natgillin/translations-raw huggingface dataset:
What benefits of Qtern have been shown in studies? 
Kakšne koristi je zdravilo Qtern izkazalo v študijah?
What are the risks associated with Qtern? 
Kakšna tveganja so povezana z zdravilom Qtern?
Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes. 
Dapagliflozin so v kombinaciji s saksagliptinom (kar je enaka kombinacija kot v zdravilu Qtern) ocenjevali v treh glavnih študijah, ki so vključevale 1 169 odraslih s sladkorno boleznijo tipa 2.
Why is Qtern approved? 
Zakaj je bilo zdravilo Qtern odobreno?
What is Qtern and what is it used for? 
Kaj je zdravilo Qtern in za kaj se uporablja?
The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually. 
Odbor CHMP je zato presodil, da se sme zdravilo Qtern uporabljati samo pri bolnikih, ki že prejemajo vsaj eno učinkovino, da ne pride do čezmernega zdravljenja in da se lahko presodi vrednost vsake učinkovine posebej.
• saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. 
• saksagliptin je zaviralec dipeptidil-peptidaze-4 (DPP-4).
Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients. 
Čeprav obe sestavini zdravila Qtern prispevata k zniževanju ravni glukoze v krvi, se učinki vsake posebej med bolniki lahko razlikujejo.
On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea. 
Na podlagi predhodnih študij s posameznimi učinkovinami zdravila Qtern, uporabljenimi skupaj s sulfonilsečnino, je odbor CHMP odobril tudi kombinacijo zdravila Qtern s sulfonilsečnino.
For more information about treatment with Qtern, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Qtern preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription. 
Zdravilo Qtern je na voljo v obliki tablet (5 mg saksagliptina in 10 mg dapagliflozina) ter se predpisuje in izdaja le na recept.
The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels). 
Najpogostejši neželeni učinki zdravila Qtern (ki lahko prizadenejo več kot 1 osebo od 10) so okužbe zgornjih dihal (kot so okužbe nosu in grla) in hipoglikemija (nizke ravni glukoze v krvi).
Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor. 
Zdravila Qtern ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) saksagliptin, dapagliflozin ali katero koli drugo sestavino zdravila ali pri katerih se je kdaj v preteklosti pojavila huda alergijska reakcija na zaviralec DPP-4 ali SGLT2.
For practical information about using Qtern, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Qtern naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels of glucose in the blood or when the body is unable to respond to insulin effectively. 
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri se telo ne more učinkovito odzvati nanj.
The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. 
Glavno merilo učinkovitosti je bila sprememba ravni snovi v krvi, ki se imenuje glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja, kar označuje uspešnost uravnavanja glukoze v krvi.
The company also provided studies that were used in the authorisation of Forxiga and Onglyza where saxagliptin or dapagliflozin were used together with a sulphonylurea. 
Družba je prav tako predložila študije, ki so bile uporabljene pri odobritvi zdravil Forxiga in Onglyza, pri katerih sta se saksagliptin oziroma dapagliflozin uporabljala skupaj s sulfonilsečnino.
For the full list of all side effects reported with Qtern, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Qtern, glejte navodilo za uporabo.
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes. 
Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k obvladovanju sladkorne bolezni tipa 2.
Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar) levels. 
Zdravilo Qtern se uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2 za izboljšanje uravnavanja ravni glukoze (sladkorja) v krvi.
How does Qtern work? 
Kako zdravilo Qtern deluje?
• dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). 
• dapagliflozin zavira beljakovino v ledvicah, imenovano natrij-glukozni soprenašalec 2 (SGLT2).
Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors. 
Kar zadeva varnostni profil, so bolniki zdravilo Qtern dobro prenašali, neželeni učinki pa so značilni za zaviralce SGLT2 in DDP-4.
Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with: 
Zdravilo Qtern se uporablja pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče v zadostni meri uravnavati:
The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin alone. 
Prva študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati samo z metforminom.
It contains the active substances saxagliptin and dapagliflozin. 
Vsebuje zdravilni učinkovini saksagliptin in dapagliflozin.
Results showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin. 
Rezultati so pokazali, da se je raven HbA1c ob hkratnem jemanju saksagliptina in dapagliflozina z metforminom po 24 tednih znižala za 1,5 odstotne točke, v primerjavi z znižanjem za 0,9 odstotne točke pri jemanju saksagliptina in metformina ter za 1,2 odstotne točke pri jemanju dapagliflozina in metformina.
By blocking the action of SGLT2, dapagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood. 
Dapagliflozin z zaviranjem delovanja prenašalca SGLT2 povzroči večje izločanje glukoze prek ledvic z urinom, kar zniža ravni glukoze v krvi.
A further study, which included patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin. 
Še ena študija, ki je vključevala bolnike, pri katerih bolezen z metforminom in saksagliptinom ni bila uravnana, je pokazala, da se je po dodajanju dapagliflozina zdravljenju s saksagliptinom in metforminom v obdobju 24 tednov raven HbA1c znižala za 0,8 odstotne točke, v primerjavi z znižanjem za 0,1 odstotne točke, ko so zdravljenju s saksagliptinom in metforminom dodajali placebo.
• metformin, a sulphonylurea and one of the components of Qtern. 
• z metforminom, sulfonilsečnino in eno od učinkovin v zdravilu Qtern.
• metformin and one of the components of Qtern; 
• z metforminom in eno od učinkovin v zdravilu Qtern;
How is Qtern used? 
Kako se zdravilo Qtern uporablja?
The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin. 
Druga študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in dapagliflozinom.
• a sulphonylurea and one of the components of Qtern; 
• s sulfonilsečnino in eno od učinkovin v zdravilu Qtern;
The CHMP also considered Qtern to be effective at controlling blood glucose levels when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or dapagliflozin. 
Prav tako je menil, da je zdravilo Qtern učinkovito pri uravnavanju ravni glukoze v krvi, kadar se uporablja pri bolnikih, pri katerih bolezen ni v zadostni meri urejena z metforminom v kombinaciji bodisi s saksagliptinom bodisi z dapagliflozinom.
The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken as separate tablets. 
Zaključil je, da je zdravilo Qtern učinkovito, če se uporablja namesto ločenih tablet saksagliptina in dapagliflozina.
Results showed that adding saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with dapagliflozin and metformin. 
Rezultati so pokazali, da se je po dodajanju saksagliptina zdravljenju z dapagliflozinom in metforminom v obdobju 24 tednov raven HbA1c znižala za 0,5 odstotne točke, v primerjavi z znižanjem za 0,2 odstotne točke, ko so zdravljenju z dapagliflozinom in metforminom dodajali placebo (zdravilo brez zdravilne učinkovine).
Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets. 
Zdravilo Qtern se lahko uporablja tudi namesto ločenih tablet saksagliptina in dapagliflozina.
Invented name Strength Pharmaceutical Form Route of Administration 
(Izmišljeno) ime Jakost
Packaging Content 
Stična ovojnina Vsebina (koncentracija)
4 (4 x 1) vials + 4 (4 x 1) ampoules (multipack) 10 (10 x 1) vials + 10 (10 x 1) ampoules (multipack) 1 pre-filled syringe 
4 (4 x 1) viale + 4 (4 x 1) ampule (skupno pakiranje)
6 (6 x 1) pre-filled syringes (multipack) 
10 (10 x 1) napolnjenih injekcijskih brizg (skupno pakiranje)
• The implementation of the 7-day prescription validity rule, in order not to impact on existing national legislation where 7 days validity exists; 
• uvedba pravila 7-dnevne veljavnosti recepta, ki ne bo vplivala na obstoječo nacionalno zakonodajo, kjer obstaja 7-dnevna veljavnost;
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for retinoid-containing medicinal products. 
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo retinoide;
• Pharmacist checklist; 
• farmacevtov kontrolni seznam;
Pregnancy is an absolute contraindication for all oral retinoids in the EU. 
Nosečnost je absolutna kontraindikacija za vse peroralne retinoide v EU.
Furthermore, the PRAC was requested to review any additional risk minimisation measures to ensure that these are optimal in terms of provision of information and delivery of effective risk management that is subject to appropriate monitoring. 
Odbor PRAC je bil zaprošen tudi, naj pregleda vse dodatne ukrepe za zmanjšanje tveganja in zagotovi, da so ti ukrepi optimalni v smislu zagotavljanja informacij in učinkovitega obvladovanja tveganja, za katerega se izvaja ustrezno spremljanje.
However, there was a consensus that several other factors may contribute to an increased systemic exposure and therefore the risk cannot be excluded. 
Soglašali pa so, da k povečani sistemski izpostavljenost lahko prispevajo drugi dejavniki, zato tveganja ni mogoče izključiti.
The CHMP clarified that the communication plan should be modified to say ‘healthcare professionals who may be involved in the management of patients treated with retinoids'. 
Odbor CHMP je pojasnil, da je treba načrt obveščanja spremeniti tako, da bo navajal „zdravstveni delavci, ki utegnejo biti vključeni v obravnavo bolnikov, zdravljenih z retinoidi“.
The PRAC has also recommended that educational materials be distributed via electronic channels such as QR codes, and websites to make better use of the existing technology bearing in mind the young patient population using these products. 
Odbor PRAC je priporočil tudi, naj se izobraževalna gradiva distribuirajo po elektronskih kanalih, kot so QR-kode in spletna mesta, s čimer se bolje izkoristi obstoječa tehnologija z mislijo na mlajšo populacijo bolnikov, ki uporabljajo ta zdravila.
Therefore, the PRAC agrees that all oral retinoids should contain a warning about the potential risk of neuropsychiatric disorders in line with some key principles. 
Zato se odbor PRAC strinja, da morajo vsi peroralni retinoidi vsebovati opozorilo o možnem tveganju za nevropsihiatrične motnje v skladu z določenimi ključnimi načeli.
The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU. 
Odbor PRAC je ugotovil, da kljub uvedbi ukrepov za preprečevanje nosečnosti, vključno s programi preprečevanja nosečnosti, v EU še naprej poročajo o primerih nosečnosti med zdravljenjem s peroralnimi retinoidi.
Although the underlying risk of psychiatric disorders within the patient populations can be significant, it is advisable that patients taking oral retinoids are warned about the potential risk of psychiatric reactions and the signs and symptoms to look out for. 
Čeprav je osnovno tveganje za psihiatrične motnje znotraj populacij bolnikov lahko precejšnje, je priporočljivo, da se bolnike, ki jemljejo peroralne retinoide, opozori o možnem tveganju za psihiatrične učinke ter o znakih in simptomih, na katere morajo biti pozorni.
The animal reproductive toxicity data for the oral retinoids demonstrate a typical pattern of retinoid embryopathy. 
Podatki o reproduktivni toksičnosti peroralnih retinoidov pri živalih kažejo značilen vzorec retinoidne embriopatije.
The data support that for isotretinoin and alitretinoin the information in section 4.4 and 4.8, of the SmPC, should be in line with the agreed outcome of the 2003 Art 30 referral for isotretinoin. 
Podatki so v prid dejstvu, da morajo biti informacije za izotretinoin in alitretinoin v poglavjih 4.4 in 4.8 povzetka glavnih značilnosti zdravila v skladu z dogovorjenim izidom napotitve v skladu s členom 30 iz leta 2003 za izotretinoin.
The review confirms the already known teratogenic risks associated with the use of oral retinoids in pregnant women. 
Pregled potrjuje že znana tveganja za teratogenost, povezana z uporabo peroralnih retinoidov pri nosečnicah.
Studies that examine the effects of human pregnancy on systemic absorption of topical retinoids are also lacking. 
Prav tako ni študij, ki bi preučevale vpliv nosečnosti pri ljudeh na sistemsko absorpcijo lokalnih retinoidov.
However, given that humans are the most sensitive species to retinoid embryopathy and that several other factors may contribute to an increased systemic exposure, such as excessive use and damaged skin barrier, the PRAC agreed that the teratogenic risk cannot be completely excluded. 
Vendar glede na dejstvo, da smo ljudje najobčutljivejša vrsta za retinoidno embriopatijo in da k povečani sistemski izpostavljenosti lahko prispeva še več drugih dejavnikov, kot sta čezmerna uporaba in poškodovana kožna pregrada, se je odbor PRAC strinjal, da tveganja za teratogenost ni mogoče popolnoma izključiti.
These include a patient reminder card, physician checklist/acknowledgement form and pharmacist checklist ensuring the understanding and the awareness of prescribers and patients on the risks. 
Ti vključujejo opozorilno kartico za bolnika, zdravnikov kontrolni seznam/potrditveni obrazec in farmacevtov kontrolni seznam, ki zagotavljajo, da predpisovalci in bolniki razumejo tveganja in se jih zavedajo.
Given that humans are the most sensitive species with respect to retinoid toxicity and considering the limitations of the available data with respect to understanding the systemic absorption and also the possible risks, the PRAC, considers that it is appropriate to take a very precautious approach. 
Glede na to, da smo ljudje najobčutljivejša vrsta, kar zadeva toksičnost retinoidov, in glede na omejenost razpoložljivih podatkov v zvezi z razumevanjem sistemske absorpcije in morebitnih tveganj odbor PRAC meni, da je primerno uporabiti previden pristop.
On 7 July 2016 the United Kingdom triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to review the routine risk minimisation measures in place for the oral and topical retinoids to ensure the available data and the risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed within the product information where appropriate and justified by data. 
Združeno kraljestvo je 7. julija 2016 sprožilo napotitev v skladu s členom 31 Direktive 2001/83/ES zaradi farmakovigilančnih podatkov in odbor PRAC zaprosilo, naj pregleda rutinske ukrepe za zmanjšanje tveganja, vzpostavljene za peroralne in lokalne retinoide, da se zagotovi, da so razpoložljivi podatki in tveganja, povezana z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami, natančno in skladno obravnavani v informacijah o zdravilu, kadar je to primerno, in utemeljeni s podatki.
The PRAC acknowledged that the implementation of the following elements of the PPP need to be considered and agreed at national level to account for the different healthcare systems in the EU: 
Odbor PRAC je potrdil, da je treba upoštevati uvedbo naslednjih elementov programov preprečevanja nosečnosti in se o njih dogovoriti na nacionalni ravni, saj se zdravstveni sistemi v EU med seboj razlikujejo:
The PRAC recognizes that the available data in relation to oral retinoids and the occurrence of neuropsychiatric disorders have a number of important limitations that preclude the establishment of a clear causal association. 
Odbor PRAC priznava, da imajo razpoložljivi podatki v povezavi s peroralnimi retinoidi in pojavom nevropsihiatričnih motenj številne pomembne omejitve, ki preprečujejo določitev jasne vzročne povezave.
• Patient signature of the physician checklist/acknowledgement form; 
• bolnikov podpis zdravnikovega kontrolnega seznama/potrditvenega obrazca;
The data suggest that the risk of adverse pregnancy outcomes is more strongly associated with the oral retinoids than the topical retinoids. 
Podatki kažejo, da je tveganje za neželene izide nosečnosti močneje povezano s peroralnimi retinoidi kot z lokalnimi retinoidi.
• A direct healthcare professional communication (DHPC) was also considered appropriate for all oral and topical retinoids. 
• tudi neposredna obvestila za zdravstvene delavce so bila ocenjena kot primerna za vse peroralne in lokalne retinoide;
After reviewing all the available data to address the concerns discussed, the PRAC adopted a recommendation on 8 February 2018 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC. 
8. februarja 2018 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES
The PRAC noted the systemic exposure is negligible following topical application of retinoids and that this does not appear to be affected to a clinically significant degree by the severity or extent of skin disease. 
Odbor PRAC je ugotovil, da je sistemska izpostavljenost po lokalni uporabi retinoidov zanemarljiva in da resnost ali obsežnost kožne bolezni nanjo ne vplivata v klinično pomembnem obsegu.
Nevertheless, the PRAC considers that the data from patients presented in case series, spontaneous case reports and individual patients' experiences are considered to be very important. 
spontanih poročilih o primerih in izkušnjah posameznih bolnikov, veljajo za zelo pomembne.
However, taking into account the target patient population, the PRAC recognised the possible underlying risk of psychiatric disorders, and therefore recommended some changes to the product information such as warnings and precautions and so that the current level of available evidence is appropriately reflected. 
upoštevanjem ciljne populacije bolnikov je odbor PRAC priznal, da obstaja možnost osnovnega tveganja za psihiatrične motnje, zato je priporočil spremembe informacij o zdravilu, kot so opozorila in previdnostni ukrepi, tako da bodo odražali trenutno razpoložljive dokaze;
• With regards to the teratogenic risk, the PRAC confirmed that all oral retinoids (acitretin, alitretinoin, bexarotene, isotretinoin and tretinoin) are highly teratogenic and therefore must continue to be contraindicated during pregnancy or in women of child bearing potential unless they are using effective contraception. 
• kar zadeva tveganje za teratogenost, je odbor PRAC potrdil, da so vsi peroralni retinoidi (acitretin, alitretinoin, beksaroten, izotretinoin in tretinoin) zelo teratogeni in morajo biti še naprej kontraindicirani med nosečnostjo in pri ženskah v rodni dobi, razen kadar te uporabljajo učinkovito kontracepcijo.
• The option of a pictogram/symbol to accompany the box warning wording and to be included in the visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product. 
• vključitev preglednice z urnikom obiskov v opozorilno kartico za bolnika; • možnost uporabe piktograma/simbola, ki spremlja opozorilo na škatli in se vključi v vizualni opomnik na zunanji embalaži, da bolnike opozarja o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila.
Compliance with the PPP is crucial to a positive benefit/risk balance for these products; therefore, the adequacy of the pregnancy prevention measures, including PPPs, for the oral retinoids acitretin, alitretinoin and isotretinoin has been reviewed to ensure that the available materials effectively encourage contraception use, regular pregnancy testing and shared responsibility between patients, doctors and pharmacists in adhering to recommendations, and that this is communicated consistently and effectively for all products. 
Skladnost s programi preprečevanja nosečnosti je ključnega pomena za pozitivno razmerje med tveganji in koristmi teh zdravil, zato je bila pregledana ustreznost ukrepov za preprečevanje nosečnosti, vključno s programi preprečevanja nosečnosti, za peroralne retinoide acitretin, alitretinoin in izotretinoin, da se zagotovi, da razpoložljiva gradiva učinkovito spodbujajo uporabo kontracepcije, redno testiranje nosečnosti in skupno odgovornost med bolniki, zdravniki in farmacevti, ter da je obveščanje pri vseh zdravilih skladno in učinkovito.
• With regards to neuropsychiatric disorders, the PRAC noted the limitations of the available data and considered that a clear causal relationship could not be established with the oral retinoids. 
• kar zadeva nevropsihiatrične motnje, je odbor PRAC ugotovil, da so razpoložljivi podatki omejeni, in ocenil, da ni mogoče določiti jasne vzročne povezave s peroralnimi retinoidi.
The PRAC reviewed all available data from pre-clinical studies, pharmacovigilance data, published literature and spontaneous reports on the risks associated with the adverse teratogenic effects and neuropsychiatric disorders of oral and topical retinoids. 
Odbor PRAC je pregledal vse razpoložljive podatke iz predkliničnih študij, farmakovigilančne podatke, objavljeno literaturo in spontana poročila o tveganjih, povezanih z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami peroralnih in lokalnih retinoidov.