natgillin/translations-raw huggingface dataset:
Further information on the HMPC assessment of fresh bilberry fruit 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.
Dodatne informacije o oceni zdravil, ki vsebujejo svež plod borovnice, 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.
Any applications for the licensing of medicines containing fresh bilberry fruit 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.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo svež plod borovnice, 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.
Information on the use and licensing of fresh bilberry fruit medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo svež plod borovnice, v državah članicah EU se obrnite na pristojni nacionalni organ.
The HMPC conclusions on the use of fresh bilberry fruit medicines for relief of discomfort and heaviness of legs related to minor blood circulatory problems and for relief of symptoms of bleeding into the skin from tiny blood vessels are based on their ‘traditional use'.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo svež plod borovnice, za lajšanje neugodja in težkih nog, povezanih z manjšimi težavami z obtočili, in za lajšanje simptomov krvavitve v kožo iz kapilar, temeljijo na njihovi „tradicionalni uporabi“.
Results from laboratory studies indicate that bilberries are rich in anthocyanins, which are thought to improve blood circulation by relaxing and dilating (widening) blood vessels and protecting blood vessels from damage.
Rezultati laboratorijskih študij kažejo, da so borovnice bogate z antocianini, ki naj bi s sproščanjem in dilatacijo (širjenjem) žil in zaščito žil pred poškodbami izboljševali krvni obtok.
How are fresh bilberry fruit medicines approved in the EU?
Kako so zdravila, ki vsebujejo svež plod borovnice, odobrena v EU?
The HMPC concluded that, on the basis of its long-standing use, fresh bilberry fruit medicines can be used to relieve discomfort and heaviness of legs related to minor blood circulatory problems and to relieve symptoms of bleeding into the skin from tiny blood vessels.
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko zdravila, ki vsebujejo svež plod borovnice, uporabljajo za lajšanje neugodja in težkih nog, povezanih z manjšimi težavami z obtočili, in za lajšanje simptomov krvavitve v kožo iz kapilar.
Other information about fresh bilberry fruit medicines
Druge informacije o zdravilih, ki vsebujejo svež plod borovnice
Detailed instructions on how to take fresh bilberry fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo svež plod borovnice, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
What evidence supports the use of fresh bilberry fruit medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo svež plod borovnice?
What are the risks associated with fresh bilberry fruit medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo svež plod borovnice?
For more information about treatment with fresh bilberry fruit medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo svež plod borovnice, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using fresh bilberry fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
This summary was last updated in 05-2016
Povzetek je bil nazadnje posodobljen 05-2016.
Jentadueto must not be used in patients with:
Zdravila Jentadueto ne smejo uporabljati bolniki z:
The European Commission granted a marketing authorisation valid throughout the European Union for Jentadueto on 20 July 2012.
Evropska komisija je dovoljenje za promet z zdravilom Jentadueto, veljavno po vsej Evropski uniji, izdala 20. julija 2012.
Jentadueto is taken twice a day.
Zdravilo Jentadueto se jemlje dvakrat na dan.
The full EPAR for Jentadueto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Jentadueto je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Jentadueto.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jentadueto.
Other information about Jentadueto
Druge informacije o zdravilu Jentadueto
What extra measures are being taken to ensure the safe and effective use of Jentadueto?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jentadueto?
Linagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Linagliptin je zaviralec dipeptidil-peptidaze-4 (DPP 4).
Linagliptin has been authorised in the European Union (EU) as Trajenta since 2011.
Linagliptin je v Evropski uniji (EU) odobren od leta 2011 kot zdravilo Trajenta.
For more information about treatment with Jentadueto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Jentadueto preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
With regard to side effects, the Committee considered that in general the risks seen were only slightly greater than those seen with placebo.
Glede neželenih učinkov je menil, da so bila opažena tveganja na splošno samo rahlo večja od tistih pri uporabi placeba.
The CHMP noted that fixed dose combinations may increase the likelihood of patients taking their medicine correctly.
Ugotovil je, da lahko fiksne kombinacije odmerkov povečajo verjetnost, da bodo bolniki zdravilo pravilno jemali.
• diabetic ketoacidosis or diabetic pre-coma (dangerous complications of diabetes);
• diabetično ketoacidozo ali predkomo (nevarnima zapletoma sladkorne bolezni);
• a condition that could lead to reduced supply of oxygen to body tissues (such as in patients who are being treated for worsening heart failure, have recently had a heart attack, have difficulty breathing or a steep fall in blood pressure);
• obolenjem, ki lahko povzroči zmanjšano dovajanje kisika v tkiva (npr. pri bolnikih, ki se zdravijo zaradi srčnega popuščanja, so pred kratkim doživeli srčni napad, imajo oteženo dihanje ali nenaden padec krvnega tlaka);
The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking before.
Jakost tablete, ki jo je treba uporabiti, je odvisna od odmerka drugih zdravil za zdravljenje sladkorne bolezni, ki ga je bolnik jemal prej.
It is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg).
Na voljo je v obliki tablet (2,5 mg/850 mg in 2,5 mg/1 000 mg).
• moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function such as dehydration, severe infection or shock;
• zmerno ali močno zmanjšanim delovanjem ledvic ali akutnimi (nenadnimi) stanji, ki lahko vplivajo na delovanje ledvic, kot so dehidracija, huda okužba ali šok;
Therefore the CHMP decided that Jentadueto's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Jentadueto večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
• in patients who are already taking a combination of linagliptin and metformin as separate tablets;
• pri bolnikih, ki že jemljejo kombinacijo linagliptina in metformina v ločenih tabletah;
A risk management plan has been developed to ensure that Jentadueto is used as safely and effectively as possible.
Za zagotovitev čim varnejše uporabe zdravila Jentadueto je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jentadueto, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What benefit has Jentadueto shown during the studies?
Kakšne koristi je zdravilo Jentadueto izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jentadueto.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Jentadueto linagliptin / metformin hydrochloride
Jentadueto linagliptin/metforminijev hidroklorid
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba koncentracije snovi, imenovane glikozilirani hemoglobin (HbA1c), v krvi po 24 tednih zdravljenja.
Jentadueto should be taken with food to reduce stomach problems caused by metformin.
Zdravilo Jentadueto je treba jemati skupaj s hrano, da bi se zmanjšale želodčne težave, ki jih povzroča metformin.
The study compared the effects of adding linagliptin to metformin in these ways, since metformin needs to be taken at least twice per day.
V študiji so primerjali učinke dodajanja linagliptina metforminu, saj je treba metformin jemati vsaj dvakrat na dan.
The maximum dose is 5 mg of linagliptin and 2,000 mg of metformin per day.
Največji odmerek je 5 mg linagliptina in 2 000 mg metformina na dan.
If Jentadueto is taken with a sulphonylurea or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Če bolnik jemlje zdravilo Jentadueto sočasno s sulfonilsečnino ali insulinom, bo morda treba zmanjšati odmerek teh zdravil, da bi preprečili hipoglikemijo (nizko raven sladkorja v krvi).
For the full list of all side effects reported with Jentadueto, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jentadueto, glejte navodilo za uporabo.
What is the risk associated with Jentadueto?
Kakšna tveganja so povezana z zdravilom Jentadueto?
The studies looked at the effectiveness of linagliptin used on its own (503 patients), in combination with metformin (701 patients), with metformin plus a sulphonylurea (1,058 patients) or with another diabetes medicine pioglitazone (389 patients).
V študijah so proučevali učinkovitost linagliptina pri uporabi kot samostojno zdravilo (503 bolniki), v kombinaciji z metforminom (701 bolnik), z metforminom in sulfonilsečnino (1 058 bolnikov) ali drugim zdravilom za zdravljenje sladkorne bolezni, tj. pioglitazonom (389 bolnikov).
The combination gave a reduction of 1.22 points when metformin was given at 500 mg and a reduction of 1.59 points when metformin was given at 1,000 mg.
Z jemanjem kombinacije zdravil je prišlo do znižanja za 1,22 točke, kadar se je metformin dajal v odmerku 500 mg, in do zmanjšanja za 1,59 točke, kadar se je metformin dajal v odmerku 1 000 mg.
Jentadueto is a medicine that contains the active substances linagliptin and metformin hydrochloride.
Jentadueto je zdravilo, ki vsebuje zdravilni učinkovini linagliptin in metforminijev hidroklorid.
Linagliptin does not work when the blood glucose is low.
Linagliptin namreč nima učinka, če je raven glukoze v krvi nizka.
This gives an indication of how well blood glucose is controlled.
To je pokazatelj, kako dobro je raven glukoze v krvi uravnana.
Jentadueto is used in adults with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Zdravilo Jentadueto se uporablja pri odraslih bolnikih s sladkorno boleznijo tipa 2 za boljše uravnavanje ravni glukoze (sladkorja) v krvi.
When linagliptin and metformin were given with a sulphonylurea or insulin, hypoglycaemia was the most frequent side effect (seen in more than 1 patient in 10).
Pri jemanju linagliptina in metformina s sulfonilsečnino ali insulinom je bil najpogostejši neželeni učinek hipoglikemija (opažen pri več kot 1 bolniku od 10).
The most frequent side effect with the combination of linagliptin plus metformin was diarrhoea (seen in around 2% of patients, with a similar rate seen in patients taking metformin plus placebo).
Najpogostejši neželeni učinek zdravila v kombinaciji z linagliptinom in metforminom je driska (opažena pri okoli 2 % bolnikov, kar je podobno pogostnosti pri bolnikih, ki so jemali metformin in placebo).
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Ti procesi skupaj znižajo raven glukoze v krvi in prispevajo k uravnavanju sladkorne bolezni tipa 2.
• in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
• pri bolnikih, pri katerih sladkorna bolezen ni zadostno uravnana samo z metforminom (zdravilom za zdravljenje sladkorne bolezni);
The company presented the results of four studies with linagliptin in patients with type 2 diabetes, which were used to support the approval of Trajenta in the EU, comparing linagliptin given at 5 mg once per day with placebo (a dummy treatment).
Družba je predstavila rezultate štirih študij z linagliptinom pri bolnikih s sladkorno boleznijo tipa 2, uporabljenih v podporo odobritvi zdravila Trajenta v EU, v katerih so jemanje linagliptina v odmerku 5 mg enkrat na dan primerjali s placebom (zdravilom brez zdravilne učinkovine).
Why has Jentadueto been approved?
Zakaj je bilo zdravilo Jentadueto odobreno?
The active substances in Jentadueto, linagliptin and metformin hydrochloride, each working in a different way.
Zdravilni učinkovini v zdravilu Jentadueto, linagliptin in metforminijev klorid, delujeta na različne načine.
The study looking at adding linagliptin 2.5 mg twice per day or 5 mg once per day to metformin showed a similar reduction in HbA1c levels compared with placebo (0.74 and 0.80 points more than placebo respectively).
Študija, v kateri so proučevali dodajanje linagliptina v odmerku 2,5 mg dvakrat na dan ali 5 mg enkrat na dan zdravljenju z metforminom, je pokazala podobno znižanje ravni HbA1c v primerjavi s placebom (za 0,74 oziroma 0,80 točke več kot pri placebu).
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 previsoke.
As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Kot posledica delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, to pa prispeva k uravnavanju sladkorne bolezni tipa 2.
The CHMP concluded that the combination of linagliptin and metformin has been shown to be effective at lowering HbA1c levels, and that linagliptin 2.5 mg twice per day was as effective as 5 mg once per day, which is approved in the EU for use on its own and in combination with metformin and with metformin plus a sulphonylurea or insulin.
Odbor CHMP je zaključil, da se je kombinacija linagliptina in metformina izkazala za učinkovito pri zniževanju ravni HbA1c ter da je bil linagliptin, ki je odobren v EU za samostojno uporabo in v kombinaciji z metforminom ali metforminom in sulfonilsečnino ali insulinom, v odmerku 2,5 mg dvakrat na dan enako učinkovit kot v odmerku 5 mg enkrat na dan.
The studies with linagliptin showed that it was more effective than placebo at reducing HbA1c levels.
Študije z linagliptinom so pokazale, da je to zdravilo pri zniževanju ravni HbA1c učinkovitejše od placeba.
Another study carried out in 1040 patients with type 2 diabetes compared patients taking 5 mg linagliptin and insulin given with metformin, with patients taking placebo given with insulin and metformin.
Opravljena je bila še ena študija s 1 040 bolniki s sladkorno boleznijo tipa 2, v kateri so primerjali bolnike, ki so jemali 5 mg linagliptina in insulina skupaj z metforminom, z bolniki, ki so jemali placebo skupaj z insulinom in metforminom.
The study looking at linagliptin in combination with metformin and insulin showed that this combination was more effective than the combination of insulin and metformin at reducing HbA1c levels (reduction of 0.77 percentage points was seen with linagliptin compared with a reduction of 0.10 percentage points with placebo).
Študija, v kateri so proučevali linagliptin v kombinaciji z metforminom in insulinom, je pokazala, da je ta kombinacija pri zniževanju ravni HbA1 učinkovitejša od kombinacije insulina in metformina (v kombinaciji z linagliptinom je zmanjšanje znašalo 0,77 odstotne točke v primerjavi z zmanjšanjem pri placebu, ki je znašalo 0,10 odstotne točke).
When given in combination, linagliptin with metformin gave a reduction of 0.56 points compared with a rise of 0.10 points; linagliptin with metformin plus a sulphonylurea gave a reduction of 0.72 points compared with 0.10 points.
Ko so linagliptin dajali v kombinaciji z metforminom, je prišlo do znižanja za 0,56 točke v primerjavi s povišanjem za 0,10 točke, medtem ko je pri jemanju linagliptina sočasno z metforminom in sulfonilsečnino prišlo do znižanja za 0,72 točke v primerjavi z 0,10 točke.
A further study was carried out involving 491 patients with type 2 diabetes taking metformin twice per day, where placebo or linagliptin at either 2.5 mg twice per day or at 5 mg once per day was added to their treatment.
Izvedena je bila tudi dodatna študija, v kateri so pri 491 bolnikih s sladkorno boleznijo tipa 2, ki so dvakrat na dan jemali metformin, dodajali placebo ali linagliptin v odmerku 2,5 mg dvakrat na dan ali 5 mg enkrat na dan.
When used on its own, linagliptin gave a reduction of 0.46 points compared with a rise of 0.22 points.
Pri uporabi linagliptina kot samostojnega zdravila je prišlo do znižanja ravni HbA1c za 0,46 točke v primerjavi s povišanjem za 0,22 točke.
This compared with a reduction of 0.45 with linagliptin alone, 0.64 with 500 mg metformin alone, 1.07 with 1,000 mg metformin alone, and 0.13 with placebo.
To so primerjali z znižanjem za 0,45 točke pri samostojnem jemanju linagliptina, 0,64 točke pri jemanju metformina v odmerku 500 mg kot samostojnega zdravila, 1,07 točke pri jemanju metformina v odmerku 1 000 mg kot samostojnega zdravila ali 0,13 točke pri jemanju placeba.
Linagliptin was given at 2.5 mg twice per day in the combination treatment and at 5 mg once per day in the single treatment.
Pri kombiniranem zdravljenju so linagliptin uporabljali v odmerku 2,5 mg dvakrat na dan, pri njegovi uporabi kot samostojnim zdravilom pa v odmerku 5 mg enkrat na dan.
What is Jentadueto used for?
Za kaj se zdravilo Jentadueto uporablja?
How has Jentadueto been studied?
Kako je bilo zdravilo Jentadueto raziskano?
Another study was carried out involving 791 patients with type 2 diabetes, where the combination of linagliptin plus metformin given twice per day was compared with giving metformin alone, linagliptin alone or placebo.
Opravljena je bila še ena študija pri 791 bolnikih s sladkorno boleznijo tipa 2, v kateri so kombinacijo linagliptina in metformina, uporabljeno dvakrat na dan, primerjali z metforminom kot samostojnim zdravilom, linagliptinom kot samostojnim zdravilom ali placebom.
What is Jentadueto?
Kaj je zdravilo Jentadueto?
• in combination with a sulphonylurea or insulin (other types of diabetes medicines) in patients who are not satisfactorily controlled on this medicine and metformin.
• v kombinaciji s sulfonilsečnino ali insulinom (drugo vrsto zdravila za zdravljenje sladkorne bolezni)
How is Jentadueto used?
Kako se zdravilo Jentadueto uporablja?
The study with the combination of linagliptin and metformin showed that it was more effective than linagliptin or metformin alone, as well as placebo, at reducing HbA1c levels.
Študija s kombinacijo linagliptina in metformina je pokazala, da je kombinacija teh zdravilnih učinkovin pri zniževanju ravni HbA1c učinkovitejša od linagliptina ali metformina kot samostojnih zdravil in od placeba.
How does Jentadueto work?
Kako zdravilo Jentadueto deluje?
Metformin was given at either 500 mg or 1,000 mg twice per day, for both the combination and the single treatment.
Pri kombiniranem in samostojnem zdravljenju so bolniki dobivali metformin v odmerku 500 mg ali 1 000 mg dvakrat na dan.
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 zmanjša tudi količino glukoze, ki nastaja v jetrih.
Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid =WC0b01ac058004d5c1
Na voljo na naslovu: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp &mid=WC0b01ac058004d5c1
• Patients currently taking a combination of these medicines, or who have any concerns or questions, should discuss their medication with their doctor at their next regular appointment.
• Bolniki, ki trenutno jemljejo kombinacijo teh zdravil ali ki imajo kakršne koli pomisleke ali vprašanja, naj se o svojih zdravilih pogovorijo z zdravnikom na naslednjem rednem pregledu.
• In a small number of patients (mostly with heart failure) there may still be a medical need to combine two classes of these medicines.
• Pri majhnem številu bolnikov (večinoma s srčnim popuščanjem) morda še vedno obstaja medicinska potreba po kombinirani uporabi dveh skupin teh zdravil.
Restriction of combined use of medicines affecting the renin-angiotensin system (RAS)
Omejitev kombinirane uporabe zdravil, ki vplivajo na renin-angiotenzinski sistem (RAS)
This is of particular concern, as these patients and patients with renal impairment are already prone to developing hyperkalaemia.
To je zlasti zaskrbljujoče, saj so ti bolniki in bolniki z ledvično okvaro nagnjeni k razvoju hiperkaliemije.
1 European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines.
1 Evropska agencija za zdravila priporoča nove kontraindikacije in opozorila za zdravila, ki vsebujejo aliskiren.
The review of RAS-acting agents was initiated at the request of the Italian Medicines Agency (AIFA), under Article 31 of Directive 2001/83/EC.
Pregled snovi, ki delujejo na renin-angiotenzinski sistem, se je začel na zahtevo italijanske agencije za zdravila (AIFA) v skladu s členom 31 Direktive 2001/83/ES.
These recommendations are based on a detailed review of the available data, including clinical trials, meta-analyses and publications, as well as advice from a group of experts on cardiovascular medicine.
Ta priporočila temeljijo na podrobnem pregledu razpoložljivih podatkov, vključno s kliničnimi preskušanji, metaanalizami in publikacijami ter nasvetu skupine strokovnjakov za srčno-žilna vprašanja.