FrancophonIA/ELRC3.0 huggingface dataset:
English: • Only the patient or carer should handle the nasal spray as it contains medication that is attractive for people to abuse.
Danish: • Kun patienten eller plejeren skal håndtere næsesprayen, da den indeholder medicin, der er attraktiv for folk at misbruge.
English: For management of respiratory depression immediate countermeasures should be started including physical or verbal stimulation of the patient.
Danish: Ved behandling af respirationsdepression bør der øjeblikkeligt indledes modforanstaltninger, herunder fysisk og verbal stimulering af patienten.
English: Instanyl that has passed the expiry date or is no longer required, may still contain enough medicine to be harmful to other people, especially children.
Danish: Instanyl, som har passeret udløbsdatoen, eller som ikke længere skal bruges, kan stadig indeholde nok medicin til at skade andre personer, specielt børn.
English: • Always to keep Instanyl out of the reach and sight of children since it can be harmful to them.
Danish: • Altid at opbevare Instanyl utilgængelig og ude af syne for børn, da det kan være skadeligt for dem.
English: The patients had an average of 1 to 4 episodes per day while taking maintenance opioid therapy.
Danish: Patienterne havde i gennemsnit 1 til 4 episoder per dag, mens de fik opioid-vedligeholdelsesbehandling.
English: If someone has accidentally taken Instanyl, they may have the same symptoms as described above for overdose.
Danish: Hvis nogen ved en fejl har taget Instanyl, kan de få de samme symptomer, som beskrevet tidligere for overdosering.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Danish: Denne virkning kunne enten skyldes ændret moderlig omsorg eller være en direkte virkning af fentanyl på ungerne.
English: It is recommended that alternative administration forms should be considered for concomitant treatment of concurrent diseases that can be treated via nasal administration.
Danish: Det anbefales, at alternative administrionsformer overvejes ved samtidig behandling af ledsagende sygdomme, som kan behandles via nasal administration.
English: However, higher values for Tmax were observed in a dose-proportionality study in healthy volunteers.
Danish: Højere Tmax-værdier blev dog observeret i et dosisproportionalitetsstudie hos raske frivillige.
English: The clinical studies demonstrated the efficacy and safety of Instanyl.
Danish: De kliniske studier demonstrerede effekten og sikkerheden ved Instanyl.
English: Instanyl may affect or be affected by other medicines.
Danish: Virkningen af Instanyl kan påvirke eller blive påvirket af anden medicin.
English: Never try to fix the nasal spray yourself or take it apart.
Danish: Forsøg aldrig at reparere næsesprayen selv eller skille den ad.
English: If uncertain of how the pump has been stored, you should check the spray pump before use.
Danish: Hvis du er usikker på, hvordan pumpen har været opbevaret, skal du tjekke spraypumpen inden brug.
English: Local tolerance studies with Instanyl in mini-pigs demonstrated that Instanyl administration was well tolerated.
Danish: Lokale tolerancestudier med Instanyl i minigrise viste, at administration af Instanyl blev udmærket tolereret.
English: Instanyl shows linear kinetics.
Danish: Instanyl udviser lineær kinetik.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20. juli 2009 Dato for seneste fornyelse: 1. juli 2019
English: Adequate body temperature and fluid intake should be maintained.
Danish: Der skal opretholdes passende kropstemperatur og væskeindtagelse.
English: During the determination of your right dose, your doctor may instruct you to change to a higher dose.
Danish: Ved fastlæggelsen af din rette dosis, vil lægen måske instruere dig i at skifte til en højere dosis.
English: Do not test before use.
Danish: Test ikke før brug.
English: More recent studies showed that effects on the embryo were due to maternal toxicity and not to direct effects of the substances on the developing embryo.
Danish: Nyere studier viser, at virkningerne på fostret skyldtes maternal toksicitet og ikke stoffets direkte virkninger på det voksende foster.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Danish: Din læge vil vurdere, om du har brug for medicin til at mindske eller fjerne abstinenssymptomerne.
English: Pharmacotherapeutic group: Analgesics, opioids, ATC code: N02AB03
Danish: Farmakoterapeutisk klassifikation: Analgetika; Opioider, ATC-kode: N02AB03
English: The nasal spray is locked and cannot be used.
Danish: Næsesprayen er låst og kan ikke bruges.
English: Pain of skin, pruritus
Danish: Smerter i huden, pruritus
English: Particular caution should be exercised when titrating Instanyl in elderly patients.
Danish: Særlig forsigtighed bør udvises ved titrering af Instanyl til ældre patienter.
English: If the display shows a battery symbol, this means that the battery life is about to run out.
Danish: Hvis displayet viser et batterisymbol, betyder det, at batteriet er ved at være opbrugt.
English: - any medicines that might have an effect on the way in which your body breaks down Instanyl, such as:
Danish: - Lægemidler, som kan påvirke din krops evne til at nedbryde Instanyl, såsom:
English: Instanyl in doses above 400 micrograms have not been evaluated in clinical trials.
Danish: Instanyl i doser på mere end 400 mikrogram er ikke blevet evalueret i kliniske forsøg.
English: Opioids may cause hypotension, especially in patients with hypovolaemia.
Danish: Opioider kan forårsage hypotension, især hos patienter med hypovolæmi.
English: Fentanyl is highly lipophilic.
Danish: Fentanyl er særdeles lipofilt.
English: Caution is advised when Instanyl is coadministered with medicinal products that affect the serotoninergic neurotransmitter systems.
Danish: Der rådes til forsigtighed, når Instanyl administreres sammen med lægemidler, der påvirker de serotoninerge neurotransmittersystemer.
English: This observation was most distinct for patients receiving Instanyl 50 micrograms.
Danish: Denne observation var mest udtalt for patienter, som fik 50 mikrogram Instanyl.
English: Fentanyl use may be associated with bradycardia.
Danish: Anvendelse af fentanyl kan være associeret med bradykardi.
English: The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.
Danish: Den smertestillende medicin i Instanyl er meget stærk og kan være livstruende for børn.
English: • If it is blocked, aim the nasal spray away from you (and any other people) and push firmly down on the pump.
Danish: • Hvis den er blokeret, peger du sprayen væk fra dig selv (og andre personer) og trykker hårdt ned på pumpen.
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Danish: Ophævelse af den narkotiske effekt kan resultere i akutte smerter og frigivelse af catecholaminer.
English: Instanyl should not be used pre-emptively.
Danish: Instanyl bør ikke anvendes forebyggende.
English: The battery cannot be replaced and you need to get a new nasal spray.
Danish: Batteriet kan ikke udskiftes, og du skal have en ny næsespray.
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Danish: I en undersøgelse af præ- og postnatal udvikling var overlevelsesprocenten hos afkommet reduceret signifikant ved doser, som reducerede moderdyrets vægt en smule.
English: - if the person has stopped breathing, you should attempt to resuscitate her/him until emergency help arrives.
Danish: - Hvis personen holder op med at trække vejret, skal du forsøge at genoplive hende/ham, indtil hjælpen når frem.
English: • aprepitant (used to treat severe nausea);
Danish: • aprepitant (bruges til behandling af kraftig kvalme);
English: Effects on somatic development and behaviour of the offspring were not observed.
Danish: Der er ikke observeret virkninger på den somatiske udvikling og opførsel hos afkommet.
English: If serotonin syndrome is suspected, treatment with Instanyl should be discontinued.
Danish: Hvis et serotonergt syndrom mistænkes, bør behandling med Instanyl seponeres.
English: Tick off one box after each dose [Tick boxes of 10, 20 or 40 tick boxes]
Danish: Kryds en boks af efter hver dosis [afkrydsningsboks med 10, 20 eller 40 afkrydsningsbokse]
English: Patients undergoing treatment with Instanyl should be advised not to drive or operate machinery.
Danish: Patienter, som er i behandling med Instanyl, bør rådes til ikke at føre motorkøretøjer eller betjene maskiner.
English: - The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Danish: - Risikoen for bivirkninger øges, hvis du tager medicin såsom visse former for medicin mod depression eller antipsykotiske midler.
English: SPECIAL STORAGE CONDITIONS Store below 30C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30 °C.
English: This is the approximate number of doses that can be delivered from the nasal spray, before the battery is too low and the display turns off.
Danish: Det er det omtrentlige antal doser, der kan pumpes fra næsesprayen, før batteriniveauet er for lavt, og displayet slukker.
English: However, opioid analgesics are known to impair the mental and/or physical ability required for driving or operating machinery.
Danish: Opioide analgetika er imidlertidigt kendt for at nedsætte den mentale og/eller fysiske evne, der kræves for at føre motorkøretøj eller betjene maskiner.
English: Furthermore, Instanyl was significantly superior to placebo in BTP relief at 10, 20, 40, and 60 minutes following administration.
Danish: Desuden var Instanyl signifikant bedre end placebo til lindring af gennembrudssmerter ved 10, 20, 40 og 60 minutter efter administration.
English: - if you have problems with your liver or kidneys.
Danish: - hvis du har problemer med din lever eller dine nyrer.
English: The lock symbol appears in the display together with a countdown-clock symbol, which shows the remaining time left of the locking period (each black mark equals 10 minutes).
Danish: Hængelåssymbolet vises i displayet sammen med et nedtællingssymbol, som viser hvor lang tid der er tilbage af låsningsperioden (hver sort markering repræsenterer 10 minutter).
English: Do not open the blister before you are ready to use the spray.
Danish: Åbn ikke blisterpakningen før du er klar til at bruge næsesprayen.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity,genotoxicity and carcinogenicity.
Danish: De prækliniske data viste ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: The plasma protein binding of fentanyl is approximately 80.
Danish: Plasmaproteinbindingen af fentanyl er cirka 80 %.
English: If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.
Danish: Hvis du tror, at du er ved at blive afhængig af Instanyl, er det vigtigt, at du informerer din læge.
English: Patients receiving Instanyl concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Danish: Patienter, der samtidig med Instanyl behandles med moderate eller stærke CYP3A4-hæmmere, bør monitoreres omhyggeligt over længere tid.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Danish: Disse tiltag kan følges op ved administration af en specifik opioidantagonist som naloxon.
English: • The pharmacist must make use of the checklist for pharmacist.
Danish: • Apoteket skal gøre brug af tjeklisten for farmaceuter.
English: Do not press the plunger yet.
Danish: Tryk ikke på stemplet endnu.
English: The display counts downward after each pump (P5, P4, P3, P2 and P1).
Danish: Displayet tæller ned efter hvert tryk på pumpen (P5, P4, P3, P2 og P1).
English: The number of doses in the display changes to 5.
Danish: Antallet af doser i displayet skifter til 5.
English: After intravenous administration of fentanyl the initial distribution half-life is approximately 6 minutes and a similar half-life is seen after the nasal administration of Instanyl.
Danish: Den initiale distributionshalveringstid er cirka 6 minutter efter intravenøs administration af fentanyl og en tilsvarende halveringstid ses efter nasal administration af Instanyl.
English: Recurrent episodes of epistaxis (see section 4.4).
Danish: Tilbagevendende episoder af epistaxis (se pkt.
English: BATTERY symbol
Danish: BATTERI-symbol
English: Opioids act by blocking the pain signals to the brain.
Danish: Opioider virker ved at blokere for smertesignaler til hjernen.
English: - if you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use.
Danish: - hvis du nogensinde tidligere har udviklet binyreinsufficiens eller mangel på kønshormoner (androgenmangel) ved anvendelse af et opioid.
English: Cachectic patients may have reduced clearance of fentanyl.
Danish: Kakektiske patienter kan have nedsat clearance af fentanyl.
English: The countdown-clock is counting downwards.
Danish: Nedtællingsuret tæller ned.
English: If you stop using Instanyl
Danish: Hvis du holder op med at bruge Instanyl
English: It is recommended that the patient sit or stand in upright position when administrating Instanyl.
Danish: Det anbefales, at patienten sidder eller står i opret position, når Instanyl administreres.
English: - while waiting for the emergency help, you must try to keep the person awake by talking to or gently shaking the person every now and then.
Danish: - Mens du venter på hjælp, skal du forsøge at holde personen vågen ved at tale til personen eller indimellem forsigtigt ruske personen.
English: The single-dose container should not be tested before use.
Danish: Enkeltdosisbeholderen skal ikke testes før brug.
English: hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Danish: hydromorphon, morfin, oxycodon, pethidin), hver dag i henhold til et regelmæssigt skema, i mindst en uge, for at kontrollere din vedvarende smerte.
English: If you feel any of the above symptoms you should seek immediate medical assistance.
Danish: Hvis du oplever nogle af ovenfor nævnte symptomer, skal du straks søge lægehjælp.
English: There have also been reports of patients developing a hole in the septum of the nose - the structure, which separates the nostrils.
Danish: Der er også rapporter om patienter, som har udviklet hul i næseseptum, som er den væg, der adskiller næseborene.
English: Typical opioid adverse reactions are to be expected with Instanyl.
Danish: Typiske bivirkninger ved opioidbehandling kan forventes med Instanyl.
English: If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.
Danish: Hvis bivirkningerne er uacceptable eller vedvarende, bør styrken reduceres, eller behandlingen med Instanyl erstattes af andre analgetika.
English: • diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Danish: • diltiazem og verapamil (medicin til behandling af forhøjet blodtryk og hjertesygdomme).
English: If you experience that the nasal spray does not work as described in the “Instructions for use” please contact your doctor or pharmacist.
Danish: Hvis du oplever, at næsesprayen ikke virker som beskrevet i ”Instruktioner vedrørende anvendelse”, skal du kontakte din læge eller apoteket.
English: The MAH shall ensure that, all physicians, pharmacists and patients expected to prescribe/dispense/use Instanyl are provided with educational material regarding the correct and safe use of the product.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, al apotekspersonale og alle patienter, der forventes at ordinere/udlevere/bruge Instanyl er forsynet med en uddannelsesmaterialet vedrørende korrekt og sikker brug af produktet.
English: Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Danish: Generelt bør vedligeholdelsesstyrken for Instanyl øges, hvis en patient har brug for mere end én dosis per gennembrudssmerteepisode i flere på hinanden følgende episoder.
English: Keep the blister in the outer carton.
Danish: Opbevar blisterpakningen i den ydre karton.
English: Explanation
Danish: Forklaring
English: If you have not been using these medicines you must not use Instanyl, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Danish: Hvis du ikke har brugt denne slags medicin, må du ikke anvende Instanyl, fordi det kan øge risikoen for, at dit åndedræt kunne blive faretruende langsomt og/eller overfladisk eller endda helt ophøre.
English: In animal studies, male and female fertility was impaired at sedative doses (see section 5.3).
Danish: I dyrestudier er observeret nedsat mandlig og kvindelig fertilitet ved sedative doser (se afsnit 5.3).
English: The major metabolite, norfentanyl is inactive.
Danish: Hovedmetabolitten norfentanyl er inaktiv.
English: This is indicated by a ‘P' in the display.
Danish: Dette er vist med et ‘P' på displayet.
English: Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
Danish: Langvarig behandling med fentanyl under graviditet kan forårsage abstinenssymptomer hos det nyfødte barn, som kan være livstruende (se punkt 2).
English: Contact your doctor to confirm the correct dose of your usual medicine if you are not sure.
Danish: Kontakt lægen hvis du er i tvivl om den korrekte dosis af din sædvanlige medicin.
English: Patients should be individually titrated to a dose that provides adequate analgesia with tolerable adverse drug reactions.
Danish: Patienter bør titreres individuelt for at finde frem til en dosis, der giver tilstrækkelig analgesi med acceptable lægemiddelbivirkninger.
English: A pharmacokinetic study has shown that Instanyl single-dose and multi-dose nasal spray are bioequivalent.
Danish: Et farmakokinetisk studie har påvist, at Instanyl enkeltdosis næsespray og flerdosis næsespray er bioækvivalente.
English: About 75 of fentanyl is excreted into the urine, mostly as inactive metabolites, with less than 10 as unchanged active substance.
Danish: Cirka 75 % af fentanyldosen udskilles i urinen, primært som inaktive metabolitter, og med mindre end 10 % som uomdannet aktivt stof.
English: Elderly patients may have a reduced clearance, a prolonged half-life and higher sensitivity to fentanyl than younger patients.
Danish: Ældre patienter kan have nedsat clearance, en forlænget halveringstid og højere følsomhed over for fentanyl end yngre patienter.
English: - if you have problems with your heart especially slow heart rate, low blood pressure or low blood volume.
Danish: - hvis du har problemer med dit hjerte, især langsom puls, lavt blodtryk eller lille blodvolumen.
English: If Instanyl nasal spray is frozen the spray pump may crack.
Danish: Hvis Instanyl-næsesprayen er frossen, kan spraypumpen knække.
English: The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience:
Danish: Følgende bivirkninger er blevet rapporteret med Instanyl og/eller andre fentanyl-holdige stoffer i kliniske studier og efter markedsføring.
English: • Only to use Instanyl nasal spray if they have received the proper information regarding the use of the device and the safety precautions from the prescriber and/or the pharmacist.
Danish: • Kun at bruge Instanyl næsespray, hvis de har modtaget nødvendig information om brugen af næsesprayenheden og sikkerhedsforanstaltningerne fra den ordinerende læge og/eller apoteket.
English: - if you suffer from recurrent episodes of nose bleeding.
Danish: - hvis du lider af tilbagevendende næseblod.
English: The safety and efficacy of Instanyl have been evaluated in patients taking the medicinal product at the onset of a breakthrough pain episode.
Danish: Sikkerheden og effekten af Instanyl er blevet evalueret hos patienter, som tager lægemidlet ved begyndelsen af en episode med gennembrudssmerter.
English: Adequate pain relief with one dose of Instanyl
Danish: Tilstrækkelig smertelindring med en dosis Instanyl
English: Animal data shows that following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat.
Danish: Data fra dyreforsøg viser følgende absorption; fentanyl distribueres hurtigt til hjernen, hjertet, lungerne, nyrerne og milten efterfulgt af en langsommere omfordeling til muskler og fedt.
English: In clinical trials elderly patients tend to titrate to a lower effective strength than patients less than 65 years of age.
Danish: I kliniske forsøg har dosistitrering hos ældre patienter tendens til en lavere effektiv styrke end patienter under 65 år.
English: There are no adequate data from the use of fentanyl in pregnant women.
Danish: Data for anvendelse af fentanyl til gravide er utilstrækkelige.
English: - if you have problems with your brain function, e.g. due to a brain tumour, a head injury or increased intracranial pressure.
Danish: - hvis du har problemer med din hjernefunktion, f.eks. på grund af en hjernesvulst, beskadigelse af hovedet eller forøget tryk i hjernen.
English: Every time you use Instanyl nasal spray, make sure you or your carer fills in the information on the card.
Danish: Hver gang du bruger Instanyl næsespray, skal du eller din omsorgsperson udfylde oplysningerne på kortet.
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Danish: Respirationsdepression efter en overdosis kan vare længere end virkningen af opioidantagonisten.
English: Instanyl is intended for nasal use only.
Danish: Instanyl er kun beregnet til nasal anvendelse.
English: Concomitant use of Instanyl with other medicinal products (other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.
Danish: Samtidig brug af Instanyl og andre lægemidler (andre end oxymetazolin), som administreres via næsen, er ikke evalueret i de kliniske studier.
English: Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects.
Danish: Klinisk signifikant respirationsdepression kan forekomme med fentanyl, og patienter skal observeres for disse symptomer.
English: If you forget to use Instanyl
Danish: Hvis du har glemt at bruge Instanyl
English: The lock symbol starts flashing, when the locking period is over.
Danish: Hængelåssymbolet begynder at blinke, når låsningsperioden er udløbet.
English: The dose of Instanyl is independent of your usual cancer pain treatment.
Danish: Instanyldosis er uafhængig af din normale cancersmertebehandling.
English: • The Instanyl nasal spray dose strengths cannot be compared with other Fentanyl products.
Danish: • Styrken af en Instanyl næsespray kan ikke sammenlignes med andre fentanylprodukter.
English: The results of summary of PID at 60 minutes (SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo (p < 0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.
Danish: Opsummeringen af resultaterne for PID ved 60 minutter (SPID0-60) viste, at alle styrker af Instanyl havde signifikant højere gennemsnitlig SPID0-60-scorer sammenlignet med placebo (p< 0,001), hvilket demonstrerer en bedre smertelindring ved Instanyl sammenlignet med placebo over 60 minutter.