natgillin/translations-raw huggingface dataset:
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Alcover v obliki zrnc niso večje od z njim povezanih tveganj ter da se dovoljenje za promet ne more izdati v Avstriji in v naslednjih državah članicah EU: na Danskem, Finskem, v Franciji, na Irskem, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu.
On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
Evropska agencija za zdravila je 22. junija 2017 končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Alcover v obliki zrnc.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 18.12.2017 izdala končni pravno zavezujoči sklep, ki velja v vseh državah članicah EU.
After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation could not be granted.
Po pregledu razlogov za to zahtevo je odbor CHMP ponovno proučil mnenje in 12. oktobra 2017 potrdil, da dovoljenja za promet z zdravilom ni mogoče izdati.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules were insufficient and of inadequate quality to demonstrate that the medicine would be effective in the proposed uses.
Odbor CHMP je glede na oceno trenutno razpoložljivih podatkov in znanstveno razpravo v odboru zaključil, da so podatki, predloženi v podporo vlogi za pridobitev dovoljenja za promet z zdravilom Alcover v obliki zrnc, nezadostni in neustrezne kakovosti za dokaz, da bi bilo zdravilo učinkovito pri predlaganih uporabah.
The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
Razlog za napotitev so bili pomisleki več držav članic, da koristi zdravila Alcover v obliki zrnc niso bile jasno dokazane in da obstaja več tveganj, vključno s tveganjem za odvisnost, napačno uporabo in neželene učinke.
Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure.
Družba Debrégeas & Associés Pharma je pri avstrijski regulativni agenciji za zdravila predložila vlogo za pridobitev dovoljenja za promet z zdravilom Alcover v obliki zrnc po decentraliziranem postopku.
However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.
Ker pa države članice niso dosegle soglasja, je avstrijska regulativna agencija za zdravila 22. decembra 2016 zadevo napotila na odbor CHMP v arbitražo.
After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted.
Po ponovni proučitvi je odbor CHMP potrdil svoje prvotno mnenje, da dovoljenja za promet z zdravilom ni mogoče izdati.
Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.
Ker se zdravilo Alcover v obliki zrnc na te receptorje veže enako kot alkohol, naj bi se uporabljalo za zdravljenje učinkov prenehanja uživanja alkohola pri bolnikih, odvisnih od alkohola, vključno z vznemirjenostjo, tremorjem (tresenjem) in težavami s spanjem, ter za podporo pri nadaljnji abstinenci.
Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption.
Zdravilo Alcover v obliki zrnc naj bi se uporabljalo za zdravljenje akutnega alkoholnega odtegnitvenega sindroma in podporo pri srednje- do dolgoročni abstinenci pri odraslih, odvisnih od alkohola, ki uživajo zelo velike količine alkohola.
This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.
Ta sklep zadeva samo vlogo za pridobitev dovoljenja za promet z zdravilom Alcover v obliki zrnc in ne vpliva na zdravilo Alcover v obliki sirupa.
The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gammaaminobutyric acid (GABA), leading to a calming of the activity of these cells.
Zdravilna učinkovina v zdravilu Alcover v obliki zrnc, natrijev oksibat, se veže na receptorje (prijemališča) za gama-aminomasleno kislino (GABA) na živčnih celicah v možganih in hrbtenjači, kar umiri dejavnost teh celic.
What are Alcover granules?
Kaj je zdravilo Alcover v obliki zrnc?
However, the CHMP concluded that, since the benefits of Alcover granules were not clearly demonstrated, the marketing authorisation could not be granted in the reference and concerned Member States.
Ker pa koristi zdravila Alcover v obliki zrnc niso bile jasno dokazane, je odbor CHMP zaključil, da dovoljenja za promet z zdravilom v referenčnih in zadevnih državah članicah ni mogoče izdati.
The European Commission granted a marketing authorisation valid throughout the EU for Imprida on 17 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Imprida, veljavno po vsej Evropski uniji, izdala 16. januarja 2007.
The full EPAR for Imprida 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 Imprida je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Imprida amlodipine / valsartan
Imprida amlodipin/valsartan
What benefit has Imprida shown during the studies?
Kakšne koristi je zdravilo Imprida izkazalo med študijami?
Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Obe učinkovini sta zdravili proti zvišanemu krvnemu tlaku, ki sta bili v Evropski uniji (EU) od sredine 90-ih let prejšnjega stoletja na voljo kot ločeni zdravili.
Other information about Imprida
Druge informacije o zdravilu Imprida
This is a summary of the European public assessment report (EPAR) for Imprida.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imprida.
The CHMP decided that Imprida's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Imprida večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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 Imprida.
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.
For more information about treatment with Imprida, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Imprida preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Imprida?
Kakšna tveganja so povezana z zdravilom Imprida?
By lowering the blood pressure, the risks associated with by high blood pressure, such as having a stroke, are reduced.
Z znižanjem krvnega tlaka se zmanjša možnost tveganj, povezanih z visokim krvnim tlakom, kot je na primer kap.
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Imprida and people taking the separate medicines.
Družba je prav tako predložila dokaze o tem, da sta bili ravni amlodipina in valsartana v krvi enaki pri ljudeh, ki so jemali zdravilo Imprida, in ljudeh, ki so obe zdravilni učinkovini jemali ločeno.
The most common side effects with Imprida (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Najpogostejši neželeni učinki zdravila Imprida (opaženi pri 1 do 10 bolnikih od 100) so glavobol, nazofaringitis (vnetje nosne votline in grla), influenca (gripa), hipokaliemija (nizke ravni kalija v krvi), različne vrste edemov (oteklin), utrujenost, pordelost, astenija (oslabelost) in navali vročine.
The dose of Imprida to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Odmerek zdravila Imprida, ki ga je treba vzeti, je odvisen od odmerkov amlodipina ali valsartana, ki ju je bolnik jemal prej.
Imprida is taken by mouth as one tablet once a day with some water.
Zdravilo Imprida se jemlje peroralno, in sicer se zaužije ena tableta na dan z malo vode.
Imprida must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Zdravila Imprida prav tako ne smejo jemati bolniki, ki imajo hude težave z jetri ali izločanjem žolča, bolniki z nekaterimi obolenji srca ter bolniki s hudo hipotenzijo (nizkim krvnim tlakom).
Imprida must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Zdravila Imprida ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) amlodipin ali druga zdravila iz razreda derivatov dihidropiridina, valsartan ali katero koli drugo sestavino zdravila.
Why has Imprida been approved?
Zakaj je bilo zdravilo Imprida odobreno?
Imprida is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Zdravilo Imprida se uporablja pri bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak), ki je ni mogoče ustrezno uravnati samo z amlodipinom ali valsartanom.
Imprida must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Zdravilo Imprida se prav tako ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), pri bolnikih s sladkorno boleznijo tipa 2 ali zmerno do hudo ledvično okvaro.
For the full list of all side effects reported with Imprida, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Imprida, glejte navodilo za uporabo.
Imprida is a medicine that contains two active substances, amlodipine and valsartan.
Imprida je zdravilo, ki vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
What is Imprida used for?
Za kaj se zdravilo Imprida uporablja?
How is Imprida used?
Kako se zdravilo Imprida uporablja?
How has Imprida been studied?
Kako je bilo zdravilo Imprida raziskano?
Imprida contains two active substances, amlodipine and valsartan.
Zdravilo Imprida vsebuje dve zdravilni učinkovini, amlodipin in valsartan.
What is Imprida?
Kaj je zdravilo Imprida?
How does Imprida work?
Kako zdravilo Imprida deluje?
16 January, 2014
16. januar 2014
The majority of these reactions were transient and reversible.
Večina teh učinkov je bila prehodnih in reverzibilnih.
• if you are 75 years old or older, you should not start taking this medicine.
• če ste stari 75 let ali več, ne smete začeti jemati tega zdravila.
This is because you may be more prone to some side effects.
To je zato, ker ste lahko bolj nagnjeni k pojavu nekaterih neželenih učinkov.
Dapagliflozin is approximately 91 % protein bound.
Dapagliflozin je približno 91-odstotno vezan na beljakovine.
In feces, approximately 15 % of the dose was excreted as parent drug.
V blatu se je približno 15 % odmerka izločilo kot matično zdravilo.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
• passing more water (urine) than usual or needing to pass water more often
• odvajanje več vode (urina) kot po navadi ali potreba po pogostejšem odvajanju urina
These clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Ti klinično pomembni učinki na glikemijo so se ohranili v dolgoročnih podaljšanjih do 104 tedne.
Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
• if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking this medicine.
• če jemljete kakšno drugo zdravilo za sladkorno bolezen, ki vsebuje "pioglitazon", ne smete začeti jemati tega zdravila.
Cardiovascular episodes were adjudicated by an independent adjudication committee.
Srčno-žilne dogodke je presojal neodvisen odbor za presojo.
• For renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
• V primeru delovanja ledvic z GFR, ki se približuje zmerni okvari ledvic in pri starejših bolnikih, vsaj 2- do 4-krat na leto.
Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects'.
Možni znaki čezmernega izgubljanja tekočine iz telesa so našteti na začetku poglavja 4, "Možni neželeni učinki".
More information is given below in ‘Other medicines and Xigduo'.
Več informacij najdete v poglavju "Druga zdravila in zdravilo Xigduo", spodaj.
• Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP'.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali škatli poleg oznake "EXP".
Patients with baseline HbA1c ≥ 9 %
Bolniki z izhodiščnim HbA1c ≥ 9 %
Due to the limited therapeutic experience with dapagliflozin in patients 75 years and older, initiation of therapy in this population is not recommended.
Zaradi omejenih terapevtskih izkušenj z dapagliflozinom pri bolnikih, starih 75 let ali več, uvedba zdravljenja v tej populaciji ni priporočljiva.
Stop taking Xigduo and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
Nehajte jemati zdravilo Xigduo in čim prej obiščite zdravnika, če opazite katerega od naslednjih resnih ali potencialno resnih neželenih učinkov:
• changes in laboratory blood tests (creatinine or urea)
• spremembe laboratorijskih izvidov krvi (kreatinin ali sečnina)
To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking this medicine.
Da boste preprečili preveliko odmerjanje, ne nadaljujte jemanja tablet dapagliflozina in metformina, če jemljete to zdravilo.
Although uncommon, if you see blood in your urine, tell your doctor immediately.
Kri v urinu se sicer ne pojavi pogosto, a če jo opazite, morate o tem takoj obvestiti svojega zdravnika.
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Prospektivna randomizirana študija (UKPDS) je ugotovila dolgoročne koristi intenzivnega obvladovanja glukoze v krvi pri sladkorni bolezni tipa 2.
Since the numerical imbalance of breast, bladder and prostate tumours must be considered with caution, it will be further investigated in post-authorisation studies.
Ker je treba številčno neravnovesje tumorjev dojke, mehurja in prostate obravnavati previdno, ga bodo še naprej preučevali v študijah po pridobitvi dovoljenja za promet z zdravilom.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30 %.
Po peroralnem odmerku je neabsorbirani delež, ki se pojavi v blatu, od 20 do 30 %.
These infections were more frequent in females, and subjects with a prior history were more likely to have a recurrent infection.
Te okužbe so bile pogostejše pri ženskah, osebe z anamnezo pa so imele večjo verjetnost za ponavljajoče se okužbe.
• discomfort when passing water (urine)
• nelagodje pri odvajanju vode (uriniranju)
A meta-analysis of cardiovascular events in the clinical program was performed.
Izvedli so metaanalizo srčno-žilnih dogodkov v kliničnem programu.
Dapagliflozin or metformin have no or negligible influence on the ability to drive and use machines.
Dapagliflozin in metformin nimata vpliva ali imata le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
• in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
• v kombinaciji z drugimi antidiabetiki, vključno z insulinom, pri bolnikih, ki niso zadostno urejeni z metforminom in temi zdravili (glejte poglavja 4.4, 4.5 in 5.1 za razpoložljive podatke o različnih kombinacijah),
• This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes, along with diet and exercise.
• To zdravilo se uporablja, če sladkorne bolezni ni mogoče urediti z drugimi zdravili za zdravljenje sladkorne bolezni, skupaj z dieto in s telesno dejavnostjo.
Xigduo should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Zdravila Xigduo se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
• if you are using corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis.
• če uporabljate kortikosteroide, ki se uporabljajo za zdravljenje vnetij in bolezni, kakršni sta astma ali artritis.
The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Vplivi kajenja, prehrane, zeliščnih pripravkov in alkohola na farmakokinetiko dapagliflozina niso raziskani.
Considering the lack of tumour findings in non-clinical studies as well as the short latency between first drug exposure and tumour diagnosis, a causal relationship is considered unlikely.
Glede na pomanjkanje izsledkov glede tumorjev v predkliničnih študijah in zaradi kratke latence med prvo izpostavljenostjo zdravilu in diagnozo tumorja vzročna povezanost ni verjetna.
Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Neraziskane kombinacije Dapagliflozin ni raziskan v kombinaciji z analogi glukagonu podobnega peptida 1 (GLP-1).
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50 % and Cmax by 81 %.
Študija pri sedmih normalnih zdravih prostovoljcih je pokazala, da je cimetidin v odmerku 400 mg dvakrat na dan povečal sistemsko izpostavljenost (AUC) metforminu za 50 % in njegovo Cmax za 81 %.
Posology Adults with normal renal function (GFR ≥ 90 mL/min)
Odmerjanje Odrasli z normalnim delovanjem ledvic (GFR ≥ 90 ml/min)
Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Metformin poveča prenašalno kapaciteto specifičnih vrst membranskih prenašalcev glukoze (GLUT-1 in GLUT
Gender The mean dapagliflozin AUCss in females was estimated to be about 22 % higher than in males.
Spol Ocenjena povprečna AUCss dapagliflozina pri ženskah je približno 22 % večja kot pri moških.
The primary end point was the time-to-first event of one of the following outcomes: cardiovascular death, stroke, myocardial infarction (MI) or hospitalisation for unstable angina.
Primarni opazovani dogodek je bil čas do prvega od naslednjih izidov: srčno-žilne smrti, možganske kapi, miokardnega infarkta (MI) ali sprejema v bolnišnico zaradi nestabilne angine pektoris.
• The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
• odbor PRAC je menil tudi, da je treba zbrati dodatne informacije o amputacijah, in sicer z ustreznimi obrazci za poročila o primerih v kliničnih preskušanjih, vprašalniki za spremljanje primerov v obdobju trženja, uporabo seznamov prednostnih izrazov MedDRA za znake, ki napovedujejo amputacijo, in ustreznimi metaanalizami velikih študij, vključno s študijami kardiovaskularnih izidov.
You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Xigduo.
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic, zdravnik pa bo morda moral prilagoditi odmerek zdravila Xigduo.
The meal resulted in a delay of 1 to 2 hours in the peak concentrations and a decrease in the maximum plasma concentration of 29 % of dapagliflozin and 17 % of metformin.
Obrok je povzročil, da je bila najvišja koncentracija dosežena 1 do 2 uri pozneje in najvišje koncentracije dapagliflozina v plazmi so bile zmanjšane za 29 % in metformina za 17 %.
Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19 % increase in AUC of simvastatin and 31 % increase in AUC of simvastatin acid.
Kombinacija enkratnega odmerka 20 mg dapagliflozina in simvastatina (substrata CYP3A4) je povzročila 19-odstotno povečanje AUC simvastatina in 31-odstotno povečanje AUC simvastatinske kisline.
If you forget to take Xigduo Do not take a double dose of this medicine to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Xigduo Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
These infections were more frequent in females (8.4 % and 1.2 % for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Te okužbe so bile pogostejše pri ženskah (8,4 % z dapagliflozinom in 1,2 % s placebom), osebe z anamnezo pa so imele večjo verjetnost za ponavljajoče se okužbe.
• if you have a history of serious heart disease or if you have had a stroke.
• če ste kdaj imeli kakšno resno bolezen srca ali če ste imeli možgansko kap.