FrancophonIA/ELRC3.0 huggingface dataset:
English: Final benefit-risk balance
Croatian: Ukupan omjer koristi i rizika
English: Organ-specific indication for Omniscan
Croatian: Indikacija za Omniscan za određene organe
English: • The CHMP took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Croatian: • CHMP je u obzir uzeo da se linearna intravenska sredstva Multihance (gadobenska kiselina) i Primovist (gadoksetična kiselina) unose u jetru te su stoga klinički korisna za snimanje lezija u jetri sa slabom vaskularizacijom, posebno u snimanju u odgođenoj fazi.
English: Therefore, the PRAC considered that the benefits of gadobenic acid and gadoxetic acid outweigh the risks related to these products in the context of liver imaging.
Croatian: Stoga PRAC smatra da koristi gadobenske kiseline i gadoksetične kiseline nadmašuju s njima povezane rizike u kontekstu snimanja jetre.
English: • In relation to the Magnevist (gadopentetic acid) for intra-articular injection, in view of the low dose, the limited potential for repeated exposure for patients and the absence of evidence of brain accumulation, PRAC considered that the benefits of this product outweigh its risks.
Croatian: • U pogledu Magnevista (gadopentetična kiselina) za intraartikularnu injekciju, uzimajući u obzir nisku dozu, ograničenu mogućnost za ponovno izlaganje bolesnika i manjak dokaza o taloženju u mozgu,
English: This was discussed with clinical experts within an ad hoc expert group meeting that confirmed a possible association but this has not yet been demonstrated.
Croatian: Klinički stručnjaci raspravili su o ovoj temi na ad hoc sastanku stručne skupine.
English: • Although no adverse neurological effects, such as cognitive or movement disorders, have yet been demonstrated to be caused by gadolinium accumulation in the brain, long-term safety data are limited.
Croatian: • Iako još nije dokazano da taloženje gadolinija u mozgu ima štetne neurološke učinke, na primjer kognitivne poremećaje ili poremećaje kretanja, podaci o dugoročnoj sigurnosti ograničeni su.
English: Harmful effects and potential interaction with disease processes are possible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium based on non-clinical data”.
Croatian: Štetni učinci i moguća interakcija s bolestima mogući su u pogledu podataka koji ukazuju na dekelaciju linearnih sredstava in vivo i poznatu toksičnost nekeliranog gadolinija na temelju nekliničkih podataka“.
English: The MAHs provided several proposals for risk minimization measures with regards the accumulation and retention of GdCA in the brain of patients exposed to these agents during diagnostic procedures:
Croatian: GdCA sredstava u mozgu bolesnika koji se izlažu tim sredstvima tijekom dijagnostičkih postupaka:
English: Toxicity of accumulation of Gd in the brain
Croatian: Toksičnost taloženja gadolinija u mozgu
English: Harmful effects and potential interaction with disease processes are plausible in view of stability data suggesting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
Croatian: Štetni učinci i moguća interakcija s bolestima vjerojatni su u pogledu podataka o stabilnosti koji ukazuju na dekeliranje linearnih sredstava in vivo i poznatu toksičnost nekeliranog gadolinija.
English: Harmful effects and potential interaction with disease processes are possible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium based on non-clinical data.
Croatian: Štetni učinci i moguća interakcija s bolestima mogući su u pogledu podataka koji ukazuju na dekeliranje linearnih sredstava in vivo i poznatu toksičnost nekeliranog gadolinija na temelju nekliničkih podataka.
English: However, they described the TEM finding of electrondense lumps in the tissues of ProHance-treated animals which at first were assumed to be Gd deposits, obviously because they looked like them.
Croatian: Međutim, opisali su TEM otkrića elektronski gustih kvržica u tkivima životinja liječenih lijekom ProHance.
English: The CHMP, as a consequence, considers that the benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid remains favourable subject to amendments to the product information.
Croatian: Omjer koristi i rizika lijekova koji sadržavaju intravenski gadobutrol, gadoteričnu kiselinu, gadoteridol, gadoksetičnu kiselinu, intravensku gadobensku kiselinu za indikaciju snimanja jetre, intraartikularnu gadoteričnu kiselinu i intraartikularnu gadopentetičnu kiselinu povoljan je i podliježe dogovorenim izmjenama u informacijama o lijeku:
English: These products undergo hepatic uptake, and have therefore a clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Croatian: Ta se korist ne može ispitati na odgovarajući način za sredstva koja se ne unose u jetru i stoga omogućuju ranu dijagnozu mogućih smrtonosnih bolesti.
English: Harmful effects and potential interaction with disease processes are plausible in view of data supporting dechelation of linear agents in vivo and the known toxicity of unchelated gadolinium.
Croatian: Štetni učinci i moguća interakcija s bolestima vjerojatni su u pogledu podataka koji ukazuju na dekeliranje linearnih sredstava in vivo i poznatu toksičnost nekeliranog gadolinija.
English: Glyxambi is used in the following groups:
Croatian: Glyxambi se primjenjuje u sljedećim skupinama:
English: The full EPAR for Glyxambi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Glyxambi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Croatian: • Linagliptin je inhibitor dipeptidil peptidaze 4 (DPP-4).
English: Empagliflozin / linagliptin
Croatian: Glyxambi empagliflozin/linagliptin
English: It works by blocking the breakdown of incretin hormones in the body.
Croatian: Djeluje tako da blokira razgradnju inkretinskih hormona u tijelu.
English: The result is a high level of glucose in the blood.
Croatian: To rezultira visokim razinama glukoze u krvi.
English: Empagliflozin has been authorised in the European Union (EU) as Jardiance since 2014.
Croatian: Empagliflozin je od 2014. odobren u Europskoj uniji (EU) pod nazivom Jardiance
English: It contains two active substances, empagliflozin and linagliptin.
Croatian: Sadrži dvije djelatne tvari, empagliflozin i linagliptin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Glyxambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Glyxambi nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Glyxambi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Glyxambi?
English: The doctor may need to reduce the dose of Glyxambi or discontinue its use in patients with reduced kidney function.
Croatian: Liječnik će možda trebati smanjiti dozu lijeka Glyxambi ili prekinuti njegovu upotrebu u bolesnika sa smanjenom funkcijom bubrega.
English: The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections.
Croatian: Najčešće nuspojave lijeka Glyxambi (koje se mogu javiti u više od 7 na 100 osoba) jesu infekcije mokraćnog sustava.
English: The most serious side effects are ketoacidosis (high blood levels of acids called ‘ketoacids'), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels).
Croatian: Najozbiljnije nuspojave su ketoacidoza (visoke razine kiselina u krvi pod nazivom „ketokiseline”), pankreatitis (upala gušterače), preosjetljivost (alergijske reakcije) i hipoglikemija (niske razine šećera u krvi).
English: This is a summary of the European public assessment report (EPAR) for Glyxambi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Glyxambi.
English: Other information about Glyxambi
Croatian: Ostale informacije o lijeku Glyxambi
English: Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Linagliptin također snižava količinu glukoze koju proizvodi jetra, povećavanjem razine inzulina i snižavanjem razine hormona glukagona.
English: Why is Glyxambi approved?
Croatian: Zašto je Glyxambi odobren?
English: Glyxambi is available as tablets containing 10 or 25 mg of empagliflozin with 5 mg of linagliptin, and can only be obtained with a prescription.
Croatian: Glyxambi je dostupan u obliku tableta koje sadrže 10 ili 25 mg empagliflozina s 5 mg linagliptina, a izdaje se samo na liječnički recept.
English: What is Glyxambi and what is it used for?
Croatian: Što je Glyxambi i za što se koristi?
English: If Glyxambi is used in combination with insulin or a sulphonylurea, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Croatian: Ako se Glyxambi primjenjuje u kombinaciji s inzulinom ili sulfonilurejom, njihove će doze možda trebati smanjiti kako bi se smanjio rizik od hipoglikemije (niske razine šećera u krvi).
English: Glyxambi must not be used in people who are hypersensitive (allergic) to empagliflozin, linagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Croatian: Glyxambi se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergične) na empagliflozin, linagliptin ili bilo koji drugi sastojak lijeka ili u onih koji su imali ozbiljne alergijske reakcije na bilo koji inhibitor DPP-4 ili SGLT2.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glyxambi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Glyxambi nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Croatian: Šećerna bolest tipa 2 bolest je u kojoj tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi ili tijelo nije u stanju učinkovito koristiti vlastiti inzulin.
English: It is not intended to provide practical advice on how to use Glyxambi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Glyxambi.
English: Patients switching from empagliflozin and linagliptin to Glyxambi should receive the strength of Glyxambi that corresponds to the doses of empagliflozin and linagliptin in the separate tablets they were taking.
Croatian: Bolesnici koji prelaze s empagliflozina i linagliptina na Glyxambi trebaju primati Glyxambi one jačine koja odgovara dozama empagliflozina i linagliptina u odvojenim tabletama koje uzimaju.
English: The two active substances in Glyxambi work in different ways to lower glucose levels:
Croatian: Dvije djelatne tvari u lijeku Glyxambi djeluju na različite načine kako bi se snizile razine glukoze:
English: Adding linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% when placebo was added.
Croatian: Dodavanjem linagliptina terapiji empagliflozinom i metforminom u trajanju od 24 tjedna, razine HbA1c smanjile su se od 7,8 % do 7,2 % u usporedbi sa smanjenjem od 7,9 % do 7,7 % kada je dodan placebo.
English: Together, these actions reduce blood glucose levels and help to control type 2 diabetes.
Croatian: Ti procesi zajedno snižavaju razine glukoze u krvi i pomažu pri kontroli šećerne bolesti tipa 2.
English: • patients who are already taking empagliflozin and linagliptin as separate tablets.
Croatian: • u bolesnika koji već uzimaju empagliflozin i linagliptin kao zasebne tablete.
English: What are the risks associated with Glyxambi?
Croatian: Koji su rizici povezani s lijekom Glyxambi?
English: • Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: • Empagliflozin djeluje blokiranjem proteina u bubrezima koji se naziva suprijenosnik natrija i glukoze 2 (SGLT2).
English: The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect.
Croatian: CHMP smatra da je Glyxambi učinkovit u kontroli razina glukoze u krvi, s tim da tom učinku pridonose obje komponente lijeka.
English: The HbA1c levels were around 8% before treatment.
Croatian: Prije liječenja, razine HbA1c bile su oko 8 %.
English: For more information about treatment with Glyxambi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Glyxambi pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: After 24 weeks treatment the fixed dose combination reduced HbA1c levels to under 6.9% whereas they were around 7.3% with empagliflozin and linagliptin used alone.
Croatian: Nakon 24 tjedna liječenja fiksnom kombiniranom dozom, razine HbA1c su se smanjile ispod 6,9 %, dok su uz primjenu samo empagliflozina i linagliptina iznosile 7,3 %.
English: Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Croatian: U pogledu sigurnosnog profila, pokazalo se da se lijek Glyxambi dobro podnosi, pri čemu su nuspojave karakteristične za inhibitore SGLT2 i DDP-4.
English: A further study compared a fixed dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin plus either empagliflozin or linagliptin in patients who were not sufficiently controlled with metformin alone.
Croatian: U daljnjem ispitivanju uspoređena je fiksna doza kombinacije empagliflozina i linagliptina (davano uz metformin) s terapijom metforminom uz dodatak empagliflozina ili linagliptina u bolesnika u kojih kontrola postignuta samo metforminom nije bila zadovoljavajuća.
English: Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Croatian: Glyxambi je lijek za liječenje šećerne bolesti koji se primjenjuje u odraslih bolesnika sa šećernom bolesti tipa 2 kako bi im se poboljšala kontrola razine glukoze (šećera) u krvi.
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Produžujući djelovanje inkretinskih hormona u krvi, linagliptin stimulira gušteraču kako bi ona proizvela više inzulina kod visokih razina glukoze u krvi.
English: Linagliptin has been authorised in the EU as Trajenta since
Croatian: Linagliptin je od 2011. odobren u Europskoj uniji (EU) pod nazivom Trajenta.
English: For practical information about using Glyxambi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Glyxambi bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Blokiranjem djelovanja proteina SGLT2, empagliflozin uzrokuje izlučivanje veće količine glukoze putem mokraće, čime se snižavaju razina glukoze u krvi.
English: Patients were then given either empagliflozin or placebo (a dummy treatment) in addition to their existing treatment.
Croatian: Stoga su bolesnici uz svoju postojeću terapiju primali ili empagliflozin ili placebo (neaktivno liječenje).
English: Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine.
Croatian: Obično, kako se krv pročišćava u bubrezima, protein SGLT2 onemogućava da glukoza iz krvi prijeđe u mokraću.
English: The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and empagliflozin.
Croatian: Drugo je ispitivanje uključivalo bolesnike u kojih nije postignuta zadovoljavajuća kontrola razina glukoze u krvi metforminom i empagliflozinom.
English: What benefits of Glyxambi have been shown in studies?
Croatian: Koje su koristi lijeka Glyxambi utvrđene u ispitivanjima?
English: How does Glyxambi work?
Croatian: Kako djeluje Glyxambi?
English: Results showed that when empagliflozin was added to linagliptin and metformin, HbA1c levels decreased by 0.7-0.8 percentage points after 24 weeks, compared with no reduction when placebo was added.
Croatian: Rezultati su pokazali da su se nakon 24 tjedna razine HbA1c smanjile za 0,7 - 0,8 postotnih točaka kada je linagliptinu i metforminu dodan empagliflozin, dok smanjenja nije bilo kada je dodan placebo.
English: • patients whose blood glucose levels are not controlled well enough by a combination of one of Glyxambi's active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea);
Croatian: • u bolesnika kod kojih se kombinacijom jedne od djelatnih tvari lijeka Glyxambi (empagliflozin ili linagliptin) i drugih lijekova protiv šećerne bolesti (metformin i/ili sulfonilureja) ne postiže dovoljno dobra kontrola razine glukoze u krvi;
English: For the full list of all side effects reported with Glyxambi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Glyxambi potražite u uputi o lijeku.
English: How is Glyxambi used?
Croatian: Kako se Glyxambi koristi?
English: The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin.
Croatian: Prvo je ispitivanje uključivalo bolesnike u kojih nije postignuta zadovoljavajuća kontrola razina glukoze u krvi metforminom i empagliflozinom.
English: Empagliflozin in combination with linagliptin (the same combination as in Glyxambi) was evaluated in 3 main studies involving 1,221 adults with type 2 diabetes.
Croatian: Djelovanje empagliflozina u kombinaciji s linagliptinom (kombinacija jednaka onoj koju sadrži lijek Glyxambi) ocijenjeno je u 3 glavna ispitivanja koja su uključivala 1221 odraslog bolesnika sa šećernom bolesti tipa 2. Glavna mjera djelotvornosti bila je promjena u razini tvari u krvi koja se naziva glikozilirani hemoglobin (HbA1c) nakon 24 tjedna liječenja, što ukazuje na uspješnost kontrole glukoze u krvi.
English: HbA1c levels were just below 8% at the start of the study.
Croatian: Na početku ispitivanja, razine HbA1c bile su malo ispod
English: Oral contraceptives may also affect bone metabolism in adolescents, although this effect is likely reversible after discontinuation of treatment.
Croatian: Oralna kontracepcijska sredstva mogu također utjecati na metabolizam kostiju u adolescenata, iako je vjerojatno da je taj učinak reverzibilan nakon prekida terapije.
English: Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo.
Croatian: Dienogest nema znatne androgene, mineralokortikoidne ili glukokortikoidne učinke in vivo.
English: Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms.
Croatian: Smatra se da kombinirana oralna kontracepcijska sredstva (COC-ovi) poboljšavaju akne putem nekoliko mehanizama.
English: In view of the above and the necessity to take an action at EU level, UK considered that it was in the interest of the Union to refer the matter to the CHMP and requested on the 18 February 2016, that it give its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products in the abovementioned indication should be maintained, varied, suspended, or revoked in relation to the below indication:
Croatian: S obzirom na prethodno navedeno i nužnost poduzimanja mjera na razini EU-a, Ujedinjena Kraljevina smatrala je da je u interesu Unije uputiti predmet CHMP-u te je 18. veljače 2016. od njega zatražila da iznese svoje mišljenje, u skladu s člankom 31. Direktive 2001/83/EZ, o tome treba li odobrenja za stavljanje u promet tih lijekova u prethodno navedenoj indikaciji zadržati, izmijeniti, obustaviti ili opozvati s obzirom na indikaciju u nastavku:
English: The contraceptive effect of this combination is based on the interaction of various effects, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Croatian: Kontracepcijski učinak te kombinacije temelji se na interakciji raznih učinaka, od kojih su najvažniji inhibicija ovulacije i promjene u cervikalnoj sluzi.
English: It is not known if the risk of VTE with DNG/EE is better or worse than that of the combined oral contraceptives containing levonorgestrel (5-7 per 10,000 women), etonorgestrel (6-12 per 10,000 women) or drospirenone (9-12 per 10,000 women as compared to 2 out of 10,000 women who do not use a combined hormonal contraceptive).
Croatian: Nije poznato je li rizik od venske tromboembolije pri primjeni DNG-a/EE-a manji ili veći od rizika pri primjeni kombiniranih oralnih kontracepcijskih sredstava koja sadržavaju levonorgestrel (5-7 na 10 000 žena), etonorgestrel (6-12 na 10 000 žena) ili drospirenon (9-12 na 10 000 žena u usporedbi s 2 na 10 000 žena koje ne primjenjuju kombiniranu hormonsku kontracepciju).
English: Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α.
Croatian: Etinilestradiol je sintetski estrogen, a dienogest je derivat nortestosterona koji na jedinstven način sadržava skupinu cijanometil na položaju 17α.
English: When considering existing data in support of the efficacy of dienogest/ethinylestradiol, the CHMP concluded that overall there is sufficient evidence in support of the use of this combination in the acne indication.
Croatian: Razmatrajući postojeće podatke u korist djelotvornosti dienogesta/etinilestradiola, CHMP je zaključio da, općenito gledajući, postoje dostatni dokazi u korist primjene te kombinacije u indikaciji za akne.
English: Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens.
Croatian: Dienogest pokazuje antiandrogenička svojstva, 10-30 puta manji afinitet prema receptoru progesterona in vitro u usporedbi s drugim sintetskim progestogenima.
English: The available safety data confirmed that the adverse event (AE) profile of DNG/EE and the comparator products in the phase III trials is very similar, with none of the safety parameters raising any concerns.
Croatian: Dostupni podatci o sigurnosti potvrđuju da je profil DNG-a/EE-a i usporednih proizvoda s obzirom na štetne događaje (AE) vrlo sličan u ispitivanjima III. faze, pri čemu ni jedan od parametara sigurnosti ne izaziva zabrinutost.