natgillin/translations-raw huggingface dataset:
The product information for Alli, which currently lists ‘hepatitis', will be updated accordingly.
Informacije o izdelku za zdravilo Alli, v katerih je zdaj naveden „hepatitis“, bodo ustrezno posodobljene.
Since authorisation, there have been some reports of severe liver problems in users of these medicines.
Od odobritve teh zdravil je bilo nekaj poročil o resnih težavah z jetri pri uporabnikih teh zdravil.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to be passed out in the stools undigested.
Če so ti encimi blokirani, ne morejo razkrojiti nekaterih maščob, zaradi česar se približno četrtina maščob, zaužitih z hrano, neprebavljenih izloči z blatom.
Patients should stop taking orlistat and inform their doctor if they experience any of these symptoms.
Prenehati morajo uživati orlistat in obvestiti svojega zdravnika, če imajo katere koli od teh bolezenskih znakov.
Since 2001 it has been recognised that some patients taking orlistat could experience very rare liverrelated side effects.
Od leta 2001 se ugotavlja, da lahko imajo nekateri bolniki, ki uživajo orlistat, zelo redke stranske učinke, povezane z jetri.
A pattern was not seen in the type of liver problems reported, and in most cases there were other factors which were likely to increase the risk of liver injury such as existing health problems or the use of other medicines.
V zvezi z vrsto sporočenih težav z jetri ni bil ugotovljen vzorec in v večini primerov so obstajali drugi dejavniki, ki verjetno povečujejo tveganje poškodbe jeter, kot so obstoječe zdravstvene težave ali uporaba drugih zdravil.
Orlistat is an anti-obesity medicine, which does not affect appetite.
Orlistat je zdravilo proti debelosti, ki ne vpliva na tek.
The current European public assessment report for Alli can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Trenutno evropsko javno poročilo o oceni zdravila za zdravilo Alli je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Xenical was authorised in 1998 and is available as capsules (120 mg) which can only be obtained with a prescription.
Zdravilo Xenical, ki je bilo odobreno leta 1998 in je na voljo v kapsulah (120 mg), je mogoče dobiti samo na zdravniški recept.
• Patients should note that symptoms of hepatitis can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage), sometimes with a loss of appetite.
• Bolniki se morajo zavedati, da lahko bolezenski znaki hepatitisa vključujejo porumenelost kože in oči, srbečico, temno obarvan urin, bolečine v trebuhu in občutljivost jeter (ki se izraža kot bolečina pod sprednjim delom prsnega koša), včasih z izgubo teka.
Consequently, the European Commission asked the CHMP to issue an opinion on orlistat and on whether the marketing authorisation for orlistat-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Evropska komisija je zato odbor CHMP pozvala, naj izda mnenje o zdravilni učinkovini orlistat in tem, ali je treba po vsej EU ohraniti, spremeniti, začasno umakniti ali preklicati dovoljenja za promet z zdravilom za zdravila, ki vsebujejo orlistat.
The current European public assessment report for Xenical can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Trenutuno evropsko javno poročilo o oceni zdravila za zdravilo Xenical je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Recent safety monitoring showed that from August 2009 to January 2011 four cases of severe liver injury were reported in patients using Xenical where the role of orlistat could not be excluded, including one fatal case of liver failure and one case leading to liver transplantation.
Nedavno spremljanje varnosti je pokazalo, da so bili od avgusta 2009 do januarja 2011 prijavljeni štirje primeri resnih poškodb jeter pri bolnikih, ki so uporabljali zdravilo Xenical, v zvezi s katerimi ni bilo mogoče izključiti vloge orlistata, vključno s smrtnim primerom zaradi odpovedi jeter in enim primerom, ki se je končal s presaditvijo jeter.
• Patients and prescribers are reminded that the benefits of orlistat-containing medicines continue to outweigh the risks.
• Bolniki in zdravniki, ki zdravilo predpisujejo, se morajo zavedati, da koristi zdravil, ki vsebujejo orlistat, še naprej prevladajo nad tveganji.
Alli was authorised in 2007 and is available as capsules (60 mg) and chewable tablets (27 mg) which can be obtained without a prescription (‘over-the-counter').
Zdravilo Alli, ki je bilo odobreno leta 2007 ter je na voljo v kapsulah (60 mg) in žvečljivih tabletah (27 mg), je na voljo brez zdravniškega recepta.
The Committee concluded that the number of reported severe liver reactions in orlistat users was low and below the background rate expected in these people, given the large number of users.
Odbor je sklenil, da je sporočenih resnih reakcij jeter pri uporabnikih orlistata malo in pod pričakovano standardno stopnjo za te osebe glede na veliko število uporabnikov.
Overall, from 1997 to January 2011, 21 cases of severe liver toxicity were reported where Xenical was considered a possible cause, although other factors that could have caused the liver injury were present.
Na splošno je bilo od leta 1997 do januarja 2011 prijavljenih 21 primerov hude toksičnosti jeter, v katerih je bilo kot možen vzrok obravnavano zdravilo Xenical, čeprav so bili prisotni drugi dejavniki, ki bi lahko povzročili poškodbo jeter.
The European Commission issued a decision for Orlistat Art. 31 on 24 April 2012.
Evropska komisija je 24. aprila 2012 na podlagi člena 31 Direktive 2001/83/ES izdala sklep o dovoljenju za promet z zdravili, ki vsebujejo zdravilno učinkovino orlistat.
The Committee also reviewed information requested from the companies that market orlistat-containing medicines, including the estimated number of people using these medicines and an analysis of the observed number of reports of severe liver problems compared with the expected background rate of liver problems in these people.
Odbor je proučil tudi informacije, zahtevane od podjetij, ki tržijo zdravila, ki vsebujejo orlistat, vključno z ocenjenim številom ljudi, ki uporabljajo ta zdravila, in analizo ugotovljenega števila poročil o resnih težavah z jetri v primerjavi s pričakovano standardno stopnjo težav z jetri pri teh osebah.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat continue to outweigh its risks, and therefore recommended that the marketing authorisations be maintained for orlistat-containing medicines.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvenih razprav v okviru odbora CHMP je ta sklenil, da koristi orlistata še vedno prevladajo nad tveganji, zato je priporočil ohranitev dovoljenja za promet z zdravilom za zdravila, ki vsebujejo orlistat.
The Committee also agreed on minor amendments to the package leaflet for all orlistat-containing medicines to ensure they give the same information, including a description of the symptoms of hepatitis to alert patients to these symptoms.
Odbor se je tudi dogovoril o manjših spremembah navodil za uporabo za vsa zdravila, ki vsebujejo orlistat, za zagotovitev, da so v njih navedene enake informacije, vključno z opisom bolezenskih znakov hepatitisa, da so bolniki tako opozorjeni nanje.
The European Medicines Agency has completed a review of orlistat-containing medicines, following concerns about the possible risk of severe liver injury with these medicines.
Evropska agencija za zdravila je dokončala pregled zdravil, ki vsebujejo orlistat, zaradi zaskrbljenosti o morebitnem tveganju za nastanek resnih poškodb jeter, ki naj bi ga povzročilo uživanje teh zdravil.
The Committee considered that while there may be very rare cases of serious liver injury for which orlistat cannot be excluded as a possible cause, the cases do not provide good evidence of a causal link.
Čeprav lahko obstajajo zelo redki primeri hude poškodbe jeter, pri katerih orlistata ni mogoče izključiti kot možnega vzroka, je odbor menil, da ti primeri ne zagotavljajo trdnih dokazov o vzročni povezavi.
The CHMP reviewed the available data on the risk of liver injury and other side effects with orlistat, including post-marketing surveillance, data from the studies supporting the marketing authorisations and population-based studies in the published literature.
Odbor CHMP je proučil razpoložljive podatke o tveganju poškodb jeter in drugih stranskih učinkih zdravilne učinkovine orlistat, vključno z nadzorom v obdobju trženja, podatke iz študij, ki podpirajo izdajo dovoljenja za promet z zdravilom, in študije med prebivalstvom v objavljeni literaturi.
The CHMP considered that there was no strong evidence that orlistat increased the risk of severe liver injury, and there was no known mechanism by which orlistat was expected to cause liver disorders.
Po mnenju odbora CHMP ni trdnih dokazov, da orlistat povečuje tveganje resnih poškodb jeter, prav tako ni bil znan mehanizem, s katerim naj bi orlistat povzročil te okvare.
There were 9 reports of liver failure in people using Alli since it was marketed in May 2007 until January 2011, although in some cases there were other possible explanations and in some cases there was insufficient information to assess the cause.
Od maja 2007, ko je bilo zdravilo Alli dano na trg, do januarja 2011 je bilo devet poročil o odpovedi jeter pri ljudeh, ki so uporabljali to zdravilo, čeprav so bili v nekaterih primerih tudi drugi možni vzroki, v nekaterih primerih pa ni bilo na voljo dovolj informacij za oceno vzroka.
Therefore, the CHMP considered it necessary to assess whether the evidence gathered over time on the risk of severe liver problems had altered the benefit-risk balance of orlistat-containing medicines.
Odbor CHMP je zato menil, da je treba oceniti, ali so dokazi o tveganju resnih težav z jetri, zbrani v daljšem časovnem obdobju, spremenili razmerje med tveganji in koristmi zdravil, ki vsebujejo orlistat.
It noted that the product information for Xenical already listed ‘hepatitis that may be serious' as a side effect of unknown frequency, and recommended that the product information for all orlistat-containing medicines should be harmonised to include this information.
Ugotovil je, da je v informacijah o izdelku za zdravilo Xenical kot stranski učinek neznane pogostnosti že naveden „hepatitis, ki je lahko resen“, in priporočil uskladitev informacij o izdelku za vsa zdravila, ki vsebujejo orlistat, z vključitvijo te informacije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of orlistat continue to outweigh its risks, and recommended that the marketing authorisations be maintained with minor amendments to the product information to ensure the same information on very rare liver-related side effects is provided for all orlistat-containing medicines.
Odbor agencije EMA za zdravila za uporabo v humani medicini (CHMP) je sklenil, da koristi zdravilne učinkovine orlistat prevladajo nad njenimi tveganji, in priporočil, naj se ohranijo dovoljenja za promet z zdravilom z manjšimi spremembami informacij o izdelku, za zagotovitev, da so navedene enake informacije o zelo redkih stranskih učinkih, povezanih z jetri, za vsa zdravila, ki vsebujejo orlistat.
The CHMP also noted that published population-based studies suggest that obesity may be associated with a higher risk of liver disease.
Poleg tega po ugotovitvah odbora CHMP študije med prebivalstvom kažejo, da je debelost mogoče povezati z večjim tveganjem bolezni jeter.
• Patients and prescribers should be aware that certain liver-related problems, including very rare serious reactions such as hepatitis, have been reported and are listed in the product information for orlistat-containing medicines as possible side effects.
• Bolniki in zdravniki, ki zdravilo predpisujejo, se morajo zavedati, da se je poročalo o nekaterih težavah, povezanih z jetri, vključno z zelo redkimi resnimi reakcijami, kot je hepatitis, in da so te kot stranski učinki navedene v informacijah o izdelku za zdravila, ki vsebujejo orlistat.
Orlistat blocks the action of gastrointestinal lipases (enzymes that digest fat).
Deluje tako, da zavira lipaze v prebavilih (encime, ki presnavljajo maščobe).
The product information for orlistat-containing medicines lists hepatitis, cholelithiasis (gall stones) and a change in liver enzyme levels as potential liver-related side effects.
morebitni stranski učinki, povezani z jetri, navedeni hepatitis, holelitiaza (žolčni kamni) in sprememba ravni jetrnih encimov.
(Invented) name Strength Pharmaceutical form Route of administration
Številka EU Zaščiteno ime Jakost
Date of first authorisation: 28 September 2012 Date of latest renewal: 13 July 2017
Datum prve odobritve: 28. september 2012 Datum zadnjega podaljšanja: 13. julij 2017
If you use more Enurev Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Če ste uporabili večji odmerek zdravila Enurev Breezhaler, kot bi smeli Če ste vdihnili preveč tega zdravila ali če kdo drug pomotoma uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno pomoč.
The European Medicines Agency has waived the obligation to submit the results of studies with Enurev Breezhaler in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Enurev Breezhaler za vse podskupine pediatrične populacije s KOPB (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended dose is the inhalation of the content of one capsule once daily using the Enurev Breezhaler inhaler.
Priporočeni odmerek je inhalacija vsebine ene kapsule enkrat na dan z uporabo inhalatorja Enurev Breezhaler.
The capsules must be administered only using the Enurev Breezhaler inhaler (see section 6.6).
Kapsule so namenjene samo uporabi z inhalatorjem Enurev Breezhaler (glejte poglavje 6.6).
How to inhale Enurev Breezhaler - In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder.
Kako inhalirati zdravilo Enurev Breezhaler - V škatli boste našli inhalator in kapsule (v pretisnih omotih), ki vsebujejo zdravilo v obliki praška za inhaliranje.
Enurev Breezhaler once daily has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ).
Odmerjanje zdravila Enurev Breezhaler enkrat dnevno je statistično značilno vplivalo tudi na z zdravjem povezano kakovost življenja, ki so jo ocenili s pomočjo vprašalnika St. George's Respiratory Questionnaire (SGRQ).
How long to continue your treatment with Enurev Breezhaler - Keep using this medicine for as long as your doctor tells you.
Kako dolgo je treba nadaljevati z uporabo zdravila Enurev Breezhaler - Zdravljenje s tem zdravilom nadaljujte tako dolgo, kot vam naroči zdravnik.
• Enurev Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Enurev Breezhaler kapsule vedno shranjujte v pretisnem omotu in jih vzemite iz njega šele tik pred uporabo.
Enurev Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Zdravilo Enurev Breezhaler v odmerku 44 mikrogramov enkrat na dan je mogoče varno uporabljati v vseh starostnih skupinah in kategorijah telesne mase bolnikov.
There are no data from the use of Enurev Breezhaler in pregnant women.
Podatkov o uporabi zdravila Enurev Breezhaler pri nosečnicah ni.
Following oral inhalation using the Enurev Breezhaler inhaler, glycopyrronium was rapidly absorbed and reached peak plasma levels at 5 minutes post dose.
Po peroralni inhalaciji zdravila s pomočjo inhalatorja Enurev Breezhaler se je glikopironij hitro absorbiral in dosegel najvišjo koncentracijo v plazmi 5 minut po odmerjanju.
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Enurev Breezhaler and to contact their doctor immediately should any of these signs or symptoms develop.
Bolnike je treba seznaniti z znaki in simptomi akutnega glavkoma zaprtega zakotja in jim naročiti, naj v primeru razvoja teh simptomov ali znakov prenehajo uporabljati zdravilo Enurev Breezhaler in takoj obvestijo svojega zdravnika.
- When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
- Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Enurev Breezhaler, ki je priložen pakiranju.
The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Enurev Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Dolgotrajno delovanje je deloma mogoče pripisati ohranjanju ustrezne koncentracije učinkovine v pljučih, kar odraža dolg terminalni razpolovni čas izločanja glikopironija po inhalaciji z inhalatorjem Enurev Breezhaler v nasprotju z razpolovnim časom po intravenskem odmerjanju zdravila (glejte poglavje 5.2).
There is no relevant use of Enurev Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Zdravilo Enurev Breezhaler ni namenjeno za uporabo pri pediatrični populaciji (v starosti pod 18 let) za indikacijo KOPB.
What Enurev Breezhaler is and what it is used for What you need to know before you use Enurev Breezhaler How to use Enurev Breezhaler Possible side effects
Kaj je zdravilo Enurev Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Enurev Breezhaler Kako uporabljati zdravilo Enurev Breezhaler Možni neželeni učinki
Enurev Breezhaler is recommended to be administered, at the same time of the day each day.
Zdravilo Enurev Breezhaler je priporočeno jemati vsak dan ob istem času.
This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
To velja tudi za zdravila, ki so podobna zdravilu Enurev Breezhaler in jih uporabljate zaradi bolezni pljuč, kot so ipratropij, oksitropij ali tiotropij (tako imenovani antiholinergiki).
Enurev Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Zdravilo Enurev Breezhaler je namenjeno enkrat dnevni uporabi za dolgotrajno vzdrževalno zdravljenje in ni indicirano za začetno zdravljenje akutnih epizod bronhospazma kot nujno zdravilo (zdravilo po potrebi).
Acute intoxication by inadvertent oral ingestion of Enurev Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%).
Akutna zastrupitev z nenamernim peroralnim zaužitjem kapsul zdravila Enurev Breezhaler je malo verjetna, saj ima učinkovina le majhno peroralno biološko uporabnost (približno 5 %).
Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Zdravilo Enurev Breezhaler je indicirano kot vzdrževalno brohodilatatorno zdravljenje za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
Enurev Breezhaler 44 micrograms once daily provided consistently statistically significant improvement in lung function (forced expiratory volume in one second, FEV1, forced vital capacity, FVC, and inspiratory capacity, IC) in a number of clinical studies.
Zdravilo Enurev Breezhaler je v odmerku 44 mikrogramov enkrat na dan v več kliničnih študijah dosledno dosegalo statistično značilno izboljšanje pljučne funkcije (forsiranega ekspiratornega volumna v prvi sekundi - FEV1, forsirane vitalne kapacitete - FVC in inspiratorne kapacitete - IC).
The absolute bioavailability of glycopyrromium inhaled via Enurev Breezhaler was estimated to be about 45% of the delivered dose.
Ocenjena absolutna biološka uporabnost glikopironija po inhaliranju s pomočjo inhalatorja Enurev Breezhaler znaša približno 45 % prejetega odmerka.
Do not use Enurev Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Ne uporabljajte zdravila Enurev Breezhaler - če ste alergični na glikopironijev bromid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In a 3-week study where exercise tolerance was tested via cycle ergometer at submaximal (80%) workload (submaximal exercise tolerance test), Enurev Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
V 3-tedenski študiji, v kateri so ocenjevali sposobnost prenašanja napora na ergometričnem kolesu, in sicer pri submaksimalni (80 %) obremenitvi (submaksimalni obremenitveni test), je zdravilo Enurev Breezhaler, ki so ga odmerjali zjutraj, zmanjšalo dinamično hiperinflacijo pljuč in podaljšalo čas, ko so bolniki lahko izvajali vajo, in sicer od prvega odmerka dalje.
In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Enurev Breezhaler can be used at the recommended dose.
Pri bolnikih s KOPB in blago oziroma zmerno okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije ≥30 ml/min/1,73 m2) je zdravilo Enurev Breezhaler mogoče uporabljati v priporočenem odmerku.
Although no formal drug interaction studies have been performed, Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Formalnih študij medsebojnega delovanja z drugimi zdravili niso izvedli, so pa zdravilo Enurev Breezhaler uporabljali sočasno z drugimi zdravili, ki so pogosto v uporabi pri zdravljenju KOPB, in pri tem ni bilo kliničnih znakov medsebojnega delovanja.
• Do not use the Enurev Breezhaler capsules with any other inhaler.
• Kapsul Enurev Breezhaler ne uporabljajte z nobenim drugim inhalatorjem.
Enurev Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Zdravilo Enurev Breezhaler v odmerku 44 mikrogramov na dan je statistično značilno zmanjšalo zadihanost po oceni z indeksom spreminjanja dispneje v času (TDI-Transitional Dyspnoea Index).
• Do not use the Enurev Breezhaler inhaler to take any other capsule medicine.
• Inhalatorja Enurev Breezhaler ne uporabljajte za inhaliranje drugih zdravil iz kapsul.
What Enurev Breezhaler looks like and contents of the pack Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Izgled zdravila Enurev Breezhaler in vsebina pakiranja Enurev Breezhaler 44 mikrogramov prašek za inhaliranje, trde kapsule so prozorne in oranžne barve ter vsebujejo bel prašek.
Only use the capsules with the inhaler provided in this pack (Enurev
Kapsule uporabljajte samo z inhalatorjem, ki je priložen v škatli (inhalator
Enurev Breezhaler should be used with caution in these patient groups.
Pri uporabi zdravila Enurev Breezhaler pri teh skupinah bolnikov je potrebna previdnost.
What you need to know before you use Enurev Breezhaler
Kaj morate vedeti, preden boste uporabili zdravilo Enurev Breezhaler
Please read the full Instructions for Use before using the Enurev Breezhaler.
Prosimo, da pred uporabo zdravila Enurev Breezhaler v celoti preberete spodnja navodila za uporabo.
When to inhale Enurev Breezhaler Use this medicine at the same time each day.
Kdaj je treba inhalirati zdravilo Enurev Breezhaler To zdravilo uporabljajte vsak dan ob istem času.