FrancophonIA/ELRC3.0 huggingface dataset:
English: Vokanamet is available as tablets containing canagliflozin and metformin in various strengths (50/850 mg, 150/850 mg, 50/1000 mg and 150/1000 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Vokanamet je na voljo v obliki tablet, ki vsebujejo kanagliflozin in metformin, različnih jakosti (50/850 mg, 150/850 mg, 50/1000 mg ter 150/1000 mg) in se izdaja le na recept.
English: What are the risks associated with Vokanamet?
Slovenian: Kakšna tveganja so povezana z zdravilom Vokanamet?
English: • Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Slovenian: • metformin deluje predvsem tako, da zavira tvorbo glukoze in zmanjšuje njeno absorpcijo v črevesju.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vokanamet's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Vokanamet večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It is not intended to provide practical advice on how to use Vokanamet.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What is Vokanamet and what is it used for?
Slovenian: Kaj je zdravilo Vokanamet in za kaj se uporablja?
English: What benefits of Vokanamet have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vokanamet izkazalo v študijah?
English: The benefits of canagliflozin used in combination with metformin have been shown in several main studies that were evaluated at the time of the authorisation of Invokana.
Slovenian: Koristi kanagliflozina, uporabljenega v kombinaciji z metforminom, so potrdili v več glavnih študijah, ki so bile ovrednotene ob odobritvi zdravila Invokana.
English: • patients who have liver impairment or are suffering from alcoholism or are intoxicated.
Slovenian: • bolnikih, ki imajo okvaro jeter, trpijo za alkoholizmom ali so pod vplivom alkohola.
English: SGLT2 absorbs glucose back into the bloodstream as the blood is filtered in the kidneys.
Slovenian: SGLT2 absorbira glukozo nazaj v krvni obtok, medtem ko se kri filtrira v ledvicah.
English: For more information about treatment with Vokanamet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vokanamet preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • patients with moderately or severely reduced kidney function or with severe conditions that could affect the kidneys such as dehydration or severe infection.
Slovenian: • bolnikih z zmerno ali močno zmanjšanim delovanjem ledvic ali z resnimi stanji, ki lahko vplivajo na ledvice - na primer dehidracija ali huda okužba;
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vokanamet, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vokanamet in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Concerning its safety, the CHMP considered that the side effects seen with Vokanamet are acceptable and can be managed in clinical practice.
Slovenian: V zvezi z varnostjo je odbor CHMP menil, da so neželeni učinki, ki so jih opazili pri uporabi zdravila Vokanamet, sprejemljivi in obvladljivi v klinični praksi.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Slovenian: Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k ureditvi sladkorne bolezni tipa 2.
English: For practical information about using Vokanamet, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vokanamet naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Why is Vokanamet approved?
Slovenian: Zakaj je bilo zdravilo Vokanamet odobreno?
English: Vokanamet can also be used to replace canagliflozin and metformin given separately.
Slovenian: Zdravilo Vokanamet se lahko uporablja tudi namesto kanagliflozina in metformina, ki se dajeta ločeno.
English: The most common side effects with Vokanamet (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose levels) when used in combination with insulin or a sulphonylurea and vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida).
Slovenian: Najpogostejša neželena učinka zdravila Vokanamet (ki lahko prizadeneta več kot 1 osebo od 10) sta hipoglikemija (nizke ravni glukoze v krvi), kadar se zdravilo uporablja v kombinaciji z insulinom ali sulfonilsečnino, in vulvovaginalna kandidoza (glivice oziroma glivična okužba ženskih spolovil, ki jo povzroča Candida).
English: When Vokanamet is used as an add-on to insulin or medicines that stimulate the secretion of insulin (e.g. sulphonylureas) the dose of these other medicines may need to be reduced to lower the risk of the patient's blood glucose becoming too low.
Slovenian: Kadar se zdravilo Vokanamet uporablja kot dodatek k insulinu ali zdravilom, ki spodbujajo izločanje insulina (npr. sulfonilsečninam), je včasih treba zmanjšati odmerek teh zdravil, da se zmanjša tveganje za prekomerno znižanje ravni glukoze v krvi bolnika.
English: • patients with a condition that could lead to body tissues being deprived of oxygen (e.g. heart or respiratory failure)
Slovenian: • bolnikih z boleznijo, ki lahko povzroči, da telesna tkiva ne dobijo dovolj kisika (npr. srčno ali respiratorno popuščanje);
English: • patients with diabetic ketoacidosis or pre-coma (dangerous complications of diabetes),
Slovenian: • bolnikih z diabetično ketoacidozo ali predkomo (nevarna zapleta, ki se lahko pojavita pri sladkorni bolezni);
English: The studies, involving over 5,000 adults with type 2 diabetes, studied canagliflozin at daily doses of 100 and 300 mg and looked mainly at how they reduced the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: V študijah, v katerih je sodelovalo več kot 5 000 odraslih s sladkorno boleznijo tipa 2, so proučevali kanagliflozin v dnevnih odmerkih 100 in 300 mg, pri čemer jih je zanimalo predvsem, v kolikšni meri odmerka znižata raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je glukoza v krvi uravnavana.
English: Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za zadovoljivo uravnavanje ravni glukoze v krvi ali pri kateri ga telo ne more učinkovito izrabiti.
English: The CHMP also noted that giving the combination of canagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Slovenian: Odbor CHMP je izpostavil tudi, da je kombinacija kanagliflozina in metformina v eni tableti lahko dodatna možnost zdravljenja za bolnike s sladkorno boleznijo tipa 2, ki bi lahko prispevala k temu, da se bodo držali predpisanega zdravljenja.
English: Patients should start Vokanamet at a strength that provides 50 mg canagliflozin and the dose of metformin they were previously taking (or a close approximation of it).
Slovenian: Bolniki morajo zdravljenje z zdravilom Vokanamet začeti z jakostjo, ki zagotavlja 50 mg kanagliflozina in enak (ali zelo podoben) odmerek metformina, kot so ga jemali pred tem.
English: It is used, together with diet and exercise, to control the blood glucose (sugar) levels in adults with type 2 diabetes whose disease is not satisfactorily controlled with metformin alone, or in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes.
Slovenian: Skupaj z dieto in telesno dejavnostjo se uporablja za uravnavanje ravni glukoze (sladkorja) v krvi pri odraslih s sladkorno boleznijo tipa 2, ki ni zadovoljivo uravnana zgolj z metforminom, ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, pri bolnikih, pri katerih bolezen ni zadostno uravnana s kombinacijo metformina in teh zdravil.
English: The benefits of metformin are well established and the added advantage of adding canagliflozin to metformin to control blood sugar has been shown in the studies.
Slovenian: Koristi metformina so dobro znane, študije pa so potrdile dodatno prednost dodajanja kanagliflozina k metforminu za uravnavanje sladkorja v krvi.
English: Three further studies evaluated canagliflozin as an add-on to combined treatment with metformin and either a sulphonylurea or pioglitazone.
Slovenian: V drugih treh študijah so ocenjevali kanagliflozin, uporabljen kot dodatek h kombiniranemu zdravljenju z metforminom in bodisi sulfonilsečnino ali pioglitazonom.
English: Vokanamet is a diabetes medicine that contains the active substances canagliflozin and metformin.
Slovenian: Vokanamet je zdravilo za zdravljenje sladkorne bolezni, ki vsebuje zdravilni učinkovini kanagliflozin in metformin.
English: How does Vokanamet work?
Slovenian: Kako zdravilo Vokanamet deluje?
English: Canagliflozin was also studied as an add-on treatment in patients who were taking insulin alone, or insulin in combination with other diabetes medicines including metformin and in patients who were taking a sulphonylurea.
Slovenian: Kanagliflozin so proučevali tudi kot dodatno zdravilo pri bolnikih, ki so uporabljali samo insulin ali insulin v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z metforminom, ter pri bolnikih, ki so uporabljali sulfonilsečnino.
English: Adding canagliflozin to treatment was shown to be effective at reducing HbA1c compared with placebo by 0.65 to 0.73 points after 18 weeks in patients receiving insulin and by 0.74 to 0.83 points in patients receiving a sulphonylurea.
Slovenian: Dodajanje kanagliflozina k zdravljenju je učinkovito znižalo ravni HbA1c v primerjavi s placebom, in sicer za 0,65 do 0,73 odstotne točke po 18 tednih pri bolnikih, ki so prejemali insulin, in za 0,74 do 0,83 odstotne točke pri bolnikih, ki so prejemali sulfonilsečnino.
English: • canagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2
Slovenian: • kanagliflozin zavira beljakovino v ledvicah, imenovano natrijev glukozni koprenašalec 2 (SGLT2).
English: In two studies evaluating canagliflozin as an add-on to metformin, the reductions in HbA1c levels after 26 weeks was 0.91 to 1.16 percentage points higher with canagliflozin than with placebo (a dummy treatment) when added to metformin and canagliflozin achieved similar reductions to two other diabetes medicines, glimepiride and sitagliptin, after 52 weeks of treatment.
Slovenian: V dveh študijah, v katerih so ocenjevali kanagliflozin kot dodatek k metforminu, je kanagliflozin ravni HbA1c po 26 tednih znižal za 0,91 do 1,16 odstotne točke več kot placebo (zdravilo brez zdravilne učinkovine), ki so ga prav tako dodajali metforminu, po 52 tednih zdravljenja pa je kanagliflozin povzročil podobna znižanja kot dve drugi zdravili za zdravljenje sladkorne bolezni, glimepirid in sitagliptin.
English: Added to metformin and pioglitazone, canagliflozin was also superior to placebo, leading to HbA1c reductions that were 0.62 and 0.76 points more than was seen by adding placebo.
Slovenian: Kanagliflozin, ki so ga dodajali metforminu in pioglitazonu, je bil prav tako učinkovitejši od placeba, saj je povzročil znižanja ravni HbA1c, ki so bila za 0,62 in 0,76 odstotne točke večja od tistih, ki so jih opazili pri dodajanju placeba.
English: By blocking the action of SGLT2, canagliflozin causes more glucose to be removed via the urine,
Slovenian: Kanagliflozin z zaviranjem delovanja prenašalca SGLT2 povzroči večje izločanje glukoze z urinom, kar zniža ravni glukoze v krvi.
English: How is Vokanamet used?
Slovenian: Kako se zdravilo Vokanamet uporablja?
English: It also leads to weight loss, which is considered beneficial in patients with diabetes.
Slovenian: Kanagliflozin povzroči tudi zmanjšanje telesne mase, kar je koristen učinek za bolnike s sladkorno boleznijo.
English: Added to metformin and a sulphonylurea, canagliflozin led to reductions in HbA1c that were between 0.71 and 0.92percentage points more than those seen with placebo after 26 weeks and similar to those seen with sitagliptin (another diabetes medicine) after 52 weeks.
Slovenian: Kanagliflozin, ki so ga dodajali k metforminu in sulfonilsečnini, je po 26 tednih ravni HbA1c znižal za 0,71 do 0,92 odstotne točke več kot placebo, po 52 tednih pa je povzročil podobna znižanja, kot so jih zabeležili pri uporabi sitagliptina (drugega zdravila za zdravljenje sladkorne bolezni).
English: EMA/324406/2015 Corr.1
Slovenian: EMA/324406/2015
English: If symptoms of dementia do not improve after 3 months or if symptoms worsen during the treatment, a doctor should be consulted.
Slovenian: Če se simptomi demence po 3 mesecih ne izboljšajo ali se simptomi med zdravljenjem poslabšajo, se je treba posvetovati z zdravnikom.
English: Bleeding such as bleeding in the eye, nose, brain or gut has also been reported.
Slovenian: Poročali so tudi o krvavitvi, npr. v očeh, nosu, možganih ali črevesju.
English: The exact way ginkgo leaf works in dementia is not fully understood but it is thought to protect brain cells from damage either directly or indirectly by regulating blood flow or by neutralising toxic forms of oxygen molecules (called oxygen free radicals).
Slovenian: Natančen način delovanja lista ginka na demenco ni popolnoma znan, vendar menijo, da neposredno ali posredno ščiti možganske celice pred poškodbo, tako da uravnava krvni pretok ali nevtralizira toksične oblike kisikovih molekul (imenovanih prosti kisikovi radikali).
English: For the treatment of minor circulation problems, a doctor or a qualified healthcare practitioner should be consulted if symptoms persist for longer than 2 weeks.
Slovenian: Pri zdravljenju manjših težav s krvnim obtokom se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem, če simptomi trajajo dlje kot 2 tedna.
English: In its assessment, the HMPC considered a number of clinical studies with ginkgo leaf looking at its effectiveness in improving memory.
Slovenian: Pri svoji oceni je odbor HMPC upošteval številne klinične študije z listom ginka, ki so proučevale njegovo učinkovitost pri izboljšanju spomina.
English: This summary is not intended to provide practical advice on how to use medicines containing ginkgo leaf.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo list ginka.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ginkgo leaf.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo lista ginka.
English: Ginkgo leaf medicines should only be used in adults.
Slovenian: Zdravila z listom ginka smejo uporabljati samo odrasli.
English: These ginkgo leaf preparations can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki iz lista ginka so lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi v nekaterih zdravilih rastlinskega izvora.
English: When used for minor circulation problems, gastrointestinal disorders (side effects affecting the gut), headaches and allergic reactions have been reported.
Slovenian: Pri uporabi zaradi manjših težav s krvnim obtokom so poročali o gastrointestinalnih motnjah (neželenih učinkih, ki prizadenejo prebavila), glavobolu in alergijskih reakcijah.
English: Medicines containing the powdered leaf should only be used after serious conditions have been excluded by a doctor.
Slovenian: Zdravila, ki vsebujejo liste v prahu, se smejo uporabljati samo, če je zdravnik izključil druge resne bolezni.
English: The dry extract is prepared using a technique to extract compounds from plant material by dissolving them in acetone which is then evaporated to obtain the dry extract.
Slovenian: Suhi izvleček se pripravlja s tehniko za ekstrakcijo sestavin iz rastlinskega materiala, tako da se ta raztopi v acetonu, ki potem izhlapi (s čimer pridobimo suhi izvleček).
English: How does ginkgo leaf work as a medicine?
Slovenian: Kako list ginka deluje kot zdravilo?
English: The most relevant clinical trials performed in adults aged 50 years and above indicated that ginkgo leaf medicines containing the dry extract could have beneficial effects on cognitive function in mild dementia.
Slovenian: Najpomembnejša klinična preskušanja, izvedena pri odraslih, starih 50 let in več, so pokazala, da imajo lahko zdravila z listom ginka, ki vsebujejo suhi izvleček, koristne učinke na kognitivno funkcijo pri blagi demenci.
English: Further information on the risks associated with ginkgo leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo list ginka, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC also concluded that, on the basis of their long-standing use, ginkgo leaf medicines containing the powdered leaf can be used for the relief of heaviness in the legs and the sensation of cold hands and feet that may occur with minor circulation problems.
Slovenian: Odbor HMPC je prav tako zaključil, da se lahko na podlagi njihove dolgotrajne uporabe zdravila z listom ginka, ki vsebujejo liste v prahu, uporabljajo za lajšanje občutka teže v nogah in mrzlih dlani ter stopal, ki so lahko posledica manjših težav s krvnim obtokom.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing ginkgo leaf.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo list ginka.
English: In patients who have a tendency to bleed or who use blood thinning medicines, ginkgo leaf medicines containing the dry extract should only be used after consulting a doctor.
Slovenian: Pri bolnikih, nagnjenih h krvavitvam ali pri tistih, ki uporabljajo zdravila za redčenje krvi, se smejo zdravila z listom ginka, ki vsebujejo suhi izvleček, uporabljati samo po posvetu z zdravnikom.
English: Information on the use and licensing of ginkgo leaf medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo list ginka, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Any applications for the licensing of medicines containing ginkgo leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo list ginka, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: The HMPC concluded that ginkgo leaf medicines containing the dry extract can be used to improve the age-related cognitive impairment (worsening of mental abilities) and quality of life of adults with mild dementia.
Slovenian: Odbor HMPC je zaključil, da se lahko zdravila z listom ginka, ki vsebujejo suhi izvleček, uporabljajo za izboljšanje s starostjo povezanega kognitivnega poslabšanja (slabšanja umskih sposobnosti) in kakovosti življenja pri odraslih z blago demenco.
English: Although clinical studies with ginkgo leaf medicines for minor circulation problems are available, they were too limited to be used as evidence and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Slovenian: Čeprav so na voljo klinične študije zdravil z listom ginka za zdravljenje blagih težav s krvnim obtokom, so preveč pomanjkljive, da bi se lahko uporabile kot dokaz učinkovitosti, zato zaključki odbora HMPC za to indikacijo temeljijo na dolgotrajni uporabi teh zdravil.
English: Further information on the HMPC assessment of ginkgo leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo list ginka, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: At the time of the HMPC assessment, the most common side effect with ginkgo leaf medicines used for the treatment of mild dementia was headache (seen in more than 1 patient in 10).
Slovenian: V času ocene odbora HMPC je bil najpogostejši neželeni učinek zdravil z listom ginka, ki se uporabljajo za zdravljenje blage demence, glavobol (ki se lahko pojavi pri več kot 1 osebi od 10).
English: The HMPC conclusions on the use of ginkgo leaf medicines for minor circulation problems are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo list ginka, proti manjšim težavam s krvnim obtokom, temeljijo na njihovi „tradicionalni uporabi“.
English: Ginkgo leaf medicines containing these preparations are usually available in liquid and solid forms to be taken by mouth.
Slovenian: Zdravila, ki vsebujejo pripravke iz lista ginka, so navadno na voljo v tekočih in trdnih oblikah za peroralno jemanje (zaužitje skozi usta).
English: How are ginkgo leaf medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo list ginka, odobrena v EU?
English: What evidence supports the use of ginkgo leaf medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo list ginka?
English: Detailed instructions on how to take ginkgo leaf medicines and who can use them can be found in the package leaflets that come with the medicines.
Slovenian: Podrobna navodila o tem, kako jemati zdravila z listom ginka in kdo jih sme uporabljati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Other information about ginkgo leaf medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo list ginka
English: What is ginkgo leaf?
Slovenian: Kaj je list ginka?
English: The HMPC conclusions on the use of ginkgo leaf medicines to improve the age-related cognitive impairment and quality of life of adults with mild dementia are based on their ‘well-established use' in this indication.
Slovenian: Zaključki odbora HMPC glede uporabe zdravil z listom ginka za izboljšanje s starostjo povezanega kognitivnega poslabšanja in kakovosti življenja pri odraslih z blago demenco temeljijo na „dobro uveljavljeni medicinski uporabi“ pri tej indikaciji.
English: What are the risks associated with ginkgo leaf medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo list ginka?
English: Ginkgo leaf
Slovenian: List ginka