FrancophonIA/ELRC3.0 huggingface dataset:
English: Jalra must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Slovenian: Zdravila Jalra ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vildagliptin ali katero koli drugo sestavino zdravila.
English: Jalra is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Slovenian: Zdravilo Jalra ni priporočljivo za bolnike, ki imajo zmerne ali hude težave z ledvicami, vključno z bolniki na hemodializi (tehniki čiščenja krvi) s končno ledvično odpovedjo.
English: Jalra should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Slovenian: Zdravilo Jalra naj bi torej uporabljali samo bolniki, za katere metformin ni primeren bodisi zaradi neželenih učinkov, ki se pojavijo zaradi jemanja metformina, bodisi ker imajo bolezen, pri kateri jemanje metformina zanje ni ustrezno.
English: Jalra has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Slovenian: Zdravilo Jalra so proučevali v 11 glavnih študijah, v katere je bilo vključenih skupno več kot 5 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih koncentracija glukoze v krvi ni bila zadostno uravnana.
English: Why has Jalra been approved?
Slovenian: Zakaj je bilo zdravilo Jalra odobreno?
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Jalra and at regular intervals during treatment.
Slovenian: Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki pred začetkom zdravljenja z zdravilom Jalra opraviti preiskave jeter in nato v rednih presledkih med zdravljenjem.
English: The CHMP also considered the use of Jalra on its own and concluded that it was effective in reducing blood glucose but was less effective than metformin.
Slovenian: CHMP je proučil tudi samostojno uporabo zdravila Jalra in zaključil, da je sicer učinkovito pri zniževanju glukoze v krvi, a manj kot metformin.
English: Jalra is not recommended for patients with liver problems.
Slovenian: Zdravilo Jalra ni priporočljivo za bolnike z okvaro jeter.
English: What is the risk associated with Jalra?
Slovenian: Kakšna tveganja so povezana z zdravilom Jalra?
English: For the full list of all side effects reported with Jalra, including side effects occurring when Jalra is taken with other antidiabetes medicines, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Jalra, vključno z neželenimi učinki, ki se pojavijo, kadar se zdravilo Jalra jemlje z drugimi zdravili proti sladkorni bolezni, glejte navodilo za uporabo.
English: • one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
Slovenian: • ena tableta zjutraj in druga zvečer (100 mg na dan) kadar se uporablja samostojno, z metforminom ali tiazolidindionom, z metfominom v kombinaciji s sulfonilsečnino ali z insulinom (z metforminom ali brez njega);
English: In the study involving 296 patients taking insulin, adding Jalra caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect was small possibly due to the fact that the study included long-term patients who were less likely to show improvement..
Slovenian: V študiji, v kateri je sodelovalo 296 bolnikov, ki so jemali insulin, je dodajanje zdravila Jalra povzročilo večje znižanje ravni HbA1c kot dodajanje placeba, vendar je bila razlika zelo majhna, kar je verjetno posledica dejstva, da je študija vključevala dolgotrajne bolnike, pri katerih je bilo izboljšanje stanja manj verjetno.
English: Four studies compared the effects of Jalra, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Slovenian: V štirih študijah so primerjali učinke zdravila Jalra v odmerku 50 ali 100 mg na dan v obdobju 24 tednov z učinki placeba, kadar je bilo uporabljeno kot dodatek k obstoječemu zdravljenju z metforminom (544 bolnikov), pioglitazonom (tiazolidindionom, 463 bolnikov), glimepiridom (sulfonilsečnino, 515 bolnikov) ali insulinom (296 bolnikov).
English: The CHMP noted that Jalra was effective as an add-on to metformin, a thiazolidinedione or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Slovenian: CHMP je ugotovil, da je bilo zdravilo Jalra učinkovito kot dodatek zdravljenju z metforminom, tiazolidindionom ali sulfonilsečnino (zdravljenje z dvema zdraviloma), kot dodatek sulfonilsečnini in metforminu (zdravljenje s tremi zdravili) ali insulinu z metforminom ali brez njega, ter zaključil, da so koristi dodatnega zdravljenja večje od tveganj.
English: Jalra is used to treat type 2 diabetes mellitus.
Slovenian: Zdravilo Jalra se uporablja za zdravljenje sladkorne bolezni tipa 2.
English: In the study comparing Jalra with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Jalra.
Slovenian: V študiji, v kateri so zdravilo Jalra primerjali z metforminom, so bili opaženi občutno boljši rezultati z metforminom: znižanje HbA1c za 1,5 odstotne točke po 52 tednih v primerjavi z znižanjem za okoli 1 odstotno točko pri bolnikih, ki so prejemali zdravilo Jalra.
English: When used as an add-on to existing treatment for type 2 diabetes, Jalra was more effective than placebo in reducing HbA1c levels.
Slovenian: Pri njegovi uporabi kot dodatna terapija k obstoječemu zdravljenju sladkorne bolezni tipa 2 je bilo zdravilo Jalra pri zniževanju koncentracije HbA1c učinkovitejše od placeba.
English: Jalra used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Slovenian: Kadar se je zdravilo Jalra uporabljalo samostojno, je bilo sicer učinkovito pri zniževanju ravni HbA1c, a manj kot primerjalna zdravila.
English: In combination with metformin and glimepiride, 50 mg Jalra taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
Slovenian: V kombinaciji z metforminom in glimepiriom je zdravilo Jalra v odmerku 50 mg dvakrat na dan znižalo ravni HbA1c za eno odstotno točko v primerjavi z znižanjem za 0,3 odstotne točke pri bolnikih, ki so jemali placebo.
English: Patients taking Jalra in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Slovenian: Pri bolnikih, ki so zdravilo Jalra jemali kot dodatek insulinu z metforminom ali brez njega, se je raven HbA1c znižala za 0,77 odstotne točke, medtem ko se je pri bolnikih, ki so kot dodatek insulinu jemali placebo, znižala le za 0,05 odstotne točke.
English: What is Jalra used for?
Slovenian: Za kaj se zdravilo Jalra uporablja?
English: Five of these studies looked at the effects of Jalra taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or or gliclazide (a sulphonylurea).
Slovenian: V petih študijah so pri skupno 3 644 bolnikih proučevali učinke zdravila Jalra, uporabljenega samostojno, ter jih primerjali z učinki placeba (zdravila brez zdravilne učinkovine), metformina, rosiglitazona (tiazolidindiona) ali gliklazida (sulfonilsečnine).
English: With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points.
Slovenian: Pri njegovi uporabi z metforminom in pioglitazonom je bil 100-miligramski dnevni odmerek učinkovitejši od 50miligramskega, pri čemer se je koncentracija HbA1c znižala za 0,8 do 1,0 odstotne točke.
English: • together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
Slovenian: • skupaj z insulinom (z metforminom ali brez njega) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena z dieto in telesno vadbo ter stalnim odmerkom insulina.
English: • together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
Slovenian: • skupaj s sulfonilsečnino in metforminom (zdravljenje s tremi zdravili) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena s temi zdravili, dieto in telesno vadbo.
English: How has Jalra been studied?
Slovenian: Kako je bilo zdravilo Jalra raziskano?
English: • on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
Slovenian: • samostojno (zdravljenje z enim zdravilom) pri bolnikih, pri katerih sladkorna bolezen ni zadostno urejena s prehrano in telesno vadbo ter ki ne morejo jemati metformina.
English: What is Jalra?
Slovenian: Kaj je zdravilo Jalra?
English: How does Jalra work?
Slovenian: Kako zdravilo Jalra deluje?
English: How is Jalra used?
Slovenian: Kako se zdravilo Jalra uporablja?
English: A further study compared Jalra with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.
Slovenian: V nadaljnji študiji so pri 318 bolnikih, ki so že jemali metformin ali glimepirid, zdravilo Jalra primerjali s placebom, če je bilo uporabljeno kot dodatek zdravljenju, .
English: A further study compared Jalra with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
Slovenian: V nadaljnji študiji so pri 449 bolnikih, ki so že jemali ustaljen odmerek insulina z dolgotrajnim delovanjem, zdravilo Jalra primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kaletra on 20 March 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kaletra, veljavno po vsej Evropski uniji, izdala 20. marca 2001.
English: The medicine is taken once or twice daily in adults, and the dose depends on the type of virus the patient is infected with.
Slovenian: Zdravilo se pri odraslih jemlje enkrat ali dvakrat dnevno, odmerek pa je odvisen od tipa virusa, s katerim je bolnik okužen.
English: The capsules and liquid must be taken with food, but the tablets can be taken with or without food.
Slovenian: Kapsule in tekočino je treba jemati s hrano, tablete pa se lahko jemljejo s hrano ali brez nje.
English: What measures are being taken to ensure the safe and effective use of Kaletra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kaletra?
English: HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: HIV je virus, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: In children, the dose depends on body weight and height.
Slovenian: Pri otrocih je odmerek odvisen od telesne mase in višine.
English: The full EPAR for Kaletra 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) za zdravilo Kaletra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Kaletra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kaletra.
English: The medicine is also well tolerated and its side effects are manageable.
Slovenian: Zdravilo tudi dobro prenašajo, njegovi neželeni učinki pa so obvladljivi.
English: Other information about Kaletra
Slovenian: Druge informacije o zdravilu Kaletra
English: The European Medicines Agency (EMA) therefore concluded that the benefits of Kaletra outweigh its risks and recommended that it be given marketing authorisation in the EU.
Slovenian: Evropska agencija za zdravila (EMA) je zato zaključila, da koristi zdravila Kaletra odtehtajo z njim povezana tveganja, in priporočila, da se zanj izda dovoljenje za promet.
English: When the enzyme is blocked, the virus does not reproduce normally slowing down its multiplication in the body.
Slovenian: Ko je encim zavrt, se virus v telesu ne razmnožuje več normalno, temveč upočasnjeno.
English: Studies have shown that Kaletra is effective at reducing viral load (the amount of virus found in the blood) to very low levels (below 400 copies/ml).
Slovenian: Študije so pokazale, da zdravilo Kaletra učinkovito zmanjšuje virusno breme (količino virusa v krvi) na zelo nizko raven (pod 400 kopij/ml).
English: What is Kaletra and what is it used for?
Slovenian: Kaj je zdravilo Kaletra in za kaj se uporablja?
English: What benefits of Kaletra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kaletra izkazalo v študijah?
English: Kaletra is an HIV medicine used in combination with other medicines to treat adults and children from over 14 days of age who are infected with HIV-1.
Slovenian: Kaletra je zdravilo proti virusu HIV, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih in otrok, starejših od 14 dni, ki so se okužili z virusom HIV-1.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kaletra 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 Kaletra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It is not intended to provide practical advice on how to use Kaletra.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Both active substances in Kaletra are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of HIV.
Slovenian: Obe zdravilni učinkovini v zdravilu Kaletra sta zaviralca proteaze: zavirata encim, imenovan proteaza, ki je vključen v razmnoževanje virusa HIV.
English: Kaletra must not be used by patients with severe liver disease or by patients who are taking St John's wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Kaletra and are harmful at high levels in the blood.
Slovenian: Zdravila Kaletra ne smejo uporabljati bolniki z resnim obolenjem jeter ali tisti, ki se zdravijo s šentjanževko (pripravkom rastlinskega izvora za zdravljenje depresije) ali zdravili, ki se presnavljajo enako kot zdravilo Kaletra in so pri visokih koncentracijah v krvi škodljiva.
English: What are the risks associated with Kaletra?
Slovenian: Kakšna tveganja so povezana z zdravilom Kaletra?
English: Kaletra does not cure HIV infection or AIDS, but it may hold off damage to the immune system, and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Kaletra ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: The most common side effects with Kaletra in adults (seen in more than 1 patient in 10) are upper respiratory tract infection (colds), nausea (feeling sick) and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Kaletra (opaženi pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (prehlad), navzeja (siljenje na bruhanje) in driska.
English: For more information about treatment with Kaletra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kaletra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Kaletra contains two active substances, lopinavir and ritonavir.
Slovenian: Zdravilo Kaletra vsebuje dve zdravilni učinkovini, lopinavir in ritonavir.
English: Kaletra is available as tablets, capsules and oral liquid.
Slovenian: Zdravilo Kaletra je na voljo v obliki tablet, kapsul in peroralne tekočine.
English: Why is Kaletra approved?
Slovenian: Zakaj je bilo zdravilo Kaletra odobreno?
English: Kaletra can only be obtained with a prescription and should be prescribed by a doctor with experience treating HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Kaletra je le na recept, predpisati pa ga mora zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
English: For practical information about using Kaletra, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kaletra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In one study of adults who had not been treated for HIV before, 79% of the patients taking Kaletra (259 out of 326) had very low levels of the virus after 24 weeks, compared with 71% of the patients taking nelfinavir (233 out of 327).
Slovenian: V eni študiji pri odraslih, pri katerih okužbe z virusom HIV pred tem niso zdravili, je bila po 24 tednih raven virusa zelo nizka pri 79 % bolnikov, ki so prejemali zdravilo Kaletra (259 od 326), v primerjavi z 71 % bolnikov, ki so prejemali nelfinavir (233 od 327).
English: For the full list of all side effects reported with Kaletra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kaletra, glejte navodilo za uporabo.
English: A second adult study in patients who had previously taken a protease inhibitor, 73% of the patients taking Kaletra (43 out of 59) had very low levels of the virus after 16 weeks, compared with 54% of the patients taking the comparator medicines (32 out of 59).
Slovenian: V drugi študiji pri odraslih bolnikih, ki so pred tem prejemali zaviralca proteaze, je bila raven virusa po 16 tednih zelo nizka pri 73 % (43 od 59) bolnikov, ki so prejemali zdravilo Kaletra, v primerjavi s 54 % (32 od 59) bolnikov, ki so prejemali primerjalna zdravila .
English: Studies in children from 14 days of age showed between 71% and 85% of patients having very low levels of the virus after 48 weeks of treatment with Kaletra.
Slovenian: Študije pri otrocih, starejših od 14 dni, so pokazale, da ima po 48 tednih zdravljenja z zdravilom Kaletra zelo nizko raven virusa med 71 % in 85 % bolnikov.
English: How is Kaletra used?
Slovenian: Kako se zdravilo Kaletra uporablja?
English: In Kaletra, lopinavir provides the activity against the virus while ritonavir mainly works as a ‘booster' to slow down the rate at which lopinavir is broken down by the liver.
Slovenian: ritonavir pa služi kot „stopnjevalec“, ki upočasni razgradnjo lopinavirja v jetrih.
English: How does Kaletra work?
Slovenian: Kako zdravilo Kaletra deluje?
English: Kaletra is effective at reducing HIV viral loads to below 400 copies/ml in the majority of adults and children from 14 days of age.
Slovenian: Zdravilo Kaletra pri večini odraslih in otrok, starejših od 14 dni, učinkovito znižuje virusno breme HIV pod 400 kopij/ml.
English: Γ.Α.Σταµάτης & Σια Λτδ.
Slovenian: Γ.Α.Σταμάτης & Σια Λτδ.
English: However, such an effect cannot be ruled out.
Slovenian: Vendar pa takega učinka ne moremo izključiti.
English: • Allergic reactions.
Slovenian: • Alergične reakcije.
English: Knowledge about the mechanism is incomplete.
Slovenian: Poznavanje mehanizma je nepopolno.
English: In some patients additional factor VIII was given.
Slovenian: Nekateri bolniki so dodatno prejeli faktor VIII.
English: This can lead to an increased risk of many types of infections.
Slovenian: To pa lahko privede do povečanega tveganja za različne tipe okužb.
English: With milk
Slovenian: Z mlekom
English: These are called CD4 white blood cells.
Slovenian: To so CD4 bele krvne celice.
English: It is very important that the correct number of tablets be taken at each dose.
Slovenian: Zelo pomembno je, da se vzame pravilno število tablet pri vsakem odmerku.
English: Other side effects which have also been reported:
Slovenian: Drugi neželeni učinki o katerih so poročali:
English: Elderly: There are no data available in the elderly.
Slovenian: Starejši: Za starejše bolnike podatki niso na voljo.
English: • Increase the number of some cells in your blood that help fight infection.
Slovenian: • poveča število nekaterih celic v vaši krvi, ki se pomagajo boriti proti okužbi.
English: In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
Slovenian: V več kot polovici poročanih primerov so zdravljenje s PI nadaljevali ali ponovno vpeljali, če je bilo prekinjeno.
English: • Infection.
Slovenian: • Okužba.
English: The virologic and immunologic responses should be monitored to assure these children achieve response to therapy.
Slovenian: Spremljati je treba virološki in imunološki odziv, da se zagotovi, da ti otroci dosežejo odziv na terapijo.
English: With food
Slovenian: S hrano
English: • Take all the mixture you make each time.
Slovenian: • Zaužijte celotno mešanico, ki jo vsakič pripravite.
English: This includes medicines that you buy without a prescription and herbal medicines.
Slovenian: To vključuje tudi zdravila, ki ste jih kupili brez recepta in zdravila rastlinskega izvora.
English: Signs of previous infections
Slovenian: Simptomi prejšnjih okužb
English: The terminal half-life in plasma was typically 3.5 to 5 hours.
Slovenian: Končna razpolovna doba v plazmi je 3,5 do 5 ur.
English: You may continue to get infections or other illnesses due to your HIV.
Slovenian: Še vedno lahko zaradi vašega virusa HIV dobite okužbe ali druge bolezni.
English: It is recommended that HIV-infected women must not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočeno je, da s HIV okužene ženske pod nobenim pogojem ne dojijo svojih otrok, da bi preprečile prenos virusa HIV.
English: Total number of tablets per day
Slovenian: Skupno število tablet na dan
English: • Yellow skin or eyes.
Slovenian: • porumenelost kože in oči.
English: If you forget to take Viracept If you forget to take a dose, take it as soon as you remember it.
Slovenian: Če ste pozabili vzeti zdravilo Viracept Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: As these data come from the spontaneous reporting system, the frequency of the adverse reactions is not confirmed.
Slovenian: Ker podatki izhajajo iz sistema spontanega poročanja, pogostnosti neželenih učinkov ni mogoče potrditi.
English: The list also includes marked laboratory abnormalities that have been observed with nelfinavir (at 48 weeks).
Slovenian: Seznam vključuje tudi izbrane laboratorijske nepravilnosti, ki so jih opazili z nelfinavirjem (pri 48 tednih).
English: Effects on drug levels % Change
Slovenian: Vplivi na koncentracije zdravil % spremembe
English: The reason for this high variability is not known but may be due to inconsistent food intake in paediatric patients.
Slovenian: Vzrok za te velike razlike ni znan, lahko pa je posledica neskladnosti prehranjevanja pri pediatričnih bolnikih.
English: The different ways are shown in separate tables below.
Slovenian: Različni načini so prikazani v ločenih preglednicah spodaj.