FrancophonIA/ELRC3.0 huggingface dataset:
English: Descovy contains tenofovir alafenamide which is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Croatian: Lijek Descovy sadrži tenofoviralafenamid koji je učinkovit pri manjoj dozi od dokazanog lijeka tenofovirdizoproksila i nudi mogućnost blažih nuspojava.
English: For more information about treatment with Descovy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Descovy pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: These studies showed that Descovy produces comparable levels of emtricitabine and tenofovir alafenamide in the body to Genvoya.
Croatian: Ta su ispitivanja pokazala da lijek Descovy proizvodi usporedive razine emtricitabina i tenofoviralafenamida u tijelu u odnosu na lijek Genvoya.
English: Similarly to Genvoya, Descovy offers an alternative option to giving emtricitabine with tenofovir disoproxil
Croatian: Slično lijeku Genvoya, lijek Descovy pruža alternativnu mogućnost da se uz tenofovirdizoproksil daje emtricitabin.
English: For practical information about using Descovy, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Descovy pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Descovy work?
Croatian: Kako djeluje Descovy?
English: What benefits of Descovy have been shown in studies?
Croatian: Koje su koristi lijeka Descovy utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Descovy, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Descovy potražite u uputi o lijeku.
English: How is Descovy used?
Croatian: Kako se Descovy koristi?
English: Descovy contains the active substances emtricitabine and tenofovir alafenamide.
Croatian: Lijek Descovy sadrži djelatne tvari emtricitabin i tenofoviralafenamid.
English: This summary was last updated in 04-2016.
Croatian: Descovy EMA/169100/2016
English: Content (concentration)
Croatian: Unutarnje pakovanje Sastav (koncentracija)
English: The recommended dose is one capsule taken three times a day.
Croatian: Preporučena doza je jedna kapsula triput dnevno.
English: Patients should be assessed every six months and treatment should be stopped if no improvement is seen.
Croatian: Bolesnike je potrebno pregledavati svakih šest mjeseci, a liječenje treba prekinuti ako ne dođe do poboljšanja.
English: The full EPAR for Elmiron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Elmiron nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: No major safety concerns were identified, and the possible risk of bleeding can be minimised with appropriate precautions.
Croatian: Nisu zabilježeni ozbiljni razlozi za zabrinutost u pogledu sigurnosti, a mogući rizik od krvarenja može se svesti na najmanju moguću mjeru odgovarajućim mjerama opreza.
English: This is a summary of the European public assessment report (EPAR) for Elmiron.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Elmiron.
English: Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU.
Croatian: Sindrom bolnog mjehura iscrpljujuće je stanje za koje do sada u Europskoj uniji nije bilo odobrenih lijekova.
English: What measures are being taken to ensure the safe and effective use of Elmiron?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Elmiron?
English: Looking at the results of the 4 studies together, 1 in 3 (33%) patients taking pentosan polysulfate sodium showed an overall improvement in their condition compared with around 1 in 6 (16%) patients taking placebo (a dummy treatment).
Croatian: Promatrajući rezultate četiriju ispitivanja zajedno, kod 1 od 3 (33 %) bolesnika koji su primali natrijev pentozanpolisulfat uočeno je opće poboljšanje stanja, u usporedbi s otprilike 1 na 6 (16 %) bolesnika koji su primali placebo (prividno liječenje).
English: Elmiron is available as 100-mg capsules and can only be obtained with a prescription.
Croatian: Lijek Elmiron dostupan je u obliku kapsula od 100 mg i izdaje se samo na liječnički recept.
English: Other information about Elmiron
Croatian: Ostale informacije o lijeku Elmiron
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Elmiron's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Elmiron nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: This reinforcement of the protective layer may reduce inflammation and bladder pain.
Croatian: Moguće je da to obnavljanje zaštitnog sloja smanjuje upalu i bol u mokraćnom mjehuru.
English: Why is Elmiron approved?
Croatian: Zašto je Elmiron odobren?
English: The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall.
Croatian: U ispitivanjima je sudjelovalo ukupno 454 bolesnika sa sitnim krvarenjima i oštećenjima na stijenci mjehura.
English: Since Elmiron may have a weak anticoagulant effect (i.e. it may stop the blood from clotting properly), it must not be used in patients who actively bleed (but this does not include women during menstrual cycle).
Croatian: Budući da lijek Elmiron može imati blagi antikoagulantni učinak (tj. može poremetiti zgrušavanje krvi), ne smije se primjenjivati u bolesnika s aktivnim krvarenjem (to ne uključuje žene za vrijeme menstruacije).
English: What is Elmiron and what is it used for?
Croatian: Što je Elmiron i za što se koristi?
English: It is not intended to provide practical advice on how to use Elmiron.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Elmiron.
English: The most common side effects with Elmiron (which may affect up to 1 in 10 people) include headache, dizziness, and effects in the digestive systems such as diarrhoea, nausea (feeling sick), abdominal (belly) pain and bleeding from the rectum.
Croatian: Najčešće nuspojave lijeka Elmiron (koje se mogu javiti u do 1 na 10 osoba) su glavobolja, omaglica, te učinci na probavni sustav kao što su proljev, mučnina, abdominalna bol (bol u trbuhu) i krvarenje iz rektuma.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elmiron have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Elmiron nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
Croatian: Pregled četiriju glavnih ispitivanja iz literature pokazao je da je natrijev pentozanpolisulfat djelotvoran u ublažavanju simptoma kao što su bol i česta potreba za mokrenjem.
English: Elmiron pentosan polysulfate sodium
Croatian: Elmiron natrijev pentozanpolisulfat
English: What are the risks associated with Elmiron?
Croatian: Koji su rizici povezani s lijekom Elmiron?
English: For more information about treatment with Elmiron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Elmiron pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature.
Croatian: Budući da je natrijev pentozanpolisulfat dobro poznata tvar provjerene medicinske uporabe u liječenju sindroma bolnog mjehura, tvrtka je dostavila podatke iz znanstvene literature.
English: In patients with small bleeds and lesions in the bladder wall, treatment with Elmiron led to significantly more patients having an overall improvement in symptoms.
Croatian: U bolesnika sa sitnim krvarenjima i oštećenjima na stijenci mjehura liječenje lijekom Elmiron dovelo je do općeg ublažavanja simptoma kod znatno većeg broja bolesnika.
English: What benefits of Elmiron have been shown in studies?
Croatian: Koje su koristi od lijeka Elmiron dokazane u ispitivanjima?
English: Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.
Croatian: Elmiron se primjenjuje u bolesnika s umjerenim do teškim bolovima koji imaju sitna krvarenja ili oštećenja (rane) na stijenci mjehura.
English: For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Elmiron bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.
Croatian: Elmiron je lijek koji se primjenjuje u liječenju odraslih osoba sa sindromom bolnog mjehura, stanja mjehura koje uzrokuje bol u zdjelici te čestu i hitnu potrebu za mokrenjem.
English: How does Elmiron work?
Croatian: Kako djeluje Elmiron?
English: Elmiron contains the active substance pentosan polysulfate sodium.
Croatian: Elmiron sadržava djelatnu tvar natrijev pentozanpolisulfat.
English: How is Elmiron used?
Croatian: Kako se Elmiron koristi?
English: For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Elmiron potražite u uputi o lijeku.
English: The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome.
Croatian: Smatra se da on prelazi u urin te se veže na zaštitni sloj sluznice mjehura, koji je oštećen u bolesnika sa sindromom bolnog mjehura, i pomaže u njegovom obnavljanju.
English: Always check both dates!
Croatian: Uvijek provjerite oba datuma!
English: Elderly population (≥ 65 years old)
Croatian: Starija populacija (≥ 65 godina)
English: • Always carry some sugar (at least 20 grams) with you.
Croatian: • Uvijek sa sobom nosite malo šećera (barem 20 grama).
English: Do not share it with anyone else.
Croatian: Nemojte je dijeliti ni sa kim drugim.
English: If not, get a new pen.
Croatian: Ako nije, uzmite novu brizgalicu.
English: • Keep it away from direct heat and light.
Croatian: • Držite je podalje od izvora izravne topline i svjetlosti.
English: These symptoms often develop before the symptoms of a low sugar level in the brain.
Croatian: Ovi simptomi često se razvijaju prije simptoma niske razine šećera u mozgu.
English: Tell a doctor straight away if you notice signs of severe allergic reaction.
Croatian: Odmah se javite liječniku ako primijetite znakove teške alergijske reakcije.
English: The following graph shows the results from a study in patients:
Croatian: Sljedeći grafikon prikazuje rezultate jednog ispitivanja provedenog u bolesnika:
English: • Never use the pen if it is damaged or if you are not sure that it is working properly.
Croatian: • Nikada nemojte upotrijebiti brizgalicu ako je oštećena ili ako niste sigurni radi li ispravno.
English: Your dose number may be different than the one in this example.
Croatian: Vaša doza možda će se razlikovati od doze prikazane u ovom primjeru.
English: Throw away the inner cap; you will not need it again.
Croatian: Bacite unutarnji zatvarač; neće Vam više trebati.
English: These include patients:
Croatian: One obuhvaćaju bolesnike:
English: Repeat until you see insulin
Croatian: Ponavljajte sve dok ne vidite inzulin
English: Do a safety check
Croatian: Provedite sigurnosnu provjeru
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE.
Croatian: MOLIMO PROČITAJTE OVE UPUTE PRIJE UPORABE.
English: Check the dose window...
Croatian: Provjerite prozorčić...
English: No new safety signals were observed in this study.
Croatian: U ovom ispitivanju nisu otkriveni novi sigurnosni signali.
English: Always check you have the right pen.
Croatian: Uvijek provjerite imate li pravu brizgalicu.
English: • Carry some information with you to show you are diabetic.
Croatian: • Nosite sa sobom neku informaciju o tome da ste dijabetičar.
English: Wash your hands before continuing.
Croatian: Prije nego što nastavite, operite ruke.
English: Your doctor will show you in which area of the skin you should inject LUSDUNA.
Croatian: Liječnik će Vam pokazati u koje područje na koži trebate injicirati lijek LUSDUNA.
English: Glucose Utilization Rate* (mg/kg/min)
Croatian: Brzina iskorištenja glukoze* (mg/kg/min)
English: To prevent the possible transmission of disease, never share your pen with anyone else.
Croatian: Kako bi se spriječio mogući prijenos bolesti, nikad nemojte dijeliti svoju brizgalicu ni sa kim drugim.
English: Please, consult your doctor for further information.
Croatian: Obratite se svom liječniku za dodatne informacije.
English: These injections are justified even if it is not certain that you have hypoglycaemia.
Croatian: Te su injekcije opravdane i onda kada nije sigurno da imate hipoglikemiju.
English: • Your doctor or nurse will show you how to use your pen.
Croatian: • Vaš liječnik ili medicinska sestra pokazat će Vam kako koristiti brizgalicu.
English: In your body
Croatian: U tijelu
English: It is very important that you dial the dose your healthcare provider recommended.
Croatian: Vrlo je važno da odmjerite dozu koju Vam je preporučio Vaš zdravstveni radnik.
English: Figure 1: Activity Profile in Patients with Type 1 Diabetes
Croatian: Slika 1: Profil djelovanja u bolesnika sa šećernom bolešću tipa 1
English: What LUSDUNA is and what it is used for
Croatian: Što je LUSDUNA i za što se koristi
English: You need one injection of LUSDUNA every day, at the same time of the day.
Croatian: Potrebna Vam je jedna injekcija lijeka LUSDUNA svakoga dana u isto vrijeme.
English: If you have not yet cleaned your injection site, do it now before you inject.
Croatian: Ako još niste očistili mjesto injiciranja, učinite to sada, prije nego što injicirate lijek.
English: If no medicine comes out, dial 2 units again and press the injection button again.
Croatian: Ako lijek ne izlazi, ponovno odmjerite 2 jedinice i opet pritisnite gumb za injiciranje.
English: Caring for your pen New pens you haven't used before:
Croatian: Održavanje brizgalice Nove brizgalice koje još niste koristili:
English: Follow the advice of your healthcare provider.
Croatian: Slijedite savjet svog zdravstvenog radnika.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama u kojima su takve sposobnosti posebno važne (primjerice, upravljanje vozilom ili rad sa strojevima).
English: You should keep it at room temperature (below 30°C).
Croatian: Čuvajte je na sobnoj temperaturi (ispod 30°C).
English: Do not stop LUSDUNA without speaking to a doctor, who will tell you what needs to be done.
Croatian: Nemojte prestati primjenjivati lijek LUSDUNA bez savjetovanja s liječnikom, koji će Vam reći što trebate učiniti.
English: The pen contains a total of 300 units.
Croatian: Brizgalica sadrži ukupno 300 jedinica.
English: See Step 9 for how to remove a needle.
Croatian: Pogledajte 9. korak za upute o tome kako ukloniti iglu.
English: Instructions for use online at www.lusdunanexvue.com
Croatian: Upute za uporabu dostupne su na internetskoj stranici www.lusdunanexvue.com
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Croatian: Imajte ovaj mogući problem na umu u svim situacijama u kojima sebe i druge možete izložiti riziku (primjerice vožnja automobila ili rad sa strojevima).
English: Since LUSDUNA is a solution, it does not require resuspension before use.
Croatian: Budući da je LUSDUNA otopina, nije ju potrebno resuspendirati prije uporabe.
English: Needles must not be re-used.
Croatian: Igle se ne smiju ponovno upotrijebiti.
English: Animal data do not indicate reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na reproduktivnu toksičnost.
English: This is a modified insulin, very similar to human insulin.
Croatian: To je izmijenjen inzulin, vrlo sličan ljudskom inzulinu.
English: The use of LUSDUNA may be considered during pregnancy, if clinically needed.
Croatian: Može se razmotriti primjena lijeka LUSDUNA tijekom trudnoće, ako je to klinički potrebno.
English: This step helps to ensure that you will get your full dose later on.
Croatian: Ovaj korak pomaže osigurati kasniju primjenu pune doze.
English: • Always have a spare pen in case your pen is lost or damaged.
Croatian: • Uvijek imajte rezervnu brizgalicu u slučaju da se brizgalica koju koristite izgubi ili ošteti.
English: LUSDUNA should be administered once daily at any time but at the same time each day.
Croatian: LUSDUNA se primjenjuje jedanput na dan, u bilo koje vrijeme, ali svaki dan u isto doba dana.
English: Place a new sterile needle, two alcohol swabs and a pen on a clean, dry surface.
Croatian: Položite novu, sterilnu iglu, dva alkoholna tupfera i brizgalicu na čistu i suhu površinu.
English: Talk to your doctor, pharmacist or nurse before using LUSDUNA.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek LUSDUNA.
English: In your brain
Croatian: U mozgu
English: • Eye reactions
Croatian: • Reakcije na oku
English: This pen works with most kinds and sizes of pen needles such as those manufactured by Becton, Dickinson & Company and Ypsomed.
Croatian: Ova brizgalica može se koristiti s većinom vrsta i veličina igala za brizgalice, poput onih koje proizvode Becton, Dickinson & Company and Ypsomed.
English: For storage conditions after removing this medicinal product from the refrigerator, see section 6.3.
Croatian: Uvjete čuvanja nakon vađenja lijeka iz hladnjaka vidjeti u dijelu 6.3.
English: If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Croatian: Ako niste sigurni da ćete prepoznati upozoravajuće simptome, izbjegavajte situacije (primjerice vožnju automobila) u kojima zbog hipoglikemije možete izložiti riziku sebe ili druge.
English: This should be kept in mind if treatment with the combination of pioglitazone and LUSDUNA is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka LUSDUNA.
English: Once you've opened and are using a pen:
Croatian: Nakon što otvorite brizgalicu i počnete je koristiti:
English: However, only very rarely, this will require a change to your insulin dose.
Croatian: Međutim, to će vrlo rijetko zahtijevati promjenu doze inzulina.
English: Do not inject LUSDUNA in a vein, since this will change its action and may cause hypoglycaemia.
Croatian: LUSDUNA se ne smije injicirati u venu jer će to promijeniti njezino djelovanje i može uzrokovati hipoglikemiju.
English: Counting to 10 allows time for all of the insulin to come out of the pen, making sure that you get your full dose.
Croatian: Brojanje do 10 pruža dovoljno vremena da sav inzulin izađe iz brizgalice i tako osigurava primjenu pune doze.
English: Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Croatian: Liječnik će Vam možda reći da ga uzimate u kombinaciji s kratkodjelujućim inzulinom ili tabletama koje se koriste za liječenje visoke razine šećera u krvi.
English: You should change injection site with each injection following the advice of your doctor.
Croatian: Mijenjajte mjesto injiciranja kod svake injekcije, prema savjetu liječnika.
English: It is important that you know how your insulin helps you and how to avoid the most common side effect - low blood sugar (hypoglycaemia), which can be serious.
Croatian: Važno je da znate kako Vam inzulin pomaže i kako izbjeći najčešću nuspojavu - nisku razinu šećera u krvi (hipoglikemiju), koja može biti ozbiljna.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Croatian: Morate ih poznavati kako biste mogli pravilno reagirati na promjene razine šećera u krvi i spriječili da ona postane previsoka ili preniska.
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for
Croatian: Primjeri uključuju: - niste injicirali inzulin ili niste injicirali dovoljno inzulina ili je djelotvornost inzulina smanjena,
English: • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Croatian: • Ako Vam injekciju daje druga osoba, mora poduzeti posebne mjere opreza kako ne bi došlo do nehotične ozljede iglom i prijenosa infekcije.
English: This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Croatian: To može dovesti do teške hiperglikemije (vrlo visoke razine šećera u krvi) i ketoacidoze (nakupljanja kiseline u krvi zbog toga što tijelo razgrađuje mast umjesto šećera).
English: Animal studies do not indicate direct harmful effects with respect to fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na izravne štetne učinke na plodnost.
English: Count to 10 slowly after you see 0 and the green stripe.
Croatian: Nakon što vidite 0 i zelenu liniju, polako brojite do 10.
English: Before first use, the pen must be stored at room temperature for 1 to 2 hours to allow it to warm up.
Croatian: Prije prve uporabe, brizgalica se mora čuvati na sobnoj temperaturi 1 - 2 sata kako bi se ugrijala.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia.
Croatian: Neophodno je da bolesnice s postojećom ili gestacijskom šećernom bolešću održavaju dobru metaboličku kontrolu tijekom trudnoće, kako bi se spriječili štetni ishodi povezani s hiperglikemijom.
English: Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Croatian: Bol u trbuhu, brzo i duboko disanje, pospanost ili čak gubitak svijesti mogu biti znakovi ozbiljnog stanja (ketoacidoza) koje nastaje zbog manjka inzulina.
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Croatian: Općenito, sigurnosni je profil u djece i adolescenata (≤ 18 godina) sličan sigurnosnom profilu u odraslih.
English: If you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose.
Croatian: Ako morate injicirati više jedinica nego što ih je preostalo u brizgalici, možete: - injicirati količinu preostalu u brizgalici i zatim upotrijebiti novu brizgalicu da biste primijenili ostatak doze ili - uzeti novu brizgalicu i njome injicirati cijelu dozu
English: Use a new needle each time.
Croatian: Svaki put upotrijebite novu iglu.