natgillin/translations-raw huggingface dataset:
The Applicant also provided data demonstrating that Rapinyl met the primary efficacy endpoint (Sum of Pain Intensity Difference from baseline to 30 minutes (SPID30)) and that the results were highly statistically significant (p=0.0004).
Predlagatelj je prav tako zagotovil podatke s katerimi dokazuje, da je zdravilo Rapinyl doseglo tudi končni učinek primarne učinkovitosti (skupna razlika v jakosti bolečine od začetka do 30 minut kasneje (SPID30)) in rezultati pa so bili statistično zelo pomembni (p=0,0004).
The initial dose of Rapinyl used should be 100 micrograms, titrating upwards as necessary through the range of available dosage strengths.
Začetni odmerek Rapinyla je 100 mikrogramov, nato odmerek povečujete, kolikor je potrebno, s pomočjo razpoložljivih odmerkov različnih jakosti.
Adverse reactions from clinical studies with Rapinyl in patients and volunteers, with a suspected relationship to treatment, are listed below by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10).
Spodaj navedeni neželeni učinki, ugotovljeni v kliničnih študijah z Rapinylom na bolnikih in prostovoljcih in so lahko povezani z zdravljenjem, so razvrščeni po organskih sistemih in pogostnosti (zelo pogosti ≥ 1/10; pogosti ≥ 1/100 do < 1/10).
Based on the review of the data and on the Applicant responses to list of outstanding issues and to the remaining issues, the CHMP considered the benefit/risk ratio of Rapinyl to be positive and the application for Rapinyl sublingual tablet 50, 100, 200, 300, 400, 600 and 800 μg to be approvable, provided that the Applicant implements the amendments made to the text of the Product Information and fulfills the conditions to the Marketing Authorisation as described in Annex IV.
Na podlagi pregledanih podatkov in odgovorov predlagatelja na vprašanja iz seznama odprtih vprašanj ter preostalih odprtih tem, CHMP meni, da je razmerje med koristmi in tveganji za zdravilo Rapinyl pozitivno, ter da se vloga za odobritev zdravila Rapinyl 50, 100, 200, 300, 400, 600 in 800 lahko potrdi, pod pogojem da predlagatelj ustrezno spremeni besedilo v informacijah o zdravilu in izpolni pogoje za pridobitev dovoljenja za promet z zdravilom, določene v Dodatku IV.
• other strong pain-relieving medicines (opioid-type medicines e.g. for pain and cough)
• druga močna zdravila proti bolečinam (zdravila na osnovi opioidov, npr. proti bolečini in kašlju)
You must always use the dose of Rapinyl as prescribed by your doctor - this may be a different dose from that which you have used with other medicines for breakthrough pain.
Rapinyl morate vedno uporabljati v odmerku, ki vam ga je predpisal vaš zdravnik - odmerek je lahko drugačen, kot so bili odmerki pri zdravilih, ki ste jih morda doslej uporabljali za lajšanje prebijajoče bolečine.
A patent airway should be established and maintained.
Vzpostaviti in zavarovati je treba bolnikovo dihalno pot.
The Applicant referred to the provided analysis of Pain Intensity Difference (PID) for Rapinyl compared to placebo from the 10 minute time point in the EN3267-005 study.
Predlagatelj se je skliceval tudi na predloženo analizo Razlika v jakosti bolečine (PID) za zdravilo Rapinyl v primerjavi s placebom, od časovne točke 10 minut v študiji EN3267-005.
The CHMP considered that this was not demonstrated by the data provided due to the questionability of the reliability of study EN3267-001, because the data does not allow the evaluation of the bioavailability of the two formulations, and because the pooled analysis cannot be endorsed.
Odbor za zdravila za uporabo v humani medicini je menil, da predloženi podatki tega niso ustrezno prikazali, saj je zanesljivost študije EN3267-001 vprašljiva, ker podatki ne omogočajo vrednotenja biološke razpoložljivosti obeh pripravkov in ker zbranih analiz ni mogoče potrditi.
You must not use Rapinyl during pregnancy unless you have been specifically told to by your doctor.
Med nosečnostjo Rapinyla ne smete jemati, razen če vam je tako izrecno rekel vaš zdravnik.
Pre-emptive use of Rapinyl for predictable pain episodes was not investigated in the clinical trials.
Uporabe Rapinyla za preprečevanje napovedljivih epizod z bolečino v kliničnih preskušanjih niso raziskovali.
Do not try to push Rapinyl sublingual tablets through the foil top, like a normal tablet
Ne skušajte Rapinyl tablet potisniti skozi krovno folijo kot pri drugih tabletah.
The CHMP considered the pharmacokinetic data in healthy volunteers vs. patients to be limited; however it agreed that the available data do not indicate alarming differences.
CHMP meni, da so predloženi farmakokinetični podatki primerjave med zdravimi prostovoljci in bolniki, omejeni, se pa kljub temu strinja, da razpoložljivi podatki ne kažejo alarmantnih razlik.
Eye disorders Common: Vision abnormal
Očesne bolezni Pogosti: nenormalni vid
The CHMP considered that while there are no reasons to suspect that individualised dose titration would not work for the majority of the patients, the CHMP noted that the highest dose was not studied and considered the study size (n=8) to be too small to draw any reliable conclusions due to the limited number of observations and the absence of statistical analysis of the available data.
CHMP je sicer menil, da ne obstajajo nobeni razlogi za dvom, da individualizirana titracija odmerkov ne bi delovala za večino bolnikov, kljub temu pa je opozoril, da največji odmerek ni bil preučen ter da je bilo sodelujočih v raziskavi premalo (n=8), tako da zaradi omejenega števila ugotovitev in odsotnosti statistične analize razpoložljivih podatkov ni bilo možen noben zanesljiv sklep.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKE OBLIKE, JAKOSTI ZDRAVILA, POSTOPKA UPORABE, PROSILCA IN IMETNIKA DOVOLJENJA ZA PROMET V DRŽAVI ČLANICI
A number of Concerned Member States considered that the bridging strategy was unacceptable and insufficient and that the fast dissolution of the Rapinyl tablet might be indicative of a higher Cmax and shorter Tmax.
Več zadevnih držav članic je menilo, da je premostitvena strategija nesprejemljiva in nezadostna ter da je hitra topljivost tablet Rapinyl lahko pokazatelj višje največje plazemske koncentracije (Cmax) ali krajšega tubulnega maksimuma (Tmax).
Strength (micrograms) of first sublingual tablet per episode of breakthrough pain
Jakost (v mikrogramih) prve podjezične tablete na epizodo prebijajoče bolečine
When you get an episode of breakthrough pain, take the dose advised by your doctor as follows:
Ko se pojavi prebijajoča bolečina, vzemite odmerek, ki vam ga je vaš zdravnik predpisal, kot sledi:
Rapinyl is a small white sublingual tablet to be inserted under the tongue.
Rapinyl je majhna bela podjezična tableta, ki jo date pod jezik.
Safety pharmacology and repeated dose toxicity data reveal no special hazard for humans that is not already covered by other sections of this SPC.
Podatki o farmakološki varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo nobenih drugih tveganj za ljudi, ki ne bi že bila opisana v ostalih poglavjih tega Povzetka glavnih značilnosti zdravila.
In addition, because limited PK data are available in patients, these data cannot be compared to the ones obtained in healthy volunteers.
Poleg tega so tudi farmakokinetični podatki pri bolnikih omejeni in jih ni mogoče primerjati s podatki, pridobljenimi pri zdravih prostovoljcih.
In addition, the sponsor provided a number of independent overwhelmingly positive benefit/risk judgements from experts in palliative care.
Poleg tega je sponzor zagotovil večje število neodvisnih in zelo pozitivnih mnenj strokovnjakov s področja paliativne nege o razmerju med koristmi in tveganji.
ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Fentanyl is a well-known and widely used synthetic short acting strong opioid analgesic, used in the treatment of patients with severe pain.
Fentanil je dobro poznan in zelo uporabljan sintetičen, kratko delujoči, močan opioidni analgetik za uporabo pri zdravljenju bolnikov s hudimi bolečinami.
In conclusion, the CHMP noted that no new data was provided by the Applicant during the procedure but disagreed with the Applicant point of view that further clinical efficacy and safety data are not needed, indeed the justification relies entirely on a bridging strategy that assumes that the bioavailability obtained with Rapinyl is twice higher than that obtained with Actiq at the same molar dose.
V sklepu je CHMP opomnil, da predlagatelj med postopkom ni predložil nobenih novih podatkov, vendar se ni strinjal s predlagateljem, da dodatni podatki o klinični učinkovitosti in varnosti niso potrebni, saj zagovor v celoti temelji na premostitveni strategiji, ki predvideva, da je biološka razpoložljivost zdravila Rapinyl dvakrat večja kot biološka razpoložljivost pridobljena z zdravilom Actiq, pri enakem molarnem odmerku.
The other ingredients are mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Pomožne snovi so manitol (E421), silicirana mikrokristalna celuloza, premrežen natrijev karmelozat in magnezijev stearat.
Dose re-adjustment:
Ponovna prilagoditev odmerka:
Rapinyl tablets are contained in blisters, available in cartons of 10 or 30 tablets.
Tablete Rapinyl so na voljo v pakiranjih po 10 ali 30 tablet.
PHARMACEUTICAL FORM AND CONTENTS Sublingual tablet
FARMACEVTSKA OBLIKA IN VSEBNOST podjezična tableta
Concomitant use of other CNS depressants, such as other morphine derivatives (analgesics and antitussives), general anaesthetics, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (ie benzodiazepines), hypnotics, antipsychotics, clonidine and related substances may produce increased CNS depressant effects.
Sočasno dajanje drugih depresorjev osrednjega živčevja, kot so drugi derivati morfina (analgetiki in antitusiki), splošni anestetiki, relaksanti gladkega mišičevja, sedativni antidepresivi, sedativni H1 antihistaminiki, barbiturati, anksiolitiki (tj benzodiazepini), hipnotiki, antipsihotiki, klonidin in sorodne učinkovine imajo lahko za posledico povečanje depresivnih učinkov na osrednje živčevje.
The safety and efficacy of Rapinyl have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Varnost in učinkovitost Rapinyla so ocenjevali pri bolnikih, ki so zdravilo jemali ob začetku epizode s prebijajočo bolečino.
Based on the review of the data and the responses, the CHMP considered the application for Rapinyl to be approvable, provided that the Applicant addressed the List of Remaining Issues satisfactorily.
Na podlagi pregleda podatkov in odzivov CHMP meni, da vlogo za zdravilo Rapinyl lahko odobri, pod pogojem, da predlagatelj ustrezno odgovori na seznam odprtih vprašanj.
The use of Rapinyl in patients with hepatic or renal impairment may increase the bioavailability of fentanyl and decrease its systemic clearance, which could lead to accumulation and increased and prolonged opioid effects.
Uporaba Rapinyla pri bolnikih z jetrno ali ledvično okvaro lahko poveča biološko razpoložljivost fentanila in zmanjša sistemski očistek, kar lahko privede do kopičenja ter močnejših in zakasnjenih opioidnih učinkov.
Safety data from EN3267-005 and EN3267-007 have also been provided based on an interim cut of the safety database in January 2008, comprising only serious adverse events (SAEs).
Predloženi so bili tudi varnostni podatki iz študij EN3267-005 in EN3267-007 na osnovi vmesnega prereza zbirke varnostnih podatkov v januarju 2008, sestavljeni le iz resnih neželenih učinkov (SAEs).
• breathing problems or suffer from myasthenia gravis (a condition characterised by muscle weakness)
• težave z dihanjem ali če imate miastenijo gravis (bolezen, za katero je značilna slabost mišic)
Fentanyl is metabolised by CYP3A4.
Fentanil se metabolizira s CYP3A4.
WHAT RAPINYL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RAPINYL IN ZA KAJ GA UPORABLJAMO
• while waiting for the doctor, keep the person awake by talking to or shaking her/him now and then
• med čakanjem na zdravnika je treba bolnika ohranjati pri zavesti, z njim govoriti ali ga sem in tja stresti
Common side effects (affects 1 to 10 users in 100) include:
Pogosti neželeni učinki (prizadenejo 1 do 10 bolnikov na 100) so:
Due to the potentially serious undesirable effects that can occur when taking an opioid therapy such as Rapinyl, patients and their carers should be made fully aware of the importance of taking Rapinyl correctly and what action to take should symptoms of overdose occur.
Ker lahko med zdravljenjem z opioidi kot je Rapinyl, pride do potencialno resnih neželenih učinkov, se morajo bolniki in njihovi skrbniki v polni meri zavedati, kako pomembno je, da se Rapinyl jemlje pravilno, in kateri ukrepi so potrebni v primeru, da pride do znakov prevelikega odmerjanja.
Tell your doctor before treatment if you have or have recently had any of the following, as your doctor will need to take account of these when prescribing your dose:
Pred začetkom zdravljenja povejte svojemu zdravniku, če ste kadarkoli ali pred kratkim imeli katero od spodaj navedenih težav, kar bo zdravnik upošteval pri predpisovanju zdravila:
The CHMP considered that the number of patients successfully titrating to an effective dose is close to the one observed for both Actiq and Effentora and observed that as 97% of the patients successfully titrating to an effective dose were able to complete the randomisation phase of the study, no particular safety issues were identified.
CHMP je menil, da je število bolnikov z uspešno titracijo učinkovitega odmerka podobno številu zabeleženem tako pri zdravilu Actiq kot tudi zdravilu Effentora ter ocenil, da je pri 97 % bolnikov titracija učinkovitega odmerka bila uspešna in da so ti bolniki uspešno zaključili randomizirano fazo študije, brez zaznav kakršnih koli varnostnih težav.
Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
Fentanil povzroča tako kot vsi agonisti µ-opioidnih receptorjev od odmerka odvisno depresijo dihanja.
Active substances that inhibit CYP3A4 activity such as macrolide antibiotics (e.g. erythromycin), azole antifungal agents (e.g. ketoconazole, itraconazole) or certain protease inhibitors (e.g. ritonavir) may increase the bioavailability of fentanyl by decreasing its systemic clearance, potentially enhancing or prolonging opioid effects.
Učinkovine, ki inhibirajo aktivnost CYP3A4, kot so makrolidni antibiotiki (npr. eritromicin), antimikotiki iz skupine derivatov triazola (npr. ketokonazol, itrakonazol) ali nekateri inhibitorji proteaz (npr. ritonavir) lahko povečajo biološko uporabnost fentanila, ker zmanjšujejo njegov sistemski očistek in s tem lahko potencirajo ali podaljšujejo opioidne učinke.
Once absorbed, fentanyl starts to work to relieve pain.
Ko je fentanil absorbiran, začne blažiti bolečine.
The Applicant discussed the previously provided SAE dataset up to the 18th January 2008 safety cut off and considered that the new safety data supplemented the bridging strategy and was in line with a further review of SAE data up to the 15th May-08.
Predlagatelj je tudi obravnaval predhodno predstavljene podatke o resnih neželenih učinkih do 18. januarja 2008, ko je prišlo do prekinitve varnostne študije ter meni, da novi podatki o varnosti dopolnjujejo premostitveno strategijo in so v skladu z nadaljnjimi pregledi podatkov o resnih neželenih učinkih, ki so se pojavili do 15. maja 2008.
In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, Rapinyl therapy may usually be discontinued immediately.
Pri bolnikih, ki nadaljujejo zdravljenje kronične bolečine z opioidi in ki ne potrebujejo več terapije za prebijajočo bolečino, se terapijo z Rapinylom lahko preneha takoj.
Rapinyl can make some people feel drowsy.
Rapinyl lahko pri nekaterih ljudeh povzroči, da postanejo zaspani.
Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Pri Rapinylu je pričakovati neželene učinke ki so značilni za opioide; njihova intenzivnost ob uporabi s časom navadno pada.
Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see section 4.4).
Titracije odmerka se je treba lotiti posebno pazljivo in bolnike skrbno opazovati, glede znakov toksičnosti fentanila ( glejte poglavje 4.4).
While not validated, the results obtained from the extrapolations compared favourably to Effentora and Actiq.
Sicer ne potrjeni rezultati pridobljeni iz ekstrapolacije so, v primerjavi z zdraviloma Effentora in Actiq, ugodni.
This was supported by the known properties of fentanyl, the submitted clinical data, the revised SPC version recommending strict individual dose titration, and the proposed Risk Management Plan.
To potrjuje že znana dejstva o lastnostih fentanila, predložene klinične podatke, pregledano in spremenjeno različico povzetka glavnih značilnosti zdravila, ki priporoča strogo individualizirano titracijo odmerkov ter predlagan načrt za obvladovanje tveganja.
Furthermore, the CHMP considered that the provided clinical data on the efficacy and safety of Rapinyl in the treatment of BTP under normal conditions are scarce and that no conclusion could be drawn from the clinical study provided.
CHMP je prav tako menil, da so predloženi klinični podatki o učinkovitosti in varnosti zdravila Rapinyl pri zdravljenju prebijajočih bolečin pri normalnih pogojih, nezadostni, ter da na osnovi predloženih kliničnih študij ni mogoče sprejeti nobenih zaključkov.
A statistically significant decrease in pain intensity was achieved and clinically important decreases in pain occurred more rapidly in patients treated with Rapinyl compared to placebo.
Statistično pomembno zmanjšanje jakosti bolečine je bilo doseženo, prav tako pa so se pojavila klinično pomembna zmanjšanja bolečine pri bolnikih zdravljenih z zdravilom Rapinyl v primerjavi s placebom.
The Applicant considered the rate and extent of absorption to be similar for Rapinyl and Actiq and that the similarity in the PK profiles during the first 30-minute rapid absorption phase is established.
Predlagatelj je menil, da sta razmerje in obseg absorpcije pri zdravilih Rapinyl in Actiq podobna, ter da je podobnost v farmakokinetičnih profilih v fazi prvih 30 minut hitre absorpcije utemeljena.
If the response (analgesia or adverse reactions) to the titrated Rapinyl dose markedly changes, an adjustment of dose may be necessary to ensure that an optimal dose is maintained.
Če se odgovor (analgezija ali neželeni učinki) na titrirani odmerek Rapinyla opazno spremeni, je potrebno odmerek prilagoditi, da se zagotovi in vzdržuje optimalni odmerek.
Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.
Sekundarni učinki fentanila na osrednje živčevje (CŽS), funkcijo dihal in prebavil so tipični za opioidne analgetike in veljajo za učinke razreda.
In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
V tem primeru bo morda potrebna endotrahealna intubacija, asistirana ventilacija in dajanje antagonistov opioidov in mišičnih relaksantov.
Do not drink grapefruit juice while you are prescribed Rapinyl treatment as it may increase the side effects of Rapinyl.
Ne pijte soka grenivke med zdravljenjem z Rapinylom, ker se zaradi tega lahko poslabšajo neželeni učinki zdravila.
Before taking Rapinyl for the first time your doctor will explain how Rapinyl should be taken to effectively treat your breakthrough pain.
Preden prvič vzamete Rapinyl, vam bo vaš zdravnik razložil, kako je treba Rapinyl jemati, da kar najbolj učinkovito zmanjša prebijajočo bolečino.
If necessary an oropharyngeal airway or endotracheal tube should be inserted, oxygen administered and mechanical ventilation initiated, as appropriate.
Po potrebi je treba vstaviti orofaringealni dovod zraka ali endotrahealno cev, dajati kisik in, če je priporočljivo, začeti z mehansko ventilacijo.
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.
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.
Like other opioids fentanyl showed mutagenic effects in vitro in mammalian cells.
Tako kot drugi opioidi, je tudi fentanil kazal in vitro mutagene učinke na celice sesalcev.
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.
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.
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.
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.
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.
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.
Total plasma clearance of fentanyl is about 0.5 l/h/kg.
Celotni očistek fentanila v plazmi je okoli 0,5 l/h/kg.
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.
Preveliko odmerjanje fentanila se kaže kot podaljšanje njegovega farmakološkega delovanja, najresnejši učinek pa je depresija dihanja, ki lahko privede do odpovedi dihanja
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.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učiniek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action.
Fentanil je močen µ-opioidni analgetik s hitrim nastopom analgezije in kratkotrajnim delovanjem.
What Rapinyl looks like and contents of the pack
Izgled zdravila Rapinyl in vsebina pakiranja
Dose titration:
Titracija odmerka:
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.
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.
It is recommended to keep Rapinyl in a locked storage space.
Zdravilo Rapinyl shranjujte v zaklenjenem prostoru.