FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Semglee 100 units/ml solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Semglee 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - sulfonamide antibiotics.
Slovenian: Med zdravili, ki lahko povzročijo znižanje koncentracije krvnega sladkorja (hipoglikemija) so: - vsa druga zdravila za zdravljenje sladkorne bolezni, - zaviralci angiotenzinske konvertaze (ACE - angiotensin converting encyme) (uporabljajo se za zdravljenje določenih bolezenskih stanj srca ali visokega krvnega tlaka), - dizopiramid (uporablja se za zdravljenje določenih bolezenskih stanj srca), - fluoksetin (uporablja se za zdravljenje depresije),
English: This pen is only for your use.
Slovenian: Ta injekcijski peresnik uporabljajte le vi sami.
English: Zinc chloride
Slovenian: Gumijasta zaporka
English: You should change your injection site for each injection.
Slovenian: Pri vsakem injiciranju mesto injiciranja zamenjajte.
English: Posology
Slovenian: NALEPKA
English: Before using Semglee pen, the instructions for use included in the package leaflet must be read carefully.
Slovenian: Pred uporabo injekcijskega peresnika z zdravilom Semglee natančno preberite navodila za ravnanje v navodilu za uporabo.
English: You must always check the insulin label before each injection to avoid mix-ups between Semglee and other insulins.
Slovenian: Da bi se izognili zamenjavi med zdravilom Semglee in drugimi insulini, vedno pred vsakim injiciranjem preverite nalepko insulina.
English: A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients aged 12 to 18 years was also performed.
Slovenian: Pri 26 mladostnikih s sladkorno boleznijo tipa 1, starih od 12 do 18 let, so opravili tudi navzkrižno študijo, v kateri so primerjali insulin glargin skupaj z insulinom lispro ter insulin NPH skupaj z navadnim humanim insulinom (vsako zdravljenje je bilo uporabljano 16 tednov v naključnem zaporedju).
English: Do not inject with the needle at an angle.
Slovenian: Injekcijskega peresnika ne shranjujte z nameščeno iglo.
English: What Semglee contains
Slovenian: Zdravilo Semglee vsebuje natrij
English: If your blood sugar level falls too low you may pass out (become unconscious).
Slovenian: Če se vam koncentracija krvnega sladkorja preveč zniža, lahko izgubite zavest.
English: - Keep this leaflet.
Slovenian: * Shranite zunanji pokrovček.
English: • Semglee pen
Slovenian: Pokrovček peresnika
English: There is no experience with the use of Semglee in children below the age of 2 years.
Slovenian: Pri otrocih, mlajših od 2 let, izkušenj z uporabo zdravila Semglee ni.
English: Do not freeze the pen.
Slovenian: Injekcijskega peresnika ne smete zamrzniti.
English: Always store the pen with the cap on, to prevent contamination.
Slovenian: Injekcijski peresnik naj ima pri shranjevanju vedno nameščen pokrovček, da preprečite kontaminacijo.
English: Keep the pen cap on the pen after each injection in order to protect from light.
Slovenian: Po vsakem injiciranju dajte pokrovček injekcijskega peresnika nazaj na injekcijski peresnik, da zagotovite zaščito pred svetlobo.
English: If you have injected too much Semglee, your blood sugar level may become too low (hypoglycaemia).
Slovenian: Če ste uporabili večji odmerek zdravila Semglee, kot bi smeli Če ste injicirali preveč zdravila Semglee, se vam lahko koncentracija krvnega sladkorja preveč zniža (hipoglikemija).
English: Semglee in pre-filled pen is only suitable for injecting just under the skin.
Slovenian: Ravnanje z injekcijskim peresnikom z zdravilom Semglee Zdravilo Semglee v napolnjenem injekcijskem peresniku je primerno le za injiciranje pod kožo.
English: • leak-resistant, and
Slovenian: • ki ne pušča in
English: Insulin mix-ups
Slovenian: ▬ insulin glargin - insulin NPH
English: The longer duration of action of subcutaneous insulin glargine is directly related to its slower rate of absorption and supports once daily administration.
Slovenian: Dolgotrajnejše delovanje subkutanega insulina glargina je neposredno povezano z njegovo počasnejšo absorpcijo in podpira uporabo enkrat na dan. Časovni potek delovanja insulina in insulinskih analogov, kakršen je insulin glargin, se lahko zelo razlikuje tako med posamezniki kot pri eni in isti osebi.
English: Visual impairment
Slovenian: Okence za odmerek
English: Water for injections
Slovenian: Gumb za injiciranje
English: Use this medicine exactly as your doctor has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM versus 4.1 mM.
Slovenian: Toda vrednosti glukoze v krvi čez noč so bile v skupini z insulinom glarginom in insulinom lispro značilno večje kot v skupini z insulinom NPH in navadnim insulinom; povprečna najnižja vrednost je bila v prvi skupini 5,4 mM in v drugi 4,1 mM Temu ustrezno je bila incidenca nočnih hipoglikemij v skupini z insulinom glarginom in insulinom lispro 32 % in v skupini z insulinom NPH in navadnim insulinom 52 %.
English: Pen assembly:
Slovenian: Zgradba peresnika:
English: When given intravenously the elimination half-life of insulin glargine and human insulin were comparable.
Slovenian: Razpolovni čas izločanja insulina glargina po intravenski uporabi je primerljiv tistemu pri humanem insulinu.
English: carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Semglee").
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi hidrati), - izgubljate ogljikove hidrate zaradi bruhanja ali driske, - pijete alkohol (zlasti če ne jeste dosti), - ste bolj dejavni kot navadno ali je telesna dejavnost drugačna kot ponavadi, - okrevate po poškodbi, operaciji ali drugem stresu, - okrevate po bolezni ali po vročini, - uporabljate ali ste nehali uporabljati določena druga zdravila (glejte poglavje 2, »Druga zdravila in zdravilo Semglee«).
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.
Slovenian: Da bi se izognili napakam zdravljenja zaradi zamenjave med insulinom glargina in drugimi insulini, je potrebno nalepko insulina vedno preveriti pred vsakim injiciranjem.
English: How to store Semglee
Slovenian: Shranjevanje zdravila Semglee
English: Attach a new needle
Slovenian: 2. korak: Namestite novo iglo
English: • It is the correct insulin type.
Slovenian: • da boste uporabili pravilno vrsto insulina, • da rok uporabnosti še ni potekel.
English: A - Always prime a new pen needle before each injection.
Slovenian: 3. korak: Pripravite iglo peresnika A - Pred vsakim injiciranjem napolnite novo iglo peresnika.
English: Step 2.
Slovenian: * Držite 10 sekund
English: Each time you use the pen
Slovenian: Ob vsaki uporabi injekcijskega peresnika
English: Semglee 100 units/ml solution for injection in pre-filled pen.
Slovenian: Semglee 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku NAVODILA ZA UPORABO
English: The cartridge is assembled in a disposable pen injector.
Slovenian: Vložek je v injekcijskem peresniku za enkratno uporabo.
English: These starting doses may also be tried for the treatment of rejection.
Slovenian: Ti začetni odmerki se lahko preskusijo tudi za zdravljenje zavrnitve.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Envarsus on 18 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Envarsus, veljavno po vsej Evropski uniji, izdala dne 18. julija 2014.
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within certain limits.
Slovenian: Zdravniki morajo spremljati ravni takrolimusa v krvi, da preverijo, ali so znotraj določenih mejnih vrednosti.
English: It is not intended to provide practical advice on how to use Envarsus.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Black patients may require higher doses than white patients.
Slovenian: Bolniki črne rase bodo morda potrebovali večje odmerke kot bolniki bele rase.
English: Treatment is adjusted according to the medicine's blood levels and the patient's response.
Slovenian: Zdravljenje se prilagaja glede na ravni zdravila v krvi in odziv bolnika.
English: Envarsus should be taken once daily with water, on an empty stomach.
Slovenian: Zdravilo Envarsus je treba jemati z vodo enkrat na dan na prazen želodec.
English: What measures are being taken to ensure the safe and effective use of Envarsus?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Envarsus?
English: The full EPAR and risk management plan summary for Envarsus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Envarsus sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These ‘prolonged-release' tablets allow tacrolimus to be released slowly from the tablet over several hours and in a form that the body can absorb easily, so that it need be given only once a day.
Slovenian: Tablete s „podaljšanim sproščanjem“ omogočajo, da se takrolimus iz tablete počasi sprošča več ur in v obliki, ki jo telo zlahka absorbira, tako da je zdravilo treba dati samo enkrat na dan.
English: Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Slovenian: Zdravilo Envarsus je na voljo v obliki tablet s podaljšanim sproščanjem, ki vsebujejo takrolimus (0,75, 1 in 4 mg).
English: The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri uporabi zdravila Envarsus (opazili so jih pri več kot 1 bolniku od 10), so tremor (tresavica), glavobol, navzeja (slabost), driska, težave z ledvicami, hiperglikemija (zvišane ravni glukoze v krvi), sladkorna bolezen, hiperkaliemija (zvišane ravni kalija v krvi), hipertenzija (visok krvni tlak) in nespečnost (težave s spanjem).
English: The main measure of effectiveness in both studies was the number of patients who had treatment failure (death, failure or rejection of the transplanted organ, or loss of the patient from follow-up) after 12 months.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bilo število bolnikov, pri katerih zdravljenje po 12 mesecih ni bilo uspešno (smrt, odpoved ali zavrnitev presajenega organa ali izguba bolnika za spremljanje).
English: Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
Slovenian: Bolniki so bodisi prešli na zdravljenje z zdravilom Envarsus enkrat na dan bodisi so nadaljevali zdravljenje z zdravilom Prograf dvakrat na dan.
English: This is a summary of the European public assessment report (EPAR) for Envarsus.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Envarsus.
English: In the prevention of rejection, doses should start at 0.17 mg per kg of body weight daily in patients who have had a kidney transplant, and 0.11 to 0.13 mg per kg daily in those who have had a liver transplant.
Slovenian: Začetni odmerek za preprečevanje zavrnitve je 0,17 mg na kg telesne mase na dan pri bolnikih, ki so jim presadili ledvice, in od 0,11 do 0,13 mg na kg na dan pri tistih, ki so jim presadili jetra.
English: A risk management plan has been developed to ensure that Envarsus is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Envarsus je bil pripravljen načrt obvladovanja tveganj.
English: Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Slovenian: Takrolimus zmanjša aktivnost določenih celic v imunskem sistemu, imenovanih T-celice, ki so najbolj odgovorne za napadanje presajenega organa (zavrnitev organa).
English: Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
Slovenian: Zdravljenje je bilo neuspešno pri 18,3 % bolnikov, zdravljenih z zdravilom Envarsus (49 od 268), in 19,6 % bolnikov, ki so prejemali zdravilo Prograf (54 od 275).
English: Patients may also have abnormal results in liver function tests.
Slovenian: Bolniki imajo lahko tudi nenormalne izvide preiskav delovanja jeter.
English: Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
Slovenian: Stopnja neuspešnosti zdravljenja je bila v obeh skupinah 2,5 % (4 od 162 bolnikov, zdravljenih z zdravilom Envarsus, in 4 od 162 bolnikov, zdravljenih z zdravilom Prograf).
English: Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Slovenian: Zdravilo Envarsus se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) takrolimus ali katero koli drugo sestavino zdravila, in pri tistih, ki so alergični na snovi, ki jih imenujemo makrolidi (med njimi so tudi antibiotiki, kot je na primer eritromicin).
English: Envarsus is a ‘hybrid medicine'.
Slovenian: Envarsus je „hibridno zdravilo“.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo dokazano, da so odobreni odmerki zdravila Envarsus po kakovosti, varnosti in učinkovitosti primerljivi z zdraviloma Advagraf in Prograf.
English: Envarsus tacrolimus
Slovenian: Envarsus takrolimus
English: Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
Slovenian: Ker je zdravilo Envarsus podobno referenčnemu zdravilu Advagraf, je predlagatelj predložil primerjalne podatke o zdravilu Advagraf.
English: This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar pa je bilo zdravilo Envarsus izdelano na drugačen način in je na voljo v drugačnih odmerkih.
English: It is used for the long-term treatment of adult patients who have had a kidney or a liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Slovenian: Uporablja se za dolgotrajno zdravljenje odraslih bolnikov po presaditvi ledvic ali jeter, da se prepreči zavrnitev (ko imunski sistem napade presajeni organ).
English: The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Slovenian: Družba je predložila tudi študije o ravneh takrolimusa v telesu po zaužitju zdravila Envarsus, ki so pokazale, da so bile ravni takrolimusa takšne kot tiste, za katere je bilo že dokazano, da so učinkovite pri zdravljenju in preprečevanju zavrnitve, rezultati pri 29 bolnikih, ki so prejemali zdravilo Envarsus po presaditvi jeter, pa so pokazali, da v 360 dneh po presaditvi nihče od njih ni zavrnil presajenega organa.
English: Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Slovenian: Zdravilo Envarsus se lahko uporablja tudi za zdravljenje zavrnitve organa pri odraslih bolnikih, pri katerih druga zdravila za zaviranje imunske odzivnosti (zdravila, ki zmanjšajo aktivnost imunskega sistema) niso učinkovita.
English: Other information about Envarsus
Slovenian: Druge informacije o zdravilu Envarsus
English: Doses of Envarsus are calculated based on the patient's weight.
Slovenian: Odmerki zdravila Envarsus se izračunajo na podlagi telesne mase bolnika.
English: What benefits of Envarsus have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Envarsus izkazalo v študijah?
English: What are the risks associated with Envarsus?
Slovenian: Kakšna tveganja so povezana z zdravilom Envarsus?
English: The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Slovenian: V prvi študiji je sodelovalo 326 bolnikov, ki so že prestali presaditev ledvic in so se zdravili z zdravilom Prograf ter drugimi zdravili za zaviranje imunske odzivnosti za preprečevanje zavrnitve.
English: Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Slovenian: Ker se takrolimus iz zdravila Envarsus v telo absorbira drugače kot iz drugih zdravil, je treba pri zamenjavi zdravila bolnikom, ki se že zdravijo s katero koli drugo obliko takrolimusa, predpisati odmerek zdravila Envarsus, ki je za 30 % manjši od odmerka, ki ga trenutno prejemajo.
English: In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
Slovenian: Poleg tega bo družba, ki trži zdravilo Envarsus, zagotovila izobraževalno gradivo za zdravstvene delavce, ki bi lahko predpisovali ali izdajali zdravilo Envarsus, s katerim jih bo opomnila na odobreno uporabo in odmerek ter na previdnost, ki je potrebna, kadar bolniki preidejo na drugo obliko takrolimusa.
English: For more information about treatment with Envarsus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Envarsus preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Lower doses may be needed in patients with reduced liver function.
Slovenian: Pri bolnikih z zmanjšanim delovanjem jeter so včasih potrebni manjši odmerki.
English: The reference medicine for Envarsus is Advagraf.
Slovenian: Referenčno zdravilo za zdravilo Envarsus je Advagraf.
English: Why is Envarsus approved?
Slovenian: Zakaj je bilo zdravilo Envarsus odobreno?
English: Switching or changes in immunosuppressive medicines should be started and monitored by experienced transplant doctors.
Slovenian: Zamenjavo zdravil za zaviranje imunske odzivnosti ali spremembe v zdravljenju s temi zdravili morajo predpisati in spremljati izkušeni zdravniki specialisti za presaditve.
English: Therefore, the CHMP's view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da koristi enako kot pri ostalih odobrenih oblikah takrolimusa odtehtajo znana tveganja.
English: What is Envarsus and what is it used for?
Slovenian: Kaj je zdravilo Envarsus in za kaj se uporablja?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Envarsus, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Envarsus in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Envarsus, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Envarsus naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Slovenian: V teh študijah so zdravilo Envarsus primerjali z zdravilom Prograf, ki je pogosto uporabljano in dobro uveljavljeno zdravilo, iz katerega se takrolimus hitreje sprošča.
English: The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Slovenian: V drugi študiji so primerjali zdravilo Envarsus in zdravilo Prograf, ki so ju dodajali standardnemu zdravljenju, pri 543 bolnikih, ki so jim pravkar presadili ledvico.
English: Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Slovenian: Izdaja zdravila Envarsus je le na recept, predpišejo pa ga lahko samo zdravniki, ki imajo izkušnje z zdravili za zaviranje imunske odzivnosti in zdravljenjem bolnikov s presadki.
English: In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Slovenian: Poleg tega so bile zaradi razlik v farmacevtski obliki/odmerkih med zdraviloma Envarsus in Advagraf predložene tudi klinične študije pri bolnikih.
English: Envarsus has been shown to be at least as effective as Prograf in two main studies in patients with kidney transplants.
Slovenian: Zdravilo Envarsus je bilo v dveh glavnih študijah pri bolnikih s presajenimi ledvicami vsaj tako učinkovito kot zdravilo Prograf.
English: Envarsus is a medicine that contains the active substance tacrolimus.
Slovenian: Envarsus je zdravilo, ki vsebuje zdravilno učinkovino takrolimus.
English: Envarsus is often given with other immunosuppressive medicines following the transplant.
Slovenian: Zdravilo Envarsus se po presaditvi pogosto daje skupaj z drugimi zdravili za zaviranje imunske odzivnosti.
English: The Committee recommended that Envarsus be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Envarsus izda dovoljenje za promet.