natgillin/translations-raw huggingface dataset:
Rezolsta is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Rezolsta je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Immune reconstitution syndrome happens when the patient's immune system starts working again and fights existing infections, causing inflammation at the site of the infection. 
Do sindroma imunske obnove pride, ko prične bolnikov imunski sistem ponovno delovati ter se boriti proti obstoječim okužbam, kar povzroči vnetje na mestu okužbe.
For more information about treatment with Rezolsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Rezolsta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rezolsta, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Rezolsta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Cobicistat acts as a ‘booster' to enhance the effects of darunavir, by prolonging the time in which it acts in the body. 
Kobicistat deluje kot ojačevalec, ki krepi učinke darunavirja, tako da podaljšuje čas njegovega delovanja v telesu.
Because darunavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Rezolsta produced similar effects and levels of darunavir in the blood to the two active substances given separately, and to darunavir given with a different booster medicine, ritonavir (an established combination). 
Ker je bila učinkovitost darunavirja in kobicistata že dokazana in ker sta odobrena za zdravljenje okužbe z virusom HIV, so bile izvedene študije v glavnem namenjene dokazovanju, da zdravilo Rezolsta dosega enake učinke in ravni darunavirja v krvi kakor zadevni zdravilni učinkovini, uporabljeni ločeno, ter kakor darunavir, uporabljen z drugim ojačevalcem, tj. ritonavirjem (uveljavljena kombinacija).
The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), and rash. 
Najpogostejši neželeni učinki zdravila Rezolsta (ki lahko prizadenejo več kot 1 osebo od 10) so driska, navzeja (slabost) in izpuščaji.
Darunavir is currently authorised as Prezista and cobicistat as Tybost. 
Darunavir je trenutno odobren kot zdravilo Prezista, kobicistat pa kot zdravilo Tybost.
Rezolsta does not cure HIV infection or AIDS, but it can delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Rezolsta ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ali ga okrepi ter zavre razvoj okužb in bolezni, ki so povezane z aidsom.
Rezolsta must not be taken by patients who have severely reduced liver function. 
Zdravila Rezolsta ne smejo jemati bolniki s hudo okvaro jeter.
Rezolsta can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection. 
Izdaja zdravila Rezolsta je le na recept, zdravljenje pa lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
For practical information about using Rezolsta, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Rezolsta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The medicine is for use only in patients who have not received HIV treatment before or previously treated patients whose disease is not expected to be resistant to darunavir and who are healthy enough and have HIV virus levels below a certain threshold. 
Lahko ga uporabljajo le bolniki, ki še niso prejemali zdravil proti virusu HIV, ali že zdravljeni bolniki, pri katerih ni pričakovati, da je virus HIV odporen na darunavir, ter so dovolj zdravi in so njihove ravni virusa HIV pod določenim pragom.
The European Commission granted a marketing authorisation valid throughout the European Union for Rezolsta on 19/11/2014. 
Evropska komisija je dovoljenje za promet z zdravilom Rezolsta, veljavno po vsej Evropski uniji, izdala
For the full list of all side effects reported with Rezolsta, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rezolsta, glejte navodilo za uporabo.
Rezolsta contains the active substances darunavir and cobicistat. 
Zdravilo Rezolsta vsebuje zdravilni učinkovini darunavir in kobicistat.
How is Rezolsta used? 
Kako se zdravilo Rezolsta uporablja?
How does Rezolsta work? 
Kako zdravilo Rezolsta deluje?
In addition, one main study was carried out to examine the safety and effectiveness of darunavir and cobicistat given with other HIV medicines, in 313 adult patients with HIV who had not been previously treated or who had been previously treated and whose infection was not expected to be resistant to darunavir. 
V njej je sodelovalo 313 odraslih bolnikov z virusom HIV, ki še niso bili zdravljeni oziroma so že bili zdravljeni, vendar ni bilo pričakovati, da je virus HIV odporen na darunavir.
This summary was last updated in 06-2018. 
Povzetek je bil nazadnje posodobljen 04-2017.
Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment. 
Ti so bili večinoma blagi do zmerni in so se v glavnem pojavili v prvem tednu zdravljenja.
Further information on Zebinix 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 Zebinix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures. 
Posledica tega je zmanjšanje aktivnosti živčnih celic v možganih ter zmanjšanje silovitosti in števila napadov.
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear. 
To je vrsta epilepsije, pri kateri prevelika električna dejavnost v enem delu možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
This compared with 25% of patients (10 out of 40) on placebo. 
Ta delež je pri bolnikih, ki so prejemali placebo, znašal 25 % (10 od 40).
What measures are being taken to ensure the safe and effective use of Zebinix? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zebinix?
It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth. 
Na voljo je v obliki tablet (200-mg, 400-mg, 600-mg in 800-mg) in v obliki suspenzije, ki se jemlje peroralno.
Other information about Zebinix 
Druge informacije o zdravilu Zebinix
In these studies, all the children also received other epilepsy medicines. 
V teh študijah so vsi otroci prejemali tudi druga zdravila proti epilepsiji.
A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used. 
V drugi študiji pri otrocih, starih od dve do 18 let, ni bila opažena razlika med zdravilom Zebinix in placebom, kar je bilo pojasnjeno z dejstvom, da so bili uporabljeni nižji odmerki.
All of the patients also received other epilepsy medicines. 
Vsi bolniki so prejemali tudi druga zdravila proti epilepsiji.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zebinix 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 Zebinix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine). 
Zdravila Zebinix ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) eslikarbazepin acetat, katero koli drugo sestavino zdravila ali druge derivate karboksamida (zdravil s podobno zgradbo kot eslikarbazepin acetat, kot sta karbamazepin ali oksikarbazepin).
Zebinix was effective, although slightly less than carbamazepine, at reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months compared with 76% of patients taking carbamazepine (300 out of 397 patients). 
Zdravilo Zebinix je bilo učinkovito, četudi nekoliko manj kot karbamazepin, pri zmanjšanju napadov po šestih mesecih zdravljenja: 71-% (276 od 388) bolnikov, ki so prejemali zdravilo Zebinix in niso predčasno prekinili študije, je bilo po šestih mesecih brez napadov v primerjavi s 76-% (300 od 397) bolnikov, ki so prejemali karbamazepin.
In clinical trials, around half of the patients treated with Zebinix experienced side effects. 
V kliničnih študijah je doživela približno polovica bolnikov, zdravljenih z zdravilom Zebinix, neželene učinke.
The effects of Zebinix were also studied in children with partial-onset seizures. 
Učinke zdravila Zebinix so proučevali tudi pri otrocih z napadi parcialnega izvora.
Zebinix can also be used in adolescents and children above 6 years of age, in combination with existing therapies, to treat partial-onset seizures with or without secondary generalisation. 
Uporablja se lahko tudi pri mladostnikih in otrocih, starejših od šest let, v kombinaciji z obstoječimi terapijami za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
In one study involving 123 children aged 6 to 16 years, Zebinix over 12 weeks halved the number of seizures in 51% of patients (42 out of 83). 
V eni študiji, ki je vključevala 123 otrok, starih med šest in 16 let, se je število napadov v 12 tednih zdravljenja z zdravilom Zebinix zmanjšalo za polovico pri 51-% (42 od 83) bolnikov.
For adults, the most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), headache and nausea. 
Najpogostejši neželeni učinki zdravila Zebinix pri odraslih (opaženi pri več kot 1 bolniku od 10) so omotica, somnolenca (zaspanost), glavobol in navzeja.
Zebinix received a marketing authorisation valid throughout the EU on 21 April 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Zebinix, veljavno po vsej Evropski uniji, izdala 21.-aprila-2009.
The European Medicines Agency decided that Zebinix's benefits are greater than its risks and that it be authorised for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zebinix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What are the risks associated with Zebinix? 
Kakšna tveganja so povezana z zdravilom Zebinix?
What benefit of Zebinix have been shown in studies? 
Kakšne koristi je zdravilo Zebinix izkazalo v študijah?
What is Zebinix and what is it used for? 
Kaj je zdravilo Zebinix in za kaj se uporablja?
Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation. 
Zdravilo Zebinix je zdravilo proti epilepsiji, ki se uporablja za zdravljenje odraslih, ki imajo napade parcialnega izvora (epileptične napade) s sekundarno generalizacijo ali brez nje.
Zebinix should not be used in patients with severe kidney problems and the dose should be adjusted in moderately impaired kidney function. 
Zdravila Zebinix ne smejo jemati bolniki s hudimi težavami z ledvicami, pri zmerni okvari delovanja ledvic pa je treba odmerek prilagoditi.
Another study compared Zebinix taken on its own with another epilepsy medicine, carbamazepine, in 815 newly diagnosed adults. 
V drugi študiji so primerjali samostojno jemanje zdravila Zebinix z drugim zdravilom proti epilepsiji, karbamazepinom, pri 815 odraslih z novoodkrito boleznijo.
The active substance in Zebinix, eslicarbazepine acetate, is converted into eslicarbazepine in the body. 
Zdravilna učinkovina v zdravilu Zebinix, eslikarbazepin acetat, se v telesu pretvori v eslikarbazepin.
Zebinix can be taken on its own, in newly diagnosed epilepsy, or can be added to existing antiepileptic medicines. 
Zdravilo Zebinix se lahko jemlje samostojno pri novoodkriti epilepsiji ali se ga doda že uporabljanim zdravilom proti epilepsiji.
Over the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix 800 mg and Zebinix 1,200 mg respectively, compared with 11.7 per month in those taking placebo. 
V 12 tednih zdravljenja se je število napadov zmanjšalo na 9,8 napadov mesečno pri bolnikih, ki so jemali zdravilo Zebinix 800-mg, oziroma na 9,0 napadov mesečno pri bolnikih, ki so jemali zdravilo Zebinix 1-200-mg, v primerjavi z 11,7 napada mesečno pri bolnikih, ki so jemali placebo.
Looking at the results of the three studies taken together, Zebinix 800 mg and 1,200 mg were more effective than placebo at reducing the number of seizures, when used as add-on to other epilepsy medicines. 
Upoštevajoč rezultate vseh treh študij skupaj sta bila 800-miligramski in 1 200-miligramski odmerek zdravila Zebinix, uporabljena kot dodatek k drugim zdravilom proti epilepsiji, učinkovitejša od placeba pri zmanjševanju števila napadov.
For adults who take Zebinix on its own, a dose up to 1,600 mg may be used. 
Odrasli, ki jemljejo zdravilo Zebinix samostojno, lahko uporabijo odmerek do 1-600-mg.
Why is Zebinix authorised? 
Zakaj je bilo zdravilo Zebinix odobreno?
Three main studies compared Zebinix with placebo (a dummy treatment) in 1,050 adults with partialonset seizures that were not controlled by other medicines. 
V treh glavnih študijah so učinke zdravila Zebinix primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 1-050 odraslih z napadi parcialnega izvora, za obvladovanje katerih niso uporabljali drugih zdravil.
For more information about using Zebinix, see the package leaflet or contact your doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Zebinix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For children and adults who use Zebinix in combination with other medicines the maximum dose is 1,200 mg once a day. 
Odrasli in otroci, ki jemljejo zdravilo Zebinix v kombinaciji z drugimi zdravili je na maksimalni odmerek 1-200-mg.
For adults and children weighing 60 kg or more, treatment is started at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks. 
Zdravljenje z zdravilom Zebinix se pri odraslih in otrocih, ki so težji od 60 kg, začne s 400miligramskim odmerkom enkrat dnevno, ki se nato po enem ali dveh tednih poveča na standardni odmerek 800-mg enkrat dnevno.
Zebinix contains the active substance eslicarbazepine acetate. 
Zdravilo Zebinix vsebuje zdravilno učinkovino eslikarbazepin acetat.
The dose is then increased after one or two weeks to 20 mg/kg per day and then to 30 mg/kg per day, based on the patient's response. 
Pri otrocih, ki tehtajo manj kot 60 kg, znaša začetni odmerek 10 mg na kg telesne mase enkrat na dan. Odmerek se nato po enem ali dveh tednih poveča na 20 mg/kg na dan in nato na 30 mg/kg na dan, odvisno od bolnikovega odziva.
How does Zebinix work? 
Kako zdravilo Zebinix deluje?
Zebinix can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Zebinix je le na recept.
For the full list of side effects and restrictions with Zebinix, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Zebinix, glejte navodilo za uporabo.
How is Zebinix used? 
Kako se zdravilo Zebinix uporablja?
Zebinix (eslicarbazepine acetate) 
Zebinix eslikarbazepin acetat
This information supplements the sections 3 and 5 for the user. 
Te informacije dopolnjujejo poglavji 3 in 5, namenjeni uporabniku.
Not known (frequency cannot be estimated from the available data) 
Neznani (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
Date of first authorisation: 01 February 2013 Date of latest renewal: 21 September 2017 
Datum prve odobritve: 01 februar 2013 Datum zadnjega podaljšanja: 21 september 2017
These effects were fully reversible within 8-18 weeks after the last injection. 
Ti učinki so bili povsem reverzibilni v 8 do 18 tednih po zadnji injekciji.
These animals also lost normal menstrual cycling. 
Te živali so tudi izgubile normalne menstruacijske cikluse.
Invasive dental procedures are also an identified risk factor. 
Invazivni zobozdravstveni postopki so prav tako opredeljeni dejavnik tveganja.
Your doctor should monitor you carefully. 
Vaš zdravnik vas mora skrbno nadzirati.
As determined per IVRS 
a Določeno z IVRS
The infusion sets should be made of one of the following materials: 
Kompleti za infundiranje naj bodo izdelani iz enega od naslednjih materialov:
This is considered as one treatment cycle. 
To velja kot en ciklus zdravljenja.
Sometimes, depending on where this happens, you may get an unusual discharge at that place. 
Včasih se vam lahko - odvisno od tega, kje se to zgodi - pojavi nenavaden izcedek na tistem mestu.
• You will usually be given an infusion once every 2 weeks. 
• Po navadi boste dobili po eno infuzijo enkrat na 2 tedna.
• in your eye, since it may severely damage it. 
• v oko, saj ga lahko hudo poškoduje.
You may need to go to the hospital for treatment. 
Morda boste morali na zdravljenje v bolnišnico.
• for at least 6 months after the last dose of treatment. 
• vsaj še 6 mesecev po zadnjem odmerku tega zdravila.
• changes in the colour of the skin. 
• spremembe barve kože.
Please also read the package leaflets for the other medicines (‘chemotherapy') that are part of your treatment, to see if they are suitable for you. 
Preberite tudi navodila za uporabo drugih zdravil ("kemoterapija"), ki so del vašega zdravljenja, da boste videli, ali so primerna za vas.
Hypertension may exacerbate underlying cardiovascular disease. 
Hipertenzija lahko poslabša osnovne kardiovaskularne bolezni.
From a microbiological point of view, the solution for infusion should be used immediately. 
Z mikrobiološkega stališča je treba raztopino za infundiranje uporabiti takoj.
You may need to read it again, or provide it to future healthcare providers. 
Morda ga boste želeli ponovno prebrati, ali ga izročiti svojim prihodnjim zdravnikom.
• feeling tired or weak 
• občutek utrujenosti ali šibkosti
The treatment cycle is repeated every 2 weeks. 
Ciklus zdravljenja se ponavlja vsaka 2 tedna.
The primary efficacy endpoint was overall survival. 
Primarni opazovani dogodek učinkovitosti je bilo celokupno preživetje.
• your level of everyday activities is limited or worsens on treatment. 
• če je vaša raven vsakodnevnih dejavnosti omejena ali se med zdravljenjem poslabša.
Men and women who can father or have children should use effective contraception: 
Moški in ženske, ki bi lahko zaplodili in imeli otroke, morajo uporabljati učinkovito kontracepcijo:
• Your doctor will decide how often you will be given the medicine and if you need a change in the dose. 
• Zdravnik bo presodil, kako pogosto boste dobivali zdravilo in ali potrebujete spremembo odmerka.
Unopened vial 3 years 
Neodprta viala 3 leta
Your doctor will decide the appropriate doses for these other chemotherapy medicines. 
Vaš zdravnik vam bo določil ustrezne odmerke teh drugih zdravil za kemoterapijo.
This medicine is not for children or adolescents under the age of 18 years because the safety and benefit of using ZALTRAP in children and adolescents have not been shown. 
To zdravilo ni primerno za otroke ali mladostnike, stare manj kot 18 let, saj varnost in korist zdravljenja z zdravilom ZALTRAP pri otrocih in mladostnikih nista dokazani.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in section 6.6. 
Zaradi pomanjkanja študij kompatibilnosti se tega zdravila ne sme mešati z drugimi zdravili ali vehikli razen s tistimi, ki so navedeni v poglavju 6.6.
It is therefore also important to tell your doctor, pharmacist or nurse if you have other heart problems since high blood pressure could make these worse. 
Pomembno je tudi, da svojemu zdravniku, farmacevtu ali medicinski sestri poveste, če imate kakšne druge težave s srcem, kajti visok krvni tlak lahko to poslabša.
If you are a woman that could become pregnant you should use effective contraception (see “Contraception” section below for details on male and female contraception). 
Če ste ženska, ki bi lahko zanosila, morate uporabljati učinkovito kontracepcijo (za podrobnosti o kontracepciji pri moških in ženskah glejte spodnje poglavje “Kontracepcija” ).
• The drip (infusion) lasts for about 1 hour. 
• Kapalna (infuzija) traja približno 1 uro.
Frequency Category 
Kategorija pogostnosti
Signs may include dizziness especially when going from sitting to standing. 
Med znaki je lahko omotica, zlasti pri vstajanju iz sedečega v stoječ položaj.
During treatment, your doctor will perform a number of tests to monitor the function of your body and how the medicine is working. 
Med zdravljenjem bo vaš zdravnik izvajal številne preiskave, s katerimi bo kontroliral delovanje vašega telesa in delovanje zdravila.
How much and how often you will receive treatment 
Koliko zdravila boste dobivali in kako pogosto
They may also prescribe a medicine called ‘G-CSF' to help prevent complications if your white blood cell count is too low. 
Predpiše vam lahko tudi zdravilo, imenovano "G-CSF", ki pomaga preprečiti zaplete, če se število belih krvnih celic preveč zmanjša.
Immunogenicity data are highly dependent on the sensitivity and specificity of the assay. 
Podatki o imunogenosti so izredno odvisni od senzitivnosti in specifičnosti preskusa.
Paediatric population The safety in paediatric patients has not been established. 
Pediatrična populacija Varnost pri pediatričnih bolnikih ni ugotovljena.
Cases of overdose should be managed by appropriate supportive measures particularly with regard to monitoring and treatment of hypertension and proteinuria. 
Primere prevelikega odmerjanja je treba obravnavati z ustreznimi podpornimi ukrepi, zlasti kar zadeva spremljanje in zdravljenje hipertenzije in proteinurije.
• during treatment with ZALTRAP and 
• med zdravljenjem z zdravilom ZALTRAP in
Any unused concentrate should be discarded. 
Ves neporabljeni koncentrat je treba zavreči.
Other sources of information 
Drug vir informacij
Do not use ZALTRAP: • if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 
Ne uporabljajte zdravila ZALTRAP: • če ste alergični na aflibercept ali katero koli drugo sestavino tega zdravila (navedeno v poglavju
• haemorrhoids, bleeding or pain in the back passage 
• hemoroidi, krvavitev ali bolečine v zadnjiku
This is because ZALTRAP may increase the risk of bleeding. 
Zdravilo ZALTRAP namreč lahko poveča tveganje za krvavitve.