natgillin/translations-raw huggingface dataset:
Zyllt can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment. 
Zdravilo Zyllt se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
Because Zyllt is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
Ker je zdravilo Zyllt generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Zyllt is a medicine that contains the active substance clopidogrel. 
Zyllt je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
Why has Zyllt been approved? 
Zakaj je bilo zdravilo Zyllt odobreno?
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction. 
Lahko se uporablja tudi pri bolnikih, pri katerih ni nenormalnega zapisa na EKG, če imajo nestabilno angino (hudo obliko bolečine v prsih) ali so imeli miokardni infarkt brez zobca Q. Zdravilo se dobi samo na recept.
The active substance in Zyllt, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Zyllt, klopidogrel, je zaviralec agregacije trombocitov.
The full EPAR for Zyllt can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zyllt je na voljo tukaj.
What is Zyllt used for? 
Za kaj se zdravilo Zyllt uporablja?
How does Zyllt work? 
Kako zdravilo Zyllt deluje?
What is Zyllt? 
Kaj je zdravilo Zyllt?
How has Zyllt been studied? 
Kako je bilo zdravilo Zyllt raziskano?
How is Zyllt used? 
Kako se zdravilo Zyllt uporablja?
It is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. 
Uporablja se pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak) in pri katerih samo s telmisartanom krvnega tlaka ni mogoče ustrezno uravnavati.
The full EPAR for Actelsar HCT 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 Actelsar HCT je 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 Actelsar HCT? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Actelsar HCT?
telmisartan / hydrochlorothiazide 
telmisartan/hidroklorotiazid
This is a summary of the European public assessment report (EPAR) for Actelsar HCT. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actelsar HCT.
This means that Actelsar HCT is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu MicardisPlus.
The Committee recommended that Actelsar HCT be approved for use in the EU. 
Priporočil je, da se zdravilo Actelsar HCT odobri za uporabo v EU.
Telmisartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II. 
Telmisartan je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
The European Commission granted a marketing authorisation valid throughout the European Union for Actelsar HCT on 13 March 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Actelsar HCT, veljavno po vsej Evropski uniji, odobrila dne 13. marca 2013.
Actelsar HCT is a ‘generic medicine'. 
Zdravilo Actelsar HCT je „generično zdravilo“.
Because Actelsar HCT is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Actelsar HCT generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What are the benefits and risks of Actelsar HCT? 
Kakšne so koristi in tveganja, povezani z zdravilom Actelsar HCT?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Actelsar HCT has been shown to have comparable quality and to be bioequivalent to MicardisPlus. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Actelsar HCT primerljivo raven kakovosti kot zdravilo MicardisPlus ter da mu je biološko enakovredno.
Actelsar HCT is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid. 
Zdravilo Actelsar HCT je na voljo v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida), ki se zaužijejo peroralno enkrat dnevno skupaj s tekočino.
For more information about treatment with Actelsar HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Actelsar HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is not intended to provide practical advice on how to use Actelsar HCT. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Safety information has been included in the summary of product characteristics and the package leaflet for Actelsar HCT, including the appropriate precautions to be followed by healthcare professionals and patients. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Actelsar HCT so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Because Actelsar HCT is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus. 
Ker je zdravilo Actelsar HCT generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu MicardisPlus.
Other information about Actelsar HCT 
Druge informacije o zdravilu Actelsar HCT
Therefore, the CHMP's view was that, as for MicardisPlus, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu MicardisPlus, odtehtajo znana tveganja.
What is Actelsar HCT and what is it used for? 
Kaj je zdravilo Actelsar HCT in za kaj se uporablja?
Actelsar HCT is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. 
Actelsar HCT je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
The dose of Actelsar HCT to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. 
Odmerek zdravila Actelsar HCT je odvisen od odmerka telmisartana, ki ga je bolnik jemal pred tem: bolniki, ki so prejemali 40 mg telmisartana, morajo jemati tablete po 40/12,5 mg, tisti, ki pa so prejemali 80 mg telmisartana, pa morajo jemati tablete po 80/12,5 mg. Tablete po 80/25 mg se dajejo bolnikom, pri katerih se krvni tlak ne uravna z jemanjem tablet po 80/12,5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo Actelsar HCT.
For practical information about using Actelsar HCT, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Actelsar HTC naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Why is Actelsar HCT approved? 
Zakaj je bilo zdravilo Actelsar HCT odobreno?
Actelsar HCT contains two active substances, telmisartan and hydrochlorothiazide. 
Zdravilo Actelsar HCT vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
How has Actelsar HCT been studied? 
Kako je bilo zdravilo Actelsar HCT raziskano?
How is Actelsar HCT used? 
Kako se zdravilo Actelsar HCT uporablja?
How does Actelsar HCT work? 
Kako zdravilo Actelsar HCT deluje?
Below is a brief description of the studies and their results: 
V nadaljevanju je kratek opis študij in njihovih rezultatov.
Further information on Humira can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/humira. 
Nadaljnje informacije o zdravilu Humira so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/humira.
Some rare but serious side effects have been reported, including serious infections. 
Poročali so o nekaterih redkih, a resnih neželenih učinkih, ki so vključevali tudi hude okužbe.
What measures are being taken to ensure the safe and effective use of Humira? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Humira?
Humira received a marketing authorisation valid throughout the EU on 8 September 2003. 
Za zdravilo Humira je bilo 8. septembra 2003 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
However, these are considered to be manageable and specific recommendations are given to help doctors manage these risks. 
Vendar se ti štejejo za obvladljive, zato morajo zdravniki prejeti posebna priporočila za obvladovanje teh tveganj.
Humira is given as an injection under the skin, usually every 2 weeks. 
Zdravilo Humira se injicira pod kožo, običajno vsaka dva tedna.
As for all medicines, data on the use of Humira are continuously monitored. 
Kot velja pri vseh zdravilih, se podatki o uporabi zdravila Humira stalno spremljajo.
Why is Humira authorised in the EU? 
Zakaj je bilo zdravilo Humira odobreno v EU?
The European Medicines Agency decided that Humira'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 Humira večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What are the risks associated with Humira? 
Kakšna tveganja so povezana z zdravilom Humira?
Other information about Humira 
Druge informacije o zdravilu Humira
What is Humira and what is it used for? 
Kaj je zdravilo Humira in za kaj se uporablja?
The study in younger children (aged 2 to 4 years) showed that the majority of children responded well to Humira treatment and this response was maintained after 24 weeks. 
Študija pri mlajših otrocih (starih od dve do štiri leta) je pokazala, da se je večina otrok dobro odzvala na zdravljenje z zdravilom Humira in da se je odziv ohranil še po 24 tednih.
What benefits of Humira have been shown in studies? 
Kakšne koristi je zdravilo Humira izkazalo v študijah?
• In non-infectious uveitis, Humira was found effective in 3 studies. 
• Pri neinfektivnem uveitisu se je zdravilo Humira izkazalo za učinkovito v treh študijah.
An overview of Humira and why it is authorised in the EU 
Pregled zdravila Humira in zakaj je odobreno v EU
Patients or their carers can inject Humira once they have been trained. 
Bolniki ali njihovi negovalci si lahko zdravilo Humira vbrizgajo sami, ko so bili ustrezno usposobljeni.
The first study involved adults whose disease was not controlled with high doses of corticosteroids. 
V prvo študijo so bili vključeni odrasli bolniki, pri katerih bolezen ni bila nadzorovana z velikimi odmerki kortikosteroidov.
Humira is a medicine that acts on the immune system and is used to treat the following conditions: 
Humira je zdravilo, ki učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Humira have also 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 Humira upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. 
Zdravilo Humira se večinoma uporablja pri odraslih, katerih bolezen je huda, zmerno huda ali se poslabšuje oziroma kadar bolnik ne more prejemati drugega zdravljenja.
Patients treated with Humira must be given a reminder card with information on the safety of the medicine. 
Bolniki, ki se zdravijo z zdravilom Humira, morajo prejeti opozorilno kartico z informacijami o varnosti zdravila.
Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body). 
Zdravilo Humira se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
The proportions of patients taking placebo who achieved this goal were 28% in the first study and 26% in the second. 
Takšen rezultat je v skupini bolnikov, ki je jemala placebo, doseglo 28 % v prvi študiji in 26 % bolnikov v drugi.
The active substance in Humira, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). 
Učinkovina v zdravilu Humira, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanj.
The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child's weight. 
Odmerek in pogostnost injiciranja sta odvisna od bolezni, ki se zdravi, pri otrocih pa se odmerek izračuna na podlagi otrokove telesne mase.
Humira, when used as directed, has been shown in clinical trials to be effective at reducing important symptoms of each of the conditions for which it is approved. 
Zdravilo Humira se je v kliničnih preskušanjih ob pravilni uporabi izkazalo za učinkovito pri zmanjševanju glavnih simptomov pri vsaki od bolezni, za katere je bilo odobreno.
Side effects reported with Humira are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o kateri so poročali pri zdravilu Humira, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using Humira. 
Zdravilo Humira in druga zdravila iz istega razreda lahko vplivajo tudi na obrambno sposobnost imunskega sistema proti okužbam in raku, saj so bili pri bolnikih, ki prejemajo zdravilo Humira, zabeleženi nekateri primeri resnih okužb in krvnega raka.
In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone. 
Pri bolnikih, ki v preteklosti še niso prejemali metotreksata, je bila kombinacija zdravila Humira in metotreksata učinkovitejša od metotreksata kot samostojnega zdravila.
This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat. 
Ta snov sodeluje pri nastanku vnetij in je prisotna v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Humira uporablja.
For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist. 
Za podrobne informacije o uporabi zdravila Humira pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The second study involved adults whose uveitis was under control with a corticosteroid but the corticosteroid dose was then reduced or stopped and Humira or placebo introduced. 
V drugo študijo so bili vključeni odrasli bolniki, katerih uveitis je bil pod nadzorom s kortikosteroidom, vendar je bil pri njih odmerek nato zmanjšan ali so ga prenehali jemati ter začeli prejemati zdravilo Humira ali placebo.
The most common side effects with Humira (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain. 
Najpogostejši neželeni učinki zdravila Humira (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe (nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals). 
Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podoben sindrom (obolenje, pri katerem imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (življenjsko nevarna reakcija z gripi podobnimi simptomi in bolečim izpuščajem, ki prizadene kožo, usta, oči in spolovila).
How is Humira used? 
Kako se zdravilo Humira uporablja?
• In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas. 
• Pri obolenju hidradenitis suppurativa je v eni glavni študiji pri 59 % bolnikov, ki so prejemali zdravilo Humira, in v drugi pri 42 % po 12 tednih prišlo do vsaj 50-odstotnega zmanjšanja abscesov in nodulov, ne da bi se povečalo število abscesov ali fistul.
How does Humira work? 
Kako zdravilo Humira deluje?
• axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation 
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno ankilozirajočega spondilitisa, in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
The studies included adult patients for the most part, but included children in studies for Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis. 
Večina bolnikov v teh študijah je bila odraslih, otroci pa so bili vključeni v študije Crohnove bolezni, psoriaze v plakih, poliartikularnega juvenilnega idiopatskega artritisa, neinfektivnega uveitisa in artritisa, povezanega z entezitisom.
In the third study in children aged 2 to 18 years with non-infectious anterior uveitis, in whom methotrexate alone did not work, treatment failed in about 60% of patients receiving placebo with methotrexate compared with about 27% of patients given Humira with methotrexate. 
V tretji študiji z otroki, starimi med dve in 18 let, ki so imeli predhodni neinfektivni uveitis in pri katerih samostojno jemanje metotreksata ni delovalo, zdravljenje ni bilo uspešno pri okoli 60 % bolnikov, ki so prejemali placebo v kombinaciji z metotreksatom, v primerjavi s 27 % bolnikov, ki so prejemali zdravilo Humira v kombinaciji z metotreksatom.
Patients adding Humira also had less joint damage and less reduction in physical function after a year. 
Bolniki, ki so kot dodatek prejemali zdravilo Humira, so imeli po enem letu zdravljenja tudi manj poškodb sklepov in manjše poslabšanje telesnih zmogljivosti.
For more information about using Humira, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij o uporabi zdravila Humira glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
• Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with clear signs of inflammation, and induction and maintenance phases of treatment for Crohn's disease, psoriasis and ulcerative colitis. 
• Prav tako je zdravilo Humira bolj izboljšalo simptome kot placebo v študijah psoriatičnega artritisa, ankilozirajočega spondilitisa, aksialnega spondiloartritisa, pri katerem ankilozirajoči spondilitis ni dokazan z rentgenom, a je opaziti jasne znake vnetja, ter pri uvodnem in vzdrževalnem zdravljenju Crohnove bolezni, psoriaze in ulceroznega kolitisa.
Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions. 
Za zdravilo Humira so bile opravljene obsežne študije, ki so pokazale, da je učinkovito pri zmanjševanju simptomov pri bolnikih z vnetnimi obolenji.
Doctors treating uveitis should also take advice from doctors who have experience of using Humira. 
Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Humira.
Fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can reduce its effects), so the results found that the use of Humira with methotrexate was more effective than Humira used alone. 
V skupini bolnikov, ki so jemali zdravilo Humira v kombinaciji z metotreksatom, je bilo manj tistih, pri katerih so se razvila protitelesa (kar lahko prepreči delovanje zdravila), zaradi česar je bilo na podlagi rezultatov ugotovljeno, da je uporaba zdravila Humira v kombinaciji z metotreksatom učinkovitejša od jemanja zdravila Humira kot samostojnega zdravila.
• In studies in adults and children with plaque psoriasis, including psoriasis of the nail, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate or placebo (a dummy treatment). 
• Študije pri odraslih in otrocih s psoriazo v plakih, vključno s psoriazo nohtov, so pokazale, da je do izboljšanja simptomov prišlo pri več bolnikih, ki so jemali zdravilo Humira, kot pri tistih, ki so jemali metotreksat ali placebo (zdravilo brez učinkovine).
• plaque psoriasis, a disease causing red, scaly patches on the skin 
• psoriaze s plaki, tj. bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži;
Treatment with Humira must be started and supervised by a doctor who has experience in the treatment of the diseases that Humira is used for. 
Zdravljenje z zdravilom Humira lahko uvede in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se to zdravilo uporablja.
In this study, treatment failure occurred in about 55% of patients receiving placebo compared with 39% receiving Humira. 
V tej študiji zdravljenje ni bilo uspešno pri približno 55 % bolnikov, ki so prejemali placebo, v primerjavi z 39 % bolnikov, ki so prejemali zdravilo Humira.