natgillin/translations-raw huggingface dataset:
Following the same precautionary principle, in view of the limited data available in treatment naïve patients with 17p deletion or TP53 mutation it was also considered that idelalisib in combination with ofatumumab should be only be used first-line in CLL patients with 17p deletion or TP53 mutation who are not eligible for any other therapies. 
Po istem previdnostnem načelu in ker so na voljo samo omejeni podatki pri predhodno nezdravljenih bolnikih z delecijo 17p ali mutacijo TP53, se je prav tako štelo, da se idelalizib v kombinaciji z ofatumumabom lahko uporablja kot zdravilo prve izbire za KLL pri bolnikih z delecijo 17p ali mutacijo TP53, ki niso primerni za kakršno koli drugo zdravljenje.
1 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL 
GS-US-312-0123, randomizirana dvojno slepa s placebom kontrolirana študija faze 3 o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno nezdravljeno KLL.
Nevertheless, as a precaution and in view of the fact that limited data are available in treatment-naïve CLL patients with 17p deletion or TP53 mutation, the PRAC recommended that idelalisib should only be used in this group of patients if they are not eligible for any other therapies. 
Odbor PRAC je kot previdnostni ukrep in ob upoštevanju dejstva, da so na voljo omejeni podatki za bolnike s KLL z delecijo 17p ali mutacijo TP53, ki še niso bili zdravljeni, priporočil, da se lahko idelalizib uporablja samo v tej skupini bolnikov, če niso primerni za kakršno koli drugo zdravljenje.
Nevertheless, in view of the limited data available in this subset and considering availability of other options for first line treatment for CLL patients, the PRAC was of the view that as a precaution, idelalisib should only be used in patients with 17p deletion or TP53 mutation if they are not eligible for any other therapies. 
Odbor PRAC je zaradi omejenih podatkov, ki so na voljo v tej skupini, in z upoštevanjem razpoložljivosti drugih možnosti za zdravljenje prvega izbora za bolnike s KLL, ocenil, da je kot previdnostni ukrep idelalizib lahko uporabljen samo pri bolnikih z delecijo 17p ali mutacijo TP53, če niso primerni za kakršno koli drugo zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Menveo on 15 March 2010. 
Evropska komisija je dovoljenje za promet z zdravilom Menveo, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
The vaccine should be given according to official recommendations. 
Cepivo je treba dajati v skladu z uradnimi priporočili.
This helps to enhance the immune response. 
To pomaga okrepiti imunski odziv.
What measures are being taken to ensure the safe and effective use of Menveo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Menveo?
The full EPAR for Menveo 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 Menveo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A risk management plan has been developed to ensure that Menveo is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Menveo je bil pripravljen načrt obvladovanja tveganj.
In children between two and 10 years old, the most common side effects were similar and also included sleepiness and irritability. 
Pri otrocih, starih od dveh do deset let, so bili najpogostejši neželeni učinki podobni, obsegali pa so še zaspanost in razdražljivost.
Other information about Menveo 
Druge informacije o zdravilu Menveo
The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in a main study involving almost 4,000 participants aged 11 years and above and in a second main study involving almost 3,000 children between two and 10 years old. 
Sposobnost cepiva Menveo pri spodbujanju tvorbe protiteles (imunogenost) je bila ovrednotena v glavni študiji, v katero je bilo vključenih skoraj 4 000 oseb, starejših od 11 let, in v drugi glavni študiji, v katero je bilo vključenih skoraj 3 000 otrok, starih od dve do deset let.
What benefit has Menveo shown during the studies? 
Kakšne koristi je zdravilo Menveo izkazalo med študijami?
It contains parts of the bacterium Neisseria meningitidis (N. meningitidis). 
Vsebuje dele bakterije Neisseria meningitidis (N. meningitidis).
For more information about treatment with Menveo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Menveo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Menveo? 
Kakšna tveganja so povezana z zdravilom Menveo?
The vaccine must not be given to anyone who has had a life-threatening reaction to a vaccine that contains similar components in the past. 
Cepivo se ne sme dati osebam, ki so v preteklosti imele smrtno nevarne reakcije na cepivo, ki vsebuje podobne sestavine.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Menveo, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Why has Menveo been approved? 
Zakaj je bilo zdravilo Menveo odobreno?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Menveo. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection). 
Invazivna bolezen se pojavi, ko se bakterija razširi po telesu in povzroči resne okužbe, kot sta meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in sepsa (okužba krvi).
Menveo is a vaccine. 
Zdravilo Menveo je cepivo.
The number of people who had an immune response against the oligosaccharides was similar for the two vaccines. 
Število ljudi, pri katerih se je pokazal imunski odziv proti oligosaharidom, je bilo pri obeh cepivih podobno.
Menveo is used in people who are at risk of exposure to the bacterium. 
Uporablja se pri ljudeh, pri katerih obstaja nevarnost izpostavljenosti tem bakterijam.
This document is a summary of the European Public Assessment Report (EPAR) for Menveo. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Menveo.
The Committee noted that Menveo offers the benefits of conjugated vaccines, including producing a stronger immune response in young children. 
Ugotovil je, da zdravilo Menveo zagotavlja koristi konjugiranih cepiv, vključno s spodbujanjem močnejšega imunskega odziva pri mlajših otrocih.
When the person is exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease. 
Ko je oseba izpostavljena bakteriji, ta protitelesa skupaj z drugimi deli imunskega sistema uničijo bakterije in pomagajo pri obrambi proti bolezni.
Menveo must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid. 
Zdravila Menveo ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila, vključno s toksoidom davice.
The most common side effects with Menveo in adults and children from the age of 11 (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), myalgia (muscle pain), as well as pain, erythema (reddening of the skin) and induration (hardening) at the site of injection. 
Najpogostejši neželeni učinki zdravila Menveo pri odraslih in otrocih, starejših od 11 let, (opaženi pri več kot 1 bolniku od 10) so glavobol, navzeja (slabost), slabo počutje, mialgija (bolečine v mišicah) ter bolečine, eritem (pordelost kože) in otrdelost na mestu injiciranja.
Menveo is given as a single injection preferably into the shoulder muscle. 
Cepivo Menveo se injicira v enem odmerku, po možnosti v ramensko mišico.
Menveo must not be given into a blood vessel or into or under the skin. 
Ne sme se injicirati v žilo oziroma v kožo ali podkožje.
The Committee therefore decided that Menveo's benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Menveo pri ljudeh, pri katerih obstaja nevarnost izpostavljenosti bakteriji N. meningitidis, večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet
For the full list of all side effects reported with Menveo, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Menveo, glejte navodilo za uporabo.
Menveo is used to protect adults and children from the age of two against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y). 
Zdravilo Menveo se uporablja za zaščito odraslih in otrok, starejših od dveh let, pred invazivno boleznijo, ki jo povzročajo štiri skupine bakterije N. meningitidis (A, C, W135 in Y).
Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated' (attached) to a protein from the bacterium Corynebacterium diphtheriae. 
Zdravilo Menveo vsebuje majhne količine oligosaharidov (vrste sladkorja), pridobljenih iz štirih skupin bakterije N. meningitidis: A, C, W135 in Y. Ti so bili prečiščeni in nato konjugirani (pripojeni) na beljakovino iz bakterije Corynebacterium diphtheriae.
It is available as a powder and solution that are mixed together to make a solution for injection. 
Sestavljata ga prašek in vehikel, ki se zmešata v raztopino za injiciranje.
Menveo was compared with a similar conjugated vaccine against N. meningitidis. 
Cepivo Menveo so primerjali s podobnim konjugiranim cepivom proti bakteriji N. meningitidis.
The CHMP noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease, and that Menveo provides broader protection than other available vaccines. 
CHMP je zaključil, da je za invazivno bolezen odgovornih pet skupin bakterije N. meningitidis (A, B, C, W135 in Y) in da cepivo Menveo zagotavlja boljšo zaščito kot druga cepiva, ki so na voljo.
The results of the main studies showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and children from the age of two. 
Rezultati glavnih študij so pokazali, da je cepivo Menveo enako učinkovito pri spodbujanju imunskega odziva proti štirim vrstam oligosaharidov bakterije N. meningitidis pri odraslih in otrocih, starejših od dveh let, kot primerjalno cepivo.
Menveo meningococcal group A, C, W135 and Y conjugate vaccine 
Menveo konjugirano cepivo proti meningokokom skupin A, C, W135 in Y
The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides. 
Glavno merilo učinkovitosti je bilo vprašanje, ali cepivo Menveo enako dobro spodbuja imunski odziv proti štirim vrstam oligosaharidov bakterije N. meningitidis kot primerjalno cepivo.
What is Menveo used for? 
Za kaj se zdravilo Menveo uporablja?
Vaccination should be postponed in people who have a high fever. 
Pri osebah, ki imajo povišano telesno temperaturo, je treba cepljenje preložiti.
How has Menveo been studied? 
Kako je bilo zdravilo Menveo raziskano?
What is Menveo? 
Kaj je zdravilo Menveo?
How is Menveo used? 
Kako se zdravilo Menveo uporablja?
How does Menveo work? 
Kako zdravilo Menveo deluje?
The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines. 
Običajni začetni odmerek je 50 mg dvakrat na dan, ki se lahko tedensko povečuje do največjega odmerka, ki znaša 300 mg dvakrat na dan, če se zdravilo uporablja samostojno, oziroma 200 mg dvakrat na dan, če se daje z drugimi zdravili za zdravljenje epilepsije.
The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg). 
Predpisovanje in izdaja zdravila je le na recept, na voljo pa je v obliki tablet (50 mg, 100 mg, 150 mg, 200 mg).
The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. 
Natančen način delovanja lakozamida doslej še ni bil pojasnjen, vendar se zdi, da zmanjšuje dejavnost natrijevih kanalčkov (por na površini živčnih celic), ki omogočajo, da se električni impulzi prenašajo med živčnimi celicami.
It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain). 
Uporablja se lahko za zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje (ko se napad posledično razširi na druge dele možganov).
The full EPAR for Lacosamide 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 Lacosamide Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Lacosamide Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Accord has been shown to be comparable to Vimpat. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Lacosamide Accord primerljivo z zdravilom Vimpat.
If treatment with Lacosamide Accord has to be stopped, the dose should be gradually reduced. 
Če je treba zdravljenje z zdravilom Lacosamide Accord prekiniti, je treba odmerek zmanjševati postopoma.
This is a summary of the European public assessment report (EPAR) for Lacosamide Accord. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lacosamide Accord.
Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older. 
Lacosamide Accord je zdravilo za epilepsijo, ki se uporablja za zdravljenje parcialnih napadov (epileptičnih napadov, ki se začnejo v določenem delu možganov) pri bolnikih z epilepsijo, starih 16 let ali več.
Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit. 
Skupaj naj bi to preprečevalo širjenje nenormalne električne dejavnosti po možganih, s čimer se zmanjša možnost pojava epileptičnega napada.
It is also thought that lacosamide might help protect nerve cells from damage. 
Pomagal naj bi tudi zaščititi živčne celice pred poškodbo.
What measures are being taken to ensure the safe and effective use of Lacosamide Accord? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lacosamide Accord?
As for every medicine, the company provided studies on the quality of Lacosamide Accord. 
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Lacosamide Accord.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord. 
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Vimpat, zato jih ni treba ponoviti za zdravilo Lacosamide Accord.
This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth. 
Dokazali so namreč, da je zdravilna učinkovina, lakozamid, zelo lahko topna in se popolnoma absorbira, kar pomeni, da skoraj 100 % snovi po peroralnem zaužitju preide v kri.
The Agency recommended that Lacosamide Accord be approved for use in the EU. 
Priporočila je, da se zdravilo Lacosamide Accord odobri za uporabo v EU.
This means that Lacosamide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Vimpat. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Vimpat.
Lacosamide Accord is given on its own or combined with other medicines for epilepsy. 
Zdravilo Lacosamide Accord se daje samostojno ali v kombinaciji z drugimi zdravili za zdravljenje epilepsije.
What are the benefits and risks of Lacosamide Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Lacosamide Accord?
There was no need for ‘bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Lacosamide Accord absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
If the doctor decides that a faster effect is needed, treatment with Lacosamide Accord may be started with a higher first dose (called a loading dose). 
potreben hitrejši učinek, se lahko zdravljenje z zdravilom Lacosamide Accord začne z večjim začetnim odmerkom (imenovanim polnilni odmerek).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lacosamide Accord have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lacosamide Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Lacosamide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Lacosamide Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Lacosamide Accord, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Lacosamide Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Lacosamide Accord and what is it used for? 
Kaj je zdravilo Lacosamide Accord in za kaj se uporablja?
It is not intended to provide practical advice on how to use Lacosamide Accord. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Therefore, the Agency's view was that, as for Vimpat, the benefit outweighs the identified risk. 
Zato je menila, da njegove koristi enako kot pri zdravilu Vimpat odtehtajo znana tveganja.
Other information about Lacosamide Accord 
Druge informacije o zdravilu Lacosamide Accord
The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine. 
Zdravilna učinkovina zdravila Lacosamide Accord, lakozamid, je zdravilo za zdravljenje epilepsije.
Why is Lacosamide Accord approved? 
Zakaj je bilo zdravilo Lacosamide Accord odobreno?
How has Lacosamide Accord been studied? 
Kako je bilo zdravilo Lacosamide Accord raziskano?
How does Lacosamide Accord work? 
Kako zdravilo Lacosamide Accord deluje?
Lacosamide Accord contains the active substance lacosamide. 
Zdravilo Lacosamide Accord vsebuje zdravilno učinkovino lakozamid.
How is Lacosamide Accord used? 
Kako se zdravilo Lacosamide Accord uporablja?
These reactions may be severe. 
Te reakcije so lahko hude.
In children this may affect growth and development. 
Pri otrocih to lahko vpliva na rast in razvoj.
if you are using the medicine for several months or longer. 
• če zdravilo uporabljate več mesecev ali dlje.
if you have cystic fibrosis. 
• če imate cistično fibrozo.
The median (50%) onset time of relief was 35.9 hours. 
Mediana vrednost (50 %) časa nastopa izboljšanja je znašala 35,9 ur.
if you have any other infection. 
• če imate katero koli drugo okužbo.
4.5 Interactions with other medicaments and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Use in children aged 3 to 11 years 
Uporaba pri otrocih, starih od 3 do 11 let
Therefore, the patient should continue regular use to achieve full therapeutic benefit. 
Zato mora bolnik zdravilo redno uporabljati, da se doseže polna terapevtska korist.
In addition, consideration should be given to referring the patient to a paediatric specialist. 
Poleg tega je treba razmisliti tudi o napotitvi bolnika k ustreznemu pediatričnemu specialistu.
Breathe out through your mouth. 
Izdihnite skozi usta.
Effect on Growth in Paediatric Population 
Vpliv na rast pri pediatrični populaciji
It is important to clean your nasal spray regularly, otherwise it may not work properly. 
• Pomembno je, da pršilo za nos redno čistite, sicer morda ne bo delovalo pravilno.
Do not stop your treatment even if you feel better unless told to do so by your doctor. 
Zdravljenja ne prekinjajte, tudi če se počutite bolje, razen če vam tako svetuje zdravnik.
Repeat steps 3 to 6 for the other nostril (Figure 3). 
Ponovite korake od 3 do 6 na drugi nosnici (slika 3).
Please read this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Do not use a larger dose or use the spray more often or for longer than your doctor tells you to. 
Ne uporabljajte večjega odmerka in pršila ne uporabljajte pogosteje ali dlje, kot vam je predpisal zdravnik.
No interactions were observed. 
Medsebojnega delovanja niso ugotovili.
Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100). 
Pogostnost je opredeljena z naslednjimi izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000
It is very important that you use your nasal spray regularly. 
Zelo pomembno je, da pršilo za nos redno uporabljate.
Systemic Effects of Corticosteroids 
Sistemski učinki kortikosteroidov
There was no effect on fertility. 
Vpliva na plodnost ni bilo.