natgillin/translations-raw huggingface dataset:
It is used in adults with type 2 diabetes to control their blood glucose (sugar) level. 
Uporablja se pri odraslih s sladkorno boleznijo tipa 2 za uravnavanje ravni glukoze (sladkorja) v krvi.
In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. 
V vseh omenjenih študijah je bila glavno merilo učinkovitosti raven glikoziliranega hemoglobina v krvi (HbA1c), ki odraža uspešnost uravnavanja glukoze v krvi.
Invokana is a diabetes medicine that contains the active substance canagliflozin. 
Invokana je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilno učinkovino kanagliflozin.
• Invokana was also shown to be at least as effective as the diabetes medicines glimepiride and sitagliptin after 52 weeks of treatment. 
• zdravilo Invokana je bilo po 52 tednih zdravljenja vsaj tako učinkovito kot zdravili za zdravljenje sladkorne bolezni glimepirid in sitagliptin;
Invokana was shown to be more effective than placebo, and at least as effective as comparator medicines, at reducing the levels of HbA1c when used alone and in combination with other diabetes medicines: 
Zdravilo Invokana se je pri znižanju ravni HbA1c izkazalo za učinkovitejše od placeba in vsaj tako učinkovito kot primerjalna zdravila, kadar so ga uporabili kot samostojno zdravilo ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni:
Invokana can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of the diabetes. 
Zdravilo Invokana se lahko uporablja tudi kot dodatek k drugim zdravilom za zdravljenje sladkorne bolezni, vključno z insulinom, kadar ta zdravila skupaj s telesno dejavnostjo in dieto ne zagotavljajo zadostnega nadzora nad sladkorno boleznijo.
Three studies looked at Invokana when used as add-on to one other diabetes medicine (metformin or insulin), and three further studies looked at Invokana when used as add-on to two other diabetes medicines (including metformin), when these medicines together with exercise and diet were not providing adequate control of the diabetes. 
V treh študijah so proučevali zdravilo Invokana, uporabljeno kot dodatek k drugemu zdravilu za sladkorno bolezen (metforminu ali insulinu), v preostalih treh študijah pa so proučevali zdravilo Invokana, uporabljeno kot dodatek k dvema drugima zdraviloma za sladkorno bolezen (vključno z metforminom) pri bolnikih, pri katerih ta zdravila skupaj s telesno dejavnostjo in dieto niso zagotovila zadostne urejenosti sladkorne bolezni.
The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called sodium‑glucose co‑transporter 2 (SGLT2). 
Zdravilna učinkovina v zdravilu Invokana, kanagliflozin, deluje tako, da zavira beljakovino v ledvicah, imenovano natrijev glukozni koprenašalec 2 (SGLT2).
How is Invokana used? 
Kako se zdravilo Invokana uporablja?
Invokana can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine). 
Zdravilo Invokana se lahko uporablja kot samostojno zdravilo pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo, metformin (drugo zdravilo za sladkorno bolezen) pa zanje ni primeren.
One of the studies compared Invokana with placebo (a dummy treatment) when used alone in patients whose blood glucose levels were not satisfactorily controlled on diet and exercise alone. 
V eni od študij so primerjali zdravilo Invokana in placebo (zdravilo brez zdravilne učinkovine), ki so ju kot samostojni zdravili dajali bolnikom, pri katerih ravni glukoze v krvi ni bilo mogoče zadovoljivo uravnavati samo z dieto in telesno dejavnostjo.
By blocking the action of SGLT2, Invokana causes more glucose to be removed via the urine, thereby reducing the levels of glucose in the blood. 
Zdravilo Invokana z zaviranjem delovanja prenašalca SGLT2 povzroči večje izločanje glukoze z urinom, kar zniža ravni glukoze v krvi.
• The study in patients with moderately reduced kidney function showed that the effects of Invokana were reduced in these patients, but still clinically relevant: the reduction of HbA1c levels compared with placebo was 0.30% with the 100 mg dose. 
• študija pri bolnikih z zmerno zmanjšanim delovanjem ledvic je pokazala, da je bila učinkovitost zdravila Invokana pri teh bolnikih manjša, vendar še vedno klinično pomembna: pri uporabi 100-miligramskega odmerka so se ravni HbA1c znižale za 0,30 % več kot pri placebu;
• Across the studies that looked at Invokana when used as add-on to one or two other diabetes medicines, the reductions in HbA1c levels after 26 weeks compared with placebo ranged from 0.76% to 0.92% with the 300 mg dose, and from 0.62% to 0.74% with the 100 mg dose. 
• v študijah, v katerih so proučevali zdravilo Invokana, uporabljeno kot dodatek k enemu ali dvema drugima zdraviloma za zdravljenje sladkorne bolezni, so se po 26 tednih ravni HbA1c v primerjavi s placebom znižale za 0,76 % do 0,92 % pri 300-miligramskem odmerku in za 0,62 % do 0,74 % pri 100-miligramskem odmerku;
• The study in older patients showed that Invokana had clinically relevant effects also in patients above 75 years of age with HbA1c reductions compared with placebo of 0.70% and 0.57% with the 300 mg and 100 mg doses, respectively. 
• študija pri starejših bolnikih je pokazala, da je imelo zdravilo Invokana klinično pomembne učinke tudi pri bolnikih, starejših od 75 let, pri katerih so se ravni HbA1c v primerjavi s placebom znižale za 0,70 % pri 300-miligramskem odmerku in za 0,57 % pri 100-miligramskem odmerku.
• When Invokana was used on its own at a dose of 100 mg, it decreased HbA1c levels by 0.91% more than placebo after 26 weeks, while the 300 mg dose led to a reduction of 1.16% more than placebo. 
• pri uporabi 100-miligramskega odmerka zdravila Invokana v monoterapiji so se po 26 tednih ravni HbA1c znižale za 0,91 % več kot pri placebu, pri uporabi 300-miligramskega odmerka pa za 1,16 % več kot pri placebu;
• When Invokana was used as add-on to insulin at a dose of 300 mg, it decreased HbA1c levels by 0.73% more than placebo after 18 weeks, while the 100 mg dose led to a reduction of 0.65% more than placebo. 
• pri uporabi 300-miligramskega odmerka zdravila Invokana kot dodatka k insulinu so se po 18 tednih ravni HbA1c znižale za 0,73 % več kot pri placebu, pri uporabi 100-miligramskega odmerka pa za 0,65 % več kot pri placebu;
How does Invokana work? 
Kako zdravilo Invokana deluje?
Intravenous use vial (glass) closed by a Teflon faced grey chlorobutyl rubber stopper 
Izmišljeno ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina Velikost pakiranja viala (steklo) zaprta z zamaškom iz sive klorbutilne gume prevlečene s teflonom viala (steklo) zaprta z neprevlečenim sivim brombutilnim gumijastim zamaškom
EU (MA) Number Invented name 
Številka (EU) dovoljenja za promet
July 2014; 109(7):950-66. 
Julij 2014; 109(7): 950-66.
More frequent monitoring than monthly is not considered practically feasible. 
Pogostejše spremljanje kot enkrat na mesec ni praktično izvedljivo.
Lancet, 27 January 2001; 357(9252):293-8. 
Lancet, 27. januar 2001; 357(9252): 293-8.
Of note, menopause constitutes a natural end to the need for treatment. 
Omeniti je treba, da menopavza predstavlja naraven konec potrebe po zdravljenju.
The PRAC also considered the views expressed by experts at an ad hoc expert group meeting. 
Odbor PRAC je upošteval tudi stališča, ki so jih izrazili strokovnjaki na sestanku ad hoc skupine strokovnjakov;
The PRAC was also of the view that the reported cases of liver injury should be closely monitored; to this effect a targeted follow up questionnaire has been included in a revised risk management plan (RMP). 
Odbor PRAC je tudi menil, da je treba prijavljene primere poškodbe jeter natančno spremljati; v ta namen je bil v revidirani načrt za obvladovanje tveganja (RMP) vključen ciljni vprašalnik za spremljanje.
On 30 November 2017, the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Evropska komisija je zato 30. novembra 2017 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgornjih pomislekov na razmerje med tveganji in koristmi zdravila Esmya ter izda priporočilo o tem, ali naj se zadevna dovoljenja za promet z zdravilom ohranijo, spremenijo, umaknejo ali razveljavijo.
Uterine fibroids are the single most common indication for hysterectomy1. 
Maternični fibroidi so najpogostejša indikacija za histerektomijo1.
The views expressed by ad-hoc experts consulted during the course of the procedure were also considered. 
Upoštevana so bila tudi stališča ad hoc strokovnjakov, s katerimi so bila med postopkom opravljena posvetovanja.
Hysterectomy is a very common curative surgical procedure within gynaecology associated with a low mortality (mortality figures quoted range from 0.02% to 0.17%) and a low risk of intra- or postoperative complications (quoted from 5% to 8%). 
Histerektomija je zelo pogost kurativni kirurški poseg v ginekologiji, povezan z nizko stopnjo umrljivosti (navedene stopnje umrljivosti segajo od 0,02 do 0,17 %) in majhnim tveganjem za med- ali pooperacijske zaplete (navedene stopnje segajo od 5 do 8 %).
Other surgical treatments such as myomectomy and uterine artery embolisation are also valid alternatives to hysterectomy, but they are not suitable for all cases and are also associated with a higher rate for complications than hysterectomy. 
Druge vrste kirurškega zdravljenja, npr. miomektomija in embolizacija maternične arterije, so prav tako ustrezne alternative histerektomiji, vendar niso primerne za vse primere in so tudi povezane z višjo stopnjo zapletov kot histerektomija.
Guidance on treatment initiation and discontinuation based on the results of these tests are included in the product information. 
Navodila o uvedbi in prenehanja zdravljenja na podlagi rezultatov teh preiskav so vključena v informacije o zdravilu.
Acknowledging the uncertainty regarding background incidence and the information in the reported cases, the seriousness of the reported cases raises concern. 
Ob priznavanju nejasnosti o osnovni incidenci in informacij v primerih, o katerih so poročali, resnost prijavljenih primerov vzbuja zaskrbljenost.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (ulipristal acetate). 
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravilo Esmya (ulipristalacetat);
However, it is recognised that a surgical treatment is not suitable for all women, due to their medical history, co-morbidities or willingness to preserve fertility. 
Priznava pa se, da kirurško zdravljenje ni primerno za vse ženske, in sicer zaradi njihove anamneze, soobolenj ali želje po ohranitvi plodnosti.
The MAH should implement these questionnaires and their results should be discussed in future periodic safety update reports (PSURs). 
Imetnik dovoljenja za promet z zdravilom mora uvesti te vprašalnike, o njihovih rezultatih pa je treba razpravljati v prihodnjih redno posodobljenih poročilih o varnosti zdravila (PSUR).
In addition, the existing physician's guide to prescribing should be updated accordingly. 
Poleg tega je treba ustrezno posodobiti obstoječa navodila o predpisovanju za zdravnike;
This last indication was authorised based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies. 
Ta zadnja indikacija je bila odobrena na podlagi rezultatov druge študije, ki je zagotovila podatke za do štiri trimesečna intermitentna zdravljenja z ulipristalacetatom, ter podatkov o večkratnih zdravljenjih iz prejšnjih študij.
However, there is sufficient information from these cases to conclude that there is at least a reasonable possibility that Esmya may infrequently contribute to hepatic injury. 
Informacije, pridobljene v teh primerih, pa zadostujejo za zaključek, da obstaja vsaj razumna možnost, da lahko zdravilo Esmya redko prispeva k poškodbi jeter.
This is the rationale that justifies the mandatory liver monitoring within the first 2 treatment courses, while during later courses, monitoring is recommended as clinically indicated. 
To je razlog, ki utemeljuje obvezno spremljanje delovanja jeter pri prvih dveh ciklusih zdravljenja, pri poznejših ciklusih pa se spremljanje priporoča v skladu s kliničnimi indikacijami.
The available data raise serious concerns, and warrant risk minimisation measures to be taken. 
Razpoložljivi podatki vzbujajo resne pomisleke in zahtevajo sprejetje ukrepov za zmanjševanje tveganja.
Given the estimated exposure to Esmya of approximately 200,000 to 275,000 patient-years, the number of cases of serious liver injury leading to liver transplantation appears higher than expected, although background incidence on drug induced liver injury is uncertain. 
Glede na ocenjeno izpostavljenost zdravilu Esmya približno od 200 000 do 275 000 bolnikovih let se zdi število primerov resne poškodbe jeter, ki je privedla do presaditve jeter, večje od pričakovanega, čeprav je osnovna incidenca z zdravili povzročene poškodbe jeter nejasna.
The existing educational material (physician's guide) should also be updated with these recommendations, and the issuing of a Direct Healthcare Professional Communication (DHPC) is also considered appropriate, to inform healthcare professionals of the recommendations of the present review. 
Ta priporočila je treba vključiti tudi v obstoječe izobraževalno gradivo (navodila za zdravnike), smiselna pa je tudi izdaja neposrednega obvestila za zdravstvene delavce (DHPC), da bi zdravstvene delavce seznanili s priporočili tega pregleda.
Data from clinical trials, non-clinical studies including in vitro testing were also reviewed. 
Pregledani so bili tudi podatki iz kliničnih preskušanj in nekliničnih študij, vključno s preskušanjem in vitro.
Although uterine fibroids are benign, moderate to severe forms are often associated with significant morbidity, such as heavy bleeding, anaemia, pain, discomfort and reduced quality of life. 
Čeprav so benigni, so zmerne do hude oblike pogosto povezane s pomembno obolevnostjo, npr. hudimi krvavitvami, anemijo, bolečinami, neugodjem in zmanjšano kakovostjo življenja.
However, due to exclusion criteria covering patients with elevated transaminases, or other signs of liver disease, as well as the limited size of the safety database in these studies, the absence of findings in clinical trials has to be interpreted with caution. 
Vendar je treba zaradi izključitvenih meril, na podlagi katerih so bile izključene bolnice z zvišanimi ravnmi transaminaz ali drugimi znaki bolezni jeter, ter omejene velikosti zbirke podatkov o varnosti pri teh študijah odsotnost ugotovitev v kliničnih preskušanjih razlagati pravilno.
The pre-operative treatment may be considered of least benefit as it reflects a situation when surgery is planned; however reductions in myoma size as well as reductions in blood loss and anaemia are considered of clinical significance. 
Predoperacijsko zdravljenje se lahko šteje za najmanj koristno, saj izraža situacijo, ko je operacija načrtovana; zmanjšanje velikosti miomov, manjša izguba krvi in znižanje stopnje anemije pa se štejejo za klinično pomembne.
Taking into account the experts' views on the topic, and after a thorough review of the available data, PRAC considered that the following risk minimisation measures should be recommended. 
Ob upoštevanju stališča strokovnjakov o tej temi in temeljitem pregledu razpoložljivih podatkov je odbor PRAC presodil, da je treba priporočiti naslednje ukrepe za zmanjševanje tveganja.
• The PRAC was also of the opinion that mechanistic studies should be conducted, to further investigate a possible mechanism for hepatic toxicity. 
• odbor PRAC je menil tudi, da je treba opraviti mehanistične študije za nadaljnjo proučitev mogočega mehanizma hepatotoksičnosti.
The PRAC considers it appropriate to also monitor liver function 2 to 4 weeks after the treatment has stopped, since for some of the reported cases, liver injury was reported a few weeks after the discontinuation of the treatment. 
Odbor PRAC meni, da je delovanje jeter smiselno preveriti tudi po dveh do štirih tednih po koncu zdravljenja, saj je bila pri nekaterih prijavljenih primerih poškodba jeter prijavljena nekaj tednov po prenehanju zdravljenja.
Treatment should be stopped in patients showing signs or symptoms compatible with liver injury and the patient should be investigated immediately. 
Zdravljenje je treba prekiniti pri vseh bolnicah, pri katerih se pokažejo znaki ali simptomi, skladni s poškodbo jeter, bolnico pa je treba takoj preiskati;
Through a pronounced reduction of bleeding, reducing anaemia and related symptoms, Esmya has been demonstrated to rapidly contribute to the improvement of the quality of life in patients who did not undertake a surgical treatment. 
Z izrazitim zmanjševanjem krvavitve, anemije in povezanih simptomov je bilo za zdravilo Esmya dokazano, da hitro prispeva k izboljševanju kakovosti življenja pri bolnicah, ki niso opravile kirurškega zdravljenja.
In order to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures, a patient card should be issued. 
Da bi zagotovili, da so bolnice ustrezno poučene o mogočih tveganjih poškodbe jeter in uvedenih ukrepih za zmanjševanje tveganja, je treba izdati kartico bolnika.
In view of the existing concerns on recently reported cases of serious liver injury and acknowledging that the magnitude of the benefit differs for different clinical situations, the PRAC considered that the use of Esmya should be limited. 
Glede na zaskrbljenost v povezavi z nedavno prijavljenimi primeri resne poškodbe jeter in ob priznavanju, da je obseg koristi različen pri različnih kliničnih situacijah, je odbor PRAC menil, da bi bilo treba uporabo zdravila Esmya omejiti.
Taking into account the clinical utility of Esmya in the intermittent treatment indication, where no other long-term pharmacological alternative is authorised, this indication should be limited to adult women of reproductive age who are not eligible for surgery. 
Ob upoštevanju klinične uporabnosti zdravila Esmya pri indikaciji za intermitentno zdravljenje, pri kateri ni odobrena nobena druga dolgoročna farmakološka alternativa, je treba to indikacijo omejiti na odrasle ženske v rodni dobi, ki niso primerne za operacijo.
In addition, the PRAC considers that warnings regarding monitoring and stopping criteria should be implemented, in order to identify a hepatic injury of any origin before the patient experiences symptoms, which could reduce the risk of developing serious injury. 
Poleg tega je odbor PRAC presodil, da je treba uvesti opozorila o spremljanju in ustavitvi, da bi lahko prepoznali poškodbo jeter kakršnega koli izvora pred pojavom simptomov pri bolnicah, s čimer bi lahko zmanjšali tveganje za nastanek resne poškodbe.
Based on the safety findings and possible mechanism of action, the experts of the ad hoc experts group were of the view that a causal association between Esmya and severe liver injury is plausible. 
Na podlagi izsledkov o varnosti in mogočega mehanizma delovanja so strokovnjaki iz ad hoc skupine strokovnjakov menili, da je vzročno razmerje med zdravilom Esmya in hudo poškodbo jeter verjetno.
PRAC considered all the data submitted by the MAH, as well as data provided by the National Competent Authorities including follow-up information on cases of liver transplantation. 
Odbor PRAC je proučil vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ter podatke, ki so jih predložili pristojni nacionalni organi, vključno z nadaljnjimi informacijami o primerih presaditve jeter.
Since a possible causal relationship between Esmya and acute liver failure could not be ruled out, these cases prompted an in-depth investigation of this risk and its impact on the benefit risk balance of Esmya. 
Ker ni bilo mogoče izključiti vzročne zveze med zdravilom Esmya in akutno odpovedjo jeter, so ti primeri sprožili poglobljeno raziskavo tega tveganja in njegovega vpliva na razmerje med tveganji in koristmi zdravila Esmya.
It was noted that no signal of hepatic toxicity was identified from non-clinical or clinical studies on Esmya. 
Ugotovljeno je bilo, da iz nekliničnih ali kliničnih študij zdravila Esmya ni bilo mogoče prepoznati nobenega signala hepatotoksičnosti.
Usually, DILI events occur within the first 6 months after starting a new medication2. 
Običajno se z zdravili povzročene poškodbe jeter pojavijo v prvih šestih mesecih po uvedbi novega zdravila2.
While uncertainties around causality remain, PRAC recognised the very serious outcome of the reported cases of liver injury. 
Čeprav nejasnosti o vzročni zvezi ostajajo, je odbor PRAC prepoznal zelo resen izid prijavljenih primerov poškodbe jeter.
Of note, the development of drug induced liver injury generally tends to be a gradual phenomenon, developing over 1-4 weeks. 
Omeniti je treba, da je z zdravili povzročena poškodba jeter na splošno postopen pojav, ki nastane v enem do štirih tednih.
Uterine fibroids are the most common female pelvic tumour. 
Maternični fibroidi so najpogostejši ženski medenični tumor.
Patients should be informed of potential adverse reactions related to liver that could be caused by the use of Esmya, as well as on the need to warn their physicians on any liver problems they may have. 
Bolnice je treba poučiti o mogočih neželenih učinkih, povezanih z jetri, ki bi jih lahko povzročila uporaba zdravila Esmya, ter o potrebi po tem, da zdravnike opozorijo na težave z jetri, ki jih morda imajo.
In the view of the remaining uncertainties, the PRAC is of the view that further data on Esmya and liver injury should be collected. 
Glede na preostale nejasnosti odbor PRAC meni, da je treba zbrati nadaljnje podatke o zdravilu Esmya in poškodbi jeter.
• The PRAC also found it necessary to introduce a patient card to be provided in each package of Esmya, to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures. 
• odbor PRAC je tudi presodil, da je treba k vsakemu pakiranju zdravila Esmya dodati kartico bolnika, da bi zagotovili, da so bolnice ustrezno poučene o mogočih tveganjih poškodbe jeter in uvedenih ukrepih za zmanjševanje tveganja.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Esmya (ulipristal acetate). 
Odbor zato priporoča spremembo pogojev dovoljenja za promet z zdravilom Esmya (ulipristalacetat).
In particular, there was a consensus among hepatologists that in at least 2 cases reported, a relation with the use of Esmya could be observed. 
Hepatologi so se zlasti strinjali, da je bilo v vsaj dveh prijavljenih primerih mogoče ugotoviti povezavo z uporabo zdravila Esmya.
Therefore, liver function tests should be performed before starting treatment with Esmya, monthly during the first two courses of treatment as well as two to four weeks after the discontinuation of the treatment. 
Preiskave jetrne funkcije je zato treba opraviti pred začetkom zdravljenja z zdravilom Esmya, vsak mesec pri prvih dveh ciklusih zdravljenja in v dveh do štirih tednih po prenehanju zdravljenja.