FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance of Levviax is telithromycin, an antibacterial medicinal product which is a novel semi-synthetic antibacterial agent belonging to a new family of antibiotics, the ketolides, closely related to the well-known macrolide antibiotics.
Slovenian: Učinkovina zdravila Levviax je telitromicin, novo, protibakterijsko zdravilo, ki je dejansko novo polsintetično protibakterijsko zdravilo in spada v novo družino antibiotikov, imenovanih ketolidi, ki so tesno povezani z znanimi makrolidnimi antibiotiki.
English: Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony France
Slovenian: Imetnik dovoljenja za promet z zdravilom: Aventis Pharma S.A. 20 avenue Raymond Aron
English: Not applicable
Slovenian: Navedba smiselno ni potrebna
English: Adverse events assessed as possibly related to study treatment were reported for 35.8% of the telithromycin patients, versus 28.3% of the comparators.
Slovenian: Pri 35,8 % bolnikov, ki so bili zdravljeni s telitromicinom, so poročali o stranskih učinkih, ki bi bili lahko povezani z uporabo telitromicina, medtem ko je ta odstotek pri zdravljenju s primerljivimi učinkovinami znašal 28,3 %.
English: The frequency and severity of increased hepatic enzyme activity and liver disease appear similar to clarithromycin but justify close post-marketing surveillance, as does the potential prolongation of the QT-interval
Slovenian: Pogostost in resnost povečane aktivnosti jetrnih encimov ter bolezni jeter se zdita podobna kot pri klaritromicinu, toda navkljub temu je potrebno skrbno postmarketinško spremljanje teh stranskih učinkov kot tudi drugega možnega stranskega učinka, podaljšanja intervala QT.
English: Clinical trials, in general, support similar efficacy of telithromycin and comparators in the indications investigated (CAP not clinically serious enough to warrant parenteral therapy but efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years, AECB, sinusitis, and pharyngotonsillitis caused by S. pyogenes).
Slovenian: Klinične raziskave v splošnem potrjujejo podobno učinkovitost telitromicina in primerjalnih učinkovin za raziskane indikacije (pljučnica, pridobljena v domačem okolju, ki glede na resnost kliničnega stanje ne potrebuje parenteralnega zdravljenja; po drugi strani pa se je telitromicin izkazal kot učinkovit pri določenem številu bolnikov s pljučnico, pridobljeno v domačem okolju, in dejavniki tveganja kot sta pnevmokokna bakteriemija ali starost nad 65 let).
English: In patients of 18 years and older: - Community-acquired pneumonia, mild or moderate, - Acute exacerbation of chronic bronchitis, - Acute sinusitis, - Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate.
Slovenian: Pri bolnikih, starejših od 18 let: - plučnica, dobljena v domačem okolju, blaga ali zmerna, - akutno poslabšanje kroničnega bronhitisa, - akutni sinuzitis, - tonzilitis/faringitis, ki ga povzročajo beta streptokoki skupine A, kot alternativno zdravilo,
English: Antibacterial for systemic use JO1
Slovenian: Zdravila za sistemsko zdravljenje bakterijskih infekcij
English: Tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate
Slovenian: Pri bolnikih, starih od 12 do 18 let: tonzilitis/faringitis, ki ga povzročajo beta-streptokoki skupine A, kot alternativno zdravilo, kadar betalaktamski antibiotiki niso primerni.
English: The pharmacological action of telithromycin involves inhibition of bacterial protein synthesis and is similar to that of macrolides, but
Slovenian: Farmakološko delovanje telitromicina temelji na zaviranju sinteze proteinov v bakterijah in je podobno delovanju makrolidov, vendarle naj bi med skupinama na molekularnem nivoju obstajale razlike v delovanju.
English: Authorised presentations:
Slovenian: Odobrene farmacevtske oblike:
English: London, 15 November 2007 Doc.
Slovenian: London, 15. november 2007 Sklic dok.
English: Ref. EMEA/519568/2007
Slovenian: EMEA/519568/2007
English: This could have had an impact on the types of treatment chosen by doctors if they had relied on the test's results.
Slovenian: To bi lahko imelo vpliv na tip zdravljenja, ki bi ga izbrali zdravniki, če bi se zanašali na rezultat testa.
English: These included healthy volunteers and patients with stomach problems.
Slovenian: Študiji sta vključevali zdrave prostovoljce in bolnike z želodčnimi težavami.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here
Slovenian: Dopis podjetja, s katerim je bila EMEA obveščena o umiku vloge, je na voljo tukaj.
English: This labelled carbon dioxide can be detected in breath samples taken every 15 to 30 minutes in the four hours after the test meal.
Slovenian: Tak označen ogljikov dioksid lahko nato zaznavamo v vzorcih izdihanega zraka, ki jih vzamemo vsakih 15 do 30 minut v štirih urah po testnem obroku.
English: In both studies, the main measure of effectiveness was how long it took for half of the stomach's solid contents to be emptied.
Slovenian: Glavno merilo učinkovitosti je bil v obeh študijah čas, ki je bil potreben za izpraznitev polovice trdne vsebine želodca.
English: International non-proprietary name (INN): 1-13C-caprylic acid
Slovenian: Mednarodno nelastniško ime (INN): 1-13C-kaprilna kislina
English: Gastromotal is a diagnostic test.
Slovenian: Zdravilo Gastromotal je diagnostični test.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for GASTROMOTAL
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo GASTROMOTAL
English: This means that it contains 13C, a non-radioactive, rare form of the carbon atom, instead of carbon-12 (12C), the form that is the most common in nature.
Slovenian: To pomeni, da vsebuje ogljik 13C, neradioaktivno, redko obliko ogljikovih atomov, namesto v naravi najpogosteje prisotnega ogljika-12 (12C).
English: The rate of stomach emptying can then be determined by looking at the speed at which labelled carbon dioxide is released in the breath.
Slovenian: Hitrost praznjenja želodca je nato mogoče določiti z ugotavljanjem hitrosti sproščanja označenega ogljikovega dioksida v izdihanem zraku.
English: In the main studies, the level of agreement between Gastromotal and the standard test was too low to be acceptable, resulting in a considerable risk of false positive and false negative results.
Slovenian: Raven skladnosti med zdravilom Gastromotal in standardnim testom je bila v glavnih študijah prenizka, da bi bilo zdravilo sprejemljivo, saj bi povzročilo znatno tveganje za napačne pozitivne ali negativne rezultate.
English: When a patient takes a dose of Gastromotal mixed into a test meal, it enters the stomach with the food.
Slovenian: Če bolnik vzame odmerek zdravila Gastromotal, vmešanega v testni obrok, zdravilo vstopi v želodec skupaj s hrano.
English: On 5 November 2007, INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solidphase gastric half emptying time in gastric motility disorders.
Slovenian: Podjetje INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH je 5. novembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Gastromotal, namenjeno za in vivo diagnozo časa praznjenja polovice vsebine želodca v trdni fazi pri motnjah z gibanjem želodca.
English: The effects of Gastromotal were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Gastromotal so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Gastromotal?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Gastromotal?
English: As the food in the stomach is gradually emptied into the gut, it takes the Gastromotal with it, where it is absorbed into the blood and then broken down, releasing carbon dioxide gas labelled with 13C into the breath.
Slovenian: Ko hrana v želodcu počasi prehaja v črevo, s seboj prenese tudi zdravilo Gastromotal, ki se tam vsrka v kri in nato razgradi, pri tem pa sprošča ogljikov dioksid, označen z ogljikom 13C, v izdihan zrak.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Gastromotal had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da koristi zdravila Gastromotal niso zadostno dokazane in da morebitne koristi niso večje od znanih tveganj.
English: The active substance in Gastromotal, 1-13C-caprylic acid, is a natural chemical called caprylic acid that has been labelled with carbon-13 (13C).
Slovenian: Zdravilna učinkovina v zdravilu Gastromotal, 1-13C-kaprilna kislina, je naravna kemikalija, imenovana kaprilna kislina, ki je označena z ogljikom-13 (13C).
English: It was to be available as a syringe containing a liquid for drinking, containing the active substance 1-13C-caprylic acid (90 mg).
Slovenian: Zdravilo naj bi bilo na voljo v obliki injekcijske brizge, ki vsebuje pitno tekočino z zdravilno učinkovino 1-13C-kaprilno kislino (90 mg).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Gastromotal.
Slovenian: Podjetje je CHMP obvestilo, da za bolnike, ki so trenutno vključeni v klinična preizkušanja ali sočutno uporabo zdravila Gastromotal, ni nobenih posledic.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Gastromotal could not have been approved for the diagnosis of delayed stomach emptying.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo Gastromotal ni mogoče odobriti dovoljenja za diagnozo upočasnjenega praznjenja želodca.
English: Gastromotal was expected to be used to diagnose delayed stomach emptying in patients with stomach problems.
Slovenian: Zdravilo Gastromotal naj bi se uporabljalo za diagnozo upočasnjenega praznjenja želodca pri bolnikih z želodčnimi težavami.
English: The CHMP was concerned that the reliability and usefulness of Gastromotal in diagnosing delayed stomach empting had not been shown.
Slovenian: CHMP je izrazil zadržke, ker zanesljivost in uporabnost zdravila Gastromotal pri diagnostiki upočasnjenega praznjenja želodca nista bili dokazani.
English: What is Gastromotal?
Slovenian: Kaj je zdravilo Gastromotal?
English: What was Gastromotal expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Gastromotal uporabljalo?
English: The effectiveness of Gastromotal has been compared with that of a standard test called 99Tc-scintigraphy (a type of scan using radioactive tracers) in two main studies involving a total of 310
Slovenian: Učinkovitost zdravila Gastromotal so primerjali s standardnim testom, imenovanim 99Tc-scintigrafija
English: The CHMP was assessing the responses given by the company to a list of questions.
Slovenian: Podjetje je umaknilo vlogo na 200. dan. CHMP je ocenil odgovore podjetja na seznam vprašanj.
English: How is Gastromotal expected to work?
Slovenian: Kako naj bi zdravilo Gastromotal delovalo?
English: 00-867 Warszawa Poland
Slovenian: 00-867 Warszawa Poljska
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: D-85540 Haar
Slovenian: D-85540 Haar Nemčija
English: Šmartinska cesta 140, 1000 Ljubljana, Slovenia
Slovenian: Šmartinska cesta 140, 1000 Ljubljana, Slovenija
English: Quinta da Fonte Edifício Vasco da Gama, 19 P.O.
Slovenian: Quinta da Fonte Edifício Vasco da Gama,
English: Powder for suspension for parenteral use (IM)
Slovenian: prašek za suspenzijo za parenterlano uporabo (i.m.)
English: Pelham House South County Business Park Leopardstown
Slovenian: Pelham House South County Business Park
English: Bucureşti-Ploieşti Nr.1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti
Slovenian: Bucureşti-Ploieşti Nr.1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti, Romuija
English: 18th Km Athens-Lamia National Road 14671 Nea Erythrea Greece
Slovenian: 18th Km Athens-Lamia National Road 14671 Nea Erythrea Grčija
English: C/ Josefa Valcárcel, 38 28027 Madrid Spain
Slovenian: C/ Josefa Valcárcel, 38 28027 Madrid Španija
English: BOX 214
Slovenian: P.O. BOX 214
English: 2770-192 Paço de Arcos Portugal
Slovenian: Porto Salvo 2770-192 Paço de Arcos
English: Via Vitorchiano, 151 - 00189 Roma
Slovenian: Via Vitorchiano, 15100189 Roma Italija
English: Box 581, 2003 PC Haarlem
Slovenian: P.O. Box 581, 2003 PC Haarlem
English: Euro Platz 2 1120 Wien Austria
Slovenian: 1120 Wien
English: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom
Slovenian: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Združeno kraljestvo Velike Britanije in Severne Irske
English: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU United Kingdom
Slovenian: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU, Združeno kraljestvo Velike Britanije in Severne Irske
English: Dry Powder for injection
Slovenian: suhi prašek za injekcije intravenska uporaba
English: Merck Sharp & Dohme, UAB, Kęstučio 59/27, LT-08124 Vilnius
Slovenian: Kęstučio 59/27, LT-08124 Vilnius,
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A, Viale Shakespeare, 47 00144 Roma
Slovenian: Viale Shakespeare, 47 00144 Roma Italija
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem
Slovenian: Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem Nizozemska
English: Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands
Slovenian: Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem Nizozemska
English: MSD SHARP & DOHME GMBH Lindenplatz 1
Slovenian: MSD SHARP & DOHME GMBH
English: 250 mg/250 mg Powder for infusion
Slovenian: 250 mg/250 mg prašek za infundiranje intravenska uporaba
English: 500 mg powder for solution for infusion 500 mg/500 mg Powder for solution for infusion Intravenous use
Slovenian: 500 mg powder for solution for infusion 500 mg/500 mg prašek za raztopino za infundiranje
English: ZIENAM° 500 mg Pulver zur Herstellung einer Infusionslösung
Slovenian: ZIENAM° 500 mg Pulver zur Herstellung einer Infusionslösung intravenska iuporaba
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, The Netherlands
Slovenian: Waarderweg 39, 2031 BN Haarlem, Nizozemska
English: 500 mg/500 mg
Slovenian: 250 mg in 500 mg
English: Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem
Slovenian: Waarderweg 39, 2031 BN Haarlem
English: Dublin 18
Slovenian: Leopardstown Dublin 18
English: PrimaxinIV 500mg Injection 500mg
Slovenian: PrimaxinIV 500mg Injection 500mg prašek za koncentrat za raztopino za infundiranje
English: Porto Salvo
Slovenian: Chaussée de Waterloo
English: Primaxin IV 500mg Injection 500mg
Slovenian: Primaxin IV 500mg Injection 500mg prašek za koncentrat za raztopino za infundiranje
English: TIENAM 500 mg/500 mg, poudre pour perfusion 500 mg/500 mg Powder for infusion
Slovenian: TIENAM 500 mg/500 mg, poudre pour perfusion
English: 500 mg/500 mg Powder for infusion
Slovenian: 500 MG/500 MG 500 mg/500 mg prašek za raztopino za infundiranje
English: 500 mg + 500 mg Powder for solution for injection Intravenous use
Slovenian: 500 mg/500 mg prašek za infundiranje intravenska uporaba
English: Further information on Keytruda can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/keytruda.
Slovenian: Nadaljnje informacije za zdravilo Keytruda so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/keytruda.
English: The European Medicines Agency decided that Keytruda's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Keytruda večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Keytruda received a marketing authorisation valid throughout the EU on 17 July 2015.
Slovenian: Za zdravilo Keytruda je bilo 17. julija 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Keytruda?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Keytruda?
English: In addition, the company will provide the final results of studies with Keytruda to confirm the longterm benefits of the medicine.
Slovenian: Poleg tega bo predložilo tudi končne rezultate študij o zdravilu Keytruda, ki naj bi potrdili dolgoročne koristi tega zdravila.
English: Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.
Slovenian: Prav tako bo opravilo analize, da bi bolje razumeli, kateri bolniki bi lahko imeli največ koristi od zdravljenja z zdravilom Keytruda.
English: When it is given with other cancer medicines, the dose is always 200 mg every three weeks.
Slovenian: Kadar se daje v kombinaciji z drugimi zdravili za zdravljenje raka, znaša odmerek vedno 200 mg vsake tri tedne.
English: The medicine can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj.
English: Why is Keytruda authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Keytruda odobreno v EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda 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 Keytruda upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What benefits of Keytruda have been shown in studies?
Slovenian: Kakšne koristi zdravila Keytruda so se pokazale v študijah?
English: As for all medicines, data on the use of Keytruda are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Keytruda stalno spremljajo.
English: The company that markets Keytruda will provide patients with an information pack and alert card to inform them about the risks of potential immune-related side effects and give instructions on when to contact their doctor if they experience symptoms.
Slovenian: Podjetje, ki trži zdravilo Keytruda, bo bolnikom priskrbelo informativni bilten in opozorilno kartico z obvestilom o tveganjih neželenih učinkov na imunski sistem in navodili za posvetovanje z zdravnikom v primeru pojava simptomov.
English: An overview of Keytruda and why it is authorised in the EU
Slovenian: Pregled zdravila Keytruda in zakaj je odobreno v EU
English: Side effects reported with Keytruda are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Keytruda, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: When Keytruda is given alone the dose is either 200 mg every three weeks or 400 mg every six weeks.
Slovenian: Kadar se zdravilo Keytruda daje kot samostojno zdravilo, znaša odmerek bodisi 200 mg vsake tri tedne bodisi 400 mg vsakih šest tednov.
English: What is Keytruda and what is it used for?
Slovenian: Kaj je zdravilo Keytruda in za kaj se uporablja?
English: The average time that patients lived without their disease getting worse again was around 11 months.
Slovenian: Povprečno trajanje obdobja brez ponovnega poslabšanja bolezni je bilo okoli enajst mesecev.
English: Keytruda is mainly used for cancers that are advanced, have spread to other parts of the body (metastatic) or are not responding to other treatments.
Slovenian: Zdravilo Keytruda se uporablja predvsem pri tistih rakavih obolenjih, ki so napredovala, se razširila na druge dele telesa (so metastatska) ali se ne odzivajo na druga zdravila.
English: Other information about Keytruda
Slovenian: Druge informacije o zdravilu Keytruda
English: For more information about using Keytruda, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Keytruda glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Keytruda?
Slovenian: Kakšna tveganja so povezana z zdravilom Keytruda?
English: Keytruda did not delay worsening of the disease compared with the other cancer medicines (time to disease worsening was 2 and 3 months respectively).
Slovenian: Zdravilo Keytruda ni upočasnilo poslabšanja bolezni v primerjavi z drugimi zdravili za zdravljenje raka (čas do poslabšanja bolezni je bil dva oziroma tri mesece).
English: The most common side effects of Keytruda given alone (which may affect more than 1 in 5 people) are tiredness, nausea (feeling sick) and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Keytruda (ki se lahko pojavijo pri več kot 1 bolniku od 5) so utrujenost, navzeja (siljenje na bruhanje) in driska.
English: At 18 months, 81% of the patients given the combination were alive, compared with 71% in the sunitinib group.
Slovenian: Po 18 mesecih je bilo 81 % bolnikov, ki so prejemali kombinacijo zdravil, še vedno živih, v primerjavi z 71 % tistih, ki so prejemali sunitinib.
English: Some cancers can make a protein (PD-L1) that combines with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Slovenian: Nekatere vrste rakavih obolenj lahko povzročijo, da beljakovina (PD-L1), ki se veže na receptor PD-1, prekine dejavnost določenih celic imunskega sistema (naravnega obrambnega mehanizma telesa), s čimer jim prepreči napadanje rakavih celic.
English: The active substance in Keytruda, pembrolizumab, is a monoclonal antibody, a protein that has been designed to recognise and block a receptor (‘target') called PD-1.
Slovenian: Učinkovina zdravila Keytruda, pembrolizumab, je monoklonsko protitelo, tj. beljakovina, ki je bila zasnovana tako, da prepozna in zavre receptor (prijemališče), imenovan PD-1.
English: Keytruda can delay worsening of melanoma and improve survival.
Slovenian: Zdravilo Keytruda lahko upočasni slabšanje melanoma in podaljša preživetje.
English: Keytruda is also effective in combination treatment of a type of NSCLC known as ‘non-squamous' cancer, based on the type of cancer cells involved.
Slovenian: Zdravilo Keytruda je učinkovito tudi pri kombiniranem zdravljenju vrste nedrobnoceličnega pljučnega raka, znanega kot „neploščatocelični“ rak, glede na vrsto prisotnih rakavih celic.
English: The side effects with this medicine are manageable and are similar to those of various other cancer treatments.
Slovenian: Neželeni učinki tega zdravila so obvladljivi in podobni neželenim učinkom, ki se pojavljajo pri številnih drugih zdravilih za zdravljenje raka.