FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant also defended the 800ug dose and discussed the safety of Rapinyl when superimposed on a continuous fentanyl or non-fentanyl opioid pain therapy and considered that the transmucosal delivery of fentanyl produces consistent results, independent of the type of baseline therapy.
Slovenian: Predlagatelj je tudi zagovarjal odmerek 800 ug in razpravljal o varnosti zdravila Rapinyl, kadar je le to uporabljeno naknadno in dodatno v osnovni trajajoči protibolečinski terapiji s fentalnimi ali nefentanilnimi opioidi ter izrazil prepričanje, da absorpcija fentanila skozi sluznico daje dosledne rezultate, neodvisne od osnovne terapije.
English: The application was based on literature data on fentanyl, supplemented with pharmacokinetic data for Rapinyl and a comparison of Rapinyl bioavailability with Actiq lozenge, an authorised transmucosally administered fentanyl on demand.
Slovenian: Osnova za vlogo so podatki o fentanilu iz literature ter podprta s farmakokinetičnimi podatki za zdravilo Rapinyl in primerjav biološke razpoložljivosti zdravila Rapinyl z zdravilom Actiq lozenge, odobrenim fentanilom na zahtevo, ki v telo prehaja skozi sluznico.
English: This risk is higher in opioid-naïve subjects than in patients experiencing severe pain or receiving chronic opioid therapy.
Slovenian: Tveganje je pri bolnikih, ki še niso prejemali opioidov, večje kot pri bolnikih, ki so izpostavljeni hudi bolečini ali ki dobivajo kronično terapijo na osnovi opioidov.
English: • Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/blisters, blockage of the gut, difficulty swallowing, being accident-prone
Slovenian: • Pogosti neželeni učinki (prizadenejo 1 do 10 bolnikov na 100): zmedenost, strah, nervoznost, halucinacije, nenormalne misli, trzajoče mišice, težave s spanjem, čudne sanje, težave z jezikom ali okusom, vročinski valovi, rane/mehurji v ustih, blokada črevesja, težave pri požiranju, nagnjenost k nezgodam
English: Any unused product should be taken, if possible, to your pharmacist to be disposed of safely.
Slovenian: Če je mogoče, neuporabljeno zdravilo vrnite v lekarno, da se ga varno odstrani.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA SPREMEMBO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: Rapinyl should be administered with caution to patients with liver or kidney dysfunction, especially during the titration phase.
Slovenian: Potrebna je previdnost pri dajanju Rapinyla bolnikom z okvaro jeter in ledvic, posebno med postopkom titriranja.
English: Finally, the CHMP considered that the database on efficacy and safety of Rapinyl in the treatment of cancer patients with BTP is rather poor and requested further safety analyses to be provided: detailed exposition of patients to Rapinyl, full safety analysis, narratives of the deaths.
Slovenian: Podatkovna baza o učinkovitosti in varnosti zdravila Rapinyl pri zdravljenju bolnikov z rakom, pri katerih se pojavlja prebijajoča bolečina, namreč po mnenju CHMP ni zadostna in zahteva dodatne varnostne analize: potrebna je temeljita izpostavljenost bolnikov zdravilu Rapinyl, popolna varnostna analiza in poročila o smrti.
English: • low blood pressure, flushing/feeling hot, slow shallow breathing, feeling weak, feeling faint,
Slovenian: • nizek krvni tlak, vročinski vali / zardevanje, počasno in plitko dihanje, občutek slabosti in omedlevice, zmanjšana občutljivost za dotik, odrevenelost ali ščemenje
English: Rapinyl has not been studied in patients with mouth wounds or mucositis.
Slovenian: Rapinyla niso preskušali na bolnikih z ranami v ustih ali z vnetjem sluznice.
English: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
Slovenian: • bruhanje, driska, zaprtost, bolečine v želodcu, občutek napihnjenosti, slaba prebava, izguba apetita
English: Patients should be carefully monitored until an appropriate dose is reached, i.e. that provides adequate analgesia with acceptable adverse reactions for each episode of breakthrough pain.
Slovenian: dokler ni dosežena ustrezna analgezija s sprejemljivimi neželenimi učinki za vsako epizodo prebijajoče bolečine.
English: Take special care with Rapinyl
Slovenian: Bodite posebno pozorni pri uporabi zdravila Rapinyl
English: Use in patients with renal and hepatic impairment Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Rapinyl titration phase (see section 4.4).
Slovenian: Bolnike z okvaro ledvic ali jeter je treba med postopkom titracije odmerka skrbno opazovati glede znakov toksičnosti fentanila ( glejte poglavje 4.4).
English: There should be no noticeable effects on cessation of treatment with Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Slovenian: Pri prenehanju zdravljenja z Rapinylom ne bi smelo biti opaznejših učinkov, kljub temu so možni odtegnitveni simptomi kot so strah, tremor, potenje, bledica, slabost in bruhanje.
English: The CHMP considered that while the efficacy data showed statistically significant difference in favour of Rapinyl versus placebo on SPID 30, the CHMP considered that the primary endpoints should include the assessment of pain intensity difference by simple scale and to define responder.
Slovenian: CHMP meni, da podatki o učinkovitosti sicer kažejo statistično pomembno razliko v korist zdravila Rapinyl v primerjavi s placebom v skupni razliki v jakosti bolečine od začetka do 30 minut kasneje (SPID30), ter da primarni končni učinek mora vsebovati tudi vrednotenje razlike v jakosti bolečine z navadno lestvico in odzivom bolnika.
English: Care should be taken when using naloxone or other opioid antagonists to treat overdose in opioidmaintained patients, due to the risk of precipitating an acute withdrawal syndrome.
Slovenian: Med obravnavanjem prevelikega odmerjanja pri bolnikih na opioidni terapiji je treba pri dajanju naloksona ali drugih antagonistov opioidov biti pazljiv, saj obstaja tveganje za nenadni pojav akutnega odtegnitvenega sindroma.
English: Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Slovenian: Obvladovanje prebijajoče bolečine pri odraslih bolnikih pod opioidno terapijo zaradi kronične rakave bolečine.
English: Maintenance therapy:
Slovenian: Vzdrževalno zdravljenje:
English: Discontinuation of therapy:
Slovenian: Prenehanje zdravljenja:
English: Uncommon: Bradycardia, tachycardia, hypertension Very rare: Arrhythmias
Slovenian: Občasni: bradikardija, tahikardija, hipertenzija
English: The Applicant concluded that Rapinyl is safe and well tolerated in patients, with an appropriate safety-profile of Rapinyl for this indication.
Slovenian: Predlagatelj tako meni, da je zdravilo Rapinyl varno in da ga bolniki dobro prenašajo, ter da je varnostni profil zdravila Rapinyl za to indikacijo ustrezen.
English: If patients are switched from another fentanyl containing product, a new dose titration with Rapinyl is required.
Slovenian: Če bolniki, ki uporabljajo druga zdravila s fentanilom, pričnejo prejematiRapinyl, je potrebna ponovna titracija odmerka.
English: • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta
English: General disorders and administration site conditions Very common: Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije Občasni: utrujenost
English: The CHMP considered the low adverse spectrum incidence in opioid-tolerant patients reassuring and noted the statement in the SPC on dose titration.
Slovenian: CHMP je menil, da je majhno število neželenih pojavov pri bolnikih, ki prenašajo opioidna zdravila, pomirjujoče ter se seznanil z navedbo o titraciji odmerkov v povzetku glavnih značilnosti zdravila.
English: However, due to the quite low number of patients exposed for a long time, the Applicant was asked to provide the final results of the studies EN3267-005 and EN3267-007 and the full safety analysis data on SAEs as conditions to the Marketing Authorisations.
Slovenian: Zaradi majhnega števila bolnikov, ki so bili zdravilu izpostavljeni dalj časa, mora predlagatelj kot pogoj za pridobitev dovoljenja za promet z zdravilom predložiti končne rezultate študij EN3267-005 in EN3267-007 ter popolne podatke varnostne analize o resnih neželenih učinkih.
English: The active substance in Rapinyl sublingual tablets is fentanyl.
Slovenian: Zdravilna učinkovina v Rapinyl podjezičnih tabletah je fenantil.
English: POSSIBLE SIDE EFFECTS Like all medicines, Rapinyl can cause side-effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Rapinyl neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The 50 microgram tablet is a white pentagon-shaped tablet.
Slovenian: 50 mikrogramska podjezična tableta je bela peterokotna tableta.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Glejte Dodatek I - Izpolni država članica]>
English: For the treatment of accidental overdose in opioid-naïve individuals, naloxone or other opioid antagonists should be used as clinically indicated and in accordance with their Summary of Product Characteristics.
Slovenian: Pri osebah, ki se predhodno niso zdravile z opioidi, naj se pri naključnem previsokem odmerjanju uporabi nalokson ali drugi antagonisti opioidov, odvisno od kliničnega stanja bolnika in v skladu s Povzetkom glavnih značilnosti zdravila.
English: For Rapinyl to work successfully, your doctor will need to identify the most appropriate dose for treating a single episode of breakthrough pain.
Slovenian: Da bo zdravilo Rapinyl učinkovalo, mora vaš zdravnik določiti odmerek, ki je za zdravljenje nastale prebijajoče bolečine za vas najbolj ustrezen.
English: The Applicant also discussed xerostomia and mucositis and was of the opinion that neither was expected to significantly affect the dissolution or absorption of sublingual Rapinyl, although noting that Rapinyl was not expected to be used in patients with severe mucositis.
Slovenian: Predlagatelj je omenil tudi pojav kserestomije in mukozitisa ter izrazil prepričanje, da nobeno od teh stanj bistveno ne vpliva na topitev ali absorpcijo sublingvalnega zdravila Rapinyl, čeprav naj bolniki z resnim mukozitisom zdravila Rapinyl ne bi uporabljali.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET [Izpolni država članica]
English: Renal and urinary disorders Uncommon: Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
Slovenian: Občasni: zadrževanje seča, spremembe v sečni frekvenci Zelo redki: krč mehurja, oligurija
English: Rapinyl should be used with caution in patients with bradyarrhythmias.
Slovenian: Pri bolnikih z bradiaritmijami je treba Rapinyl uporabljati previdno.
English: - the CHMP considered the benefit/risk of Rapinyl to be positive the CHMP has recommended the amendment of the Summaries of Product Characteristics and the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Rapinyl and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev povzetka glavnih značilnosti zdravila in odobritev dovoljenja za promet z zdravilom za katero so povzetek glavnih značilnosti zdravila, označevanja in navodila za uporabo, navedeni v Dodatku III za zdravilo Rapinyl in z njim povezana imena (glejte Dodatek I).
English: Fentanyl should therefore be given to patients with caution if administered concomitantly with CYP3A4 inhibitors.
Slovenian: Pri dajanju fentanila bolnikom, ki sočasno dobivajo inhibitorje CYP3A4, je zato potrebna previdnost.
English: The CHMP adopted a List of Questions (LoQ) to be addressed by the Applicant.
Slovenian: Ta je sestavil seznam vprašanj za predlagatelja.
English: No more than two (2) sublingual tablets should be administered for a single episode of breakthrough pain during this titration phase.
Slovenian: Med posamezno epizodo prebijajoče bolečine se sme med fazo titriranja odmeriti največ dve (2) sublingvalni tableti.
English: Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Slovenian: Rapinyl 100 mikrogramske podjezične tablete Rapinyl 200 mikrogramske podjezične tablete Rapinyl 300 mikrogramske podjezične tablete Rapinyl 400 mikrogramske podjezične tablete Rapinyl 600 mikrogramske podjezične tablete Rapinyl 800 mikrogramske podjezične tablete
English: Sublingual tablet
Slovenian: podjezična tableta
English: There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Slovenian: Pri ukinitvi zdravljenja z Rapinylom ne bi smelo biti opaznejših učinkov, kljub temu so možni odtegnitveni simptomi kot so strah, tremor, potenje, bledica, slabost in bruhanje.
English: You may need to try different strengths of Rapinyl sublingual tablets over a number of episodes of breakthrough pain to find the most appropriate dose.
Slovenian: Morda bo potrebno tekom zdravljenja več epizod prebijajoče bolečine uporabiti različne jakosti, preden se določi odmerek, ki je za vas najprimernejši.
English: Applicant for analyzing only SAEs at this stage are endorsed, and the absence of new important safety issues was considered re-assuring by the CHMP, a full safety analysis should be provided by the Applicant.
Slovenian: Odbor za zdravila za uporabo v humani medicini sicer sprejema razloge predlagatelja za analiziranje le resnih neželenih dogodkov v tej fazi in pozitivno ocenjuje dejstvo, da se niso pojavila nobena nova varnostna vprašanja, hkrati pa meni, da mora predlagatelj predložiti tudi popolno varnostno analizo.
English: Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed child. Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child.
Slovenian: Fentanil naj bi se doječim ženskam predpisoval samo, če koristi jasno odtehtajo potencialne nevarnosti tako za mater kot za otroka.
English: Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Slovenian: Zdravilo Rapinyl je namenjeno lajšanju prebijajočih bolečin pri bolnikih s kroničnimi bolečinami zaradi raka, ki se zdravijo z opioidnimi terapijami.
English: Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Slovenian: Vsaka sublingvalna tableta vsebuje 50 mikrogramov fentanila v obliki fentanilijevega citrata 100 mikrogramov fentanila v obliki fentanilijevega citrata
English: Similarly, the Applicant considered the clinical safety of fentanyl products to be well established and well tolerated in both volunteers and the target population and that the pattern of side effects was consistent with other fentanyl products, including those used for treating BTP.
Slovenian: Predlagatelj je nadalje menil, da je klinična varnost zdravil s fentanilom ustrezno dokazana, da jih tako prostovoljci kot tudi ciljna populacija dobro prenašajo in da so vzorci neželenih učinkov podobni kot pri drugih zdravilih s fentanilom, vključno s tistimi za zdravljenje prebijajočih bolečin pri raku.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA OZNAČEVANJE IN NAVODILO ZA UPORABO
English: If you take more Rapinyl than you should
Slovenian: Če ste uporabili večji odmerek zdravila Rapinyl, kot bi smeli:
English: Therefore, the CHMP was unable to agree that the safety and efficacy profile of Rapinyl could be anticipated from the provided documentation.
Slovenian: Tako CHMP ni mogel potrditi, da se lahko na osnovi podatkov, predloženih v dokumentaciji, sklepa o profilu varnosti in učinkovitosti zdravila Rapinyl.
English: What Rapinyl is and what it is used for Before you take Rapinyl How to take Rapinyl Possible side effects How to store Rapinyl Further information
Slovenian: Kaj je Rapinyl in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Rapinyl Kako jemati Rapinyl
English: Repeated administration of the opioid antagonist may be necessary if the duration of respiratory depression is prolonged.
Slovenian: Če depresija dihanja traja dalj časa, bo morda potrebno antagonist opioida dati večkrat.
English: Ask your doctor or pharmacist for advice before taking any medicine when pregnant or breast-feeding.
Slovenian: Če ste noseči ali če dojite, se posvetujte s svojim zdravnikom, preden začnete jemati kakršnokoli zdravilo.
English: Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa.
Slovenian: Zdravilo Rapinyl je hitro topljiva sublingvalna tableta, oblikovana tako, da fentanil hitro in načrtno pronica skozi oralno sluznico.
English: - the dose range of Rapinyl and the dose proportionalilty between Actiq and Rapinyl was considered as established
Slovenian: - sta razpon odmerkov zdravila Rapinyl in sorazmernost odmerkov med zdravilom Actiq in zdravilom Rapinyl ustrezno dokazana,
English: Whereas
Slovenian: Ob upoštevanju, da
English: Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3
Slovenian: Farmakoterapevtska skupina: Derivati fenilpiperidina.
English: You should only stop taking Rapinyl sublingual tablets on the advice of your doctor.
Slovenian: Z jemanjem Rapinyl podjezičnih tablet smete prenehati samo, če vam je tako naročil vaš zdravnik.
English: Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Slovenian: Pogosti: bruhanje, bolečine v trebuhu, driska, zaprtost, neprijeten občutek v želodcu, dispepsija, suha usta
English: Rapinyl is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Slovenian: Pri sočasni uporabi zaviralcev MAO in opioidnih analgetikov so poročali o resnem in nepredvidljivem potenciranju učinkov opioidnih analgetikov, zato se uporaba Rapinyla ne priporoča pri bolnikih, ki so v obdobju 14 dni prejemali zaviralce monoaminooksidaze (MAO).
English: What Rapinyl contains
Slovenian: Kaj vsebuje zdravilo Rapinyl
English: Spain
Slovenian: ¨Španija
English: Taking the medicine
Slovenian: Uporaba zdravila:
English: The packaging is colour-coded for each Rapinyl sublingual tablet strength.
Slovenian: Barva ovojnine se razlikuje glede na jakost Rapinyl sublingvalnih tablet.
English: Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects.
Slovenian: Peroralno odmerjen fentanil je izrazito podvržen predsistemskemu metabolizmu v jetrih in prebavilih.
English: The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child. Rapinyl must be kept out of the reach and sight of children.
Slovenian: Učinkovina za lajšanje bolečin v zdravilu Rapinyl je zelo močna in lahko ogrozi življenje, če ga po nesreči vzame otrok.
English: Renal/hepatic impairment
Slovenian: Okvara ledvic/jeter
English: HOW TO TAKE RAPINYL
Slovenian: KAKO JEMATI ZDRAVILO RAPINYL
English: Up to this date there were no reports of any SAEs assessed as being related to Rapinyl in either study.
Slovenian: Do danes ni nobenih poročil o resnih neželenih učinkih pri kateri koli od navedenih študij, ki bi bili posledica uporabe zdravila Rapinyl.
English: Driving and using machines
Slovenian: Vpliv na vožnjo in sposobnost upravljanja strojev:
English: Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
Slovenian: Pogosti: gastrointestinalna okluzija, disfagija, razjede v ustih/stomatitis, spremembe na jeziku Občasni: povečan trebuh, flatulenca, žeja
English: An extrapolation of the PID at 10 and 15 minutes to responder rates has been provided by the Applicant.
Slovenian: Predlagatelj je predložil tudi ekstrapolacijo razlik v jakosti bolečine pri sodelujočih v 10 in 15 minutah.
English: Rapinyl should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain.
Slovenian: Rapinyl se naj daje samo bolnikom, za katere velja, da so razvili toleranco na opioide pri zdravljenju kronične bolečine pri raku.
English: The safety of fentanyl in pregnancy has not been established.
Slovenian: Za uporabo fentanila med nosečnostjo niso ugotovili, ali je varna.
English: Carton Label
Slovenian: Oznaka na ovojnini
English: The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “D”-shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Slovenian: 600 mikrogramska Podjezična tableta je bela tableta v obliki črke D. 800 mikrogramska Podjezična tableta je bela tableta v obliki kapsule.
English: Due to the low number of patients exposed for a long time, the final results of the studies EN3267-005 and EN3267-007 should be provided as conditions to the Marketing Authorisations.
Slovenian: Zaradi majhnega števila bolnikov, ki so bili zdravilu izpostavljeni dalj časa, je kot pogoj za pridobitev dovoljenja za promet z zdravilom potrebno predložiti tudi končne rezultate študij En3267
English: Rapinyl 800 µg sublingual tablets
Slovenian: Rapinyl 800 µg podjezične tablete
English: • You should not drink or eat anything until the tablet has completely dissolved under your tongue.
Slovenian: • Dokler se tableta ni do konca raztopila pod vašim jezikom, ne smete ne jesti ne piti.
English: One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Slovenian: Ena podjezična tableta vsebuje: 50 mikrogramov fentanila v obliki fentanilijevega citrata
English: Rapinyl 400 µg sublingual tablets
Slovenian: Rapinyl 400 µg podjezične tablete
English: Rapinyl 300 µg sublingual tablets
Slovenian: Rapinyl 300 µg podjezične tablete
English: Rapinyl 100 µg sublingual tablets
Slovenian: Rapinyl 100 µg podjezične tablete
English: 800 micrograms fentanyl (as citrate)
Slovenian: 800 mikrogramov fentanila v obliki fentanilijevega citrata
English: Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids.
Slovenian: Pri fentanilu in drugih opioidih so poročali o mišični otrplosti, ki otežuje dihanje.
English: 600 micrograms fentanyl (as citrate)
Slovenian: 600 mikrogramov fentanila v obliki fentanilijevega citrata
English: 200 micrograms fentanyl (as citrate)
Slovenian: 200 mikrogramov fentanila v obliki fentanilijevega citrata
English: 400 micrograms fentanyl (as citrate)
Slovenian: 400 mikrogramov fentanila v obliki fentanilijevega citrata
English: Rapinyl 200 µg sublingual tablets
Slovenian: Rapinyl 200 µg podjezične tablete
English: Rapinyl 600 µg sublingual tablets
Slovenian: Rapinyl 600 µg podjezične tablete
English: 300 micrograms fentanyl (as citrate)
Slovenian: 300 mikrogramov fentanila v obliki fentanilijevega citrata
English: Silicified microcrystalline cellulose Croscarmellose sodium
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) silicirana mikrokristalna celuloza natrijev karmelozat, premreženi magnezijev stearat
English: Rapinyl 800 microgram sublingual tablets
Slovenian: Rapinyl 800 mikrogramske podjezične tablete