FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Slovenian: Tenofovir je nukleotidni zaviralec reverzne transkriptaze.
English: The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima to zdravilo primerljivo raven kakovosti kot referenčno zdravilo Atripla ter da mu je biološko enakovredno.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Opravila je tudi študijo, ki je pokazala, da je zdravilo biološko enakovredno referenčnemu zdravilu.
English: All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Slovenian: Vse tri zdravilne učinkovine zavirajo dejavnost reverzne transkriptaze, tj. encima, ki virusu HIV omogoča razmnoževanje v okuženih celicah.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Efavirenz/emtricitabin/dizoproksiltenofovirat Krka je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti-1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: This medicine is available as tablets and can only be obtained with a prescription.
Slovenian: To zdravilo je na voljo v obliki tablet, predpisovanje in izdaja zdravila pa je le na recept.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Atripla, and do not need to be repeated for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Atripla, zato jih ni treba ponoviti za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka.
English: How is the medicine used?
Slovenian: Kako se zdravilo uporablja?
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The full EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Efavirenz/emtricitabin/dizoproksiltenofovirat Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: How has the medicine been studied?
Slovenian: Kako je bilo zdravilo raziskano?
English: Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Slovenian: Nukleozidni in nukleotidni zaviralci reverzne transkriptaze so splošno znani pod kratico NRTI.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka keeps the amount of HIV in the blood at a low level.
Slovenian: Zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka ohranja nizko raven virusa HIV v krvi.
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Slovenian: To zdravilo vsebuje tri zdravilne učinkovine: efavirenz, ki je nenukleozidni zaviralec reverzne transkriptaze (NNRTI), emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, in dizoproksiltenofovirat, ki je predzdravilo tenofovirja, kar pomeni, da se v telesu pretvori v zdravilno učinkovino tenofovir.
English: Therefore, the Agency's view was that, as for Atripla, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Atripla odtehtajo znana tveganja.
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka.
English: The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine'.
Slovenian: Zdravilo vsebuje zdravilne učinkovine efavirenz, emtricitabin in dizoproksiltenofovirat in je „generično zdravilo“.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz / emtricitabine / tenofovir disoproxil
Slovenian: Efavirenz/emtricitabin/dizoproksiltenofovirat Krka efavirenz/emtricitabin/dizoproksiltenofovirat
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and what is it used for?
Slovenian: Kaj je zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka in za kaj se uporablja?
English: For more information about treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Efavirenz/emtricitabin/dizoproksiltenofovirat Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Efavirenz/emtricitabin/dizoproksiltenofovirat Krka naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is recommended that the medicine is taken on an empty stomach, preferably at bedtime.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan. Priporočljivo je, da se zdravilo jemlje na prazen želodec, po možnosti pred spanjem.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Slovenian: Druge informacije o zdravilu Efavirenz/emtricitabin/dizoproksiltenofovirat Krka
English: How does it work?
Slovenian: Kako zdravilo deluje?
English: It can be used in the following ways:
Slovenian: Lahko se uporablja na naslednje načine:
English: This summary was last updated in 11-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2012.
English: Some of the patients were also taking metformin.
Slovenian: Nekateri bolniki so jemali tudi metformin.
English: The daily dose should not exceed two tablets (100 mg).
Slovenian: Dnevni odmerek ne sme preseči dveh tablet (100 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiliarx on 19 November 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xiliarx , veljavno po vsej Evropski uniji, odobrila 19. novembra 2008.
English: It is available as tablets (50 mg).
Slovenian: Na voljo je v obliki tablet (50 mg).
English: This is a summary of the European public assessment report (EPAR) for Xiliarx.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xiliarx.
English: The full EPAR for Xiliarx 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 Xiliarx je na voljo na spletni strani agencije website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • one tablet in the morning (50 mg per day) when taken with a sulphonylurea.
Slovenian: • ena tableta zjutraj (50 mg na dan) pri jemanju s sulfonilsečnino.
English: For more information about treatment with Xiliarx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xiliarx preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Slovenian: Ti procesi skupaj znižujejo raven glukoze v krvi in pomagajo pri nadzoru sladkorne bolezni tipa 2.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiliarx.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Xiliarx, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effect with Xiliarx (seen in between 1 and 10 patients in 100) is dizziness.
Slovenian: Najpogostejši neželeni učinek zdravila Xiliarx (opažen pri 1 do 10 bolnikih od 100) je omotica.
English: The active substance in Xiliarx, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Xiliarx, vildagliptin, je zaviralec dipeptidil peptidaze 4 (DPP-4).
English: In adults, the recommended dose of Xiliarx is:
Slovenian: Pri odraslih znaša priporočeni odmerek zdravila Xiliarx:
English: Xiliarx must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Slovenian: Zdravila Xiliarx ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) vildagliptin ali katero koli drugo sestavino zdravila.
English: Vildagliptin does not work when the blood glucose is low.
Slovenian: Vildagliptin ne učinkuje, ko je raven glukoze v krvi nizka.
English: What benefit has Xiliarx shown during the studies?
Slovenian: Kakšne koristi je zdravilo Xiliarx izkazalo med študijami?
English: Xiliarx 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 Xiliarx 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: Other information about Xiliarx
Slovenian: Druge informacije o zdravilu Xiliarx
English: The CHMP also considered the use of Xiliarx on its own and concluded that it was effective in reducing blood glucose but less so than metformin.
Slovenian: CHMP je proučil tudi samostojno uporabo zdravila Xiliarx in zaključil, da je sicer učinkovito pri zniževanju glukoze v krvi, a manj kot metformin.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze (sladkorja) v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
English: In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti sprememba koncentracije snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi, ki kaže, kako dobro je krvni sladkor uravnan.
English: Xiliarx 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 Xiliarx 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: Xiliarx is a medicine that contains the active substance vildagliptin.
Slovenian: Xiliarx je zdravilo, ki vsebuje zdravilno učinkovino vildagliptin.
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Xiliarx and at regular intervals during treatment.
Slovenian: Ker vildagliptin povezujejo z okvaro jeter, morajo bolniki pred začetkom zdravljenja z zdravilom Xiliarx opraviti preiskave jeter in nato v rednih presledkih med zdravljenjem.
English: A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
Slovenian: Morda bo treba odmerek sulfonilsečnine znižati, da se zmanjša tveganje za pojav hipoglikemije (nizkih ravni krvnega sladkorja).
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: Xiliarx is used to treat type 2 diabetes mellitus.
Slovenian: Zdravilo Xiliarx se uporablja za zdravljenje sladkorne bolezni tipa 2.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Slovenian: Deluje tako, da zavira razgradnjo hormonov inkretinov v telesu.
English: Four studies compared the effects of Xiliarx, 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 Xiliarx 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 Xiliarx 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 Xiliarx 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: For the full list of all side effects reported with Xiliarx, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Xiliarx, glejte navodilo za uporabo.
English: In the study involving 296 patients taking insulin, adding Galvus 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 Xiliarx 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: In the study comparing Xiliarx 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 Xiliarx.
Slovenian: V študiji, v kateri so zdravilo Xiliarx 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 Xiliarx.
English: However, in another study involving 449 patients taking insulin, the size of this effect was significant.
Slovenian: Vendar pa je bila v drugi študiji, v kateri je sodelovalo 449 bolnikov, razlika precej pomembnejša.
English: What is the risk associated with Xiliarx?
Slovenian: Kakšna tveganja so povezana z zdravilom Xiliarx?
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Slovenian: Ti se sproščajo po obroku in spodbujajo trebušno slinavko k tvorjenju insulina.
English: • together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient's diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
Slovenian: • skupaj z metforminom, tiazolidindionom ali sulfonilsečnino (zdravljenje z dvema zdraviloma), kadar sladkorna bolezen ni zadostno urejena samo s tem drugim zdravilom, vendar se v kombinaciji s sulfonilsečnino uporablja samo pri bolnikih, ki ne morejo jemati metformina;
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Slovenian: Vildagliptin s povečanjem koncentracije hormonov inkretinov v krvi spodbuja trebušno slinavko, da tvori več insulina, ko je raven glukoze v krvi visoka.
English: In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points.
Slovenian: Pri njegovi uporabi v kombinaciji z glimepiridom sta 50-miligramski in 100-miligramski dnevni odmerek povzročila znižanje za približno 0,6 odstotne točke.
English: When used as an add-on to existing treatment for type 2 diabetes, Xiliarx 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 pri zniževanju koncentracije HbA1c učinkovitejše od placeba.
English: Why has Xiliarx been approved?
Slovenian: Zakaj je bilo zdravilo Xiliarx odobreno?
English: Xiliarx used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Slovenian: Kadar se je zdravilo Xiliarx uporabljalo samostojno, je bilo sicer učinkovito pri zniževanju ravni HbA1c, a manj kot primerjalna zdravila.
English: Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Slovenian: Zmanjšuje tudi tvorbo glukoze v jetrih, in sicer z zviševanjem koncentracije insulina in zniževanjem koncentracije hormona glukagona.
English: In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.
Slovenian: Nasprotno pa je bila pri bolnikih, ki so poleg obstoječega zdravljenja prejemali placebo, sprememba koncentracije HbA1c manjša in je znašala od znižanja za 0,3 odstotne točke do povečanja za 0,2 odstotne točke.
English: In combination with metformin and glimepiride, 50 mg Galvus 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 glimepiridom je zdravilo Xiliarx 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 Galvus 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 Xiliarx 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: • 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: • 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 ustaljenim odmerkom insulina.
English: Five of these studies looked at the effects of Xiliarx taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Slovenian: V petih študijah so pri skupno 3 644 bolnikih proučevali učinke zdravila Xiliarx, 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 50-miligramskega, pri čemer se je koncentracija HbA1c znižala za 0,8 do 1,0 odstotne točke.
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: How has Xiliarx been studied?
Slovenian: Kako je bilo zdravilo Xiliarx raziskano?
English: What is Xiliarx used for?
Slovenian: Za kaj se zdravilo Xiliarx uporablja?
English: What is Xiliarx?
Slovenian: Kaj je zdravilo Xiliarx?
English: How does Xiliarx work?
Slovenian: Kako zdravilo Xiliarx deluje?
English: A further study compared Galvus 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 Xiliarx primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
English: How is Xiliarx used?
Slovenian: Kako se zdravilo Xiliarx uporablja?
English: A further study compared Galvus 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 Xiliarx primerjali s placebom, kadar sta bila uporabljena kot dodatek zdravljenju.
English: This medicine is the same as Galvus, which is already authorised in the European Union (EU).
Slovenian: Ta odobritev je temeljila na dovoljenju za promet, odobrenemu za zdravilo Galvus leta 2007 (uporaba dokumentacije s soglasjem).
English: The physician information should contain the following key messages:
Slovenian: Informacije za zdravnika morajo vsebovati naslednje pomembne informacije: