FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, the Committee could not exclude the possibility that Tyverb in combination with paclitaxel is inferior to the standard treatment, trastuzumab plus paclitaxel.
Slovenian: Odbor predvsem ni mogel izključiti možnosti, da je zdravilo Tyverb v kombinaciji s paklitakselom manj učinkovito kot standardno zdravljenje - trastuzumab v kombinaciji s paklitakselom.
English: The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Slovenian: Zdravilna učinkovina v zdravilu Tyverb, lapatinib, spada v skupino zdravil, ki se imenujejo zaviralci proteinske kinaze.
English: About a quarter of breast cancers express HER2.
Slovenian: HER2 je izražen pri približno četrtini primerov raka dojke.
English: What is happening with Tyverb used in combination with capecitabine or with an aromatase inhibitor?
Slovenian: Kakšne so posledice za zdravilo Tyverb v kombinaciji s kapecitabinom ali zaviralcem aromataze?
English: How is Tyverb expected to work?
Slovenian: Kako naj bi zdravilo Tyverb delovalo?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tyverb at this time.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnice, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Tyverb.
English: The CHMP was concerned that the main study, which compared Tyverb with placebo, did not allow the Committee to conclude on how Tyverb compares with other authorised treatments.
Slovenian: Odbor CHMP je menil, da na podlagi glavne študije, v kateri so primerjali zdravilo Tyverb s placebom, ni bilo mogoče sklepati o delovanju zdravila Tyverb v primerjavi z drugimi odobrenimi zdravili.
English: Tyverb is used in combination with capecitabine or with an aromatase inhibitor (other anticancer medicines) to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Slovenian: Zdravilo Tyverb se uporablja v kombinaciji s kapecitabinom ali z zaviralcem aromataze (drugim zdravilom za zdravljenje raka) za zdravljenje bolnic z rakom dojke, za katerega so ugotovili, da „zraža“ velike količine HER2.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the CHMP's assessment that the lack of a study comparing Tyverb with another treatment hampered the proper assessment of the benefit-risk balance in European patients in the applied indication.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je odločitev za umik vloge temeljila na oceni odbora CHMP, da zaradi odsotnosti študije, ki bi primerjala zdravilo Tyverb z drugim zdravilom, ni bilo mogoče ustrezno ovrednotiti razmerja med koristmi in tveganji pri evropskih bolnicah za uporabljeno indikacijo.
English: Tyverb was also expected to be used in combination with paclitaxel (another anticancer medicine) for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2.
Slovenian: Za zdravilo Tyverb so načrtovali tudi uporabo v kombinaciji s paklitakselom (drugim zdravilom za zdravljenje raka) za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji pretirano izražajo HER2.
English: The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Slovenian: V času umika je odbor CHMP ocenjeval odgovore družbe na predložena vprašanja.
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the tumour cells.
Slovenian: To pomeni, da rak na površini tumorskih celic tvori velike količine določene beljakovine HER2 (imenovane tudi ErbB2).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not addressed its concerns and that the benefit-risk balance of Tyverb in combination with paclitaxel for the treatment of metastatic breast cancer could not be properly assessed.
Slovenian: Zato je ob umiku menil, da družba ni obravnavala njegovih zadržkov ter da razmerja med koristmi in tveganji pri uporabi zdravila Tyverb v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke ni bilo mogoče ustrezno oceniti.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Tyverb could not have been approved for use in combination with paclitaxel in the treatment of metastatic breast cancer.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil, ob umiku izrazil določene zadržke ter začasno menil, da zdravila Tyverb ni mogoče odobriti za uporabo v kombinaciji s paklitakselom za zdravljenje metastatskega raka dojke.
English: By blocking these receptors, Tyverb helps to control cell division.
Slovenian: Zdravilo Tyverb pomaga nadzorovati delitev celic tako, da te receptorje zavira.
English: The study compared Tyverb with placebo (a dummy treatment), both of which were taken together with paclitaxel.
Slovenian: V študiji so primerjali zdravilo Tyverb s placebom (zdravilom brez zdravilne učinkovine).
English: Further information on Dengvaxia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
Slovenian: Nadaljnje informacije o zdravilu Dengvaxia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Dengvaxia.
English: Three studies were carried out in Asia and Latin America involving over 35,000 children aged 2 to 16 years.
Slovenian: Izvedene so bile tri študije v Aziji in Latinski Ameriki, ki so zajele več kot 35 000 otrok, starih od 2 do 16 let.
English: Additional studies showed that the vaccine is also effective in people aged 16 to 45 years.
Slovenian: Dodatne študije so pokazale, da je cepivo učinkovito tudi pri osebah, starih od 16 do 45 let.
English: What measures are being taken to ensure the safe and effective use of Dengvaxia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dengvaxia?
English: Cases of dengue disease were recorded for one year after the last injection.
Slovenian: Primere bolezni denge so spremljali eno leto po zadnji injekciji cepiva.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend the body against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznijo.
English: There are several varieties (called serotypes) of dengue virus and Dengvaxia protects against serotypes 1, 2, 3 and 4.
Slovenian: Obstaja več vrst (serotipov) virusa denge, pri čemer cepivo Dengvaxia ščiti pred serotipi 1, 2, 3 in 4.
English: Allergic reactions, which may be severe, are a very rare side effect of Dengvaxia.
Slovenian: Alergijske reakcije, ki utegnejo biti resne, so zelo redek neželeni učinek zdravila Dengvaxia.
English: The injection is given under the skin, preferably in the upper arm.
Slovenian: Injekcija se vbrizga pod kožo, po možnosti v nadlaket.
English: Other information about Dengvaxia
Slovenian: Druge informacije o zdravilu Dengvaxia
English: Dengvaxia's side effects are usually mild or moderate and do not last longer than three days.
Slovenian: Neželeni učinki cepiva Dengvaxia so običajno blagi ali zmerni in ne trajajo več kot tri dni.
English: The European Medicines Agency therefore decided that Dengvaxia's benefits are greater than its risks and it can be authorised for use in the EU in areas where dengue disease is endemic.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi cepiva Dengvaxia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU na endemičnih območjih bolezni denge.
English: Dengvaxia must also not be given to women who are pregnant or breastfeeding.
Slovenian: Zdravila Dengvaxia prav tako ne smejo prejeti ženske, ki so noseče ali dojijo.
English: Endemic areas are areas where the disease occurs regularly throughout the year.
Slovenian: Endemična območja so predeli, kjer prihaja do rednih izbruhov bolezni.
English: Dengvaxia contains weakened viruses that do not cause disease.
Slovenian: Cepivo Dengvaxia vsebuje oslabljene viruse, ki ne povzročajo bolezni.
English: As for all medicines, data on the use of Dengvaxia are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi cepiva Dengvaxia stalno spremljajo.
English: The most common side effects with Dengvaxia (which may affect more than 1 in 10 people) are headache, injection site pain, malaise (feeling unwell), muscle pain, weakness and fever.
Slovenian: Najpogostejši neželeni učinki cepiva Dengvaxia (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, bolečine na mestu injiciranja, slabo počutje, bolečine v mišicah, oslabelost in povišana telesna temperatura.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dengvaxia 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 cepiva Dengvaxia upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Dengvaxia are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri cepivu Dengvaxia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: In the future, when the person comes into contact with dengue virus, these antibodies together with other components of the immune system will be able to kill the virus and help protect against the disease.
Slovenian: Ob ponovni izpostaviti virusu denge v prihodnosti bodo lahko ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničila virus in pripomogla k zaščiti pred boleznijo.
English: Why is Dengvaxia authorised in the EU?
Slovenian: Zakaj je zdravilo Dengvaxia odobreno v EU?
English: For more information about using Dengvaxia, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe cepiva Dengvaxia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Dengvaxia and why it is authorised in the EU
Slovenian: Pregled zdravila Dengvaxia in zakaj je odobreno v EU
English: However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage.
Slovenian: Toda pri manjšem številu ljudi lahko ta virus povzroči hujšo obliko bolezni z življenjsko nevarnimi krvavitvami in poškodbami organov.
English: The company that markets Dengvaxia will provide educational material for healthcare professionals with information on the use of Dengvaxia including the need to test for previous dengue infection and how to detect early dengue disease.
Slovenian: Podjetje, ki trži cepivo Dengvaxia, bo zagotovilo izobraževalno gradivo za zdravstvene delavce, ki bo vsebovalo informacije o uporabi cepiva Dengvaxia, vključno z zahtevo po testiranju na prisotnost predhodne okužbe z virusom denge in napotki za odkrivanje zgodnjih znakov bolezni.
English: Dengvaxia must not be given to people with weakened immune systems, including people whose immune system has been weakened by HIV infection or medicines such as cancer medicines or high doses of corticosteroids.
Slovenian: Cepivo Dengvaxia se ne sme dati osebam z oslabljenim imunskim sistemom, vključno tistim z oslabljenim imunskim zaradi okužbe z virusom HIV ali prejemanja zdravil proti raku ali visokih odmerkov kortikosteroidov.
English: There is no other vaccine for dengue disease and neither is there a specific treatment.
Slovenian: Za bolezen denge ne obstaja nobeno drugo cepivo ali posebno zdravljenje.
English: What benefits of Dengvaxia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Dengvaxia izkazalo v študijah?
English: What are the risks associated with Dengvaxia?
Slovenian: Kakšna tveganja so povezana z zdravilom Dengvaxia?
English: What is Dengvaxia and what is it used for?
Slovenian: Kaj je zdravilo Dengvaxia in za kaj se uporablja?
English: The risk of severe disease is higher in people who have been infected a second time.
Slovenian: Tveganje za nastop hujše oblike bolezni je večje pri ljudeh, ki so se z virusom ponovno okužili.
English: Available data are not sufficient to confirm how well the vaccine works in individuals previously infected by dengue virus and younger than 9 years.
Slovenian: Razpoložljivi podatki ne zadostujejo za potrditev učinkovitosti cepiva pri posameznikih, ki so v preteklosti že bili okuženi z virusom denge in so mlajši od 9 let.
English: The vaccine is given as 3 doses, 6 months apart.
Slovenian: Daje se v treh odmerkih, med katerimi je šestmesečni razmik.
English: Overall, among children aged between 9 and 16 years and who had previous dengue infection, there were around 79% fewer cases of dengue disease in children vaccinated with 3 doses of Dengvaxia compared with placebo.
Slovenian: Na splošno je bilo med otroci, starimi od 9 do 16 let, ki so z virusom denge že bili okuženi v preteklosti, okoli 79 % manj primerov bolezni pri tistih otrocih, ki so prejeli tri odmerke cepiva Dengvaxia, v primerjavi s placebom.
English: Dengvaxia can only be obtained with a prescription and should be used according to official recommendations.
Slovenian: Predpisovanje in izdaja cepiva Dengvaxia je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
English: However, among children aged between 9 and 16 years who had not had previous dengue infection, the risk of severe dengue disease if they later became infected with the virus was higher in people vaccinated compared with those given placebo (estimated at 2 additional cases per 1000 people vaccinated over 5 years).
Slovenian: Vendar pa je med otroci, starimi od 9 do 16 let, ki z virusom denge še niso bili okuženi, tveganje za hujšo obliko bolezni denge v primeru kasnejše okužbe večje pri cepljenih otrocih kot pa pri tistih, ki so prejeli placebo (po ocenah dva dodatna primera na 1 000 cepljenih oseb v obdobju petih let).
English: Therefore, the vaccine should only be given to people who have had a previous dengue infection, as confirmed by laboratory testing.
Slovenian: Zato se cepivo lahko daje samo osebam, ki so z virusom denge že bili okuženi v preteklosti, kar mora biti potrjeno z laboratorijskimi testi.
English: Dengvaxia is effective at reducing the number of cases of dengue disease in people aged between 9 and 45 years who have had the infection in the past.
Slovenian: Cepivo Dengvaxia je učinkovito pri zmanjševanju števila primerov bolezni denge pri ljudeh, starih od 9 do 45 let, ki so z virusom denge že bili okuženi v preteklosti.
English: For the full list of side effects and restrictions with Dengvaxia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Dengvaxia glejte navodilo za uporabo.
English: Children were given either 3 injections of Dengvaxia or 3 injections of placebo (a dummy vaccine) with 6 months between each injection.
Slovenian: Otroci so v šestmesečnih razmikih prejeli bodisi tri injekcije cepiva Dengvaxia bodisi placebo (cepivo brez učinkovine).
English: Dengvaxia is a vaccine used to help protect against dengue disease.
Slovenian: Zdravilo Dengvaxia je cepivo, ki se uporablja za zaščito pred vročico denga.
English: Dengvaxia contains attenuated (weakened) yellow fever viruses that have been manipulated so that they contain proteins from dengue virus.
Slovenian: Cepivo Dengvaxia vsebuje atenuirane (oslabljene) viruse rumene mrzlice, katerim so bile dodane beljakovine virusa denge.
English: Dengue disease is a mosquito-borne tropical disease caused by the dengue virus leading to mild, flulike symptoms in most people.
Slovenian: Denga je tropska bolezen, ki jo prenašajo komarji, povzroča pa jo okužba z virusom denge, ki se pri večini ljudi izraža v obliki blagih, gripi podobnih simptomov.
English: However, people who have not had dengue infection in the past may have a higher risk of severe dengue disease if they become infected with the virus after vaccination with Dengvaxia.
Slovenian: Pri ljudeh, ki pa s tem virusom še niso bili okuženi, je tveganje za hujšo obliko bolezni denge v primeru okužbe s tem virusom po injiciranju cepiva Dengvaxia večje.
English: Dengvaxia must only be given to people who have had a positive test result showing a previous infection with dengue virus.
Slovenian: Cepivo Dengvaxia se lahko daje samo ljudem s pozitivnim testom, ki kaže, da so že bili okuženi z virusom denge v preteklosti.
English: The studies included both children who had and had not been infected with dengue virus in the past.
Slovenian: Študije so vključevale otroke z okužbo z virusom denge v preteklosti in tiste brez nje.
English: When a person is given the vaccine, the immune system recognises the dengue proteins in the weakened viruses as
Slovenian: Ko oseba prejme cepivo, njen imunski sistem prepozna beljakovine denge v oslabljenih virusih kot „tujke“ in začne proti njim tvoriti protitelesa.
English: Dengvaxia is only for use in people from 9 to 45 years of age who have been infected with dengue virus before and who live in areas where this infection is endemic.
Slovenian: Cepivo Dengvaxia se lahko uporablja samo pri ljudeh, starih od 9 do 45 let, ki so se z virusom denge že okužili v preteklosti in živijo na endemičnih območjih.
English: How does Dengvaxia work?
Slovenian: Kako zdravilo Dengvaxia deluje?
English: How is Dengvaxia used?
Slovenian: Kako se zdravilo Dengvaxia uporablja?
English: 10 ml (10 mg/ml) 2 vials
Slovenian: 2 viali
English: Pack size
Slovenian: 1 viala
English: The educational leaflet shall contain the following key elements:
Slovenian: Izobraževalna brošura mora vsebovati naslednje ključne elemente:
English: The Member States shall ensure that prior to launch the MAH provides health care professionals in dialysis centres and retail pharmacies with:
Slovenian: Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom pred lansiranjem zdravila zdravnikom v centrih za dializo in maloprodajnim lekarnam predloži naslednje:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UPOŠTEVATI DRŽAVE ČLANICE
English: • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated
Slovenian: • Treba je raziskati izgubo učinkovitosti ali druge simptome pojava imunogenosti.
English: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA)
Slovenian: • Uporaba zdravil z epoteinom alfa lahko povzroči imunogenost, ki lahko v redkih primerih povzroči čisto aplastično anemijo (Pure Red Cell Aplasia - PRCA).
English: • Therefore, the sc route is not recommended for patients with CKD
Slovenian: • Subkutana pot odmerjanja zato ni priporočena za bolnike s KLB.
English: • Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • izobraževalno brošuro; • povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
English: • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route.
Slovenian: • Pri drugih zdravilih, ki vsebujejo epotein, je tveganje za pojav imunogenosti pri kronični ledvični bolezni (KLB) povečano pri uporabi subkutane (s. c.) poti odmerjanja.
English: • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with sc use
Slovenian: • Podatkov o zdravilu Epoetin alfa HEXAL je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila.
English: • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Slovenian: • Vse primere suma čiste aplastične anemije ali pojava imunogenosti je treba sporočiti imetniku dovoljenja za promet z zdravilom.
English: Never take two doses at the same time (morning or evening).
Slovenian: Nikoli ne vzemite dveh odmerkov hkrati (zjutraj ali zvečer).
English: (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Slovenian: (Glejte poglavja 4.4, 4.5 in 5.1 za podatke , ki so na voljo za različne kombinacije).
English: Your body can also make too much sugar.
Slovenian: Poleg tega lahko telo izdeluje preveč sladkorja.
English: The red blood cells most likely represent a secondary compartment of distribution.
Slovenian: Rdeče krvne celice najverjetneje predstavljajo sekundarni razdelek porazdelitve.
English: Take the medicine pack with you.
Slovenian: Pakiranje zdravila vzemite s seboj.
English: The clinical relevance of these decreases is unknown.
Slovenian: Klinični pomen teh zmanjšanj ni znan.
English: Elimination Following administration of an oral [
Slovenian: Izločanje Po dajanju peroralnega odmerka [
English: It is unknown if this medicine is harmful to the unborn child.
Slovenian: Ni znano, ali lahko to zdravilo nerojenemu otroku škoduje.
English: Multiple-dose study: data are restricted to one study.
Slovenian: Študija z večkratnimi odmerki: na voljo so podatki ene študije.
English: (95% CI)
Slovenian: (95-% IZ)
English: Effects on plasma lipids were generally neutral.
Slovenian: Učinki na lipide v plazmi so bili večinoma nevtralni.
English: Organic cation transporters (OCT)
Slovenian: Organski kationski prenašalci (OCT)
English: However, a double dose should not be taken at the same time.
Slovenian: Dvojnega odmerka ne sme vzeti naenkrat.
English: These changes are not likely to be clinically meaningful.
Slovenian: Ni verjetno, da bi bile te spremembe klinično pomembne.
English: Doses of background anti-diabetic therapy were kept stable during the first 12 weeks, after which adjustments were permitted.
Slovenian: Odmerki osnovnega antidiabetičnega zdravljenje so bili prvih 12 tednov stabilni, nato jih je bilo dovoljeno prilagoditi.
English: When this happens, sugar (glucose) builds up in the blood.
Slovenian: Če se to zgodi, se sladkor (glukoza) kopiči v krvi.
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
English: How much to take
Slovenian: Koliko zdravila vzeti
English: Alcohol
Slovenian: Alkohol
English: Due to the limited nature of the data set the results should be interpreted cautiously.
Slovenian: Zaradi omejenega nabora podatkov, je pri interpretaciji rezultatov potrebna previdnost.
English: Your doctor will tell you exactly the dose of this medicine to take.
Slovenian: Zdravnik vam bo natančno povedal, kolikšen odmerek zdravila morate jemati.
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Slovenian: Podatki o varnosti iz te študije so bili skladni s prej znanim varnostnim profilom linagliptina.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Slovenian: Pri bolnikih s povečanim tveganjem dodatnega napredovanja okvare ledvic in pri starejših je treba delovanje ledvic oceniti pogosteje, na primer vsake 3 do 6 mesecev.
English: The starting dose is at most half of the maximum dose.
Slovenian: Začetni odmerek je največ polovica največjega odmerka.
English: The mean volume of distribution (Vd) ranged between 63-276 l.
Slovenian: Povprečni volumen porazdelitve (Vd ) je med 63 in 276 l.
English: Concomitant use not recommended
Slovenian: Sočasna uporaba ni priporočljiva