FrancophonIA/ELRC3.0 huggingface dataset:
English: Why was meprobamate reviewed?
Slovenian: Zakaj je bil meprobamat pregledan?
English: Oral meprobamate-containing medicines have been authorised in a number of EU Member States for several decades via national procedures.
Slovenian: Peroralna zdravila, ki vsebujejo meprobamat, so bila z nacionalnimi postopki odobrena v številnih državah članicah EU že pred desetletji.
English: These included restricting these medicines to patients who could not use alternative medicines and limiting treatment to a maximum of twelve weeks.
Slovenian: Ti ukrepi so vključevali omejitev teh zdravil na bolnike, ki niso mogli uporabljati drugih nadomestnih zdravil, in omejitev zdravljenja na največ dvanajst tednov.
English: Measures to minimise the risks with meprobamate had already been taken in France.
Slovenian: V Franciji so že sprejeli ukrepe za zmanjšanje tveganj, povezanih z meprobamatom.
English: It will be the responsibility of each Member State to set the precise timeframe for this market withdrawal at national level, within the 15 month framework, and to assess the need for other activities, such as recommendations for prescribers and patients on safe and effective alternatives.
Slovenian: Vsaka država članica bo odgovorna za določitev natančnega časovnega okvira za ta umik zdravila na nacionalni ravni v okviru 15 mesecev ter za oceno potreb po drugih ukrepih, npr. priporočilih za zdravnike, ki predpisujejo zdravilo, in bolnike o varnih in učinkovitih drugih nadomestnih vrstah zdravljenja.
English: To ensure prescribers have enough time to determine the most appropriate treatments for individual patients, the Committee recommended that the withdrawal of the medicines from the market be carried out gradually, within 15 months of the adoption of the European Commission decision.
Slovenian: Da bi zdravnikom, ki predpisujejo zdravilo, zagotovili dovolj časa za določitev najustreznejšega zdravljenja za posamezne bolnike, je Odbor priporočil postopen umik zdravil s trga, in sicer 15 mesecih po sprejetju odločbe Evropske komisije.
English: They are available as tablets containing meprobamate on its own or in combination with other medicines.
Slovenian: Na voljo so v obliki tablet, ki vsebujejo samo meprobamat ali pa v kombinaciji z drugimi zdravili.
English: The French medicines agency was also concerned by reports of these medicines being taken for longer than recommended and cases of overdose (sometimes in combination with other medicines) leading to coma or death.
Slovenian: Francoska regulatorna agencija za zdravila je izrazila tudi zaskrbljenost zaradi poročil o jemanju teh zdravil v daljšem obdobju od priporočenega ter o primerih prevelikih odmerkov (včasih v kombinaciji z drugimi zdravili), ki so povzročili komo ali smrt.
English: Questions and answers on the suspension of the marketing authorisations for oral meprobamatecontaining medicines
Slovenian: Vprašanja in odgovori v zvezi z začasnim umikom dovoljenj za promet z zdravili za peroralno uporabo, ki vsebujejo meprobamat
English: Meprobamate is a sedative medicine used to treat the symptoms of anxiety and related conditions, including anxiety states, alcohol withdrawal, migraine attacks, digestive disorders, muscle tension or cramps and insomnia.
Slovenian: Meprobamat je pomirjevalo, ki se uporablja za zdravljenje simptomov anksioznosti in povezanih stanj, vključno s stanji anksioznosti, odtegnitvijo alkohola, migrenskimi napadi, prebavnimi motnjami, mišično napetostjo ali krči ter nespečnostjo.
English: The French medicines agency concluded in July 2011 that these measures had not been sufficient to prevent overdose and serious side effects from occurring in France.
Slovenian: Francoska regulatorna agencija za zdravila je julija 2011 sklenila, da ti ukrepi niso bili zadostni za preprečitev jemanja prevelikih odmerkov in resnih neželenih učinkov v Franciji.
English: As required by Article 107, France informed the CHMP of its intention to suspend the marketing authorisations in France, so that the Committee could prepare an opinion on whether the marketing authorisations for products containing meprobamate should be maintained, changed, suspended or withdrawn across the EU.
Slovenian: Francija je, kot to zahteva člen 107, odbor CHMP obvestila, da namerava začasno umakniti dovoljenja za promet z zdravili v Franciji, da bi Odbor lahko pripravil mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo meprobamat, v vsej EU ohraniti, spremeniti, začasno umakniti ali preklicati.
English: • Patients should not stop their treatment without speaking to their doctor, since stopping treatment abruptly may lead to severe withdrawal symptoms.
Slovenian: • Bolniki naj ne prekinejo zdravljenja, ne da bi se pogovorili prej z zdravnikom, saj lahko nenadna prekinitev zdravljenja povzroči hude odtegnitvene simptome.
English: All oral meprobamatecontaining medicines will be withdrawn from the EU market until any further data show that the benefits outweigh the risks.
Slovenian: Vsa zdravila za peroralno uporabo, ki vsebujejo meprobamat, bodo s trga EU umaknjena, dokler morebitni nadaljnji podatki ne bodo dokazali, da koristi tega zdravila ne odtehtajo z njim povezanih tveganj.
English: The Committee also considered information requested from the companies that market meprobamatecontaining medicines in the EU.
Slovenian: Odbor je upošteval tudi informacije, pridobljene od družb, ki v EU tržijo zdravila, ki vsebujejo meprobamat.
English: This included data from studies, post-marketing surveillance and the published literature, as well as from poison control centres on cases of poisoning with meprobamate.
Slovenian: Vključili so podatke iz študij, nadzor v obdobju trženja in objavljeno literaturo ter podatke iz centrov za zastrupitve o primerih zastrupitev z meprobamatom.
English: The Committee considered that these risks were increased by the danger of unintentional overdose due to the small difference between the treating dose and the dose that can harm patients, including elderly people.
Slovenian: Presodil je, da so ta tveganja še večja zaradi nevarnosti nenamernega prevelikega odmerka zaradi majhne razlike med terapevtskim odmerkom in odmerkom, ki lahko bolnikom, vključno s starejšimi osebami, škoduje.
English: The CHMP considered the benefit-risk assessment carried out by the French medicines agency for meprobamate-containing medicines marketed in France, covering data from the period 2009 to 2011.
Slovenian: Odbor CHMP je upošteval oceno med koristmi in tveganji, ki jo je izvedla francoska agencija za zdravila za peroralna zdravila, ki vsebujejo meprobamat in so na trgu v Franciji, in ki je zajemala podatke za obdobje od leta 2009 do leta 2011.
English: Finally, the CHMP considered that there was limited data on the benefits of meprobamate.
Slovenian: Na koncu je ugotovil, da so podatki o koristih meprobamata omejeni.
English: • Prescribers should be aware that the availability of meprobamate-containing medicines will decrease as the withdrawal from the market takes place according to national timeframes.
Slovenian: • Zdravniki, ki predpisujejo zdravilo, se morajo zavedati, da bo razpoložljivost zdravil, ki vsebujejo meprobamat, upadla z uveljavitvijo njihovega umika s trga v skladu z nacionalnimi časovnimi okviri.
English: These included confusion and loss of consciousness, particularly in elderly people, and the risk of addiction to the medicine when used for prolonged periods, with severe withdrawal symptoms on stopping treatment abruptly.
Slovenian: Ti so vključevali zmedenost in izgubo zavesti, zlasti pri starejših osebah, in tveganje za odvisnost od zdravila ob uporabi v daljših obdobjih, z resnimi odtegnitvenimi simptomi ob nenadnem prenehanju zdravljenja.
English: Meprobamatecontaining medicines can only be obtained with a prescription.
Slovenian: Zdravila, ki vsebujejo meprobamat, se izdajajo samo na recept.
English: • Doctors should not start new patients on meprobamate-containing medicines.
Slovenian: • Zdravniki naj ne začenjajo zdravljenja novih bolnikov z zdravili, ki vsebujejo meprobamat.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of meprobamate do not outweigh its risks, and that all marketing authorisations for oral medicines containing meprobamate should be suspended throughout the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da koristi meprobamata ne odtehtajo z njim povezanih tveganj in da je treba vsa dovoljenja za promet z zdravili za peroralno uporabo, ki vsebujejo meprobamat, v celotni Evropski uniji (EU) začasno umakniti.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of oral meprobamate-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations for oral meprobamate-containing medicines should be suspended throughout the EU.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravil za peroralno uporabo, ki vsebujejo meprobamat, ne odtehtajo z njim povezanih tveganj, in priporočil, da se vsa dovoljenja za promet z zdravili za peroralno uporabo, ki vsebujejo meprobamat, v vsej EU začasno umaknejo.
English: • Doctors should review the treatment of patients currently taking meprobamate-containing medicines with a view to switching them to alternative treatments, in line with national recommendations for the condition being treated.
Slovenian: • Zdravniki naj pregledajo zdravljenje bolnikov, ki trenutno jemljejo zdravila, ki vsebujejo meprobamat z namenom njihove zamenjave z drugimi nadomestnimi vrstami zdravljenja v skladu z nacionalnimi priporočili za zdravljeno bolezen.
English: • Patients currently using meprobamate-containing medicines should speak to their doctor at their next scheduled appointment to review their treatment.
Slovenian: • Bolniki, ki trenutno uporabljajo zdravila, ki vsebujejo meprobamat, naj se ob naslednjem načrtovanem obisku posvetujejo z zdravnikom, ki bo preučil njihovo zdravljenje.
English: What are the recommendations for prescribers?
Slovenian: Kakšna so priporočila za zdravnike, ki predpisujejo zdravilo?
English: In July 2011, the French medicines regulatory agency announced its intention to suspend the marketing authorisations for oral meprobamate-containing medicines because of serious side effects seen with these medicines.
Slovenian: Julija 2011 je francoska regulatorna agencija za zdravila objavila, da namerava začasno umakniti dovoljenja za promet z zdravili za peroralno uporabo, ki vsebujejo meprobamat, zaradi resnih neželenih učinkov, ki so jih opazili v povezavi s tem zdravilom.
English: The European Medicines Agency has completed a review of the safety and effectiveness of oral meprobamate-containing medicines, due to serious side effects seen with the medicine.
Slovenian: Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti zdravil za peroralno uporabo, ki vsebujejo meprobamat, zaradi hujših neželenih učinkov, ki so jih opazili v zvezi s tem zdravilom.
English: The Committee acknowledged that it is important to allow for patients currently taking meprobamatecontaining medicines to be transferred gradually to alternative treatments, particularly due to the risks of severe withdrawal symptoms on stopping treatment abruptly.
Slovenian: Odbor je potrdil, da je treba bolnikom, ki trenutno jemljejo peroralna zdravila, ki vsebujejo meprobamat, omogočiti postopen prehod na druga nadomestna zdravljenja, še zlasti zaradi tveganj za resne odtegnitvene simptome ob nenadni prekinitvi zdravljenja.
English: The CHMP noted that there was a risk of serious and potentially fatal side effects in patients taking meprobamate-containing medicines under normal conditions of use, including coma.
Slovenian: Odbor CHMP je ugotovil, da pri bolnikih, ki ob običajnih pogojih uporabe jemljejo peroralna zdravila, ki vsebujejo meprobamat, obstaja tveganje za resne in potencialno smrtne neželene učinke, vključno s komo.
English: The Committee recommended that the suspension should be implemented gradually to avoid the risk of severe withdrawal symptoms in patients stopping treatment abruptly.
Slovenian: Odbor je priporočil postopen umik dovoljenj za promet z zdravili, da bi se tako preprečilo tveganje pojava resnih odtegnitvenih simptomov pri bolnikih, ki bi zdravljenje nenadno prekinili.
English: The CHMP also noted that some patients can become addicted to the medicine, leading to serious side effects if they stop treatment abruptly after using it for a long time.
Slovenian: Prav tako je opozoril, da lahko nekateri bolniki postanejo odvisni od zdravila, kar povzroči resne neželene učinke, če z zdravljenjem po dolgotrajni uporabi zdravila nenadoma prenehajo.
English: The Committee considered that this risk was significant despite the measures proposed by the company to minimise it.
Slovenian: Odbor je menil, da je to tveganje pomembno kljub ukrepom, ki jih je predlagala družba za njegovo zmanjšanje.
English: What consequences does this refusal have for patients in clinical trials?
Slovenian: Kakšne so posledice umika vloge za bolnike, ki sodelujejo v kliničnih preskušanjih?
English: The company presented the results of 2 main studies of 4 and 26 weeks' duration.
Slovenian: Družba je predstavila rezultate dveh glavnih študij, od katerih je ena trajala štiri tedne, druga pa 26 tednov.
English: By blocking these receptors, iloperidone is expected to normalise the activity of the brain and reduce the symptoms of the disease.
Slovenian: Z zaviranjem teh receptorjev naj bi iloperidon normaliziral dejavnost možganov in zmanjšal simptome bolezni.
English: In this study, the main measure of effectiveness was the change in the patients' symptoms after 4 weeks, assessed using a standard scale for schizophrenia.
Slovenian: V tej študiji je bilo glavno merilo učinkovitosti sprememba simptomov pri bolnikih po štirih tednih, ocenjena s standardno lestvico za shizofrenijo.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone) EMA/729957/2017
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Fanaptum (iloperidon) EMA/729957/2017
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 (false beliefs).
Slovenian: Shizofrenija je duševna bolezen, ki ima vrsto simptomov, vključno z nepovezanim mišljenjem in govorom, halucinacijami (bolnik vidi ali sliši stvari, ki jih ni), sumničavostjo ter blodnjami (zmotnimi prepričanji).
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in 9. novembra 2017 potrdil zavrnitev vloge za dovoljenje za promet.
English: The way it works is unclear, but it is thought to attach to certain receptors (targets) for neurotransmitters on nerve cells in the brain.
Slovenian: Njegov način delovanja ni povsem jasen, predvideva pa se, da se veže na določene receptorje (prijemališča) za živčne prenašalce na površini živčnih celic v možganih.
English: The company informed the CHMP that there are no ongoing clinical studies with Fanaptum in the EU at the present time.
Slovenian: Družba je odbor CHMP obvestila, da v EU trenutno ne potekajo klinična preskušanja z zdravilom Fanaptum.
English: As a result, some patients may have increased blood concentrations of Fanaptum, which would increase their risk of QT prolongation.
Slovenian: Posledično lahko pri nekaterih bolnikih pride do povišanih koncentracij zdravila Fanaptum v krvi, kar poveča tveganje za podaljšanje intervala QT.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Fanaptum, intended for the treatment of schizophrenia.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 20. julija 2017 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Fanaptum, namenjenim zdravljenju shizofrenije.
English: Iloperidone is thought to block receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin), which play a role in schizophrenia.
Slovenian: Iloperidon naj bi zaviral receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin), ki imata pomembno vlogo pri shizofreniji.
English: The CHMP also noted that the medicine starts to have its effects after 2 to 3 weeks of treatment, which is a concern when treating sudden (acute) episodes of schizophrenia.
Slovenian: Prav tako je opozoril, da zdravilo začne učinkovati po dveh do treh tednih zdravljenja, kar je zaskrbljujoče, če se zdravijo nenadne (akutne) epizode shizofrenije.
English: At the time of the initial recommendation, the CHMP considered that the effectiveness of Fanaptum in studies was modest.
Slovenian: V času izdaje prvotnega priporočila je odbor CHMP menil, da je bila učinkovitost zdravila Fanaptum v študijah zmerna.
English: Fanaptum was expected to be used to treat schizophrenia in adults.
Slovenian: Zdravilo Fanaptum naj bi se uporabljalo za zdravljenje shizofrenije pri odraslih.
English: It measured the time until the patient's symptoms came back (first relapse).
Slovenian: V študiji so merili čas do ponovitve simptomov pri bolnikih (prvi relaps).
English: The longterm study, involving 193 patients, compared Fanaptum with placebo.
Slovenian: V dolgotrajni študiji, v kateri je sodelovalo 193 bolnikov, so zdravilo Fanaptum primerjali s placebom.
English: Finally, the CHMP was concerned that Fanaptum is broken down in the body by liver enzymes whose activity is reduced in certain patients and by certain other medicines.
Slovenian: Nazadnje je izpostavil zaskrbljenost, da se zdravilo Fanaptum v telesu razgrajuje s pomočjo jetrnih encimov, katerih delovanje je zmanjšano pri nekaterih bolnikih in pri uporabi določenih drugih zdravil.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Slovenian: Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje sosednjih živčnih celic.
English: In terms of safety, the CHMP was concerned about the medicine's effects on the heart: Fanaptum causes QT prolongation, a change in the heart's electrical activity which can cause a life-threatening abnormality of heart rhythm.
Slovenian: V zvezi z varnostjo je odbor izpostavil zaskrbljenost glede učinkov zdravila na srce: zdravilo Fanaptum povzroča podaljšanje intervala QT, tj. spremembo električne dejavnosti srca, ki lahko povzroči smrtno nevaren nenormalen srčni ritem.
English: Therefore, the CHMP concluded that the benefits of Fanaptum did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Slovenian: Posledično je sklenil, da koristi zdravila Fanaptum ne odtehtajo z njim povezanih tveganj, in ohranil svoje prvotno priporočilo, da se dovoljenje za promet z njim zavrne.
English: However, the CHMP was still concerned about the risk of QT prolongation and considered that the measures proposed would not appropriately address this risk in clinical practice.
Slovenian: Kljub temu je odbor izrazil zaskrbljenost glede podaljšanja intervala QT in menil, da predlagani ukrepi niso ustrezna rešitev za zmanjšanje tveganja v klinični praksi.
English: In addition, the Committee was still concerned by the modest effectiveness of Fanaptum and its delayed onset of action.
Slovenian: Poleg tega je še enkrat izrazil zaskrbljenost glede zmerne učinkovitosti zdravila Fanaptum in njegovega zakasnjenega delovanja.
English: The active substance in Fanaptum, iloperidone, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina v zdravilu Fanaptum, iloperidon, je antipsihotik.
English: Fanaptum is a medicine that contains the active substance iloperidone.
Slovenian: Fanaptum je zdravilo, ki vsebuje zdravilno učinkovino iloperidon.
English: Refusal of the marketing authorisation for Fanaptum (iloperidone)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Fanaptum (iloperidon)
English: The company that applied for authorisation is Vanda Pharmaceuticals Ltd.
Slovenian: Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Vanda Pharmaceuticals Ltd.
English: What was Fanaptum expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Fanaptum uporabljalo?
English: The short-term study, involving 567 patients, compared Fanaptum with the schizophrenia medicine ziprasidone and with placebo (a dummy treatment).
Slovenian: V kratkotrajni študiji, v kateri je sodelovalo 567 bolnikov, so zdravilo Fanaptum primerjali z ziprasidonom (zdravilom za zdravljenje shizofrenije) in placebom (zdravilom brez zdravilne učinkovine).
English: What is Fanaptum?
Slovenian: Kaj je zdravilo Fanaptum?
English: How does Fanaptum work?
Slovenian: Kako zdravilo Fanaptum deluje?
English: The measures included restricting use to patients whose treatment with another antipsychotic did not work or was no longer tolerated, and prohibiting use in patients who cannot effectively break down the medicine or are taking certain other medicines.
Slovenian: Odbor CHMP je med ponovnim pregledom znova proučil podatke, ki jih je predložila družba, in njen predlog, da se uvedejo nekateri novi ukrepi za obvladovanje tveganja za podaljšanje intervala QT. Ti ukrepi zajemajo omejitev uporabe zdravila zgolj na bolnike, pri katerih zdravljenje z drugimi antipsihotiki bodisi ni bilo učinkovito bodisi jih niso prenašali, in prepoved uporabe zdravila pri bolnikih, pri katerih je razgradnja zdravila ovirana ali ki jemljejo določena druga zdravila.
English: A clinical response is normally seen within 3-4 days.
Slovenian: Klinični odziv je običajno opazen v roku 3-4 dni.
English: Do not use in dogs less than 6 weeks of age.
Slovenian: Ne uporabite pri psih, starih manj kot 6 tednov.
English: Please carefully follow the instructions of the veterinarian.
Slovenian: Skrbno upoštevajte veterinarjeva navodila.
English: Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Slovenian: Zdravljenje je treba prekiniti najkasneje po 10 dneh, če ni opaznega kliničnega izboljšanja.
English: Each ml contains:
Slovenian: En mililiter vsebuje:
English: Date of first authorisation: 23/02/2012
Slovenian: Datum pridobitve dovoljenja za promet : 23/02/2012
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Slovenian: Približno 97 % meloksikama se veže na plazemske beljakovine.
English: This product is for dogs and should not be used in cats as it is not suitable for use in this species.
Slovenian: To je zdravilo za pse, zato ga ne smete uporabljati za mačke, saj ni primerno za to živalsko vrsto.
English: Meloxicam is eliminated with a half-life of 24 hours.
Slovenian: Meloksikam se izloča z razpolovno dobo 24 ur.
English: These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
Slovenian: Ti neželeni učinki se običajno pojavijo v prvem tednu zdravljenja in so povečini prehodni ter izginejo po prekinitvi zdravljenja, vendar pa so v zelo redkih primerih lahko hudi ali smrtni.
English: In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
Slovenian: S študijami in vitro in in vivo so dokazali, da meloksikam zavira ciklooksigenazo-2 (COX-2) v večji meri kot ciklooksigenazo-1 (COX-1).
English: Remove Cap
Slovenian: Odstranite pokrov
English: Use during pregnancy and lactation: See section "Contraindications".
Slovenian: Uporaba v obdobju brejosti in laktacije: Glejte poglavje "Kontraindikacije".
English: All major metabolites have been shown to be pharmacologically inactive.
Slovenian: Pokazalo se je, da so vsi bistveni presnovki farmakološko neaktivni.