natgillin/translations-raw huggingface dataset:
Because the hepatitis B virus can become resistant to Lamivudine Teva, the doctor should only consider prescribing Lamivudine Teva if other treatments that are less likely to lead to resistance cannot be used.
Ker lahko virus hepatitisa B postane odporen na zdravilo Lamivudine Teva, naj ga zdravnik predpiše le, če drugih zdravil, pri katerih obstaja manjša verjetnost, da bo prišlo do razvoja odpornosti, ni mogoče uporabiti.
Therefore, the CHMP's view was that, as for Zeffix, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Zeffix, odtehtajo znana tveganja.
The Committee recommended that Lamivudine Teva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Lamivudine Teva odobri dovoljenje za promet.
Lamivudine interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
Lamivudin zavira delovanje virusnega encima DNK-polimeraze, ki je udeležen pri tvorbi virusne DNK.
Other information about Lamivudine Teva
Druge informacije o zdravilu Lamivudine Teva:
Because Lamivudine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Zeffix.
Ker je zdravilo Lamivudine Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Zeffix.
Lamivudine Teva is a medicine that contains the active substance lamivudine.
Lamivudine Teva je zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva has been shown to have comparable quality and to be bioequivalent to Zeffix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lamivudine Teva primerljivo raven kakovosti kot zdravilo Zeffix ter da mu je biološko enakovredno.
The active substance in Lamivudine Teva, lamivudine, is an antiviral agent belonging to the class of the nucleoside analogues.
Zdravilna učinkovina zdravila Lamivudine Teva, lamivudin, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
Why has Lamivudine Teva been approved?
Zakaj je bilo zdravilo Lamivudine Teva odobreno?
Lamivudine Teva is not suitable for patients who require doses below 100 mg.
Zdravilo Lamivudine Teva ni primeren za bolnike, ki potrebujejo odmerke, nižje od 100 mg. Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje.
How has Lamivudine Teva been studied?
Kako je bilo zdravilo Lamivudine Teva raziskano?
What is Lamivudine Teva?
Kaj je zdravilo Lamivudine Teva?
The dose needs to be lowered for patients who have problems with their kidneys.
Pri bolnikih, ki imajo težave z ledvicami, bo odmerek morda treba prilagoditi.
How is Lamivudine Teva used?
Kako se zdravilo Lamivudine Teva uporablja?
What is Lamivudine Teva used for?
Za kaj se zdravilo Lamivudine Teva uporablja?
How does Lamivudine Teva work?
Kako zdravilo Lamivudine Teva deluje?
It should be given twice a week for 12 weeks, and then once a week for 24 weeks.
Daje se dvakrat tedensko v obdobju 12 tednov, zatem pa enkrat tedensko še 24 tednov.
The patients were followed up for up to 10 years.
Stanje bolnikov so spremljali do 10 let.
The main measure of effectiveness was the number of patients who survived without the disease coming back.
Glavno merilo učinkovitosti je bilo število preživelih bolnikov brez ponovitve bolezni.
It must not be given as a bolus injection (all at once).
Ne sme se uporabljati kot bolus injekcija (vsega naenkrat).
The most common side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), loss of appetite, headache, dizziness, tachycardia (rapid heartbeat), hypertension (high blood pressure), hypotension (low blood pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing), cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache), nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia (joint pain), back pain, pain in extremity (the arms and legs), fever, chills, fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling unwell), asthenia (weakness) and chest pain.
Najpogostejši neželeni učinki zdravila Mepact (opaženi pri več kot 1 bolniku od 10) so anemija (majhno število rdečih krvničk), izguba apetita, glavobol, vrtoglavica, tahikardija (hitro bitje srca), hipertenzija (visok krvni tlak), hipotenzija (nizek krvni tlak), dispneja (oteženo dihanje), tahipneja (hitro dihanje), kašelj, bruhanje, driska, zaprtje, bolečine v trebuhu, slabost, hiperhidroza (pretirano potenje), mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), bolečine v hrbtu, bolečine v okončinah (v rokah in nogah), zvišana telesna temperatura, mrzlica, utrujenost, hipotermija (nizka telesna temperatura), splošna bolečina, občutek neugodja, astenija (šibkost) in bolečina v prsih.
The European Commission granted a marketing authorisation valid throughout the European Union for Mepact on 6 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom Mepact, veljavno po vsej Evropski uniji, odobrila dne 6. marca 2009.
‘High grade' means that the cancer is of a severe type, and ‘non-metastatic' means that it is at an early stage and has not spread far within the body.
„Visoka stopnja“ pomeni, da je rak hujše oblike, „nemetastatski“ pa pomeni, da je v zgodnji fazi in da se ni razširil daleč po telesu.
Other information about Mepact:
Druge informacije o zdravilu Mepact:
After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines.
Po kirurški odstranitvi raka so vsi bolniki prejeli različne kombinacije zdravil za zdravljenje raka.
Mepact, used with other anticancer medicines, increased how long patients survived without their disease coming back: 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340).
Zdravilo Mepact je v kombinaciji z drugimi zdravili za zdravljenje raka povečalo trajanje preživetja bolnikov brez ponovitve bolezni: 68 % bolnikov, ki so prejeli zdravilo Mepact (231 od 338), je preživelo brez ponovitve bolezni, v primerjavi z 61 % bolnikov, ki ga niso prejeli (207 od 340).
For more information about treatment with Mepact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mepact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.
Zdravljenje z zdravilom Mepact mora uvesti in nadzorovati specializiran zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem osteosarkoma.
It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system).
Deluje tako, da aktivira makrofage in monocite (vrsti belih krvničk, ki so del imunskega sistema).
The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
Natančen mehanizem, s katerim mifamurtid deluje na osteosarkom, ni v celoti znan, domneva pa se, da povzroči sprostitev kemičnih snovi iz belih krvničk, ki uničijo rakave celice.
What benefit has Mepact shown during the studies?
Kakšne koristi je zdravilo Mepact izkazalo med študijami?
The summary of the opinion of the Committee for Orphan Medicinal Products for Mepact is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Mepact je na voljo tukaj.
This document is a summary of the European public assessment report (EPAR) for Mepact.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mepact.
The dose of Mepact depends on the patient's height and weight.
Odmerek zdravila Mepact je odvisen od bolnikove telesne višine in mase.
It must not be used at the same time as ciclosporin or other calcineurin inhibitors (medicines that reduce the activity of the immune system), or high doses of non-steroidal anti-inflammatory drugs (NSAIDs; used to treat pain and inflammation).
Ne sme se uporabljati hkrati s ciklosporinom ali drugimi inhibitorji kalcinevrina (zdravili, ki zmanjšajo delovanje imunskega sistema) ali z visokimi odmerki nesteroidnih protivnetnih zdravil (NSAID, ki se uporabljajo za zdravljenje bolečine in vnetja).
Because the number of patients with osteosarcoma is low, the disease is considered ‘rare', and Mepact was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Ker je bolnikov z osteosarkomom malo, velja bolezen za redko, zato je bilo zdravilo Mepact 21. junija 2004 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
The study compared patients who were given Mepact with those who were not.
V študiji so primerjali bolnike, ki so prejeli zdravilo Mepact, in tiste, ki zdravila niso prejeli.
Half of the patients were also given Mepact.
Polovica bolnikov je prejela tudi zdravilo Mepact.
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 Mepact.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Mepact, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma.
Zdravilo Mepact je bilo raziskano v eni glavni študiji, v kateri je sodelovalo 678 bolnikov, starih od enega do 31 let z nemetastatskim osteosarkomom visoke stopnje.
Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients.
Zdravila Mepact ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) mifamurtid ali katero koli drugo sestavino zdravila.
The risk of dying was also reduced by 28% in patients receiving Mepact.
Prav tako se je pri bolnikih, ki so prejemali zdravilo Mepact, tveganje za smrt zmanjšalo za 28 %.
Mepact is used to treat high-grade non-metastatic osteosarcoma (a type of bone cancer) in patients aged between two and 30 years.
Zdravilo Mepact se uporablja za zdravljenje nemetastatskega osteosarkoma (vrste kostnega raka) visoke stopnje pri bolnikih, starih od dve do 30 let.
Mepact is used with other anticancer medicines after the cancer has been removed by surgery.
Zdravilo Mepact se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka po tem, ko je bil rak kirurško odstranjen.
What is the risk associated with Mepact?
Kakšna tveganja so povezana z zdravilom Mepact?
The active substance in Mepact, mifamurtide, is an immunomodulator.
Zdravilna učinkovina zdravila Mepact, mifamurtid, je imunomodulator.
The CHMP decided that Mepact's benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Mepact, kadar se uporablja v kombinaciji z drugimi zdravili proti raku, večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For the full list of all side effects reported with Mepact, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Mepact, glejte navodilo za uporabo.
Why has Mepact been approved?
Zakaj je bilo zdravilo Mepact odobreno?
Mepact is given as a slow infusion lasting an hour.
Zdravilo Mepact se daje v obliki počasne, enourne intravenske infuzije.
Mepact is a powder that is made up into a suspension for infusion (drip into a vein).
Zdravilo Mepact je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
It contains the active substance mifamurtide.
Zdravilo vsebuje zdravilno učinkovino mifamurtid.
How has Mepact been studied?
Kako je bilo zdravilo Mepact raziskano?
What is Mepact?
Kaj je zdravilo Mepact?
How does Mepact work?
Kako zdravilo Mepact deluje?
What is Mepact used for?
Za kaj se zdravilo Mepact uporablja?
The full EPAR for Mepact can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mepact je na voljo tukaj.
How is Mepact used?
Kako se zdravilo Mepact uporablja?
4 implants + 1 applicator
4 implantati + 1 aplikator
Subcutaneous use sachet (PET/LDPE/alu)
Implantat subkutana uporaba Vrečka (PET/LDPE/Alu)
Studies lasted for six months or one year.
Študije so trajale od šest mesecev do enega leta.
The correct dose is determined individually for each patient.
Ustrezen odmerek se določi za vsakega bolnika posebej.
After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year.
Po 26 tednih zdravljenja so se lahko bolniki lahko odločili, ali želijo zdravljenje prekiniti ali ga nadaljevati še eno leto.
Tresiba insulin degludec
Tresiba insulin degludek
The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013.
Evropska komisija je dovoljenje za promet z zdravilom Tresiba, veljavno po vsej Evropski uniji, izdala 21. januarja 2013.
The full EPAR for Tresiba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tresiba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Tresiba?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tresiba?
This is a summary of the European public assessment report (EPAR) for Tresiba.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tresiba.
Other information about Tresiba
Druge informacije o zdravilu Tresiba
It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml and 200 units/ml).
Na voljo je kot raztopina za injiciranje v injekcijskem vložku (100 enot/ml) in napolnjenem injekcijskem peresniku (100 enot/ml in 200 enot/ml).
Tresiba is injected once a day, preferably at the same time every day.
Zdravilo Tresiba se injicira enkrat na dan, po možnosti vsak dan ob istem času.
The place within the chosen area should be changed with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin absorbed.
Mesto injiciranja na posameznem delu telesa je treba menjati ob vsakem injiciranju, da se zmanjša tveganje za lipodistrofijo (spremembe v porazdelitvi telesnega maščevja) pod kožo, ki lahko vpliva na količino absorbiranega insulina.
For more information about treatment with Tresiba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Tresiba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that Tresiba is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Tresiba je bil pripravljen načrt obvladovanja tveganj.
Tresiba is a replacement insulin that is very similar to the natural insulin with a difference that it is absorbed more slowly in the body and takes longer to reach its target.
Zdravilo Tresiba je nadomestni insulin, ki je zelo podoben naravnemu insulinu, a se od njega razlikuje po tem, da se v telesu absorbira počasneje, zato traja dlje, da doseže svoj cilj.
The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Najpogosteje opaženi neželeni učinek med zdravljenjem z zdravilom Tresiba (ki lahko prizadene več kot eno osebo od 10) je hipoglikemija (nizke ravni glukoze v krvi).
After 26 weeks of treatment with Tresiba, the average reduction in HbA1c was 0.2 percentage points (HbA1c decreased from 8.2% to 8.0%) compared with a reduction of 0.3 percentage points with insulin detemir (HbA1c decreased from 8.0% to 7.7%).
Po 26 tednih zdravljenja z zdravilom Tresiba se je HbA1c v povprečju znižal za 0,2 odstotne točke (HbA1c se je z 8,2 % znižal na 8,0 %) v primerjavi z znižanjem za 0,3 odstotne točke pri insulinu detemirju (HbA1c se je z 8,0 % znižal na 7,7 %).
What benefit has Tresiba shown during the studies?
Kakšne koristi je zdravilo Tresiba izkazalo med študijami?
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 Tresiba.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist).
Injicira se pod kožo v stegno, nadlaket ali trebušno steno (sprednji del pasu).
All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
V vseh študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), oziroma delež hemoglobina v krvi, vezanega na glukozo.
Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
Glede varnosti zdravila je ugotovil, da je zdravilo Tresiba na splošno varno in da so njegovi neželeni učinki primerljivi z neželenimi učinki drugih insulinskih analogov brez poročil o nepričakovanih neželenih učinkih.
Tresiba is a medicine that contains the active substance insulin degludec.
Tresiba je zdravilo, ki vsebuje zdravilno učinkovino insulin degludek.
The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba in order to ensure that the patient is prescribed the correct strength.
Družba, ki trži zdravilo Tresiba, bo zagotovila izobraževalno gradivo za zdravstvene delavce, ki bodo predvidoma zdravili bolnike s sladkorno boleznijo ali jim izdajali zdravila, namenjeno predvsem povečanju ozaveščenosti o večji jakosti zdravila za zagotovitev, da se bo bolniku predpisala ustrezna jakost.
What is the risk associated with Tresiba?
Kakšna tveganja so povezana z zdravilom Tresiba?
Tresiba acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Zdravilo enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tresiba, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For the full list of side effects and restrictions with Tresiba, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Tresiba glejte navodilo za uporabo.
In addition Tresiba was compared with insulin detemir in one main study involving 350 children aged 1 to 18 years of age with type 1 diabetes.
Poleg tega so zdravilo Tresiba z insulinom detemirjem primerjali v glavni študiji, ki je vključevala 350 otrok s sladkorno boleznijo tipa 1, starih od enega leta do 18 let.
Why has Tresiba been approved?
Zakaj je bilo zdravilo Tresiba odobreno?
For adolescents with type 2 diabetes, the CHMP concluded that although safety and effectiveness had only been shown for type 1 diabetes, the results of studies carried out in adolescents with type 1 and other studies in adults with type 2 diabetes could be applied to adolescents with type 2.
Pri mladoletnikih s sladkorno boleznijo tipa 2 je zaključil, da bi lahko kljub dejstvu, da sta bila varnost in učinkovitost zdravila dokazani samo za sladkorno bolezen tipa 1, rezultati študij, ki so jih izvedli pri mladostnikih s sladkorno boleznijo tipa 1, in drugih študij pri odraslih s sladkorno boleznijo tipa 2 veljali tudi za mladostnike s sladkorno boleznijo tipa 2.
Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.
Zdravilo Tresiba se uporablja za zdravljenje sladkorne bolezni tipa 1 in 2 pri odraslih in otrocih, starih od enega leta do 18 let.
The CHMP decided that Tresiba's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Tresiba večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Another main study involving 177 adults with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP-1 receptor agonist).
V še eni glavni študiji, v kateri je sodelovalo 177 odraslih bolnikov s sladkorno boleznijo tipa 2, so proučevali učinkovitost dajanja kombinacije zdravila Tresiba in liraglutida (spodbujevalca receptorjev GLP-1).
It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.
Prav tako bo za bolnike pripravila izobraževalno gradivo o pravilni uporabi zdravila Tresiba, ki jim ga bo razdelil zdravnik in ki jih bo poučil tudi o pravilni uporabi zdravila.
The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), which would allow these patients to take their daily dose in a single injection rather than two injections.
Ugotovil je tudi, da je zdravilo Tresiba v odmerku večje jakosti zadovoljilo zdravstvene potrebe bolnikov, ki potrebujejo večji odmerek insulina (na primer bolniki s prekomerno telesno maso), in menil, da tem bolnikom omogoča vnos ustreznega dnevnega odmerka z enkratnim injiciranjem namesto dveh.
Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed.
Bolniki so v tej študiji po potrebi prejemali tudi druga zdravila za zdravljenje sladkorne bolezni ali hitrodelujoči insulin, ki se daje med obroki.
Across the studies, the average reduction in HbA1c levels with Tresiba treatment was 0.6 percentage points in adults with type 1 diabetes and 1.2 points in adults with type 2 diabetes.
V študijah so se ravni HbA1c pri zdravljenju z zdravilom Tresiba povprečno znižale za 0,6 odstotne točke pri odraslih bolnikih s sladkorno boleznijo tipa 1 in 1,2 odstotne točke pri odraslih bolnikih s sladkorno boleznijo tipa 2.
In children, the effects of Tresiba on blood glucose control were similar to those of insulin detemir.
Pri otrocih so bili učinki zdravila Tresiba na uravnavanje glukoze v krvi podobni učinkom insulina detemirja.
Tresiba has been studied in three main studies involving 1,578 adults with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).
Zdravilo Tresiba so raziskovali v treh glavnih študijah, v katere je bilo vključenih 1 578 odraslih bolnikov s sladkorno boleznijo tipa 1 in v katerih so to zdravilo (v kombinaciji s hitrodelujočim insulinom, ki se daje med obroki) primerjali z insulinom glarginom ali insulinom detemirjem (drugima dolgodelujočima insulinoma).