natgillin/translations-raw huggingface dataset:
Decrease in ALP of at least 15%, n (%) Total bilirubin less than or equal to 1-times ULNf, n a Percentage of subjects achieving a response, defined as an ALP less than 1.67-times the ULN, total bilirubin within the normal range, and an ALP decrease of at least 15%.
ULN, skupni bilirubin znotraj normalnega razpona in zmanjšanje vrednosti ALP za vsaj 15 %.
NAME OF THE MEDICINAL PRODUCT OCALIVA 10 mg film-coated tablets obeticholic acid
OCALIVA 10 mg filmsko obložene tablete obetiholna kislina
These findings were maintained at 48 weeks.
Te ugotovitve so veljale tudi v 48. tednu.
Further information on Intelence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Intelence so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Intelence?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intelence?
Other information about Intelence
Druge informacije o zdravilu Intelence
The European Medicines Agency therefore decided that its benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Intelence večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Intelence received a marketing authorisation valid throughout the EU on 28 August 2008.
Za zdravilo Intelence je bilo 28. avgusta 2008 izdano dovoljenje za promet, veljavno po vsej EU.
Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately.
Bolniki, ki tablete ne morejo pogoltniti, jo lahko raztopijo v kozarcu vode in raztopino takoj popijejo.
As for all medicines, data on the use of Intelence are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Intelence stalno spremljajo.
In adults, the recommended dose of Intelence is 200 mg twice a day after a meal while in children the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day.
Pri odraslih je priporočeni odmerek zdravila Intelence 200 mg dvakrat dnevno po obroku, pri otrocih pa je odmerek odvisen od telesne mase in znaša od 100 mg dvakrat dnevno do 200 mg dvakrat dnevno.
What benefits of Intelence have been shown in studies?
Kakšne koristi zdravila Intelence so se pokazale v študijah?
An overview of Intelence and why it is authorised in the EU
Pregled zdravila Intelence in zakaj je odobreno v EU
Intelence is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water.
Zdravilo Intelence je na voljo v obliki tablet (25 mg, 100 mg in 200 mg), ki jih je treba pogoltniti cele s kozarcem vode.
In two main studies in a total of 1,203 adults, the average viral load was 70,000 copies/ml at the start of treatment.
V dveh glavnih študijah, v kateri so bili vključeni 1 203 odrasli, je bilo povprečno virusno breme ob začetku zdravljenja 70 000 kopij/ml.
What is Intelence and what is it used for?
Kaj je zdravilo Intelence in za kaj se uporablja?
Why is Intelence authorised in the EU?
Zakaj je bilo zdravilo Intelence odobreno v EU?
What are the risks associated with Intelence?
Kakšna tveganja so povezana z zdravilom Intelence?
Side effects reported with Intelence are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Intelence, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intelence have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Intelence upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 6 years of age.
Zdravilo Intelence je zdravilo za zdravljenje okužb s humanim virusom imunske pomanjkljivosti tipa 1 (HIV-1) pri odraslih in otrocih, starejših od šest let.
It contains the active substance etravirine.
Zdravilo vsebuje učinkovino etravirin.
The most common side effects with Intelence (which may affect more than 1 in 10 people) are rash, diarrhoea, nausea (feeling sick) and headache.
Najpogostejši neželeni učinki zdravila Intelence (ki se lahko pojavijo pri več kot 1 bolniku od 10) so izpuščaj, driska, navzeja (slabost) in glavobol.
The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Učinkovina v zdravilu Intelence, etravirin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
In a main study of 101 children aged between 6 and 17 years, about half of them had undetectable levels of HIV after 24 weeks of taking Intelence in combination with other medicines, and the proportion of children with undetectable levels of HIV increased slightly after 48 weeks.
V glavni študiji, ki je vključevala 101 otroka, starega od šest do 17 let, je imela približno polovica po 24 tednih jemanja zdravila Intelence v kombinaciji z drugimi zdravili nezaznavno raven virusa HIV, delež otrok z nezaznavno ravnijo virusa HIV pa se je po 48. tednu rahlo povečal.
For further information about using Intelence, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Intelence glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Intelence does not cure HIV infection or AIDS, but it may delay damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Intelence ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, povezanih z aidsom.
Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor'.
Zdravilo Intelence se uporablja samo pri bolnikih, pri katerih je bila okužba z virusom HIV že zdravljena, in ga je treba uporabljati skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, ki vključujejo „okrepljeni zaviralec proteaze“.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Ta zavira delovanje reverzne transkriptaze, encima, ki ga tvori virus HIV ter ki omogoča okužbo celic v telesu in nastajanje novih virusov.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
By blocking this enzyme, Intelence, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Intelence z zaviranjem tega encima v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV zniža količino tega virusa v krvi in jo ohranja na nizki ravni.
After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo (a dummy treatment) plus the other HIV medicines.
Po 24 tednih je imelo nezaznavno raven virusa HIV 59 % bolnikov, ki so jemali zdravilo Intelence skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, in 41 % bolnikov, ki so jemali placebo (zdravilo brez učinkovine) v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
How does Intelence work?
Kako zdravilo Intelence deluje?
Intelence is effective at reducing viral load to undetectable levels in both adults and children and its side effects are considered manageable.
Zdravilo Intelence pri odraslih in otrocih učinkovito zmanjšuje virusno breme na nezaznavno raven, njegovi neželeni učinki pa veljajo za obvladljive.
Studies have shown that Intelence, in combination with other medicines, is effective at reducing the level of HIV in the blood (viral load) to undetectable levels (below 50 copies/ml) in many patients with HIV-1 infection.
Študije so pokazale, da zdravilo Intelence v kombinaciji z drugimi zdravili pri številnih bolnikih, okuženih z okužbo z virusom HIV-1, učinkovito zmanjšuje raven tega virusa v krvi (virusno breme) na nezaznavno raven (pod 50 kopij/ml).
How is Intelence used?
Kako se zdravilo Intelence uporablja?
Intelence must not be used together with elbasvir/grazoprevir, a medicine to treat hepatitis C infection.
Zdravilo Intelence se ne sme uporabljati v kombinaciji z elbasvirjem ali grazoprevirjem, zdraviloma za zdravljenje okužbe s hepatitisom C. Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Intelence glejte navodilo za uporabo.
10 June 2010
10. junija 2010
1 Article 35 of Directive 2001/82/EC
1 Člen 35 Direktive 2001/82/ES
The final opinion was converted into a Decision by the European Commission on 10 June 2010.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 10. junija 2010.
The referral procedure started on 16 April 2009.
Napotitveni postopek se je začel 16. aprila 2009.
The rapporteur and co-rapporteur appointed were: Prof. Christian Friis and Dr Karolina Törneke, respectively.
Za poročevalca oziroma soporočevalko sta bila imenovana: prof. Christian Friis in dr Karolina Törneke.
Written explanations were provided by the applicants/marketing authorisation holders on 15 July 2009 and 13 January 2010.
Predlagatelji/imetniki dovoljenja za promet z zdravilom so pisna pojasnila predložili 15. julija 2009 in 13. januarja 2010.
Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics.
Kolistinijev sulfat je polipeptidni antibiotik, ki spada v skupino antibiotikov polimiksinov.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in the Annex III.
Seznam zadevnih imen izdelkov je podan v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, dopolnjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo pa v Dodatku III.
Due to concerns that the differences in posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species may present a potential serious risk to public and animal health, the United Kingdom referred the matter to the Agency on 1 April 2009, under Article 35 of Directive 2001/82/EC.
Zaradi zaskrbljenosti, da bi lahko razlike v odmerjanju in karenci, določenih v različnih državah Evropske unije za formulacije za uporabo v veterinarski medicini, ki vsebujejo kolistin v koncentraciji 2 000 000 i.e./ml in so namenjene dajanju vrstam živali za proizvodnjo živil s pitno vodo, lahko predstavljajo možno resno tveganje za zdravje ljudi in živali, je Združeno kraljestvo v skladu s členom 35 Direktive 2001/82/ES zadevo 1. aprila 2009 napotilo na agencijo.
Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU per ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.
Formulacije za uporabo v veterinarski medicini, ki vsebujejo kolistinijev sulfat v koncentraciji 2 000 000 i.e./ml in so namenjene dajanju teletom, prašičem, jagenjčkom in perutnini s pitno vodo, se uporabljajo za zdravljenje okužb prebavil, ki jih povzročata bakteriji Escherichia coli in Salmonella spp, občutljivi na kolistin.
Based on the rapporteurs' assessment of the currently available data, the CVMP, adopted, on 10 February 2010, an opinion recommending variations of the marketing authorisations for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species in order to amend the summary of the product characteristics (SPC), labelling and package leaflet to harmonise the posology and withdrawal periods (where applicable) for the concerned products.
Na podlagi poročevalčeve ocene trenutno razpoložljivih podatkov je Odbor za zdravila za uporabo v veterinarski medicini dne 10. februarja 2010 sprejel mnenje, v katerem priporoča spremembe dovoljenj za promet z zdravilom za formulacije za uporabo v veterinarski medicini, ki vsebujejo kolistin v koncentraciji 2 000 000 i.e./ml in so namenjene dajanju vrstam živalim za proizvodnjo živil s pitno vodo, da bi spremenili povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo zaradi uskladitve odmerjanja in karence (če obstaja) za zadevna zdravila.
referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species
Mnenje v zvezi z napotitvijo v skladu s členom 351 za formulacije za uporabo v veterinarski medicini, ki vsebujejo kolistin v koncentraciji 2 000 000 i.e./ml in so namenjene dajanju živalim za proizvodnjo živil s pitno vodo
This summary was last updated in 09-2014.
Povzetek je bil nazadnje posodobljen 09-2014.
In both studies, the main measure of effectiveness was the number of patients with a complete or partial response to treatment.
V obeh študijah je bilo glavno merilo učinkovitosti število bolnikov s popolnim ali delnim odzivom na zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union for Noxafil on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Noxafil, veljavno po vsej Evropski uniji, izdala 25. oktobra 2005.
After 14 days of treatment, both medicines had been successful in curing or improving about 92% of patients.
Po 14 dneh zdravljenja sta obe zdravili uspešno ozdravili ali izboljšali stanje pri 92 % bolnikov.
The full EPAR for Noxafil 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 Noxafil je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This document is a summary of the European public assessment report (EPAR) for Noxafil.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Noxafil.
It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Deluje tako, da preprečuje nastajanje ergosterola, ki je pomemben del celičnih sten glivic.
What measures are being taken to ensure the safe and effective use of Noxafil?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Noxafil?
Noxafil must not be used in patients who are taking any of the following medicines:
Zdravila Noxafil ne smejo uporabljati bolniki, ki jemljejo katero od naslednjih zdravil:
Gastroresistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
„Gastrorezistentne“ pomeni, da tablete potujejo skozi želodec, ne da bi se v njem razgradile, dokler ne dosežejo črevesja.
Caution is also needed when Noxafil is taken at the same time as other medicines.
Prav tako je potrebna previdnost pri sočasnem jemanju zdravila Noxafil z drugimi zdravili.
Other information about Noxafil
Druge informacije o zdravilu Noxafil
A risk management plan has been developed to ensure that Noxafil is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Noxafil je bil pripravljen načrt obvladovanja tveganj.
What benefit has Noxafil shown during the studies?
Kakšne koristi je zdravilo Noxafil izkazalo med študijami?
For more information about treatment with Noxafil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Noxafil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Committee decided that Noxafil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila Noxafil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The studies looked at the number of patients who developed an invasive fungal infection.
V študijah so merili število bolnikov, pri katerih se je pojavila invazivna glivična okužba.
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 Noxafil.
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.
It is used in patients whose infection is severe or patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Uporablja se pri bolnikih s hudo obliko okužbe ali z oslabljenim imunskim sistemom, kadar lokalno uporabljena zdravila (neposredno na oprh) verjetno ne bodo delovala.
• Noxafil oral suspension is taken with a meal or nutritional supplement; the suspension must be shaken well before use.
• Peroralna suspenzija zdravila Noxafil se jemlje sočasno z obrokom hrane ali prehranskim dopolnilom, pred uporabo pa jo je treba dobro pretresti.
Without ergosterol, the fungus dies or is prevented from spreading.
Brez ergosterola glivica odmre oziroma se ne more širiti.
Noxafil treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Zdravljenje z zdravilom Noxafil mora uvesti zdravnik, ki ima izkušnje z obravnavo glivičnih okužb ali zdravljenjem bolnikov z velikim tveganjem za invazivne glivične okužbe.
The results obtained with Noxafil were compared with the records of 218 patients who were treated with other antifungal medicines.
Rezultate, ki so jih dobili z zdravilom Noxafil, so primerjali s poročili 218 bolnikov, ki so se zdravili z drugimi protiglivičnimi zdravili.
• simvastatin, lovastatin or atorvastatin (used to lower cholesterol).
• simvastatin, lovastatin ali atorvastatin (ki se uporabljajo za zniževanje holesterola).
Noxafil is used to treat adults (aged 18 years or over) with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Zdravilo Noxafil se uporablja za zdravljenje naslednjih glivičnih obolenj pri odraslih (starejših od 18 let), kadar ti zdravljenja z drugimi protiglivičnimi zdravili (amfotericinom B, itrakonazolom ali flukonazolom) ne prenašajo ali pa zdravljenje ni bilo uspešno:
• chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
• kromoblastomikoze in micetoma (dolgotrajnih glivičnih okužb kože in podkožnega tkiva, ki ju navadno povzročajo glivične spore, ki okužijo nastale rane zaradi trnov ali trsk),
The active substance in Noxafil, posaconazole, is an antifungal medicine that belongs to the triazole group.
Zdravilna učinkovina zdravila Noxafil, posakonazol, je protiglivično zdravilo, ki spada v skupino triazolov.
What is the risk associated with Noxafil?
Kakšna tveganja so povezana z zdravilom Noxafil?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Noxafil, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu z njim so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The study included 107 patients with aspergillosis, 18 patients with fusariosis, 11 with chromoblastomycosis or mycetoma, and 16 with coccidioidomycosis.
V študijo je bilo vključenih 107 bolnikov z aspergilozo, 18 bolnikov s fuzariozo, 11 bolnikov s kromoblastomikozo ali micetomom in 16 s kokcidioidomikozo.
In invasive aspergillosis, a successful response at the end of treatment was seen in 42% of the patients taking Noxafil oral suspension, compared with 26% of the patients in the comparator group.
Pri invazivni aspergilozi so uspešen odziv ob koncu zdravljenja ugotovili pri 42 % bolnikov, ki so prejemali peroralno suspenzijo zdravila Noxafil, v primerjavi s 26 % bolnikov v primerjalni skupini.
Other common side effects include vomiting, diarrhoea, pyrexia (fever) and increased bilirubin (a sign of liver problems) in the blood.
Drugi pogosti neželeni učinki so bruhanje, driska, pireksija (povišana telesna temperatura) in povišane ravni bilirubina v krvi (kar nakazuje na težave z jetri).
Noxafil also successfully treated 11 of the 18 patients who had proven or probable fusariosis, 9 of the 11 patients with chromoblastomycosis or mycetoma, and 11 of the 16 patients with coccidioidomycosis.
Zdravilo Noxafil je prav tako uspešno ozdravilo 11 od 18 bolnikov, ki so imeli dokazano ali verjetno fuzariozo, 9 od 11 bolnikov s kromoblastomikozo ali micetomom in 11 od 16 bolnikov s kokcidioidomikozo.
The list of fungi against which Noxafil is active can be found in the summary of product characteristics (also part of the EPAR).
Za seznam glivic, proti katerim deluje zdravilo Noxafil, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
• pimozide (used for treating mental illness),
• pimozid (ki se uporablja za zdravljenje duševnih bolezni),
Noxafil oral suspension, solution for infusion and gastro-resistant tablets are also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a transplant of cells that make blood cells).
Peroralna suspenzija, raztopina za infundiranje in gastrorezistentne tablete zdravila Noxafil se lahko uporabljajo tudi za preprečevanje invazivne glivične okužbe pri bolnikih, ki imajo oslabljen imunski sistem zaradi zdravil za zdravljenje krvnega raka ali raka kostnega mozga ali zdravil, uporabljenih pri presaditvi krvotvornih matičnih celic (presaditvi celic, ki proizvajajo krvne celice).
The most common side effect with Noxafil, seen in more than one patient in 10, is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Noxafil, opažen pri 1 bolniku od 10, je navzeja (slabost).
• cisapride (used for stomach problems),
• cisaprid (ki se uporablja za zdravljenje želodčnih težav),
In one main study, Noxafil oral suspension was studied in 238 patients with invasive fungal infections that did not respond to standard antifungal treatment.
V eni glavni študiji so peroralno suspenzijo zdravila Noxafil proučevali pri 238 bolnikih z invazivnimi glivičnimi okužbami, ki se niso odzivali na standardno protiglivično zdravljenje.
• Noxafil tablets can be taken with or without food and should be swallowed whole with water; the tablets should not be crushed, chewed, broken or dissolved.
• Tablete zdravila Noxafil se lahko jemljejo s hrano ali brez nje, pri čemer jih je treba pogoltniti cele sočasno z vodo.