FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with the highest strength of Copalia HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Slovenian: Zdravljenje z največjim odmerkom zdravila Copalia HCT je bilo pri zdravljenju hipertenzije učinkovitejše od zdravljenja z dvojnimi kombinacijami, ki so vsebovale po dve zdravilni učinkovini.
English: The full EPAR for Copalia HCT 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 Copalia HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Za več informacij o zdravljenju z zdravilom Copalia HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.
Slovenian: Ker valsartan ustavi njegovo delovanje z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, hormonu prepreči učinkovanje, zaradi česar se krvne žile lahko razširijo, krvni tlak pa zniža.Hidroklorotiazid je diuretik.
English: Finally, Copalia HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Slovenian: Zdravila Copalia HCT poleg tega ne smejo uporabljati bolniki s hipokaliemijo (nizko ravnjo kalija v krvi), hiponatriemijo (nizko ravnjo natrija v krvi) in hiperkalciemijo (visoko ravnjo kalcija v krvi), ki se ne odzivajo na zdravljenje, ter bolniki s simptomatsko hiperurikemijo (visoko koncentracijo sečne kisline v krvi).
English: What is the risk associated with Copalia HCT?
Slovenian: Kakšna tveganja so povezana z zdravilom Copalia HCT?
English: Copalia HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Slovenian: Prav tako se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
English: Why has Copalia HCT been approved?
Slovenian: Zakaj je bilo zdravilo Copalia HCT odobreno?
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
Slovenian: CHMP je menil, da bi uporaba zdravila Copalia HCT, pri katerem so tri zdravilne učinkovine prisotne v eni tableti, bolnikom, ki tri zdravilne učinkovine že prejemajo ločeno, omogočila doslednejše jemanje zdravila.
English: What is Copalia HCT?
Slovenian: Kaj je zdravilo Copalia HCT?
English: How has Copalia HCT been studied?
Slovenian: Kako je bilo zdravilo Copalia HCT raziskano?
English: What is Copalia HCT used for?
Slovenian: Za kaj se zdravilo Copalia HCT uporablja?
English: How does Copalia HCT work?
Slovenian: Kako zdravilo Copalia HCT deluje?
English: How is Copalia HCT used?
Slovenian: Kako se zdravilo Copalia HCT uporablja?
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku Koordinacijske skupine.
English: b L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology c adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
Slovenian: ahumani papilomavirus = HPV bL1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C-5 (sev 1895)) cadsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (225 mikrogramov Al)
English: Human Papillomavirusa Type 6 L1 proteinb,c
Slovenian: 1 odmerek (0,5 ml) vsebuje približno: L1 proteinb,c humanega papilomavirusaa tipa 6
English: 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga + 2 igli
English: This protein is often found on the surface of cells where it plays a role in regulating cell multiplication.
Slovenian: Ta beljakovina je pogosto prisotna na površini celic, kjer ima vlogo pri uravnavanju razmnoževanja celic.
English: What measures are being taken to ensure the safe and effective use of Lartruvo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lartruvo?
English: This is a summary of the European public assessment report (EPAR) for Lartruvo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lartruvo.
English: The most serious side effects were neutropenia and musculoskeletal pain.
Slovenian: Najresnejša neželena učinka sta bila nevtropenija in mišično-skeletna bolečina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo'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 zato zaključil, da so koristi zdravila Lartruvo večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained staff and equipment for emergency resuscitation should be available.
Slovenian: Med infuzijo je treba bolnike spremljati zaradi pojava znakov in simptomov reakcij, povezanih z infuzijo, na voljo pa morata biti usposobljeno osebje in oprema za oživljanje v nujnem primeru.
English: Other information about Lartruvo
Slovenian: Druge informacije o zdravilu Lartruvo
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Lartruvo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is not intended to provide practical advice on how to use Lartruvo.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: However, because of the small number of patients included in the main study, further data will be needed from the company that markets the medicine.
Slovenian: Zaradi majhnega števila bolnikov, vključenih v glavno študijo, bo morala družba, ki trži zdravilo, predložiti nadaljnje podatke.
English: Doxorubicin is given on day 1 of each cycle, after the Lartruvo infusion.
Slovenian: Doksorubicin se daje 1. dan vsakega cikla po infuziji zdravila Lartruvo.
English: Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare', and Lartruvo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 February 2015.
Slovenian: Ker je bolnikov s sarkomom mehkih tkiv malo, velja ta bolezen za redko, zato je bilo zdravilo Lartruvo 12. februarja 2015 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Lartruvo has been given ‘conditional approval'.
Slovenian: Zdravilo Lartruvo je pridobilo „pogojno dovoljenje za promet“.
English: What benefits of Lartruvo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lartruvo izkazalo v študijah?
English: By attaching to PDGFRα on sarcoma cells, Lartruvo is expected to block its activity, thereby slowing down the growth of the cancer.
Slovenian: Z vezavo na PDGFRα na celicah sarkoma naj bi zdravilo Lartruvo zavrlo njegovo aktivnost in tako upočasnilo rast raka.
English: What are the risks associated with Lartruvo?
Slovenian: Kakšna tveganja so povezana z zdravilom Lartruvo?
English: Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
Slovenian: Ker je zdravilo Lartruvo pridobilo pogojno dovoljenje za promet, bo družba, ki ga trži, zagotovila dodatne podatke iz potekajoče študije in tako dodatno potrdila učinkovitost in varnost zdravila.
English: What is Lartruvo and what is it used for?
Slovenian: Kaj je zdravilo Lartruvo in za kaj se uporablja?
English: Lartruvo can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila Lartruvo je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: For more information about treatment with Lartruvo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lartruvo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In cancers such as soft tissue sarcoma, this protein is present in high levels or is overactive, causing cells to become cancerous.
Slovenian: Pri vrstah raka, kakršen je sarkom mehkih tkiv, je ta beljakovina prisotna v prevelikih količinah ali je čezmerno aktivna, zato celice postanejo rakave.
English: The full EPAR for Lartruvo 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 Lartruvo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin (26.5 versus 14.7 months, respectively).
Slovenian: Poleg tega so bolniki, zdravljeni s kombinacijo zdravila Lartruvo in doksorubicina, celokupno živeli skoraj dvakrat dlje kot bolniki, zdravljeni z doksorubicinom (26,5 v primerjavi s 14,7 meseca).
English: The most frequent side effects which lead to treatment termination were infusion-related reactions (allergic reactions which can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis.
Slovenian: Najpogostejši neželeni učinki, ki privedejo do prenehanja zdravljenja, so bile reakcije, povezane z infuzijo (alergijske reakcije, ki so lahko resne, s simptomi, kot so mrzlica, povišana telesna temperatura in težave z dihanjem), in mukozitis.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lartruvo have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha' (PDGFRα).
Slovenian: Zdravilna učinkovina v zdravilu Lartruvo, olaratumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano za prepoznavo in vezavo na beljakovino, imenovano receptor alfa za trombocitni rastni dejavnik (PDGFRα).
English: For practical information about using Lartruvo, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lartruvo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Why is Lartruvo approved?
Slovenian: Zakaj je bilo zdravilo Lartruvo odobreno?
English: Lartruvo is available as a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Lartruvo je na voljo kot raztopina za infundiranje (kapalno infuzijo) v veno.
English: Lartruvo is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels and fat tissue.
Slovenian: Lartruvo je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z napredovalim sarkomom mehkih tkiv, tj. vrste raka, ki prizadene mehka podporna tkiva v telesu, kot so mišice, krvne žile in maščobno tkivo.
English: For the full list of all side effects and restrictions with Lartruvo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lartruvo glejte navodilo za uporabo.
English: What information is still awaited for Lartruvo?
Slovenian: Katere informacije o zdravilu Lartruvo še pričakujemo?
English: Patients treated with Lartruvo plus doxorubicin lived for an average of 6.6 months without their disease getting worse, compared with 4.1 months for patients treated with doxorubicin alone.
Slovenian: Bolniki, zdravljeni z zdravilom Lartruvo v kombinaciji z doksorubicinom, so brez poslabšanja bolezni živeli povprečno 6,6 meseca, v primerjavi s 4,1 meseca pri bolnikih, ki so se zdravili samo z doksorubicinom.
English: The most common side effects with Lartruvo (which may affect more than 1 in 10 people) include nausea (feeling sick), musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cells that fights infection) and mucositis (inflammation of the body's moist surfaces, most commonly affecting the mouth and throat).
Slovenian: Najpogostejši neželeni učinki zdravila Lartruvo (ki se lahko pojavijo pri več kot 1 bolniku od 10) vključujejo navzejo (slabost), mišično-skeletno bolečino (bolečino v kosteh in mišicah), nevtropenijo (nizke vrednosti nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) in mukozitis (vnetje telesnih sluznic, najpogosteje ust in žrela).
English: With regards to the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of side effects; however, in view of the benefits of treatment, side effects were considered tolerable and manageable.
Slovenian: Kar zadeva varnostni profil zdravila, so opazili, da so bili neželeni učinki pri bolnikih, zdravljenih z zdravilom Lartruvo in doksorubicinom, pogostejši, vendar pa so bili neželeni učinki z vidika koristi zdravljenja ocenjeni kot znosni in obvladljivi.
English: Lartruvo has been investigated in one main study involving 133 adults with advanced soft tissue sarcoma who couldn't undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin).
Slovenian: Zdravilo Lartruvo so proučevali v eni glavni študiji, ki je vključevala 133 odraslih z napredovalim sarkomom mehkih tkiv, ki jih ni bilo mogoče zdraviti z operacijo ali radioterapijo in ki se predhodno še niso zdravili z antraciklini (skupino zdravil proti raku, ki vključuje doksorubicin).
English: Lartruvo is used together with doxorubicin (another cancer medicine) in patients who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin.
Slovenian: Zdravilo Lartruvo se uporablja skupaj z doksorubicinom (drugim zdravilom proti raku) pri bolnikih, ki jih ni mogoče zdraviti z operacijo ali radioterapijo (zdravljenjem z obsevanjem) in ki se predhodno še niso zdravili z doksorubicinom.
English: The study showed that Lartruvo plus doxorubicin was more effective than doxorubicin alone at prolonging the time patients live without their disease getting worse (progression-free survival).
Slovenian: Študija je pokazala, da je zdravilo Lartruvo v kombinaciji z doksorubicinom učinkovitejše od doksorubicina kot samostojnega zdravljenja pri podaljševanju časa do poslabšanja bolezni (preživetja brez napredovanja).
English: Data from the main study show that Lartruvo in combination with doxorubicin improves progressionfree and overall survival of patients with advanced soft tissue sarcoma.
Slovenian: Podatki iz glavne študije kažejo, da zdravilo Lartruvo v kombinaciji z doksorubicinom pri bolnikih z napredovalim sarkomom mehkih tkiv izboljša preživetje brez napredovanja in celokupno preživetje.
English: How does Lartruvo work?
Slovenian: Kako zdravilo Lartruvo deluje?
English: Lartruvo is given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.
Slovenian: Zdravilo Lartruvo se največ 8 ciklov zdravljenja daje v kombinaciji z doksorubicinom, čemur pri bolnikih, ki se jim bolezen ni poslabšala, sledi samostojno zdravljenje z zdravilom Lartruvo.
English: How is Lartruvo used?
Slovenian: Kako se zdravilo Lartruvo uporablja?
English: The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8.
Slovenian: Priporočeni odmerek zdravila Lartruvo je 15 mg na kilogram telesne mase in se daje dvakrat v treh tednih, in sicer 1. in 8. dan. Ti tritedenski cikli se ponavljajo, dokler se bolezen ne poslabša ali neželeni učinki ne postanejo nesprejemljivi.
English: What measures are being taken to ensure the safe and effective use of Herzuma?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Herzuma?
English: This means that Herzuma is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: Herzuma can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Slovenian: Zdravilo Herzuma lahko povzroča kardiotoksičnost (škoduje srcu), vključno s srčnim popuščanjem (srce ne deluje tako dobro, kot bi moralo).
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Slovenian: Pri bolnikih, ki dobro prenesejo prvo 90-minutno infundiranje, lahko naslednje infuzije trajajo 30 minut.
English: The infusion may be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Slovenian: Infuzija je lahko povezana z alergijskimi reakcijami, zato je treba bolnika med infundiranjem in po njem opazovati.
English: This is a summary of the European public assessment report (EPAR) for Herzuma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Herzuma.
English: The full EPAR for Herzuma 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 Herzuma je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There were no relevant differences in the main measure of effectiveness (absence of invasive cancer cells in the breast or in linked tissues called lymph nodes) between the two products: this was seen in nearly 44% of those given Herzuma (118 of 271) and 47% of those given Herceptin (131 of 278).
Slovenian: Med zdraviloma ni bilo pomembnih razlik glede glavnega merila učinkovitosti (odsotnost invazivnih rakavih celic v dojki ali z njo povezanih tkivih, imenovanih bezgavke): to je bilo opaženo pri skoraj 44 % bolnic, ki so prejemale zdravilo Herzuma (118 od 271), in pri 47 % bolnic, ki so prejemale zdravilo Herceptin (131 od 278).
English: The most common or serious side effects with Herzuma are heart problems, reactions related to the Herzuma infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Slovenian: Najpogostejši ali resni neželeni učinki zdravila Herzuma so težave s srcem, reakcije, povezane z infuzijo zdravila Herzuma, zmanjšana količina krvnih celic (zlasti belih krvnih celic), okužbe in težave s pljuči.
English: Herzuma is a cancer medicine used to treat the following conditions:
Slovenian: Herzuma je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi trastuzumaba glejte navodilo za uporabo.
English: The infusion is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer.
Slovenian: Infuzija se daje 90 minut vsak teden ali vsake tri tedne pri raku dojke in vsake tri tedne pri raku želodca.
English: In addition, one main study involving 549 patients with early breast cancer that overexpressed HER2 showed that Herzuma was as effective as Herceptin.
Slovenian: Poleg tega je ena glavna študija, v katero je bilo vključenih 549 bolnic z zgodnjim rakom dojke, ki je čezmerno izražal beljakovino HER2, pokazala, da je zdravilo Herzuma enako učinkovito kot zdravilo Herceptin.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Slovenian: HER2 se čezmerno izraža pri približno četrtini rakov dojke in petini rakov želodca.
English: Other information about Herzuma
Slovenian: Druge informacije o zdravilu Herzuma
English: It must not be used in patients who have serious breathing problems because of advanced cancer, even when resting, or who need oxygen therapy.
Slovenian: Ne sme se uporabljati pri bolnikih, ki imajo zaradi napredovalega raka resne težave z dihanjem tudi med počitkom, in bolnikih, ki potrebujejo zdravljenje s kisikom.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Slovenian: Uporablja se tudi v kombinaciji z drugimi zdravili proti raku: s paklitakselom ali docetakselom ali drugim razredom zdravil, imenovanim zaviralci aromataze;
English: What are the risks associated with Herzuma?
Slovenian: Kakšna tveganja so povezana z zdravilom Herzuma?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Herzuma have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Herzuma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It is available as a powder used to make up a solution for adding to an infusion (drip) into a vein.
Slovenian: Na voljo je v obliki praška za pripravo raztopine, ki se doda (kapalni) infuziji v veno.
English: Herzuma must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Slovenian: Zdravila Herzuma ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) trastuzumab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: What is Herzuma and what is it used for?
Slovenian: Kaj je zdravilo Herzuma in za kaj se uporablja?
English: For more information about treatment with Herzuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Herzuma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.