FrancophonIA/ELRC3.0 huggingface dataset:
English: In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms; however, patients should be titrated to the optimal dose of Instanyl for treating BTP in cancer (see section 4.2).
Danish: I kliniske forsøg med cancerpatienter er 100 og 200 mikrogram de hyppigst anvendte doser; patienterne skal dog titreres til den optimale dosis Instanyl til behandling af gennembrudssmerter ved cancer (se pkt.
English: Instanyl should be used with caution in patients with cerebral tumour or head injury.
Danish: Instanyl bør anvendes med forsigtighed til patienter med cerebral tumor eller kvæstelser i hovedet.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Danish: Patienter i opioid-vedligeholdelsesbehandling tager mindst 60 mg oral morfin dagligt, mindst 25 mikrogram transdermal fentanyl pr. time, mindst 30 mg oxycodon dagligt, mindst 8 mg oral hydromorfon dagligt eller en tilsvarende ækvianalgetisk dosis af et andet opioid i en uge eller længere.
English: - other medicines taken via the nose, especially oxymetazoline, xylometazoline and similar medicines, which are used for relief of nose congestions.
Danish: - Andre lægemidler som anvendes via næsen, specielt oxymetazolin, xylometazolin eller tilsvarende medicin, som bruges til lindring af tilstoppet næse.
English: Instanyl incorporates an electronic dose counter, and a lock out period between doses to minimise the risk of accidental overdose, misuse and abuse and to provide some reassurance to patients regarding these risks.
Danish: Næsespraybeholderen har en elektronisk dosistæller og er forsynet med en låsemekanisme, der virker mellem doser for at minimere risikoen for utilsigtet overdosering, forkert brug og misbrug og for at give patienterne en vis grad af sikkerhed vedrørende disse risici.
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.
Danish: Forholdsregler inden håndtering eller administration af lægemidlet Inden Instanyl anvendes første gang, skal næsesprayen klargøres.
English: Instanyl should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Danish: Behandlingen med Instanyl bør straks afbrydes, hvis patienten ikke længere oplever episoder med gennembrudssmerter.
English: It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the newborn (neonate).
Danish: Det frarådes at bruge fentanyl under veer og fødsel (herunder kejsersnit), da fentanyl passerer placenta og kan forårsage respirationsdepression hos den nyfødte.
English: You should however continue to take your usual pain relieving medicine to treat your cancer pain.
Danish: Du skal fortsætte med at tage din sædvanlige smertestillende medicin til behandling af dine cancersmerter.
English: In order to keep track of the number of doses of Instanyl used, you should use the tick-boxes in the booklet placed on top of the child-resistant outer box.
Danish: For at holde styr på antal brugte doser af Instanyl, skal du bruge afkrydsningsfelterne i papirfolderen, der er placeret på toppen af den børnesikrede ydre æske.
English: - if you take antidepressants or antipsychotics, please refer to the section ‘Other medicines and Instanyl'.
Danish: - hvis du tager medicin mod depression eller antipsykotiske midler, se punktet "Brug af anden medicin sammen med Instanyl".
English: Do not change the dose of Instanyl or your other pain medicines on your own.
Danish: Du må ikke selv ændre din Instanyldosis eller doseringen af din sædvanlige smertestillende medicin.
English: Before using the nasal spray for the first time, it must be pumped 5 times (primed) to give a full dose of Instanyl.
Danish: Inden næsesprayen bruges første gang, skal du pumpe på den 5 gange (klargøre den) for at den giver en rigtig dosis Instanyl.
English: Note to carers
Danish: Bemærkning til plejere
English: The secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Danish: De sekundære farmakologiske virkninger er respirationsdepression, bradykardi, hypothermi, obstipation, miosis, fysisk afhængighed og eufori.
English: Subjects with allergic rhinitis received oxymetazoline nasal spray one hour prior to Instanyl.
Danish: Personer med allergisk rhinitis fik oxymetazolin som næsespray en time før de fik Instanyl.
English: The nasal spray is empty when the display shows ‘0' and the lock symbol appears.
Danish: Næsesprayen er tom, når displayet viser ‘0', og hængelåssymbolet vises.
English: Hold the edge of the foil, peel the foil back and take the nasal spray out.
Danish: Hold på kanten af folien, træk folien tilbage og tag næsesprayen ud.
English: DK-2630 Taastrup Denmark
Danish: DK-2630 Taastrup
English: After each dose, the number is counting downwards on the display.
Danish: Efter hver dosis tælles der ned i displayet.
English: - you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Danish: • oplever en kombination af følgende symptomer: kvalme, opkastning, anoreksi, træthed, svaghed, svimmelhed og lavt blodtryk.
English: The content is:
Danish: Instanyl indeholder:
English: Educational material for the patients should contain the following:
Danish: Uddannelsesmaterialet til patienter skal indeholde følgende:
English: Do not use Instanyl: - if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Instanyl - hvis du er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer (anført under pkt.
English: The battery life is about to run out.
Danish: Batteriet er ved at være opbrugt.
English: - if the person has difficulty breathing, you should prompt the person to breathe in every
Danish: - Hvis personen har problemer med at trække vejret, skal du opfordre personen til at trække vejret hvert 5-10 sekund.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.8 ml - 10 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1,8 ml - 10 doser
English: • Blow your nose if it feels blocked or you have a cold.
Danish: • Puds din næse hvis den føles stoppet eller hvis du er forkølet.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients.
Danish: Behandling bør initieres og vedligeholdes under kontrol fra en læge med erfaring i behandling af cancerpatienter med opioider.
English: Fentanyl is metabolised primarily in the liver via CYP3A4.
Danish: Biotransformation Fentanyl metaboliseres primært i leveren via CYP3A4.
English: However, iatrogenic addiction following therapeutic use of opioids is known to occur in the treatment of cancer related pain.
Danish: Der er kendt forekomst af iatrogen afhængighed efter terapeutisk anvendelse af opioider ved behandling af cancerrelaterede smerter.
English: • For the multi-dose nasal spray: information about the dose counting scheme.
Danish: • For flerdosisnæsesprayen: Information om afkrydsningsskemaet til dosistælling.
English: Remove the protective cap from the spray.
Danish: Fjern beskyttelseshætten fra næsesprayen.
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Danish: Tegn på toksicitet er dyb sedation, ataksi, myosis, kramper og respirationsdepression, som er det primære symptom.
English: For nasal use
Danish: Til nasal anvendelse
English: 5.0 ml - 40 doses
Danish: 5,0 ml - 40 doser
English: Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating arms and legs.
Danish: Søvnighed, døsighed, svimmelhed, nedsat kropstemperatur, langsom puls, problemer med at koordinere arme og ben.
English: Nasal septum perforation, dyspnoea
Danish: Perforeret septum nasi, dyspnø
English: The clinical experience with Instanyl in patients with background opioid treatment equivalent to ≥ 500 mg/day morphine or ≥ 200 micrograms/hour transdermal fentanyl is limited.
Danish: Den kliniske erfaring med Instanyl til patienter, som får en baggrundsterapi med opioid svarende til ≥ 500 mg/dag af morphin eller ≥ 200 mikrogram/time af transdermalt fentanyl er begrænset.
English: • Priming should be performed in a well ventilated area.
Danish: • Skal klargøring foretages på et sted med god udluftning.
English: Fentanyl exhibits three compartment distribution kinetics.
Danish: Fentanyl har en 3-kompartment-distributionskinetik.
English: If you experience recurrent nose bleeding or nasal discomfort whilst being treated with Instanyl, you must contact your doctor, who will consider alternative treatment for your breakthrough pain.
Danish: Hvis du oplever tilbagevendende næseblod eller ubehag i næsen, når du er i behandling med Instanyl, skal du kontakte lægen, som kan overveje en alternativ behandling af dine gennembrudssmerter.
English: Fentanyl should therefore be used with caution in patients with previous or pre-existing bradyarrhythmias.
Danish: Fentanyl bør derfor anvendes med forsigtighed til patienter med tidligere eller allerede eksisterende bradyarytmier.
English: The ‘P' symbol disappears from the display, when the nasal spray is primed again, by spraying once.
Danish: ‘P' symbolet forsvinder fra displayet, når næsesprayen klargøres igen med ét pump.
English: - if you have serious difficulties breathing or suffer from a serious obstructive lung disease.
Danish: - hvis du har alvorlige vejrtrækningsproblemer eller lider af en alvorlig obstruktiv lungesygdom.
English: The number of doses left in the nasal spray.
Danish: Antallet af doser, der er tilbage i næsesprayen.
English: Pack sizes: 2, 6, 8 and 10 single-dose containers.
Danish: Pakningsstørrelser: 2, 6, 8 og 10 enkeltdosisbeholdere.
English: Therefore, the patient must be instructed that the priming should be conducted in a well ventilated area, pointing away from the patient and other people, and away from surfaces and objects that could come into contact with other people, particularly children.
Danish: Derfor skal patienten informeres om, at klargøringen skal foretages på et sted med god udluftning, og at næsesprayen skal pege væk fra patienten og andre personer samt flader og genstande, som kan komme i kontakt med andre personer, især børn.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Instanyl på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: If you think someone has accidentally taken Instanyl, please seek immediate medical assistance.
Danish: Hvis du tror, nogen ved en fejl har taget Instanyl, så søg straks læge.
English: 2.9 ml - 20 doses
Danish: 2,9 ml - 20 doser
English: You must make sure the pump is pressed all the way down.
Danish: Du skal trykke pumpen helt i bund.
English: If you have to take a second dose after 10 minutes to get sufficient pain relief, this dose should be taken in the other nostril.
Danish: Hvis du efter 10 minutter er nødt til at tage en ekstra dosis for at opnå tilstrækkelig smertelindring, bør denne dosis tages i det modsatte næsebor.
English: Cleaning of the nasal spray tip is required after each use.
Danish: Rengøring af spidsen på næsesprayen er nødvendig efter hver administration.
English: Available in the following presentations:
Danish: Findes i følgende pakningsstørrelser:
English: Patients being treated with medicinal products containing sodium oxybate.
Danish: Patienter der er i behandling med lægemidler, som indeholder natriumoxybat.
English: You may not feel the dose in your nose, but you have received it when the plunger has been pressed up.
Danish: Det er ikke sikkert, at du kan mærke medicinen i din næse, men du har fået den, når stemplet har været trykket ned.
English: The side effects will often stop or reduce in intensity with continued use of the product.
Danish: Bivirkningerne vil ofte ophøre eller blive svagere i intensitet ved vedvarende brug af medicinen.
English: Fentanyl should be used with caution in patients with evidence of increased intracranial pressure, impaired consciousness or coma.
Danish: Fentanyl bør anvendes med forsigtighed til patienter med tegn på øget intrakranielt tryk, nedsat bevidsthedsniveau eller koma.
English: Somnolence, dizziness, headache
Danish: Træthed, svimmelhed, hovedpine
English: Remember to press the white button on the side before pumping the nasal spray.
Danish: Husk at trykke på den hvide knap på siden, inden du pumper væske ud.
English: If you see the person taking Instanyl suddenly acting slowly, having difficulties breathing or if you have difficulties waking the person up: - you should immediately call for emergency help.
Danish: Hvis du oplever at personen, som bruger Instanyl, pludselig har en langsom adfærd, har problemer med at trække vejret, eller du har svært ved at vække personen: - Skal du straks ringe 112 for hjælp.
English: Hallucination, drug dependence (addiction), drug abuse
Danish: Hallucinationer, stofafhængighed, stofmisbrug
English: Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.
Danish: Justering af baggrundsopioidbehandling skal overvejes efter en revurdering af smerterne, hvis patienten ofte har episoder med gennembrudssmerter med kortere mellemrum end 4 timer eller mere end fire episoder med gennembrudssmerter per 24 timer.
English: - experience extreme dizziness.
Danish: - oplever voldsom svimmelhed.
English: If the breakthrough pain has stopped, do not take Instanyl until the next episode of breakthrough pain occurs.
Danish: Ved ophør af dine gennembrudssmerter, skal du ikke bruge Instanyl, før næste episode med gennembrudssmerter opstår.
English: The signs and symptoms of fentanyl overdose are expected to be an extension of its pharmacological actions e.g. lethargy, coma and severe respiratory depression.
Danish: Tegnene og symptomerne på fentanyloverdosering forventes at være et resultat af fentanyls farmakologiske egenskaber, f.eks. letargi, koma og svær respirationsdepression.
English: The overall extent of fentanyl exposure in subjects with allergic rhinitis without prior treatment with nasal vasoconstrictor is comparable to that in healthy subjects.
Danish: Den totale eksponeringsgrad af fentanyl hos patienter med allergisk rhinitis uden forudgående behandling med nasale vasokonstriktorer er sammenlignelig med eksponeringsgraden hos raske personer.
English: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Danish: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Tyskland
English: - When closing the box, make sure that the side tabs locate back into the slots - Press down firmly until the side tabs click into position
Danish: - Ved lukning af æsken, skal du sikre dig, at flapperne er tilbage i sprækkerne - Tryk omhyggeligt indtil flapperne er tilbage i position og giver et klik.
English: Press the pump down quickly and completely with two fingers, once, while breathing in through your nose.
Danish: Tryk pumpen hurtigt og helt ned én gang med to fingre, samtidig med at du trækker vejret gennem næsen.
English: Following long-term treatment, fentanyl may cause withdrawal in the new-born infant.
Danish: Efter langtidsbehandling kan fentanyl medføre abstinenssymptomer hos det nyfødte barn.
English: - Press side tabs inwards using your thumb and middle finger - At the same time, place your other thumb on the front pressure pad and also press inwards - Continue to apply pressure on all three points
Danish: - Tryk sideflapperne ind med tommelfingeren og langfingeren - Placer samtidig din anden tommelfinger på den forreste flap og tryk også denne ind - Fortsæt med at trykke på alle tre flapper
English: • Not to use Instanyl nasal spray for treatment of more than four breakthrough cancer pain episodes a day.
Danish: • Ikke at bruge Instanyl næsespray til behandling af mere end fire episoder med cancergennembrudssmerter i døgnet.
English: Dose linearity from 50 micrograms to 400 micrograms of Instanyl has been demonstrated in healthy subjects.
Danish: Dosislinearitet er påvist fra 50 til 400 mikrogram Instanyl hos raske personer.
English: If the patient has insufficient pain relief, redosing with same strength can be undertaken at the earliest after 10 minutes.
Danish: Hvis patienten har utilstrækkelig smertelindring, kan en gendosering med den samme styrke tidligst ske efter 10 minutter.
English: - if you are taking a medicine which contains sodium oxybate.
Danish: - hvis du tager medicin, der indeholder natriumoxybat.
English: The overall extent of fentanyl exposure in subjects with common cold without prior treatment with nasal vasoconstrictor is comparable to that in healthy subjects.
Danish: Den totale eksponeringsgrad af fentanyl hos personer med almindelig forkølelse uden forudgående behandling med nasale vasokonstriktorer er sammenlignelig med eksponeringsgraden hos raske personer.
English: Fentanyl is an opioid analgesic interacting primarily with the opioid μ-receptor as a pure agonist with low affinity for the - and κ-opioid receptors.
Danish: Fentanyl er et opioidanalgetikum, som primært interagerer med den µ-opioide receptor, som en ren agonist med lav affinitet for δ- og κ-opioide receptorer.
English: The Instanyl nasal spray has:
Danish: Instanyl næsespray har:
English: *opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl
Danish: * Seponeringssymptomer ved opioider, såsom kvalme, opkastning, diaré, angst, kulderystelser, tremor og sveden, er blevet observeret ved transmucosal fentanyl.
English: Single-dose container consisting of a vial (clear type I glass) integrated in a polypropylene spray container, packed in child-resistant blister.
Danish: Enkeltdosisbeholderen består af en glasbeholder (klar type I-glas) integreret i en polypropylenspraybeholder pakket i en børnesikret blisterpakning.
English: If after 10 minutes you need a second dose of Instanyl to relieve your pain, repeat steps 1 to 8 in the other nostril.
Danish: Hvis du efter 10 minutter har behov for endnu en dosis Instanyl for at lindre smerterne, gentages trin 1 til 8 i det andet næsebor.
English: Press the pump down completely with two fingers one time while breathing through the nose.
Danish: Tryk pumpen helt ned med to fingre én gang, samtidig med at du trækker vejret gennem næsen.
English: Consult your doctor while using Instanyl, if: - you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor.
Danish: • oplever smerter eller øget følsomhed for smerte (hyperalgesi), der ikke reagerer på en højere dosis af din medicin, som lægen har ordineret.
English: If Instanyl nasal spray is blocked or does not spray properly:
Danish: Hvis Instanyl næsesprayen er blokeret eller ikke sprayer, som den skal:
English: • Gently hold the single-dose container with your thumb supporting it at the plunger at the bottom and your index and middle finger on either side of the spray tip (see drawing).
Danish: • Hold enkeltdosisbeholderen forsigtigt og med din tommelfinger så den støtter stemplet i bunden, og din pege- og langefinger på hver sin side af næsesprayens spids (se tegning).
English: When the time has passed the lock symbol starts flashing.
Danish: Når tiden er gået, begynder hængelåssymbolet af blinke.
English: Press the white button on the side of the nasal spray (the flashing lock symbol disappears).
Danish: Tryk på den hvide knap på siden af næsesprayen (det blinkende hængelåssymbol forsvinder).
English: The nasal spray can only be used when the lock symbol is not visible in the display.
Danish: Næsesprayen kan kun bruges, når hængelåssymbolet er væk fra i displayet.
English: The display now shows ‘P4' and a lock symbol appears.
Danish: Displayet viser nu ‘P4', og der fremkommer et hængelåssymbol.
English: You should discontinue Instanyl when you no longer have any breakthrough pain.
Danish: Du skal stoppe med at bruge Instanyl, hvis du ikke længere har gennembrudssmerter.
English: • Do not point the nasal spray in the direction of yourself and other people.
Danish: • Må du ikke pege næsesprayen mod dig selv og andre.
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: • Each single-dose container is sealed in a child-resistant blister.
Danish: • Hver enkeltdosisbeholder ligger i en forseglet børnesikret blisterpakning.
English: The labelling of the three Instanyl strengths is differentiated by colour: 50 micrograms labelling is orange.
Danish: Mærkningen af de tre styrker af Instanyl har hver deres farve: 50 mikrogram er orange.
English: Generally you should wait 4 hours before treating another episode of breakthrough pain.
Danish: Generelt skal du vente 4 timer, inden du behandler en ny episode med gennembrudssmerter.
English: Following administration of two doses within 60 minutes, Instanyl will lock for a period of 2 hours, from the first dose taken, before another dose can be administered.
Danish: Efter indtagelse af to doser indenfor 60 minutter låses spraybeholderen i 2 timer fra dosering af første dosis, inden den næste dosis kan doseres.
English: Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).
Danish: Samtidig administration af lægemidler, der indeholder natriumoxybat og fentanyl er kontraindiceret (se pkt.
English: Previous facial radiotherapy.
Danish: Tidligere strålebehandlig i ansigtet.
English: If adequate analgesia is not achieved, redosing of the same strength may be administered at the earliest after 10 minutes.
Danish: Hvis der ikke opnås tilstrækkelig analgesi, kan der tidligst gives en ny dosis af samme styrke efter 10 minutter.
English: Elderly and Cachectic population
Danish: Ældre og kakektiske patienter
English: Withdrawal symptoms may be precipitated through the administration of substances with opioid antagonist activity, e.g. naloxone, or mixed agonist/antagonist analgesic (e.g. pentazocine, butorphanol, buprenorphine, nalbuphine).
Danish: Abstinenssymptomer kan blive fremskyndet, ved administration af stoffer med opioid antagonistaktivitet, f.eks. naloxon, eller blandet agonist/antagonist analgetikum (f.eks, pentazocin, butorphanol, buprenorphin, nalbuphin).
English: Do not use Instanyl after the expiry date which is stated on the bottle after EXP.
Danish: Brug ikke Instanyl efter den udløbsdato (EXP), der står på flasken.
English: Manufacturer Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Danish: Fremstiller Takeda GmbH Robert-Bosch-Strasse 8 D-78224 Singen Tyskland
English: 1.8 ml - 10 doses 2.9 ml - 20 doses 5.0 ml - 40 doses
Danish: 1,8 ml - 10 doser 2,9 ml - 20 doser 5,0 ml - 40 doser
English: If after 10 minutes you need a second dose of Instanyl to relieve your pain, repeat step 1 to 7 in the other nostril.
Danish: Hvis du efter 10 minutter har brug for en ny dosis Instanyl for at lindre dine smerter, skal du gentage trin 1 - 7 i det andet næsebor.
English: A polypropylene (PP) nasal spray container consisting of a glass bottle (brown Type 1 glass) with metering pump.
Danish: Polypropylen (PP) næsespraybeholder bestående af en glasflaske (brun type I-glas) forsynet med doseringspumpe.