FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Thalidomide Celgene used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs).
Slovenian: Najpogostejši neželeni učinki zdravila Thalidomide Celgene v kombinaciji z melfalanom in prednizonom (ki so se pojavili pri več kot 1 od 10 bolnikov) so nevtropenija (nizka raven nevtrofilcev, tj. vrste belih krvničk), levkopenija (nizka raven belih krvničk), anemija (nizka raven rdečih krvničk), limfopenija (nizka raven limfocitov, tj. druge vrste belih krvničk), trombocitopenija (nizka raven trombocitov v krvi), periferna nevropatija (poškodba živcev, ki povzroči mravljinčenje, bolečino in odrevenelost rok in stopal), tresavica, omotica, parestezija (neobičajni občutki zbadanja), disestezija (zmanjšana občutljivost za dotik), zaspanost, zaprtje in periferni edemi (otekanje, običajno nog).
English: What measures are being taken to ensure the safe and effective use of Thalidomide Celgene?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Thalidomide Celgene?
English: Thalidomide is a powerful human ‘teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects.
Slovenian: Talidomid je močen humani teratogen, kar pomeni, da škodljivo učinkuje na nerojenega otroka ter povzroča resne in smrtno nevarne prirojene okvare.
English: The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime.
Slovenian: Priporočeni odmerek je 200 mg (štiri kapsule) na dan, ki ga je treba vzeti vedno ob istem času, po možnosti pred spanjem.
English: The doctor must also understand the risks of thalidomide and how its use must be monitored.
Slovenian: Zdravnik mora prav tako poznati tveganja, povezana s talidomidom, ter načine spremljanja uporabe zdravila.
English: The study included patients over 65 years of age, as well as younger patients who could not be treated with high-dose chemotherapy.
Slovenian: Študija je vključevala bolnike, starejše od 65 let, in tudi mlajše bolnike, ki jih ni bilo mogoče zdraviti s kemoterapijo v visokem odmerku.
English: Each Member State will also ensure that educational materials and patient cards are provided as necessary to prescribers and patients.
Slovenian: Vsaka država članica bo tudi zagotovila, da bodo po potrebi zdravnikom, ki predpisujejo zdravilo, in bolnikom zagotovljena izobraževalna gradiva in kartice za bolnike.
English: Thalidomide Celgene must never be used by the following groups:
Slovenian: Zdravila Thalidomide Celgene ne smejo v nobenem primeru jemati naslednje skupine bolnikov:
English: Previously known as Thalidomide Pharmion.
Slovenian: Predhodno znano kot zdravilo Thalidomide Pharmion.
English: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomide-pharmion.
Slovenian: Nadaljnje informacije o zdravilu Thalidomide Celgene so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/thalidomide-celgene-previously-thalidomidepharmion.
English: Side effects reported with Thalidomide Celgene are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Thalidomide Celgene, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Slovenian: Bolniki, ki so prejemali melfalan in prednizon, so v povprečju preživeli 33,2 meseca od začetka študije, medtem ko so bolniki pri zdravljenju, ki je vključevalo tudi zdravilo Thalidomide Celgene, preživeli 51,6 meseca.
English: As for all medicines, data on the use of Thalidomide Celgene are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Thalidomide Celgene stalno spremljajo.
English: The boxes containing Thalidomide Celgene capsules will include a warning that thalidomide is harmful to the unborn child.
Slovenian: Škatle s kapsulami zdravila Thalidomide Celgene bodo vsebovale opozorilo, da je talidomid škodljiv za nerojenega otroka.
English: It will provide educational kits for healthcare workers and brochures for patients, detailing the steps that need to be taken for the medicine to be used safely.
Slovenian: Priskrbelo bo izobraževalni paket za zdravstvene delavce ter brošure za bolnike, kjer bodo natančno opisani postopki, ki jih je treba upoštevati za varno jemanje zdravila.
English: It is used in patients aged 65 years or over, and in younger patients if they cannot be treated with high-dose chemotherapy.
Slovenian: Uporablja se pri bolnikih, starih 65 let ali več, ter pri mlajših bolnikih, če zanje zdravljenje s kemoterapijo v visokih odmerkih ni primerno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thalidomide Celgene have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Thalidomide Celgene upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Thalidomide Celgene thalidomide
Slovenian: Thalidomide Celgene1
English: Why is Thalidomide Celgene authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Thalidomide Celgene odobreno v EU?
English: Most patients taking thalidomide get side effects.
Slovenian: Pri večini bolnikov, ki jemljejo talidomid, se pojavijo neželeni učinki.
English: Thalidomide Celgene must be prescribed and dispensed according to a special programme put in place to prevent the exposure of unborn children to the medicine.
Slovenian: Zdravilo Thalidomide Celgene mora biti predpisano in izdano v skladu s posebnim programom, uvedenim za preprečevanje izpostavljanja nerojenega otroka zdravilu.
English: Other information about Thalidomide Celgene
Slovenian: Druge informacije o zdravilu Thalidomide Celgene
English: For more information about using Thalidomide Celgene, see the package leaflet or contact tour doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Thalidomide Celgene glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Thalidomide Celgene have been shown in studies?
Slovenian: Kakšne koristi zdravila Thalidomide Celgene so se pokazale v študijah?
English: The study compared the effect of melphalan and prednisone, with or without Thalidomide Celgene.
Slovenian: V študiji so primerjali učinek melfalana in prednizona v kombinaciji z zdravilom Thalidomide Celgene oziroma brez njega.
English: Thalidomide Celgene can only be obtained with a prescription and treatment must be started and monitored under the supervision of a doctor skilled in using medicines that modulate the immune system or medicines to treat cancer.
Slovenian: Predpisovanje in izdaja zdravila Thalidomide Celgene je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki je usposobljen za uporabo zdravil, ki spreminjajo imunsko odzivnost, ali zdravil za zdravljenje raka.
English: What is Thalidomide Celgene and what is it used for?
Slovenian: Kaj je zdravilo Thalidomide Celgene in za kaj se uporablja?
English: Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with the cancer medicines melphalan and prednisone in patients who have not been treated for multiple myeloma before.
Slovenian: Zdravilo Thalidomide Celgene se uporablja za zdravljenje multiplega mieloma (raka kostnega mozga) v kombinaciji z zdraviloma za zdravljenje raka melfalanom in prednizonom pri bolnikih s predhodno nezdravljenim multiplim mielomom.
English: What are the risks associated with Thalidomide Celgene?
Slovenian: Kakšna tveganja so povezana z zdravilom Thalidomide Celgene?
English: It contains the active substance thalidomide.
Slovenian: Vsebuje učinkovino talidomid.
English: Thalidomide Celgene, in combination with melphalan and prednisone, has been shown to prolong the life of patients with multiple myeloma.
Slovenian: Zdravilo Thalidomide Celgene v kombinaciji z melfalanom in prednizonom dokazano podaljšuje čas preživetja bolnikov z multiplim mielomom.
English: The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘induction' treatment for multiple myeloma for use before high-dose chemotherapy.
Slovenian: Podjetje je predstavilo tudi rezultate študije, v kateri so proučevali kombinacijo zdravila Thalidomide Celgene in deksametazona kot „indukcijskega“ zdravljenja multiplega mieloma, namenjenega za uporabo pred kemoterapijo z visokimi odmerki, vendar pa je podjetje to vlogo med začetnim vrednotenjem zdravila umaknilo.
English: For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thalidomide Celgene, glejte navodilo za uporabo.
English: How is Thalidomide Celgene used?
Slovenian: Kako se zdravilo Thalidomide Celgene uporablja?
English: The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system
Slovenian: Učinkovina zdravila Thalidomide Celgene, talidomid, naj bi učinkovala tako, da zavira razvoj rakavih celic ter spodbuja nekatere specifične celice v imunskem sistemu (naravni obrambni mehanizem telesa), da napadejo rakave celice.
English: The strict conditions put in place to prevent pregnancy and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
Slovenian: Vsi moški in ženske, ki jemljejo to zdravilo, morajo izpolnjevati stroge pogoje, določene za preprečevanje nosečnosti in izpostavljanja nerojenih otrok talidomidu.
English: How does Thalidomide Celgene work?
Slovenian: Kako zdravilo Thalidomide Celgene deluje?
English: Thalidomide Celgene increased the time patients lived in one main study involving 447 patients with multiple myeloma.
Slovenian: V eni glavni študiji, ki je vključevala 447 bolnikov z multiplim mielomom, je zdravilo Thalidomide Celgene podaljšalo čas preživetja bolnikov.
English: This summary was last updated in 02-2014.
Slovenian: Povzetek je bil nazadnje posodobljen 2-2014.
English: Overall, the effect of Eperzan in reducing HbA1c varied between 0.6 and 0.9%.
Slovenian: V celoti je učinek zdravila Eperzan pri zmanjševanju HbA1c znašal med 0,6 % in 0,9 %.
English: Eperzan albiglutide
Slovenian: Eperzan albiglutid
English: What measures are being taken to ensure the safe and effective use of Eperzan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eperzan?
English: This was considered to be clinically meaningful and there were three-year data showing that this effect was maintained during long-term treatment.
Slovenian: Učinek so zabeležili kot klinično pomemben, triletni podatki pa so pokazali, da se je med dolgotrajnim zdravljenjem ohranil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eperzan on 28 March 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Eperzan, veljavno po vsej Evropski uniji, izdala dne 21. marca 2014.
English: The full EPAR and risk management plan summary for Eperzan 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) in povzetek načrta obvladovanja tveganj za zdravilo Eperzan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Eperzan and what is it used for?
Slovenian: Kaj je zdravilo Eperzan in za kaj se uporablja?
English: This is a summary of the European public assessment report (EPAR) for Eperzan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eperzan.
English: A risk management plan has been developed to ensure that Eperzan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Eperzan je bil pripravljen načrt obvladovanja tveganj.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Eperzan's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Eperzan večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The risks seen with the medicine were similar to those of other medicines in its class and Eperzan has the advantage of being given only once a week.
Slovenian: Tveganja, opažena pri tem zdravilu, so bila podobna tveganjem drugih zdravil v tem razredu, ima pa zdravilo Eperzan to prednost, da se daje samo enkrat na teden.
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen, thigh or the upper arm.
Slovenian: Bolniki si zdravilo injicirajo sami (po ustreznem usposabljanju) pod kožo v trebuh, stegno ali nadlaket.
English: What benefits of Eperzan have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Eperzan izkazalo v študijah?
English: What are the risks associated with Eperzan?
Slovenian: Kakšna tveganja so povezana z zdravilom Eperzan?
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Slovenian: Deluje tako, da se veže na receptorje za snov, imenovano glukagonu podoben peptid 1 (GLP-1), ki so na površini celic v trebušni slinavki, in spodbuja njihovo izločanje insulina.
English: Other information about Eperzan
Slovenian: Druge informacije o zdravilu Eperzan
English: The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Slovenian: Glavno merilo učinkovitosti je bila sprememba vrednosti glikoziliranega hemoglobina (HbA1c), tj. deleža hemoglobina v krvi, vezanega na glukozo.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Slovenian: HbA1c kaže, kako dobro je glukoza v krvi uravnana
English: Why is Eperzan approved?
Slovenian: Zakaj je bilo zdravilo Eperzan odobreno?
English: It is not intended to provide practical advice on how to use Eperzan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Eperzan, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Eperzan in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Two other medicines, pioglitazone and liraglutide, were found to be more effective as an add-on than Eperzan.
Slovenian: Dve drugi zdravili, tj. pioglitazon in liraglutid, sta bili kot dodatek učinkovitejši kot zdravilo Eperzan.
English: The most common side effects with Eperzan, affecting more than 1 in 20 people, are diarrhoea, nausea (feeling sick) and reactions at the injection site including rash, redness, or itching.
Slovenian: Najpogostejši neželeni učinki zdravila Eperzan, ki prizadenejo več kot enega bolnika od 20, so driska, slabost (siljenje na bruhanje) in reakcije na mestu injiciranja, vključno z izpuščajem, rdečino ali srbenjem.
English: Eperzan is available as prefilled pens that contain a powder (30 and 50 mg) and solvent for making a solution to be injected under the skin.
Slovenian: Zdravilo Eperzan je na voljo v napolnjenih peresnikih, ki vsebujejo prašek (30 in 50 mg) in vehikel za pripravo raztopine, ki se injicira pod kožo.
English: When used in combination with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Slovenian: Če bolnik jemlje zdravilo Eperzan s sulfonilsečnino ali insulinom, bo morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da se prepreči hipoglikemija (nizka raven sladkorja v krvi).
English: For more information about treatment with Eperzan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Eperzan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Eperzan can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Slovenian: Zdravilo Eperzan se lahko uporablja tudi kot „dodatek“ k drugim zdravilom za zdravljenje sladkorne bolezni, vključno z insulinom, kadar ta zdravila skupaj s telesno dejavnostjo in dieto ne zagotavljajo zadostne urejenosti glukoze v krvi.
English: For practical information about using Eperzan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Eperzan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: When Eperzan is injected, albiglutide reaches the receptors in the pancreas and activates them.
Slovenian: Po injiciranju zdravila Eperzan albiglutid doseže receptorje v trebušni slinavki in jih aktivira.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Slovenian: To povzroči sprostitev insulina in pomaga zmanjšati ravni glukoze v krvi, s tem pa uravnavati sladkorno bolezen tipa 2.
English: The CHMP noted that the effects of Eperzan in controlling blood glucose were shown to be clinically meaningful when the medicine was used alone and when compared with other medicines in combination treatments.
Slovenian: Odbor CHMP je zabeležil, da so učinki zdravila Eperzan pri uravnavanju glukoze v krvi klinično pomembni, kadar se zdravilo uporablja samostojno in kadar se primerja z drugimi zdravili v kombiniranih zdravljenjih.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri v trebušni slinavki ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi ali ga telo ne more učinkovito izkoristiti.
English: Eperzan can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Slovenian: Zdravilo Eperzan se lahko uporablja samostojno pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo, in pri bolnikih, ki ne morejo jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
English: The active substance in Eperzan, albiglutide, is a ‘GLP-1 receptor agonist'.
Slovenian: Zdravilna učinkovina zdravila Eperzan je albiglutid, ki je „agonist receptorjev GLP-1“.
English: Eperzan was more effective than placebo at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines sitagliptin and glimepiride and comparable to insulin glargine and insulin lispro when used as add-on to other treatments.
Slovenian: Zdravilo Eperzan je bilo učinkovitejše od placeba pri zmanjševanju ravni HbA1c, kadar se uporablja samostojno, in učinkovitejše od zdravil za zdravljenje sladkorne bolezni sitagliptin in glimepirid ter primerljivo z insulinom glarginom in insulinom lispro, kadar se uporablja kot dodatek k drugim zdravljenjem.
English: Eperzan is a diabetes medicine that contains the active substance albiglutide.
Slovenian: Eperzan je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino albiglutid.
English: The benefits of Eperzan were studied in over 5,000 patients with type 2 diabetes in which Eperzan was compared with placebo (a dummy treatment) or with other diabetes medicines when used as an addon to various combination treatments or when used alone.
Slovenian: Koristi zdravila Eperzan so proučevali pri več kot 5000 bolnikih s sladkorno boleznijo tipa 2, pri katerih so zdravilo Eperzan primerjali s placebom (zdravilom brez zdravilne učinkovine) ali z drugimi zdravili za zdravljenje sladkorne bolezni, kadar se zdravilo Eperzan uporablja kot dodatek k različnim kombiniranim zdravljenjem ali samostojno.
English: The recommended dose is 30 mg injected once a week, though this may be increased by their doctor to 50 mg depending on the effects on their blood sugar levels.
Slovenian: Zdravnik lahko odmerek zviša na 50 mg, odvisno od vpliva na koncentracijo sladkorja v krvi.
English: How is Eperzan used?
Slovenian: Kako se zdravilo Eperzan uporablja?
English: How does Eperzan work?
Slovenian: Kako zdravilo Eperzan deluje?
English: The final content, format and distribution modalities of both documents should be agreed with the national competent authority in each Member State.
Slovenian: Končno vsebino, obliko in načine distribucije obeh dokumentov je treba določiti v soglasju s pristojnim nacionalnim organom v vsaki državi članici.
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing.
Slovenian: Imetnik dovoljenja za promet mora izvesti ta načrt izobraževanja na nacionalni ravni pred začetkom trženja zdravila.
English: Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Slovenian: Oba dokumenta je treba uporabiti v okviru načrta izobraževanja, katerega cilj je zmanjšati tveganja za napake pri uporabi zdravila, tveganje za trombembolične dogodke zaradi zvišane ravni neproteolitično aktiviranega rFXIII v zvezi z nepravilnim shranjevanjem ter tveganje za neodobreno uporabo za zdravljenje vmesnih krvavitev.
English: • distribution and use of the patient brochure and the need to ensure that the patient has read and understood the brochure
Slovenian: • distribuiranje in uporabo brošure za bolnike ter opozorilo, da je treba poskrbeti, da bolnik brošuro prebere in jo razume
English: The MAH should ensure harmonisation between terminology used in the brochures and the product information.
Slovenian: Imetnik dovoljenja za promet mora poskrbeti za uskladitev terminologije, uporabljene v brošurah in informacijah o zdravilu.
English: The physician brochure should contain the following key elements and item:
Slovenian: Brošura za zdravnika mora vsebovati naslednje ključne elemente in postavke:
English: • embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Slovenian: • embolične in trombembolične dogodke, vključno z večjim tveganjem za zaporo žile pri bolnikih, ki imajo tveganje za trombozo
English: • Summary of Product Characteristics
Slovenian: • povzetek glavnih značilnosti zdravila