FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP adopted a List of Questions (LoQ) to be addressed by the Applicant.
Danish: CHMP udarbejdede en liste med spørgsmål (LoQ), som ansøgeren skulle besvare.
English: Rapinyl must not be used in patients less than 18 years of age due to a lack of data on safety and efficacy.
Danish: Rapinyl må ikke anvendes til patienter under 18 år på grund af mangel på data om sikkerhed og virkning
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen
English: Switching from other fentanyl containing products to Rapinyl must not occur at a 1:1 ratio because of different absorption profiles.
Danish: Et skift fra andre fentanylholdige produkter til Rapinyl må ikke ske i forholdet 1:1 på grund af forskellige absorptionsprofiler.
English: Do not consume alcohol without consulting your doctor as it might make you feel more drowsy than usual.
Danish: Drik ikke alkohol uden at rådføre Dem med lægen, da det kan få Dem til at føle Dem mere døsig end sædvanlig.
English: 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.
Danish: Selv om der ikke blev foretaget en analyse af 30% og 50% af de responderende efter 10 og 15 minutter i interimanalysen, blev denne analyse krævet af sponsor i den endelige kliniske forsøgsrapport.
English: 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.
Danish: Selv om antallet af analyserede patienter er temmelig lavt, er der nu tilgængelige oplysninger om behandlingen af BTP hos cancerpatienter i et dosisområde fra 100-800 µg, og der var ingen nye sikkerhedssignaler.
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Danish: Dyreforsøg har vist nedsat fertilitet og øget mortalitet hos rottefostre.
English: • increased sensitivity to sound and noise, blurred or double vision
Danish: • øget følsomhed over for lyd og støj, sløret syn eller dobbeltsyn
English: Upon repeated administration of opioids such as fentanyl, tolerance and physical and/or psychological dependence may develop.
Danish: Ved gentagen indtagelse af opioider såsom fentanyl kan der udvikles tolerans og fysisk og/eller psykologisk afhængighed.
English: It is therefore important that you do not suck, chew or swallow the tablet.
Danish: Det er derfor vigtigt, at De ikke suger, tygger eller synker resoribletten.
English: • slow, shallow breathing If these occur, seek emergency medical help immediately.
Danish: • langsom, overfladisk vejrtrækning Hvis dette forekommer, så tilkald akut lægehjælp.
English: Care should be taken in treating patients with hypovolaemia and hypotension.
Danish: Der skal udvises forsigtighed ved behandling af patienter med hypovolæmi og hypotension.
English: Rapinyl can make some people feel drowsy.
Danish: Rapinyl kan få nogle personer til at føle sig døsige.
English: Responses to the Remaining Issues and CHMP assessment
Danish: Svar på de resterende spørgsmål og CHMP-vurderingen
English: • You should not drink or eat anything until the tablet has completely dissolved under your tongue.
Danish: • De må ikke drikke eller spise noget, før resoribletten er fuldstændig opløst under tungen.
English: Iatrogenic addiction following therapeutic use of opioids is rare.
Danish: Iatrogen afhængighed efter terapeutisk brug af opioider er sjælden.
English: 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:
Danish: Fortæl det til lægen inden behandlingen, hvis De har eller for nylig har oplevet noget af følgende, fordi lægen er nødt til at tage hensyn hertil, når han/hun ordinerer Deres dosis:
English: Fentanyl is approximately 100-fold more potent than morphine as an analgesic.
Danish: Fentanyl er ca. 100 gange mere potent end morfin som analgetikum.
English: 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.
Danish: Følgende dosisregime anbefales for titrering, selv om lægen under alle omstændigheder skal tage patientens kliniske behov, alder og ledsagende sygdom i betragtning.
English: 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.
Danish: Ansøgeren beskrev også den foreslåede risikohåndteringsplan, ændringerne til produktinformationen og uddannelsesprogrammet henvendt til sundhedspersonale, patienter og plejere, der skal iværksættes ved produktlanceringen.
English: • extreme drowsiness
Danish: • ekstrem sløvhed
English: - the responses provided by the Applicant, in particular the additional clinical data submitted during the CHMP referral procedure, successfully addressed the CHMP concerns,
Danish: - Svarene fremsendt af ansøgeren, i særlig grad de yderligere kliniske data fremsendt under CHMP's indbringelsesprocedure, besvarer CHMP's spørgsmål tilfredsstillende,
English: 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.
Danish: Patienter kan anses for at være opioidtolerante, hvis de tager mindst 60 mg morfin peroralt om dagen, 25 mikrogram transdermal fentanyl pr. time eller en ækvianalgetisk dosis af et andet opioid i en uge eller mere.
English: It is imperative that any dose re-titration of any analgesic is monitored by a health professional.
Danish: Det er bydende nødvendigt, at enhver gentitrering af dosis af et hvilket som helst analgetikum bliver kontrolleret af sundhedspersonale.
English: However, if you are concerned about your pain relief, you should talk to your doctor.
Danish: Hvis De imidlertid er bekymret for Deres smertelindring, så tal med lægen.
English: Patients (n=23) treated with Rapinyl only experienced dizziness, nausea and vomiting.
Danish: Patienter (n=23), der blev behandlet med Rapinyl, oplevede kun svimmelhed, kvalme og opkastning.
English: 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.
Danish: Patienter/plejere skal opfordres til at returnere evt. ubrugte produkter til apoteket, hvor det vil blive destrueret i henhold til nationale og lokale retningslinier.
English: • medicines containing clonidine (used to treat high blood pressure).
Danish: • medicin, der indeholder clonidin (bruges til at behandle højt blodtryk).
English: Repeated administration of the opioid antagonist may be necessary if the duration of respiratory depression is prolonged.
Danish: Gentagen administration af opioidantagonister kan være nødvendig, hvis varigheden af respirationsdepressionen er forlænget.
English: ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH UK
Danish: ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH Forenede Kongerige
English: OTHER SPECIAL WARNING(S), IF NECESSARY This product should ONLY be used as prescribed.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Dette produkt må KUN anvendes som ordineret.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ}.
English: Do not drink grapefruit juice while you are prescribed Rapinyl treatment as it may increase the side effects of Rapinyl.
Danish: Drik ikke grapefrugtjuice mens De er i behandling med Rapinyl, da det kan øge Rapinyls bivirkninger.
English: 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.
Danish: Når en passende dosis er opnået, som kan være mere end en tablet, skal patienter vedligeholdes på denne dosis og skal begrænse indtagelsen til højst fire Rapinyl doser dagligt.
English: 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.
Danish: For at minimere risikoen for opioidrelaterede bivirkninger og for at identificere den passende dosis, er det bydende nødvendigt, at patienterne kontrolleres nøje af sundhedspersonale under titreringsprocessen.
English: • a head injury, because Rapinyl may cover up the extent of the injury
Danish: • et kranietraume, fordi Rapinyl kan skjule omfanget af traumet
English: Breakthrough pain is pain which occurs suddenly, even though you have taken or used your usual opioid pain-relieving medicine.
Danish: Gennembrudssmerter er smerter, der kommer pludseligt, selv om De har taget eller brugt Deres sædvanlige opioide smertelindrende medicin.
English: Patients should be advised not to eat or drink anything until the sublingual tablet is completely dissolved.
Danish: Patienter skal rådes til ikke at spise eller drikke noget, før den sublinguale resoriblet er helt opløst.
English: - and provided that the Applicant fulfils the conditions to the Marketing Authorisation as listed in Annex IV
Danish: - Og under forudsætning af, at ansøgeren opfylder betingelserne for markedsføringstilladelsen som angivet i bilag IV,
English: Long-term treatment during pregnancy may cause withdrawal symptoms in the new-born infant.
Danish: Langtidsbehandling under graviditet kan medføre abstinenssymptomer hos den nyfødte.
English: If you think someone has taken Rapinyl by accident seek emergency medical help immediately.
Danish: Hvis De mener, at en person har taget Rapinyl ved en fejltagelse, så tilkald straks akut lægehjælp.
English: 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.
Danish: Spørg lægen til råds og brug ikke Rapinyl mens De ammer, medmindre lægen mener, at fordelene for Dem er større end risici for barnet.
English: Respiratory depression, hypotension and profound sedation may occur.
Danish: Respirationsdepression, hypotension og udtalt sedation kan forekomme.
English: The CHMP therefore concluded that the comparability of patients to healthy volunteers was not demonstrated.
Danish: CHMP konkluderede derfor, at der ikke var påvist sammenlignelighed mellem patienter og raske frivillige.
English: The volume of distribution of fentanyl at steady state is about 3-6 l/kg.
Danish: Fentanyls distributionsvolumen ved steady state er ca. 3-6 l/kg.
English: • Rapinyl will dissolve rapidly under the tongue and be absorbed in order to provide pain relief.
Danish: • Rapinyl vil hurtigt blive opløst under tungen og blive absorberet for at give smertelindring.
English: Safety pharmacology and repeated dose toxicity data reveal no special hazard for humans that is not already covered by other sections of this SPC.
Danish: Data vedrørende sikkerhedsfarmakologi og toksicitet efter gentagne doserviser ingen særlig risiko for mennesker, der ikke allerede er omtalt i af andre afsnit af dette produktresumé.
English: 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)):
Danish: Følgende bivirkninger forbundet med andre fentanylprodukter er ligeledes rapporteret (meget almindelig ≥1/10; almindelig ≥1/100 til <1/10; ikke almindelig ≥ 1/1.000 til <1/100; sjælden ≥1/10 000; meget sjælden <1/10.000; ikke kendte (kan ikke estimeres ud fra forhåndenværende data)).
English: Long-term treatment with opioids typically leads to development of tolerance to their secondary effects.
Danish: Langtidsbehandling med opioider fører typisk til toleranceudvikling over for de sekundære virkninger.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATIONS
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSERNE
English: A dose of Rapinyl may consist of more than one tablet.
Danish: En dosis Rapinyl kan bestå af mere end én resoriblet.
English: • Remove the tablet(s) from the blister pack immediately before use.
Danish: • Tag resoribletter (resoribletterne) ud af blisterpakningen lige inden brug.
English: 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.
Danish: En række berørte medlemsstater anså, at strategien om at bygge bro var uacceptabel og utilstrækkelig og mente, at den hurtige opløsning af Rapinyl-tabletten kunne være tegn på et højere Cmax og et kortere Tmax.
English: Rapinyl may add to the effect of medicines that make you feel sleepy, including:
Danish: Rapinyl kan øge virkningen af medicin, der gør Dem søvnig, herunder:
English: Fentanyl is metabolised primarily via CYP3A4 to a number of pharmacologically inactive metabolites, including norfentanyl.
Danish: Fentanyl metaboliseres primært via CYP3A4 til et antal farmakologisk inaktive metabolitter, herunder norfentanyl.
English: Responses to the LoOI and CHMP assessment
Danish: Svar på LoOI og CHMP-vurderingen
English: 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
Danish: BILAG I LISTE OVER NAVNE, LÆGEMIDDELFORM, LÆGEMIDLETS STYRKE, INDGIVELSESVEJ, ANSØGER OG INDEHAVER AF MARKETINGSGODKENDELSE I MEDLEMSSTATERNE
English: Do not use Rapinyl after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke Rapinyl efter den udløbsdato, der står på pakningen.
English: The dose strength for the supplemental sublingual tablet should be increased from 100 to 200 micrograms at doses of 400 micrograms and higher.
Danish: Dosisstyrken af den supplerende sublinguale resoriblet skal øges fra 100 til 200 mikrogram ved doser på 400 mikrogram og derover.
English: 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.
Danish: Hvis der opnås tilstrækkelig analgesi ved den højere dosis, men uønskede virkninger anses for uacceptable, kan en intermediær dosis (på 50 mikrogram eller 100 mikrogram sublingual resoriblet, hvor det er passende) indgives.
English: 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.
Danish: Hvis der opleves mere end fire perioder af gennembrudssmerter om dagen i mere end fire på hinanden følgende dage, skal dosis af det anvendte langtidsvirkende opioid mod persisterende smerter revurderes.
English: 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.
Danish: På baggrund af gennemgangen af data og respons vurderede CHMP, at ansøgningen om Rapinyl kunne godkendes, forudsat at ansøgeren besvarer listen med de resterende spørgsmål tilfredsstillende.
English: The following medicines may increase the effects of Rapinyl:
Danish: Følgende medicin kan øge virkningen af Rapinyl:
English: Do not try to push Rapinyl sublingual tablets through the foil top, like a normal tablet
Danish: Prøv ikke på at presse Rapinyl resoribletten gennem folien, som med en almindelig tablet.
English: In common with all opioids, there is a risk of clinically significant respiratory depression associated with the use of Rapinyl.
Danish: Fælles for alle opioider er der en risiko for klinisk signifikant respirationsdepression forbundet med brugen af Rapinyl.
English: • liver or kidney disease, as this may require your doctor to more carefully adjust your dose
Danish: • lever- eller nyresygdom, fordi det kan kræve at lægen skal justere dosis mere forsigtigt
English: 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).
Danish: Bivirkninger set i kliniske undersøgelser med Rapinyl hos patienter og frivillige forsøgspersoner med et formodet forhold til behandling er anført herunder efter systemorganklasse og hyppighed (meget almindelig ≥1/10; almindelig ≥1/100 til <1/10).
English: It comes in a range of different strengths and shapes.
Danish: Den findes i et udvalg af forskellige styrker og faconer.
English: Eye disorders Common: Vision abnormal
Danish: Øjne Almindelig: Abnormt syn
English: 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.
Danish: I betragtning af den smalle terapeutiske bredde for fentanyl er effekt-/sikkerhedsprofilen stærkt afhængig af den systemiske eksponering for dette lægemiddel, og som følge heraf er sammenligneligheden af den systemiske eksponering afgørende.
English: All patients must start therapy with a single 100 microgram sublingual tablet.
Danish: Alle patienter skal starte behandling med en enkelt 100 mikrogram sublingual resoriblet.
English: If severe or persistent hypotension occurs, hypovolaemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Danish: Hvis alvorlig eller persisterende hypotension forekommer, bør hypovolæmi overvejes, og tilstanden bør behandles med passende parenteral væsketerapi.
English: Injury, poisoning and procedural complications Common: Accidental injuries
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig: Tilskadekomster
English: The reasonably low intra-individual variation in fentanyl plasma concentrations was also noted, including variation related to fluid intake, mouth wounds, xerostomia (dry mouth) and mucositis.
Danish: Den rimeligt lave intraindividuelle variation i plasmakoncentrationerne af fentanyl blev også registreret, herunder variationen med relation til væskeindtagelse, sår i munden, xerostomi (mundtørhed) og mucositis.
English: When you get an episode of breakthrough pain, take the dose advised by your doctor as follows:
Danish: Når De får en episode af gennembrudssmerter så tag den dosis, som lægen har anvist, på følgende måde:
English: • breathing problems or suffer from myasthenia gravis (a condition characterised by muscle weakness)
Danish: • vejrtrækningsproblemer eller myasthenia gravis (en tilstand der er karakteriseret ved muskelsvaghed)
English: Rapinyl sublingual tablets are packaged in OPA/PVC/aluminium/aluminium blisters contained in a cardboard outer carton.
Danish: Rapinyl sublinguale resoribletter er pakket i OPA/PVC/aluminium/aluminiumblistre, der er anbragt i en papæske.
English: About 9% of the dose is recovered in the faeces, primarily as metabolites.
Danish: Ca. 9 % af dosis genfindes i fæces primært som metabolitter.
English: There may be a risk of increased systemic drug exposure in such patients and therefore extra caution is recommended during dose titration.
Danish: Der kan være en risiko for øget systemisk lægemiddeleksponering hos sådanne patienter, og derfor anbefales det at udvise ekstra forsigtighed under dosistitrering.
English: You should only stop taking Rapinyl sublingual tablets on the advice of your doctor.
Danish: De må kun holde op med at tage Rapinyl sublinguale resoribletter efter lægens råd.
English: • 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)
Danish: • en hjernesvulst og/eller forhøjet intrakranielt tryk (en stigning i trykket inde i hjernen, som giver svær hovedpine, følelse af at være syg og tågesyn)
English: The CHMP reviewed the death narratives and agreed with the Applicant conclusions.
Danish: CHMP gennemgik beretningerne om dødsfaldene og var enig i ansøgerens konklusioner.
English: 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.
Danish: Data fra intravenøse studier med fentanyl tyder på, at ældre patienter kan have nedsat clearance og forlænget halveringstid, og de kan være mere følsomme over for det aktive stof end yngre patienter.
English: Impaired hepatic or renal function could cause increased serum concentrations.
Danish: Nedsat lever- eller nyrefunktion kan forårsage øgede serumkoncentrationer.
English: The other ingredients are mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Danish: Øvrige indholdsstoffer: Mannitol (E421), silificeret mikrokrystallinsk cellulose, croscarmellosenatrium og magnesiumstearat.
English: If you feel dizzy, sleepy or have blurred vision when you take Rapinyl, do not drive or use machinery.
Danish: Hvis De føler Dem svimmel, søvnig eller har tågesyn, når De tager Rapinyl, så må De ikke føre motorkøretøj eller betjene maskiner.
English: • medicines used to treat o depression o allergies o anxiety and psychosis
Danish: • medicin til behandling af o depression o allergier o angst og psykose
English: When taking Rapinyl, if you are to have any surgery, inform your doctor or dentist that you are taking this medicine.
Danish: Hvis De skal opereres, og De tager Rapinyl, skal De fortælle det til lægen eller tandlægen, at De tager denne medicin.
English: 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.
Danish: Inden for 72 timer efter intravenøs administration af fentanyl udskilles ca. 75 % af dosis gennem urinen, mest som metabolitter med mindre end 10 % som uomdannet lægemiddel.
English: The Applicant therefore believes the benefit/risk for Rapinyl to be positive and that the outcome of any further clinical safety and efficacy studies with Rapinyl are predictable and hence, unnecessary.
Danish: Ansøgeren mener derfor, at risk/benefit-forholdet for Rapinyl er positivt, og at udfaldet af eventuelle yderligere kliniske sikkerheds- og effektforsøg med Rapinyl er forudsigelige og derfor unødvendige.
English: 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.
Danish: Patienter skal rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de bliver svimle eller døsige eller oplever tåge- eller dobbeltsyn, mens de tager Rapinyl.
English: 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).
Danish: Ansøgeren fremsendte også data, der påviste, at Rapinyl opfyldte det primære endepunkt for effekt (samlet forskel i smerteintensitet fra baseline til 30 minutter (SPID30)), og at resultaterne var yderst statistisk signifikante (p=0,0004).
English: 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.
Danish: Ansøgeren ProStrakan Ltd har via den decentraliserede procedure indsendt en ansøgning om markedsføringstilladelse for Rapinyl, en sublingual tablet, der indeholder 50, 100, 200, 300, 400, 600 eller 800 µg fentanyl, som citrat.
English: If you stop taking Rapinyl
Danish: Hvis De holder op med at tage Rapinyl