natgillin/translations-raw huggingface dataset:
The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets. 
Družba je predložila dokaze, da je bila raven zdravilne učinkovine v krvi enaka pri osebah, ki so jemale zdravilo Tandemact, in pri tistih, ki so jemali ločene tablete.
The company that markets Tandemact will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting. 
Družba, ki trži zdravilo Tandemact, bo pripravila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in bo vključevalo možno tveganje za srčno popuščanje in rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter prekinitvi zdravljenja, če bolnikom ne koristi več.
Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. 
Pioglitazon poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. 
Študije so trajale od štiri mesece do dve leti, v njih pa so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi uravnavana.
The Committee decided that Tandemact's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi zdravila Tandemact večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Tandemact. 
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.
Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin. 
Glimepirid je sulfonilsečnina; spodbuja trebušno slinavko, da proizvede več insulina.
Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride. 
Tandemact je zdravilo, ki vsebuje dve zdravilni učinkovini, pioiglitazon in glimepirid.
Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact. 
Bolniki, ki jemljejo pioglitazon skupaj z drugim zdravilom iz istega razreda, kot je glimepirid (npr. drugo sulfonilsečnino), morajo s te druge sufonilsečnine najprej preiti na glimepirid, preden lahko začnejo uporabljati zdravilo Tandemact.
What is the risk associated with Tandemact? 
Kakšna tveganja so povezana z zdravilom Tandemact?
The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed. 
Odbor CHMP je zaključil, da je bila učinkovitost pioglitazona in glimepirida pri zdravljenju sladkorne bolezni tipa 2 dokazana in da zdravilo Tandemact poenostavlja zdravljenje ter izboljšuje zavezanost bolnikov k jemanju zdravila, kadar je potrebna kombinacija zdravilnih učinkovin.
As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes. 
Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k vzpostavitvi nadzora nad sladkorno boleznijo tipa 2.
It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding. 
Ne smejo ga uporabljati bolniki s sladkorno boleznijo tipa 1, bolniki z zapletom sladkorne bolezni (diabetično ketoacidozo ali diabetično komo) ali nosečnice in doječe matere.
It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride. 
Uporablja se pri bolnikih, za katere metformin (vrsta zdravila za zdravljenje sladkorne bolezni) ni primeren in ki so že bili zdravljeni s kombinacijo tablet z dvema zdravilnima učinkovinama, pioglitazonom in glimepiridom.
Tandemact is used to treat adult patients who have type 2 diabetes. 
Zdravilo Tandemact se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2.
These studies used pioglitazone and sulphonylureas given as separate tablets. 
V teh študijah sta bila pioglitazon in sulfonilsečnina dajana kot ločeni tableti.
In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose. 
V vseh treh študijah se je pri bolnikih, ki so uporabljali kombinacijo pioglitazona in sulfonilsečnine, izboljšal nadzor nad glukozo v krvi.
Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets. 
Bolniki, pri katerih se je pojavila hipoglikemija (nizka raven sladkorja v krvi), ko so jemali zdravilo Tandemact, bodo morda morali začeti jemati nižji odmerek ali pa se vrniti na uporabo ločenih tablet.
Tandemact contains two active substances, each of which has a different mode of action. 
Zdravilo Tandemact vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
For the full list of all side effects reported with Tandemact, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tandemact, glejte navodilo za uporabo.
The company used three studies to support the use of Tandemact in the same indication. 
V podporo uporabi zdravila Tandemact za isto indikacijo je družba predložila tri študije.
Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. 
Zdravilo Actos je odobreno za uporabo skupaj s sulfonilsečnino pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni bilo mogoče doseči zadovoljivega uravnavanja.
Why has Tandemact been approved? 
Zakaj je bilo zdravilo Tandemact odobreno?
Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys. 
Zdravila Tandemact ne smejo jemati bolniki s srčnim popuščanjem ter bolniki, ki imajo težave z jetri ali hude težave z ledvicami.
Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems. 
Zdravila Tandemact ne smejo uporabljati bolniki z resnimi obolenji ledvic ali bolniki, ki imajo težave z jetri.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tandemact have also been included in the summary of product characteristics and the package leaflet. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Tandemact.
What is Tandemact? 
Kaj je zdravilo Tandemact?
What is Tandemact used for? 
Za kaj se zdravilo Tandemact uporablja?
How does Tandemact work? 
Kako zdravilo Tandemact deluje?
How is Tandemact used? 
Kako se zdravilo Tandemact uporablja?
How has Tandemact been studied? 
Kako je bilo zdravilo Tandemact raziskano?
The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Xalkori, veljavno po vsej Evropski uniji, izdala 23. oktobra 2012.
If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day. 
Če pride do določenih neželenih učinkov, se lahko zdravnik odloči za prekinitev zdravljenja ali zmanjšanje odmerka na 200 mg dvakrat dnevno in nato na 250 mg enkrat dnevno.
What measures are being taken to ensure the safe and effective use of Xalkori? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xalkori?
The full EPAR for Xalkori 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 Xalkori je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Xalkori. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xalkori.
For the previously untreated patients, 6 out of 7 responded to treatment. 
Med predhodno nezdravljenimi bolniki se jih je šest od sedmih odzvalo na zdravljenje.
This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them. 
To se zdi ugoden odziv glede na stopnjo odziva na prejšnja zdravljenja, ki je bila od 20 do 30 % med bolniki, ki so ta zdravljenja prejemali.
This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1. 
To pomeni, da rakave celice vsebujejo spremembe, ki vplivajo na gen, odgovoren za beljakovino ROS1.
Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključila, da so koristi zdravila Xalkori večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment. 
Študija, v katero je bilo vključenih 53 ROS1-pozitivnih bolnikov, pri katerih je bolezen napredovala, je pokazala, da se je približno 70 % (37 od 53) bolnikov, ki so jemali zdravilo Xalkori, popolnoma ali deloma odzvalo na zdravljenje.
Other information about Xalkori 
Druge informacije o zdravilu Xalkori
The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness. 
Najpogostejši neželeni učinki zdravila Xalkori (opaženi pri več kot 1 bolniku od 4) so motnje vida, navzeja (slabost), driska, bruhanje, edem (oteklina), povišanje jetrnih encimov v krvi, zmanjšanje teka, zaprtje, omotica, nevropatija (bolečine zaradi okvare živcev) in utrujenost.
For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments. 
Pri bolnikih z ROS1-pozitivnim nedrobnoceličnim pljučnim rakom, za katere trenutno ni na voljo posebnega zdravljenja, je agencija ugotovila visoko stopnjo odziva, zlasti med bolniki, ki so predhodno prejemali druga zdravila za zdravljenje raka.
ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells. 
ALK in ROS1 spadata v skupino beljakovin, imenovanih receptorji tirozinske kinaze (RTK), ki sodelujejo pri rasti celic.
The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart). 
Najresnejši neželeni učinki so poškodbe jeter, pnevmonitis (vnetje pljuč), nevtropenija (nizko število nevtrofilcev, vrste belih krvničk) in podaljšan interval QT (težava z električno dejavnostjo srca).
What benefits of Xalkori have been shown in studies? 
Kakšne koristi je zdravilo Xalkori izkazalo v študijah?
What is Xalkori and what is it used for? 
Kaj je zdravilo Xalkori in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xalkori upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC. 
Deluje predvsem tako, da zavira aktivnost ALK ali ROS1, tudi ob prisotnosti genske spremembe, in s tem zmanjšuje rast in širitev raka pri ALK-pozitivnem ali ROS 1-pozitivnem nedrobnoceličnem pljučnem raku.
• It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase). 
• Uporablja se, če je nedrobnocelični pljučni rak ALK-pozitiven, kar pomeni, da rakave celice vsebujejo določene spremembe, ki vplivajo na gen, odgovoren za beljakovino, imenovano anaplastična limfomska kinaza (ALK).
For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Xalkori preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Xalkori? 
Kakšna tveganja so povezana z zdravilom Xalkori?
Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines. 
Zdravljenje z zdravilom Xalkori lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori. 
Prisotnost genskih sprememb, ki vplivajo na anaplastično limfomsko kinazo (ALK-pozitivni status) ali ROS1 (ROS1-pozitivni status), je treba pred zdravljenjem z zdravilom Xalkori potrditi.
The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine's summary of product characteristics and a patient alert card to be given to patients. 
Družba, ki trži zdravilo Xalkori, bo zagotovila, da bodo zdravniki, ki naj bi zdravilo predpisovali, prejeli izobraževalno gradivo s povzetkom glavnih značilnosti zdravila in opozorilno kartico za bolnike, ki se izroči bolniku.
It is not intended to provide practical advice on how to use Xalkori. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced: 
Xalkori je zdravilo, ki se uporablja za zdravljenje odraslih z vrsto pljučnega raka, imenovano nedrobnocelični pljučni rak (NSCLC), pri katerih je bolezen napredovala.
In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them. 
Pri bolnikih, ki so ALK-pozitivni ali ROS1-pozitivni, sta ALK in ROS1 beljakovini nenormalno aktivni in lahko spodbudita rast rakavih celic ter nastanek novih krvnih žil, ki te celice oskrbujejo.
Why is Xalkori approved? 
Zakaj je bilo zdravilo Xalkori odobreno?
Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day. 
Zdravilo Xalkori je na voljo v kapsulah (200 in 250 mg).
For the full list of all side effects reported with Xalkori, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xalkori, glejte navodilo za uporabo.
For practical information about using Xalkori, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Xalkori naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated. 
Evropska agencija za zdravila je zaključila, da zdravljenje z zdravilom Xalkori pri bolnikih z ALK-pozitivnim nedrobnoceličnim pljučnim rakom podaljša čas življenja brez poslabšanja bolezni, ne glede na to, ali so bili predhodno zdravljeni.
• It is also used when the NSCLC is ‘ROS1-positive'. 
• Uporablja se tudi, kadar je nedrobnocelični pljučni rak ROS1-pozitiven.
In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy. 
V drugi študiji, v katero je bilo vključenih 343 bolnikov, ki pred tem še niso bili zdravljeni zaradi nedrobnoceličnega pljučnega raka, so tisti, ki so bili zdravljeni z zdravilom Xalkori, v povprečju živeli skoraj enajst mesecev brez poslabšanja bolezni, medtem ko so bolniki, ki so bili predhodno zdravljeni z zdravili, ki so vsebovala pemetreksed, brez poslabšanja bolezni živeli sedem mesecev.
Doses may need to be adjusted in patients with severely reduced kidney function. 
Pri bolnikih s hudo okvaro delovanja ledvic je odmerke morda treba prilagoditi.
A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel. 
Študija, v katero je bilo vključenih 347 predhodno zdravljenih ALK-pozitivnih bolnikov, je pokazala, da so tisti, ki so jemali zdravilo Xalkori, v povprečju živeli osem mesecev brez poslabšanja bolezni, medtem ko so bolniki, ki so bili predhodno zdravljeni s pemetreksedom ali docetakselom, brez poslabšanja bolezni živeli tri mesece.
How is Xalkori used? 
Kako se zdravilo Xalkori uporablja?
ROS1-positive NSCLC 
ROS1-pozitiven nedrobnocelični pljučni rak
The active substance in Xalkori, crizotinib, is an RTK inhibitor. 
Zdravilna učinkovina v zdravilu Xalkori, krizotinib, je zaviralec receptorjev tirozinske kinaze.
How does Xalkori work? 
Kako zdravilo Xalkori deluje?
ALK-positive NSCLC 
ALK-pozitiven nedrobnocelični pljučni rak
Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects. 
Če se pri bolniku pojavijo določeni resni neželeni učinki, bo morda treba zdravljenje začasno ali trajno prekiniti.
Xalkori contains the active substance crizotinib. 
Zdravilo Xalkori vsebuje zdravilno učinkovino krizotinib.
The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Vepacel, veljavno po vsej Evropski uniji, odobrila 17. februarja 2012.
What measures are being taken to ensure the safe and effective use of Vepacel? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vepacel?
The vaccine is given according to official recommendations. 
Cepivo se lahko daje samo v skladu z uradnimi priporočili.
The full EPAR for Vepacel 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 Vepacel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Vepacel 
Druge informacije o zdravilu Vepacel
If vaccination is necessary, facilities to resuscitate patients need to be immediately available. 
Če je cepljenje vseeno potrebno, je treba zagotoviti opremo za oživljanje, ki mora biti takoj na voljo.
This is a summary of the European public assessment report (EPAR) for Vepacel. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vepacel.
Two main studies provided data on vaccination with Vepacel in adults. 
V dveh glavnih študijah so pridobili podatke o cepljenju z zdravilom Vepacel pri odraslih.
What is the risk associated with Vepacel? 
Kakšna tveganja so povezana z zdravilom Vepacel?
What benefit has Vepacel shown during the studies? 
Kakšne koristi je zdravilo Vepacel izkazalo med študijami?
Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1). 
Zdravilo Vepacel vsebuje sev gripe, imenovan A/Vietnam/1203/2004 (H5N1).
Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein. 
Zdravilo Vepacel se ne sme dajati osebam, ki so imele anafilaktično (hudo alergijsko) reakcijo na katero koli sestavino cepiva ali na katero koli izmed snovi, prisotno v cepivu v sledeh (v zelo nizkih koncentracijah), npr. formaldehid, benzonaza, saharoza, tripsin ali beljakovine celic vero.
Vepacel is a ‘prepandemic' vaccine. 
Zdravilo Vepacel je „prepandemsko“ cepivo.
A risk management plan has been developed to ensure that Vepacel is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Vepacel je bil pripravljen načrt obvladovanja tveganj.
Both studies looked separately at people aged above and below 60 years old. 
V obeh študijah so ločeno proučevali osebe, mlajše od 60 let in starejše od 60 let.
For more information about treatment with Vepacel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Vepacel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness. 
Poleg tega so bile zaščitne ravni protiteles opažene pri 71,6 % bolnikov z oslabljenim imunskim sistemom in 77,5 % bolnikov s kronično boleznijo.
The vaccine is given by injection into the shoulder or thigh in two single doses, at least three weeks apart. 
Cepivo se daje z injiciranjem v rame ali stegno z dvema posamičnima odmerkoma, med katerima mora biti vsaj tritedenski premor.
No major safety issues were seen during the studies and the side effects seen were generally mild and similar to those seen with other flu vaccines. 
Med študijami niso bili izpostavljeni nobeni večji varnostni pomisleki, opaženi neželeni učinki pa so bili večinoma blagi in podobni tistim, ki se opažajo pri drugih cepivih proti gripi.
The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation. 
CHMP je zaključil, da so koristi cepiva Vepacel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.