natgillin/translations-raw huggingface dataset:
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Riximyo has a highly similar structure, purity and biological activity to MabThera 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 Riximyo po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se po telesu enako porazdeli.
Because Riximyo is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Riximyo. 
Zdravilo Riximyo je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti rituksimaba, izvedenih z zdravilom MabThera, z zdravilom Riximyo ni treba ponavljati.
Laboratory studies comparing Riximyo with the reference medicine MabThera have shown that the active substance in Riximyo is highly similar to that in MabThera in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Riximyo primerjali z referenčnim zdravilom MabThera, so pokazale, da je učinkovina v zdravilu Riximyo po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu MabThera.
How is Riximyo used? 
Kako se zdravilo Riximyo uporablja?
Riximyo is a ‘biosimilar medicine'. 
Zdravilo Riximyo je „podobno biološko zdravilo“.
How does Riximyo work? 
Kako zdravilo Riximyo deluje?
When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in pemphigus (where B cells are involved in inflammation). 
Učinkovina v zdravilu Riximyo, rituksimab, je monoklonsko protitelo, ki je zasnovano tako, da se veže na beljakovino, imenovano CD20, ki se nahaja na površini celic B. Rituksimab z vezavo na CD20 povzroči, da celice B odmrejo, kar pripomore pri zdravljenju limfoma in kronične limfocitne levkemije (pri katerih so celice B postale rakaste) ter pemfigusa (pri katerem celice B sodelujejo pri vnetju).
Riximyo can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Riximyo je le na recept.
Riximyo contains the active substance rituximab. 
Zdravilo Riximyo vsebuje učinkovino rituksimab.
Studies have also shown that giving Riximyo produces similar levels of the active substance in the body to giving MabThera. 
Študije so pokazale tudi, da je količina učinkovine v telesu pri zdravilu Riximyo podobna kot pri zdravilu MabThera.
With regard to safety, no major issues were identified and side effects were manageable. 
Kar zadeva varnost, ni bilo ugotovljenih večjih težav, neželeni učinki pa so bili obvladljivi.
The full EPAR and risk management plan summary for Episalvan 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) in povzetek načrta obvladovanja tveganj za zdravilo Episalvan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Episalvan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Episalvan?
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Episalvan's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Episalvan večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Episalvan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Episalvan.
Other information about Episalvan 
Druge informacije o zdravilu Episalvan
The exact way Episalvan works is not fully understood. 
Točno delovanje zdravila Episalvan ni v celoti znano.
A risk management plan has been developed to ensure that Episalvan is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Episalvan je bil pripravljen načrt obvladovanja tveganj.
Both wound halves were also covered with a wound dressing. 
Obe polovici rane so pokrili tudi s povojem.
The respective times were 16.0 and 15.1 days respectively in the second study. 
V drugi študiji je bil ta čas 16,0 oziroma 15,1 dneva.
Although the differences were small they were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and for which treatment options are limited. 
Čeprav so bile razlike majhne, so za bolnike z ranami delne debeline kože pomembne, saj se te rane težko celijo, možnosti zdravljenja pa so omejene.
These are wounds where the upper layers of the skin have been lost, for example by a burn or during surgical skin grafting. 
To so rane, pri katerih zgornje plasti kože ni več, na primer zaradi opekline ali kirurške presaditve kože.
It is not intended to provide practical advice on how to use Episalvan. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The most common side effects with Episalvan are wound complications, pain in the skin (both of which may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people). 
Najpogostejši neželeni učinki zdravila Episalvan so zapleti pri rani, bolečine na koži (ki lahko prizadeneta več kot 3 osebe od 100) in pruritus (srbenje) (ki lahko prizadene več kot 1 osebo od 100).
Why is Episalvan approved? 
Zakaj je bilo zdravilo Episalvan odobreno?
What benefits of Episalvan have been shown in studies? 
Kakšne koristi je zdravilo Episalvan izkazalo v študijah?
For more information about treatment with Episalvan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Episalvan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Episalvan? 
Kakšna tveganja so povezana z zdravilom Episalvan?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Episalvan, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Episalvan in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Episalvan, glejte navodilo za uporabo.
Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in patients who underwent skin graft surgery. 
Zdravilo Episalvan so proučevali v dveh glavnih študijah, v kateri je bilo vključenih 217 bolnikov z ranami delne debeline kože, ki so prestali kirurški poseg za odvzem presadka.
What is Episalvan and what is it used for? 
Kaj je zdravilo Episalvan in za kaj se uporablja?
The gel should be re-applied with every dressing change, until the wound is healed, for up to 4 weeks. 
Gel je treba do 4 tedne ponovno nanesti pri vsakem previjanju rane, dokler ni rana zaceljena.
It is thought that the active substance in Episalvan, birch bark extract, helps the cells that make up the outer layer of the skin (keratinocytes) grow and move quickly towards the gap created by the wound, therefore helping wounds to heal faster. 
Domneva se, da zdravilna učinkovina zdravila Episalvan, ekstrakt skorje breze, pomaga pri rasti celic, ki sestavljajo zunanjo plast kože (keratinocitom), in njihovem hitrejšem premikanju proti vrzeli, ki je nastala zaradi rane, ter tako pripomore k hitrejšemu celjenju rane.
For practical information about using Episalvan, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Episalvan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Episalvan is a medicine used in adults to treat partial-thickness skin wounds. 
Zdravilo Episalvan se uporablja pri odraslih za zdravljenje ran delne debeline kože.
The average time to wound closure was 8.8 days for the wounds treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan. 
Povprečni čas do zaprtja rane pri ranah, zdravljenih s standardnim gelom za razkuževanje, je bil 8,8 dneva, pri ranah, zdravljenih z zdravilom Episalvan, pa 7,6 dneva.
Episalvan gel was shown to reduce wound healing times. 
Dokazano je bilo, da zdravilo Episalvan gel zmanjšuje čas celjenja ran.
A third study involved 57 patients with partial-thickness burn wounds who had half their wound treated with Episalvan and the other half with a standard disinfectant gel. 
Tretja študija je vključevala 57 bolnikov z opeklinskimi ranami delne debeline kože, pri katerih so polovico rane zdravili z zdravilom Episalvan, drugo polovico pa s standardnim gelom za razkuževanje.
Episalvan birch bark extract 
Episalvan ekstrakt skorje breze
Episalvan is available as a gel that should be applied as a thin layer (1 mm in thickness) to the wound, which should then be covered by a wound dressing. 
Zdravilo Episalvan je na voljo v obliki gela, ki se nanese na rano v tanki plasti (v debelini 1 mm), nato pa je treba rano pokriti s povojem.
The patients received Episalvan together with wound dressing on one half of the wound, while the other half of the wound was treated with standard wound dressing only. 
Bolniki so na enem delu rane prejemali zdravilo Episalvan skupaj s povojem, drugo polovico rane pa so zdravili samo s standardnim povojem.
In the first study, the average time from surgery to wound closure was 17.1 days for the wounds treated with standard wound dressing only and 15.5 days for the wounds also treated with Episalvan. 
V prvi študiji je bil pri ranah, zdravljenih samo s standardnim povojem, povprečni čas od kirurškega posega do zaprtja rane 17,1 dneva, pri ranah, zdravljenih tudi z zdravilom Episalvan, pa 15,5 dneva.
How is Episalvan used? 
Kako se zdravilo Episalvan uporablja?
How does Episalvan work? 
Kako zdravilo Episalvan deluje?
Episalvan contains a dry extract from birch bark. 
Zdravilo Episalvan vsebuje suh ekstrakt skorje breze.
Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) EMA/577551/2017 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fulphila (pegfilgrastim) EMA/577551/2017
In addition, one study in 194 patients receiving cancer medicines compared the safety, effectiveness and immunogenicity, meaning the medicine's ability to trigger the production of antibodies, of Fulphila and Neulasta. 
Poleg tega so s študijo pri 194 bolnikih, ki so prejemali zdravila proti raku, primerjali varnost, učinkovitost in imunogenost, tj. zmožnost zdravila, da sproži nastajanje protiteles, zdravil Fulphila in Neulasta.
Neutropenia is a side effect of certain cancer treatments and can lead to development of serious infections. 
Nevtropenija je neželeni učinek določenih zdravil za zdravljenje raka in lahko vodi do razvoja resnih okužb.
This means that Fulphila was intended to be highly similar to a biological medicine already authorised in the European Union (the ‘reference medicine') called Neulasta. 
To pomeni, da naj bi bilo zelo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji, in sicer zdravilu Neulasta.
Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product. 
Drugi pomisleki so se nanašali na opis proizvodnega postopka, nadzor nečistot v zdravilni učinkovini in sterilizacijo končnega zdravila.
It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections. 
mozeg spodbuja k proizvodnji večjega števila nevtrofilcev in izboljša bolnikovo sposobnost boja proti okužbam.
Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fulphila (pegfilgrastim)
Fulphila was to be used in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever). 
Zdravilo Fulphila naj bi se uporabljalo pri bolnikih z rakom za skrajšanje trajanja nevtropenije (nizkih vrednosti nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) in zmanjšanje pogostnosti pojavljanja febrilne nevtropenije (nevtropenije z zvišano telesno temperaturo).
Fulphila is a medicine that contains the active substance pegfilgrastim. 
Fulphila je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim.
The company presented results of studies designed to show that Fulphila is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine. 
Družba je predstavila rezultate študij, ki naj bi pokazale, da je zdravilo Fulphila po kemijski sestavi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol). 
Zdravilna učinkovina v zdravilih Fulphila in Neulasta, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).
Fulphila was developed as a ‘biosimilar' medicine. 
Zdravilo Fulphila je bilo razvito kot „podobno biološko zdravilo“.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the quality of Fulphila had not been demonstrated. 
Zato je odbor CHMP ob umiku vloge menil, da kakovost zdravila Fulphila ni bila dokazana.
protein called granulocyte-colony-stimulating factor (G-CSF). 
Filgrastim je zelo podoben človeški beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (G-CSF).
One of the CHMP's main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product. 
Eden od glavnih pomislekov odbora CMHP je bil odsotnost potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila could not have been approved to reduce neutropenia in patients taking cancer treatments. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Fulphila ni mogoče odobriti za zmanjšanje nevtropenije pri bolnikih, ki jemljejo zdravila proti raku.
The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Fulphila. 
Družba je odbor CHMP obvestila, da zavrnitev nima vpliva na klinična preskušanja, ki trenutno potekajo z zdravilom Fulphila.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments. 
je 3. avgusta 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Fulphila, namenjenim zmanjševanju nevtropenije pri bolnikih, ki jemljejo zdravila proti raku.
What is Fulphila? 
Kaj je zdravilo Fulphila?
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila could not be obtained in the time available. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo Fulphila, ne more pridobiti v razpoložljivem času.
What was Fulphila expected to be used for? 
Za kaj naj bi se zdravilo Fulphila uporabljalo?
The CHMP was assessing the company's responses to the questions at the time of the withdrawal. 
Ob umiku vloge je odbor CHMP ocenjeval odgovore družbe na zastavljena vprašanja.
1 vial +1 infusion bag +1 syringe +1 vial adaptor 
1 viala + 1 infuzijska vrečka + 1 brizga + 1 nastavek za vialo
Powder : 200mg Solvent: 20 ml (10 mg/ml) 
200 mg prašek in vehikel za raztopino za infundiranje prašek: viala (steklo) vehikel: infuzijska vrečka prašek: 200 mg vehikel: 20 ml (10 mg/ml)
Powder for oral suspension 
1 viala prašek za peroralno suspenzijo plastenka (HDPE) 45 g
Intravenous use vial (glass) 
200 mg prašek za raztopino za infundiranje viala (steklo)
They should be taken within one hour after morning and evening meals. 
Jemati jih je treba v eni uri po jutranjem in večernem obroku.
The Agency considered that the measures put in place are adequate to manage these risks. 
Agencija je menila, da so uvedeni ukrepi ustrezni za obvladovanje teh tveganj.
The tablets are taken twice a day on certain days of each treatment cycle. 
Tablete se jemljejo dvakrat na dan na določene dneve vsakega cikla zdravljenja.
Further information on Lonsurf can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lonsurf. 
Nadaljnje informacije za zdravilo Lonsurf so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/lonsurf.
What measures are being taken to ensure the safe and effective use of Lonsurf? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lonsurf?
Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016. 
Za zdravilo Lonsurf je bilo 25. aprila 2016 izdano dovoljenje za promet, veljavno po vsej EU.
Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days. 
Zdravilo Lonsurf je na voljo v obliki tablet (15 mg trifluridina in 6,14 mg tipiracila; 20 mg trifluridina in 8,19 mg tipiracila), daje pa se v 28-dnevnih ciklih.
The European Medicines Agency decided that Lonsurf's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Lonsurf večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
All patients received supportive care. 
Vsi bolniki v študiji so prejemali podporno zdravljenje.
Other information about Lonsurf 
Druge informacije o zdravilu Lonsurf
This therefore boosts trifluridine's effect. 
To okrepi učinek trifluridina.
As for all medicines, data on the use of Lonsurf are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lonsurf stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonsurf 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 Lonsurf upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Lonsurf authorised in the EU? 
Zakaj je bilo zdravilo Lonsurf odobreno v EU?
What benefits of Lonsurf have been shown in studies? 
Kakšne koristi zdravila Lonsurf so se pokazale v študijah?
In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells. 
Trifluridin se v telesu pretvori v aktivno obliko, ki se vgradi neposredno v DNK, genetski material celic.
Tipiracil increases the level of trifluridine in the blood by slowing its breakdown. 
Tipiracil poviša raven trifluridina v telesu tako, da upočasni njegovo razgradnjo.
It is used when the cancer is metastatic (has spread to other parts of the body) in patients who have already been treated with, or who cannot be given, other treatments for their cancer. 
Uporablja se, kadar je rak metastatski (se je razširil na druge dele telesa), pri bolnikih, ki so že prejemali druge razpoložljive oblike zdravljenja ali pa teh ne morejo prejemati.
Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines. 
Zdravljenje z zdravilom Lonsurf mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Lonsurf, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. 
Pretvorba trifluridina v aktivno obliko lažje poteka v rakavih celicah kot v normalnih celicah, kar privede do večje koncentracije aktivne oblike zdravila in njegovega daljšega učinkovanja v rakavih celicah.
For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Lonsurf glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Lonsurf? 
Kakšna tveganja so povezana z zdravilom Lonsurf?
This reduces the growth of cancer cells, while normal cells are only slightly affected. 
To upočasni rast rakavih celic, medtem ko je vpliv na normalne celice zelo majhen.
Gastric cancer 
Rak želodca
Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable. 
Zdravljenje z zdravilom Lonsurf je treba nadaljevati, dokler so vidne koristi in dokler je neželene učinke mogoče prenašati.
All patients had previously received other treatments. 
Vsi bolniki so prejeli vsaj dve predhodni zdravljenji.
The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts). 
Najpogostejši neželeni učinki zdravila Lonsurf (ki se lahko pojavijo pri več kot 3 bolnikih od 10) so nevtropenija (nizke vrednosti nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam), slabost, utrujenost in anemija (nizka raven rdečih krvnih celic).
What is Lonsurf and what is it used for? 
Kaj je zdravilo Lonsurf in za kaj se uporablja?
It contains two active substances: trifluridine and tipiracil. 
Vsebuje dve učinkovini: trifluridin in tipiracil.
In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment). 
V glavni študiji, ki je vključevala 800 bolnikov, so tisti, ki so prejemali zdravilo Lonsurf, živeli povprečno 7,1 meseca, v primerjavi s 5,3 meseca pri bolnikih, zdravljenih s placebom (zdravilom brez učinkovine).
Regarding its safety, although Lonsurf's side effects can be serious they are in line with what can be expected for this type of medicine. 
Z vidika varnosti so neželeni učinki zdravila Lonsurf sicer lahko resni, vendar so v skladu s pričakovanji za citotoksično zdravilo.
Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells). 
Zdravilo Lonsurf je citotoksično zdravilo (zdravilo, ki uniči celice, ki se delijo, kot so rakave celice).
The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick). 
Najpogostejši resni neželeni učinki so supresija kostnega mozga (kadar kostni mozeg proizvaja manj krvnih celic kot običajno) in neželeni učinki na prebavila (driska in slabost).