natgillin/translations-raw huggingface dataset:
RXULTI 1 mg film-coated tablets Each film-coated tablet contains 1 mg brexpiprazole. 
RXULTI 1 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1 mg brekspiprazola.
• dizziness, 
• izpuščaj,
Gastric lavage and treatment with an emetic may be useful immediately after overdose. 
Takoj po prevelikem odmerjanju je lahko koristno izpiranje želodca in dajanje emetika.
Dosing modifications to half the recommended doses is required for patients with known CYP2D6 poor metaboliser status. 
Pri bolnikih, pri katerih je znano stanje slabe presnove CYP2D6, je treba odmerke prilagoditi na polovico priporočenih.
RXULTI 4 mg film-coated tablets Each film-coated tablet contains 4 mg brexpiprazole. 
RXULTI 4 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 4 mg brekspiprazola.
Each film-coated tablet contains 48.2 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 48,2 mg laktoze (v obliki monohidrata).
• The active substance is brexpiprazole. 
• Zdravilna učinkovina je brekspiprazol.
• seizure, 
• napenjanje,
STATEMENT OF ACTIVE SUBSTANCE(S) 
LS povprečna sprememba od izhodiščne vrednosti (SE)
• rash, 
• driska,
How to store RXULTI 
Shranjevanje zdravila RXULTI
Each film-coated tablet contains 1 mg brexpiprazole. 
Ena filmsko obložena tableta vsebuje 1 mg brekspiprazola.
RXULTI 2 mg film-coated tablets Each film-coated tablet contains 2 mg brexpiprazole. 
RXULTI 2 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2 mg brekspiprazola.
Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking brexpiprazole. 
Pri bolnikih se lahko pojavijo povečane težnje, zlasti po igrah na srečo,
RXULTI 3 mg film-coated tablets Each film-coated tablet contains 3 mg brexpiprazole. 
RXULTI 3 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 3 mg brekspiprazola.
Strong CYP2D6 inhibitors 
Močni zaviralci CYP2D6
Blood pressure increased 
Zvišanje prolaktina v krvi1
Placebo Brexpiprazole (2 mg/day)* 113 96.55 Brexpiprazole (4 mg/day) Placebo Brexpiprazole (2 mg/day to 4 mg/day 
Placebo Brekspiprazol (2 mg/dan)* 113 96,55
LS Mean Least-squares mean. 
LS po metodi najmanjših kvadratov (Least-squares) IZ interval zaupanja
RXULTI 1 mg film-coated tablets 
RXULTI 1 mg filmsko obložene tablete
Each film-coated tablet contains 4 mg brexpiprazole. 
Ena filmsko obložena tableta vsebuje 4 mg brekspiprazola.
Each film-coated tablet contains 2 mg brexpiprazole. 
Ena filmsko obložena tableta vsebuje 2 mg brekspiprazola.
Each film-coated tablet contains 47.9 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 47,9 mg laktoze (v obliki monohidrata).
Mean dose 3.5 mg/day 
2 in 4 mg/dan.
Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side. 
Svetlo oranžna, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 0.5 na eni strani.
Each film-coated tablet contains 3 mg brexpiprazole. 
Ena filmsko obložena tableta vsebuje 3 mg brekspiprazola.
Akathisia was the most frequently reported EPS related ADR in the brexpiprazole 2 mg/day to 4 mg/day group (5.6 %) compared to 4.5 % in placebo, followed by tremor (2.7 %) compared to 1.2 % in placebo. 
Najpogostejši neželeni učinek, o katerem so poročali in ki je povezan z EPS, je bila akatizija v skupini, ki je prejemala brekspiprazol v odmerku od 2 do 4 mg/dan (5,6 %), v primerjavi s 4,5 % v skupini s placebom.
RXULTI 2 mg film-coated tablets 
RXULTI 2 mg filmsko obložene tablete
RXULTI 0.5 mg film-coated tablets 
RXULTI 0,5 mg filmsko obložene tablete
• during blood tests your doctor may find higher amounts of creatine kinase (also called creatine phosphokinase) in your blood (enzyme important for muscle function). 
(imenovane tudi kreatin fosfokinaze) (encim, pomemben za delovanje mišic).
RXULTI 1 mg film-coated tablets brexpiprazole 
RXULTI 1 mg filmsko obložene tablete brekspiprazola
RXULTI 0.5 mg film-coated tablets brexpiprazole 
RXULTI 0,5 mg filmsko obložene tablete brekspiprazola
RXULTI 0.25 mg film-coated tablets 
RXULTI 0,25 mg filmsko obložene tablete
RXULTI 3 mg film-coated tablets 
RXULTI 3 mg filmsko obložene tablete
RXULTI 4 mg film-coated tablets brexpiprazole 
RXULTI 4 mg filmsko obložene tablete brekspiprazola
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms. 
• nezmožnost upreti se impulzu, težnji ali skušnjavi po dejanjih, ki bi lahko škodila vam ali drugim, kot so: - močna želja po čezmernem hazardiranju ne glede na posledice za vas ali za družino,
RXULTI 0.25 mg film-coated tablets brexpiprazole 
RXULTI 0,25 mg filmsko obložene tablete brekspiprazola
RXULTI 2 mg film-coated tablets brexpiprazole 
RXULTI 2 mg filmsko obložene tablete brekspiprazola
Each film-coated tablet contains 46.4 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 46,4 mg laktoze (v obliki monohidrata).
RXULTI 3 mg film-coated tablets brexpiprazole 
RXULTI 3 mg filmsko obložene tablete brekspiprazola
RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets) 
RXULTI 3 mg filmsko obložene tablete EU/1/18/1294/006 (28 filmsko obložene tablete)
Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side. 
Svetlo rjava, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm z vtisnjeno oznako BRX in 0.25 na eni strani.
In trial 1, statistically significant greater improvement on the CGI-S, the key secondary efficacy measure, at week 6 was also shown for the 2 mg/day and 4 mg/day compared to the placebo dose groups. 
V 1. preskušanju se je v primerjavi s skupino bolnikov, ki je prejemala placebo, v 6. tednu pokazalo statistično značilno večje izboljšanje CGI-S, ključnega sekundarnega parametra učinkovitosti, tudi pri
• back pain, 
• bolečine v hrbtu,
RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black) 
Železov oksid E 172 (rdeči, črni)
RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets) 
RXULTI 4 mg filmsko obložene tablete EU/1/18/1294/007 (28 filmsko obložene tablete)
Each film-coated tablet contains 45.4 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 45,4 mg laktoze (v obliki monohidrata).
RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black) 
Železov oksid E 172 (rumeni, rdeči, črni)
Light yellow, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 1 on one side. 
Svetlo rumena, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 1 na eni strani.
If brexpiprazole is used concomitantly with strong CYP3A4 inducers (e.g. rifampicin), in a patient stabilised on brexpiprazole it is necessary to titrate the daily dose of brexpiprazole stepwise up to double the recommended dose over the course of 1 to 2 weeks. 
(npr. rifampicin), je treba v 1- do 2-tedenskem obdobju postopno titrirati dnevni odmerek brekspiprazola do podvojitve priporočenega odmerka.
CYP2D6 poor metabolisers 
Slabi presnavljalci CYP2D6
RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets) 
RXULTI 2 mg filmsko obložene tablete EU/1/18/1294/005 (28 filmsko obložene tablete)
Light green, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 2 on one side. 
Svetlo zelena, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 2 na eni strani.
Each film-coated tablet contains 47.4 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 47,4 mg laktoze (v obliki monohidrata).
RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets) 
RXULTI 0,5 mg filmsko obložene tablete EU/1/18/1294/002 (28 filmsko obložene tablete)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 
PODATKI NA PRIMARNI OVOJNINI ZUNANJA OVOJNINA
RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets) 
RXULTI 0,25 mg filmsko obložene tablete EU/1/18/1294/001 (28 filmsko obložene tablete)
Each film-coated tablet contains 44.4 mg lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 44,4 mg laktoze (v obliki monohidrata).
Seizures 
Prolaktin
Hepatic impairment 
Srčno-žilne bolezni
Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax. 
7 dni), močnega zaviralca CYP2D6, je povečala AUC brekspiprazola za 94 % in ni spremenila vrednosti Cmax.
Light purple, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 3 on one side. 
Svetlo vijolična, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 3 na eni strani.
SOC 
Navzea
Diarrhoea Nausea Abdominal pain upper 
Bolečine v zgornjem delu trebuha
RXULTI 4 mg film-coated tablets White, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 4 one side. 
Bela, okrogla, plitko konveksna tableta s prirezanimi robovi premera 6 mm, z vtisnjeno oznako BRX in 4 na eni strani.
Standard error 
SE standardna napaka aritmetične sredine
Maintenance of efficacy trial 
UČINKOVITO UPORABO ZDRAVILA
The maximum recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) is reduced to 3 mg once daily (see section 5.2). 
Pugh ≥ 7) je zmanjšan na 3 mg enkrat na dan (glejte poglavje 5.2).
RXULTI 2 mg film-coated tablets Iron oxide E 172 (yellow, black) 
Železov oksid E 172 (rumeni, črni)
RXULTI 0.5 mg film-coated tablets Iron oxide E 172 (yellow, red) 
Železov oksid E 172 (rumeni, rdeči)
Standard deviation 
Placebo SD standardni odklon
Tardive dyskinesia 
Presku šanje
Use in children and adolescents: 
Uporaba pri otrocih in mladostnikih:
Taking Rapinyl with food and drink 
Jemanje Rapinyla skupaj s hrano in pijačo
• Medicines containing alcohol 
• zdravila, ki vsebujejo alkohol
Long-term carcinogenicity studies have not been performed. 
Dolgoročnih študij rakotvornosti niso izvedli.
136 50 Haninge Sweden 
136 50 Haninge
The data submitted builds on clinical data from 221 volunteers and 41 patients. 
Predloženi podatki so zasnovani na kliničnih podatkih 221 prostovoljcev in 41 bolnikov.
Tell your doctor if you have taken this type of medicine within the last two weeks 
Povejte svojem zdravniku, v kolikor ste tovrstna zdravila jemali v zadnjih dveh tednih.
BATCH NUMBER Lot: XXXX 
ŠTEVILKA SERIJE Lot: XXXX
(Invented) Name Strength 
(Izmišljeno ime) ime
Notwithstanding this, the Applicant remains committed to the proposed comprehensive risk management plan that will be put in place. 
Kljub temu pa se predlagatelj zavezuje, da bo oblikoval predlagan jasen načrt za obvladovanje tveganja.
Teratogenic effects have, however, not been demonstrated. 
Teratogenih učinkov niso ugotovili.
• tell your carer or another person in your house what has happened 
• povejte skrbniku ali kaki drugi osebi v bližini, kaj se je zgodilo
This is illustrated in the schedule below. 
To je prikazano v tabeli spodaj.
The bioavailability of Rapinyl has not been studied but is estimated to be about 70%. 
Biološke razpoložljivosti Rapinyla se ni raziskovalo, ocenjuje se, da je približno 70%.
This calculation seems reasonable, however, responder analysis should be provided when available. 
Ta izračun se zdi smiseln, kljub temu pa je potrebno predložiti analizo sodelujočih, ko bo ta na razpolago.
• If your mouth is dry, take a sip of water to moisten it. 
• Če imate suha usta, naredite majhen požirek vode, da jih navlažite.
Rapinyl must not be used in patients less than 18 years of age due to a lack of data on safety and efficacy. 
Rapinyla se pri bolnikih pod 18 leti zaradi pomanjkanja podatkov o varnosti in učinkovitosti ne sme uporabljati.
The expiry date refers to the last day of that month. 
Datum izteka roka uporabnosti je zadnji dan v navedenem mesecu.
Spit out or swallow the water. 
Vodo izpljunite ali pogoltnite.
If the product is used by anyone else it could represent a SERIOUS risk to their health 
Če zdravilo uporabi katerakoli druga oseba, bi to lahko pomenilo RESNO nevarnost za njeno zdravje.
PACKAGE LEAFLET: INFORMATION FOR THE USER 
NAVODILO ZA UPORABO: PODATKI ZA UPORABNIKA
• a head injury, because Rapinyl may cover up the extent of the injury 
• poškodbo glave, saj lahko Rapinyl prikrije resnost poškodbe
In such a case, opioids should be used only if absolutely necessary. 
V takih primerih se sme opioide uporabljati samo, kadar je to absolutno potrebno.
The following medicines may increase the effects of Rapinyl: 
Naslednja zdravila lahko povečajo učinke Rapinyla:
Medicines should not be disposed of via wastewater or household waste. 
Zdravila se ne sme odvreči v odpadne vode ali med gospodinjske odpadke.
• a slow heart rate or low blood pressure 
• počasen srčni utrip ali nizek krvni tlak
Adequate body temperature and parenteral fluid intake should be maintained. 
Vzdržuje naj se primerna telesna temperatura in vnos parenteralne tekočine.
This leaflet was last approved in {MM/YYYY}. 
Navodilo je bilo nazadnje odobreno {MM/YYYY}.
Long-term treatment during pregnancy may cause withdrawal symptoms in the new-born infant. 
Dolgotrajno zdravljenje med nosečnostjo lahko pri novorojenčku povzroči odtegnitvene simptome.
• you or your carer should immediately contact your doctor, pharmacist or local hospital and discuss what action to take 
• vi ali vaš skrbnik morate nemudoma poklicati vašega zdravnika, farmacevta ali najbližjo bolnišnico in se pogovoriti o tem, kaj storiti
• remove any remaining tablets from your mouth 
• odstranite iz ust preostanek tablet
Do not store above 25°C. 
Shranjujte pri temperaturi do 25°C.
For a full list of excipients, see section 6.1. 
Za celoten seznam pomožnih snovi glejte poglavje 6.1
Upon repeated administration of opioids such as fentanyl, tolerance and physical and/or psychological dependence may develop. 
Pri ponavljajočem jemanju opioidov, kot je fentanil, se lahko razvije toleranca in fizična in/ali psihična odvisnost.
A mutagenic risk with therapeutic use seems unlikely since effects were induced only at very high concentrations. 
Tveganje mutagenih učinkov med terapevtsko uporabo ni verjetno, ker so bili ti učinki prisotni le pri zelo visokih koncentracijah.
If you have not, this medicine could cause severe breathing difficulties (see section 4 - Possible side effects). 
Če ne, vam to zdravilo lahko povzroči resne težave pri dihanju (glejte poglavje 4 - možni neželeni učinki).
• Place the tablet under your tongue as far back as you can and let it dissolve completely. 
• Porinite tableto pod jezik kolikor mogoče daleč in pustite, da se do konca raztopi.
Fentanyl should only be used during pregnancy when clearly necessary. 
Fentanil naj bi se med nosečnostjo uporabljal samo, če je nujno potrebno.
Initial Phase - Finding the most appropriate dose 
Začetna faza - določitev ustreznega odmerka
If you start to feel unusually or extremely sleepy or your breathing becomes slow or shallow, you or your carer should immediately contact your doctor or local hospital for emergency help (see also section 3 “If you take more Rapinyl than you should”). 
Če začutite, da ste neobičajno ali izredno zaspani, ali če vaše dihanje postane počasno in plitko, morate vi ali vaš skrbnik nemudoma poklicati vašega zdravnika ali najbližjo bolnišnico za nujno pomoč (glejte tudi poglavje "Če ste uporabili večji odmerek zdravila Rapinyl, kot bi smeli")
The CHMP therefore concluded that the comparability of patients to healthy volunteers was not demonstrated. 
CHMP je tako sklenil, da primerljivost bolnikov z zdravimi prostovoljci ni bila prikazana.
Animal studies have shown reduced fertility and increased mortality in rat foetuses. 
Študije na živalih so pokazale zmanjšano rodnost in povečano smrtnost pri fetusih podgan.
Consult your doctor and do not use Rapinyl during breast-feeding unless your doctor considers that the benefits for you are greater than the risks to the child. 
Posvetujte se s svojim zdravnikom in med dojenjem ne uporabljajte Rapinyla, razen če vaš zdravnik oceni, da koristi za vas odtehtajo nevarnosti za otroka.
If you stop taking Rapinyl 
Če ste prenehali jemati Rapinyl
Once an appropriate dose has been established, which may be more than one tablet, patients should be maintained on this dose and should limit consumption to a maximum of four Rapinyl doses per day. 
Ko je enkrat določen ustrezen odmerek, kar zna biti več kot ena tableta, je treba bolnike vzdrževati na tem odmerku in porabo omejiti na največ štiri odmerke Rapinyla na dan.
Patients should be advised not to eat or drink anything until the sublingual tablet is completely dissolved. 
Bolnikom je treba dati navodilo, naj ne jejo in ne pijejo, dokler se sublingvalna tableta ni v celoti raztopila.
OTHER SPECIAL WARNING(S), IF NECESSARY This product should ONLY be used as prescribed. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA To zdravilo se sme uporabljati SAMO, kot je predpisano.
• increased sensitivity to sound and noise, blurred or double vision 
• povečana občutljivost za zvoke in za hrup, zabrisan ali dvojen vid
It comes in a range of different strengths and shapes. 
Na voljo je v različnih jakostih in oblikah.
The following medicines may reduce the effects of Rapinyl: • Certain types of strong pain killers containing e.g. buprenorphine or pentazocine 
Naslednja zdravila lahko zmanjšajo učinke Rapinyla: • določene vrste močnih zdravil proti bolečinam, ki vsebujejo npr. buprenorfin ali pentazocin
About 80-85% of fentanyl is bound by plasma proteins, mainly α1-glycoprotein and to a lesser extent albumin and lipoprotein. 
Okoli 80-85% fentanila se veže na proteine v plazmi, večinoma na α1-glikoprotein in v manjši meri na albumin in lipoprotein.
• medicines containing clonidine (used to treat high blood pressure). 
• zdravila, ki vsebujejo klonidin (uporablja se jih za zdravljenje visokega krvnega tlaka)
Iatrogenic addiction following therapeutic use of opioids is rare. 
Iatrogenska odvisnost po terapevtski uporabi opioidov je redka.
This product should ONLY be used by you according to your doctor's instructions. 
To zdravilo smete uporabljati SAMO vi, v skladu z zdravnikovimi navodili.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
V vsaki pogostnostni skupini, so neželeni učinki navedeni po padajoči resnosti.
• Remove the tablet(s) from the blister pack immediately before use. 
• Tableto(e) vzemite iz pretisnega omota tik pred uporabo.
A dose of Rapinyl may consist of more than one tablet. 
Rapinyla lahko vsebuje več kot eno tableto.
If you are not sure, talk to your doctor. 
Če ste negotovi, se pogovorite s svojim zdravnikom.
While no analysis of 30% and 50% responders at 10 and 15 minutes was conducted in the interim analysis, this analysis was requested from the sponsor in the final clinical study report. 
Medtem ko v vmesnih študijah ni bila izvedena nobena analiza 30 % in 50 % odzivnostne stopnje pri časovni točki 10 in 15 minut, je takšna analiza bila pri sponzorju naročena pri končnem poročilu o klinični študiji.
Use in elderly patients 
Uporaba pri starejših bolnikih:
It is therefore important that you do not suck, chew or swallow the tablet. 
Pomembno je torej, da tablete ne sesate, žvečite ali ne pogoltnete.
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems 
• če ste alergični na (preobčutljivi za) fentanil ali katerokoli sestavino Rapinyla • če imate resne težave z dihanjem
Doses higher than 800 micrograms have not been evaluated in clinical studies. 
V kliničnih študijah niso vrednotili odmerkov nad 800 mikrogramov.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RAPINYL AND ASSOCIATED NAMES (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA RAPINYL IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
All patients must start therapy with a single 100 microgram sublingual tablet. 
Vsi bolniki morajo terapijo začeti z eno 100 mikrogramsko sublingvalno tableto.
The main use of the referred interim analyses is in the detection of any new safety signals and as a comparison of the efficacy in relation to earlier findings. 
Glavni pomen vmesne analize je zaznavanje kakršnih koli novih varnostnih opozoril in primerjava rezultatov učinkovitosti s predhodnimi rezultati.
Sublingual use. 
Sublingvalna uporaba.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (other than your regular opioid pain-relieving medicine), including medicines obtained without a prescription. 
Povejte svojemu zdravniku ali farmacevtu, če jemljete ali ste pred kratkim jemali druga zdravila (poleg vaših običajnih zdravil za lajšanje bolečine), vključno z zdravili, ki ste jih dobili brez recepta.
In this study, the primary criteria chosen (SPID) and the time chosen for assessment of efficacy (30 min) do not seem appropriate to evaluate the efficacy of a treatment on BTP episodes, which are known to present a median duration of 30 min. 
V tej študiji je izbran primarni kriterij (SPID) in izbran čas za ocenjevanje učinkovitosti (30 min), kar se ne zdi ustrezen kriterij za ocenjevanje učinkovitosti zdravljenja epizod prebijajoče bolečine, katerih srednji čas trajanja znaša 30 min.
After Rapinyl administration, the main elimination half-life of fentanyl is about 7 hours (range 3-12.5 hours) and the terminal half-life is about 20 hours (range 11.5-25 hours). 
Po uporabi Rapinyla je najpogostejši razpolovni čas eliminacije fentanila okoli 7 ur (razpon 3-12,5 ur) in terminalna razpolovna doba okoli 20 ur (razpon 11,5-25 ur).
The Applicant also described the proposed Risk Management Plan, the amendments to the Product Information and the education programme directed at healthcare professionals, patients and carers to be introduced at product launch. 
Predlagatelj je opisal tudi predlagan načrt obvladovanja tveganja, spremembe informacij o zdravilu ter izobraževalni program namenjenem zdravstvenemu osebju, bolnikom in skrbnikom pri uvrstitvi zdravila na trg.
- the responses provided by the Applicant, in particular the additional clinical data submitted during the CHMP referral procedure, successfully addressed the CHMP concerns, 
- so ponujeni odgovori predlagatelja, zlasti dodatni klinični podatki, predloženi med napotitvenim postopkom Odbora za zdravila za uporabo v humani medicini, uspešno odpravili zadržke, ki jih je imel CHMP,
Several doses are available for use during the dose titration phase. 
Za uporabo med fazo titracije je na razpolago več odmerkov.
Rapinyl may add to the effect of medicines that make you feel sleepy, including: 
Rapinyl lahko poveča učinek zdravil, zaradi katerih čutite zaspanost, med drugim:
As the safety of transmucosal fentanyl is well described, any relevant safety issues would have been observed as serious events. 
Varnost absorpcije fentanila skozi sluznico je dobro opisana, vse pomembna varnostna vprašanja pa bi bila zaznana kot resni dogodki.
Even though the number of patients analysed is rather low, information is now available on the treatment of BTP in cancer patients at a dose range from 100 µg up to 800 µg and there were no new safety signals. 
Čeprav je število zajetih bolnikov relativno majhno, so zdaj na voljo informacije o zdravljenju prebijajočih bolečin pri bolnikih z rakavimi obolenji z odmerki od 100 µg do 800 µg, ni pa nobenih novih varnostnih znakov.