FrancophonIA/ELRC3.0 huggingface dataset:
English: • Certain types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin ).
Slovenian: • določene vrste antibiotikov, s katerimi se zdravi infekcije (imenujejo se makrolidi, vsebujejo npr. eritromicin)
English: The 50 microgram strength sublingual tablet may be used for an intermediate dose-titration step.
Slovenian: Za vmesni korak pri titraciji odmerka se lahko uporabi 50 mikrogramska sublingvalna tableta .
English: Thus the Applicant considered the safety-profile of Rapinyl to be appropriate for this indication.
Slovenian: Predlagatelj tako meni, da je varnostni profil zdravila Rapinyl ustrezen za takšno indiciranje.
English: In addition, the oral cavity was inspected by the clinician or nurse 15-20 minutes after treatment to check for local irritation, no abnormal results were identified and the tablets were well tolerated after both single and repeat doses.
Slovenian: Poleg tega je ustne votline sodelujočih po 15 do 20 minutah po zaužitju zdravila pregledal zdravstveni tehnik ali sestra, s čimer sta preverila ali zdravilo povzroča lokalno razdražljivost; opaženi niso bili nobeni nenormalni znaki, iz česar izhaja, da so sodelujoči tablete dobro prenašali, tako po enojnem kot tudi večkratnih odmerkih.
English: The optimal dose of Rapinyl will be determined by upward titration, on an individual patient basis.
Slovenian: Optimalni odmerek Rapinyla se določa s titracijo od nižjega k višjemu odmerku za vsakega bolnika posebej.
English: Furthermore, the data generated for Rapinyl and the substantial additional cancer patient exposure data demonstrate that volunteers and patients have similar pharmacokinetics, negating the need for additional studies in healthy volunteers.
Slovenian: Tudi podatki pridobljeni za zdravilo Rapinyl in dodatni trdni podatki o izpostavljenosti bolnikov z rakom kažejo podobno farmakokinetiko pri prostovoljcih in bolnikih, kar pomeni, da dodatne študije pri zdravih prostovoljcih niso potrebne.
English: The CHMP also considered it necessary to assess the full report of the analysis on the comparability of Rapinyl and Actiq, as the available PK data could not support the similarity of both products.
Slovenian: Menil je tudi, da je potrebno preučiti celotno poročilo analize primerljivosti zdravil Rapinyl in Actiq, saj razpoložljivi farmakokinetični podatki niso ustrezno potrdili podobnosti obeh zdravil.
English: - and provided that the Applicant fulfils the conditions to the Marketing Authorisation as listed in Annex IV
Slovenian: - bo predlagatelj izpolnil pogoje, navedene v Dodatku IV, za pridobitev dovoljenja za promet,
English: Store in the original blister in order to protect from moisture.
Slovenian: Shranjujte v originalnem pretisnem omotu za zagotovitev zaščite pred vlago.
English: This titration should follow the course of administering a single sublingual tablet, with administration of a supplemental second sublingual tablet after 15-30 minutes, if inadequate pain relief is obtained.
Slovenian: Titriranje naj se izvaja z odmerkom ene same sublingvalne tablete, ki ji po 15-30 minutah sledi dodatna sublingvalna tableta, v kolikor z uporabo ene tablete ne dosežemo želenega olajšanja bolečine.
English: The Applicant further described data from the time of the safety cut-off (Jan-08) and considered that the derived information compared favourably to values quoted for Effentora and Actiq, although the reason for patient drop-out was not provided by the sponsor.
Slovenian: Predlagatelj je tudi podrobneje opisal podatke od trenutka prekinitve varnostne študije (januar 2008) in menil, da so pridobljene informacije v primerjavi z vrednostmi navedenimi za zdravili Effentora in Actiq ugodne, čeprav sponzor ni navedel razlogov zaradi katerih so bolniki izstopili iz varnostne študije.
English: The CHMP acknowledged the data submitted, noting and assessing the data from the clinical studies EN3267-005 and EN3267-007.
Slovenian: CHMP je predložene podatke ter podatke iz kliničnih študij EN3267-005 in EN3267-007 upošteval in ovrednotil.
English: The Applicant has characterised the pharmacokinetic profile of Rapinyl by demonstrating rapid delivery, predictable PK over the proposed dose range and also showing that Rapinyl achieves similar plasma concentrations and pharmacokinetic profiles as Actiq at both low and high doses.
Slovenian: Predlagatelj je podrobno opisal farmakokinetični okvir zdravila Rapinyl, tako da je jasno prikazal hitro absorpcijo zdravila, predvidljivo farmakokinetično delovanje s predlaganim razponom odmerkov, prav tako pa je dokazal, da zdravilo Rapinyl dosega podobne plazmeske koncentracije in farmakokinetične profile kot zdravilo Actiq, tako pri manjših kot pri večjih odmerkih.
English: Pharmacokinetic characterisation following treatment with Rapinyl and pharmacokinetic comparisons of Rapinyl versus Actiq have been used as a basis for bridging to the extensive published data regarding clinical efficacy and safety data for authorized fentanyl products.
Slovenian: Farmakokinetične lastnosti zdravljenja z zdravilom Rapinyl in farmakokinetična primerjava zdravila Rapinyl in zdravila Actiq so podlaga za premostitev do obsežnih objavljenih podatkov v zvezi s klinično učinkovitostjo in podatki o varnosti za odobrena zdravila s fentanilom.
English: • Rare side effects (affects 1 to 10 users in 10,000): hiccups
Slovenian: • Redki neželeni učinki (prizadenejo 1 do 10 bolnikov na 10.000): kolcanje
English: Other very commonly reported adverse reactions include: nausea, vomiting, constipation, headache, somnolence/fatigue and dizziness.
Slovenian: Drugi zelo pogosto omenjeni neželeni učinki so med drugim: slabost, bruhanje, zaprtost, glavobol, zaspanost/utrujenost in omotica.
English: Common: Asthenia, application site irritation
Slovenian: Pogosti: astenija, razdraženost na mestu aplikacije
English: The Applicant was able to provide in the response to the LoOI the interim analyses from 2 ongoing Phase III safety and efficacy clinical studies (EN3267-005 and EN3267-007), performed in the US by Endo.
Slovenian: Predlagatelj je uspel zagotoviti kot odgovor na seznam odprtih vprašanj vmesno analizo iz dveh potekajočih kliničnih študij o varnosti in učinkovitosti faze III (EN3267-005 in EN3267-007), ki ju je v Združenih državah Amerike izvedla družba Endo.
English: If inadequate pain relief is obtained with 2 x 100 microgram sublingual tablets, an increase in dose to the next higher available strength for the next episode of breakthrough pain should be considered.
Slovenian: Če se z dvema 100 mikrogramskima sublingvalnima tabletama ne doseže primernega olajšanja bolečine, je treba pri naslednji epizodi prebijajoče bolečine pretehtati uporabo naslednje višje jakosti, ki je na razpolago.
English: In conclusion, the CHMP considered that the Applicant provided limited information on the patient treatment (titration towards an efficient dose, multiple administrations, administration up to the highest dosage) which prevented an evaluation of efficacy and safety of Rapinyl in the clinical setting and characterisation of the full clinically relevant time effect profile of the drug.
Slovenian: Poleg tega je CHMP menil, da je predlagatelj predložil le omejene informacije o zdravljenju bolnikov (titracija za opredelitev učinkovitega odmerka, večkratno dajanje zdravila, uporaba največjega možnega odmerka), kar onemogoča vrednotenje učinkovitosti in varnosti zdravila Rapinyl v kliničnem okolju in določitev točnega kliničnega ustreznega časa za delovanje zdravila.
English: The Applicant considered that Rapinyl can be successfully titrated and repeatedly administered effectively and safely to treat patients with multiple episodes of breakthrough pain.
Slovenian: Predlagatelj meni, da se zdravilo Rapinyl lahko uspešno titrira in se lahko ponavljajoče uporablja za učinkovito in varno zdravljenje bolnikov z večkratnimi epizodami prebijajoče bolečine.
English: Fentanyl belongs to a group of strong pain-relieving medicines called opioids.
Slovenian: Fenantil spada v skupino močnih zdravil za lajšanje bolečin, ki se imenujejo opioidi.
English: • Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e.g. ritonavir).
Slovenian: • določene vrste protivirusnih zdravil, s katerimi se zdravi virusna obolenja (imenujejo se inhibitorji proteaz, vsebujejo npr. ritonavir)
English: In common with all opioids, there is a risk of clinically significant respiratory depression associated with the use of Rapinyl.
Slovenian: Kot za vse opioide, obstaja tudi pri uporabi Rapinyla tveganje za klinično pomembno depresijo dihanja.
English: • Peel back the tab of the foil top of one blister and gently remove the tablet.
Slovenian: • Odlepite zavihek na enem od pretisov in previdno odstranite tableto.
English: Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally]
Slovenian: Rapinyl in povezana imena (glejte Dodatek I) 50 mikrogramske podjezične tablete <[Glejte Dodatek I - Izpolni država članica]>
English: The Applicant also discussed the difference between the volunteers (opioid-naïve) and the target patient population (chronic opioid users), noting that the pattern of related events was consistent with available literature on the safety profile of fentanyl products and the absence of dose-related trends in the incidence of adverse events.
Slovenian: Predlagatelj je predstavil tudi razliko med prostovoljci (ki še niso uporabljali opioidov) in ciljno populacijo bolnikov (redni uporabniki opioidov), pri čemer je izpostavil vzorec povezanih učinkov, skladen s podatki iz razpoložljive literature o varnostnem profilu zdravil s fentanilom, ter odsotnost trenda pojavnosti neželenih dogodkov na podlagi odmerkov.
English: In conclusion, the Applicant considered that the results from studies EN3267-005 and EN3267-007 confirm the conclusions based on the original bridging strategy and demonstrate that Rapinyl can be safely and effectively used to treat multiple episodes of cancer breakthrough pain in opioid-tolerant patients.
Slovenian: Predlagatelj je prepričan, da tudi rezultati študij EN3267-005 in EN3267-007 potrjujejo zaključke zasnovane na originalni premostitveni strategiji in kažejo, da lahko zdravilo Rapinyl uporablja za varno in učinkovito zdravljenje večkratnih epizod prebijajoče bolečine pri bolnikih, ki dobro prenašajo opioidne terapije.
English: • Very rare side effects (affects less than 1 user in 10,000): irregular heartbeat, stopping breathing, blood in the saliva, decrease in amount of urine, painful contraction of the bladder
Slovenian: • Zelo redki neželeni učinki (prizadenejo manj kot 1 bolnika na 10.000): nereden srčni utrip, prenehanje dihanja, kri v slini, zmanjšana količina urina, boleče krčenje mehurja
English: A large number of Rapinyl doses have been administered during these Phase III studies and high doses of Rapinyl have been used for long periods of administration without any cause for concern over the nature and frequency of reported SAEs.
Slovenian: Med fazo III študij je bilo danih veliko število odmerkov zdravila Rapinyl, veliki odmerki zdravila Rapinyl pa so se uporabljali tudi v daljšem obdobju, ne da bi prišlo do vzrokov za skrb glede narave in pogostosti prej sporočenih resnih neželenih učinkov.
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [Izpolni država članica]
English: • runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
Slovenian: • izcedek iz nosu ali zamašen nos, suha usta, boleče grlo, srbeča koža, kožni spuščaj, razdraženost pod jezikom
English: • muscle relaxants
Slovenian: • zdravila za sprostitev mišic
English: Therefore, although the CHMP considers that Rapinyl could be used for the treatment of breakthrough pain in cancer patients the combined available pharmacokinetic, pharmacological and clinical data were considered insufficient and the CHMP requested the Applicant to provide clinical demonstration of the efficacy and safety of Rapinyl at the proposed dosages, including the highest one.
Slovenian: CHMP je sicer menil, da bi se zdravilo Rapinyl lahko uporabljalo za lajšanje prebijajoče bolečine pri bolnikih z rakavimi obolenji, a združeni razpoložljivi farmakokinetični, farmakološki in klinični podatki niso zadostni, in zato je od predlagatelja zahteval dodatne klinične dokaze o učinkovitosti in varnosti zdravila Rapinyl pri predlaganih odmerkih, vključno z največjim možnim odmerkom.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The Applicant provided an overview of the current knowledge of cancer breakthrough pain (BTP), describing the currently available treatment, and the published data and available safety and efficacy data for other fentanyl products, concluding that fentanyl is an ideal analgesic for treatment of breakthrough pain.
Slovenian: Predlagatelj je predložil pregled trenutnega vedenja o prebijajočih bolečinah pri raku (BTP), in sicer z obrazložitvijo trenutno razpoložljivih zdravljenj ter objavljenih podatkov in razpoložljivih podatkov o učinkovitosti in varnosti drugih zdravil s fentanilom, na podlagi predloženega pa je zaključil, da je fentanil najboljši analgetik za zdravljenje prebijajočih bolečin.
English: Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
Slovenian: Preden začnete z zdravljenjem z Rapinylom, ste morali za lajšanje vztrajajoče bolečine redno jemati ali uporabljati močno zdravilo na recept za lajšanje bolečin, tako imenovani opioid.
English: Furthermore, the CHMP was not convinced by the Applicant claim of bioavailability of fentanyl comparison between Rapinyl and Actiq, requesting a robust demonstration of similarity in systemic exposure.
Slovenian: Nadalje CHMP ni prepričalo predlagateljevo zatrjevanje o biološki razpoložljivosti fentanila v primerjavi med zdraviloma Rapinyl in Actiq in je tako zahteval prikaz podobnosti glede sistemske izpostavljenosti.
English: Very common side effects (affects more than 1 user in 10) include: • nausea, headache, sleepiness/tiredness, dizziness.
Slovenian: Zelo pogosti neželeni učinki (prizadenejo več kot 1 bolnika na 10) so: • slabost, glavobol, nespečnost/utrujenost, vrtoglavica.
English: Rapinyl is a different type of medicine from other medicines you may have used to treat your breakthrough pain.
Slovenian: Rapinyl je vrsta zdravila, ki se od drugih zdravil, ki ste jih mogoče za lajšanje prebijajoče bolečine doslej uporabljali, razlikuje.
English: In patients with chronic cancer pain on stable maintenance doses of opioids, Rapinyl has been shown to induce significantly superior relief of breakthrough pain compared to placebo from 15 minutes after administration onwards, with a significantly lower need for rescue analgesic therapy.
Slovenian: Pri bolnikih s kronično rakavo bolečino, ki so na stabilno vzdrževanih odmerkih opioidov je bilo za Rapinyl ugotovljeno, da ima v 15 minutah po pričetku jemanja signifikantno boljši odgovor na prebijajočo bolečino v primerjavi s placebom, s čimer se bistveno zmanjša potreba po dodatni analgetični terapiji.
English: The CHMP considered that the information provided was sufficient for concluding that repeat dose data following Actiq and Rapinyl are similar, and the dose proportionalilty between Actiq and Rapinyl was considered as established through the single dose data, pending further clinical safety and efficacy data.
Slovenian: CHMP je menil, da predložene informacije v zadostni meri potrjujejo, da so podatki o ponovljenih odmerkih zdravila Actiq in Rapinyl podobni, da je sorazmerje odmerkov med zdraviloma Actiq in Rapinyl ustrezno določeno s podatki o enem odmerku, dokler ne bo novih podatkov o varnosti in učinkovitosti.
English: The CHMP not endorse the Applicant claims of dose-relationship between Rapinyl and Actiq and therefore could not conclude on the comparability of systemic exposure obtained with Rapinyl and
Slovenian: CHMP ni podprl predlagateljevih trditev o odnosu med odmerki zdravila Rapinyl in zdravila Actiq in tako ni mogel potrditi primerljivosti sistemske izpostavljenosti za zdravili Rapinyl in Actiq.
English: The Applicant described the observed SAE signals and noted that only one case was evaluated as related to the study drug by the investigator..
Slovenian: Predlagatelj je opisal zaznane znake resnih neželenih učinkov in opozoril, da je preiskovalec ovrednotil le en primer kot posledico sodelovanja v študiji zdravila.
English: In patients who have a dry mouth water may be used to moisten the buccal mucosa before taking Rapinyl.
Slovenian: Pri bolnikih, ki imajo suha usta, se lahko pred odmerkom Rapinyla ustno sluznico navlaži z vodo.
English: In conclusion, the Applicant believes that the demonstration of a statistically significant improvement in PID at 10 and 15 minutes in EN3267005 is the appropriate, clinically relevant measure of the early effectiveness of Rapinyl, and that an improvement in PID is directly reflected in an increase in responder rate.
Slovenian: Predlagatelj tudi verjame, da je predstavitev statistično pomembnih izboljšav v razlikah v jakosti bolečine pri 10 in 15 minutah v študiji EN3267005 ustrezna in klinično pomembna meritev zgodnje učinkovitosti zdravila Rapinyl ter da se izboljšava razlike v jakosti bolečine neposredno kaže v povečanju razmerja sodelujočih.
English: The Applicant provided further reassurances on the use of Rapinyl in patiens with mucositis, based on publications and guidelines, concluding that patients with mild/moderate mucositis can use oral medication, while transmucosal forms of fentanyl are not suitable for use in patients with severe mucositis where other routes of analgesia administration are preferable.
Slovenian: Predlagatelj je ponudil dodatna zagotovila o uporabi zdravila Rapinyl pri bolnikih z mukozitisom, zasnovana na podlagi publikacij in smernic, iz katerih izhaja, da bolniki z rahlim/zmernim mukozitisom lahko uporabljajo peroralna zdravila, medtem ko oblike fentanila, ki prehajajo skozi sluznico niso primerne za bolnike z močnim mukozitisom in se priporočajo druge oblike dajanja analgetikov.
English: The Applicant implemented a revised a cautionary statement in section 4.4 of the SPC, recommending extra caution during the titration of patients with mouth wounds or mucositis.
Slovenian: Predlagatelj je upošteval predlagane spremembe v razdelku 4.4 o opozorilih pri uporabi v povzetku glavnih značilnosti zdravila ter priporoča posebno pozornost med titracijo pri bolnikih z ranami v ustni votlini ali mukozitisom.
English: • mouth wounds or mucositis (swelling and redness of the inside of the mouth)
Slovenian: • rane v ustih ali vnetje sluznice (zateklo ali pordečeno notranjost ust)
English: Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
Slovenian: Fentanil je visoko lipofilno zdravilo, ki se zelo hitro absorbira skozi sluznico v ustih in počasneje v gastrointestinalnem traktu.
English: Very common: Dizziness, somnolence, headache Common: Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis
Slovenian: Zelo pogosti: omotica, zaspanost, glavobol Pogosti: vazovagalna reakcija, hipoestezija, parestezija, hiperakuzija
English: The Applicant also presented and extensively discussed exposure data for the 131 patients that successfully titrated in studies EN3267-005 and 007 and for the patients completing the 3 and 12-month follow-up periods.
Slovenian: Predlagatelj je tudi obširno predstavil podatke izpostavljenosti za 131 bolnikov, pri katerih je bila titracija v študijah EN3267-005 in EN3267-007 uspešna in za bolnike, ki so zaključili 3- in 12-mesečna poštudijska obdobja.
English: In addition, the suicidality should be monitored, as depression and mood liability are part of the reported AEs for Actiq.
Slovenian: Poleg tega je potrebno spremljati tudi pojav samomorilnosti, saj sta depresija in spremembe razpoloženja navedena kot neželena učinka za zdravilo Actiq.
English: Injury, poisoning and procedural complications Common: Accidental injuries
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih
English: The Applicant believes that the original bridging strategy plus the significant body of confirmatory efficacy and safety data in cancer patients provided demonstrate that Rapinyl does indeed have a positive benefit-risk profile.
Slovenian: Predlagatelj verjame, da originalna premostitvena strategija skupaj z obsežnimi dokumentiranimi podatki o učinkovitosti in varnosti pri bolnikih z rakom, nazorno prikazuje, da ima zdravilo Rapinyl pozitivno razmerje med koristmi in tveganji.
English: • Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell
Slovenian: • Občasni neželeni učinki (prizadenejo 1 do 10 bolnikov na 1.000): nemir, občutek odtujenosti, nihajoče razpoloženje, trepetanje, težave pri govoru, pozabljivost, izguba koordinacije, vrtoglavica, počasen ali hiter srčni utrip, visok krvni tlak, težave pri dihanju, počasno ali plitko dihanje, astma, napihnjenost, vetrovi, žeja, težave pri opravljanju potrebe, spremembe v pogostnosti opravljanja potrebe, slabo počutje
English: Before Rapinyl therapy is initiated, it is important that the patient's long-acting opioid treatment used to control their persistent pain has been stabilised.
Slovenian: Preden se začne s terapijo z Rapinylom, je pomembno, da je bolnikovo dolgotrajno zdravljenje z opioidi, katerega cilj je kontrola kronične bolečine, stabilno.
English: The pharmacokinetics of Rapinyl are dose proportional and predictable with single and multiple dosing and this simple and quick to administer formulation therefore fulfils an unmet need for a product indicated for the treatment of breakthrough pain in cancer patients.
Slovenian: Farmakokinetika zdravila Rapinyl je sorazmerna z odmerki in predvidljiva z enojnimi ali večkratnimi odmerki, farmacevtska oblika pa omogoča preprosto in hitro uporabo zdravila ter tako izpolnjuje potrebo po zdravilu, indiciranem za zdravljenje prebijajoče bolečine pri bolnikih z rakavimi obolenji.
English: Rapinyl should be used sublingually.
Slovenian: Rapinyl je namenjen za podjezično uporabo.
English: Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally]
Slovenian: Rapinyl in povezana imena (glejte Dodatek I) 50 mikrogramske podjezične tablete [Glejte Dodatek I - Izpolni država članica]
English: Rapinyl is a quick dissolving sublingual tablet formulation.
Slovenian: Rapinyl je formuliran kot hitro se topeča sublingvalna tableta.
English: Vascular disorders Common: Vasodilation
Slovenian: Pogosti: vazodilatacija
English: Do not swallow
Slovenian: Pretisni omoti
English: Respiratory, thoracic and mediastinal disorders Common: Respiratory depression, rhinitis, pharyngitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti: depresija dihanja, rinitis, faringitis
English: Once you and your doctor have found a dose of Rapinyl tablets that controls your breakthrough pain you should take this dose no more than four times a day.
Slovenian: Vzdrževalna faza - ko je določen ustrezen odmerek Ko ste skupaj s svojim zdravnikom določili ustrezen odmerek Rapinyl tablet za nadzor vaše prebijajoče bolečine, smete ta odmerek vzeti ne več kot štirikrat na dan.