FrancophonIA/ELRC3.0 huggingface dataset:
English: − Send out a letter to all customers receiving the CattleMarker IBR Inactivated for the first time with additional information to raise awareness for possible BNP cases.
Slovenian: − vsem kupcem, ki prvič kupijo cepivo CattleMarker IBR Inactivated, pošlje dopis z dodatnimi informacijami, da poveča zavedanje o možnih primerih BNP;
English: − The marketing authorisation holder should consider the development a method for assaying the protein content in the finished product.
Slovenian: − imetnik dovoljenja za promet z zdravilom preuči razvoj metode za preizkušanje vsebnosti beljakovin v končnem cepivu;
English: The potential risk deriving from the intended use of CattleMarker IBR Inactivated to trigger BNP is associated with the composition and manufacture of the vaccine and more specifically with the amount of Antigens Not related to the Active Substance (ANAS) and is also linked to the use of the vaccine in female cattle subject to repeated vaccinations.
Slovenian: Možno tveganje pojava BNP zaradi predvidene uporabe cepiva CattleMarker IBR Inactivated je povezano s sestavo in izdelavo cepiva ter zlasti s količino antigenov, ki niso povezani z zdravilno učinkovino (ANAS), in z uporabo cepiva pri govedu ženskega spola, pri katerih se izvajajo ponavljajoča cepljenja.
English: CattleMarker IBR Inactivated fulfils the criteria for an effective IBR marker vaccine and provides the full therapeutic benefit.
Slovenian: Cepivo CattleMarker IBR Inactivated izpolnjuje merila za učinkovito markirano cepivo proti infekcioznemu bovinemu rinotraheitisu in zagotavlja popolno terapevtsko korist.
English: − Utilise the existing colostrum practices in case of BNP cases and develop further mitigation measure for colostrum.
Slovenian: − ob pojavu okužb z BNP uporabi obstoječe prakse za kolostrum in pripravi nadaljnji ukrep za zmanjšanje tveganja pri kolostrumu.
English: In the past initially epidemiological information and then rapidly increasing pharmacovigilance data documented an increase of the frequency of this alloimmune reaction between the dam and the foetus and finally a close relationship between the occurrences of BNP and the repeated vaccination of dams with PregSure BVD was established.
Slovenian: V preteklosti so beležili povečanje pogostnosti te aloimunske reakcije med materjo in plodom, najprej na podlagi epidemioloških informacij in pozneje hitro naraščajočih farmakovigilančnih podatkov, kar je vodilo do ugotovitve o tesni povezavi med pojavi BNP in ponavljajočim cepljenjem samic s cepivom PregSure BVD.
English: Applicant/marketing authorisation holder
Slovenian: Vlagatelj/imetnik dovoljenja za promet z zdravilom
English: Several live and inactivated IBR marker vaccines are authorised and successfully used throughout the EU.
Slovenian: V EU je odobrenih več živih in inaktiviranih markiranih cepiv proti infekcioznemu bovinemu rinotraheitisu, ki se uspešno uporabljajo.
English: The abovementioned study results should be provided to the relevant national competent authorities for assessment prior to placing CattleMarker IBR Inactivated on the EU market and within 24 months of the Commission Decision.
Slovenian: Rezultate zgoraj navedene študije je treba pred dajanjem cepiva CattleMarker IBR Inactivated na trg EU predložiti ustreznim pristojnim nacionalnim organom v oceno in v 24 mesecih po izdaji sklepa Komisije.
English: Furthermore, the MAH has made post authorisation commitments to set a maximum level of total proteins for batch release and to perform two additional studies in order to investigate possible interactions of vaccinations with CattleMarker IBR Inactivated in animals previously vaccinated with PregSure BVD or other vaccines.
Slovenian: Poleg tega se je imetnik dovoljenja za promet z zdravilom po pridobitvi dovoljenja za promet zavezal, da bo določil najvišjo vsebnost skupnih beljakovin za sproščanje serij in da bo opravil dve dodatni študiji, s katerima bo raziskal možno medsebojno delovanje cepljenja s cepivom CattleMarker IBR Inactivated pri živalih, ki so bile že cepljene s cepivom PregSure BVD ali drugimi cepivi.
English: The MAH proposed a post-marketing pharmacovigilance surveillance program utilising its usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal program za nadzor farmakovigilance v obdobju trženja z uporabo običajnega sistema farmakovigilance za spremljanje živali, cepljenih s cepivom CattleMarker IBR Inactivated.
English: The potential risk of recurrence of BNP linked to the use of this vaccine in pregnant cows has been addressed by the MAH; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je obravnaval možno tveganje za ponovitev pancitopenije novorojenega goveda v povezavi z uporabo tega cepiva pri brejih kravah, vendar pa je bilo po mnenju Nemčije predlagano obvladovanje tveganja neustrezno in bi moral imetnik dovoljenja za promet z zdravilom začeti obsežno študijo o varnosti zdravila po pridobitvi dovoljenja za promet.
English: • The marketing authorisation holder shall conduct a controlled laboratory study to confirm that hyperimmunisation of cattle with CattleMarker IBR Inactivated does not induce a significant alloantibody response to MHC-I and MDBK cells and also to assess if vaccination with other cattle vaccines produced on bovine cell lines and with high amount of ANAS followed by booster with CattleMarker IBR Inactivated leads to a significant increase in alloantibody titres against MHC-I and MDBK cells.
Slovenian: • imetnik dovoljenja za promet z zdravilom bo opravil kontrolirano laboratorijsko študijo, s katero bo potrdil, da hiperimunizacija goveda s cepivom CattleMarker IBR Inactivated ne sproži večjega odziva aloprotiteles na celice MHC-I in MDBK, in tudi ocenil, ali cepljenje z drugimi cepivi za govedo, proizvedenimi na celičnih linijah goveda, in z velikimi količinami ANAS, ki se pojavijo po obnovitvenem cepljenju s cepivom CattleMarker IBR Inactivated, povzroči znatno povečanje titrov aloprotiteles proti celicam MHC-I in MDBK.
English: If alive, profound thrombocytopenia (with or without neutropenia, lymphopenia and nonregenerative anaemia).
Slovenian: 3. če je žival živa, se ugotavlja izražena trombocitopenija (z nevtropenijo, limfopenijo in neregenerativno anemijo ali brez njih);
English: • to reduce the clinical signs (pyrexia and duration of dyspnoea) of infectious bovine rhinotracheitis (IBR) and virus shedding caused by BoHV-1 infection;
Slovenian: • zmanjšanja kliničnih znakov (pireksije in trajanja dispneje) infekcioznega bovinega rinotraheitisa (IBR) in skrajšanja trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1;
English: CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated) is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Slovenian: Emulzija za injiciranje za govedo CattleMarker IBR Inactivated (v nadaljnjem besedilu: CattleMarker IBR Inactivated) je inaktivirano cepivo proti infekcioznemu bovinemu rinotraheitisu (IBR), ki vsebuje glikoprotein E (gE)-negativen goveji herpesvirus tipa 1 (BoHV-1), sev Difivac.
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Slovenian: Cepivo je indicirano za aktivno imunizacijo seronegativnega goveda, starega dva tedna ali več, za zmanjšanje kliničnih znakov (pireksije in depresije) infekcioznega bovinega rinotraheitisa in skrajšanje trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1.
English: Onset and duration of protection for the seronegative cattle form 2 weeks of age is 2 weeks and 6 months respectively after completion of the primary vaccination
Slovenian: Pri seronegativnem govedu, starem dva tedna ali več, se zaščita razvije dva tedna po zaključku osnovnega cepljenja in traja šest mesecev po osnovnem cepljenju.
English: Later the marketing authorisations for PregSure BVD were withdrawn by the MAH Pfizer (now Zoetis) from all EU and in 2011 even from non-EU countries after reports about BNP cases in PregSure BVD-vaccinated herds in New Zealand became public.
Slovenian: Po objavi poročil o primerih BNP v čredah živali, cepljenih s cepivom PregSure BVD na Novi Zelandiji, je imetnik dovoljenja za promet z zdravilom, družba Pfizer (zdaj Zoetis), umaknil dovoljenja za promet s cepivom PregSure BVD iz vseh držav EU in leta 2011 tudi iz držav, ki niso članice EU.
English: During the MRP Germany raised a concern about the immunological safety of CattleMarker IBR Inactivated, as the composition of this product is similar to PregSure BVD, a vaccine which has been shown to induce a long-lasting allogeneic antibody response which has been associated with Bovine Neonatal Pancytopenia (BNP), a neonatal alloimmune disease, in the progeny of vaccinated dams.
Slovenian: Nemčija je med postopkom z medsebojnim priznavanjem izrazila zaskrbljenost glede imunološke varnosti cepiva CattleMarker IBR Inactivated, ker je sestava tega cepiva podobna sestavi cepiva PregSure BVD, za katerega je bilo dokazano, da pri potomcih cepljenih samic sproža dolgotrajen alogenski odziv protiteles, povezan s pancitopenijo novorojenega goveda (BNP), ki je aloimunska bolezen novorojenega goveda.
English: Finally, by comparison with published data on alloantibody response triggered by other marketed vaccines, the BNP risk for CattleMarker IBR Inactivated appears to be significantly lower than this for PregSure BVD.
Slovenian: V primerjavi z objavljenimi podatki o odzivu aloprotiteles, ki so ga sprožila druga cepiva na trgu, je tveganje za BNP pri cepljenju s cepivom CattleMarker IBR Inactivated očitno znatno nižje kot pri uporabi cepiva PregSure BVD.
English: − Utilise the existing GMP product/batch recall procedures.
Slovenian: − uporabi obstoječe postopke dobre proizvodne prakse (DPP) za odpoklic cepiva/serije.
English: − Provide a contingency plan in the unlikely circumstance that BNP reports occur that involve CattleMarker IBR Inactivated vaccinated dams.
Slovenian: − zagotovi načrt ukrepov ob nepredvidljivih dogodkih v malo verjetnih okoliščinah, ko se pojavijo poročila o okužbi z BNP pri samicah, ki so bile cepljene s cepivom CattleMarker IBR Inactivated;
English: Overall, the benefit-risk balance for CattleMarker IBR Inactivated emulsion for injection is considered positive, subject to the conduct of additional studies and the implementation of further measures specified in a RMP.
Slovenian: Ocena splošnega razmerja med tveganji in koristmi Razmerje med tveganji in koristmi za cepivo CattleMarker IBR Inactivated emulzija za injiciranje je na splošno pozitivno, pod pogojem, da bodo opravljene dodatne študije in izvedeni nadaljnji ukrepi, opredeljeni v načrtu za obvladovanje tveganj.
English: • The marketing authorisation holder shall conduct a study to assess the potential booster of CattleMarker IBR Inactivated on any MHC-I or opsonizing alloantibody responses in cattle previously vaccinated using PregSure BVD.
Slovenian: • imetnik dovoljenja za promet z zdravilom bo opravil študijo, s katero bo ocenil možno obnovitveno cepljenje s cepivom CattleMarker IBR Inactivated na celicah MHC-I ali opsonizacijske odzive aloprotiteles pri govedu, ki je bilo že cepljeno s cepivom PregSure BVD.
English: gE deleted IBR vaccines such as CattleMarker IBR Inactivated are “DIVA vaccines”, differentiating infected from vaccinated animals.
Slovenian: Cepiva IBR, ki imajo delecijo specifičnega gena (gE), kot je CattleMarker IBR Inactivated, so „cepiva DIVA“, pri katerih gre za razlikovanje med okuženimi in cepljenimi živalmi.
English: which will be included in a risk management plan and are deemed adequate and proportionate to the identified risk of development of BNP; the CVMP has recommended the granting of the marketing authorisation for CattleMarker IBR Inactivated emulsion for injection for cattle subject to conditions affecting the marketing authorisations as set out in Annex IV.
Slovenian: • imetnik dovoljenja za promet z zdravilom je predlagal številne ukrepe za izboljšanje kakovosti ter zmanjševanje tveganja in nadzor, ki bodo vključeni v načrt za obvladovanje tveganj ter se štejejo za ustrezne in sorazmerne ugotovljenim tveganjem za BNP, je odbor CVMP priporočil, da se izda dovoljenje za promet s cepivom CattleMarker IBR Inactivated emulzija za injiciranje za govedo, pod pogoji, ki vplivajo na dovoljenja za promet, kot je določeno v Prilogi IV.
English: Evaluation of the overall benefit-risk balance
Slovenian: Ocena razmerja med tveganji in koristmi
English: Grounds for the granting of the marketing authorisations
Slovenian: Podlaga za izdajo dovoljenj za promet z zdravilom
English: In a hyperimmunisation study it has been demonstrated that these remaining ANAS from the manufacturing process of CattleMarker IBR Inactivated did not trigger the production of alloantibodies at a level similar to this of animals hyperimmunised with PregSure BVD.
Slovenian: S študijo hiperimunizacije je bilo dokazano, da ti ostanki ANAS, ki nastanejo v postopku izdelave cepiva CattleMarker IBR Inactivated, ne povzročijo nastanka enakih količin aloprotiteles kot pri živalih, hiperimuniziranih s cepivom PregSure BVD.
English: In a hyperimmunisation study, repeated injections of CattleMarker IBR Inactivated did not trigger the production of alloantibodies at a level similar to this of animals hyperimmunised with PregSure BVD.
Slovenian: Med študijo hiperimunizacije ponovljena injiciranja cepiva CattleMarker IBR Inactivated niso povzročila nastanka podobnih količin aloprotiteles kot pri živalih, hiperimuniziranih s cepivom PregSure BVD.
English: CattleMarker IBR Inactivated contains the same adjuvant Procision-A as PregSure BVD and the virus production also utilises a bovine-derived kidney cell line (MDBK).
Slovenian: Cepivo CattleMarker IBR Inactivated vsebuje enak adjuvans Procision-A kot cepivo PregSure BVD, za proizvodnjo virusa pa se prav tako uporablja ledvična celična linija, pridobljena iz goveda (MDBK).
English: Data has been provided to demonstrate that CattleMarker IBR Inactivated, unlike PregSure BVD, has a reduced amount of immunologically significant amount of ANAS remaining from its manufacturing process on the bovine derived kidney cell line in the final product.
Slovenian: Na podlagi posredovanih podatkov je bilo dokazano, da ima cepivo CattleMarker IBR Inactivated v nasprotju s cepivom PregSure BVD v končnem zdravilu manj imunološko značilnih ANAS, ki so ostali po postopku izdelave na ledvični celični liniji, pridobljeni iz goveda.
English: CattleMarker IBR Inactivated has the same highly potent adjuvant, Procision-A, and is grown on the same bovine-derived kidney cell line (MDBK) as PregSure BVD.
Slovenian: Cepivo CattleMarker IBR Inactivated ima enak zelo močan adjuvans Procision-A in se goji na enaki ledvični celični liniji, pridobljeni iz goveda (MDBK), kot cepivo PregSure BVD.
English: CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant, Procision-A, as PregSure BVD.
Slovenian: Cepivo CattleMarker IBR Inactivated se proizvaja na enaki celični liniji goveda kot cepivo PregSure BVD in dodan mu je enak zelo močan adjuvans, Procision-A.
English: Romania Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Romunija Zoetis Belgium SA Rue Laid Burniat 1
English: The MAH committed to conducting thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of vaccinesThese measures are proportionate to the BNP risk and include all the current knowledge on BNP gathered from the PregSure BVD incident.
Slovenian: Zavezal se je, da bo natančno raziskal vsako nepojasnjeno smrt mladičev cepljenih živali po zabeleženi uporabi cepiv.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Bolgarija Zoetis Belgium SA Rue Laid Burniat 1
English: However the manufacturing process of CattleMarker IBR Inactivated leads to an amount of remnant of ANAS (e.g. MDBK cell debris) lower than the one of PregSure BVD.
Slovenian: Vendar pa je količina ostankov ANAS (npr. ostanki celic MDBK), ki nastanejo pri postopku izdelave cepiva CattleMarker IBR Inactivated, manjša kot pri cepivu PregSure BVD.
English: Germany Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: Portugalska Zoetis Belgium SA Rue Laid Burniat 1
English: • The MAH has provided data demonstrating that the risk that repeated injections with the vaccine
Slovenian: • imetnik dovoljenja za promet z zdravilom je predložil podatke, ki so dokazovali, da je tveganje, da bi lahko ponavljajoče injiciranje cepiva CattleMarker IBR Inactivated sprožilo pojav BNP, znatno nižje kot pri uporabi cepiva PregSure BVD;
English: Further information on Tagrisso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Tagrisso so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was switched to a full marketing authorisation on 24 April 2017.
Slovenian: To je bilo 24. aprila 2017 spremenjeno v običajno dovoljenje za promet.
English: The European Medicines Agency therefore concluded that Tagrisso's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Tagrisso večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Patients with EGFR mutations have a poor prognosis and limited treatment options; therefore there is a high unmet medical need.
Slovenian: Bolniki z mutacijami EGFR imajo slabo prognozo in zelo omejene možnosti zdravljenja, zato obstaja velika neizpolnjena medicinska potreba.
English: Tagrisso is available as 40 and 80 mg tablets.
Slovenian: Zdravilo Tagrisso je na voljo v obliki 40- in 80-miligramskih tablet.
English: If certain side effects develop the doctor may decide to reduce the dose or stop treatment.
Slovenian: Če se pojavijo določeni neželeni učinki, se lahko zdravnik odloči, da bo zmanjšal odmerek ali prekinil zdravljenje.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Slovenian: Ko je podjetje predložilo dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
English: The patient should take 80 mg once a day for as long as the disease improves or remains stable and the side effects are tolerable.
Slovenian: Bolnik mora jemati 80-miligramski odmerek zdravila enkrat na dan, dokler se bolezen izboljšuje oziroma ostaja stabilna, neželeni učinki pa so znosni.
English: It blocks the activity of EGFR, which normally controls growth and division of cells.
Slovenian: Zavira aktivnost EGFR, ki običajno nadzoruje rast in delitev celic.
English: What measures are being taken to ensure the safe and effective use of Tagrisso?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tagrisso?
English: Before starting treatment, doctors should use a genetic test to confirm that the patient has an EGFR mutation.
Slovenian: Pred začetkom zdravljenja morajo zdravniki opraviti genetsko testiranje, da potrdijo, da bolnik ima mutacijo EGFR.
English: Tagrisso received a conditional marketing authorisation valid throughout the EU on on 2 February 2016.
Slovenian: Za zdravilo Tagrisso je bilo 2. februarja 2016 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: In patients with T790 mutation, the medicine may be given after other treatments.
Slovenian: Pri bolnikih z mutacijo T790 se zdravilo lahko daje po drugih zdravljenjih.
English: In these studies, Tagrisso was not compared with any other treatment.
Slovenian: V teh študijah zdravila Tagrisso niso primerjali z nobenim drugim zdravilom.
English: Tagrisso was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Slovenian: Zdravilo Tagrisso je prvotno pridobilo „pogojno dovoljenje za promet“, ker so bili pričakovani dodatni dokazi o zdravilu.
English: Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.
Slovenian: Kar se tiče varnosti, so bili neželeni učinki zdravila Tagrisso podobni kot pri drugih zdravilih istega razreda in veljajo za sprejemljive.
English: As for all medicines, data on the use of Tagrisso are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tagrisso stalno spremljajo.
English: Other information about Tagrisso
Slovenian: Druge informacije o zdravilu Tagrisso
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tagrisso have 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 Tagrisso upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The most common side effects with Tagrisso (which may affect more than 1 in 10 people) are diarrhoea, rash, dry skin, paronychia (nail bed infection), itching, stomatitis (inflammation of the lining of the mouth) and a decrease in the levels of white blood cells and platelets.
Slovenian: Najpogostejši neželeni učinki zdravila Tagrisso (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so driska, izpuščaj, suha koža, zanohtnica (okužba obnohtja), srbenje, stomatitis (vnetje ustne sluznice) in zmanjšanje ravni belih krvnih celic in trombocitov.
English: Treatment with Tagrisso should be started and supervised by a doctor who is experienced in the use of cancer medicines.
Slovenian: Zdravljenje z zdravilom Tagrisso mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: It is used in patients who have mutations (changes) in a gene for a protein called EGFR.
Slovenian: Uporablja se pri bolnikih z mutacijami (spremembami) gena za beljakovino, imenovano EGFR.
English: If a patient has mutations known as an ‘activating mutations', Tagrisso is given as the first treatment.
Slovenian: Če ima bolnik mutacije, poznane kot „aktivirajoče mutacije“, se zdravilo Tagrisso daje kot prvo zdravilo.
English: What benefits of Tagrisso have been shown in studies?
Slovenian: Kakšne koristi zdravila Tagrisso so se pokazale v študijah?
English: In patients taking Tagrisso, the cancer did not get worse for around 10.1 months compared with 4.4 months in patients on chemotherapy.
Slovenian: Pri bolnikih, ki so jemali zdravilo Tagrisso, se rak ni poslabšal približno 10,1 meseca, v primerjavi s 4,4 meseca pri bolnikih, ki so prejemali kemoterapijo.
English: It contains the active substance osimertinib.
Slovenian: Vsebuje učinkovino osimertinib.
English: An overview of Tagrisso and why it is authorised in the EU
Slovenian: Pregled zdravila Tagrisso in zakaj je odobreno v EU
English: Why is Tagrisso authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Tagrisso odobreno v EU?
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled growth of cancer cells.
Slovenian: V rakavih celicah pljuč je EGFR pogosto čezmerno dejavna in povzroča nenadzorovano rast rakavih celic.
English: Side effects reported with Tagrisso are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Tagrisso, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Tagrisso, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Tagrisso glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.