natgillin/translations-raw huggingface dataset:
Patients/carers should be encouraged to return any unused product to the Pharmacy, where it should be disposed of in accordance with national and local requirements. 
Bolnikom/skrbnikom se svetuje, da neuporabljeno zdravilo vrnejo v lekarno, kjer ga bodo odstranili v skladu z lokalnimi predpisi.
The following adverse reactions associated with other medicinal products containing fentanyl have also been reported (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥ 1/1000 to < 1/100; rare ≥ 1/10,000 to < 1/1000; very rare < 1/10,000; not known (cannot be estimated from available data)): 
Poročali so tudi o naslednjih neželenih učinkih, povezanih z uporabo drugih zdravil s fentanilom (zelo pogosti ≥ 1/10; pogosti ≥ 1/100 do < 1/10; občasni ≥ 1/1.000 do < 1/100; redki ≥ 1/10.000 do < 1/1.000; zelo redki < 1/10.000, ni znano (ni mogoče oceniti iz razpoložljivih podatkov)); Srčne bolezni
The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended. 
Sočasnega jemanja delnih opioidnih agonistov/antagonistov (npr. buprenorfina, nalbufina, pentazocina) se ne priporoča.
Do not consume alcohol without consulting your doctor as it might make you feel more drowsy than usual. 
Ne uživajte alkohola, ne da bi se posvetovali s svojim zdravnikom, ker vas lahko to uspava bolj kot je običajno.
The CHMP agreed and considered the issue to be resolved. 
CHMP se je strinjal in s tem je bilo to vprašanje razrešeno.
If you feel dizzy, sleepy or have blurred vision when you take Rapinyl, do not drive or use machinery. 
Če med jemanjem Rapinyla čutite vrtoglavico, zaspanost ali imate moten vid, ne vozite in ne upravljajte s stroji.
• a brain tumour and/or raised intracranial pressure (an increase of pressure in the brain which causes severe headache, a feeling of sickness and blurred vision) 
• tumor na možganih in/ali zvišan lobanjski pritisk (povečanje pritiska na možgane, ki povzroča težke glavobole, občutek slabosti in zamegljen vid)
Pack size: Packs of 10 or 30 sublingual tablets. 
Velikost pakiranj: pakiranja z 10 ali 30 sublingvalnih tablet.
Patients can be considered opioid tolerant if they take at least 60 mg oral morphine per day, 25 micrograms transdermal fentanyl per hour, or an equianalgesic dose of another opioid for a week or longer. 
Kot tolerantne na opioide je treba bolnike razumeti v primeru, da jemljejo peroralno najmanj 60 mg morfija na dan, 25 mikrogramov fentanila na uro transdermalno, ali ekvivalentni analgetični odmerek kakega drugega opioida za dobo enega tedna ali več.
• Medicines called monoamine-oxidase (MAO) inhibitors, which are used for severe depression and Parkinson's disease. 
• zdravila, ki se imenujejo zaviralci monoaminooksidaze (MAO), s katerimi se zdravi hude depresije in Parkinsonovo bolezen.
Breakthrough pain is pain which occurs suddenly, even though you have taken or used your usual opioid pain-relieving medicine. 
Prebijajoča bolečina je bolečina, ki se nenadoma pojavi, ne glede na to, da ste svoje običajno opioidno zdravilo za lajšanje bolečin dobili oziroma vzeli.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET
Strength (micrograms) of supplemental (second) sublingual tablet to be taken 15-30 minutes after first tablet, if required 
Jakost (v mikrogramih) dodatne (druge) podjezične tablete, ki se jo da 15-30 minut po prvi tableti, če je to potrebno
Within 72 hours of intravenous fentanyl administration around 75% of the dose is excreted into the urine, mostly as metabolites, with less than 10% as unchanged drug. 
72 ur po intravenski uporabi fentanila se v urin izloči okoli 75% odmerka, večinoma v obliki metabolitov, z manj kot 10% nespremenjenega zdravila.
Care should be taken in treating patients with hypovolaemia and hypotension. 
Potrebna je previdnost pri zdravljenju bolnikov z hipervolemijo in hipotenzijo.
Respiratory depression, hypotension and profound sedation may occur. 
Pride lahko do depresije dihanja, hipotenzije in globoke sedacije.
Switching from other fentanyl containing products to Rapinyl must not occur at a 1:1 ratio because of different absorption profiles. 
Z drugih zdravil, ki vsebujejo fentanil, se na Rapinyl ne sme preiti v razmerju 1:1 zaradi razlik v absorpcijskih profilih.
SPECIAL STORAGE CONDITIONS Do not store above 25°C. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25°C.
The available data on exposition was provided as requested and even if the data are not the definitive ones, the CHMP considered that exposure to Rapinyl is sufficient at this point in time. 
Na zahtevo so bili predloženi tudi razpoložljivi podatki o izpostavljenosti in čeprav ne gre za končne podatke, CHMP meni, da je bila izpostavljenost zdravilu Rapinyl v tem trenutku zadostna.
The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock. 
Najbolj resni možni neželeni učinki, ki so povezani z uporabo opioidov, so depresija dihanja (ki lahko pripelje do zastoja dihanja), hipotenzija in šok.
Responses to the Remaining Issues and CHMP assessment 
Odgovori na odprta vprašanja in vrednotenje CHMP
When taking Rapinyl, if you are to have any surgery, inform your doctor or dentist that you are taking this medicine. 
Če jemljete Rapinyl in če imate kirurški poseg, povejte zdravniku ali zobozdravniku, da jemljete to zdravilo.
However, if you are concerned about your pain relief, you should talk to your doctor. 
Če ste zaskrbljeni glede lajšanja bolečin, se pogovorite s svojim zdravnikom.
Considering the narrow therapeutic margin of fentanyl, the efficacy/safety profile is tightly dependant on systemic exposure to this drug and as a consequence the comparability of systemic exposure is pivotal. 
Upoštevajoč ozko terapevtsko uporabnost fentanila, je profil učinkovitosti/varnosti močno odvisen od sistemske izpostavljenosti zdravilu in zato je primerljivost sistemskih izpostavljenosti ključnega pomena.
Patients (n=23) treated with Rapinyl only experienced dizziness, nausea and vomiting. 
Pri bolnikih (n=23), zdravljenih z Rapinylom, se je pojavila samo omotica, slabost in bruhanje.
Rapinyl sublingual tablets should be administered directly under the tongue at the deepest part. Rapinyl sublingual tablets should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking. 
Rapinyl podjezične tablete se daje neposredno pod jezik na najgloblji del. Rapinyl podjezične tablete se ne sme pogoltniti, temveč je treba pustiti, da se v celoti raztopijo pod jezikom, ne da bi se jih žvečilo ali sesalo.
This allows the extrapolation of the conclusions from these studies to Rapinyl. 
To omogoča ekstrapolacijo zaključkov iz teh študij na zdravilo Rapinyl.
The CHMP reviewed the death narratives and agreed with the Applicant conclusions. 
CHMP je pregledal poročilo o smrti in se strinjal z zaključki predlagatelja.
If you think that the dose of Rapinyl that you are using is not controlling your breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose. 
Če menite, da z odmerkom Rapinyla, ki ga uporabljate, vaša prebijajoča bolečina ni ustrezno nadzorovana, se obrnite na svojega zdravnika, mogoče bo moral prilagoditi vaš odmerek.
Rapid absorption of fentanyl occurs over about 30 minutes following administration of Rapinyl. 
Do hitre absorpcije fentanila pride tekom približno 30 minut po jemanju Rapinyla.
About 9% of the dose is recovered in the faeces, primarily as metabolites. 
Okoli 9% odmerka se izloči v blatu, predvsem v obliki metabolitov.
While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination. 
Čeprav opioidi na splošno povečujejo tonus v gladkem mišičju urinarnega trakta, je neto učinek spremenljiv, v nekaterih primerih pride do urinarne urgence, pri drugih do težav pri mokrenju.
Fentanyl is metabolised primarily via CYP3A4 to a number of pharmacologically inactive metabolites, including norfentanyl. 
Fentanil se metabolizira primarno s CYP3A4 v številne farmakološko neaktivne metabolite, med njimi v norfentanil.
Rapinyl sublingual tablets are packaged in OPA/PVC/aluminium/aluminium blisters contained in a cardboard outer carton. 
Rapinyl podjezične tablete so pakirane v pretisnih omotih iz OPA/PVC/aluminija, ki so shranjeni v zunanji ovojnini iz lepenke.
• general anaesthetics (used to make you sleep during operations) 
• splošni anestetiki (ki se uporabljajo za uspavanje med operacijami)
It should not be used by anyone else as it could present a SERIOUS risk to their health, especially in children. 
Jemati ga ne sme nihče drug, posebno ne otroci, ker lahko pomeni RESNO nevarnost za njihovo zdravje.
Unused product should be taken, if possible, to your pharmacist. 
Neuporabljeno zdravilo vrnite, če je mogoče, svojem farmacevtu.
Your doctor will advise you which strength of tablet to use. 
Vaš zdravnik vam bo svetoval, katero jakost zdravila morate vzeti.
• sleeping tablets 
• tablete za spanje
Mutagenicity testing in bacteria and in rodents yielded negative results. 
Rezultati testov mutagenosti na bakterijah in pri glodavcih so bili negativni.
However, the CHMP still considers that the safety of Rapinyl needs further clarification, in particular with regards to repeated administration, the 800 µg dose and the dose titration. 
Kljub temu pa je CHMP prepričan, da varnost zdravila Rapinyl potrebuje dodatna pojasnila, zlasti ob večkratnem dajanju zdravila, odmerku 800 µg in titraciji odmerkov.
If adequate analgesia is achieved at the higher dose, but undesirable effects are considered unacceptable, an intermediate dose (using the 50 microgram or 100 microgram sublingual tablet where appropriate) may be administered. 
V kolikor se pri zvišanem odmerku doseže primerna analgezija, vendar se za neželene učinke meni, da niso sprejemljivi, naj se odmeri vmesni odmerek (ob uporabi 50 oziroma 100 mikrogramske podjezične tablete, kot je primerno).
It is imperative that any dose re-titration of any analgesic is monitored by a health professional. 
Za vse ponovne titracije kakršnegakoli analgetika je obvezno, da jih nadzoruje zdravstveni delavec.
• medicines used to treat o depression o allergies o anxiety and psychosis 
• zdravila za zdravljenje o depresije o alergije o strahu in psihoze
However, fentanyl may impair the mental or physical ability to perform potentially hazardous tasks such as driving or operating machinery. 
Fentanil lahko zmanjša umsko in telesno sposobnost za opravljanje nalog, ki so lahko nevarne, kot sta vožnja in upravljanje s stroji.
Long-term treatment with opioids typically leads to development of tolerance to their secondary effects. 
Dolgotrajno zdravljenje z opioidi ima značilno posledico, in sicer razvoj tolerance na njihove sekundarne učinke.
If you think someone has taken Rapinyl by accident seek emergency medical help immediately. 
V kolikor mislite, da je kaka oseba po nesreči vzela Rapinyl, je treba nemudoma poklicati prvo pomoč.
• depression, difficulty in concentrating, excessive feeling of well being 
• depresija, težave s koncentracijo, pretirana dobra volja
Other known side effects associated with fentanyl products include: 
Drugi znani neželeni učinki, ki so povezani z zdravili na osnovi fentanila, so:
The following dose regimen is recommended for titration, although in all cases the physician should take into account the clinical need of the patient, age and concomitant illness. 
Za titracijo se priporoča spodaj opisani režim odmerjanja, čeprav mora zdravnik pri vseh primerih upoštevati klinično sliko bolnika, njegovo starost in spremljajoče bolezni.
You must continue to take/use your regular opioid pain relieving medicine for persistent pain as advised by your doctor. 
Nadaljevati morate z jemanjem/uporabo vašega običajnega opioidnega zdravila za lajšanje trajnih bolečin, kot vam ga je predpisal vaš zdravnik.
ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH UK 
ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH Združeno kraljestvo
A range of dose strengths allow individualised upward titration from the recommended starting dose to a dose that provides analgesia with acceptable side-effects. 
Širok izbor jakosti odmerkov omogoča individualizirano naraščajočo titracijo od priporočenega začetnega odmerka do odmerka, ki zagotavlja analgezijo s sprejemljivimi neželenimi učinki.
A marketing authorization application was submitted by the Applicant ProStrakan Ltd through the Decentralised Procedure for Rapinyl, a sublingual tablet containing 50, 100, 200, 300, 400, 600 or 800 µg fentanyl, as citrate. 
Družba ProStrakan Ltd je z decentraliziranim postopkom predložila vlogo za dovoljenje za promet z zdravilom Rapinyl, sublingvalne tablete, ki vsebujejo 50, 100, 200, 300, 400, 600 ali 800 µg fentanila kot citrata.
Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain. 
Prebijajoča bolečina je prehodno poslabšanje kronične bolečine v ozadju, ki je sicer pod nadzorom.
If more than four episodes of breakthrough pain are experienced per day over a period of more than four consecutive days, then the dose of the long acting opioid used for persistent pain should be reevaluated. 
Če se tekom štirih zaporednih dni prebijajoča bolečina pojavi več kot štirikrat, potem je treba pretehtati uporabo dolgo delujočega opioida , ki se ga uporablja za vztrajajočo bolečino.
In the absence of the data, the Applicant provided data demonstrating a direct correlation between 33% responder analysis and PID, and used the current available pain data and the PID values to estimate the responder rates between active and placebo treatment at earlier time points. 
Zaradi pomanjkanja teh podatkov je naročnik ponudil podatke, ki prikazujejo neposredno korelacijo med analizo 33 % odzivnih in Razliko v jakosti bolečine ter uporabil trenutno razpoložljive podatke o bolečini in vrednosti razlik v jakosti bolečine, za ocenitev količnika med aktivnim in placebo zdravljenjem v zgodnejših časovnih točkah.
Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life and they may be more sensitive to the active substance than younger patients. 
Rezultati študij z intravensko uporabljenim fentanilom kažejo, da imajo starejši bolniki lahko zmanjšan očistek, podaljšan razpolovni čas in so lahko bolj občutljivi na zdravilno učinkovino kot mlajši bolniki.
The CHMP was of the opinion that the Applicant should provide an analysis of the percentage of 30% and 50% responders at 10 and 15 minutes in order to better evaluate the clinically relevant time-effect profile. 
Odbor za zdravila za uporabo v humani medicini meni, da mora predlagatelj predložiti analizo 30 % in 50 % odzivnostne stopnje pri 10 in 15 minutah, kar bo omogočilo boljše vrednotenje profila klinično relevantnega časovnega učinkovanja.
• Rapinyl will dissolve rapidly under the tongue and be absorbed in order to provide pain relief. 
• Rapinyl se bo pod jezikom hitro raztopil in absorbiral, tako da začne delovati proti bolečinam.
Fentanyl is approximately 100-fold more potent than morphine as an analgesic. 
Fentanil je kot analgetik približno 100-krat močnejši od morfina.
• extreme drowsiness 
• izredna zaspanost
The analgesic effects of fentanyl are related to the blood level of the active substance; in opioid-naïve patients, minimum effective analgesic serum concentrations of fentanyl range from 0.3-1.2 ng/ml, while blood levels of 10-20 ng/ml produce surgical anaesthesia and profound respiratory depression. 
Analgetični učinki fentanila so povezani z nivojem učinkovine v krvi; pri bolnikih, ki še niso prejemali opioidov, znašajo minimalne učinkovite analgetične koncentracije fentanila v serumu 0,3-1,2 ng/ml, koncentracije v krvi 10-20 ng/ml pa imajo za posledico kirurško anastezijo in globoko depresijo dihanja.
Mean maximal plasma concentrations of fentanyl range from 0.2 to 1.3 ng/ml (after administration of 100 to 800 µg Rapinyl) and are reached within 22.5 to 240 minutes. 
Povprečne maksimalne koncentracije fentanila v plazmi so med 0,2 do 1,3 ng/ml (po jemanju 100 do 800 µg Rapinyla) in so dosežene v 22,5 do 240 minutah.
Patients and their carers must be instructed that Rapinyl contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children. 
Bolnike in njihove skrbnike je treba poučiti, da Rapinyl vsebuje zdravilno učinkovino v količini, ki je lahko smrtna za otroka, zato je treba vse tablete shranjevati otrokom nedostopno.
There may be a risk of increased systemic drug exposure in such patients and therefore extra caution is recommended during dose titration. 
Pri teh bolnikihpride lahko do tveganja povečane sistemske izpostavljenosti zdravilu, zato se med postopkom titracije priporoča posebna skrb.
Patients should be advised not to drive or operate machinery if they become dizzy or drowsy or experience blurred or double vision while taking Rapinyl. 
Bolnikom je treba svetovati, da ne vozijo in upravljajo s stroji, če se jim ob jemanju Rapinyla začne vrteti, če postanejo zaspani ali če vidijo motno ali dvojno.
In order to minimise the risk of opioid-related adverse reactions and to identify the appropriate dose, it is imperative that patients be monitored closely by health professionals during the titration process. 
Da bi zmanjšali nevarnost z opioidi povezanih neželenih učinkov in določili ustrezen odmerek, morajo zdravstveni delavci med postopkom titracije bolnike skrbno nadzorovati.
The conditions to the Marketing Authorisation as listed in Annex IV. 
Pogoji za dovoljenje za promet z zdravilom so navedeni v Dodatku IV.
In conclusion, the CHMP considered that the Applicant had answered the questions adequately. 
CHMP je menil, da je predlagatelj zadovoljivo odgovoril na vsa zastavljena vprašanja.
The pharmacokinetics of Rapinyl have been shown to be dose proportional over the dose range of 100 to 800 µg. 
Za farmakokinetiko Rapinyla je bilo ugotovljeno, da je za razpon odmerkov med 100 in 800 µg sorazmerna odmerku.
Alcohol potentiates the sedative effects of morphine-based analgesics, therefore concomitant administration of alcoholic beverages or medicinal products containing alcohol with Rapinyl is not recommended. 
Alkohol stopnjuje sedativne učinke analgetikov derivatov morfina, tako da se uživanje alkoholnih pijač ali zdravil, ki vsebujejo alkohol, sočasno z jemanjem Rapinyla ne priporoča.
Dose escalation should continue in a stepwise manner until adequate analgesia is achieved. 
Z višanjem odmerka je treba nadaljevati postopoma toliko časa, dokler ne dosežemo ustrezne analgezije.
Impaired hepatic or renal function could cause increased serum concentrations. 
Okvarjeno delovanje jeter ali ledvic ima lahko za posledico povečane koncentracije v serumu.
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