FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking some of the components of Stribild, certain rare but serious side effects have been seen including lactic acidosis (excess lactic acid in the blood) and severe kidney problems that may also affect bones.
Slovenian: Pri bolnikih, ki jemljejo nekatere sestavine zdravila Stribild, se lahko pojavijo nekateri redki, vendar resni neželeni učinki, vključno z laktatno acidozo (presežek mlečne kisline v krvi) in hudimi težavami z ledvicami, ki lahko prizadenejo tudi kosti.
English: It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Uporablja se za zdravljenje bolnikov, starejših od 12 let in s telesno maso vsaj 35 kg, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Stribild elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Slovenian: Stribild elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat
English: Stribild does not cure HIV-1 infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Stribild ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: A third study involving 50 adolescents aged 12 to 18 years who had not been previously treated for HIV-1 showed that Stribild was also effective in reducing viral load in this age group; 88% (44 of 50 patients) responded to treatment after 24 weeks, and the response persisted after 48 weeks.
Slovenian: Tretja študija, v katero je bilo vključenih 50 mladostnikov, starih od 12 do 18 let, ki še niso prejemali zdravljenja za okužbo z virusom HIV-1, je pokazala, da je zdravilo Stribild učinkovito zmanjšalo virusno breme tudi v tej starostni skupini; 88 % (44 bolnikov od 50) se je odzvalo na zdravljenje po 24 tednih, odziv pa je trajal tudi še po 48 tednih.
English: Stribild was investigated in two main studies involving 1,422 adult patients with HIV-1 who had not been treated before, where Stribild was compared with other HIV medicines.
Slovenian: Zdravilo Stribild so proučevali v dveh glavnih študijah, ki sta vključevali 1 422 odraslih bolnikov, okuženih z virusom HIV-1, ki se še niso zdravili, pri čemer so ga primerjali z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: Cobicistat enhances the effects of elvitegravir, by prolonging the time for which elvitegravir continues to work.
Slovenian: Kobicistat povečuje učinke elvitegravirja, tako da podaljšuje čas njegovega delovanja.
English: The most common side effects with Stribild are nausea (feeling sick) and diarrhoea, which can affect more than 1 in 10 people.
Slovenian: Najpogostejša neželena učinka zdravila Stribild sta navzeja (občutek siljenja na bruhanje) in driska, ki se lahko pojavita pri več kot 1 bolniku od 10.
English: For practical information about using Stribild, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Stribild naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.
Slovenian: Zdravilo Stribild z zaviranjem reverzne transkriptaze in integraze zniža količino virusa HIV-1 v krvi in jo zadržuje na nizki ravni.
English: Tenofovir disoproxil is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Slovenian: Dizoproksiltenofovirat je „predzdravilo“ tenofovirja, kar pomeni, da se v telesu pretvori v zdravilno učinkovino tenofovir.
English: Stribild must not be used in patients who have previously stopped treatment with tenofovir disoproxil due to kidney toxicity.
Slovenian: Zdravilo Stribild se ne sme uporabljati pri bolnikih, ki so se pred tem prenehali zdraviti z dizoproksiltenofovirjem zaradi ledvične toksičnosti.
English: Patients whose viral load was reduced to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Slovenian: Bolniki, pri katerih je bilo virusno breme po 48 tednih zdravljenja manjše od 50 HIV-1 RNA kopij/ml, so bili opredeljeni kot bolniki, ki so se odzvali na zdravljenje.
English: It blocks an HIV-1 enzyme called integrase, which is involved in thevirus's replication, thereby reducing the virus's ability to replicate normally and slowing down its spread.
Slovenian: Zavira encim virusa HIV-1, imenovan integraza, ki je vključen v razmnoževanje virusa, s čimer zmanjšuje njegovo zmožnost za normalno razmnoževanje in upočasnjuje njegovo širjenje.
English: After 48 weeks, around 88% of patients treated with Stribild (305 out of 348) responded to treatment compared with around 84% of patients treated with the comparator medicine (296 out of 352).
Slovenian: Po 48 tednih se je na zdravljenje odzvalo približno 88 % (305 od 348) bolnikov, zdravljenih z zdravilom Stribild, v primerjavi s približno 84 % (296 od 352) bolnikov, ki so bili zdravljeni s primerjalnim zdravilom.
English: Stribild can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Stribild je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
English: In the second study, involving 707 patients, Stribild was compared with a medicine containing efavirenz, emtricitabine and tenofovir disoproxil.
Slovenian: V drugi študiji, v katero je bilo vključenih 707 bolnikov, so zdravilo Stribild primerjali z zdravilom, ki je vsebovalo efavirenz, emtricitabin in dizoproksiltenofovirat.
English: Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors.
Slovenian: Tenofovir in emtricitabin sta zelo podobni protivirusni sredstvi, imenovani zaviralca reverzne transkriptaze.
English: After 48 weeks, around 90% of patients treated with Stribild (316 out of 353) responded to treatment compared with around 87% of patients treated with the comparator treatment (308 out of
Slovenian: Po 48 tednih se je na zdravljenje odzvalo približno 90 % (316 od 353) bolnikov, zdravljenih z zdravilom Stribild, v primerjavi s 87 % (308 od 355) bolnikov, ki so bili zdravljeni s primerjalnim zdravilom.
English: In the first study, involving 715 patients, Stribild was compared with the combination of ritonavir, atazanavir plus a medicine containing emtricitabine and tenofovir disoproxil (which are also contained in Stribild).
Slovenian: V prvi študiji, v katero je bilo vključenih 715 bolnikov, so zdravilo Stribild primerjali s kombinacijo ritonavirja, atanazavirja in zdravila, ki je vsebovalo emtricitabin in dizoproksiltenofovirat (ki sta tudi sestavini zdravila Stribild).
English: Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Slovenian: Stribild je zdravilo, ki vsebuje zdravilne učinkovine elvitegravir, kobicistat, emtricitabin in dizoproksiltenofovirat.
English: How is Stribild used?
Slovenian: Kako se zdravilo Stribild uporablja?
English: For the full list of all side effects reported with Stribild, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stribild, glejte navodilo za uporabo.
English: They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body.
Slovenian: Zavirata aktivnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV-1, kar virusu omogoča razmnoževanje v okuženih celicah.
English: In particular, the Agency concluded that the benefits of Stribild in reducing HIV viral load had been clearly shown in studies, and noted that it has the advantage of being taken once per day.
Slovenian: Natančneje, agencija je zaključila, da so študije jasno pokazale koristi zdravila Stribild pri zmanjševanju virusnega bremena HIV in ugotovila, da je njegova prednost, da se jemlje enkrat na dan. Agencija je prepoznala tudi tveganje za neželene učinke na ledvice in priporočila, da se pred začetkom jemanja zdravila Stribild natančno oceni delovanje ledvic, ki ga je nato treba spremljati med zdravljenjem.
English: How does Stribild work?
Slovenian: Kako zdravilo Stribild deluje?
English: It is used only in patients who have not received HIV medicines before or whose disease is not expected to be resistant to any of the antiviral agents in Stribild; it should only be used in patients under 18 years if other HIV medicines not including tenofovir disoproxil cannot be used because of side effects.
Slovenian: Uporablja se lahko samo pri bolnikih, mlajših od 18 let, če zaradi neželenih učinkov ni mogoče uporabiti drugih zdravil za zdravljenje okužbe z virusom HIV, ki ne vključujejo dizoproksiltenofovirata.
English: The European Commission issued a decision on 7 May 2009.
Slovenian: Evropska komisija je odločbo izdala dne 7. maja 2009.
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Slovenian: 1 Člen 29 Direktive 2001/83/ES kakor je bila spremenjena, napotitev na podlagi potencialnega resnega tveganja za javno zdravje.
English: Dr Michal Pirożynski (Poland)
Slovenian: dr. Michal Pirożynski (Poljska)
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: Pregled je bil izveden v skladu z napotitvenim postopkom iz „člena 29“.
English: The grounds for the referral were a disagreement among Member States on the use of the medicine in adolescents and children (over 6 years of age).
Slovenian: Razlog za napotitev je bilo nesoglasje med državami članicami glede uporabe zdravila pri mladostnikih in otrocih (starejših od 6 let).
English: 19 February 2009
Slovenian: 19. februar 2009
English: Dr Barbara Van Zwieten-Boot (the Netherlands)
Slovenian: dr. Barbara Van Zwieten-Boot (Nizozemska)
English: The German authorities recommended that the medicine should not be authorised for use in children, as no studies had been carried out in this age group.
Slovenian: Nemški pristojni organ je priporočil, da se uporaba zdravila pri otrocih ne odobri, ker za to starostno skupino niso bile izvedene nobene študije.
English: Ref. EMEA/CHMP/259505/2009 EMEA/H/A-29/1062
Slovenian: EMEA/H/A-29/1062
English: Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Budesonide Sandoz nosna suspenzija z 32 ali 64 mikrogrami na vpih
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 4 August 2008.
Slovenian: Ker pa omenjene države članice niso dosegle soglasja, je nemški regulatorni organ dne 4. avgusta 2008 zadevo napotil na CHMP v arbitražo.
English: The CHMP also recommended that the product information for the medicine in Germany be amended.
Slovenian: CHMP je priporočil tudi, da se informacije o tem zdravilu v Nemčiji dopolnijo.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom).
Slovenian: To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Nemčija) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Češki republiki, na Danskem, v Franciji, na Nizozemskem, Norveškem, Švedskem in v Združenem kraljestvu).
English: The active substance, budesonide, is a corticosteroid, which is a type of substance that helps to reduce inflammation.
Slovenian: Zdravilna učinkovina budesonid je kortikosteroid, tj. vrsta snovi, ki pomaga ublažiti vnetje.
English: It is used to treat and prevent the symptoms of seasonal allergic rhinitis (allergy to pollen, also known as hayfever) and perennial allergic rhinitis (when the allergy is due to other triggers, such as house dust or animals).
Slovenian: Uporablja se za zdravljenje in preprečevanje simptomov sezonskega alergijskega rinitisa (alergije na cvetni prah, poznane tudi pod imenom seneni nahod) in celoletnega alergijskega rinitisa (pri katerem alergijo sprožijo drugi dejavniki, kot so denimo hišni prah ali živali).
English: It can also be used to treat nasal polyps (growths in the lining of the nose).
Slovenian: Lahko se uporablja tudi za zdravljenje nosnih polipov (izrastkov v nosni sluznici).
English: Based on evaluation of the currently available data, including the studies carried out to compare the way Budesonide Sandoz is handled by the body to that of Rhinocort, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Budesonide Sandoz outweigh its risks, and that therefore the marketing authorisation for Budesonide Sandoz should be granted in all concerned Member States for patients aged from 6 years.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov, vključno s študijami, ki so primerjale zdravilo Budesonide Sandoz in zdravilo Rhinocort glede tega, kako ju telo presnavlja, in znanstvene razprave v Odboru, je CHMP zaključil, da koristi zdravila Budesonide Sandoz odtehtajo z njim povezana tveganja in da se zato dovoljenje za promet za uporabo zdravila Budesonide Sandoz pri bolnikih, starejših od 6 let, lahko odobri v vseh zadevnih državah članicah.
English: However, another Member State, the Netherlands, recommended that the medicine should also be authorised for use in children, as the medicine on which it is based, Rhinocort, can be used in this population.
Slovenian: Druga država članica, Nizozemska, pa je priporočila, da se uporaba zdravila pri otrocih odobri, saj se zdravilo Rhinocort, na katerem temelji zdravilo Budesonide Sandoz, lahko uporablja v tej populaciji.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Budesonide Sandoz outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the European Union, the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da koristi zdravila Budesonide Sandoz odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom lahko odobri v Nemčiji in naslednjih državah članicah Evropske unije: Češki republiki, na Danskem, v Franciji, na Nizozemskem, Norveškem, Švedskem in v Združenem kraljestvu.
English: Sandoz Pharmaceuticals GmbH submitted Budesonide Sandoz to the German medicines regulatory agency for a decentralised procedure.
Slovenian: Družba Sandoz Pharmaceuticals GmbH je predložila zdravilo Budesonide Sandoz nemškemu regulatornemu organu za zdravila v presojo po decentraliziranem postopku.
English: Budesonide Sandoz is almost identical to another medicine authorised in the European Union, Rhinocort.
Slovenian: Zdravilo Budesonide Sandoz je skoraj popolnoma enako drugemu zdravilu, ki je že odobreno v Evropski uniji, in sicer zdravilu Rhinocort.
English: London, 3 June 2009
Slovenian: London, 3. junija 2009 Sklic dok.
English: Referral start date:
Slovenian: Datum izdaje mnenja:
English: Why was Budesonide Sandoz reviewed?
Slovenian: Zakaj je bilo zdravilo Budesonide Sandoz pregledano?
English: The only difference is that it contains very small amounts of ascorbic acid (an antioxidant).
Slovenian: Edina razlika med njima je, da zdravilo Budesonide Sandoz vsebuje majhne količine askorbinske kisline (antioksidant).
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Budesonide Sandoz.
Slovenian: Evropska agencija za zdravila (EMEA) je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Budesonide Sandoz zaključila arbitražni postopek.
English: What is Budesonide Sandoz?
Slovenian: Kaj je zdravilo Budesonide Sandoz?
English: Co-Rapporteur:
Slovenian: Soporočevaec:
English: Budesonide Sandoz is an anti-inflammatory medicine.
Slovenian: Zdravilo Budesonide Sandoz je protivnetno zdravilo.
English: Company responses provided on: 24 December 2008 Opinion date:
Slovenian: Odgovori družbe poslani dne:
English: This summary was last updated in 06-2011.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kentera on 15 June 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kentera, veljavno po vsej Evropski uniji, odobrila dne 15. junija 2004.
English: The full EPAR for Kentera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kentera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For the transdermal patches, one patch is used twice a week (every three to four days).
Slovenian: Pri transdermalnih obližih se uporabi en obliž dvakrat na teden (na vsake tri do štiri dni).
English: It blocks some receptors in the body called muscarinic M1 and M3 receptors.
Slovenian: Zavira nekatere receptorje v telesu, imenovane muskarinski receptorji M1 in M3.
English: Kentera was more effective than placebo.
Slovenian: Zdravilo Kentera je bilo učinkovitejše od placeba.
English: This helps Kentera to prevent unwanted urination.
Slovenian: Na ta način zdravilo Kentera pomaga preprečiti neželeno uhajanje urina.
English: EPAR summary for the public oxybutynin
Slovenian: Povzetek EPAR za javnost oksibutinin
English: The main measure of effectiveness was the number of incontinence episodes over either three or seven days.
Slovenian: Glavno merilo učinkovitosti je bilo število inkontinenčnih epizod v obdobju treh ali sedmih dni.
English: This is a summary of the European public assessment report (EPAR) for Kentera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kentera.
English: Oxybutynin has been available as a tablet for the treatment of overactive bladder since the 1970s.
Slovenian: Oksibutinin je kot tableta za zdravljenje čezmerno aktivnega sečnega mehurja na voljo od sedemdesetih let 20. stoletja.
English: For more information about treatment with Kentera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kenetra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The main measure of effectiveness was the change in the number of daily incontinence episodes after 12 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba števila dnevnih inkotinenčnih epizod po 12 tednih zdravljenja.
English: What benefit has Kentera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Kentera izkazalo med študijami?
English: Kentera patches were as effective as tolterodine, with both treatments decreasing the number of episodes by about three per day.
Slovenian: Obliži Kentera so bili tako učinkoviti kot tolterodin, pri obeh zdravljenjih se je število epizod zmanjšalo za približno tri na dan.
English: For the gel, the recommended daily dose is 4 mg of oxybutynin once a day, which corresponds to one gram of gel delivered using a metering pump or to the content of one sachet.
Slovenian: Priporočeni dnevni odmerek gela je 4 mg oksibutinina enkrat dnevno, kar ustreza enemu gramu gela, ki se odmeri s pomočjo črpalke za odmerjanje, ali vsebini ene vrečke.
English: In the other, they were compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients.
Slovenian: V drugi študiji so zdravilo primerjali s kapsulami tolterodina (drugim zdravilom za zdravljenje urgentne incontinence) pri 361 bolnikih.
English: Other information about Kentera
Slovenian: Druge informacije o zdravilu Kentera:
English: The Committee therefore decided that the benefits of Kentera gel also outweighed its risks and recommended the approval of the new formulation.
Slovenian: Zato je CHMP odločil, da so tudi koristi gela Kentera večje od z njim povezanih tveganj in priporočil odobritev nove formulacije.
English: Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients.
Slovenian: Zdravila Kentera ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) oksibutinin ali katero koli drugo sestavino zdravila.
English: 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 Kentera.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Kentera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: A new application site should be chosen for each new patch so that the same area of skin is not used more than once within a week.
Slovenian: Za vsak nov obliž je treba izbrati novo mesto nanosa, tako da ga ne namestimo na isti predel kože več kot enkrat tedensko.
English: The most commonly reported side effect with Kentera gel is dry mouth (seen in between 1 and 10 patients in 100).
Slovenian: Najpogostejši neželeni učinek zdravila Kentera so suha usta (opažen pri 1 do 10 bolnikov od 100).
English: The Committee recommended that the Kentera patch be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Kentera odobri dovoljenje za promet.
English: Kentera gel was compared with placebo in one main study in 789 patients with overactive bladders.
Slovenian: Gel Kentera so primerjali s placebom v eni glavni študiji s 789 bolniki s čezmerno aktivnim mehurjem.
English: In the study on the gel, after 12 weeks the average number of daily incontinence episodes, which was initially at 5.4, was reduced by 2.7 episodes per day in patients receiving Kentera gel compared with a drop on average of 2 episodes per day in patients receiving placebo.
Slovenian: V študiji gela se je povprečno število dnevnih inkontinenčnih epizod po 12 tednih zmanjšalo s prvotnih 5,4 za 2,7 epizod na dan pri bolnikih, ki so prejemali gel Kentera, v primerjavi z zmanjšanjem za povprečno 2 epizodi na dan pri bolnikih, ki so prejemali placebo.
English: The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Slovenian: Zdravilna učinkovina zdravila Kentera, oksibutinin, je antiholinergično zdravilo.
English: What is the risk associated with Kentera?
Slovenian: Kakšna tveganja so povezana z zdravilom Kentera?
English: Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
Slovenian: Zdravilo Kentera se uporablja za zdravljenje urgentne inkontinence (nenadne izgube nadzora nad uriniranjem), povečane pogostosti mokrenja (potrebe po pogostem uriniranju) in urgence (nenadne močne nuje po mokrenju) pri odraslih s čezmerno aktivnim sečnim mehurjem (za katerega je značilno nenadno krčenje mišic sečnega mehurja).