FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
Danish: Der bør derfor udvises forsigtighed ved behandling af ældre, kakektiske eller svækkede patienter.
English: • The prescribing physician must ensure that the patient understands how to use Instanyl correctly, according to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) and ensure that patients and carers are aware of the risks associated with Instanyl, including risks of overdose, misuse, drug dependence and abuse.
Danish: • Den ordinerende læge skal sikre, at patienten forstår at bruge Instanyl korrekt i henhold til produktresuméet (SPC) og indlægssedlen (PIL), og sikre, at patienter og plejere er opmærksomme på de risici, der er forbundet med brugen af Instanyl, herunder risici for overdosis, forkert brug, stofafhængighed og misbrug.
English: Physicians should keep in mind the potential of abuse, misuse, addiction and overdose of fentanyl.
Danish: Lægen bør være opmærksom på risikoen for misbrug, forkert brug, afhængighed og overdosering af fentanyl.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Instanyl is given concurrently with medicinal products that affect CYP3A4 activity.
Danish: Fentanyl metaboliseres hovedsagelig via det humane cytokrom P450 3A4-isoenzymsystem (CYP3A4), og der kan derfor potentielt forekomme interaktioner, når Instanyl gives samtidig med lægemidler, der påvirker CYP3A4-aktiviteten.
English: Frequently, most of these will cease or decrease in intensity with continued use of the medicinal product.
Danish: Ofte vil de ophøre eller aftage i intensitet ved fortsat brug af lægemidlet.
English: The nasal spray container contains batteries.
Danish: Næsespraybeholderen indeholder batterier.
English: You should not start breast-feeding until at least 5 days after the last dose of Instanyl.
Danish: Du må først begynde at amme tidligst 5 dage efter den sidste dosis Instanyl.
English: • Not to use Instanyl nasal spray to treat any other kind of pain, such as headaches, back pain or toothache.
Danish: • Ikke at bruge Instanyl næsespray til at behandle andre former for smerte, såsom hovedpine, rygsmerter eller tandpine.
English: Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Danish: Maksimal daglig dosis: Behandling af op til fire episoder af gennembrudssmerte, hver med højst to doser med mindst 10 minutters mellemrum.
English: Repeat this procedure for ‘P2' and ‘P1' (press the white button and pump) until the display changes to show the number of doses in the nasal spray (i.e. 10, 20, 30 or 40 doses) and flashing lock symbol.
Danish: Gentag denne procedure for ‘P2' og ‘P1' (tryk på den hvide knap og på pumpen) indtil displayet begynder at vise antallet af doser i næsesprayen (dvs. 10, 20, 30 eller 40 doser) og et blinkende hængelåssymbol.
English: Special care should be taken if you are treated with any of the following medicines: - any medicines which might normally make you sleepy (have a sedative effect) such as sleeping pills, medicines to treat anxiety, antihistamines, or tranquillisers.
Danish: Vær ekstra forsigtig, hvis du er i behandling med nogle af følgende lægemidler: - Lægemidler, som normalt kan gøre dig søvnig (har en sederende effekt) som sovemedicin, medicin til behandling af angst, antihistaminer eller beroligende medicin.
English: If you experience difficulties breathing while being treated with Instanyl, it is very important that you contact your doctor or hospital immediately.
Danish: Hvis du får problemer med at trække vejret, mens du er i behandling med Instanyl, er det meget vigtigt, at du straks kontakter lægen eller hospitalet.
English: Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age.
Danish: Data for farmakokinetik, sikkerhed og virkning er begrænsede for brug af Instanyl hos patienter over 65 år.
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Danish: Patienter der ikke modtager opioid-vedligeholdelsesbehandling, da der er øget risiko for respirationsdepression.
English: All three strengths of Instanyl demonstrated statistically significant (p < 0.001) higher pain intensity difference at 10 minutes (PID10) compared with placebo.
Danish: Alle tre styrker af Instanyl viste statistisk signifikant (p< 0,001) højere ændring i smerteintensiteten efter 10 minutter (PID10) sammenlignet med placebo.
English: A drug-drug-interaction study was performed with a nasal vasoconstrictor (oxymetazoline).
Danish: Der er udført et lægemiddelinteraktionsstudie med en nasal vasokonstriktor (oxymetazolin).
English: About 9 of the dose is recovered in the faeces primarily as metabolites.
Danish: Cirka 9 % af dosis kan genfindes i fæces, primært som metabolitter.
English: The adverse reactions considered to be at least possibly related to treatment in the clinical trials of Instanyl are included in the table below.
Danish: De bivirkninger fra de kliniske studier, der som minimum er betragtet som mulige bivirkninger relateret til behandlingen med Instanyl, er inkluderet i tabellen nedenfor.
English: Other side effects reported after use of Instanyl:
Danish: Andre indberettede bivirkninger ved brug af Instanyl:
English: On exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must wait at least 2 hours before doing so.
Danish: I helt særlige tilfælde, hvor en ny episode opstår tidligere, kan du bruge Instanyl til at behandle den, men du skal vente mindst 2 timer, før du gør det.
English: • Instanyl nasal spray should not be used to treat any other short-term pain or pain status.
Danish: • Instanyl næsespray bør ikke anvendes til at behandle andre former for kortvarige smerter og smertetilstande.
English: Depending on the nasal spray, the starting number can be 10, 20, 30 or 40.
Danish: Afhængigt af pakningsvarianten kan det første tal være 10, 20, 30 eller 40.
English: The number of doses in the display changes to ‘5'.
Danish: Antallet af doser i displayet skifter til ‘5'.
English: Titration to a higher dose necessitates contact with the health care professional.
Danish: Ved optitrering til en højere dosis er kontakt med sundhedspersonale nødvendig.
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the physician as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Danish: Hvis det er påkrævet at seponere hele opioidbehandlingen, bør patienten følges tæt af lægen, da gradvis nedadgående opioidtitrering er nødvendig for at undgå risikoen for pludselige abstinenssymptomer.
English: The COUNTDOWN-CLOCK symbol is displayed together with the LOCK-symbol.
Danish: NEDTÆLLINGSUR-symbolet vises sammen med HÆNGELÅS-symbolet.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: If the patient experiences recurrent episodes of epistaxis or nasal discomfort while taking Instanyl, an alternative administration form for treatment of breakthrough pain should be considered.
Danish: Hvis patienten oplever tilbagevendende episoder af epistaxis eller nasal ubehag ved brug af Instanyl, bør en alternativ administrationsform til behandling af gennembrudssmerter overvejes.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of Instanyl.
Danish: Samtidig administration af lægemidler, der inducerer CYP3A4-aktivitet, kan reducere effekten af Instanyl.
English: In these patients, opioids may decrease respiratory drive.
Danish: Hos disse patienter kan opioider nedsætte respirationsdriften.
English: If Instanyl has been administered, an antidote for the child should be readily available.
Danish: Hvis der har været givet Instanyl, skal der være en antidot parat til barnet.
English: The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP).
Danish: Virkningen og sikkerheden af Instanyl (50, 100 og 200 mikrogram) er blevet vurderet i to randomiserede, dobbeltblinde, crossover, placebokontrollerede pivotale studier med 279 opioidtolerante voksne cancerpatienter (alder 32-86 år) med gennembrudssmerter.
English: Your single-dose container is now empty
Danish: • Din enkeltdosisbeholder er nu tom.
English: Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients.
Danish: Der foreligger kun begrænsede data vedrørende farmakokinetikken ved brug af fentanyl hos kakektiske (svækkede) patienter.
English: - if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl,
Danish: - hvis du ikke regelmæssigt bruger ordineret medicin (opioider) (f.eks. codein, fentanyl,
English: In a pharmacokinetic interaction study it was found that the maximum plasma concentration of nasally applied fentanyl was reduced about 50% by the concomitant use of oxymetazoline, while the time to reach Cmax (Tmax) was doubled.
Danish: Et farmakokinetisk interaktionsstudie har påvist, at den maksimale plasmakoncentration ved nasalt indgivet fentanyl var reduceret med omtrent 50 % ved samtidig brug af oxymetazolin, mens tiden til at nå Cmax (Tmax) var fordoblet.
English: In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing difficulties (very slow or shallow breathing).
Danish: I alvorlige tilfælde, hvor du har taget for meget Instanyl, kan resultere i koma, sløvhed, kramper eller alvorlige vejrtrækningsproblemer (meget langsom eller overfladisk vejrtrækning).
English: On exceptional occasions where a new episode occurs earlier, patients can use Instanyl to treat it but they must wait at least 2 hours before doing so.
Danish: I helt særlige tilfælde, hvor en ny episode opstår tidligere, kan patienter bruge Instanyl til behandling af denne, men de skal vente mindst 2 timer, før de gør det.
English: Discontinue the treatment and contact your doctor, hospital or emergency room immediately, if you: - experience severe breathing difficulties.
Danish: Afbryd behandlingen og kontakt din læge, hospitalet eller skadestuen omgående, hvis du: - oplever alvorlige vejrtrækningsproblemer.
English: If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor.
Danish: Hvis du stadig har en igangværende gennembrudssmerte, kan du bruge Instanyl som foreskrevet af din læge.
English: Comparable bioavailability (AUC) of fentanyl was achieved with and without oxymetazoline, while fentanyl Cmax decreased and Tmax increased by a factor two when oxymetazoline was administered.
Danish: Der er opnået sammenlignelige biotilgængeligheder (AUC) for fentanyl med og uden oxymetazolin, mens fentanyls Cmax faldt og Tmax steg med en faktor to, når der var givet oxymetazolin.
English: - medicines called Monoamine Oxidase Inhibitors (MAOI) used for severe depression, even if you have been treated with one in the past 2 weeks.
Danish: - Lægemidler, som kaldes monoaminooxidasehæmmere (MAO-hæmmere) (bruges ved svær depression), selv ved behandling med en MAO-hæmmer indenfor de seneste 2 uger.
English: You may experience withdrawal symptoms similar to the possible side effects of Instanyl when discontinuing Instanyl.
Danish: Du kan opleve abstinenssymptomer svarende til de mulige bivirkninger for Instanyl, når du stopper med at bruge Instanyl.
English: The initial strength should be one dose of 50 micrograms in one nostril, titrating upwards as necessary through the range of available strengths (50, 100, and 200 micrograms).
Danish: Den initiale styrke bør være én dosis på 50 mikrogram i et næsebor, og hvis det er nødvendigt, titreres dosis opad gennem rækken af tilgængelige styrker (50, 100 og 200 mikrogram).
English: Once primed, the display shows the number of doses left and the nasal spray is ready for use again.
Danish: Efter klargøring viser displayet det antal doser, der er tilbage, og næsesprayen er igen klar til brug.
English: You should tell your doctor if you experience recurrent episodes of nose bleeding or nasal discomfort.
Danish: Du skal fortælle det til din læge, hvis du oplever gentagne episoder med næseblod eller ubehag i næsen.
English: The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.
Danish: Pædiatrisk population Instanyls sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: - if you suffer from short-term pain other than breakthrough pain.
Danish: - hvis du lider af andre kortvarige smerter end gennembrudssmerter.
English: • The prescribers of Instanyl nasal spray must critically select the patients, carefully monitor them throughout the whole treatment and counsel them on:
Danish: Lægen, der ordinerer Instanylnæsespray, skal kritisk udvælge patienterne, nøje overvåge dem gennem hele behandlingen og vejlede dem om:
English: The nasal spray is now ready for use, when the next breakthrough pain episode occurs.
Danish: Næsesprayen er nu klar til brug, når næste episode med gennembrudssmerter opstår.
English: • troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial infections);
Danish: • troleandomycin, clarithromycin eller erythromycin (medicin til behandling af bakterieinfektioner);
English: When you first start using Instanyl, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Danish: Når du starter med at bruge Instanyl, vil du og din læge sammen finde frem til den dosis, som kan lindre dine gennembrudsmerter.
English: 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.
Danish: De har høj affinitet til opioid-receptorer med relativ lav intrinsic activity og modvirker derfor delvist fentanyls analgetiske virkning og kan forårsage abstinenssymptomer hos opioidafhængige patienter.
English: - if you have previously received facial radiotherapy.
Danish: - hvis du tidligere har fået strålebehandling i ansigtet.
English: Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients may be reduced.
Danish: Smertepatienter, som modtager kronisk opioidbehandling, udvikler tolerance mod respirationsdepression, og derfor kan risikoen for respirationsdepression være reduceret hos disse patienter.
English: If the battery symbol appears in the display, it is recommended that you contact your doctor to get a new nasal spray.
Danish: Hvis batterisymbolet vises i displayet, anbefales du at kontakte din læge for at få en ny næsespray.
English: Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.
Danish: Inden patienter titreres med Instanyl, forventes det, at deres kroniske baggrundssmerter er kontrolleret ved brug af kronisk opioidbehandling, og at de ikke oplever flere end fire episoder med gennembrudssmerter om dagen.
English: INSTRUCTIONS FOR USE OF INSTANYL
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSE AF INSTANYL
English: The nasal spray is ready, when the display shows the number of doses (i.e. 10, 20, 30 or 40 doses).
Danish: Næsesprayen er klar, når displayet viser antallet af doser (dvs. 10, 20, 30 eller 40 doser).
English: Instruction for opening and closing the box: - Pick up the box
Danish: Instruktion vedrørende åbning og lukning af æsken Tag æsken op
English: The nasal spray must be pumped 5 times (primed), before it can be used (see section ‘Preparing the Instanyl nasal spray').
Danish: Du skal pumpe på næsesprayen 5 gange (klargøre den), inden den kan bruges (se afsnittet ‘Klargøring af Instanyl næsespray').
English: - if you use other nasal spray products, e.g. for common cold or allergy.
Danish: - hvis du bruger andre næsesprayprodukter, f.eks. mod almindelig forkølelse eller allergi.
English: Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called opioids.
Danish: Instanyl indeholder det aktive stof fentanyl og tilhører gruppen af stærkt smertestillende medicin kaldet opioider.
English: If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this episode.
Danish: Hvis dine gennembrudssmerter ikke er lindret efter 10 minutter, må du kun anvende ét pust mere til dette smerteanfald.
English: Prior to launch of the multi-dose and single-dose product in each Member State the MAH shall agree the final educational material with the National Competent Authority.
Danish: Forud for lancering af flerdosis og enkeltdosis produktet i hver medlemsstat skal indehaveren af markedsføringstilladelsen blive enig med den nationale myndighed om indholdet og udformningen af undervisningsmaterialet.
English: Keep track of how many doses you have used and how many you have left in your nasal spray by using the dose-counting card provided with Instanyl nasal spray.
Danish: Hold styr på, hvor mange doser du har brugt, og hvor mange du har tilbage i næsesprayen, ved hjælp af dosistællerkortet, som følger med Instanyl næsesprayen.
English: • The pharmacist should be aware that off label prescription and suspected abuse or misuse of Instanyl should be reported according to your local guidelines for adverse reactions reporting.
Danish: • Apoteket skal være opmærksom på, at off label ordinering og mistanke om misbrug af Instanyl skal rapporteret i henhold til lokale retningslinjer for bivirkningsrapportering.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: Furthermore, studies in female rats revealed reduced fertility and enhanced embryonal mortality.
Danish: Endvidere viste forsøg med hunrotter reduceret fertilitet og øget fosterdød.
English: Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems in the new-born child.
Danish: Instanyl må ikke anvendes i forbindelse med fødsel, da fentanyl kan give alvorlige vejrtrækningsproblemer hos det nyfødte barn.
English: Dose obtained
Danish: Dosis opnået
English: Breakthrough pain is an additional sudden pain that occurs despite you having taken your usual opioid pain relieving medicines.
Danish: Gennembrudssmerter er en yderligere smerte, der kommer pludseligt, selvom du har taget din sædvanlige smertestillende opioidmedicin.
English: A priming sequence of 5 actuations of the nasal spray container is required, indicated by ‘P5', ‘P4', ‘P3', ‘P2' and ‘P1' in the display.
Danish: Der kræves en klargøringssekvens på 5 aktiveringer af næsespraybeholderen, som vises ved ‘P5', ‘P4', ‘P3', ‘P2' og ‘P1' i displayet.
English: Instanyl should therefore be used with caution in patients with hypotension and/or hypovolaemia.
Danish: Instanyl bør derfor anvendes med forsigtighed til patienter med hypotension og/eller hypovolæmi.
English: Clinical data show that fentanyl is absorbed very rapidly through the nasal mucosa.
Danish: Kliniske data viser, at fentanyl absorberes meget hurtigt via næseslimhinden.
English: You may not feel the dose in your nose, but you have received it when you have pressed the pump.
Danish: Det er ikke sikkert, at du kan mærke medicinen i din næse, men du har fået den, når du har trykket på pumpen.
English: Other signs may be hypothermia, decreased muscle tonus, bradycardia and hypotension.
Danish: Andre tegn kan være hypotermi, nedsat muskeltonus, bradykardi og hypotension.
English: Sedation, myoclonus, paraesthesia, dysaesthesia, dysgeusia
Danish: Sedation, myoclonus, paræstesi, dysæstesi, dysgeusi
English: Instanyl should not be used in pregnancy unless clearly necessary and if the benefits outweigh the risks.
Danish: Instanyl bør kun anvendes på tvingende indikation til gravide, og hvis fordelene opvejer risiciene.
English: The treatment for the persistent background pain should be kept as prescribed.
Danish: Behandlingen af de kroniske baggrundssmerter bør fortsætte som ordineret.
English: Administration of Instanyl in single doses ranging from 50 to 200 micrograms fentanyl per dose in opioid tolerant cancer patients produces a rapid Cmax level of 0.35 to 1.2 ng/ml.
Danish: Administration af Instanyl i enkeltdoser fra 50 til 200 mikrogram fentanyl per dosis til opioidtolerante cancerpatienter forårsager en hurtig Cmax-værdi på 0,35 til 1,2 ng/ml.
English: It is recommended that the patient's head is in upright position when administrating Instanyl.
Danish: Det anbefales, at patientens hoved holdes i opret position, når Instanyl indgives.
English: • CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections);
Danish: • CYP3A4-hæmmere, som ketoconazol, itraconazol eller fluconazol (bruges til behandling af svampeinfektioner);
English: You will hear a ‘click' sound when the pump is pressed down completely and the nasal spray has delivered the dose.
Danish: Du hører en klikkende lyd, når pumpen er trykket helt i bund, og næsesprayen har leveret dosen.
English: If severe or persistent hypotension occurs, hypovolemia should be considered and the condition should be managed with appropiate parenteral fluid therapy.
Danish: Hvis der forekommer alvorlig eller vedvarende hypotension, bør hypovolæmi overvejes, og tilstanden bør behandles med relevant parenteral væskebehandling.
English: The display will now turn on and show ‘P5'.
Danish: Nu tændes displayet og viser ‘P5'.
English: Keep the bottle stored upright.
Danish: Opbevar flasken opretstående.
English: The display counts down one number and the lock symbol is displayed shortly.
Danish: Displayet tæller ét nummer ned, og hængelåssymbolet vises kortvarigt.
English: - If you get any side effects, talk to your doctor, nurse or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: What you need to know before you use Instanyl
Danish: Det skal du vide, før du begynder at bruge Instanyl
English: The most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
Danish: De mest alvorlige bivirkninger er respirationsdepression (der kan føre til apnø eller respirationsstop), kredsløbsdepression, hypotension og shock, og alle patienter bør overvåges nøje for disse bivirkninger.
English: • Only to use Instanyl nasal spray if they are using other opioid pain medicine on a daily basis.
Danish: • Kun at bruge Instanyl næsespray, hvis de dagligt tager anden opioid smertestillende medicin.
English: The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of breakthrough pain.
Danish: Den indledende dosis er et pust à 50 mikrogram i et næsebor, hver gang du oplever gennembrudssmerter.
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Danish: Samtidig anvendelse af centralnervesystemiske (CNS)-depressiva kan øge risikoen for respirationsdepression (se pkt.