FrancophonIA/ELRC3.0 huggingface dataset:
English: • You must keep PecFent in the child resistant storage container when you are not using it, even if you have used all 2 sprays.
Danish: • Du skal opbevare PecFent i den børnesikrede opbevaringsbeholder, når du ikke bruger det, selv hvis du har brugt alle 2 doser.
English: o other pain killers called partial agonist/antagonist like buprenorphine, nalbuphine, pentazocine.
Danish: o Andre smertestillende midler, der kaldes delvise agonister/antagonister, såsom buprenorphin, nalbuphin, pentazocin.
English: The patients entering the double-blind phase treated up to 10 episodes of BTP with either PecFent (7 episodes) or placebo (3 episodes) in a random order.
Danish: Patienterne, som indgik i den dobbeltblinde fase, fik PecFent (7 episoder) eller placebo (3 episoder) som behandling af 10 episoder med gennembrudsbehandling i en tilfældig rækkefølge.
English: Put the nozzle a short distance (about 1 cm) into your nostril.
Danish: Spidsen føres et lille stykke (omkring 1 cm) op i dit næsebor.
English: There was no clinically significant effect of acute rhinitis on Cmax, Tmax or overall exposure to fentanyl, comparing the unchallenged with the acutely challenged states.
Danish: Der var ingen klinisk signifikant virkning af akut rhinitis på Cmax, Tmax eller samlet eksponering over for fentanyl, når de uprovokerede og akut provokerede stadier blev sammenlignet.
English: Dose-proportionality was demonstrated for Cmax and area under the curve (AUC) in the dose range 100 micrograms to 800 micrograms (see Figure 3).
Danish: Dosisproportionalitet blev påvist for Cmax og for arealet under kurven (AUC) i doseringsintervallet fra 100 mikrogram til 800 mikrogram (se Figur 3).
English: [8 spray bottle:]
Danish: [Flaske med 8 spraydoser:]
English: A pharmacokinetic study was conducted to evaluate the absorption and tolerability of a single dose of PecFent in patients with pollen-induced seasonal allergic rhinitis, comparing the un-challenged, acutely challenged (rhinitic) and acutely challenged and then treated with oxymetazoline, states.
Danish: En farmakokinetisk undersøgelse blev udført for at evaluere absorption og tolerabilitet af en enkeltdosis af PecFent hos patienter med polleninduceret sæsonbetinget allergisk rhinitis, som sammenlignede de uprovokerede og akut provokerede (rhinitiske) stadier og et stadie med akut provokation og efterfølgende behandling med oxymetazolin.
English: In particular tell your doctor or pharmacist before using PecFent if you are taking or have recently taken any of the following medicines:
Danish: Det er især vigtigt at fortælle lægen eller på apoteket, før du bruger PecFent, hvis du tager følgende medicin, eller har gjort det for nylig:
English: The PecSys system allows the product to be sprayed into the front area of the nasal cavity as a fine mist of droplets, which gel on contact with the calcium ions present in the nasal mucosa.
Danish: PecSys-systemet gør det muligt at spraye lægemidlet ind i næseborenes forreste område som en fin tåge af små dråber, der omdannes til en gel ved kontakt med calciumionerne, der findes i næseslimhinden.
English: PecFent bottles in their child resistant containers are supplied in cartons containing 1, 4 or 12 bottles.
Danish: Flaskerne med PecFent i deres børnesikrede beholdere leveres i kartoner med 1, 4 eller 12 flasker.
English: Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl.
Danish: Opioid-abstinenssymptomer, såsom kvalme, opkastning, diarré, angst, kulderystelser, tremor og svedtendens er blevet observeret med transmukosalt fentanyl.
English: One spray administered into each nostril
Danish: En spraydosis administreret i hvert næsebor
English: Concomitant use of nasally administered oxymetazoline has been shown to decrease the absorption of PecFent (see section 5.2).
Danish: Samtidig brug af oxymetazolin, som administreres via næsen, har vist sig at nedsætte absorptionen af PecFent (se pkt.
English: Educational material for patients should highlight the following:
Danish: Uddannelsesmaterialet for patienterne bør fremhæve det følgende:
English: • allergic reaction, rash
Danish: • allergisk reaktion, udslæt
English: Propylparahydroxybenzoate (E216) Sucrose
Danish: Propylparahydroxybenzoat (E216) Saccharose
English: The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Danish: Samtidig brug af andre centralnervesystem-deprimerende midler, herunder andre opioider, sedativa eller hypnotika, generelle anæstetika, phenothiaziner, beroligende midler, midler til afslapning af skeletmuskulaturen, sederende antihistaminer og alkohol kan medføre additive deprimerende virkninger.
English: • Put the bottle back in the child resistant container.
Danish: • Sæt flasken tilbage i den børnesikrede beholder.
English: • PecFent nasal spray should be prescribed only by physicians experienced in the management of opioid therapy in cancer patients.
Danish: • PecFent næsespray bør kun ordineres af læger med erfaring i opioidbehandling hos cancerpatienter
English: [8 spray bottle:] After first-use, use within 60 days
Danish: [Flaske med 8 spraydoser:] Bruges i løbet af 60 dage efter første anvendelse
English: When you see the number “2” in the counting window, there is still medicine in the bottle that you must empty.
Danish: Når du ser tallet ”2” i tællervinduet, er der stadig medicin tilbage i flasken, som du skal pumpe ud.
English: • numbness or tingling in the mouth, tongue, or nose, or other tongue problems, mouth ulcers, dry mouth
Danish: • følelsesløshed eller prikkende fornemmelse i mund, tunge eller næse, eller andre tungeproblemer, mundsår, tør mund
English: Take off the clear plastic protective cap from the nozzle (Figure 1).
Danish: Fjern den klare beskyttelseshætte af plastic fra spidsen (Figur 1).
English: • you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and
Danish: • du tager medicin mod depression eller antipsykotiske midler, se punktet om ”Brug af anden medicin sammen med PecFent”.
English: PecFent is used in adults with cancer for a type of pain called ‘breakthrough' pain.
Danish: PecFent bruges til en slags smerter hos voksne cancerpatienter, som kaldes ‘gennembruds'-smerter.
English: EU/1/10/644/001 EU/1/10/644/002 EU/1/10/644/005
Danish: EU/1/10/644/007 EU/1/10/644/001 EU/1/10/644/002 EU/1/10/644/005 EU/1/10/644/003 EU/1/10/644/004 EU/1/10/644/006
English: Consult your doctor while using PecFent if:
Danish: Kontakt lægen, hvis du, mens du bruger PecFent:
English: Put the bottle back in the child-resistant container after each use.
Danish: Flasken sættes tilbage i den børnesikrede beholder efter hver brug.
English: As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered.
Danish: Som ved andre opioider skal muligheden for opioidinduceret hyperalgesi overvejes i tilfælde af utilstrækkelig smertekontrol som reaktion på en øget dosis af fentanyl.
English: Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breast-feeding should not be restarted until at least 5 days after the last administration of fentanyl.
Danish: Fentanyl må ikke anvendes af ammende kvinder, og amning bør ikke genoptages, indtil mindst 5 dage efter den sidste administration af fentanyl.
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the nasal mucosa and more slowly by the gastrointestinal route.
Danish: Fentanyl er særdeles lipofilt og kan absorberes meget hurtigt gennem næseslimhinden, og langsommere via mave-tarm-kanalen.
English: Hyperalgesia
Danish: Hyperalgesi
English: Bottles in their child resistant containers are supplied in cartons containing: For 2 spray bottle: 1 bottle.
Danish: Flaskerne i deres børnesikrede beholdere leveres i kartoner med: Flaske med 2 spraydoser: 1 flaske.
English: PecFent contains fentanyl, which is a strong pain-relieving medicine known as an opioid pain killer.
Danish: PecFent indeholder fentanyl, som er en stærkt smertestillende medicin, som tilhører en gruppe smertestillende midler, som kaldes opioider.
English: When you see the number “8” in the counting window, there is still medicine in the bottle that you must empty.
Danish: Når du ser tallet ”8” i tællervinduet, er der stadig medicin tilbage i flasken, som du skal pumpe ud.
English: Confusional state Depression
Danish: Forvirret tilstand
English: • If you can see a number, other than 2 in the counting window, you have NOT used all 2 sprays in the bottle.
Danish: Hvis du kan se et andet tal end 2 i tællervinduet, har du IKKE brugt alle 2 spraydoser i flasken.
English: Point it inwards towards the wall of your nose.
Danish: Ret den indad mod din næseskillevæg.
English: Take off the white plastic protective cap from the nozzle (Figure 1).
Danish: Fjern den hvide beskyttelseshætte af plastic fra spidsen (Figur 1).
English: Memory impairment Parosmia
Danish: Svækket hukommelse Parosmi
English: To administer PecFent the nozzle is placed a short distance (about 1 cm) into the nostril and pointed slightly towards the bridge of the nose.
Danish: Når PecFent administreres, skal spidsen føres et kort stykke (ca. 1 cm) op i næseboret og pege let mod næseryggen.
English: • Only use PecFent nasal spray if you have been experiencing breakthrough cancer pain episodes
Danish: • Anvend kun PecFent næsespray, hvis du har oplevet episoder med cancer gennembrudssmerter
English: Bottle (clear Type I glass) with an attached metering pump incorporating an audible dose counter and a protective cap (solid white cap for the 2 spray and translucent cap for the 8 spray).
Danish: Flaske (klar type I-glas) med påsat doseringspumpe med hørbar dosistæller og en beskyttelseshætte (helt hvid hætte til flasken med 2 spraydoser og halvgennemsigtig hætte til flasken med 8 spraydoser).
English: • you have breathing problems such as asthma, wheezing or shortness of breath
Danish: • du har problemer med din vejrtrækning, såsom astma, hiven efter vejret eller stakåndethed.
English: PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain.
Danish: PecFent er indiceret til behandling af gennembrudssmerter (breakthrough pain, BTP) hos voksne, der i forvejen er i vedligeholdelsesbehandling med opioider for kroniske cancersmerter.
English: Keep the bottle in the child resistant container in order to protect from light.
Danish: Opbevar flasken i den børnesikrede beholder for at beskytte mod lys.
English: PecFent is available in two strengths: 100 micrograms/spray and 400 micrograms/spray.
Danish: PecFent fås i to styrker: 100 mikrogram/spray og 400 mikrogram/spray.
English: 0.95 ml (950 micrograms fentanyl) - 2 spray bottle or
Danish: 0,95 ml (950 mikrogram fentanyl) - flaske med 2 spraydoser eller
English: In each case the product is packed in a clam-shell-like child resistant container.
Danish: Produktet er i begge tilfælde pakket i en børnesikret beholder, som ligner en muslingeskal.
English: • Keep the bottle in its child resistant container in order to protect from light.
Danish: • Opbevar flasken i den børnesikrede beholder for at beskytte mod lys.
English: • Do not use more than the dose your doctor prescribes for any single breakthrough pain episode.
Danish: • Du må ikke bruge mere end den dosis, din læge har ordineret til hver enkelt episode med gennembrudssmerter.
English: Keep out of the sight and reach of children (Figure 6)
Danish: Opbevares utilgængeligt for børn (Figur 6).
English: • Withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,
Danish: • abstinenssyndrom (kan vise sig ved, at der opstår følgende bivirkninger: kvalme, opkastning,
English: • muscle convulsions or trembling
Danish: • muskelkramper eller rysten
English: PecFent contains propylparahydroxybenzoate (E216).
Danish: PecFent indeholder propylparahydroxybenzoat (E216).
English: The pump has a spray counter that clicks, so you can hear as well as see that the spray has been given.
Danish: Pumpen har en doseringstæller, som klikker, så du kan både høre og se, at en dosis er givet, og en beskyttelseshætte.
English: EXP After first-use, use within 60 days.
Danish: EXP Bruges i løbet af 60 dage efter første anvendelse
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic medicinal products such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with medicinal products which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Danish: Udviklingen af et muligt livstruende serotonergt syndrom kan forekomme ved samtidig brug af serotoninerge lægemidler, såsom selektive serotoningenoptagshæmmere (selective serotonin re-uptake inhibitors, SSRI'er) og serotonin-noradrenalingenoptagshæmmere (serotonin norepinephrine re-uptake inhibitors, SNRI'er), og sammen med lægemidler, der hæmmer serotoninmetabolismen (herunder monoaminoxidasehæmmere [monoamine oxidase inhibitors, MAO-hæmmere]).
English: Wipe the nozzle with a tissue and flush the tissue down the toilet.
Danish: Spidsen tørres af med en serviet, og servietten skylles ud i toilettet.
English: Educational material for physicians should highlight the following:
Danish: Uddannelsesmaterialet for læger bør fremhæve det følgende:
English: Hold the PecFent bottle with your thumb on the bottom of the bottle and your first and middle fingers on the finger grips (Figure 4).
Danish: Hold flasken med PecFent med din tommelfinger på bunden af flasken og din pegefinger og langemand i fingergrebene (Figur 4).
English: • cough, sneezing, catarrh or cold, changes in the fluid produced by your nose
Danish: • hoste, nysen, katar eller forkølelse, ændring i din næses væskeproduktion
English: EU/1/10/644/007 100 micrograms, 2 sprays, 1 bottle EU/1/10/644/001 100 micrograms, 8 sprays, 1 bottle EU/1/10/644/002 100 micrograms, 8 sprays, 4 bottles EU/1/10/644/005 100 micrograms, 8 sprays, 12 bottles
Danish: EU/1/10/644/007 100 mikrogram, 2 spraydoser, 1 flaske EU/1/10/644/001 100 mikrogram, 8 spraydoser, 1 flaske EU/1/10/644/002 100 mikrogram, 8 spraydoser, 4 flasker EU/1/10/644/005 100 mikrogram, 8 spraydoser, 12 flasker
English: Oral hypoaesthesia Oral paraesthesia Diarrhoea
Danish: Tarmperforation Peritonitis Oral hypæstesi Oral paræstesi Diarré
English: • When you see a red 8 in the counting window, the bottle is finished and you will no longer be able to get a full spray from it.
Danish: • Når du ser et rødt 8-tal i tællervinduet, er flasken tom, og du kan ikke længere opnå en fuld spraydosis fra den.
English: Each PecFent bottle is supplied in a child resistant container.
Danish: Hver flaske med PecFent leveres i en børnesikret beholder.
English: EU/1/10/644/003 400 micrograms, 8 sprays, 1 bottle EU/1/10/644/004 400 micrograms, 8 sprays, 4 bottles EU/1/10/644/006 400 micrograms, 8 sprays, 12 bottles
Danish: EU/1/10/644/003 400 mikrogram, 8 spraydoser, 1 flaske EU/1/10/644/004 400 mikrogram, 8 spraydoser, 4 flasker EU/1/10/644/006 400 mikrogram, 8 spraydoser, 12 flasker
English: Blow your nose if you feel you need to.
Danish: Hvis du har behov for det, skal du pudse din næse.
English: Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment.
Danish: Derfor bør der udvises særlig forsigtighed i løbet af titreringsforløbet hos patienter med moderat til svært nedsat lever- eller nyrefunktion.
English: 2 spray bottle:
Danish: Flaske med 2 spraydoser: