natgillin/translations-raw huggingface dataset:
In the absence of specific studies, no other veterinary medicinal product should be administered concurrently with the product. 
Ker ni podatkov posebnih raziskav, odsvetujemo sočasno uporabo tega cepiva z drugimi zdravili za uporabo v veterinarski medicini.
The vaccine must be administered by subcutaneous route or by in ovo route. 
Cepivo se injicira ali subkutano ali in ovo.
Live vHVT013-69 recombinant virus, at least ....................................................... 3.6 to 5.0 log10 PFU* Excipients .................................................................................................................................... qs 1 dose Diluent: 
Vehikel: Vehikel ................................................................................................................................ q.s 1 odmerek
1 bag of 200 ml 1 bag of 400 ml 1 bag of 600 ml. 
1 vrečka s po 200 ml 1 vrečka s po 400 ml 1 vrečka s po 600 ml 1 vrečka s po 800 ml 1 vrečka s po 1000 ml 1 vrečka s po 1200 ml 1 vrečka s po 1400 ml 1 vrečka s po 1600 ml 1 vrečka s po 1800 ml 1 vrečka s po 2400 ml
• Draw up 2 ml of the contents of the diluent into the syringe. 
• V brizgo potegnite 2 ml vehikla.
ATCvet code QI01AD15 
Oznaka ATCvet: QI01AD15 Živo rekombinantno cepivo proti bolezni Gumboro in Marekovi bolezni.
Suspension: 
Odmerjanje
The full EPAR for Palonosetron Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Palonosetron Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord has been shown to be comparable to Aloxi. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Palonosetron Accord primerljivo z zdravilom Aloxi.
What measures are being taken to ensure the safe and effective use of Palonosetron Accord? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Palonosetron Accord?
It is available as a solution for injection or infusion (drip) into a vein, which should be given by a healthcare professional about 30 minutes before the start of chemotherapy. 
Na voljo je v obliki raztopine za injiciranje ali infundiranje (kapalne infuzije) v veno, ki jo mora dati zdravstveni delavec približno 30 minut pred začetkom kemoterapije.
Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Palonosetron Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Palonosetron Accord. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Palonosetron Accord.
The Committee recommended that Palonosetron Accord be approved for use in the EU. 
Priporočil je, da se zdravilo Palonosetron Accord odobri za uporabo v EU.
What are the benefits and risks of Palonosetron Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Palonosetron Accord?
A risk management plan has been developed to ensure that Palonosetron Accord is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Palonosetron Accord je bil pripravljen načrt obvladovanja tveganj.
Other information about Palonosetron Accord 
Druge informacije o zdravilu Palonosetron Accord
This means that Palonosetron Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aloxi.
Palonosetron Accord should only be given before chemotherapy. 
Zdravilo Palonosetron Accord se sme dati samo pred kemoterapijo.
What is Palonosetron Accord and what is it used for? 
Kaj je zdravilo Palonosetron Accord in za kaj se uporablja?
It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect. 
Za povečanje učinkovitosti se mu lahko doda kortikosteroid (druga vrsta zdravila, ki se lahko uporablja za preprečevanje slabosti in bruhanja).
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Accord, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Palonosetron Accord in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
By blocking these receptors, Palonosetron Accord prevents the nausea and vomiting that often happen after chemotherapy. 
Zdravilo Palonosetron Accord z zaviranjem teh receptorjev prepreči slabost in bruhanje, ki se pogosto pojavita po kemoterapiji.
For more information about treatment with Palonosetron Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Palonosetron Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Palonosetron Accord, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Palonosetron Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Palonosetron Accord is a medicine used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer). 
Zdravilo Palonosetron Accord se uporablja za preprečevanje navzeje (slabosti) in bruhanja, ki ju povzroča kemoterapija (zdravila za zdravljenje raka).
The active substance in Palonosetron Accord, palonosetron, is a ‘5HT3 antagonist'. 
Zdravilna učinkovina zdravila Palonosetron Accord, palonosetron, je „antagonist 5HT3“.
It is not intended to provide practical advice on how to use Palonosetron Accord. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In children, the solution should be given by infusion into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight. 
Pri otrocih se raztopina v odmerku 20 mikrogramov na kilogram telesne mase daje s 15-minutnim infundiranjem v veno.
Why is Palonosetron Accord approved? 
Zakaj je bilo zdravilo Palonosetron Accord odobreno?
Palonosetron Accord contains the active substance palonosetron. 
Zdravilo Palonosetron Accord vsebuje zdravilno učinkovino palonosetron.
No additional studies were needed as Palonosetron Accord is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi. 
Ker je zdravilo Palonosetron Accord generično zdravilo, ki se daje z injekcijo in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Aloxi, niso bile potrebne nobene dodatne študije.
How is Palonosetron Accord used? 
Kako se zdravilo Palonosetron Accord uporablja?
How has Palonosetron Accord been studied? 
Kako je bilo zdravilo Palonosetron Accord raziskano?
How does Palonosetron Accord work? 
Kako zdravilo Palonosetron Accord deluje?
the change to the authorisation is Eli Lilly. 
Družba, ki je vložila vlogo za spremembo dovoljenj za promet z zdravilom, je Eli Lilly.
It may request a retive opinion. 
Predlagatelj je zaprosil za ponovni pregled mnenja.
There was also insufficient evidence th time, which is important when treating a long-term condition. 
Prav tako ni bilo zadostnih dokazov, da je ta učinek mogoče vzdrževati dlje časa, kar je pomembno pri zdravljenju dolgotrajnih bolezni.
Neurotransmitters are chemica cells to communicate with one another. 
Nevrotransmitorji so kemične snovi, ki omogočajo medsebojno komunikacijo živčnih celic.
The CHMP noted that the studies had not proven that duloxetine would provide a r the indication applied for. 
Odbor CHMP je ugotovil, da študije niso dokazale, da duloksetin omogoča bistvene koristi pri indikaciji, za katero je bilo vloga vložena.
It works by preventi the neurotransmitters 5-hydroxytrypamine (also called serotonin) and no back up into nerve cells in the brain and spinal cord. 
Deluje tako, da preprečuje ponovni privzem nevrotransmitorjev 5-hidroksitripamina (imenovanega tudi serotonin) in noradrenalina v živčne celice v možganih in hrbtenjači.
What consequences does this refusal have for patients in clin compassionate use programm 
Kakšne posledice ima ta zavrnitev za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
What were the CHMP's main concerns that led to the refusal to the 
Kateri so bili glavni zadržki CHMP, ki so privedli do zavrnitve spremembe dovoljenj za promet z zdravili?
Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage extremities that can occur in patients with diabetes). 
Zdravilo Ariclaim se uporablja za zdravljenje bolečin zaradi diabetične periferne nevropatije (poškodbe živcev v okončinah, ki se pojavljajo pri bolnikih s sladkorno boleznijo).
MP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar. 
Dne 21. julija 2011 je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel negativno mnenje, s katerim priporoča zavrnitev spremembe dovoljenj za promet z zdravili Ariclaim, Cymbalta in Xeristar, ki vsebujejo duloksetin.
In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (nonsteroidal anti-inflammatory drugs). 
Poleg odobrenih načinov uporabe so nameravali vsa tri zdravila uporabljati za zdravljenje zmerne do hude kronične (dolgotrajne) somatske bolečine pri bolnikih, ki ne jemljejo protibolečinskih zdravil NSAID (nesteroidnih antirevmatikov).
ts of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in ne or placebo (a nts taking them in combination with NSAIDs. 
Družba je predstavila rezultate petih glavnih študij pri 839 bolnikih s kronično somatsko bolečino: dve študiji pri bolnikih z bolečino v kolenu, ki jo je povzročil osteoartritis (otekanje in bolečina v sklepih) in tri študije pri bolnikih s kronično bolečino v križu.
Since these neurotransmitters are i of pain, blocking their re-uptake into nerve cells may improve the symptoms of p 
Ker ti nevrotransmitorji sodelujejo pri zmanjševanju občutka bolečine, se lahko z zaviranjem njihovega ponovnega privzema v živčne celice izboljšajo tudi simptomi bolečine.
The change concerned the addition of a new e chronic somatic pain in patients not taking NSAIDs regularly. 
Sprememba se je nanašala na dodatek nove indikacije, zdravljenja zmerne do hude kronične somatske bolečine pri bolnikih, ki ne jemljejo redno nesteroidnih antirevmatikov.
Somatic pain is from the body surfaces (such as skin) or 
Somatska bolečina izvira s telesnih površin (na primer s kože) ali iz mišično-skeletnih tkiv (kot so skeletne mišice, kosti in sklepi).
It does not include pain from h and intestines. 
Ne vključuje pa bolečine, ki izvira iz notranjih organov, kot so želodec in prebavila.
Ariclaim, Cymbalta and Xeristar are medicines containin 
Ariclaim, Cymbalta in Xeristar so zdravila, ki vsebujejo zdravilno učinkovino duloksetin.
By blocking their re-uptake, dul of these neurotransmitters in the spaces between these nerve cel communication between the cells. 
Duloksetin z zaviranjem njihovega ponovnega privzema poveča količino teh nevrotrasmitorjev v prostorih med živčnimi celicami, s čimer se poveča stopnja komunikacije med celicami.
Patients in the studies were treated with duloxeti dummy treatment) with some patie effectiveness was the change in the severity of pain, as recorded by the patients after 12 or 13 weeks of treatment. 
Glavno merilo učinkovitosti je bila sprememba resnosti bolečine, kot so jo vsakodnevno zabeležili bolniki na podlagi 11-točkovne lestvice po 12 ali 13 tednih zdravljenja.
The medicines are expected to work in the same way they do in diabetic periphera active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor. 
Zdravilna učinkovina duloksetin je zaviralec ponovnega privzema serotonina in noradrenalina.
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.
31 July 2021 
31. julij 2021
• 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.