FrancophonIA/ELRC3.0 huggingface dataset:
English: When added to metformin the dose of metformin should remain unchanged, however when combined with a sulphonylurea or insulin, a lower dose of the sulphonylurea or insulin may be considered because of the risk of hypoglycaemia (low blood sugar).
Slovenian: Kadar se zdravilo dodaja metforminu, mora odmerek metformina ostati enak, pri kombinaciji s sulfonilsečnino ali insulinom pa je morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da se zmanjša tveganje hipoglikemije (nizke ravni sladkorja v krvi).
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Slovenian: Linagliptin s podaljševanjem delovanja inkretinskih hormonov v krvi spodbuja trebušno slinavko k tvorjenju večje količine insulina, kadar so ravni glukoze v krvi visoke.
English: This gives an indication of how well blood glucose is controlled.
Slovenian: Ta kaže, kako dobro je raven glukoze v krvi uravnana.
English: Trajenta is also used on its own in patients whose blood sugar levels are not adequately controlled by diet and exercise alone and who cannot be treated with metformin because they cannot tolerate it or because they have kidney problems.
Slovenian: Zdravilo Trajenta se kot samostojno zdravilo uporablja tudi pri bolnikih, pri katerih samo z dieto in telesno vadbo ni mogoče zadovoljivo uravnati sladkorja v krvi in ki se ne smejo zdraviti z metforminom, ker ga ne prenašajo ali imajo težave z ledvicami.
English: Trajenta was also more effective than placebo when used on its own, reducing HbA1c levels by 0.46 percentage points compared with a rise of 0.22 percentage points seen with placebo.
Slovenian: Zdravilo Trajenta je bilo učinkovitejše tudi od samostojno uporabljenega placeba, saj so se ravni HbA1c pri uporabi zdravila Trajenta znižale za 0,46 odstotne točke, medtem ko so se pri uporabi placeba povečale za 0,22 odstotne točke.
English: Based on the results of the main studies, the CHMP concluded that significant benefits in controlling blood glucose levels were seen in the combinations of Trajenta with metformin, with metformin plus a sulphonylurea, and with insulin with or without metformin.
Slovenian: Na podlagi rezultatov glavnih študij je CHMP zaključil, da so bile pri jemanju zdravila Trajenta v kombinaciji z metforminom, v kombinaciji z metforminom in sulfonilsečnino in v kombinaciji z insulinom ob sočasnem jemanju metformina ali brez njega opažene pomembne koristi pri uravnavanju ravni glukoze v krvi.
English: Trajenta is used to treat type 2 diabetes with the following antidiabetes medicines when blood sugar levels are not already adequately controlled by diet, exercise and these antidiabetes medicines taken alone:
Slovenian: Zdravilo Trajenta se uporablja za zdravljenje sladkorne bolezni tipa 2 v kombinaciji s spodaj navedenimi zdravili za zdravljenje sladkorne bolezni, kadar raven sladkorja v krvi ni zadovoljivo uravnana z dieto, telesno vadbo in jemanjem zadevnih zdravil kot samostojnih zdravil:
English: How has Trajenta been studied?
Slovenian: Kako je bilo zdravilo Trajenta raziskano?
English: • when used in combination with a metformin plus a sulphonylurea, a reduction of 0.72 percentage points was seen with Trajenta compared with a reduction of 0.10 percentage points with placebo;
Slovenian: • pri uporabi zdravila Trajenta v kombinaciji z metforminom in sulfonilsečnino so zabeležili znižanje za 0,72 odstotne točke v primerjavi s porastom za 0,10 odstotne točke v kombinaciji s placebom;
English: • when used in combination with metformin, a reduction of 0.56 percentage points was seen with
Slovenian: • pri uporabi zdravila Trajenta v kombinaciji z metforminom so zabeležili znižanje za 0,56 odstotne
English: What is Trajenta used for?
Slovenian: Za kaj se zdravilo Trajenta uporablja?
English: How is Trajenta used?
Slovenian: Kako se zdravilo Trajenta uporablja?
English: • in combination with insulin with or without metformin and/or pioglitazone, a reduction of 0.55
Slovenian: • pri uporabi zdravila Trajenta v kombinaciji z insulinom ob sočasni uporabi metformina in/ali pioglitazona so zabeležili znižanje za 0,55 odstotne točke v primerjavi s porastom za 0,10 odstotne točke v kombinaciji s placebom.
English: • in combination with pioglitazone, a reduction of 1.25 percentage points was seen with Trajenta compared with a reduction of 0.75 percentage points with placebo;
Slovenian: • pri uporabi zdravila Trajenta v kombinaciji s pioglitazonom so zabeležili znižanje za 1,25 odstotne
English: What is Trajenta?
Slovenian: Kaj je zdravilo Trajenta?
English: How does Trajenta work?
Slovenian: Kako zdravilo Trajenta deluje?
English: • Educational brochure
Slovenian: • izobraževalno knjižico,
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • Povzetek glavnih značilnosti zdravila (SPC), Navodilo za uporabo in Označevanje.
English: • Brief background on Tasigna, its authorised indication and posology
Slovenian: • kratek opis zdravila Tasigna, njegovih odobrenih indikacij in odmerjanja,
English: • The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes
Slovenian: • da je treba bolnike obvestiti o vplivu hrane na zdravilo Tasigna in sicer: o naj ne jedo dve uri pred zaužitjem zdravila Tasigna in eno uro po njem, o naj se izogibajo uživanju živil, kot je grenivkin sok, ki zavira encime CYP3A4.
English: The MAH shall ensure that prior to launch, all doctors who intend to prescribe Tasigna, and all pharmacists who may dispense Tasigna, are provided with a healthcare professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na tržišče vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Tasigna, in vsi lekarnarji, ki bodo lahko izdajali zdravilo Tasigna, prejeli komplet podatkov za strokovno zdravstveno osebje, ki bo vseboval sledeče:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE, KI SO V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA POSTAVLJENI DRŽAVAM ČLANICAM
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da se vzpostavijo vsi pogoji oziroma omejitve glede varne in učinkovite uporabe zdravila, kot so opisani spodaj:
English: Key elements to be included in the educational brochure
Slovenian: Izobraževalna knjižica mora vsebovati sledeče ključne vsebine:
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: DODATEK POGOJI ALI OMEJITVE, KI JIH MORAJO V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA ZAGOTOVITI DRŽAVE ČLANICE
English: • Information on the cardiac risks associated with the use of Tasigna o That Tasigna can cause prolongation of the QT interval and that patients at risk of arrythmia, especially torsade de pointes, should not be prescribed Tasigna.
Slovenian: • informacije o tveganju za srce v povezavi z uporabo zdravila Tasigna in sicer: o da zdravilo Tasigna lahko povzroča podaljšanje intervala QT in da se ga ne sme predpisovati bolnikom s tveganjem za aritmije, še posebno ne tistim s tveganjem za torsade de pointes, o da se je treba izogibati predpisovanju sočasne uporabe drugih zdravil, ki bi lahko podaljševala interval QT, o da je potrebna previdnost pri predpisovanju zdravila bolnikom z anamnezo koronarne bolezni ali s tveganjem za zanjo, o da zdravilo Tasigna lahko povzroča zastajanje tekočine, popuščanje srca in pljučni edem,
English: • That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna.
Slovenian: • da se zdravilo Tasigna presnavlja s CYP3A4 in da močni zaviralci ali induktorji tega encima lahko pomembno vplivajo na izpostavljenost zdravilu Tasigna: o da zaviralci lahko povečajo možnost neželenih učinkov, še posebno podaljšanja intervala QT, o da je treba bolnike opozoriti glede uporabe zdravil brez recepta, še posebno šentjanževke,
English: The tablet should be swallowed whole with a little water.
Slovenian: Tableto je treba pogoltniti celo z malo vode.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tandemact on 8 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tandemact, veljavno po vsej Evropski uniji, izdala 8. januarja 2007.
English: The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day.
Slovenian: Običajni odmerek zdravila Tandemact je ena tableta enkrat dnevno tik pred ali med prvim dnevnim obrokom.
English: Other information about Tandemact
Slovenian: Druge informacije o zdravilu Tandemact
English: The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Slovenian: Njihove ravni HbA1c so z izhodiščne vrednosti nad 7,5 % padle od 1,22 do 1,64 %.
English: Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Slovenian: Ker je pioglitazon v Evropski uniji (EU) odobren od leta 2000 pod imenom Actos in ker se glimepirid uporablja v že odobrenih zdravilih v EU, je družba predložila podatke iz predhodnih študij in objavljene literature.
English: The full EPAR for Tandemact 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 Tandemact je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Tandemact?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tandemact?
English: It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Slovenian: Na voljo je v obliki tablet (30 mg pioglitazona in 2 mg ali 4 mg glimepirida oziroma 45 mg pioglitazona in 4 mg glimepirida).
English: At least 64% of the patients treated were classified as ‘responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Slovenian: Vsaj 64 % zdravljenih bolnikov je bilo razvrščenih med „odzivne bolnike“, ker so njihove ravni Hb1Ac med trajanjem študije padle za vsaj 0,6 % izhodiščne vrednosti, ali pa so njihove ravni HbA1c ob koncu študije znašale 6,1 % ali manj.
English: This is a summary of the European public assessment report (EPAR) for Tandemact.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tandemact.
English: Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Slovenian: Zdravljenje z zdravilom Tandemact je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
English: For more information about treatment with Tandemact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tandemact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Tandemact pioglitazone and glimepiride
Slovenian: Tandemact pioglitazon in glimepirid
English: What benefit has Tandemact shown during the studies?
Slovenian: Kakšne koristi je zdravilo Tandemact izkazalo med študijami?
English: The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling).
Slovenian: Najpogostejši neželeni učinki zdravila Tandemact (opaženi pri 1 do 10 bolnikih od 100) so okužba zgornjih dihal (prehladi), hipestezija (zmanjšan občutek za dotik), zlomi kosti, povečanje telesne mase, vrtoglavica, napenjanje (vetrovi) in edem (oteklina).
English: The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
Slovenian: V te študije je bilo vključenih 1 390 bolnikov, ki so pioglitazon dodajali svojemu že obstoječemu zdravljenju s sulfonilsečnino.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Pioglitazon poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: 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.
Slovenian: 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.
English: The Committee decided that Tandemact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Tandemact večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Tandemact.
Slovenian: 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.
English: Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Slovenian: Glimepirid je sulfonilsečnina; spodbuja trebušno slinavko, da proizvede več insulina.
English: Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Slovenian: Tandemact je zdravilo, ki vsebuje dve zdravilni učinkovini, pioiglitazon in glimepirid.
English: 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.
Slovenian: 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.
English: What is the risk associated with Tandemact?
Slovenian: Kakšna tveganja so povezana z zdravilom Tandemact?
English: 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.
Slovenian: 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.
English: As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Slovenian: Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k vzpostavitvi nadzora nad sladkorno boleznijo tipa 2.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Tandemact is used to treat adult patients who have type 2 diabetes.
Slovenian: Zdravilo Tandemact se uporablja za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2.
English: These studies used pioglitazone and sulphonylureas given as separate tablets.
Slovenian: V teh študijah sta bila pioglitazon in sulfonilsečnina dajana kot ločeni tableti.
English: In all three studies, patients who used a combination of pioglitazone and a sulphonylurea had an improvement in the control of their blood glucose.
Slovenian: V vseh treh študijah se je pri bolnikih, ki so uporabljali kombinacijo pioglitazona in sulfonilsečnine, izboljšal nadzor nad glukozo v krvi.
English: 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.
Slovenian: 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.
English: Tandemact contains two active substances, each of which has a different mode of action.
Slovenian: Zdravilo Tandemact vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
English: For the full list of all side effects reported with Tandemact, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tandemact, glejte navodilo za uporabo.
English: The company used three studies to support the use of Tandemact in the same indication.
Slovenian: V podporo uporabi zdravila Tandemact za isto indikacijo je družba predložila tri študije.
English: Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Slovenian: 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.
English: Why has Tandemact been approved?
Slovenian: Zakaj je bilo zdravilo Tandemact odobreno?
English: Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Slovenian: Zdravila Tandemact ne smejo jemati bolniki s srčnim popuščanjem ter bolniki, ki imajo težave z jetri ali hude težave z ledvicami.
English: Tandemact cannot be used in patients who have severe kidney problems, or in patients who have liver problems.
Slovenian: Zdravila Tandemact ne smejo uporabljati bolniki z resnimi obolenji ledvic ali bolniki, ki imajo težave z jetri.
English: 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.
Slovenian: 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.
English: What is Tandemact?
Slovenian: Kaj je zdravilo Tandemact?
English: What is Tandemact used for?
Slovenian: Za kaj se zdravilo Tandemact uporablja?
English: How does Tandemact work?
Slovenian: Kako zdravilo Tandemact deluje?
English: How is Tandemact used?
Slovenian: Kako se zdravilo Tandemact uporablja?
English: How has Tandemact been studied?
Slovenian: Kako je bilo zdravilo Tandemact raziskano?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xalkori on 23 October 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xalkori, veljavno po vsej Evropski uniji, izdala 23. oktobra 2012.
English: 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.
Slovenian: 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.
English: What measures are being taken to ensure the safe and effective use of Xalkori?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xalkori?
English: The full EPAR for Xalkori 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 Xalkori 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 Xalkori.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xalkori.
English: For the previously untreated patients, 6 out of 7 responded to treatment.
Slovenian: Med predhodno nezdravljenimi bolniki se jih je šest od sedmih odzvalo na zdravljenje.
English: 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.
Slovenian: 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.
English: This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
Slovenian: To pomeni, da rakave celice vsebujejo spremembe, ki vplivajo na gen, odgovoren za beljakovino ROS1.
English: Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključila, da so koristi zdravila Xalkori večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.