FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Skupna analiza rezultatov štirih študij je pokazala, da je do skupnega izboljšanja stanja prišlo pri 1 od 3 (33 %) bolnikov, ki so jemali natrijev pentosan polisulfat, v primerjavi s približno 1 od 6 (16 %) bolnikov, ki so jemali placebo (zdravilo brez zdravilne učinkovine).
English: What benefits of Elmiron have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Elmiron izkazalo v študijah?
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.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Elmiron upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Elmiron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Elmiron preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Elmiron pentosan polysulfate sodium
Slovenian: Elmiron natrijev pentosan polisulfat
English: What are the risks associated with Elmiron?
Slovenian: Kakšna tveganja so povezana z zdravilom Elmiron?
English: Elmiron is available as 100-mg capsules and can only be obtained with a prescription.
Slovenian: Zdravilo Elmiron je na voljo v obliki 100-miligramskih kapsul, njegovo predpisovanje in izdaja pa je le na recept.
English: What is Elmiron and what is it used for?
Slovenian: Kaj je zdravilo Elmiron in za kaj se uporablja?
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.
Slovenian: Najpogostejši neželeni učinki zdravila Elmiron (ki se lahko pojavijo pri več kot 1 bolniku od 10) vključujejo glavobol, omotico in učinke na prebavila, kot so driska, navzeja (siljenje na bruhanje), bolečine v trebuhu in krvavitev iz danke.
English: For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Elmiron naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
Slovenian: Kar zadeva bolnike z majhnimi krvavitvami in lezijami na steni mehurja, so se simptomi pri zdravljenju z zdravilom Elmiron skupno izboljšali pri velikem številu bolnikov.
English: Why is Elmiron approved?
Slovenian: Zakaj je bilo zdravilo Elmiron odobreno?
English: Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.
Slovenian: Zdravilo Elmiron se uporablja pri bolnikih z zmerno do hudo bolečino, ki imajo majhne krvavitve ali lezije (razjede) na steni mehurja.
English: It is not intended to provide practical advice on how to use Elmiron.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Elmiron glejte navodilo za uporabo.
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.
Slovenian: Zdravilo Elmiron se uporablja za zdravljenje odraslih s sindromom bolečega mehurja, boleznijo mehurja, ki povzroča bolečino v medeničnem predelu ter pogosto in nujno potrebo po uriniranju.
English: Elmiron contains the active substance pentosan polysulfate sodium.
Slovenian: Zdravilo Elmiron vsebuje zdravilno učinkovino natrijev pentosan polisulfat.
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.
Slovenian: Delovanje zdravilne učinkovine zdravila Elmiron, natrijevega pentosan polisulfata, ni v celoti znano, vendar prehaja v urin in naj bi se pritrdila na zaščitni sloj sluznice mehurja, ki je pri bolnikih s
English: How does Elmiron work?
Slovenian: Kako zdravilo Elmiron deluje?
English: How is Elmiron used?
Slovenian: Kako se zdravilo Elmiron uporablja?
English: In most cases you will need a doctor.
Slovenian: V večini primerov boste potrebovali zdravnika.
English: Always check both dates!
Slovenian: Vedno preverite oba datuma!
English: Tell your relatives, friends and close colleagues the following:
Slovenian: Sorodnikom, prijateljem in bližnjim sodelavcem povejte naslednje:
English: Your dose number may be different than the one in this example.
Slovenian: Številka vašega odmerka bo morda drugačna od tiste, ki je prikazana v tem primeru.
English: • Always carry some sugar (at least 20 grams) with you.
Slovenian: • Pri sebi vedno imejte nekaj sladkorja (vsaj 20 gramov).
English: Wash your hands before continuing.
Slovenian: Preden nadaljujete, si umijte roke.
English: These include:
Slovenian: Ti dejavniki vključujejo:
English: This step helps to ensure that you will get your full dose later on.
Slovenian: Ta korak pomaga zagotoviti, da boste kasneje prejeli celoten odmerek.
English: Be careful when you start or stop taking another medicine.
Slovenian: Previdni bodite, kadar začnete ali prenehate uporabljati katero drugo zdravilo.
English: If it does not work, you will need to try with a new needle.
Slovenian: Če ne deluje, boste morali poskusiti z novo iglo.
English: • Keep it away from direct heat and light.
Slovenian: • Zaščitite ga pred neposredno vročino in svetlobo.
English: These injections are justified even if it is not certain that you have hypoglycaemia.
Slovenian: Uporaba teh injekcij je upravičena tudi, če ni gotovo, da imate hipoglikemijo.
English: Always tell people who are caring for you or treating you that you require insulin.
Slovenian: Osebam, ki za vas skrbijo ali vas zdravijo, vedno povejte, da potrebujete insulin.
English: It may take up to five tries.
Slovenian: Morda boste morali poskusiti tudi do petkrat.
English: The potency of this medicinal product is stated in units.
Slovenian: Jakost tega zdravila je navedena v enotah.
English: Glucose Utilization Rate* (mg/kg/min)
Slovenian: Hitrost porabljanja glukoze* (mg/kg/min)
English: Do not use it after this time period.
Slovenian: Po tem času ga ne uporabljajte več.
English: Do not stop LUSDUNA without speaking to a doctor, who will tell you what needs to be done.
Slovenian: Ne prenehajte uporabljati zdravila LUSDUNA, ne da bi se posvetovali z zdravnikom, ki vam bo povedal, kaj je treba storiti.
English: Be familiar with your warning symptoms.
Slovenian: Poznajte svoje opozorilne simptome.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Slovenian: To lahko predstavlja tveganje v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
English: In your body
Slovenian: V telesu
English: For storage conditions after removing this medicinal product from the refrigerator, see section 6.3.
Slovenian: Za pogoje shranjevanja po tem, ko se zdravilo vzame iz hladilnika, glejte poglavje 6.3.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Slovenian: Nemudoma zaužijte približno 10 do 20 gramov sladkorja, na primer v obliki glukoze, kock sladkorja ali s sladkorjem sladkane pijače.
English: This kills germs that might make you sick.
Slovenian: To uniči bakterije, zaradi katerih bi lahko zboleli.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Slovenian: Običajno bi morali biti zmožni prepoznati, ko se vam krvni sladkor preveč zniža, tako da lahko pravilno ukrepate.
English: • Your doctor or nurse will show you how to use your pen.
Slovenian: • Zdravnik ali medicinska sestra vam bosta pokazala, kako uporabljati injekcijski peresnik.
English: Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Slovenian: Posebno skrbno spremljanje vaše sladkorne bolezni in preprečevanje hipoglikemij sta pomembna za zdravje vašega otroka.
English: Careful monitoring of glucose control is essential.
Slovenian: Natančno spremljanje urejenosti glukoze je ključnega pomena.
English: Repeat until you see insulin
Slovenian: Ponavljajte, dokler ne zagledate insulina
English: See Step 9 for how to remove a needle.
Slovenian: Glejte 9. korak o tem, kako odstranite iglo.
English: Check your insulin
Slovenian: Preverite svoj insulin
English: Your doctor will show you in which area of the skin you should inject LUSDUNA.
Slovenian: Zdravnik vam bo pokazal, v kateri predel kože morate injicirati zdravilo LUSDUNA.
English: Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Slovenian: Bolniki s sladkorno boleznijo tipa 1 morajo še naprej redno uživati vsaj malo ogljikovih hidratov, tudi če lahko zaužijejo le malo ali nič hrane, ali če bruhajo, itd. ter ne smejo nikoli povsem opustiti insulina.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Slovenian: Nekatera zdravila povzročijo spremembo koncentracije krvnega sladkorja (znižanje, zvišanje ali oboje, odvisno od okoliščin).
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Slovenian: Piaglitazon je treba ukiniti, če se pojavi kakršno koli poslabšanje srčnih simptomov.
English: Do a safety check
Slovenian: Opravite varnostni preizkus
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.
Slovenian: Te dejavnike morate poznati, da se boste lahko pravilno odzvali na spremembe v koncentraciji krvnega sladkorja in preprečili, da bi postala previsoka ali prenizka.
English: Before travelling consult your doctor.
Slovenian: Preden se odpravite na potovanje, se posvetujte z zdravnikom.
English: If you have not yet cleaned your injection site, do it now before you inject.
Slovenian: Če še niste očistili mesta za injiciranje, naredite to pred injiciranjem.
English: This is a modified insulin, very similar to human insulin.
Slovenian: To je modificiran insulin, zelo podoben humanemu (človeškemu) insulinu.
English: During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
Slovenian: V prvih tednih je treba to zmanjšanje vsaj delno nadomestiti s povečanjem odmerkov insulina ob obrokih, po tem obdobju pa je treba zdravljenje prilagajati individualno.
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for
Slovenian: Med možnimi vzroki so: - insulina si niste injicirali, ga niste injicirali dovolj ali je postal manj učinkovit, na primer zaradi
English: Do not shake or mix it before use.
Slovenian: Pred uporabo ne pretresajte in ne mešajte.
English: Needles and alcohol swabs are not included.
Slovenian: Igle in alkoholni zloženci niso priloženi.
English: This can spread around the injection site.
Slovenian: To se lahko razširi okoli mesta injiciranja.
English: Transferring a patient to another type or brand of insulin should be done under strict medical supervision.
Slovenian: Prehod bolnika na drugo vrsto ali znamko insulina se mora opraviti pod strogim zdravniškim nadzorom.
English: Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Slovenian: Sekundarni opazovani dogodki so vključevali umrljivost zaradi vseh vzrokov in sestavljen mikrovaskularni izid.
English: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Slovenian: Čas pojava hipoglikemije je odvisen od profila delovanja uporabljenih insulinov in se zato lahko spremeni, ko se spremeni shema zdravljenja.
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.
Slovenian: Če se ne morete povsem zanesti na prepoznavo svojih opozorilnih simptomov, se izogibajte okoliščinam (npr. vožnji avta), v katerih bi zaradi hipoglikemije ogrožali sebe ali druge.
English: You must use the pen as described in these Instructions for Use.
Slovenian: Injekcijski peresnik morate uporabljati, kot je opisano v teh navodilih za uporabo.
English: In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose.
Slovenian: V številnih primerih je indicirano testiranje urina za ketone in je treba pogosto prilagoditi odmerek insulina.
English: Immediate-type allergic reactions to insulin are rare.
Slovenian: Alergijske reakcije takojšnjega tipa na insulin so redke.
English: You need one injection of LUSDUNA every day, at the same time of the day.
Slovenian: Vsak dan potrebujete eno injekcijo zdravila LUSDUNA, vsak dan ob istem času.
English: If no medicine comes out, dial 2 units again and press the injection button again.
Slovenian: Če iz injekcijskega peresnika ne pride nič zdravila, znova nastavite 2 enoti in znova pritisnite gumb za injiciranje.
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.
Slovenian: Bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali celo izguba zavesti so lahko znaki resnega stanja (ketoacidoze), ki se pojavi zaradi pomanjkanja insulina.
English: Throw away the inner cap; you will not need it again.
Slovenian: Notranji pokrovček zavrzite, ker ga ne boste več potrebovali.
English: You should keep it at room temperature (below 30°C).
Slovenian: Shranjevati ga morate na sobni temperaturi (do 30 °C).
English: The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring.
Slovenian: Prehod z enega insulina na drugega zahteva zdravniški recept, zdravniški nadzor in spremljanje glukoze v krvi.
English: Instructions for use online at www.lusdunanexvue.com
Slovenian: Navodila za uporabo so na voljo na spletni strani www.lusdunanexvue.com.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Slovenian: Večina manjših reakcij na insuline ponavadi izzveni v nekaj dneh do nekaj tednih.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Slovenian: V prvem trimesečju se lahko potreba po insulinu zmanjša, v drugem in tretjem trimesečju pa se na splošno poveča.
English: In your brain
Slovenian: V možganih
English: Figure 1: Activity Profile in Patients with Type 1 Diabetes
Slovenian: Slika 1: Potek delovanja pri bolnikih s sladkorno boleznijo tipa 1
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.
Slovenian: Pomembno je, da veste, kako vam insulin pomaga in kako preprečiti najpogostejši neželeni učineknizek krvni sladkor (hipoglikemijo), ki je lahko resen.
English: PLEASE READ THESE INSTRUCTIONS BEFORE USE.
Slovenian: PRED UPORABO PREBERITE TA NAVODILA.
English: Use a new needle each time.
Slovenian: Vsakič uporabite novo iglo.
English: To prevent the possible transmission of disease, never share your pen with anyone else.
Slovenian: Da bi preprečili morebiten prenos bolezni, svojega injekcijskega peresnika nikoli ne smete deliti z nikomer.
English: (needle will attach here)
Slovenian: (sem bo nameščena igla)
English: Do not inject LUSDUNA in a vein, since this will change its action and may cause hypoglycaemia.
Slovenian: Zdravila LUSDUNA ne smete injicirati v veno, ker to spremeni njegovo delovanje in lahko povzroči hipoglikemijo.
English: • Never use the pen if it is damaged or if you are not sure that it is working properly.
Slovenian: • Nikoli ne uporabljajte injekcijskega peresnika, če je poškodovan ali če niste prepričani, da
English: Do not reuse the needle; throw it away safely following the directions.
Slovenian: Igle ne uporabite ponovno, temveč jo varno zavrzite v skladu z navodili.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki injekcijskega peresnika poleg oznake "EXP".
English: • This pen is only for your use.
Slovenian: • Ta peresnik je namenjen samo za vašo uporabo.
English: In general, the safety profile for children and adolescents (≤ 18 years of age) is similar to the safety profile for adults.
Slovenian: Na splošno je varnostni profil pri otrocih in mladostnikih (starih ≤ 18 let) podoben kot pri odraslih.
English: Severe allergic reactions to insulins may become life-threatening.
Slovenian: Hude alergijske reakcije na insuline lahko postanejo življenjsko nevarne.
English: Needles are not included in the pack.
Slovenian: Igle niso priložene v pakiranju.
English: Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
Slovenian: Glede na vaš življenjski slog, rezultate meritev krvnega sladkorja (glukoze) in vašo prejšnjo uporabo insulina, bo zdravnik:
English: Pharmacokinetics in children aged 2 to less than 6 years with type 1 diabetes mellitus was assessed in one clinical study (see section 5.1).
Slovenian: Farmakokinetiko pri otrocih s sladkorno boleznijo tipa 1, starih od 2 do manj kot 6 let, so ocenili v eni klinični študiji (glejte poglavje 5.1).
English: Check your blood sugar frequently.
Slovenian: Krvni sladkor si pogosto merite.
English: The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light.
Slovenian: Zdravilo je dovoljeno shranjevati največ 28 dni pri temperaturi do 30 °C in zaščiteno pred neposredno toploto ali svetlobo.
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.
Slovenian: Zdravnik vam lahko naroči, da ga uporabljajte v kombinaciji s kratkodelujočim insulinom ali s tabletami za zdravljenje visokega krvnega sladkorja.
English: The dose regimen (dose and timing) should be individually adjusted.
Slovenian: Shemo odmerjanja (odmerek in čas uporabe) je treba prilagoditi vsakemu bolniku posamezno.
English: If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked.
Slovenian: Če je treba, lahko pogostejše merjenje krvnega sladkorja pomaga odkriti blage hipoglikemije, ki bi sicer ostale prezrte.
English: Manufacturer NV Organon Molenstraat 110 5342 CC Oss The Netherlands
Slovenian: Izdelovalec NV Organon Molenstraat 110 5342 CC Oss Nizozemska
English: Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Slovenian: Hipoglikemija (nizek krvni sladkor) je lahko zelo resna in je zelo pogosta pri zdravljenju z insulinom (pojavi se lahko pri več kot 1 od 10 bolnikov).
English: This helps to make sure you get the right insulin dose and it lowers your chances of any pain or illness from germs.
Slovenian: To pomaga zagotoviti, da dobite pravi odmerek insulina in zmanjša možnost za bolečine ali bolezen zaradi bacilov.
English: In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar.
Slovenian: Da bi preprečili hipoglikemijo, morate na splošno zaužiti več hrane in kontrolirati krvni sladkor.
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.
Slovenian: • Če vam injekcijo daje druga oseba, mora posebej paziti, da se izogne naključni poškodbi z iglo
English: Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.
Slovenian: Morda bodo potrebne prilagoditve odmerka zdravila, razporeda obrokov ali telesne aktivnosti.
English: Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished.
Slovenian: Bolniki se morajo zavedati okoliščin, v katerih se opozorilni simptomi hipoglikemije lahko zmanjšajo.
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).
Slovenian: Na to bodite pozorni v vseh okoliščinah, v katerih bi lahko ogrozili sebe ali druge (npr. pri vožnji avtomobila ali upravljanju strojev).
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.
Slovenian: Nujno je, da bolnice z obstoječim ali gestacijskim diabetesom vso nosečnost vzdržujejo dobro urejeno metabolno presnovo, da preprečijo neželene izide, povezane s hiperglikemijo.
English: The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare:
Slovenian: Naslednji z zdravilom povezani neželeni učinki iz kliničnih preskušanj so spodaj našteti po organskih sistemih glede na MedDRA terminologijo in po padajoči pogostnosti (zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 do < 1/10, občasni: ≥ 1/1.000 do < 1/100, redki: ≥ 1/10.000 do < 1/1.000, zelo redki:
English: *determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values)
Slovenian: *določena kot količina infundirane glukoze, potrebna za vzdrževanje stalne koncentracije glukoze v plazmi (povprečne urne vrednosti).
English: If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates.
Slovenian: Če imate sladkorno bolezen tipa 1 (od insulina odvisno sladkorno bolezen), ne prenehajte uporabljati insulina in še naprej uživajte dovolj ogljikovih hidratov.
English: Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Slovenian: Takoj se pogovorite z zdravnikom, če hipoglikemije ne morete obvladati ali se ponavlja.
English: Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
Slovenian: Pozor: Umetna sladila in hrana z umetnimi sladili (na primer dietne pijače) pri hipoglikemiji ne pomagajo.
English: Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Slovenian: Potem zaužijte nekaj, kar krvni sladkor zviša za dalj časa (na primer kruh ali testenine).
English: LUSDUNA should be administered once daily at any time but at the same time each day.
Slovenian: Zdravilo LUSDUNA je treba aplicirati enkrat na dan kadar koli, vendar vsak dan ob istem času.