FrancophonIA/ELRC3.0 huggingface dataset:
English: In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
Slovenian: V tem primeru bo morda potrebna endotrahealna intubacija, asistirana ventilacija in dajanje antagonistov opioidov in mišičnih relaksantov.
English: Do not drink grapefruit juice while you are prescribed Rapinyl treatment as it may increase the side effects of Rapinyl.
Slovenian: Ne pijte soka grenivke med zdravljenjem z Rapinylom, ker se zaradi tega lahko poslabšajo neželeni učinki zdravila.
English: Before taking Rapinyl for the first time your doctor will explain how Rapinyl should be taken to effectively treat your breakthrough pain.
Slovenian: Preden prvič vzamete Rapinyl, vam bo vaš zdravnik razložil, kako je treba Rapinyl jemati, da kar najbolj učinkovito zmanjša prebijajočo bolečino.
English: If necessary an oropharyngeal airway or endotracheal tube should be inserted, oxygen administered and mechanical ventilation initiated, as appropriate.
Slovenian: Po potrebi je treba vstaviti orofaringealni dovod zraka ali endotrahealno cev, dajati kisik in, če je priporočljivo, začeti z mehansko ventilacijo.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.
Slovenian: Imajo visoko afiniteto za opioidne receptorje, pri tem pa relativno nizko lastno aktivnost, tako da lahko delno antagonirajo analgetičen učinek fentanila in pri bolnikih z opioidno odvisnostjo inducirajo znake odvajanja.
English: Like other opioids fentanyl showed mutagenic effects in vitro in mammalian cells.
Slovenian: Tako kot drugi opioidi, je tudi fentanil kazal in vitro mutagene učinke na celice sesalcev.
English: The CHMP welcomed the new interim analyses of efficacy and safety data for Rapinyl, but considered that the new data must be regarded as preliminary data, as the complete trial results are not yet available for assessment.
Slovenian: CHMP je pozdravil novo vmesno poročilo in varnostne podatke o zdravilu Rapinyl, vendar meni, da morajo biti ti obravnavani kot predhodni podatki, saj končni podatki študij še niso na razpolago za vrednotenje.
English: If you do not get adequate pain relief from one tablet your doctor may ask you to take two tablets to treat an episode of breakthrough pain.
Slovenian: V kolikor vam ena sama tableta ne bo olajšala bolečin, bo vaš zdravnik morebiti zahteval, da vzamete za zdravljenje med epizodo prebijajoče bolečine dve tableti.
English: The Applicant therefore believes the benefit/risk for Rapinyl to be positive and that the outcome of any further clinical safety and efficacy studies with Rapinyl are predictable and hence, unnecessary.
Slovenian: Predlagatelj je prepričan, da je razmerje med koristmi in tveganji za zdravilo Rapinyl pozitivno ter da so rezultati nadaljnjih kliničnih študij o varnosti in učinkovitosti zdravila Rapinyl predvidljivi in posledično nepotrebni.
English: Total plasma clearance of fentanyl is about 0.5 l/h/kg.
Slovenian: Celotni očistek fentanila v plazmi je okoli 0,5 l/h/kg.
English: The symptoms of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression, which may lead to respiratory arrest.
Slovenian: Preveliko odmerjanje fentanila se kaže kot podaljšanje njegovega farmakološkega delovanja, najresnejši učinek pa je depresija dihanja, ki lahko privede do odpovedi dihanja
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učiniek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action.
Slovenian: Fentanil je močen µ-opioidni analgetik s hitrim nastopom analgezije in kratkotrajnim delovanjem.
English: What Rapinyl looks like and contents of the pack
Slovenian: Izgled zdravila Rapinyl in vsebina pakiranja
English: Dose titration:
Slovenian: Titracija odmerka:
English: The Applicant confirmed that the tablets used in the Endo Phase III studies, EN3267-005 and EN3267-007, are qualitatively and quantitatively identical to the tablets currently under review in Europe and that the manufacturing process is the same using fentanyl citrate from the same supplier, with identical specifications.
Slovenian: Predlagatelj je potrdil, da so tablete, uporabljene v fazi III študij Endo, EN3267-005 in EN3267-007, kvalitativno in količinsko istovetne tabletam, ki se trenutno nahajajo v postopku vrednotenja v Evropi ter da se v proizvodnem procesu uporablja enak fentanil citrat od istega proizvajalca, z enakimi specifikacijami.
English: It is recommended to keep Rapinyl in a locked storage space.
Slovenian: Zdravilo Rapinyl shranjujte v zaklenjenem prostoru.
English: Particular caution should be exercised during dose titration with Rapinyl in patients with chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression (e.g. myasthenia gravis) because of the risk of further respiratory depression, which could lead to respiratory failure.
Slovenian: Še posebej je potrebna previdnost med postopkom titracije odmerkov Rapinyla pri bolnikih s kronično obstruktivno boleznijo pljuč ali drugimi zdravstvenimi stanji, zaradi katerih imajo ti bolniki več možnosti, da se pri njih razvije depresija dihanja (npr. miastenia gravis), saj pri njih obstaja tveganje za nadaljnjo depresijo dihanja, ki bi lahko imela za posledico odpoved dihal.
English: If severe or persistent hypotension occurs, hypovolaemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Slovenian: Če pride do hude ali vztrajajoče hipotenzije, je treba upoštevati možnost pojava hipovolemije in stanje nadzorovati s parenteralnim nadomeščanjem tekočine.
English: Therefore the efficacy/safety profile of Rapinyl could be established.
Slovenian: Tako bi bil profil učinkovitosti/varnosti za zdravilo Rapinyl ustrezno dokazan.
English: The CHMP also agreed that the proposed dose range for Rapinyl is sufficiently documented and that further efficacy and safety data on dose titration is not necessary.
Slovenian: CHMP se je tudi strinjal, da je predlagan razpon odmerkov za zdravilo Rapinyl ustrezno dokumentiran ter da nadaljnji podatki o varnosti in učinkovitosti pri titraciji odmerkov niso potrebni.
English: Taking other medicines
Slovenian: Uporaba drugih zdravil:
English: The Applicant provided data supporting the pharmacokinetic bridging strategy and demonstrating that fentanyl delivery from Rapinyl provides effective pain relief in the target population.
Slovenian: Predlagatelj je predložil podatke v podporo farmakokinetični premostitveni strategiji in prikazal, da fentanil iz zdravila Rapinyl zagotavlja učinkovito lajšanje bolečin pri ciljni populaciji.
English: The Applicant provided the case narratives for all the deaths notified to the Applicant and reviewed the adverse events with an outcome of death, and concluded that these deaths not considered as related to the study drug by the study investigators.
Slovenian: Predlagatelj je predložil poročila za vse primere smrti o katerih je bil obveščen, ter pregledal neželene dogodke s posledično smrtjo in sklenil, da so preiskovalci ugotovili, da ti primeri smrti niso bili povezani s sodelovanjem v študiji.
English: Thus, only limited clinical data have been generated for the use of Rapinyl.
Slovenian: Tako glede uporabe zdravila Rapinyl obstajajo le omejeni klinični podatki.
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
Slovenian: Opioidi povečujejo tonus in zmanjšujejo propulzivna krčenja gladkega mišičja v gastrointestinalnem traktu s posledico, da se gastrointestinalni čas prehoda podaljša, kar je lahko vzrok za zaprtost zaradi fentanila.
English: From the efficacy and safety data provided, Rapinyl seems to be comparable to other fentanyl containing products (Actiq and Effentora) for the treatment of BTP in cancer patients.
Slovenian: Iz predloženih podatkov o varnosti in učinkovitosti je razvidno, da je zdraviloRapinyl primerljivo z drugimi zdravili, ki vsebujejo fentanil (Actiq in Effentora) za zdravljenje prebijajočih bolečin pri bolnikih z rakom.
English: The Applicant concluded that an optimal dose of Rapinyl provides a rapid onset of analgesia which mirrors the profile of cancer breakthrough pain.
Slovenian: Predlagatelj je prepričan, da optimalni odmerek zdravila Rapinyl zagotavlja takojšen analgetični učinek, ki odraža profil prebijajoče bolečine pri raku.
English: The Applicant provided data from a study investigating the pharmacokinetics of Rapinyl in 8 opioid tolerant cancer patients, which demonstrated that the pharmacokinetic parameters in patients were not different from those in healthy volunteers, with a similar pharmacokinetic variability.
Slovenian: Predlagatelj je predložil podatke raziskovalne študije o farmakokinetiki zdravila Rapinyl pri osmih bolnikih z rakom, ki dobro prenašajo zdravljenje z opioidi, kar potrjuje, da se farmakokinetični parametri pri bolnikih ne razlikujejo od tistih pri zdravih prostovoljcih, s podobno farmakokinetično spremenljivostjo.
English: Very common: Nausea
Slovenian: Zelo pogosti: slabost
English: Grapefruit juice is also known to inhibit CYP3A4.
Slovenian: Znano je tudi, da sok grenivke inhibira CYP3A4.
English: The dose strength for the supplemental sublingual tablet should be increased from 100 to 200 micrograms at doses of 400 micrograms and higher.
Slovenian: Jakost odmerka za dodatno sublingvalno tableto je pri odmerkih 400 mikrogramov in več treba s 100 mikrogramov povečati na 200 mikrogramov.
English: Rapinyl sublingual tablets are available in a range of strengths.
Slovenian: Rapinyl podjezične tablete so na voljo v različnih jakostih.
English: You must not change your dose of Rapinyl unless directed by your doctor.
Slovenian: Odmerka Rapinyla ne smete spreminjati, razen če vam je tako naročil vaš zdravnik.
English: Marketing authorisation holder: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: Imetnik dovoljenja za promet: <[Glejte Dodatek I - Izpolni država članica]> {Name and address} <{tel.}> <{fax}> <{e-mail}>
English: One patient had a successful suicide attempt but while suicidal ideation is known to be more common in patients with cancer than in the general population, neither suicide nor suicidal ideation has been reported as an adverse event associated with Actiq nor with Fentora/Effentora and based on the similar pharmacokinetic profile of Rapinyl and Actiq, the Applicant believes that this was a sporadic case, consistent with the investigator's assessment as being unrelated.
Slovenian: En bolnik je storil samomor in čeprav je mišljenje o samomoru pogostejše pri bolnikih z rakavimi obolenji kot v splošni populaciji, se o samomoru niti o samomorilskih namenih ni poročalo kot o neželenih učinkih, povezanih z zdravilom Actiq ali zdravilom Effentora, na osnovi podobnega farmakokinetičnega profila zdravila Rapinyl in zdravila Actiq, pa je predlagatelj prepričan, da je to bil osamljen primer, v skladu z oceno preiskovalca, da primer ni povezan s sodelovanjem v študiji.
English: Elderly, cachectic, or debilitated patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Slovenian: Starejši, kahektični in izčrpani bolniki morajo biti pod skrbnim nadzorom glede znakov toksičnosti fentanila, prav tako pa jim je po potrebi treba zmanjšati odmerek.
English: The reasonably low intra-individual variation in fentanyl plasma concentrations was also noted, including variation related to fluid intake, mouth wounds, xerostomia (dry mouth) and mucositis.
Slovenian: Zabeležene so bile tudi relativno majhna intra-individualna odstopanja fentanila v plazemski koncentraciji, vključno z odstopanji zaradi zaužite tekočine, ran v ustni votlini, kserestomije (suha usta) in mukozitisa.
English: To be dissolved under the tongue.
Slovenian: Tableto raztopite pod jezikom.
English: Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
Slovenian: Starejši, izčrpani in na splošno prizadeti bolniki imajo lahko zmanjšan očistek za fentanil, kar bi lahko imelo za posledico podaljšanje končnega razpolovnega časa za to učinkovino (glejte poglavji 4.2 in
English: Your doctor will prescribe the strength (shape) and number of tablets suitable for you.
Slovenian: Vaš zdravnik vam bo predpisal jakost (obliko) in za vas ustrezno število tablet.
English: The Applicant further considered the current bridging strategy to be appropriate for the approval of Rapinyl over the 100-800µg dose range for the treatment of BTP in patients as Rapinyl delivers fentanyl within a plasma concentration range already established as safe and effective.
Slovenian: Predlagatelj je prav tako ocenil, da je trenutna premostitvena strategija ustrezna za odobritev zdravila Rapinyl, z razponom odmerkov med 100-800µg za zdravljenje prebijajočih bolečin pri bolnikih, saj se fentanil iz zdravila Rapinyl absorbira v okviru plazemske koncentracije, za katero je že ugotovljeno, da je varna in učinkovita.
English: As a consequence, additional efficacy and safety data were required for the approval of Rapinyl for the management of breakthrough pain in the target population and the procedure was referred to the CHMP.
Slovenian: Posledično so bili potrebni dodatni podatki o učinkovitosti in varnosti za odobritev zdravila Rapinyl, za zdravljenje prebijajočih bolečin v ciljni populaciji, postopek pa je bil napoten na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: • Certain types of antifungal medicines containing e.g. ketoconazole or itraconazole (used to treat fungal infections).
Slovenian: • določene vrste zdravil proti glivicam, ki vsebujejo npr. ketokonazol ali itrakonazol (z namenom zdraviti glivične okužbe)
English: However, although the interim data support the proposed dose range for Rapinyl, the CHMP requested additional clinical data clearly demonstrating the efficacy/safety of Rapinyl.
Slovenian: Kljub temu, da podatki iz vmesnega poročila potrjujejo razpon odmerkov zdravila Rapinyl, je CHMP zahteval dodatne klinične podatke, ki bodo nazorno prikazali učinkovitost/varnost zdravila Rapinyl.
English: Severe respiratory depression or severe obstructive lung conditions.
Slovenian: Huda depresija dihanja ali huda obstruktivna stanja na pljučih.
English: In patients with head injuries, the clinical course may be masked by the use of opioids.
Slovenian: Pri bolnikih s poškodbami glave lahko uporaba opioidov zabriše klinični razvoj.
English: Fentanyl should not be used during labour and delivery (including caesarean section) since fentanyl crosses the placenta and may cause respiratory depression in the foetus or in the new-born infant.
Slovenian: Fentanila ne smete uporabljati med porodnimi popadki in porodom (vključno s carskim rezom), ker fentanil prehaja skozi placento in lahko pri plodu ali pri novorojenem otroku povzroči depresijo dihanja.
English: In conclusion, the CHMP requested additional data supporting the efficacy and safety of Rapinyl (independently of Actiq) in the treatment of BTP and adopted a List of Outstanding Issues.
Slovenian: V sklepu je tako CHMP zahteval dodatne podatke za potrditev učinkovitosti in varnosti zdravila Rapinyl (neodvisno od zdravila Actiq) pri zdravljenju prebijajoče bolečine pri raku ter sprejel seznam odprtih vprašanj.
English: Waste material should be disposed of safely.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Odpadke je treba odstranjevati na varen način.
English: If the long acting opioid or dose of long acting opioid is changed the Rapinyl dose should be re-evaluated and re-titrated as necessary to ensure the patient is on an optimal dose.
Slovenian: Če se zamenja dolgo delujoči opioid ali če se spremeni njegov odmerek, je treba preveriti odmerjanje Rapinyla in ga ponovno titrirati, da se bolniku zagotovi prejemanje optimalnega odmerka.
English: For patients no longer requiring any opioid therapy, the Rapinyl dose should be taken into consideration before a gradual downward titration of opioids to minimise possible withdrawal effects.
Slovenian: Za bolnike, ki terapije z opioidi ne potrebujejo več, je pri postopnem titriranju opioidov v smeri zmanjševanja odmerka upoštevati odmerek Rapinyla, da bi se kolikor mogoče zmanjšalo možne učinke odvajanja.
English: The volume of distribution of fentanyl at steady state is about 3-6 l/kg.
Slovenian: Volumen porazdelitve fentanila v stanju dinamičnega ravnovesja je okoli 36 l/kg.
English: Intravenous fentanyl has been shown to cause bradycardia.
Slovenian: Za intravenski fenantil je znano, da povzroča bradikardijo.
English: Do not take a second tablet unless your doctor tells you to as this may result in overdose.
Slovenian: Ne vzemite druge tablete, če vam vaš zdravnik ni tako svetoval, ker lahko pride do prevelikega odmerjanja.
English: • liver or kidney disease, as this may require your doctor to more carefully adjust your dose
Slovenian: • bolezen jeter ali ledvic, zaradi česar bo moral zdravnik biti bolj previden pri odmerjanju zdravila
English: Do not use Rapinyl after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Rapinyl is a treatment for people who must already regularly be taking strong pain-relieving medicine (opioids) for their persistent cancer pain, but require treatment for their breakthrough pain.
Slovenian: Rapinyl je zdravilo za bolnike, ki že morajo redno jemati močno zdravilo (opioide) za lajšanje vztrajajoče bolečine zaradi raka, in potrebujejo tudi zdravljenje prebijajoče bolečine.
English: If adequate analgesia is not obtained within 15-30 minutes of administration of a single sublingual tablet, a second 100 microgram sublingual tablet may be administered.
Slovenian: Če v času 1530 minut po odmerku ene podjezične tablete ni dosežena primerna analgezija, se sme odmeriti še eno 100 mikrogramsko sublingvalno tableto.
English: [See Annex I - To be completed nationally]
Slovenian: <[Glejte Dodatek I - Izpolni država članica]>
English: Rapinyl should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of hyperkapnia, such as those showing evidence of raised intracranial pressure, reduced consciousness, coma or brain tumours.
Slovenian: Samo s posebno skrbjo se sme Rapinyl dajati bolnikom, ki so posebno občutljivi za intrakranialne vplive hiperkapnije, kot so recimo bolniki z zvišanim intrakranialnim tlakom, zmanjšanjem zavesti, komo ali možganskimi tumorji.
English: The CHMP was reassured by the absence of safety signals related to SAEs were reported but requested the Applicant to submit a full safety analysis as conditions to the Marketing Authorisations.
Slovenian: CHMP je odsotnost varnostnih znakov v zvezi z resnimi neželenimi učinki, o katerih se je sicer poročalo, pomirila, vendar je od predlagatelja kljub temu zahteval popolno varnostno analizo kot pogoj za pridobitev dovoljenja za promet z zdravilom.
English: Symptoms of overdose include:
Slovenian: Znaki previsokega odmerjanja so:
English: Your doctor will help you do this and will work with you to find the best strength of tablet to use.
Slovenian: Vaš zdravnik vam bo pri tem pomagal, tako da bosta skupaj ugotovila, katera jakost tablet je za vas najprimernejša.
English: Fentanyl is passed on into breast milk and may cause extreme drowsiness and shallow breathing in the breastfed child.
Slovenian: Fentanil prehaja v materino mleko in lahko pri dojenem otroku povzroči skrajno zaspanost in plitko dihanje.
English: This means that the tablet should be placed under the tongue where it dissolves rapidly in order to allow fentanyl to be absorbed across the lining of the mouth.
Slovenian: To pomeni, da namestite tableto pod jezik, kjer se bo hitro raztopila in tako omogočila, da se fentanil absorbira skozi ustno sluznico.
English: In addition, a clinically relevant time-effect profile appropriate for an episode of breakthrough painl and meaningful clinical benefits for the patients were shown; patients could identify an effective dose of Rapinyl and use it successfully to control multiple episodes of breakthrough pain.
Slovenian: Poleg tega so bili prikazani tudi klinično relevantni profili časovnega učinkovanja, primerni za epizode prebijajoče bolečine in pomembne klinične prednosti za bolnike, ki lahko sami določijo ustrezen odmerek zdravila Rapinyl ter tako sami uspešno nadzorujejo večkratne epizode prebijajoče bolečine.
English: Management of opioid overdose in the immediate term includes removal of any remaining Rapinyl sublingual tablets from the mouth, physical and verbal stimulation of the patient and an assessment of the level of consciousness.
Slovenian: Preveliko odmerjanje opioida je treba obravnavati nemudoma, in sicer je iz ust bolnika takoj potrebno odstraniti ostanke Rapinyl sublingvalnih tablet, fizično in besedno spodbujati bolnika ter ugotoviti njegovo stanje zavesti.
English: The CHMP agreed that the pharmacodynamic properties and the effectiveness of fentanyl are well established and noted the pain model in BTP.
Slovenian: CHMP se je strinjal, da so farmakodinamične lastnosti in učinkovitost fentanila ustrezno dokazane in navedel vzorec bolečine pri prebijajoči bolečini pri raku.
English: In addition, there is solid experience in treating BTP in patients with chronic cancer already receiving a stable dose of background analgesia with strong opioids.
Slovenian: Poleg tega obstajajo tudi zadostne izkušnje pri zdravljenju prebijajoče bolečine pri bolnikih s kroničnim rakavim obolenjem, ki že prejemajo trajne osnovne analgetike z močnimi opioidi.
English: The efficacy data show that Rapinyl is statistically different from placebo in the treatment of BTP and these results seem clinically relevant.
Slovenian: Podatki o učinkovitosti kažejo, da se rezultati zdravljenja z zdravilom Rapinyl statistično razlikujejo od rezultatov zdravljenja prebijajočih bolečin s placebom, ter da so ti rezultati klinično pomembni.
English: However, the successful suicidal attempt requires attention, and because depression and mood liability are adverse events listed in the SPC of Actiq, the CHMP considered that these kinds of events should be closely monitored and requested the issue to be followed up in post-marketing Pharmacovigilance.
Slovenian: Kljub temu pa uspešen poskus samomora zahteva posebno pozornost, saj sta tako depresija kot spremembe razpoloženj navedena kot neželena učinka v povzetku glavnih značilnosti zdravila Actiq, zato Odbor za zdravila za uporabo v humani medicini meni, da je potrebno takšne dogodke posebej pozorno spremljati in o tem poročati v farmakovigilanci po začetku trženja.
English: Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
Slovenian: Pogosti: halucinacije, zmedenost, strah, nervoza, nenormalno mišljenje, nenormalne sanje Občasni: razburjenje, depersonalizacija, čustvena labilnost
English: Rapinyl 50 micrograms Rapinyl 100 micrograms Rapinyl 200 micrograms Rapinyl 300 micrograms Rapinyl 400 micrograms Rapinyl 600 micrograms Rapinyl 800 micrograms
Slovenian: Rapinyl 50 mikrogramov Rapinyl 100 mikrogramov Rapinyl 200 mikrogramov Rapinyl 300 mikrogramov Rapinyl 400 mikrogramov Rapinyl 600 mikrogramov Rapinyl 800 mikrogramov
English: • Very common side effects (affects more than 1 user in 10 people): excessive sweating
Slovenian: • Zelo pogosti neželeni učinki (prizadenejo več kot 1 bolnika na 10): pretirano potenje