natgillin/translations-raw huggingface dataset:
It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation. 
Deluje kot kortikosteroidi (družina naravno prisotnih hormonov), in sicer tako, da zavira aktivnost imunskega sistema in zmanjšuje vnetje.
RETISERT was studied in one main study involving 146 patients who had had non-infectious uveitis affecting the posterior part of one or both eyes for at least a year, and had been treated with corticosteroids or immunosuppressant medicines for at least a month. 
Zdravilo RETISERT so preučevali v eni glavni študiji s 146 bolniki, ki so imeli najmanj eno leto neinfektivni uveitis, ki je prizadel zadnji del enega ali obeh oči, in so se najmanj en mesec zdravili z kortikosteroidi ali imunosupresivi.
The company informed the CHMP that there are no clinical trials with RETISERT ongoing in Europe. 
Podjetje je CHMP obvestilo, da trenutno v Evropi ne potekajo nobena klinična preizkušanja zdravila RETISERT.
The effects of RETISERT, implanted into the more severely affected eye, were compared to those of standard care (the use of corticosteroids or immunosuppressant medicines affecting the whole body). 
Učinke zdravila RETISERT, vsajenega v huje prizadeto oko, so primerjali z učinki standardne oskrbe (uporabe kortikosteroidov ali imunosupresivov, ki vplivajo na celotno telo).
The use of RETISERT was also linked to side effects, including eye pain, increased pressure within the eyeball and cataracts, which led to vision problems in some patients. 
Uporaba zdravila RETISERT je bila povezana tudi z neželenimi učinki, vključno z bolečino v očesu, povečanim tlakom v očesnem zrklu in katarakto, kar je pri nekaterih bolnikih povzročilo težave z vidom.
On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005. 
Podjetje Bausch & Lomb je dne 16. julija 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za izdajo dovoljenja za promet z zdravilom RETISERT, namenjenim za zdravljenje kroničnega neinfektivnega uveitisa, ki prizadene zadnji očesni segment.
The active substance in RETISERT, fluocinolone acetonide, is a synthetic corticosteroid. 
Zdravilna učinkovina zdravila RETISERT, fluocinolon acetonid, je sintetični kortikosteroid.
It contains the active substance fluocinolone acetonide, which is released slowly by the implant over a period of around three years. 
Vsebuje zdravilno učinkovino fluocinolon acetonid, ki se počasi sprošča iz vsadka približno tri leta.
The CHMP was concerned that a benefit of RETISERT had not been demonstrated based on the two year results presented in the application, since the patients receiving RETISERT in the main study did not have a longer time until their disease came back than those taking standard care. 
CHMP je bil zaskrbljen, da koristi zdravila RETISERT, na podlagi rezultatov za dve leti, predstavljenih v vlogi, niso bile dokazane, ker pri bolnikih v glavni študiji, ki so prejemali zdravilo RETISERT, čas do ponovitve bolezni ni bil daljši kot pri bolnikih s standardno oskrbo.
RETISERT was expected to be used to treat chronic (persistent) non-infectious uveitis affecting the posterior (rear) part of the eye. 
Zdravilo RETISERT naj bi se uporabljalo za zdravljenje kroničnega (trdovratnega) neinfektivnega uveitisa, ki prizadene zadnji del očesa.
This is inflammation within the eye, which is not caused by an infection, but which affects areas including the retina (the light-sensitive layer at the back of the eye), and the choroid (the layer below the retina that contains blood vessels). 
To je vnetje v očesu, ki ga ne povzroča okužba, vendar pa prizadene predele, kot sta mrežnica (na svetlobo občutljiva plast na zadnji strani očesa) in horoidea (membrana pod mrežnico, ki vsebuje krvne žile).
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 RETISERT could not have been approved for the treatment of chronic non-infectious uveitis. 
Na podlagi pregleda podatkov je imel CHMP v času umika vloge določene zadržke in bil začasnega mnenja, da za zdravilo RETISERT ni mogoče odobriti dovoljenja za zdravljenje kroničnega neinfektivnega uveitisa.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of RETISERT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je bil v času umika vloge CHMP mnenja, da koristi zdravila RETISERT niso zadostno dokazane in da niso večje od znanih tveganj.
This anti-inflammatory activity was expected to reduce the symptoms of uveitis. 
Ta protivnetna aktivnost bi naj po pričakovanjih zmanjševala simptome uveitisa.
RETISERT is an intravitreal implant (inserted into the vitreous humour, the jelly-like fluid in the central chamber of the eye). 
Zdravilo RETISERT je intravitrealni vsadek (vstavi se v steklovino, želatini podobno tekočino v osrednji očesni komori).
The application was at day 120 when the company withdrew. 
Podjetje je umaknilo vlogo na 120. dan postopka.
What is RETISERT? 
Kaj je zdravilo RETISERT?
What was RETISERT expected to be used for? 
Za kaj bi se naj zdravilo RETISERT uporabljalo?
How is RETISERT expected to work? 
Kako bi naj zdravilo RETISERT delovalo?
It is given as 2 tablets of the appropriate strength once a day with food. 
Daje se v obliki dveh tablet ustrezne jakosti enkrat na dan s hrano.
It is used to treat type 2 diabetes in: 
Uporablja se za zdravljenje sladkorne bolezni tipa 2 pri:
Further information on Qtrilmet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/qtrilmet. 
Nadaljnje informacije za zdravilo Qtrilmet so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/qtrilmet.
These studies measured the change in HbA1c levels after 24 weeks of treatment. 
V teh študijah so bile izmerjene spremembe ravni HbA1c po 24 tednih zdravljenja.
What measures are being taken to ensure the safe and effective use of Qtrilmet? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Qtrilmet?
The HbA1c levels of patients in the studies were at least 8% and treatment was aimed at reducing HbA1c levels to 7% or less. 
Ravni HbA1c bolnikov v študijah so bile vsaj 8 %, zdravljenje pa je bilo namenjeno znižanju ravni HbA1c na 7 % ali manj.
Having all three active ingredients in one tablet reduces the number of tablets the patient needs to take and may improve adherence to treatment, which can improve overall management of the disease. 
Z vsemi tremi učinkovinami v eni tableti se zmanjša število tablet, ki jih mora vzeti bolnik, prav tako se lahko izboljša upoštevanje predpisanega zdravljenja, s čimer se lahko izboljša splošno obvladovanje bolezni.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin or when the body cannot use insulin effectively. 
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina ali pri kateri telo insulina ne more učinkovito izrabiti.
However, reducing doses or interrupting treatment with Qtrilmet is more complicated than using the active ingredients separately. 
Vendar je zmanjšanje odmerkov ali prekinitev zdravljenja z zdravilom Qtrilmet bolj zapleteno, kot ločena uporaba posameznih učinkovin.
The Agency decided that Qtrilmet's benefits are greater than its risks and it can be authorised for use in the EU. 
Agencija je zaključila, da so koristi zdravila Qtrilmet večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Insulin is important for controlling how the body converts glucose (a type of sugar) to energy and how the glucose is stored in the body. 
Insulin je pomemben za nadzor nad tem, kako telo pretvori glukozo (vrsto sladkorja) v energijo in kako se glukoza shrani v telesu.
Qtrilmet contains three active substances which all work in different ways. 
Zdravilo Qtrilmet vsebuje tri učinkovine, ki delujejo na različne načine.
Saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, has been authorised in the EU as Onglyza since 2009. 
Saksagliptin, zaviralec dipeptidil-peptidaze-4 (DPP-4), je v EU odobren od leta 2009 kot zdravilo Onglyza.
As for all medicines, data on the use of Qtrilmet are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Qtrilmet stalno spremljajo.
Other information about Qtrilmet 
Druge informacije o zdravilu Qtrilmet
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtrilmet 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 Qtrilmet upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Dapagliflozin has been authorised in the EU as Forxiga since 2012 
Dapagliflozin je v EU odobren od leta 2012 kot zdravilo Forxiga.
The European Medicines Agency considered that the combined use of the active ingredients in Qtrilmet produces worthwhile reduction in HbA1c and that all the active ingredients contribute to this effect. 
Evropska agencija za zdravila je zaključila, da kombinirana uporaba učinkovin v zdravilu Qtrilmet koristno zmanjša raven HbA1c in da k temu prispevajo vse učinkovine.
Why is Qtrilmet authorised in the EU? 
Zakaj je bilo zdravilo Qtrilmet odobreno v EU?
Qtrilmet (metformin / saxagliptin / dapagliflozin) 
Qtrilmet (metformin/saksagliptin/dapagliflozin)
What benefits of Qtrilmet have been shown in studies? 
Kakšne koristi zdravila Qtrilmet so se pokazale v študijah?
HbA1c (glycosylated haemoglobin) is an indicator of glucose levels in the blood over the previous 2 to 3 months. 
HbA1c (glikozilirani hemoglobin) je kazalnik ravni glukoze v krvi v zadnjih dveh do treh mesecih.
Side effects reported with Qtrilmet are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Qtrilmet, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Qtrilmet and why it is authorised in the EU 
Pregled zdravila Qtrilmet in zakaj je odobreno v EU
What are the risks associated with Qtrilmet? 
Kakšna tveganja so povezana z zdravilom Qtrilmet?
Diabetes leads to high levels of glucose in the blood. 
Sladkorna bolezen vodi do visokih ravni glukoze v krvi.
• Metformin works mainly by reducing glucose production and reducing its absorption from the gut. 
• Metformin deluje predvsem tako, da zavira tvorbo glukoze in zmanjšuje njeno absorpcijo v črevesju.
What is Qtrilmet and what is it used for? 
Kaj je zdravilo Qtrilmet in za kaj se uporablja?
Qtrilmet must also not be used in patients with certain kidney, liver or heart problems or metabolic acidosis (build-up of acid in the blood), or in patients with certain conditions that can lead to metabolic acidosis. 
Prav tako se ne sme uporabljati pri bolnikih z določenimi težavami z ledvicami, jetri ali srcem ali metabolično acidozo (kopičenjem kisline v krvi) ali pri bolnikih z določenimi obolenji, ki lahko povzročijo metabolično acidozo.
It is available in two strengths of tablets containing: metformin 850 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg; and metformin 1,000 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg. 
Na voljo je v tabletah dveh jakosti, ki vsebujejo: 850 mg metformina, 2,5 mg saksagliptina in 5 mg dapagliflozina ter 1 000 mg metformina, 2,5 mg saksagliptina in 5 mg dapagliflozina.
The dose of Qtrilmet is calculated to match the dose of metformin the patient has been taking. 
Odmerek zdravila Qtrilmet se izračuna na podlagi odmerka metformina, ki ga jemlje bolnik.
The most common side effects with Qtrilmet (which may affect more than 1 in 10 people) are infections of the nose and throat, hypoglycaemia (low blood sugar) when used with a sulphonylurea and effects on the gut such as nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite. 
Najpogostejši neželeni učinki zdravila Qtrilmet (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe nosu in grla, hipoglikemija (nizke ravni sladkorja v krvi), kadar se uporablja v kombinaciji s sulfonilsečnino, in učinki na črevesje, kot so navzeja (siljenje na bruhanje), bruhanje, driska, bolečine v trebuhu in izguba teka.
• Dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). 
• Dapagliflozin zavira delovanje beljakovine v ledvicah, imenovane natrij-glukozni soprenašalec 2 (SGLT2).
• adults whose blood sugar is not controlled well enough with metformin combined with either saxagliptin or dapagliflozin (including those also taking a sulphonylurea, another type of diabetes medicine); 
• odraslih, katerih krvni sladkor ni zadovoljivo uravnan z metforminom v kombinaciji s saksagliptinom ali dapagliflozinom (vključno s tistimi, ki jemljejo sulfonilsečnino, drugo vrsto zdravila za zdravljenje sladkorne bolezni);
Qtrilmet must not be used in people who are hypersensitive (allergic) to metformin, saxagliptin or dapagliflozin or to any of the other ingredients or in people who have had serious allergic reactions to a DPP-4 inhibitor (medicines similar to saxagliptin) or to a SGLT2 inhibitor (medicines similar to dapagliflozin). 
Zdravila Qtrilmet ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) metformin, saksagliptin ali dapagliflozin ali katere koli druge sestavine, ali osebe, ki so imele resne alergijske reakcije na zaviralec DPP-4 (zdravila, podobna saksagliptinu) ali na zaviralec SGLT2 (zdravila, podobna dapagliflozinu).
Three main studies have shown that the combination of metformin, saxagliptin and dapagliflozin was effective at lowering blood glucose in adults with type 2 diabetes. 
Tri glavne študije so pokazale, da je kombinacija metformina, saksagliptina in dapagliflozina učinkovita pri zniževanju glukoze v krvi pri odraslih s sladkorno boleznijo tipa 2.
• adults who are already taking metformin, saxagliptin and dapagliflozin. 
• odraslih, ki že jemljejo metformin, saksagliptin in dapagliflozin.
• Saxagliptin blocks the breakdown of incretin hormones, which are released after a meal and cause the pancreas to produce insulin. 
• Saksagliptin zavira razgradnjo inkretinskih hormonov, ki se sprostijo po obroku in povzročijo, da trebušna slinavka tvori insulin.
For the full list of side effects and restrictions of Qtrilmet, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Qtrilmet glejte navodilo za uporabo.
Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin. 
Qtrilmet je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje učinkovine metformin, saksagliptin in dapagliflozin.
How is Qtrilmet used? 
Kako se zdravilo Qtrilmet uporablja?
How does Qtrilmet work? 
Kako zdravilo Qtrilmet deluje?
In the first main study in 534 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 1.47 percentage points compared with metformin combined with either saxagliptin (0.88 percentage point reduction) or dapagliflozin (1.20 percentage point reduction). 
V prvi glavni študiji pri 534 bolnikih je kombinacija metformina, saksagliptina in dapagliflozina znižala povprečno raven HbA1c za 1,47 odstotne točke v primerjavi z metforminom v kombinaciji s saksagliptinom (znižanje za 0,88 odstotne točke) ali dapagliflozinom (znižanje za 1,20 odstotne točke).
The pattern of Qtrilmet's side effects is manageable and similar to that in patients treated with saxagliptin and dapagliflozin added to metformin. 
Vzorec neželenih učinkov zdravila Qtrilmet je obvladljiv in podoben vzorcu pri bolnikih, zdravljenih s saksagliptinom in dapagliflozinom, dodanima metforminu.
In the third study in 320 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.82 percentage points compared with a reduction of 0.10 percentage points in patients receiving metformin, saxagliptin and placebo. 
V tretji študiji pri 320 bolnikih je kombinacija metformina, saksagliptina in dapagliflozina znižala povprečno raven HbA1c za 0,82 odstotne točke v primerjavi z znižanjem za 0,10 odstotne točke pri bolnikih, ki so prejemali metformin, saksagliptin in placebo.
Qtrilmet can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Qtrilmet je le na recept.
By blocking their breakdown, saxagliptin causes the pancreas to produce more insulin when blood glucose levels are high. 
Z zaviranjem njihove razgradnje povzroči, da trebušna slinavka tvori več insulina, ko je raven glukoze v krvi visoka.
In the second study in 315 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.51 percentage points compared with a reduction of 0.16 percentage points in patients receiving metformin, dapagliflozin and placebo (dummy treatment). 
V drugi študiji pri 315 bolnikih je kombinacija metformina, saksagliptina in dapagliflozina znižala povprečno raven HbA1c za 0,51 odstotne točke v primerjavi z znižanjem za 0,16 odstotne točke pri bolnikih, ki so prejemali metformin, dapagliflozin in placebo (zdravilo brez učinkovine).
In the first study, the patients had an average of 0.021 serious infections per year. 
V prvi študiji so imeli bolniki v povprečju 0,021 resnih okužb na leto.
IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. 
IgG se kot zdravilo uporablja od osemdesetih let preteklega stoletja in ima širok razpon delovanja proti organizmom, ki lahko povzročijo okužbo.
In babies and young children, hereditary fructose intolerance may not yet have been diagnosed and may be fatal; this medicine must therefore not be given to babies and children below two years of age. 
Pri dojenčkih in majhnih otrocih fruktozna intoleranca morda še ni bila diagnosticirana in utegne biti usodna, zato se tega zdravila dojenčkom in otrokom, mlajšim od dveh let, ne sme dajati.
In the second study, up to 14 (73%) of the 19 patients who remained in the study had a platelet count above 50 million platelets per millilitre at least once during the study. 
V drugi študiji je do 14 (73 %) od 19 bolnikov, ki so ostali vključeni v študijo, imelo koncentracijo trombocitov nad 50 milijonov trombocitov na mililiter vsaj enkrat med študijo.
The main measure of effectiveness was the number of serious bacterial infections over a year's treatment. 
Glavno merilo učinkovitosti je bilo število resnih bakterijskih okužb v obdobju enoletnega zdravljenja.
The dose and frequency of infusion depend on the disease being treated, and may need to be adjusted for patients depending on their response. 
Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni in ju bo morda treba bolnikom prilagoditi glede na njihov odziv.
The European Commission granted a marketing authorisation valid throughout the European Union for Flebogammadif on 23 August 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Flebogammadif, veljavno po vsej Evropski uniji, odobrila dne 23. avgusta 2007.
Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective in replacing the patient's antibodies. 
Ker je ta vrednost nižja od vnaprej določene mejne vrednosti, enake eni okužbi na leto, to kaže, da je zdravilo učinkovito pri nadomeščanju bolnikovih protiteles.
It contains immunoglobulin G (IgG), which is a type of antibody. 
Ta vsebuje imunoglobulin G (IgG), ki je vrsta protitelesa.
The main measure of effectiveness was the highest blood platelet level that was achieved during the three-month study. 
Glavno merilo učinkovitosti je bila najvišja koncentracija trombocitov v krvi, dosežena med trimesečno študijo.
The full EPAR for Flebogamma DIF 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 Flebogamma DIF je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In the first study, involving 46 patients with PID, the medicine was infused every 21 to 28 days. 
V prvi študiji, v katero je bilo vključenih 46 bolnikov s sindromom primarne imunske pomanjkljivosti, je bilo zdravilo infundirano vsakih 21 do 28 dni.
They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases. 
Odobrena so lahko tudi za zdravljenje bolnikov z Guillain-Barréjevim sindromom, bolnikov s Kawasakijevim sindromom ter bolnikov, pri katerih je bila izvedena presaditev krvotvornih matičnih celic, ne da bi bilo treba za te bolezni izvajati posebne študije.
This is a summary of the European public assessment report (EPAR) for Flebogamma DIF. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Flebogamma DIF.
• Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body; 
• Guillain-Barréjevega sindroma, ki povzroča večkratna vnetja živcev v telesu;
Therefore, the CHMP concluded that Flebogamma DIF's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zato zaključil, da so koristi zdravila Flebogamma DIF večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Flebogamma DIF is used in patients who need more antibodies in their blood to help fight infections and other diseases. 
Zdravilo Flebogamma DIF se uporablja pri bolnikih, ki potrebujejo več protiteles v krvi, da jim pomagajo pri premagovanju okužb in drugih bolezni.
The name of the medicine was changed to Flebogamma DIF on 2 September 2010. 
Ime zdravila je bilo 2. septembra 2010 spremenjeno v Flebogamma DIF.
Flebogamma DIF was not compared with any other treatment in either study. 
Zdravila Flebogamma DIF v nobeni študiji niso primerjali s kakim drugim zdravljenjem.
• Acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent infections. 
• sindroma pridobljene imunske pomanjkljivosti (aidsa) pri otrocih, ki so se z virusom HIV okužili ob rojstvu in imajo pogoste okužbe.
As human normal immunoglobulin has been used to treat these diseases for some time, only two small studies were needed to establish the effectiveness and safety of Flebogamma DIF in patients. 
Ker se humani normalni imunoglobulin že dlje časa uporablja za zdravljenje teh bolezni, sta za potrditev učinkovitosti in varnosti zdravila Flebogamma DIF pri bolnikih zadostovali le dve manjši študiji.
For more information about treatment with Flebogamma DIF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Flebogamma DIF preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.