FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of Segluromet may be reduced or it may be stopped if the kidneys are not working well enough.
Slovenian: Če bolnikove ledvice ne delujejo dovolj dobro, se lahko odmerek zdravila Segluromet zmanjša ali pa bolnik zdravilo preneha jemati.
English: How does Segluromet work?
Slovenian: Kako zdravilo Segluromet deluje?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Uptravi on 12 May 2016.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Uptravi, veljavno po vsej Evropski uniji, izdala 12. maja 2016.
English: What measures are being taken to ensure the safe and effective use of Uptravi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Uptravi?
English: The full EPAR for Uptravi 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 Uptravi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Uptravi is available as tablets (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Slovenian: Zdravilo Uptravi je na voljo v obliki tablet (200, 400, 600, 800, 1 000, 1 200, 1 400 in 1 600 mikrogramov).
English: What is Uptravi and what is it used for?
Slovenian: Kaj je zdravilo Uptravi in za kaj se uporablja?
English: Overall, 24.4% (140 out of 574) of patients treated with Uptravi either died or showed signs of worsening disease compared with 36.4% (212 out of 582) of patients treated with placebo.
Slovenian: Skupno je umrlo ali pokazalo znake poslabšanja bolezni 24,4 % (140 od 574) bolnikov, ki so bili zdravljeni z zdravilom Uptravi, v primerjavi s 36,4 % (212 od 582) bolnikov, ki so bili zdravljeni s placebom.
English: These effects are mild or moderate and are most frequently seen while the dose of Uptravi is being increased.
Slovenian: Ti učinki so blagi ali zmerni in so jih najpogosteje opazili pri povečanju odmerka zdravila Uptravi.
English: It is not intended to provide practical advice on how to use Uptravi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Uptravi selexipag
Slovenian: Uptravi seleksipag
English: What benefits of Uptravi have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Uptravi izkazalo v študijah?
English: This is a summary of the European public assessment report (EPAR) for Uptravi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Uptravi.
English: The main measure of effectiveness was based on the number of patients whose disease worsened or who died during treatment or shortly after treatment had ended.
Slovenian: Glavno merilo učinkovitost je bilo število bolnikov, pri katerih se je bolezen poslabšala ali so med zdravljenjem ali kmalu po njem umrli.
English: Patients may tolerate treatment better if they take their tablets with food and take the first tablet of an increased dose in the evening rather than the morning.
Slovenian: Bolniki lahko zdravljenje bolje prenašajo, če tablete jemljejo sočasno s hrano in prvo tableto povečanega odmerka vzamejo zvečer, ne zjutraj.
English: Other information about Uptravi
Slovenian: Druge informacije o zdravilu Uptravi
English: It must also not be used in patients who have had a stroke within the last 3 months.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki so v zadnjih treh mesecih doživeli možgansko kap.
English: What are the risks associated with Uptravi?
Slovenian: Kakšna tveganja so povezana z zdravilom Uptravi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Uptravi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Uptravi večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Although the CHMP noted a small apparent increase in the rate of death for patients taking Uptravi when compared with placebo, they considered that this was due to chance or to the way the study was designed and therefore did not impact the benefits or risks of the medicine.
Slovenian: Čeprav je odbor CHMP ugotovil majhno dozdevno povišanje deleža smrti bolnikov, ki so jemali zdravilo Uptravi, v primerjavi s placebom, je ocenil, da je razlog za to naključje ali način, kako je bila študija zasnovana, zato to ni vplivalo na koristi ali tveganja zdravila.
English: Why is Uptravi approved?
Slovenian: Zakaj je bilo zdravilo Uptravi odobreno?
English: Treatment should be started at a dose of 200 micrograms twice a day, approximately 12 hours apart.
Slovenian: Zdravljenje je treba začeti z odmerkom 200 mikrogramov dvakrat dnevno, v razmiku približno 12 ur.
English: If the patient cannot tolerate an increased dose, the doctor may have to reduce it.
Slovenian: Če bolnik povečanega odmerka ne prenaša, ga bo moral zdravnik morda zmanjšati.
English: The benefits of Uptravi for PAH were shown in one main study involving 1,156 patients with PAH.
Slovenian: Koristi zdravila Uptravi pri pljučni arterijski hipertenziji so dokazali v eni glavni študiji, v katero je bilo vključenih 1 156 bolnikov s pljučno arterijsko hipertenzijo.
English: If stopping treatment with Uptravi, the dose should be reduced gradually.
Slovenian: Ob prenehanju zdravljenja z zdravilom Uptravi je treba odmerek zmanjševati postopoma.
English: For patients with other heart problems, Uptravi must only be used under close medical supervision.
Slovenian: Pri bolnikih z drugimi boleznimi srca se sme zdravilo Uptravi uporabljati le pod skrbnim zdravniškim nadzorom.
English: It can be used in combination with other medicines called endothelin receptor antagonists (ERA) or phosphodiesterase type-5 (PDE-5) inhibitors or on its own for patients for whom these medicines are not suitable.
Slovenian: Uporablja se lahko v kombinaciji z drugimi zdravili, imenovanimi antagonisti endotelinskih receptorjev (ERA) ali zaviralci fosfodiesteraze tipa 5 (FDE-5), ali kot samostojno zdravilo pri bolnikih, za katere te oblike zdravljenja niso primerne.
English: Patients with moderately reduced liver function should start with 200 micrograms once daily.
Slovenian: Bolniki z zmerno zmanjšanim delovanjem jeter morajo začeti z odmerkom 200 mikrogramov enkrat dnevno.
English: For more information about treatment with Uptravi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Uptravi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Regarding safety, the side effects with Uptravi are considered acceptable.
Slovenian: Kar zadeva varnost, so neželeni učinki zdravila Uptravi sprejemljivi.
English: The diary contains boxes for the patient to mark the number and strength of tablets they take each day.
Slovenian: Dnevnik vsebuje okvirčke, v katerih bo bolnik označil število in jakost tablet, ki jih bo vzel vsak dan.
English: Patients with PAH currently have very limited treatment options; therefore there is a high unmet medical need.
Slovenian: Bolniki s pljučno arterijsko hipertenzijo imajo zaenkrat zelo omejene možnosti zdravljenja, zato obstaja velika neizpolnjena potreba po zdravilih.
English: The company will provide educational materials for the healthcare professionals who will prescribe and dispense the medicine to help them prescribe the medicine correctly and avoid medication errors.
Slovenian: Družba bo zdravstvenim delavcem, ki bodo to zdravilo predpisovali in izdajali, priskrbela izobraževalno gradivo, ki jim bo pomagalo, da bodo zdravilo pravilno predpisovali in se izognili napakam pri njegovi uporabi.
English: The most common side effects with Uptravi (which may affect more than 1 in 10 people) are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia (muscle pain), pain in the limbs, arthralgia (joint pain) and flushing.
Slovenian: Najpogostejši neželeni učinki zdravila Uptravi (ki lahko prizadenejo več kot 1 osebo od 10) so glavobol, driska, slabost in bruhanje, bolečine v čeljustih, mialgija (bolečine v mišicah), bolečine v okončinah, artralgija (bolečine v sklepih) in vročinski oblivi.
English: These materials will also include a guide and diary to be given to patients to help them keep track of the number of tablets to take and explain how doses should be increased.
Slovenian: To gradivo bo vključevalo tudi navodilo in dnevnik, ki ju bodo bolniki prejeli za pomoč pri beleženju števila tablet, ki jih morajo vzeti, in kjer bo razloženo, kako je treba odmerke povečevati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Uptravi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Uptravi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Compared with other medicines in the same class which are given into a vein, Uptravi has the advantage of being given by mouth.
Slovenian: V primerjavi z drugimi zdravili iz istega razreda, ki se dajejo v veno, je prednost zdravila Uptravi, da se daje peroralno.
English: Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Slovenian: Zdravilo Uptravi se uporablja za zdravljenje odraslih s pljučno arterijsko hipertenzijo (PAH, nenormalno visokim krvnim tlakom v pljučnih arterijah).
English: It must not be used in patients with severe arrhythmias (unstable heartbeat) or defects in the heart valves.
Slovenian: Ne sme se uporabljati pri bolnikih s hudimi aritmijami (nestabilnim srčnim utripom) ali napakami na srčnih zaklopkah.
English: Uptravi must not be taken at the same time as medicines, such as gemfibrozil, that are strong blockers (inhibitors) of the liver enzyme CYP2C8.
Slovenian: Zdravila Uptravi se ne sme jemati sočasno z zdravili, kot je denimo gemfibrozil, ki je močan zaviralec jetrnega encima CYP2C8.
English: The active substance in Uptravi, selexipag, is a ‘prostacyclin receptor agonist'.
Slovenian: Zdravilna učinkovina v zdravilu Uptravi, seleksipag, je agonist prostaciklinskih receptorjev.
English: By attaching to prostacyclin receptors, Uptravi also widens the blood vessels and so lowers the pressure inside them, improving symptoms of the disease.
Slovenian: Z vezavo na prostaciklinske receptorje tudi zdravilo Uptravi razširi žile in s tem zmanjša tlak v njih, s čimer izboljša simptome bolezni.
English: If tolerated, this dose can be increased weekly.
Slovenian: Če bolniki odmerek dobro prenašajo, ga je mogoče tedensko povečevati.
English: Uptravi can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Slovenian: Predpisovanje in izdaja zdravila Uptravi je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem pljučne arterijske hipertenzije.
English: For practical information about using Uptravi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Uptravi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Uptravi must not be used in patients who have had a heart attack within the last 6 months, severe coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle) or unstable angina (a severe type of chest pain).
Slovenian: Zdravilo Uptravi se ne sme uporabljati pri bolnikih, ki so v zadnjih šestih mesecih doživeli srčni infarkt, in bolnikih s hudo koronarno srčno boleznijo (boleznijo srca, ki jo povzroči zapora žil, ki oskrbujejo srčno mišico) ali nestabilno angino pektoris (hudo obliko bolečine v prsih).
English: Patients with severely reduced liver function should not take Uptravi.
Slovenian: Bolniki z močno zmanjšanim delovanjem jeter zdravila Uptravi ne smejo jemati.
English: For the full list of restrictions and side effects reported with Uptravi, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Uptravi, glejte navodilo za uporabo.
English: The dose is then increased weekly, as long as it is tolerated, to a maximum of 1,600 micrograms twice daily, which is then continued afterwards.
Slovenian: Odmerek se tedensko povečuje, dokler ga bolnik prenaša, do največ 1 600 mikrogramov dvakrat dnevno.
English: This means that it works in a similar way to prostacyclin, a naturally occurring substance that regulates blood pressure by attaching to receptors in the muscles of blood vessel walls, causing the vessels to relax and widen.
Slovenian: To pomeni, da deluje podobno kot prostaciklin, naravno prisotna snov, ki z vezavo na receptorje v mišicah v stenah žil uravnava krvni tlak tako, da sprosti in razširi žile.
English: Patients were given either Uptravi or placebo (a dummy treatment) for around 70 weeks.
Slovenian: Bolniki so 70 tednov prejemali zdravilo Uptravi ali placebo (zdravilo brez zdravilne učinkovine).
English: Any prescriber of Uptravi will have to register first with the company that markets Uptravi before being able to prescribe it.
Slovenian: Vsakdo, ki bo želel predpisovati zdravilo Uptravi, se bo moral pred začetkom predpisovanja registrirati pri družbi, ki trži to zdravilo.
English: Uptravi has been shown to be more effective than placebo at preventing worsening of PAH, on its own and when used in addition to an ERA and/or a PDE-5 inhibitor.
Slovenian: Zdravilo Uptravi se je pri preprečevanju poslabšanja pljučne arterijske hipertenzije izkazalo kot učinkovitejše od placeba tako pri uporabi kot samostojno zdravilo kot tudi v kombinaciji z ERA in/ali zaviralcem FDE-5.
English: Patients were either previously untreated or receiving treatment with other PAH medicines (ERA or PDE-5 inhibitors).
Slovenian: Bolniki pred tem niso bili zdravljeni ali pa so bili zdravljeni z drugimi zdravili za pljučno arterijsko hipertenzijo (ERA ali zaviralci FDE5).
English: How is Uptravi used?
Slovenian: Kako se zdravilo Uptravi uporablja?
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Slovenian: Zdravilo Uptravi se uporablja pri bolnikih s pljučno arterijsko hipertenzijo funkcionalnega razreda II ali III. Funkcionalni razred odraža resnost bolezni: razred II pomeni blažjo omejitev telesne zmogljivosti, razred III pa izrazito omejitev telesne zmogljivosti.
English: Uptravi contains the active substance selexipag.
Slovenian: Zdravilo Uptravi vsebuje zdravilno učinkovino seleksipag.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Slovenian: Pljučna arterijska hipertenzija je izčrpavajoča bolezen, pri kateri pride do hudega zoženja krvnih žil v pljučih.
English: How does Uptravi work?
Slovenian: Kako zdravilo Uptravi deluje?
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Slovenian: Kot je zahtevano, bodo po odločbi komisije pristojni organi držav članic, po posvetovanju z referenčno državo članico, lahko posodobili informacije o zdravilu.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo zdravila so končne različice, ki so bile dogovorjene med postopkom Skupine za usklajevanje.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Slovenian: Opomba: Ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, veljavne ob izdaji odločbe komisije.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Zato ta povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo mogoče potem ne bodo več predstavljali veljavnega besedila.
English: Transdermal use metering pump (PP/LDPE);
Slovenian: 30 vrečic odmerna črpalka (PP/LDPE);
English: 1 metering pump
Slovenian: 1 odmerna črpalka
English: Transdermal use sachet (LDPE/paper laminate)
Slovenian: Velikost pakiranja transdermalna obliža
English: • Contraindication in neonates;
Slovenian: • kontraindikacijo pri novorojenčkih;
English: Retrieved from http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Articl e_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
Slovenian: Pridobljeno iz http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/ Article_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
English: • The revocation of the marketing authorisations for:
Slovenian: • razveljavitev dovoljenj za promet z zdravili za:
English: Metoclopramide has been authorised in the European Union since the 1960's and marketing authorisations currently exist in all Member States as well as in Norway and Iceland.
Slovenian: Metoklopramid je v Evropski uniji odobren od 60. let prejšnjega stoletja, dovoljenja za promet z njim pa so trenutno odobrena v vseh državah članicah ter tudi na Norveškem in Islandiji.
English: o Is not favourable in children under 1 year of age for any indication.
Slovenian: o ni ugodno pri otrocih, mlajših od 1 leta, za katero koli indikacijo;
English: The French Competent Authority considered it particularly important that the therapeutic indications and safety information be made consistent across Member States.
Slovenian: Francoski pristojni organ je menil, da je zlasti pomembno, da se uskladijo terapevtske indikacije in informacije o varnosti v vseh državah članicah.
English: There is no clinical data available to allow for a discussion on this point.
Slovenian: Na voljo ni nobenih podatkov, ki bi omogočali razpravo o tej točki.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for metoclopramide-containing medicinal products.
Slovenian: • odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metoklopramid;
English: Overall summary of the scientific evaluation of metoclopramide-only containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo samo metoklopramid (glejte Prilogo I)
English: Risk Minimisation Measures
Slovenian: Ukrepi za zmanjšanje tveganja
English: The authorised indications for the concerned products are different but can broadly be grouped in the following way:
Slovenian: Odobrene indikacije za zadevna zdravila so različne, vendar jih je mogoče na splošno razvrstiti v naslednje skupine:
English: There is no clear correlation between formulations and indications.
Slovenian: Jasne povezave med posameznimi pripravki in indikacijami ni.
English: Therefore it would be appropriate not to use metoclopramide during breastfeeding.
Slovenian: Zato bi bilo primerno, da se metoklopramid ne bi uporabljal med dojenjem.
English: Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Slovenian: Čeprav klinična pomembnost ni dokazana, je treba bolnike spremljati glede neželenih učinkov.
English: Therefore the risk to newborns cannot be excluded and metoclopramide should be avoided at the end of pregnancy.
Slovenian: Tveganja za novorojenčke torej ni mogoče izključiti, zato se je treba izogibati uporabi metoklopramida proti koncu nosečnosti.
English: Metoclopramide can therefore be used during pregnancy, if clinically justified.
Slovenian: Metoklopramid se torej lahko uporablja med nosečnostjo, kadar je to klinično upravičeno.
English: In children there is also a significant number of reported cases of overdose.
Slovenian: Pri otrocih so poročali tudi o velikem številu primerov prevelikega odmerjanja.
English: Furthermore, existing studies included a very small number of patients and focused on a small duration of treatment.
Slovenian: Poleg tega so v obstoječih študijah obravnavali zelo majhno število bolnikov, ki so zdravljenje prejemali zgolj kratek čas.
English: The review by Lee et al. provides a complete overview of the evidence of efficacy in diabetic gastroparesis.
Slovenian: Lee in drugi so pripravili popoln pregled dokazov o učinkovitosti pri diabetični gastroparezi.
English: The data presented is limited and was generated in different settings during which nausea and vomiting may occur.
Slovenian: Predloženi podatki so omejeni in so bili pridobljeni v različnih okoliščinah, v katerih se lahko pojavita slabost in bruhanje.
English: The CHMP endorsed a communication i.e. Dear Healthcare Professional Communication (DHPC), to rapidly communicate the outcome of the present review.
Slovenian: CHMP je odobril obvestilo zdravstvenim delavcem (DHPC - Dear Healthcare Professional Communication), da se jim v najkrajšem možnem času sporoči izid tega pregleda.
English: Each individual product is authorised for one or more of these indications, and in some cases the indication is specific to adults and/or children.
Slovenian: Posamezna zdravila so odobrena za eno ali več navedenih indikacij, ki so v nekaterih primerih odobrene samo pri odraslih bolnikih in/ali otrocih.
English: For severe hepatic impairment, the existing recommendation for 50% dose reduction is appropriate.
Slovenian: Za hudo okvaro jeter je ustrezno obstoječe priporočilo o zmanjšanju odmerka za 50 %.
English: Metoclopramide is excreted in breast milk, and although the available data does no raise concerns, effects in the breast fed infant cannot be excluded.
Slovenian: Metoklopramid se izloča v materino mleko in čeprav razpoložljivi podatki niso zaskrbljujoči, učinkov na dojenega otroka ni mogoče izključiti.
English: • Limiting the maximum concentration/dosing in certain formulations to ensure that patients are not unintentionally exposed to doses higher than the single recommended dose for the product.
Slovenian: • omejitev največje koncentracije/odmerka pri nekaterih pripravkih, da se prepreči nenamerna izpostavljenost bolnikov odmerkom, ki so večji od priporočenega enkratnega odmerka zdravila;
English: This was based on insufficient evidence of efficacy in children in the concerned indications and on the safety issue of neurological symptoms.
Slovenian: Odločitev je temeljila na pomanjkljivih dokazih o učinkovitosti pri otrocih pri zadevnih indikacijah in na varnostnih zadržkih, povezanih z nevrološkimi simptomi.
English: Safety data
Slovenian: Podatki o varnosti
English: Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine' (oral route)
Slovenian: Metoklopramid se lahko uporablja v kombinaciji s peroralnimi analgetiki za izboljšanje absorpcije analgetikov pri akutni migreni“ (peroralna uporaba);
English: Based on the risk of neurological and cardiovascular adverse events, as well as on the limited evidence of efficacy for all indications approved, the French Competent Authority triggered a referral under Article 31 of Directive 2001/83/EC and asked the CHMP to review the benefit-risk balance of metoclopramide-containing products in all populations, particularly in children and the elderly.
Slovenian: Zaradi tveganja za nevrološke in srčno-žilne neželene dogodke in tudi zaradi omejenih dokazov o učinkovitosti pri vseh odobrenih indikacijah je francoski pristojni organ sprožil napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES in zahteval, da CHMP ponovno preuči razmerje med tveganji in koristmi zdravil, ki vsebujejo metoklopramid, pri vseh populacijah, zlasti pa pri otrocih in starejših.