natgillin/translations-raw huggingface dataset:
The main measure of on an 11-point scale of the change elevant benefit in at its effect could be maintained over nformation was n elderly patients and its safety in the intended patients including the elderly.
Poleg tega bi potrebovali več podatkov o učinkih duloksetina pri starejših bolnikih in njegovi varnosti za bolnike, ki naj bi jih zdravili, vključno s starejšimi bolniki.
The CHMP therefore concluded that the benefits of d chronic somatic pain in patients not regularly taking NSAIDs had not been and recommended that
Odbor CHMP je zato sklenil, da dokazane koristi duloksetina pri zdravljenju zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov, večje od z njim povezanih tveganj.
On 21 July 2011, the Committee for Medicinal Products for Human Use (CH
Agencija Evropske unije© Evropska agencija za zdravila, 2011.
The company informed the CHMP that there are currently no ongoing clinical t Cymb
Družba je obvestila odbor CHMP, da trenutno v Evropi ne poteka nobeno klinično preskušanje zdravil Ariclaim, Cymbalta in Xeristar pri bolnikih s kronično somatsko bolečino.
uloxetine in the treatment of moderate to severe shown to outweigh its risks the change to the marketing authorisations be refused.
Kljub temu je odbor sklenil, da njegovi zadržki še vedno niso zadovoljivo odpravljeni ter potrdil svoje prvotno negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili.
The company that applied for examination of the opinion within 15 days of receipt of notification of this nega
Po proučitvi utemeljitve za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 17. novembra 2011 potrdil zavrnitev spremembe za dovoljenja za promet z zdravili.
1 pre-filled syringe with needle safety guard
injekcijskih brizg napolnjena injekcijska brizga (steklena) z varnostno zaščito za iglo napolnjena injekcijska brizga (steklena) z varnostno zaščito za iglo
You will also have blood tests during your treatment.
Prav tako boste med zdravljenjem opravljali preiskave krvi.
Details on how to minimise the safety concerns through appropriate monitoring and management.
Podrobnosti, kako zmanjšati varnostna tveganja z ustreznim spremljanjem in obvladovanjem.
For all subgroup analyses, formal statistical testing was not planned.
Za vse analize podskupin formalno statistično testiranje ni bilo načrtovano.
• Your doctor will monitor you carefully during the first infusion.
• Zdravnik vas bo med prvo infuzijo skrbno nadziral.
Do not try to treat yourself with other medicines.
Ne poskušajte se zdraviti sami z drugimi zdravili.
Before your treatment, your doctor will check your general health.
Pred zdravljenjem bo zdravnik preveril vaše splošno zdravstveno stanje.
• have been told that your cancer has spread to your brain
• so vam povedali, da se vam je rak razširil v možgane,
NE (NE)
NO (NO)
Pack of one vial.
Pakiranje z eno vialo.
This medicine should not be given to children or adolescents below 18 years of age.
Tega zdravila ne smejo dobiti otroci ali mladostniki, mlajši od 18 let.
The time to onset was 18 and 33 days.
Čas do pojava je bil 18 in 33 dni.
Aseptic preparation, handling and storage
Aseptična priprava, ravnanje in shranjevanje
Your healthcare professional will throw away any medicines that are no longer being used.
Zdravstveni delavec bo zavrgel vso zdravilo, ki se ne uporablja več.
• Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
• Zdravniku morate povedati, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
Median in months
Mediana v mesecih
For the treatment to be fully effective, it is very important to keep having the infusions.
Da bi bilo zdravljenje resnično učinkovito, je zelo pomembno, da nadaljujete s prejemanjem infuzij.
The median age was 73 years.
Mediana starost je bila 73 let.
A total of 931 patients were enrolled.
Skupno so vključili 931 bolnikov.
Your doctor may:
Vaš zdravnik:
The primary efficacy outcome was overall survival.
Primarni izid učinkovitosti je bilo celokupno preživetje.
The study enrolled a total of 438 patients and had two patient cohorts.
Študija je skupaj vključila 438 bolnikov in je imela dve kohorti.
The frequency is based on the program wide exposure.
Pogostnost temelji na široki izpostavljenosti.
Reduce infusion rate or interrupt.
Zmanjšajte hitrost infundiranja ali ga prekinite.
• protein in urine (proteinuria)
• beljakovine v urinu (proteinurija)
ATC code: L01XC32
Oznaka ATC: L01XC32
This is because stopping treatment may stop the effect of the medicine.
S prenehanjem zdravljenja namreč lahko preneha tudi učinek zdravila.
OS results for each of steps 2 and 3 could be formally tested for statistical significance only if the result in the preceding step was statistically significant.
Rezultati celokupnega preživetja za vsakega od korakov 2 in 3 so lahko formalno testirali glede statistične značilnosti le, če je bil rezultat v prejšnjem koraku statistično značilen.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
• Brief introduction to atezolizumab (indication and purpose of this tool)
• Kratko predstavitev atezolizumaba (indikacija in namen te kartice).
This regimen is administered every three weeks for four cycles.
Ta shema se aplicira na vsake tri tedne v skupno štirih ciklih.
These results should be interpreted with caution due to the open-label design of the study.
Te rezultate je treba zaradi odprte zasnove študije interpretirati previdno.
• No decline in ECOG performance status
• brez poslabšanja stanja zmogljivosti po ECOG;
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovi dokumentaciji.
This includes medicines obtained without a prescription, including herbal medicines.
To velja tudi za zdravila, ki ste jih dobili brez recepta, vključno z zdravili rastlinskega izvora.
The Marketing Authorisation Holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
The stratified log-rank p-value was 0.41 and therefore the results are considered not statistically significant in this population.
Stratificirana log-rang p-vrednost je bila 0,41, zato se rezultati v tej populaciji ne štejejo kot statistično značilni.
The storage details are as follows:
Podrobnosti shranjevanja so:
It is used when this cancer is advanced.
Pri tem raku ga uporabljamo, če je rak napredoval.
The management guidelines for these adverse reactions are described in sections 4.2 and 4.4.
Smernice za obravnavo teh neželenih učinkov so opisane v poglavjih 4.2 in 4.4.
• have an auto-immune disease (a condition where the body attacks its own cells)
• imate kakšno avtoimunsko bolezen (bolezen, pri kateri telo napade svoje lastne celice),
The median survival follow-up is 17 months.
Mediano spremljanje preživetja je 17 mesecev.
Antibodies are cleared principally by catabolism.
Protitelesa se odstranijo predvsem s katabolizmom.
Efficacy in elderly patients
Učinkovitost pri starejših bolnikih
The safety and efficacy of Tecentriq in children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost zdravila Tecentriq pri otrocih in mladostnikih, mlajših od 18 let, nista dokazani.
Patients were staged according to the American Joint Committee on Cancer (AJCC) 7th edition.
Stadij je bil pri bolnikih določen v skladu s 7. izdajo AJCC (American Joint Committee on Cancer).
• Do not use if this medicine is cloudy, discoloured or contains particles
• Zdravila ne uporabljajte, če je motno, obarvano ali vsebuje delce.
They may happen weeks or months after your last dose.
Ti neželeni učinki se lahko pojavijo še tedne ali mesece po zadnjem odmerku zdravila.
It is important that you also read the package leaflet for nab-paclitaxel.
Pomembno je, da preberete tudi navodilo za uporabo nab-paklitaksela.
• have had serious side effects because of other antibody therapies that help your immune system to fight cancer
• ste imeli resne neželene učinke zaradi drugih zdravljenj s protitelesi, ki pomagajo vašemu imunskemu sistemu, da premaguje raka,
Overall, ADA status appeared to have no clinically relevant impact on safety.
Prisotnost ADA po vsem sodeč ni klinično pomembno vplivala na varnost.
Immune-related adverse reactions affecting more than one body system have been observed.
Opazili so imunsko pogojene neželene učinke, ki vplivajo na več kot en organski sistem.
• low levels of adrenal hormones
• nizka raven nadledvičnih hormonov
Updated PFS results are also presented in Figures 4 and 5.
Posodobljeni rezultati PFS so prav tako prikazani na slikah 4 in 5.
Tecentriq may cause some side effects that you must tell your doctor about straight away.
Zdravilo Tecentriq lahko povzroči nekatere neželene učinke, o katerih morate takoj obvestiti svojega zdravnika.
Reported in studies outside the pooled dataset.
Zabeleženo v študijah izven združenih podatkov.
• have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C
• imate ali ste imeli kronično virusno okužbo jeter, vključno s hepatitisom B (HBV) ali hepatitisom C (HCV),
• have been given a live, attenuated vaccine
• ste se cepili z živim, oslabljenim cepivom.
• Give you other medicines to prevent complications and reduce symptoms.
• vam lahko da druga zdravila, da prepreči zaplete in zmanjša simptome,
This is because the effects of Tecentriq in this age group are not known.
Učinki zdravila Tecentriq v tej starostni skupini namreč niso znani.
A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body.
Monoklonsko protitelo je vrsta beljakovine in je zgrajeno tako, da prepozna specifično tarčo v telesu in se nanjo veže.
Asian patients
Azijski bolniki
No dose reduction was allowed.
Zmanjšanje odmerka ni bilo dovoljeno.
It is important that you also read the package leaflet for these medicines.
Pomembno je, da si preberete tudi navodila za uporabo teh zdravil.
A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Skupno je bilo vključenih 1225 bolnikov, v skladu z načrtom za analizo so prvih 850 randomiziranih bolnikov vključili v primarno analizo učinkovitosti.
The following information is intended for healthcare professionals only: Instructions for dilution
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za redčenje
• you are allergic to atezolizumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na atezolizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• You will not be given Tecentriq if you are pregnant unless your doctor considers it necessary.
• Če ste noseči, zdravila Tecentriq ne boste dobili, razen če vaš zdravnik meni, da je nujno.
• Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznak Uporabno do/EXP.
Tecentriq is available in a pack containing 1 glass vial.
Zdravilo Tecentriq je na voljo v pakiranjih, ki vsebujejo 1 stekleno vialo.
The following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Uporabljene so naslednje kategorije pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
The use of in-line filter membranes is optional.
Uporaba linijskega membranskega filtra ni obvezna.
Primary efficacy endpoints n=185
Primarni opazovani dogodki učinkovitosti n = 185
A decision must be made whether to discontinue breast-feeding or to discontinue Tecentriq therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba ali za prenehanje dojenja ali za prenehanje uporabe zdravila Tecentriq, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
However, monoclonal antibodies are not expected to alter DNA or chromosomes.
Za monoklonska protitelesa ni pričakovano, da bi spremenila DNA ali kromosome.
• decreased number of lymphocyte (a type of white blood cells), which is associated with an increased risk of infection
• zmanjšano število limfocitov (vrste belih krvnih celic), ki je povezano s povečanim tveganjem okužbe
Do not co-administer other medicinal products through the same infusion line.
Drugih zdravil ne dajate sočasno z isto infuzijsko linijo.
Treatment with atezolizumab until loss of clinical benefit was permitted as defined by the following criteria:
Zdravljenje z atezolizumabom do izgube klinične koristi je bilo dovoljeno, kot je opredeljeno v naslednjih merilih:
Tell your doctor straight away if you notice any of the symptoms below:
Zdravnika morate takoj obvestiti, če opazite katerega od naslednjih simptomov:
Patients excluded from clinical trials
Bolniki, ki niso bili vključeni v klinična preskušanja
• myasthenia gravis, an illness that can cause muscle weakness
• miastenija gravis, bolezen, ki lahko povzroči šibkost mišic
*** Responses were ongoing in 63% of responders in the atezolizumab arm and in 21% of responders in the chemotherapy arm.
*** Odgovori so potekali pri 63 % odzivnih bolnikov v skupini z atezolizumabom in pri 21 % odzivnih bolnikov v skupini s kemoterapijo.
Isolated hypothyroidism may be managed with replacement therapy and without corticosteroids.
Izolirani hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem in brez kortikosteroidov.
• The card should also prompt to enter contact details of the physician and include a warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Tecentriq.
• Kartica mora vključevati tudi prostor za navedbo kontaktnih podatkov zdravnika in vsebovati opozorilo za zdravstvene delavce, ki kadarkoli zdravijo bolnika, tudi v nujnih stanjih, da bolnik uporablja zdravilo Tecentriq.
• Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
• Opozorilo za bolnike glede pomena takojšnjega posvetovanja z zdravnikom, če imajo kateregakoli od navedenih znakov in simptomov, ter o pomembnosti dejstva, da se ne poskušajo zdraviti sami.
• Absence of tumour progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be readily managed and stabilised by protocol-allowed medical interventions prior to repeat dosing
• odsotnost napredovanja tumorja na kritičnih anatomskih mestih (npr. leptomeningealna bolezen), ki jih pred ponovno uporabo zdravila ni mogoče enostavno obvladati in stabilizirati z zdravljenjem, dovoljenim po protokolu;
*The primary analysis population consists of the first 850 randomised patients
*Populacijo za primarno analizo sestavlja prvih 850 randomiziranih bolnikov.
Atezolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with atezolizumab.
Atezolizumaba se med nosečnostjo ne sme uporabljati, razen če bolničino klinično stanje zahteva zdravljenje z atezolizumabom.
Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
Stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) ≥ 2
If you notice any of the symptoms above, tell your doctor straight away.
Če opazite katerega od zgoraj naštetih simptomov, morate takoj obvestiti zdravnika.
The primary analysis was performed when all patients had at least 24 weeks of follow-up.
Primarna analiza je bila izvedena, ko so vse bolnike spremljali vsaj 24 tednov.
It belongs to a group of medicines called monoclonal antibodies.
Spada v skupino zdravil, imenovanih monoklonska protitelesa.
• have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome
• imate okužbo z virusom humane imunske pomanjkljivosti (HIV) ali sindrom pridobljene imunske pomanjkljivosti (AIDS),
No dose adjustments are recommended.
Drugih sprememb niso priporočili.
(10.0, NE)
(10,0; NO)
Atezolizumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Atezolizumab je monoklonsko protitelo in pričakovano je, da je prisoten v prvem mleku ter v majhni koncentraciji pozneje.
The key results from this analysis as well as from the updated PFS analysis in the ITT population are summarised in Tables 6 and 7.
Ključni rezultati te analize kot tudi posodobljene analize PFS v populaciji ITT so povzeti v preglednicah 6 in 7.
The recommended dose is either:
Priporočeni odmerek je:
The MAH shall ensure that in each Member State where Tecentriq is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Tecentriq have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Tecentriq trži, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Tecentriq, imeli dostop ali prejeli naslednji paket izobraževanih gradiv:
The recommended dose of Tecentriq is:
Priporočeni odmerek zdravila Tecentriq je:
Seven (0.2%) patients required the use of corticosteroids.
Pri 7 (0,2 %) bolnikih je bilo treba uporabiti kortikosteroide.
** Based on Kaplan-Meier estimate
** Na osnovi Kaplan-Meierjeve ocene.
Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m2 every three weeks.
Zaradi povečane hematološke toksičnosti, ki so jo opazili pri azijskih bolnikih v študiji IMpower150, je priporočljivo, da je začetni odmerek paklitaksela 175 mg/m na tri tedne.
Further details on serious adverse reactions are provided in Section 4.4 Warnings & Precautions.
Nadaljnje podrobnosti o resnih neželenih učinkih so navedene v poglavju 4.4 Posebna opozorila in previdnostni ukrepi.
Patients experiencing fatigue should be advised not to drive and use machines until symptoms abate (see section 4.8).
Bolnikom, ki se jim pojavi utrujenost, je treba naročiti, naj ne vozijo in ne upravljajo strojev, dokler simptomi ne izzvenijo (glejte poglavje 4.8).
Seventy-five percent of patients received only one prior platinum-based therapeutic regimen.
75 % bolnikov je prejelo le eno predhodno terapevtsko shemo na osnovi platine.
No data are available to allow conclusions to be drawn on possible effects of neutralising antibodies.
Podatkov, ki bi omogočili sklepanje na morebitne učinke nevtralizirajočih protiteles, ni na voljo.
• Store in a refrigerator (2 °C - 8 °C).
• Shranjujte v hladilniku (2 °C do 8 °C).
The time to onset was 1.2 months.
Čas do pojava je bil 1,2 meseca.
Patients who met established criteria and who agreed to be treated beyond disease progression had tumour assessments conducted every 6 weeks until treatment discontinuation.
Bolnikom, ki so izpolnjevali postavljena merila in so soglašali z zdravljenjem po napredovanju bolezni, so oceno tumorja opravili vsakih 6 tednov do prenehanja zdravljenja.
The primary analysis of Cohort 2 was performed when all patients had at least 24 weeks of follow-up.
Primarna analiza 2. kohorte je bila izvedena, ko so vse bolnike spremljali vsaj 24 tednov.
• Absence of symptoms and signs (including worsening of laboratory values [e.g., new or worsening hypercalcaemia]) indicating unequivocal progression of disease
• odsotnost simptomov in znakov (vključno s poslabšanjem laboratorijskih vrednosti [npr. novonastalo hiperkalciemijo ali poslabšanjem hiperkalciemije]), ki nedvomno kažejo napredovanje bolezni;
These results indicate a potential risk, based on its mechanism of action, that administration of atezolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Ti rezultati kažejo možno tveganje, da bi uporaba atezolizumaba med nosečnostjo zaradi njegovega mehanizma delovanja lahko povzročila okvaro ploda, vključno z večjimi deleži splavov ali mrtvorojenosti.
This is because the effect of Tecentriq in pregnant women is not known - it is possible that it could harm your unborn baby.
Vpliv zdravila Tecentriq pri nosečnicah namreč ni znan in zdravilo bi morda lahko škodovalo vašemu nerojenemu otroku.
• Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
Od 107 bolnikov v skupini B, ki so po uvodnem zdravljenju dosegli odziv stabilne bolezni, delnega odgovora ali popolnega odgovora, jih je 40 nadaljevalo vzdrževalno zdravljenje zamenjano s pemetreksedom.
For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Pri sumu na imunsko pogojene neželene učinke je treba opraviti temeljito oceno za potrditev etiologije oziroma izključitev drugih vzrokov.
Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with systemic corticosteroid use, administration of other systemic immunosuppressants may be considered.
Na podlagi majhnega števila podatkov iz kliničnih študij pri bolnikih, katerih imunsko pogojenih neželenih učinkov ni mogoče nadzorovati s sistemskim zdravljenjem s kortikosteroidi, se lahko razmisli o uvedbi drugih sistemskih imunosupresivov.
This protein suppresses the body's immune (defense) system, thereby protecting cancer cells from being attacked by the immune cells.
Ta beljakovina zavira imunski (obrambni) sistem telesa, s čimer ščiti rakave celice pred napadom imunskih celic.
• numbness or paralysis, which may be signs of Guillain-Barré syndrome
• omrtvičenost ali paraliza, ki sta lahko znaka t. i. Guillain-Barréjevega sindroma
• If you do not have an infusion reaction during the first infusion, the next infusions will be given to you over a period of 30 minutes.
• Če med prvo infuzijo ne boste imeli reakcije na infundiranje, boste naslednje infuzije prejeli v
How long treatment lasts
Kako dolgo traja zdravljenje
There are no data from the use of atezolizumab in pregnant women.
Podatkov o uporabi atezolizumaba pri nosečnicah ni.
OS was not mature with an event patient ratio of approximately 40%.
Celokupno preživetje ni bilo dozorelo; razmerje bolnikov z dogodki je bilo približno 40 %.
Patients received treatment until radiographic disease progression per RECIST v1.1, or unacceptable toxicity.
Bolniki so zdravljenje prejemali do radiografskega napredovanja po merilih RECIST v1.1 ali do nesprejemljivih toksičnih učinkov.