used for
Croatian: Što je Epivir i za što se koristi
English: These differences were observed in each different age group studied.
Croatian: Ove su razlike opažene u svakoj pojedinoj ispitivanoj dobnoj skupini.
English: Hold the bottle firmly.
Croatian: Držite bočicu čvrsto.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • koji također uzimaju protuupalne lijekove koji se zovu kortikosteroidi
English: Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Croatian: Epivir ne može potpuno izliječiti infekciju HIV-om; smanjuje količinu virusa u tijelu i održava je na niskoj razini.
English: • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
Croatian: • ozbiljne alergijske reakcije koje uzrokuju oticanje lica, jezika ili grla, što može izazvati teškoće s gutanjem ili disanjem
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih bolesnika.
English: Other medicines and Epivir
Croatian: Drugi lijekovi i Epivir
English: Pancreatitis: Cases of pancreatitis have occurred rarely.
Croatian: Pankreatitis: Rijetko su zabilježeni slučajevi pankreatitisa.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Croatian: Te simptome vjerojatno uzrokuje imunološki sustav koji postaje jači kako bi se tijelo počelo boriti s infekcijama.
English: Do not take other medicines for the infection without your doctor's advice.
Croatian: Ne uzimajte druge lijekove za infekciju ako Vam to nije savjetovao liječnik.
English: mannitol, lactitol or maltitol), if taken regularly
Croatian: manitola, laktitola ili maltitola), ako se uzimaju redovito
English: Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in paediatric patients below 12 years of age.
Croatian: Djeca: Apsolutna bioraspoloživost lamivudina (približno 58-66%) bila je smanjena u pedijatrijskih bolesnika mlađih od 12 godina.
English: • if they have been taking combination therapy for a long time
Croatian: • koji duže vrijeme uzimaju kombiniranu terapiju
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Croatian: Nakon peroralne primjene, srednja vrijednost vremena (tmax) do maksimalne serumske koncentracije (Cmax) iznosi oko jedan sat.
English: If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Epivir.
Croatian: Ako ste trudni, ostanete trudni ili planirate trudnoću, razgovarajte sa svojim liječnikom o rizicima i prednostima uzimanja lijeka Epivir za Vas i Vaše dijete.
English: Epivir is a type of medicine known as an anti-retroviral.
Croatian: Epivir je tip lijeka poznat kao antiretrovirusni lijek.
English: The dose should therefore be adjusted (see tables).
Croatian: Stoga je potrebna prilagodba doze (vidjeti tablice).
English: Epivir can be used during pregnancy if clinically needed.
Croatian: Epivir se može primjenjivati u trudnoći samo ako je to klinički potrebno.
English: What Epivir is and what it is used for What you need to know before you take Epivir How to take Epivir
Croatian: Što je Epivir i za što se koristi Što morate znati prije nego počnete uzimati Epivir Kako uzimati Epivir
English: If you have taken Epivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Epivir uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: Epivir and similar medicines may cause side effects in unborn babies.
Croatian: Epivir i slični lijekovi mogu uzrokovati nuspojave u nerođene djece.
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany
Croatian: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe
English: Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations (see section 5.2).
Croatian: Djeca mlađa od 3 mjeseca: Dostupni su tek ograničeni podaci koji nisu dostatni za davanje specifičnih preporuka za doziranje (vidjeti dio 5.2).
English: This conclusion is based on the physiochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Croatian: Ovaj se zaključak temelji na fizičko-kemijskim i farmakokinetičkim podacima pod pretpostavkom da bolesnik zdrobi i prenese 100% tablete i odmah je proguta.
English: Insert the syringe firmly into the adapter.
Croatian: Stavite štrcaljku čvrsto u adapter.
English: • aches and pains (especially in the hip, knee or shoulder)
Croatian: • bolove (posebno u kuku, koljenu ili ramenu)
English: Instructions for use are included in the pack.
Croatian: Upute za primjenu su uključene u pakiranje.
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Croatian: Liječenje treba započeti liječnik s iskustvom u liječenju HIV infekcije.
English: • an increase in the level of liver enzymes.
Croatian: • povišene vrijednosti jetrenih enzima.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ukoliko primijetite bilo koje simptome infekcije ili druge simptome kao što su mišićna slabost, slabost koja počinje u rukama i nogama i kreće se prema trupu tijela, lupanje srca, nevoljno drhtanje ili hiperaktivnost, javite se odmah svom liječniku kako bi dobili potrebno liječenje.
English: Keep in touch with your doctor, and do not stop taking Epivir without your doctor's advice.
Croatian: Budite u kontaktu sa svojim liječnikom i nemojte prestati uzimati Epivir ako Vam to nije savjetovao liječnik.
English: This is consistent with the lower rates of antiviral suppression observed in these patients.
Croatian: To je u skladu s nižim stopama virusne supresije opaženima u tih bolesnika.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: EXP {MM/YYYY}
Croatian: EXP{MM/GGGG}
English: Absorption differences have been observed between adult and paediatric populations (see Special populations).
Croatian: Između odrasle i pedijatrijske populacije primijećene su razlike u apsorpciji (vidjeti 'Posebne populacije').
English: More than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect.
Croatian: Više od 1000 ishoda nakon izloženosti u prvom tromjesečju trudnoće i više od 1000 ishoda nakon izloženosti u drugom i trećem tromjesečju trudnoće ne ukazuju na malformacijske učinke kao ni učinke na plod/novorođenče.
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koje druge lijekove, odnosno ako ste ih uzimali nedavno, uključujući i biljne lijekove ili lijekove koji se mogu nabaviti bez recepta.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Croatian: Žene koje su HIV-pozitivne ne smiju dojiti jer se infekcija HIV-om može majčinim mlijekom prenijeti na dijete.
English: Tell your doctor immediately.
Croatian: Odmah se javite svom liječniku.
English: Clear, colourless to pale yellow solution.
Croatian: Bijela, bezbojna do blijedo žuta otopina.
English: A small amount of the ingredients in Epivir can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Epivir također može prijeći u majčino mlijeko.
English: If you take too much, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Croatian: Ako ste uzeli preveliku dozu, javite se svom liječniku ili ljekarniku ili na odjel hitne pomoći najbliže bolnice i zatražite savjet.
English: • general feeling of being unwell
Croatian: • općenito se osjećate loše
English: If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be considered.
Croatian: Ako režim primjene dvaput na dan nije moguće provesti, može se razmotriti režim primjene jedanput na dan (10 mg/kg/dan).
English: Epivir can be taken with or without food.
Croatian: Epivir se može uzimati s hranom ili bez hrane.
English: You need to know about important signs and symptoms to look out for while you are taking Epivir.
Croatian: Trebate biti upoznati s važnim znakovima i simptomima dok uzimate Epivir.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Croatian: CD4 stanice su vrsta bijelih krvnih stanica koje imaju važnu ulogu u pružanju podrške organizmu u obrani od infekcija.
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85%.
Croatian: Lamivudin se dobro apsorbira iz gastrointestinalnog trakta, a bioraspoloživost peroralno primijenjenog lamivudina u odraslih normalno je između 80 i 85%.
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite te nastavite s liječenjem na uobičajen način.
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Croatian: Ljudi s uznapredovalom HIV-infekcijom (SIDA) imaju oslabljen imunološki sustav i skloniji su razvoju ozbiljnih infekcija (oportunističkih infekcija).
English: • if their immune systems are very weak
Croatian: • čiji je imunološki sustav jako oslabljen
English: • fever (high temperature)
Croatian: • vrućica (povišena tjelesna temperatura)
English: • tingling or numbness of the arms, legs, hands or feet.
Croatian: • osjećaj trnjenja ili ukočenosti ruku, nogu, šaka ili stopala.
English: 3 to 12 years (N=35)
Croatian: 3-12 godina (N=35)
English: Older people: No specific data are available; however, special care is advised in this age group due to age-associated changes such as the decrease in renal function and alteration of haematological parameters.
Croatian: Starije osobe: Nisu dostupni specifični podaci; međutim, u toj se dobnoj skupini preporučuje poseban oprez zbog mogućih promjena povezanih s dobi, poput smanjene bubrežne funkcije i promjena u hematološkim parametrima.
English: The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans.
Croatian: Rezultati dugoročnih studija karcinogenosti u miševa i štakora nisu pokazali da lamivudin ima karcinogeni potencijal relevantan za ljude.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Croatian: Ako postoje dokazi o pogoršanju oboljenja jetre u tih bolesnika, mora se razmotriti privremeni ili trajni prekid liječenja (vidjeti dio 4.8).
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) is not significantly altered.
Croatian: Zabilježen je umjeren porast Cmax (28%) zidovudina pri istodobnoj primjeni s lamivudinom, ali se ukupna izloženost (AUC) nije značajno promijenila.
English: These may cause allergic reactions (possibly delayed).
Croatian: Oni mogu izazvati alergijske reakcije (moguće i reakcije odgođene preosjetljivosti).
English: Swallow the tablet with some water.
Croatian: Tabletu progutajte s vodom.
English: Push the plastic adapter into the neck of the bottle.
Croatian: Ugurajte plastični nastavak u grlo bočice.
English: Not everyone responds to treatment with Epivir in the same way.
Croatian: Ne reagiraju svi jednako na liječenje lijekom Epivir.