natgillin/translations-raw huggingface dataset:
After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed. 
Po odstranitvi čim večjega dela možganskega tumorja bi naj kirurg v področje, iz katerega je bil tumor odstranjen, vbrizgal do 70 majhnih injekcij zdravila Cerepro.
This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation. 
Ta encim sodeluje pri pretvorbi ganciklovira v obliko, ki lahko ubije celice, ki se razmnožujejo, kot so na primer rakave celice, ki niso bile odstranjene med operacijo.
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 given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma. 
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj CHMP je v času umika vloge CHMP izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet za zdravilo Cerepro, namenjeno zdravljenju bolnikov z operabilnimi visoko malignimi gliomi.
Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells). 
Gliom je vrsta možganskega tumorja, ki se prične v nevroglijski celici (celici, ki obkroža in podpira živčno celico).
In addition, the CHMP considered there to be insufficient information on the safety of Cerepro, and, since the benefits of the medicine had not been demonstrated, that its risks, when used in combination with ganciclovir, could be of concern. 
Poleg tega je CHMP menil, da ni dovolj informacij o varnosti zdravila Cerepro ter da utegnejo biti glede na dejstvo, da korist zdravila ni bila dokazana, njegova tveganja ob uporabi v kombinaciji z ganciklovirjem zaskrbljujoča.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Cerepro. 
Podjetje je CHMP obvestilo, da ni posledic za bolnike, ki trenutno sodelujejo v kliničnih preizkušanjih zdravila Cerepro.
The gene is carried within a ‘vector', a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body. 
Gen se prenaša s pomočjo „vektorja“, vrste virusa, ki je bila genetsko spremenjena tako, da lahko prenaša gen (DNA) v celice telesa.
Cerepro would only have worked in combination with ganciclovir. 
Zdravilo Cerepro bi delovalo izključno v kombinaciji z ganciklovirjem.
What is Cerepro? 
Kaj je zdravilo Cerepro?
Cerepro was intended for use during an operation. 
Zdravilo Cerepro bi se naj uporabljalo med operacijo.
The virus in Cerepro is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans. 
Virus, uporabljen pri zdravilu Cerepro, je „adenovirus“, ki je bil gensko spremenjen tako, da se ne more podvojevati in posledično v ljudeh ne more povzročiti okužbe.
The CHMP had concerns that a benefit of Cerepro had not yet been shown. 
CHMP je izrazil zadržek, da korist zdravila Cerepro še ni bila dokazana.
Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery. 
Zdravilo Cerepro bi se naj v kombinaciji z ganciklovir natrijem uporabljalo za zdravljenje visoko malignih gliomov pri bolnikih, primernih za operacijo.
What was Cerepro expected to be used for? 
Za kaj naj bi se zdravilo Cerepro uporabljalo?
It is made up into a solution that is injected directly into the brain during surgery. 
Zdravilo se pripravi v obliki raztopine, ki se med operacijo injicira neposredno v možgane.
When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites. 
Ko se zdravilo Cerepro injicira v možgane, celice v bližini mesta injiciranja privzamejo spremenjeni virus.
How is Cerepro expected to work? 
Kako naj bi zdravilo Cerepro delovalo?
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
CHMP je zato v času umika menil, da koristi zdravila Cerepro niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus. 
Cerepro je zdravilo, ki vsebuje gen (gen za timidin kinazo virusa Herpes simplex), ki ga nosi adenovirus.
The cells then start to produce the thymidine kinase enzyme. 
Celice pričnejo tvoriti encim timidin kinazo.
Cerepro contains the gene for the enzyme ‘thymidine kinase' from the herpes virus. 
Zdravilo Cerepro vsebuje gen za encim „timidin kinazo“ iz virusa herpesa.
Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene 
Zdravilna učinkovina: gen za timidin kinazo virusa Herpes simplex, posredovan z adenovirusom
Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim. 
Nadaljnje informacije o zdravilu Nivestim so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/nivestim.
Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010. 
Za zdravilo Nivestim je bilo 8. junija 2010 izdano dovoljenje za promet, veljavno po vsej EU.
This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Nivestim? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nivestim?
An overview of Nivestim and why it is authorised in the EU 
Pregled zdravila Nivestim in zakaj je odobreno v EU
What is Nivestim and what is it used for? 
Kaj je zdravilo Nivestim in za kaj se uporablja?
What benefits of Nivestim have been shown in studies? 
Kakšne koristi zdravila Nivestim so se pokazale v študijah?
What are the risks associated with Nivestim? 
Kakšna tveganja so povezana z zdravilom Nivestim?
The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). 
Učinkovina zdravila Nivestim, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells. 
Filgrastim deluje enako kot naravno tvorjeni G-CSF, kar pomeni, da spodbuja kostni mozeg k tvorjenju večjega števila belih krvnih celic.
As for all medicines, data on the use of Nivestim are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nivestim stalno spremljajo.
In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen. 
Poleg tega je študija pri 279 odraslih bolnicah z rakom dojke, ki so se zdravile z zdravili za zdravljenje raka, pokazala, da je zdravilo Nivestim primerljivo z referenčnim zdravilom Neupogen.
Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment. 
Predpisovanje in izdaja zdravila Nivestim je le na recept, zdravljenje pa se lahko uvede v sodelovanju z centrom za zdravljenje raka.
Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for. 
Drugi neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov, odvisno od bolezni, ki se zdravi z zdravilom Nivestim.
For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Nivestim glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment. 
Način dajanja in odmerjanje zdravila Nivestim ter trajanje zdravljenja z njim so odvisni od razloga za uporabo zdravila, telesne mase bolnika in odziva na zdravljenje.
The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein. 
Zdravilo je na voljo v obliki napolnjenih injekcijskih brizg in se daje z injiciranjem v podkožje ali infundiranjem (kapalno infuzijo) v veno.
Nivestim can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow. 
Zdravilo Nivestim lahko uporabljajo tudi darovalci krvnih matičnih celic, namenjenih za presaditev, da se olajša sproščanje teh celic iz kostnega mozga.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nivestim upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Nivestim are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Nivestim, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick). 
Najpogostejši neželeni učinki zdravila Nivestim (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so povišana telesna temperatura, mišično-skeletne bolečine (bolečine v mišicah in kosteh), anemija (nizko število rdečih krvnih celic), bruhanje in navzeja (slabost).
Why is Nivestim approved? 
Zakaj je bilo zdravilo Nivestim odobreno?
• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections; 
• za povišanje ravni nevtrofilcev in zmanjšanje tveganja okužb pri bolnikih z nevtropenijo, ki imajo anamnezo hudih, ponavljajočih se okužb;
The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen. 
Pri bolnikih, ki so prejemali zdravilo Nivestim, je huda nevtropenija trajala podobno dolgo kot pri bolnikih, ki so prejemali zdravilo Neupogen.
The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen. 
Varnost zdravila Nivestim je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neupogen.
All these data were considered sufficient to conclude that Nivestim will behave in the same way as Neupogen in terms of effectiveness and safety in its authorised uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Nivestim pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neupogen.
Other information about Nivestim 
Druge informacije o zdravilu Nivestim
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes). 
• za skrajšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvnih celic) in preprečevanje pojava febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih z rakom (razen pri bolnikih s kronično mieloično levkemijo ali mielodisplastičnimi sindromi).
Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU. 
Menila je, da so koristi zdravila Nivestim, enako kot pri zdravilu Neupogen, večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Nivestim po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neupogen in da se po telesu enako prenaša.
Nivestim contains the active substance filgrastim. 
Zdravilo Nivestim vsebuje učinkovino filgrastim.
• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia; 
• za skrajšanje trajanja nevtropenije pri bolnikih, ki prejemajo zdravljenje za uničenje celic kostnega mozga pred njegovo presaditvijo (kot npr. pri nekaterih bolnikih z levkemijo) in pri katerih obstaja tveganje za dolgotrajno, hudo obliko nevtropenije;
Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim. 
Zdravilo Nivestim je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti filgrastima, ki so že bile izvedene z zdravilom Neupogen, z zdravilom Nivestim ni treba ponavljati.
The reference medicine for Nivestim is Neupogen. 
Referenčno zdravilo za zdravilo Nivestim je zdravilo Neupogen.
Nivestim is a medicine that stimulates the production of white blood cells and is used: 
Nivestim je zdravilo, ki se uporablja za spodbujanje tvorbe belih krvnih celic v naslednjih primerih:
How is Nivestim used? 
Kako se zdravilo Nivestim uporablja?
Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections. 
Nevtropenija je pogost neželeni učinek zdravljenja raka, zaradi česar so ti bolniki bolj dovzetni za okužbe;
Nivestim is a ‘biosimilar' medicine. 
Zdravilo Nivestim je „biološko podobno“ zdravilo.
For the full list of side effects and restrictions with Nivestim, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nivestim glejte navodilo za uporabo.
How does Nivestim work? 
Kako zdravilo Nivestim deluje?
Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Nivestim primerjali z zdravilom Neupogen, so pokazale, da je učinkovina zdravila Nivestim po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neupogen.
Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen. 
Študije so pokazale tudi, da zdravilo Nivestim v telesu vzpostavi podobne ravni učinkovine kot zdravilo Neupogen.
The pregnancy section has been revised in line with the relevant guideline[9]. 
Poglavje o nosečnosti je bilo popravljeno v skladu z ustrezno smernico[9].
The safety and efficacy of Vepesid and associated names in children below 18 years of age have not been established. 
Varnost in učinkovitost zdravila Vepesid in povezanih imen pri otrocih, mlajših od 18 let, še nista bili dokazani.
Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days. 
Na podlagi podatkov o biološki uporabnosti[1][2] je priporočeni peroralni odmerek od 100 do 200 mg/m2/dan od 1. do 5. dneva 21- ali 28-dnevnega cikla ali 200 mg/m2/dan v obdobju treh dni (najpogosteje od 1. do 3. dneva ali na 1., 3. in 5. dan) 21- ali 28-dnevnega cikla.
The text on breastfeeding has been amended accordingly. 
Besedilo o dojenju je bilo popravljeno v skladu s tem.
The first European approval was in NL on 29 May 1981. 
Zdravilo je dovoljenje za promet v Evropi prvič pridobilo 29. maja 1981 na Nizozemskem.
Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU. 
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zgoraj navedenim zdravilom, je Evropska komisija 14. oktobra 2015 obvestila odbor CHMP pri Evropski agenciji za zdravila o napotitvi v skladu s členom 30 Direktive 2001/83/ES za zdravilo Vepesid in povezana imena z namenom odprave neskladij med nacionalno odobrenimi informacijami o zdravilu in uskladitve različnih informacij o zdravilu po vsej EU.
In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7]. 
Pri bolnikih z ledvično okvaro se je odbor CHMP strinjal, da ne priporoči zmanjšanega odmerka, kadar je očistek kreatinina > 50 ml/min, kot podpira razpoložljiva literatura[3][4][5][6][7].
In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended. 
Pri ledvični okvari (očistek kreatinina (CrCl) 15-5 ml/min) se priporoča zmanjšanje odmerka za 25 %.
The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously. 
Razpoložljivi podatki o učinkovitosti za etopozid pri različnih indikacijah večinoma temeljijo na študijah, v katerih so etopozid uporabljali intravensko.
With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication. 
Kar zadeva dojenje, se etopozid izloča v materino mleko (Medications and Mothers' Milk (Zdravila in materino mleko): Thomas W. Hale), zato je bilo dojenje vključeno med kontraindikacije.
This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer). 
To je zlasti pomembno pri kurativnem zdravljenju bolnikov (npr. pri raku mod).
Vepesid is available as 50mg and 100 mg capsules for oral use. 
Zdravilo Vepesid je na voljo v obliki 50- in 100-miligramskih kapsul za peroralno uporabo.
The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential. 
V poglavju 4.4 so bili usklajeni naslednja posebna opozorila in previdnostni ukrepi, ki so bili v nekatere ali večino nacionalnih povzetkov glavnih značilnosti zdravila že vključeni: razlike pri posameznem bolniku, mielosupresija, sekundarna levkemija, preobčutljivost, reakcija na mestu injiciranja, nizka raven albumina v serumu, oslabljeno delovanje ledvic in jeter, sindrom tumorske lize in mutageni potencial.
The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%). 
Koeficient variacije pri peroralni uporabi je približno 30 %, pri intravenski pa 10 % (razlike med bolniki so pri intravenski in peroralni uporabi podobne, tj. 30-40 %).
The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are: 
Revidirane indikacije v poglavju 4.1 povzetka glavnih značilnosti zdravila so naslednje:
The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[8]. 
Podatki v literaturi za bolnike s CrCl pod 15 ml/min, ki se zdravijo z dializo, jasno kažejo, da je pri teh bolnikih potrebno nadaljnje zmanjšanje odmerka, kot so v preglednem članku objavili Inoue et al. (2004)[8].
• The Committee agreed on a harmonised product information for Vepesid and associated names. 
• odbor se je strinjal z usklajenimi informacijami o zdravilu Vepesid in povezanih imenih.
The CHMP as a consequence, concluded that the benefit-risk balance of Vepesid and associated names remains favourable, subject to the agreed changes to the product information. 
Posledično je odbor zaključil, da je razmerje med tveganji in koristmi zdravila Vepesid in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
• The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information. 
• odbor je obravnaval razlike, ugotovljene v obvestilu za zdravilo Vepesid in povezana imena, ter preostala poglavja informacij o zdravilu;
- Acute myeloid leukaemia 
- akutna mieloična levkemija;
Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC. 
Zdravilo Vepesid in povezana imena so vključena na seznam zdravil, pri katerih je potrebna uskladitev povzetkov glavnih značilnosti zdravila, ki ga je sestavila skupina CMD(h) v skladu s členom 30(2) Direktive 2001/83/ES.
The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Vepesid and associated names (see Annex I). 
Odbor CHMP je priporočil spremembo pogojev dovoljenj za promet z zdravilom Vepesid in povezanimi imeni, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I).
It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration. 
Ugotovili so, da so pri peroralni uporabi razlike v izpostavljenosti pri posameznem bolniku (tj. med cikli) bistveno večje kot po intravenski uporabi.
Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally. 
Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, kadar je bilo to ustrezno, vendar je bilo treba večino poglavij dopolniti na nacionalni
For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration, which should be evaluated on an individual basis. 
Zato je nujno skrbno pretehtati prednosti peroralne uporabe in slabosti večjih razlik v izpostavljenosti pri posameznem bolniku po peroralni uporabi, kar je treba ovrednotiti pri vsakem bolniku posebej.
Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment 
Večje razlike v izpostavljenosti pri posameznem bolniku lahko privedejo do večjih razlik v odvisnosti odziva od odmerka, tj. večjih razlik v bolnikovi občutljivosti za toksičnost, povezano z