FrancophonIA/ELRC3.0 huggingface dataset:
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Slovenian: Shizofrenija je duševna bolezen s številnimi simptomi, kot so neorganizirano mišljenje in govor, halucinacije (prisluhi ali prividi), sumničavost ter blodnje (zmotna prepričanja).
English: However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and welltolerated dose of oral olanzapine has been found.
Slovenian: Kljub temu pa lahko bolniki, stari od 65 do 75 let, ali bolniki z ledvičnimi oziroma jetrnimi težavami zdravilo Zypadhera uporabljajo, če je bil ugotovljen odmerek peroralnega olanzapina, ki je učinkovit in ga bolniki dobro prenašajo.
English: Other information about Zypadhera
Slovenian: Druge informacije o zdravilu Zypadhera
English: In addition, it is not possible to stop treatment after giving a prolonged-release injection, which would not be suitable for patients experiencing side effects.
Slovenian: Poleg tega zdravljenja po uporabi injekcijske brizge s podaljšanim izločanjem ni mogoče zaustaviti, kar ne bi bilo primerno za bolnike, pri katerih se pojavijo neželeni učinki.
English: All of the patients in this study had been stabilised with other treatments for schizophrenia and had been taking olanzapine by mouth for at least six weeks before the study began.
Slovenian: Vse bolnike v tej študiji so stabilizirali z drugimi vrstami zdravljenja shizofrenije, olanzapin pa so jemali peroralno vsaj šest tednov pred začetkom študije.
English: It is available as a powder and solvent that are made up into a prolonged-release suspension for injection.
Slovenian: Na voljo je kot prašek in vehikel za pripravo suspenzijo za injiciranje s podaljšanim sproščanjem.
English: In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth: 10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth.
Slovenian: V študiji, s katero so opazovali vzdrževanje odziva na zdravljenje z olanzapinom, je bilo zdravilo Zypadhera enako učinkovito kot olanzapin, ki so ga bolniki jemali peroralno: pri 10 % bolnikov, ki so prejemali zdravilo Zypadhera vsake dva tedna, so se simptomi poslabšali, v primerjavi s 7 % tistih, ki so olanzapin jemali peroralno.
English: The ‘high' doses of Zypadhera were more effective at preventing a worsening of symptoms than the ‘low' dose.
Slovenian: Visoki odmerki zdravila Zypadhera so bili bolj učinkoviti pri preprečevanju poslabšanja simptomov kot nizki odmerki.
English: Zypadhera has been studied in two main studies involving adults with schizophrenia.
Slovenian: Zdravilo Zypadhera so raziskali v dveh glavnih študijah, ki sta vključevali odrasle bolnike s shizofrenijo.
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 Zypadhera.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zypadhera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness), orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Slovenian: Najpogostejši neželeni učinki zdravila Zypadhera (opaženi pri več kot 1 od 10 bolnikov) so povečanje telesne mase, somnolenca (zaspanost), ortostatska hipotenzija (nenaden padec krvnega tlaka v stoječem položaju) in zvišane koncentracije prolaktina (hormona).
English: As a result, the active substance is released slowly for more than four weeks after injection of Zypadhera.
Slovenian: Zato se zdravilna učinkovina v zdravilu sprošča počasi, dlje kot štiri tedne po vbrizganju zdravila Zypadhera.
English: The Committee decided that Zypadhera's benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Zypadhera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo.
Slovenian: V študiji začetnega zdravljenja shizofrenije je bilo zdravilo Zypadhera učinkovitejše od placeba.
English: What benefit has Zypadhera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zypadhera izkazalo med študijami?
English: The effectiveness of Zypadhera was greater than placebo from the second week of treatment onwards.
Slovenian: Učinkovitost zdravila Zypadhera je bila večja kot pri placebu od drugega tedna zdravljenja dalje.
English: Because patients should be monitored by qualified staff for these symptoms for at least three hours after injection, they should receive Zypadhera at a centre with the appropriate facilities to deal with a potential overdose.
Slovenian: Ker mora za ugotavljanje pojava teh simptomov bolnike vsaj tri ure po vbrizganju nadzorovati usposobljeno osebje, morajo bolniki zdravilo Zypadhera prejeti v zdravstvenem zavodu, ki je primerno opremljen za ukrepanje ob morebitnem prekomernem odmerku.
English: The dose depends on the dose of olanzapine that the patient was previously taking by mouth.
Slovenian: Odmerek je odvisen od odmerka olanzapina, ki ga je bolnik pred tem jemal peroralno.
English: In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein.
Slovenian: V redkih primerih se lahko pri bolnikih, ki prejemajo zdravilo Zypadhera, pojavijo simptomi prekomernega odmerka olanzapina po injekciji, če se zdravilo po nesreči vbrizga v veno.
English: Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection.
Slovenian: Zdravilo Zypadhera dasta z globoko injekcijo v zadnjično mišico zdravnik ali sestra, ki sta usposobljena za tako injiciranje.
English: The CHMP noted that Zypadhera is effective both in the initial treatment of schizophrenia and in maintaining a response to treatment in schizophrenia.
Slovenian: CHMP je zaključil, da je zdravilo Zypadhera učinkovito pri začetnem zdravljenju shizofrenije in vzdrževanju odziva na zdravljenje shizofrenije.
English: Zypadhera must not be used in patients who are hypersensitive (allergic) to olanzapine or any of the other ingredients.
Slovenian: Zdravila Zypadhera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) olanzapin ali katero koli drugo sestavino zdravila.
English: The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment:
Slovenian: V prvi študiji so opazovali začetno zdravljenje shizofrenije, v drugi pa vzdrževanje odziva na zdravljenje z olanzapinom:
English: For the full list of all side effects reported with Zypadhera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zypadhera, glejte navodilo za uporabo.
English: Zypadhera is a medicine that contains the active substance olanzapine.
Slovenian: Zypadhera je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Slovenian: Podaljšano sproščanje pomeni, da se zdravilna učinkovina po injiciranju sprošča nekaj tednov.
English: What is the risk associated with Zypadhera?
Slovenian: Kakšna tveganja so povezana z zdravilom Zypadhera?
English: Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.
Slovenian: Zdravilo Zypadhera se uporablja za vzdrževanje izboljšanja simptomov pri bolnikih s shizofrenijo, ki so že dosegli stabilno stanje v začetnemu zdravljenju z olanzapinom, vzetim peroralno.
English: • the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients.
Slovenian: • v študiji začetnega zdravljenja so pri 404 bolnikih primerjali učinke treh odmerkov zdravila Zypadhera z učinki placeba (injekcijami zdravila brez zdravilne učinkovine).
English: A lower starting dose may be necessary in patients whose bodies may break olanzapine down slowly, such as those with moderate liver problems.
Slovenian: Pri bolnikih, ki morda počasneje presnavljajo olanzapin, kot npr. tisti z zmernimi jetrnimi težavami, bo morda potreben nižji začetni odmerek.
English: Why has Zypadhera been approved?
Slovenian: Zakaj je bilo zdravilo Zypadhera odobreno?
English: The active substance in Zypadhera, olanzapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Zypadhera je olanzapin, ki je antipsihotično zdravilo.
English: • the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients.
Slovenian: • v študiji vzdrževalnega zdravljenja pri 1 065 bolnikih so primerjali učinke štirih odmerkov zdravila Zypadhera z učinki peroralno zaužitega olanzapina.
English: The olanzapine in Zypadhera is presented as a ‘pamoate' salt, which makes the olanzapine less soluble.
Slovenian: Olanzapin v zdravilu Zypadhera je v obliki soli pamoata, zaradi česar je manj topen.
English: What is Zypadhera used for?
Slovenian: Za kaj se zdravilo Zypadhera uporablja?
English: What is Zypadhera?
Slovenian: Kaj je zdravilo Zypadhera?
English: How has Zypadhera been studied?
Slovenian: Kako je bilo zdravilo Zypadhera raziskano?
English: How is Zypadhera used?
Slovenian: Kako se zdravilo Zypadhera uporablja?
English: How does Zypadhera work?
Slovenian: Kako zdravilo Zypadhera deluje?
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Slovenian: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za {ime(-na) zdravilne(-ih) učinkovine(učinkovin)} odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) {ime(-na) zdravilne(-ih) učinkovine(učinkovin)} nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: OF THE MARKETING AUTHORISATION(S)
Slovenian: POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za {ime(-na) zdravilne(-ih) učinkovine(učinkovin)} je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Outcome of a procedure under Article 36 of Directive 2001/83/EC as amended
Slovenian: Izid postopka v skladu s členom 36 Direktive 2001/83/ES, kakor je bila spremenjena
English: The European Commission issued a decision on 16 September 2011.
Slovenian: Evropska komisija je odločbo izdala dne 16. septembra 2011.
English: What is Goserelin?
Slovenian: Kaj je goserelin?
English: Why was Goserelin reviewed?
Slovenian: Zakaj je bil goserelin pregledan?
English: Goserelin is used to treat patients with advanced prostate cancer.
Slovenian: Goserelin se uporablja za zdravljenje bolnikov z napredovalim rakom prostate.
English: It is a copy of the natural hormone (luteinizing hormone-releasing hormone) that regulates many processes in the body.
Slovenian: Je kopija naravnega hormona (hormona, ki sprošča luteinizirajoči hormon), ki vpliva na več procesov v telesu.
English: In prostate cancer it works by depriving prostate cancer cells of the male hormone testosterone on which they depend to grow and spread.
Slovenian: Pri raku prostate deluje tako, da rakavim celicam prostate preprečuje oskrbo z moškim hormonom testosteronom, ki ga potrebujejo za rast in širjenje.
English: The marketing authorisation should therefore be suspended in all member states until the companies provide new studies showing therapeutic equivalence and being GCP compliant.
Slovenian: Dovoljenje za promet z zdravilom je zato treba v vseh državah članicah začasno umakniti, dokler družbe ne predložijo novih študij, ki bodo dokazovale terapevtsko enakovrednost in skladnost z načeli dobre klinične prakse.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da ni bilo dokazano, da so ta zdravila enakovredna referenčnemu zdravilu (Zoladex), in da je zato treba dovoljenja za promet z zdravili začasno umakniti, dokler ne bo dokazana terapevtska enakovrednost.
English: Based on the evaluation of the studies that were submitted in support of the marketing authorisation application and the scientific discussion within the Committee, the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative.
Slovenian: Na podlagi ocene študij, ki so bile predložene v podporo vlogi za pridobitev dovoljenja za promet z zdravilom, in znanstvene razprave v Odboru, je CHMP zaključil, da terapevtska enakovrednost ni bila dokazana, zato velja, da je razmerje med tveganji in koristmi teh hibridnih zdravil negativno.
English: The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed.
Slovenian: Nemška regulativna agencija za zdravila je menila, da je potreben začasni umik dovoljenj za promet z zdravili, ki so že bila odobrena, saj ni mogoče zagotoviti terapevtske enakovrednosti z referenčnim zdravilom.
English: Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.
Slovenian: Goserelin se trži kot hibrid zdravila Zoladex pod tržnimi imeni Novimp, Goserelin Cell Pharma, Novosis Goserelin in povezanimi imeni.
English: The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).
Slovenian: Evropska agencija za zdravila je zaključila pregled kliničnih študij, ki so bile predložene kot del vloge za pridobitev dovoljenja za promet s hibridnimi (vrsta generičnih) zdravili Novosis Goserelin, Goserelin Cell Pharm, Novimp in povezanih imen (goserelin, 3,6 mg implantat).
English: Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin containing medicines were not conducted in accordance with Good Clinical Practice (GCP) and questioned whether their results could be relied on.
Slovenian: Nemška regulativna agencija za zdravila je po pregledu ugotovila, da klinične študije, ki so bile izvedene kot del vloge za pridobitev dovoljenja za promet z nekaterimi zdravili, ki vsebujejo goserelin, niso bile izvedene v skladu z načeli dobre klinične prakse, in izrazila dvom o zanesljivosti rezultatov teh študij.
English: whether the marketing authorisations for Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Nemška agencija je dne 16. marca 2011 zadevo napotila na CHMP, da bi Odbor lahko izdal mnenje o tem, ali je treba dovoljenja za promet z zdravili Novosis Goserelin, Goserelin Cell Pharm, Novimp in povezanimi imeni ohraniti, spremeniti, začasno umakniti ali ukiniti po vsej EU.
English: The physician information should contain the following key messages:
Slovenian: Informacije za zdravnika morajo vsebovati naslednja ključna sporočila:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Država članica mora zagotoviti, da bo izpolnjevala vse pogoje ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisani spodaj:
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Slovenian: • Potreba po ovrednotenju bolnikov za tako aktivno kot neaktivno tuberkulozo pred začetkom zdravljenja, vključno z uporabo ustreznih presejalnih testiranj
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet mora pred lansiranjem zdravila zagotoviti, da vsi zdravniki, ki bodo verjetno predpisovali/uporabljali zdravilo Cimzia, prejmejo paket z informacijami za zdravnike, ki vsebuje:
English: • The role and use of patient alert card.
Slovenian: • Vloga in uporaba opozorilne kartice za bolnika
English: • The contraindication of Cimzia in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Cimzia,
Slovenian: • Kontraindikacije zdravila Cimzia pri bolnikih z anamnezo zmerne do hude srčne odpovedi (NYAHA III/IV) in možno tveganje za poslabšanje kongestivne odpovedi srca zaradi zdravila Cimzia
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Cimzia,
Slovenian: • Tveganje za resne okužbe, vključno z oportunističnimi bakterijskimi, virusnimi in glivičnimi okužbami pri bolnikih, ki se zdravijo z zdravilom Cimzia
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Slovenian: • Tveganje za akutne reakcije, povezane z injiciranjem in zakasnjene resne sistemske preobčutljivostne reakcije, potreba po izobraževanju bolnikov o načinu uporabe in vodenje strokovnjakov z zdravstvenega področja pri poročanju napak pri uporabi
English: 24 August 2011
Slovenian: 24. avgust 2011
English: The mutual recognition procedure (UK/V/0373/001/MR) started on 29 July 2010.
Slovenian: Postopek medsebojnega priznavanja (UK/V/0373/001/MR) se je začel 29. julija 2010.
English: The final opinion was converted into a Decision by the European Commission on 24 August 2011.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 24. avgusta 2011.
English: The referral procedure started on 9 February 2011.
Slovenian: Napotitveni postopek se je začel 9. februarja 2011.
English: On 28 January 2011, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by two of the Concerned Member States, the Netherlands and Sweden, that the safety and efficacy of the product had not been sufficiently demonstrated.
Slovenian: Dne 28. januarja 2011 je Združeno kraljestvo, kot referenčna država članica, zadevo napotilo na Evropsko agencijo za zdravila v skladu s členom 33(4) Direktive 2001/82/ES zaradi pomislekov o varnosti, ki sta jih izrazili dve zadevni državi članici, Nizozemska in Švedska, da varnost in učinkovitost zdravila nista bili ustrezno dokazani.
English: names is positive, and therefore adopted an opinion on 6 April 2011 recommending the granting of the marketing authorisation.
Slovenian: povezana imena pozitiven, zato je 6. aprila 2011 sprejel mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Ms Helen Jukes as co-rapporteur.
Slovenian: Odbor je za poročevalko imenoval dr. Karolino Törneke in za so-poročevalko g. Heleno Jukes.
English: The marketing authorisation holder, Dechra Ltd, submitted an application for Clavudale 50 mg via a mutual recognition procedure in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden on the basis of the marketing authorisation granted by the United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom, Dechra Ltd, je predložil vlogo za zdravilo Clavudale 50 mg v okviru postopka medsebojnega priznavanja v Avstriji, Belgiji, na Češkem, Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Islandiji, Irskem, v Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, na Slovaškem, v Španiji in na Švedskem na podlagi dovoljenja za promet z zdravilom, odobrenega v Združenem kraljestvu.
English: International non-proprietary name (inn): amoxicillin, clavulanic acid
Slovenian: Mednarodno nelastniško ime (INN): amoksicilin, klavulanska kislina
English: There was disagreement between the Reference Member State and these Concerned Member States on the demonstration of bioequivalence in the cat target species.
Slovenian: Referenčna država članica in zadevni državi članici se niso strinjale z dokazovanjem biološke enakovrednosti pri ciljni vrsti živali, tj. mačke.
English: The list of product names concerned is given in Annex I. The scientific conclusions for the granting of the marketing authorisation are provided in Annex II.
Slovenian: Seznam zadevnih zdravil je naveden v Prilogi I. Priloga II vsebuje znanstvene zaključke za odobritev dovoljenja za promet z zdravilom.
English: Written explanations were provided by the marketing authorisation holder on 11 April 2011.
Slovenian: Imetnik dovoljenja za promet z zdravilom je 11. aprila 2011 podal pisne obrazložitve.
English: The summary of product characteristics, labelling and package leaflet are provided in Annex III.
Slovenian: Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Prilogi III.
English: The application was submitted as a generic of the reference product, Synulox Palatable Tablets 50 mg marketed by Pfizer Ltd.
Slovenian: Vloga je bila predložena za generik referenčnega zdravila, Synulox Palatable Tablets 50 mg, ki ga trži družba Pfizer Ltd.
English: Clavudale 50 mg tablet for cats and dogs and associated names (Clavudale 50 mg) contains amoxicillin and clavulanic acid.
Slovenian: Zdravilo Clavudale 50 mg tablete za mačke in pse in povezana imena (Clavudale 50 mg) vsebujejo amoksicilin in klavulansko kislino.