FrancophonIA/ELRC3.0 huggingface dataset:
English: Instanyl is not recommended for use in patients who have received Monoamine Oxidase Inhibitors (MAOIs) within 14 days because severe and unpredictable potentiation by MAOIs inhibitors has been reported with opioid analgesics.
Danish: Brug af Instanyl frarådes til patienter, der har fået monoaminooxidasehæmmere (MAO-hæmmere) indenfor de sidste 14 dage, da det er rapporteret, at MAO-hæmmere forårsager alvorlig og uforudsigelig forstærket virkning af opioidanalgetika.
English: Instanyl can cause dizziness, drowsiness and visual disturbances, which may affect your ability to drive or use machines.
Danish: Instanyl kan medføre svimmelhed, døsighed og synsforstyrrelser, som kan påvirke din evne til at føre motorkøretøjer eller betjene maskiner.
English: • Only to use Instanyl nasal spray if they have been experiencing breakthrough cancer pain episodes.
Danish: • Kun at bruge Instanyl næsespray, hvis de har oplevet episoder med gennembrudssmerter i forbindelse med cancer.
English: Impaired renal or hepatic function
Danish: Svækket nyre- eller leverfunktion
English: • Always to put the child-resistant cap back on to the multi-dose nasal spray DoseGuard, and close after use.
Danish: • Altid at sætte den børnesikrede hætte tilbage på flerdosisnæsesprayen DoseGuard og lukke den efter brug.
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of Instanyl nasal spray they have to keep it in a safe place to avoid misuse and diversion.
Danish: • Apoteket skal, for at forebygge tyveri og misbrug af Instanyl næsespray, informere patienter om, at de skal opbevare næsesprayen et sikkert sted for at undgå misbrug og videresalg.
English: Educational material for the physicians should contain the following:
Danish: Uddannelsesmateriale til læger skal indeholde følgende:
English: Instanyl comes in different pack sizes of 2, 6, 8 and 10 single-dose containers.
Danish: Instanyl fås i pakningsstørrelser af 2, 6, 8, 10 enkeltdosisbeholdere.
English: • To open cut with scissors along the line (above the scissors symbol) on the blister.
Danish: • For at åbne pakningen, skal du klippe med en saks langs linjen (over saksesymbolet) på blisterpakningen.
English: Priming should be performed in a well ventilated area.
Danish: Skal klargøring foretages på et sted med god udluftning.
English: Instanyl can cause somnolence, dizziness, visual disturbances or other adverse reactions which may affect their ability to drive or operate machinery.
Danish: Instanyl kan forårsage træthed, svimmelhed, synsforstyrrelser eller andre uønskede bivirkninger, som kan påvirke deres evne til at føre motorkøretøjer eller betjene maskiner.
English: How to remove and re-attach the child-resistant cap Remove the child-resistant cap by pressing on both sides of the cap, and then turn the cap counter clockwise and lift it off.
Danish: Sådan fjernes den børnesikrede hætte og sættes på igen Fjern den børnesikrede hætte ved at trykke på begge sider af hætten, dreje hætten mod uret og løfte den af.
English: Remember to always put the child-resistant cap back on to the nasal spray and close it after use.
Danish: Husk altid at sætte den børnesikrede hætte tilbage på næsesprayen og luk den efter brug.
English: It is contained in a brown glass bottle with a metering pump.
Danish: Beholderen er en brun glasflaske med doseringspumpe.
English: When the lock symbol starts flashing, press the white side button; the lock symbol disappears in the display.
Danish: Når hængelåssymbolet begynder at blinke, skal du trykke på den hvide knap i siden, hvorefter symbolet forsvinder i displayet.
English: The symbol disappears from the display, when the white button on the side of the nasal spray is pressed.
Danish: Symbolet forsvinder i displayet ved tryk på den hvide knap på siden af næsesprayen.
English: Concomitant use of nasal vasoconstrictor should be avoided (see section 4.5).
Danish: Samtidig brug af nasale vasokonstriktorer bør undgås (se pkt.
English: You could experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).
Danish: Du kan komme til at opleve symptomer på seponeringssyndrom (kvalme, opkastning, diaré, angst, kulderystelser, rystebevægelse og sveden).
English: 10 doses (2.0 ml) 20 doses (3.2 ml) 30 doses (4.3 ml) 40 doses (5.3 ml)
Danish: 10 doser (2,0 ml) 20 doser (3,2 ml) 30 doser (4,3 ml) 40 doser (5,3 ml)
English: The single-dose container contains 1 dose of Instanyl and and is supplied in a child-resistant blister.
Danish: Hver enkeltdosisbeholder indeholder 1 dosis og den leveres i en børnesikret blisterpakning.
English: You can use Instanyl to treat up to 4 episodes of breakthrough pain per day.
Danish: Du kan bruge Instanyl til at behandle op til 4 episoder med gennembrudssmerter pr. dag.
English: During this priming process medicine will be expelled.
Danish: Under denne klargøringsproces pumpes lægemiddel ud.
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate.
Danish: Hvis den kliniske situation berettiger til det, skal der etableres og opretholdes åben luftvej, om muligt med en orofaryngeal luftvej eller endotracheal tubus.
English: The use of such other drugs at the same time as Instanyl, may cause deep sedation and affect your ability to breath, which may lead to coma and be life-threatening.
Danish: Hvis du bruger sådanne lægemidler samtidig med Instanyl, kan det medføre dyb bevidstløshed og påvirke din evne til at trække vejret, hvilket kan føre til koma og være livstruende.
English: • Instructions for opening and closing of the child-resistant box (for the multi-dose nasal spray) or the child resistant cap (for the multi-dose nasal spray DoseGuard) or opening of the blister (for the single-dose nasal spray).
Danish: • Vejledning i åbning og lukning af den børnesikrede æske (for flerdosisnæsesprayen) eller den børnesikrede hætte (til flerdosisnæsespray DoseGuard) eller åbning af blisterpakningen (for enkeltdosisnæsesprayen)
English: Chronic pulmonary disease
Danish: Kronisk obstruktiv lungesygdom
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 µg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
Danish: I et fertilitets-og et tidligt embryoføtalt udviklingsstudie med rotter, blev der observeret en hankønsmedieret effekt ved høje doser (300 mikrogram/kg/dag, s.c.).
English: It is contained in a nasal spray with a metering pump, an electronic display, a dose counter, an in-built lock-out mechanism and a child-resistant cap.
Danish: Pakningen består af en næsespraybeholder med en doseringspumpe, et elektronisk display, en dosistæller, en indbygget låsemekanisme og en børnesikret hætte.
English: If a child is accidentally exposed to Instanyl it may cause death, please seek immediate medical assistance.
Danish: Hvis et barn ved et uheld bliver udsat for Instanyl, kan det medføre dødsfald.
English: - Remove the tamper evidence the first time the box is opened - Place a thumb and a middle finger on the side tabs
Danish: Fjern forseglingen første gang æsken åbnes - Placer tommelfingeren og langfingeren på æskens sideflapper
English: Please read the instruction for use at the end of this leaflet to learn how to use Instanyl.
Danish: Læs Instruktioner vedrørende anvendelse i slutningen af indlægssedlen for at få mere at vide om brugen af Instanyl
English: • Information about dose counting scheme included in the labelling and the educational material for the multi-dose nasal spray.
Danish: • Information om afkrydsningsskemaet til dosistælling, som fremgår af mærkningen og undervisningsmaterialet for flerdosisnæsesprayen
English: The concomitant use of Instanyl with strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Danish: Samtidig brug af Instanyl og stærke CYP3A4-hæmmere (f.eks. ritonavir, ketoconazol, itraconazol, troleandomycin, clarithromycin og nelfinavir) eller moderate CYP3A4-hæmmere (f.eks. amprenavir, aprepitant, diltiazem, erythromycin, fluconazol, fosamprenavir, og verapamil) kan resultere i forhøjede plasmakoncentrationer af fentanyl, hvilket potentielt kan forårsage alvorlige bivirkninger, herunder fatal respirationsdepression.
English: Sleepiness, dizziness even with difficulties keeping balance, headache, irritation of the throat, nausea, vomiting, flushing, feeling very warm, excessive sweating.
Danish: Søvnighed, svimmelhed der påvirker balancen, hovedpine, irritation i halsen, kvalme, opkastning, rødmen, kraftig varmefornemmelse, overdreven svedtendens.
English: - if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal syndrome.
Danish: - hvis du tager lægemidler, som kaldes partielle agonister/antagonister f.eks. buprenorphin, nalbuphin og pentazocin (smertestillende medicin), da du kan komme til at opleve symptomer på seponeringssyndrom.
English: The labelling of the three Instanyl strengths is differentiated by colour: 50 micrograms/dose labelling is orange.
Danish: Mærkningen af de tre styrker af Instanyl har hver deres farve: 50 mikrogram/dosis er orange
English: Each black mark equals 10 minutes; the maximum locking period is 2 hours.
Danish: Hver sort afmærkning repræsenterer 10 minutter.
English: Do not point in the direction of surfaces and objects that could come into contact with other people, particularly children.
Danish: Må du ikke pege næsesprayen mod flader og genstande, som kan komme i kontakt med andre personer, især børn.
English: The nasal spray is supplied in a child-resistant outer box and comes in three different pack sizes: 1.8 ml (equal to 10 doses), 2.9 ml (equal to 20 doses) and 5.0 ml (equal to 40 doses).
Danish: Næsesprayen leveres i en børnesikret ydre æske og fås i tre forskellige pakningsstørrelser: 1,8 ml (svarende til 10 doser), 2,9 ml (svarende til 20 doser) og 5,0 ml (svarende til 40 doser).
English: - Pull lid to open - After use of Instanyl the nasal spray must be placed in the inner tray again and the box closed
Danish: - Træk i låget for at åbne - Efter brug skal Instanyl igen placeres i den indvendige plastbakke og æsken lukkes
English: When priming, please refer to the above safety instructions.
Danish: Følg ovenstående sikkerhedsanvisninger ved klargøring.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Hyperhidrose
English: The nasal spray allows for up to two doses per breakthrough pain episodes.
Danish: Næsesprayen kan levere op til to doser for hver episode med gennembrudssmerter.
English: Do not throw away Instanyl via wastewater or household waste.
Danish: Du må ikke smide rester af Instanyl i afløbet, toilettet eller skraldespanden.
English: Throat irritation Respiratory depression, epistaxis, nasal ulcer, rhinorrhea
Danish: Respirationsdepression, epistaxis, nasale sår, rinoré
English: For concomitant use of nasal vasoconstrictor see section 4.5.
Danish: For samtidig brug af nasale vasokonstriktorer se pkt.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Du må ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Blow your nose if it feels blocked or you have a cold. 2.
Danish: Puds din næse, hvis den føles stoppet, eller hvis du er forkølet.
English: Do not use Instanyl if you are breast-feeding.
Danish: Du må ikke anvende Instanyl, hvis du ammer.
English: 200 micrograms/dose labelling is greenish-blue.
Danish: 200 mikrogram/dosis er blågrøn
English: Other medicines and Instanyl
Danish: Brug af anden medicin sammen med Instanyl
English: Coadministration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Danish: Samtidig administration af fentanyl og et serotoninergt stof, såsom en selektiv serotoningenoptagshæmmer (SSRI) eller en serotonin-noradrenalingenoptagshæmmer (SNRI) eller en monoamineoxidasehæmmer (MAO-hæmmer), kan øge risikoen for serotonergt syndrom, en muligt livstruende sygdom.
English: Remember to clean the nasal spray tip after use with a clean tissue, and then discard afterwards.
Danish: Husk at rengøre næsesprayens spids efter brug med en ren serviet, og smid derefter servietten ud.
English: Do not use Instanyl after the expiry date which is stated on the carton and the single-dose container after EXP.
Danish: Brug ikke Instanyl efter den udløbsdato (EXP), der står på æske og enkeltdosisbeholder.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskompli-kati oner
English: Therefore, the use of any of these medicinal products concomitantly with Instanyl requires special patient care and observation.
Danish: Derfor kræves der særlig patientpleje og observation, hvis nogen af disse lægemidler bruges samtidig med Instanyl.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Takeda Pharma A/S
English: You should wait for 4 hours before treating the next episode of breakthrough pain.
Danish: Du bør vente i 4 timer, inden du tager medicin for næste episode af gennembrudssmerter.
English: Instanyl acts rapidly and is used for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain.
Danish: Instanyl virker hurtigt og bruges til lindring af gennembrudssmerter hos voksne cancerpatienter, som allerede er i behandling med opioider for deres baggrundssmerter.
English: Please read the following instructions carefully to learn how to use Instanyl nasal spray.
Danish: Læs følgende instruktioner grundigt for at lære at bruge Instanyl næsespray:
English: 2 single-dose containers 6 single-dose containers 8 single-dose containers 10 single-dose containers
Danish: 2 enkeltdosisbeholdere 6 enkeltdosisbeholdere 8 enkeltdosisbeholdere 10 enkeltdosisbeholdere
English: Precautions to be taken before handling or administering the medicinal product Before using Instanyl for the first time, the nasal spray must be primed until a fine mist appears; 3 to 4 actuations of the nasal spray are usually required.
Danish: Forholdsregler inden håndtering eller administration af lægemidlet Inden Instanyl anvendes første gang, skal næsesprayen klargøres ved at pumpe 3 - 4 gange på pumpen, indtil der kommer en fin tågesky.
English: Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Danish: Gennembrudssmerter er en kortvarig forværring af en ellers kontrolleret kronisk baggrundssmerte.
English: No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients receiving low maintenance opioid dose tended to achieve effective pain relief with a lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose.
Danish: Imidlertid var der i det andet pivotale studie en tendens til, at patienter, som fik en lav opioidvedligeholdelsesdosis opnåede en effektiv smertelindring ved en tilsvarende lavere dosis af Instanyl sammenlignet med patienter, som fik en højere opioidvedligeholdelsesdosis.
English: Do not point the nasal spray in the direction of yourself and other people.
Danish: Må du ikke pege næsesprayen mod dig selv eller andre.
English: Convulsions, loss of consciousness
Danish: Krampeanfald, bevidstløshed
English: • Instanyl nasal spray should be used only by physicians experienced, knowledgeable and skilled in the management of opioid therapy in cancer patients.
Danish: • Instanyl næsespray bør kun ordineres af læger, som har erfaring med, er velinformeret og kvalificeret ibehandling af cancerpatienter med opioider.
English: It is recommended that concomitant use of nasal decongestants is avoided (see section 5.2).
Danish: Det anbefales, at samtidig anvendelse af detumescerende lægemidler til nasal anvendelse undgås (se pkt.
English: Please refer to the section Other medicines and Instanyl for more information.
Danish: Se punktet ”Brug af anden medicin sammen med Instanyl” for at få yderligere oplysninger.
English: The display now shows ‘P3' and the lock symbol.
Danish: Displayet viser nu ‘P3' og hængelåssymbolet igen.
English: If you use more Instanyl than you should or if you think someone has accidentally used Instanyl You should contact your doctor, hospital or emergency room for assessment of the risk and for advice if you have taken more Instanyl than you should.
Danish: Kontakt lægen, hospitalet eller skadestuen for rådgivning og risikovurdering, hvis du har brugt mere Instanyl, end du burde.
English: If you experience more than 4 episodes of breakthrough pain per day, you should contact your doctor as your usual cancer pain treatment may have to be changed.
Danish: Hvis du oplever mere end 4 episoder med gennembrudssmerter pr. dag, skal du kontakte din læge, da der muligvis er brug for at ændre din sædvanlige behandling for cancersmerter.
English: Instanyl may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38 °C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Danish: Instanyl kan påvirke disse lægemidler, og du kan opleve ændringer af din mentale status (f.eks. ophidselse, hallucinationer, koma) og andre virkninger som en kropstemperatur over 38 °C, øget hjertefrekvens, ustabilt blodtryk og overdrevne reflekser, muskelstivhed, manglende koordination og/eller mave-tarm-symptomer (f.eks. kvalme, opkastning, diarré).
English: Instanyl incorporates an electronic dose counter, and a lock out period between doses to reduce the risk of overdose, and helps you to use it adequately.The dose counter enables you, and your doctor, to monitor and adapt your use.
Danish: Næsespraybeholderen har en elektronisk dosistæller, og er forsynet med en låsemekanisme, der virker mellem doser for at nedsætte risikoen for for høj dosis og gøre det nemmere for dig at bruge den korrekt.Dosistælleren gør det muligt for dig og din læge at holde øje med og tilpasse din brug af Instanyl.Efter indtagelse af to doser inden for 60 minutter låses spraybeholderen i 2 timer fra indtagelse af første dosis, inden den næste dosis kan tages.
English: An in-built lock-out mechanism which controls how often the nasal spray can be used A child-resistant cap, which must be put on the nasal spray, when the nasal spray is not used An electronic display which:
Danish: En indbygget låsemekanisme, som styrer, hvor ofte næsesprayen kan bruges En børnesikret hætte, som skal sættes på næsesprayen, når den ikke bruges Et elektronisk display, som  giver oplysninger om antallet af klargøringspump  viser antallet af tilbageværende doser  viser om næsesprayen er låst eller klar til brug
English: Each single-dose container contains only one dose.
Danish: Hver enkeltdosisbeholder indeholder kun en dosis.
English: • ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection);
Danish: • ritanavir, nelfinavir, amprenavir og fosamprenavir (medicin til kontrol af HIV-infektion);
English: Please read the instruction for use at the end of this leaflet to learn how to use the nasal spray.
Danish: Læs Instruktioner vedrørende anvendelse i slutningen af indlægssedlen for at få mere at vide om brugen af næsesprayen.
English: Fall, diarrhoea, convulsions (fits), loss of consciousness, swelling of arms or legs, seeing or hearing things that are not really there (hallucinations), drug dependence (addiction), drug abuse, fatigue, malaise, withdrawal syndrome (may manifest by the occurrence of the following side effects nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shortness of breath.
Danish: Fald, diarré, krampeanfald (kramper), bevidstløshed, hævede arme og ben; se eller høre ting, der faktisk slet ikke er der (hallucinationer), stofafhængighed, stofmisbrug, træthed, utilpashed, seponeringssyndrom (der kan give sig til udtryk ved forekomsten af følgende bivirkninger Kvalme, opkastning, diarré, angst, kulderystelser, rystebevægelse og sveden), åndenød.
English: How to use Instanyl
Danish: Sådan skal du bruge Instanyl
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Danish: Samtidig brug af partielle opioidagonister/antagonister (f.eks. buprenorphin, nalbuphin, pentazocin) frarådes.
English: The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Danish: Dosen af Instanyl til behandling af gennembrudssmerter var i de kliniske studier uafhængig af den daglige opioid-vedligeholdelsesdosis.
English: Do not use Instanyl after the expiry date which is stated on the nasal spray after EXP.
Danish: Brug ikke Instanyl efter den udløbsdato (EXP), der står på næsesprayen.
English: Each single-dose container contains only one dose of Instanyl.
Danish: Hver enkeltdosisbeholder indeholder kun en dosis Instanyl.
English: Fentanyl should be administered with caution to patients with moderate to severe hepatic or renal impairment.
Danish: Fentanyl bør administreres med forsigtighed til patienter med moderat til svært nedsat lever- eller nyrefunktion.
English: - medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain).
Danish: - Lægemidler som kaldes partielle agonister/antagonister f.eks. buprenorphin, nalbuphin og pentazocin (smertestillende medicin).
English: Talk to your doctor before using Instanyl, especially: - if you suffer from a long-term obstructive lung disease, your breathing may be impaired by
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du bruger Instanyl, især: - hvis du lider af en længerevarende obstruktiv lungesygdom, kan din vejrtrækning blive hæmmet af Instanyl.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INTERMEDIATE CHILD-RESISTANT BLISTER PACK (Single dose)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BØRNESIKRET BLISTERPAKNING (Enkeltdosis)
English: The nasal spray comes in four different pack sizes: 2.0 ml (equal to 10 doses), 3.2 ml (equal to 20 doses), 4.3 ml (equal to 30 doses) and 5.3 ml (equal to 40 doses).
Danish: Næsesprayen leveres i fire forskellige pakningsstørrelser: 2,0 ml (svarer til 10 doser), 3,2 ml (svarer til 20 doser), 4,3 ml (svarer til 30 doser) og 5,3 ml (svarer til 40 doser).
English: Store below 30 C.
Danish: Opbevares ved temperaturer under 30 °C.
English: Bottle (brown Type 1 glass) with metering pump and dust cap packed in a child-resistant outer box.
Danish: Flaske (brun type I-glas) med doseringspumpe og beskyttelseshætte pakket i en børnesikret ydre æske.
English: Hold the nasal spray upright and pump the nasal spray in the air again.
Danish: Hold næsesprayen lodret med spisen opad og pump op i luften igen.
English: • Instanyl nasal spray is only indicated and licensed for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Danish: • Instanyl næsespray er kun indiceret og godkendt til behandling af gennembrudssmerter hos voksne, som allerede modtager vedligeholdelses-opioidbehandling for kroniske cancersmerter.