natgillin/translations-raw huggingface dataset:
• 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);
• pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče dobro uravnavati s kombinacijo ene od zdravilnih učinkovin zdravila Glyxambi (empagliflozina ali linagliptina) in drugih zdravil za zdravljenje sladkorne bolezni (metformina in/ali sulfonilsečnine);
What are the risks associated with Glyxambi?
Kakšna tveganja so povezana z zdravilom Glyxambi?
Glyxambi is used in the following groups:
Zdravilo Glyxambi se uporablja pri naslednjih skupinah bolnikov:
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.
Po 24 tednih dodajanja linagliptina zdravljenju z empagliflozinom in metforminom se je raven HbA1c znižala s 7,8 % na 7,2 % v primerjavi z zmanjšanjem s 7,9 % na 7,7 % pri dodajanju placeba.
• Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
• Empagliflozin zavira beljakovino v ledvicah, imenovano natrijev glukozni koprenašalec 2 (SGLT2).
For practical information about using Glyxambi, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Glyxambi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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).
Če se zdravilo Glyxambi uporablja v kombinaciji z insulinom ali sulfonilsečnino, bo za zmanjšanje tveganja hipoglikemije (nizke ravni sladkorja v krvi) morda treba njun odmerek zmanjšati.
What is Glyxambi and what is it used for?
Kaj je zdravilo Glyxambi in za kaj se uporablja?
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.
V naslednji študiji so fiksno kombinacijo empagliflozina in linagliptina (ki so jo dodajali metforminu) primerjali z zdravljenjem z metforminom in bodisi empagliflozinom ali linagliptinom pri bolnikih, pri katerih uravnavanje samo z metforminom ni bilo zadostno.
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, imenovane glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja, ki kaže, kako dobro je uravnana raven glukoze v krvi.
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.
Zdravilo Glyxambi je na voljo v obliki tablet, ki vsebujejo 10 ali 25 mg empagliflozina in 5 mg linagliptina.
For the full list of all side effects reported with Glyxambi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glyxambi, glejte navodilo za uporabo.
Why is Glyxambi approved?
Zakaj je bilo zdravilo Glyxambi odobreno?
Glyxambi is a diabetes medicine used in adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Glyxambi je zdravilo za zdravljenje sladkorne bolezni, ki se uporablja pri odraslih s sladkorno boleznijo tipa 2 za izboljšanje uravnavanja ravni glukoze (sladkorja) v krvi.
Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Kar zadeva varnostni profil, so bolniki zdravilo Glyxambi dobro prenašali, opaženi neželeni učinki pa so značilni za zaviralce SGLT2 in DDP-4.
The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect.
Odbor CHMP je presodil, da je zdravilo Glyxambi učinkovito pri uravnavanju ravni sladkorja v krvi, pri čemer k temu učinku prispevata obe komponenti.
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.
Rezultati so pokazali, da se je raven HbA1c pri dodajanju empagliflozina linagliptinu in metforminu po 24 tednih zmanjšala za 0,7-0,8 odstotne točke v primerjavi z odsotnostjo zmanjšanja pri dodajanju placeba.
The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and empagliflozin.
Druga študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in empagliflozinom.
The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin and linagliptin.
Prva študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in linagliptinom.
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.
Raven HbA1c se je po 24 tednih zdravljenja s fiksno kombinacijo znižala pod 6,9 %, s samostojno uporabo empagliflozina in linagliptina pa na raven okoli 7,3 %.
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.
Priporočeni odmerek je ena tableta enkrat na dan. Bolniki, ki bodo prešli z empagliflozina in linagliptina na zdravilo Glyxambi, morajo prejeti tako jakost zdravila Glyxambi, ki ustreza odmerkoma empagliflozina in linagliptina v ločenih tabletah, ki jih jemljejo.
Normally, as blood is filtered by the kidneys, SGLT2 stops glucose in the blood from being passed out into the urine.
Ko se kri filtrira skozi ledvice, SGLT2 prepreči, da bi se glukoza v krvnem obtoku izločala v urin.
By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Linagliptin s podaljšanjem delovanja inkretinov v krvi spodbuja trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni glukoze v krvi visoke.
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.
Empagliflozin z zaviranjem delovanja koprenašalca SGLT2 povzroči povečano izločanje glukoze z urinom, kar zniža ravni glukoze v krvi.
It is not intended to provide practical advice on how to use Glyxambi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Glyxambi work?
Kako zdravilo Glyxambi deluje?
How is Glyxambi used?
Kako se zdravilo Glyxambi uporablja?
The doctor may need to reduce the dose of Glyxambi or discontinue its use in patients with reduced kidney function.
Pri bolnikih z zmanjšanim delovanjem ledvic bo moral zdravnik morda zmanjšati odmerek zdravila Glyxambi ali njegovo uporabo prekiniti.
The two active substances in Glyxambi work in different ways to lower glucose levels:
Zdravilni učinkovini v zdravilu Glyxambi raven glukoze v krvi znižujeta na različna načina:
The recommended dose is one tablet once a day.
Predpisovanje in zdaja zdravila je le na recept.
Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
S povišanjem ravni insulina in znižanjem ravni hormona glukagona linagliptin zmanjša tudi količino glukoze, ki nastaja v jetrih.
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:
Z upoštevanjem zgoraj navedenega in potrebe po ukrepanju na ravni EU je Združeno kraljestvo menilo, da je v interesu Unije, da se zadeva napoti na odbor CHMP, in je 18. februarja 2016 zaprosilo, naj odbor v skladu s členom 31 Direktive 2001/83/ES poda svoje mnenje o tem, ali naj se dovoljenja za promet s temi zdravili pri navedeni indikaciji ohranijo, spremenijo, začasno umaknejo ali ukinejo, in sicer v povezavi s spodnjo indikacijo:
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).
Ni znano, ali je tveganje za vensko trombembolijo pri dienogestu/etinilestradiolu večje ali manjše kot tveganje pri kombiniranih peroralnih kontraceptivih, ki vsebujejo levonorgestrel (5-7 na 10 000 žensk), etonorgestrel (6-12 na 10 000 žensk) ali drospirenon (9-12 na 10 000 žensk v primerjavi z 2 od 10 000 žensk, ki ne uporabljajo kombiniranih hormonskih kontraceptivov).
Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α.
Etinilestradiol je sintetični estrogen, dienogest pa je derivat nortestosterona, ki ima na položaju 17α vezano cianometilno skupino.
The phase III clinical studies showed that predominantly moderate acne vulgaris dominated in the studies.
Klinične študije III. faze so pokazale, da v študijah prevladujejo zmerne akne vulgaris.
Oral contraceptives may also affect bone metabolism in adolescents, although this effect is likely reversible after discontinuation of treatment.
Peroralni kontraceptivi lahko pri mladostnicah vplivajo tudi na presnovo kosti, čeprav je ta učinek po prenehanju zdravljenja verjetno reverzibilen.
Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo.
Dienogest in vivo nima pomembnih androgenih, mineralokortikoidnih ali glukokortikoidnih učinkov.
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.
Po preučitvi obstoječih podatkov v podporo učinkovitosti dienogesta/etinilestradiola je odbor CHMP zaključil, da je v celoti dovolj dokazov, ki podpirajo uporabo te kombinacije za indikacijo aken.
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.
Kontracepcijski učinek omenjene kombinacije temelji na medsebojnem delovanju različnih učinkov, med katerimi so najpomembnejši zaviranje ovulacije in spremembe izločkov materničnega vratu.
“Treatment of acne with moderate severity in women without contraindications for oral contraceptives and in whom topical treatment was ineffective”.
„Zdravljenje zmernih aken pri ženskah brez kontraindikacij za peroralne kontraceptive, pri katerih je bilo topično zdravljenje neučinkovito.“
This is in line with the current treatment guidelines which state that combined oral contraceptives (COCs) are not indicated in mild acne, but are considered as treatment alternatives in females with moderate to severe acne.
To je v skladu s trenutnimi smernicami zdravljenja, ki navajajo, da kombinirani peroralni kontraceptivi niso indicirani pri blagih aknah, pač pa so na voljo kot možnost zdravljenja pri ženskah z zmernimi do hudimi aknami.
Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens.
Dienogest ima antiandrogene lastnosti in 10- do 30-krat manjšo afiniteto do progesteronskih receptorjev in vitro v primerjavi z drugimi sintetičnimi progestogeni.
Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms.
Kombinirani peroralni kontraceptivi naj bi prek več mehanizmov izboljševali stanje aken.
Considering the nature of the disorder, the observed benefits and the relative risks compared to available treatment alternatives and guideline recommendations, local therapies or oral antibiotic treatment should be tried first before resorting to a COC.
Glede na naravo motnje, ugotovljene koristi in relativna tveganja v primerjavi z drugimi razpoložljivimi možnostmi zdravljenja in priporočili smernic je treba pred uporabo kombiniranega peroralnega kontraceptiva najprej preskusiti lokalno zdravljenje ali peroralno antibiotično zdravljenje.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicines containing dienogest (DNG) 2 mg and ethinylestradiol (EE) 0.03 mg for moderately severe acne in women in whom topical treatment was ineffective.
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg za zmerno hude akne pri ženskah, pri katerih je bilo topično zdravljenje neučinkovito;
The risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE) is of particular importance as to date there is insufficient data to clearly determine the relative risk for thromboembolic events compared to other combined hormonal contraceptives containing other progestogens.
Še zlasti pomembno je tveganje za vensko trombembolijo in arterijsko trombembolijo, saj doslej ni dovolj podatkov, da bi lahko jasno določili relativno tveganje za trombembolijo v primerjavi z drugimi kombiniranimi hormonski kontraceptivi, ki vsebujejo druge progestogene.
This conclusion was reached considering that treatment would be necessary for at least 3 months for an effect to be seen, with the most prominent effect on acne seen after 6 months of treatment (as supported by the results of both phase III studies), and that in view of the still to be quantified risk of VTE, women should be assessed periodically to review the need for continuation of treatment.
Do tega zaključka so prišli z upoštevanjem, da je za viden učinek potrebno vsaj trimesečno zdravljenje, pri čemer je največji učinek na akne viden po šestih mesecih zdravljenja (kot kažejo rezultati obeh študij III. faze), in da je treba glede na tveganje za trombembolijo, ki ga je še treba ovrednotiti, ženske ocenjevati v rednih časovnih presledkih, da se preuči potreba po nadaljevanju zdravljenja;
The CHMP therefore agreed that the indication should be restricted to women who elect to use an oral contraceptive, and that a conscious and well-considered decision needs to be made when choosing this COC.
Odbor CHMP se je torej strinjal, da je treba indikacijo omejiti na ženske, ki se odločijo za uporabo peroralnega kontraceptiva, in da je pri odločitvi za ta kombinirani peroralni kontraceptiv potreben zavesten in dobro pretehtan razmislek;
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.
Razpoložljivi podatki o varnosti so potrdili, da je profil neželenih učinkov dienogesta/etinilestradiola in primerjalnih zdravil v preskušanjih III. faze zelo podoben, pri čemer nobeden od parametrov varnosti ni vzbudil pomislekov.
At the time of triggering the referral, the UK considered that the benefit-risk analysis for the acne indication was not favourable based on insufficient data on the efficacy of the combination in the acne indication, an unacceptable safety profile, in particular regarding to the risk of venous thromboembolic events (VTE) and the fact that the target population covered by the abovementioned indication is broad and would unnecessarily expose women to a treatment with limited efficacy and to a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
Ob sprožitvi napotitve je Združeno kraljestvo ocenilo, da analiza razmerja med tveganji in koristmi za indikacijo aken ni ugodna, in sicer na podlagi nezadostnih podatkov o učinkovitosti kombinacije pri indikaciji aken, nesprejemljivega varnostnega profila, zlasti glede tveganja za vensko trombembolijo in dejstva, da je ciljna populacija, ki jo zajema zgornja indikacija, široka in bi bile ženske po nepotrebnem izpostavljene zdravljenju z omejeno učinkovitostjo in morebitnemu povišanemu tveganju za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken.
However, the CHMP noted that there were no cases of VTE in the phase III studies and the safety data provided by MAHs does not raise any new safety concern.
Odbor CHMP je opozoril, da v študijah III. faze ni bilo primerov venske trombembolije, in tudi podatki o varnosti, ki so jih predložili imetniki dovoljenj za promet z zdravilom, ne vzbujajo novih pomislekov o varnosti.
• The CHMP noted that the risk of VTE with dienogest containing combined hormonal contraceptive is not yet fully characterised.
• odbor CHMP je opozoril, da tveganje za vensko trombembolijo s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo dienogest, še ni v celoti ovrednoteno.
• The CHMP also noted that the initial acne indication was too broad and would unnecessarily expose women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
• odbor CHMP je opozoril tudi, da je bila prvotna indikacija za akne preširoka in bi z njo po nepotrebnem izpostavili ženske zdravljenju s potencialno večjim tveganjem za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken.
• The CHMP agreed that patients treated for acne should be assessed 3-6 months after starting treatment and periodically thereafter.
• odbor CHMP se je strinjal, da je treba bolnice, ki se zdravijo zaradi aken, oceniti po 36 mesecih zdravljenja in nato v rednih časovnih presledkih.
• The CHMP considered the totality of the available clinical studies, published literature and postmarketing experience, including responses from marketing authorisation holders (MAHs) on the efficacy of DNG/EE in the treatment of acne, and on the safety of these medicines, in particular regarding the risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE).
• odbor CHMP je preučil vse razpoložljive klinične študije, objavljeno literaturo in izkušnje iz obdobja trženja, vključno z odgovori imetnikov dovoljenj za promet z zdravilom o učinkovitosti dienogesta/etinilestradiola pri zdravljenju aken in o varnosti teh zdravil, zlasti v zvezi s tveganjem za vensko trombembolijo in arterijsko trombembolijo;
• The CHMP considered that the efficacy of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of moderately severe acne in women in whom topical treatment or oral antibiotic was ineffective is well supported by phase III clinical trial data and further supported by a Cochrane review of combined oral contraceptive pills for treatment of acne.
• odbor CHMP je ocenil, da je učinkovitost zdravil, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg, pri zdravljenju zmerno hudih aken pri ženskah, pri katerih je bilo zdravljenje s topičnim zdravilom ali peroralnim antibiotikom neučinkovito, dobro podprta s podatki iz kliničnih preskušanj III. faze, nadalje pa tudi s Cochranovim pregledom kombiniranih peroralnih kontracepcijskih tablet za zdravljenje aken;
• The CHMP is of the opinion that the benefits of dienogest/ethinylestradiol containing medicinal products continue to outweigh the risks in the second-line treatment of moderate acne in women who elect to use an oral contraceptive, provided that the medicinal products are only used after suitable topical therapies or oral antibiotic treatments have failed.
• odbor CHMP meni, da koristi zdravil, ki vsebujejo dienogest/etinilestradiol, še vedno odtehtajo tveganja kot druga izbira zdravljenja zmernih aken pri ženskah, ki se odločijo za uporabo peroralnega kontraceptiva, pod pogojem, da se ta zdravila uporabijo šele, kadar zdravljenje z ustreznimi topičnimi zdravili ali peroralnim antibiotikom ni bilo uspešno.
In view of the most prominent effect on acne seen after 6 months of treatment, paired with the still to be quantified risk of VTE, women should be assessed 3-6 months after initiating treatment and periodically thereafter to review the need for continuation of treatment.
Na podlagi najočitnejšega učinka na akne, vidnega po šestih mesecih zdravljenja, skupaj s tveganjem za vensko trombembolijo, ki ga je še treba ovrednotiti, je treba ženske oceniti po 3-6 mesecih zdravljenja, potem pa v rednih časovnih presledkih, da se preuči potreba po nadaljevanju zdravljenja.
The CHMP also noted that in order to avoid unnecessarily exposing women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available that the indication should be restricted to women who elect contraception, and that a conscious and wellconsidered decision needs to be made when choosing this COC.
Odbor CHMP je prav tako opozoril, da je treba v izogib nepotrebnemu izpostavljanju žensk zdravilu s potencialno večjim tveganjem za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken, indikacijo omejiti na ženske, ki se odločijo za kontracepcijo, in da je pri odločitvi za ta kombinirani peroralni kontraceptiv potreben zavesten in dobro pretehtan razmislek.
Therefore, the benefit-risk relationship of DNG/EE is considered favourable for a second-line treatment of women with moderate acne.
Zato je razmerje med tveganji in koristmi dienogesta/etinilestradiola ugodno kot zdravljenje druge izbire za ženske z zmernimi aknami.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for dienogest/ethinylestradiol containing medicinal products indicated in acne.
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo dienogest/etinilestradiol, za indikacijo aken.
The CHMP, as a consequence, considers that the benefit-risk balance of dienogest/ethinylestradiol containing medicinal products indicated in acne remains favourable subject to the amendments to the product information described above.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo dienogest/etinilestradiol, še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
In view of the above, the CHMP concluded that the benefit-risk balance of dienogest/ethinylestradiol containing products indicated in acne is favourable subject to changes to the product information as described above.
Z upoštevanjem zgoraj navedenega je odbor CHMP zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo dienogest/etinilestradiol, ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
Asparaginase is an enzyme that has been used to treat cancer for many years, and is already approved under various trade names in the EU.
Asparaginaza je encim, ki se že dolga leta uporablja za zdravljenje raka in je v EU odobren pod različnimi tržnimi imeni.
it can cause allergic reactions, but by enclosing it in red blood cells the risk of allergy is expected to be reduced.
povzroča alergijske reakcije, z vključitvijo v rdeče krvne celice pa naj bi se tveganje za alergijo zmanjšalo.
Withdrawal of the marketing authorisation application for Graspa (eryaspase) EMA/817193/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (eriaspaza) EMA/817193/2016