FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased mortality was noted in all treatment groups.
Danish: Der blev iagttaget en øget mortalitet i alle behandlingsgrupper.
English: 35, 80339 Munich, Germany.
Danish: 35 80339 München Tyskland.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first utilisation: 25 June 2018
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25 juni 2018
English: The majority (>90%) of healthcare professionals found Dzuveo easy to use.
Danish: Størstedelen (> 90 %) af sundhedspersonalet fandt Dzuveo nemt at anvende.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Abuse potential and tolerance
Danish: Misbrugspotentiale og tolerans
English: Of the 221 patients, 147 received active treatment and 74 received placebo.
Danish: Af de 221 patienter fik 147 aktiv behandling, og 74 fik placebo.
English: The frequencies are defined as:
Danish: Hyppigheden angives på følgende måde:
English: Contents of the pouch are shown below:
Danish: Posens indhold er angivet nedenfor:
English: Each pack contains either 5 or 10 pouches.
Danish: Hver pakning indeholder 5 eller 10 poser.
English: Email: edgar.fenzl@fgk-rs.de
Danish: E-mail: edgar.fenzl@fgk-rs.de
English: It can increase the risk of experiencing severe breathing problems.
Danish: Det kan øge risikoen for svære vejrtrækningsproblemer.
English: Phone: +49 - 89-893 119 22
Danish: Telefon: +49 - 89-893 119 22 Fax:
English: Medicines should not be thrown away via wastewater or household waste.
Danish: Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: Administer product immediately after opening pouch.
Danish: Produktet administreres straks efter åbning af posen.
English: No specific dose adjustment is required in elderly patients.
Danish: Ingen specifik dosisjustering er nødvendig hos ældre patienter.
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Danish: Alle virkninger af sufentanil kan blokeres øjeblikkeligt og fuldstændigt ved administration af en specifik antagonist såsom naloxon.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Danish: I så fald kan opioidantagonisten administreres gentagne gange eller ved infusion.
English: Dzuveo should not be used beyond 48 hours.
Danish: Dzuveo bør ikke anvendes i mere end 48 timer.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest revideret
English: If you are having a blood test ensure your doctor knows you are taking this medicine.
Danish: Hvis du får taget en blodprøve, skal du sikre dig, at lægen ved, at du får dette lægemiddel.
English: The oxygen absorber packet should be discarded.
Danish: Oxygenabsorberpakken bør kasseres.
English: Patient weight and age are key covariates on clearance.
Danish: Patientens vægt og alder er de vigtigste kovariater for clearance.
English: The applicator, with the tablet inside, is enclosed within a pouch.
Danish: Applikatoren, med resoribletten indeni, er indeholdt i en pose.
English: If sufentanil is administered to the mother during this time, an antidote for the child should be readily available.
Danish: Hvis sufentanil administreres til moderen i dette tidsrum, bør en antidot til barnet være umiddelbart tilgængelig.
English: Children and adolescents Dzuveo should not be used in children and adolescents below 18 years.
Danish: Børn og unge Dzuveo bør ikke anvendes hos børn og unge under 18 år.
English: The single-dose applicator (SDA) must be discarded in accordance to the institutional policies and local requirements.
Danish: Enkeltdosisapplikatoren skal bortskaffes i overensstemmelse med institutionens politik og de lokale krav.
English: Steady-state clearance is 129.3 L/hr.
Danish: Steady state-clearance er 129,3 l/t.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Danish: Alt efter den individuelle følsomhed afgøres det kliniske billede af graden af respirationsdepression.
English: Interaction with other sublingually administered products or products intended to dilute/establish an effect in the oral cavity were not evaluated and simultaneous administration should be avoided.
Danish: Interaktion med andre sublingualt administrerede produkter eller produkter til at opløses/etablere en effekt i mundhulen er ikke vurderet, og samtidig administration bør undgås.
English: Your healthcare provider will dispose of any waste according to hospital policies.
Danish: Din sundhedsudbyder vil bortskaffe affald i henhold til hospitalets retningslinjer.
English: Sufentanil has potential for abuse.
Danish: Sufentanil har potentiale for misbrug.
English: No special population studies were performed using Dzuveo in the elderly.
Danish: Der er ikke udført særlige populationsstudier med Dzuveo hos ældre.
English: In humans the potency is 7 to 10-fold higher than fentanyl and 500 to 1,000-fold higher than morphine (per oral).
Danish: Hos mennesker er potensen 7 til 10 gange højere end af fentanyl og 500 til 1.000 gange højere end af morfin (per oral).
English: When Dzuveo is administered every hour, steady-state plasma concentrations are achieved by 7 doses.
Danish: Når Dzuveo administreres hver time, opnås steady state plasmakoncentrationer efter 7 doser.
English: Talk to your doctor or nurse before using Dzuveo.
Danish: Kontakt lægen eller sygeplejersken, før du bruger Dzuveo.
English: Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an increase in the amount of time between doses (see section 4.2).
Danish: En ændring i effekt/tolerabilitet forbundet med den øgede eksponering vil i praksis blive kompenseret med en forøgelse af tiden mellem doserne (se pkt.
English: After receiving a dose you will not be given another dose for at least one hour.
Danish: Når du har fået en dosis, vil du først kunne få en ny, når der er gået mindst 1 time.
English: Primary attention should be given to obstruction of airways and the necessity of assisted or controlled ventilation.
Danish: Behandlingen bør primært vedrøre obstruktion af luftveje og nødvendigheden af assisteret eller kontrolleret ventilation.
English: Risk from concomitant use of sedative medicines such as benzodiazepines or related medicinal products
Danish: Risiko ved samtidig brug af beroligende lægemidler såsom benzodiazepiner eller beslægtede lægemidler
English: Buccal administration showed an increased bioavailability of 78% when the tablets were placed in front of the front lower teeth.
Danish: Buccal administration viste en øget biotilgængelighed på 78 %, når resoribletterne blev placeret foran de forreste tænder i undermunden.
English: • The minimum dosing interval of one sublingual tablet per hour, in order to prevent / minimise the important identified risk of respiratory depression and the important potential risk of overdose;
Danish: • Mindste doseringsinterval på én sublingual resoriblet i timen for at forhindre/minimere den vigtige identificerede risiko for respirationsdepression og den vigtige potentielle risiko for overdosering;
English: Other CNS effects
Danish: Andre CNS-virkninger
English: Hypnotic activity can be demonstrated by EEG alterations.
Danish: Hypnotisk aktivitet kan påvises ved EEGforandringer.
English: Interaction with calcium channel and/or beta blockers
Danish: Interaktion med calciumkanalblokkere og/eller beta-blokkere
English: It measures 3 mm in diameter and is enclosed within a single-dose applicator (labelled [sublingual tablet]).
Danish: Den måler 3 mm i diameter og er indeholdt i en enkeltdosisapplikator (mærket [sublingual resoriblet]).
English: After your treatment the medical staff will dispose of the applicator accordingly.
Danish: Efter behandlingen vil sundhedspersonalet bortskaffe applikatoren.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for sufentanil, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for sufentanil er CHMP nået frem til følgende videnskabelige konklusioner:
English: The maximum daily dose is 720 micrograms (24 tablets per day).
Danish: Den maksimale dagsdosis er 720 mikrogram (24 tabletter).
English: Sufentanil is rapidly metabolised to a number of inactive metabolites, with oxidative N- and O-dealkylation being the major routes of elimination.
Danish: Sufentanil metaboliseres hurtigt til en række inaktive metabolitter med oxidativ N- og O-dealkylering som de vigtigste eliminationsveje.
English: Appropriate measures should be taken to maintain stable arterial pressure.
Danish: Stabilt arterielt tryk bør derfor opretholdes ved passende foranstaltninger.
English: For sublingual use only.
Danish: Kun til sublingual anvendelse.
English: Effect of BMI on dosing
Danish: Virkning af BMI på doseringen
English: It is only prescribed by a doctor who is experienced in the use of strong painkillers like sufentanil and knows the effects it may have on you, in particular on your breathing (see ‘Warnings and precautions' above).
Danish: Det ordineres kun af en læge, der har erfaring med anvendelse af stærke smertestillende midler som sufentanil, og som ved, hvilke virkninger det kan have på dig, især på din vejrtrækning (se "Advarsler og forsigtighedsregler" ovenfor).
English: - Increased heart rate, high blood pressure, low blood pressure.
Danish: - Forhøjet hjerterytme, højt blodtryk, lavt blodtryk.
English: Sufentanil may cause hypotension, especially in hypovolemic patients.
Danish: Sufentanil kan medføre hypotension, navnlig hos hypovolæmiske patienter.
English: Sufentanil should not be used in pregnancy, because it crosses the placenta and the foetal respiratory center is sensitive to opiates.
Danish: Sufentanil bør ikke anvendes under graviditet, da det passerer placenta, og da det føtale respiratoriske center er følsomt for opiater.
English: - Inability to manage blood sugar (diabetes), increased cholesterol.
Danish: Manglende blodsukkerregulering (sukkersyge), forhøjet kolesterol.
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Danish: Gentagen administration af en antagonist kan være nødvendig, da virkningen af respirationsdepressionen kan være mere langvarig end virkningen af antagonisten (se pkt.
English: Patients were predominantly female (63%), mean age was 41 years (range 18-74 years), BMI 15.8 to 53.5 kg/m2, race was predominately White (69%) and Black or African American (21%).
Danish: Patienterne var overvejende kvinder (63 %), gennemsnitsalderen var 41 år (interval 18-74 år), BMI 15,8 til 53,5 kg/m2, racen var overvejende hvid (69 %) og sort eller afroamerikansk (21 %).
English: The most serious side effects are severe breathing problems, like slow and shallow breathing, which may even lead to you stopping breathing.
Danish: De alvorligste bivirkninger er svære vejrtrækningsproblemer som langsom og overfladisk vejrtrækning, som endda kan medføre, at du helt holder op med at trække vejret.
English: The central volume of distribution after intravenous application of sufentanil is approximately 14 litres and the volume of distribution at steady state is approximately 350 litres.
Danish: Det centrale fordelingsvolumen efter intravenøs administration af sufentanil er ca. 14 liter, og fordelingsvolumenet ved steady state er ca. 350 liter.
English: See section 6.6 for instructions regarding handling of the Dzuveo sublingual tablet and applicator.
Danish: 6.6 vedrørende instruktioner for håndtering af Dzuveo sublingual resoriblet og applikator.
English: Gastrointestinal effects
Danish: Gastrointestinale virkninger
English: The dispensed sublingual tablet should dissolve under the tongue and should not be chewed or swallowed.
Danish: Den dispenserede sublinguale resoriblet bør opløses under tungen og bør ikke tygges eller synkes.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Propak Health Ltd
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Propak Health Ltd
English: The shorter duration of activity of the opiate antagonist compared to that of sufentanil should be taken into account.
Danish: Opiatantagonistens mere kortvarige aktivitet i forhold til sufentanil bør tages i betragtning.
English: Sufentanil does not induce histamine release.
Danish: Sufentanil inducerer ikke frigivelse af histamin.
English: If swallowed, the oral bioavailability of Dzuveo is only 9% which would result in a subtherapeutic dose.
Danish: Hvis Dzuveo synkes, er den orale biotilgængelighed kun 9 %, hvilket vil medføre subterapeutisk dosis.
English: Over 24 hours, the mean number of Dzuveo doses administered was 7.0 (210 micrograms/day).
Danish: I løbet af 24 timer var det gennemsnitlige antal administrerede doser af Dzuveo 7,0 (210 mikrogram/dag).
English: These medicines must not be taken in the 2 weeks before or at the same time as Dzuveo is given.
Danish: Disse lægemidler må ikke tages i 2 uger før eller samtidigt med, at der gives Dzuveo.
English: Minimum 1 hour dosing interval.
Danish: Mindste doseringsinterval 1 time.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF 5 OR 10 POUCHES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON MED 5 ELLER 10 POSER
English: Local tolerance Two local tolerance studies were conducted in the hamster cheek pouch with the sufentanil sublingual tablets.
Danish: Lokal tolerance Der udført to studier af lokal tolerance i kindposen på hamstre med sufentanil sublinguale resoribletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1284/001 EU/1/18/1284/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/18/1284/001 EU/1/18/1284/002
English: • Detailed instruction on how to handle overdose / respiratory depression
Danish: • detaljeret vejledning om behandling af overdosering/respirationsdepression.
English: You should only drive and use machines if sufficient time has elapsed after your last dose of Dzuveo.
Danish: Du bør kun føre motorkøretøj og betjene maskiner, hvis der er gået tilstrækkeligt lang tid siden din sidste dosis af Dzuveo.
English: The recommended dose is a maximum of one 30 microgram sublingual tablet per hour.
Danish: Den anbefalede dosis er maksimalt én 30 mikrogram sublingual resoriblet i timen.
English: The pharmacokinetics of sufentanil after administration of Dzuveo can be described as a twocompartment model with first-order absorption.
Danish: Farmakokinetikken af sufentanil efter administration af Dzuveo kan beskrives ved en to-compartment model med førsteordens-absorption.
English: • The method of use of the device;
Danish: • brugsanvisning for udstyret;
English: Population pharmacokinetic analysis with weight as a covariate showed that patients with a higher BMI dosed more frequently.
Danish: Populationsfarmakokinetisk analyse med vægt som kovariat viste, at patienter med højere BMI blev doseret hyppigere.
English: Sufentanil is excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Danish: Sufentanil udskilles i human mælk i så stor en mængde, at en påvirkning af ammede nyfødte/spædbørn er sandsynlig.
English: There are no or limited amount of data from the use of sufentanil in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af sufentanil til gravide kvinder.
English: This route of administration results in higher absolute bioavailability than oral (swallowed) administration by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Danish: Denne administrationsvej fører til højere absolut biotilgængelighed end oral (sunket) administration, idet man undgår intestinal metabolisering og first pass metabolisering i leveren gennem enzymet 3A4.
English: For Dzuveo, population pharmacokinetic analysis showed an effect of age, with an 18% decrease in clearance in the elderly (above 65 years of age).
Danish: Populationsfarmakokinetisk analyse af Dzuveo viste en aldersvirkning med 18 % lavere clearance hos ældre (over 65 år).
English: Mean absolute bioavailability after a single sublingual administration of the sufentanil tablet relative to a one-minute intravenous sufentanil infusion of the same dose was 53%.
Danish: Den gennemsnitlige absolutte biotilgængelighed efter en enkelt sublingual administration af sufentanil resoribletten i forhold til ét minuts intravenøs sufentanil infusion af samme dosis var 53 %.
English: Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible, or when sufentanil is used in an emergency setting.
Danish: På grund af disse risici bør ordination sammen med disse beroligende lægemidler forbeholdes patienter, som ikke har andre behandlingsmuligheder, eller når sufentanil anvendes akut.
English: • The key message to convey during patients counselling, about possible respiratory depression / overdose;
Danish: • hovedbudskabet, der skal formidles ved patientrådgivning, vedrørende muligheden for respirationsdepression/overdosis;
English: The Ames test revealed no mutagenic activity of sufentanil.
Danish: Ames' test viste ikke mutagen aktivitet af sufentanil.
English: Pharmacotherapeutic group: Anesthetics, opioid anesthetics, ATC Code: N01AH03.
Danish: Farmakoterapeutisk klassifikation: Anesthetica; generelle, opioid-anesthetica, ATC-kode: N01AH03.
English: Carcinogenicity Carcinogenicity studies have not been conducted with sufentanil.
Danish: Carcinogenicitet Der er ikke udført Carcinogenicitetsstudier med sufentanil.
English: Dzuveo is provided in a disposable single-dose applicator, to be administered by a healthcare provider as needed by the individual patient, but no more than once every hour, resulting in a maximum dose of 720 micrograms /day.
Danish: Dzuveo leveres i en enkeltdosisapplikator til engangsbrug, der skal administreres af en sundhedsperson på grundlag af den enkelte patients behov, dog højst en gang i timen, hvilket svarer til en maksimal dosis på 720 mikrogram/dag.
English: This medicine must be given to you by a doctor or a nurse using the single-dose administration device.
Danish: Dette lægemiddel skal du have af en læge eller sygeplejerske ved hjælp af enkeltdosisudstyret.
English: Rest the SDA lightly on the patient's teeth or lips.
Danish: Lad engangsapplikatoren hvile let mod patientens tænder eller læber.
English: Management of sufentanil overdose should be focused on treating symptoms of μ-opioid receptor agonism, including administration of oxygen.
Danish: Behandling af overdosering af sufentanil bør fokuseres på at behandle symptomer på μopioidreceptoragonisme, herunder administration af ilt.
English: It was concluded from these studies that sufentanil sublingual tablets have no or minimal potential for local irritation.
Danish: Af studierne blev det konkluderet, at sufentanil sublinguale resoribletter har ringe eller intet potentiale for lokalirritation.
English: Cardiovascular stability is also the result of minimal effects on cardiac preload, cardiac flow rate and myocardial oxygen consumption.
Danish: Kardiovaskulær stabilitet er desuden et resultat af minimale virkninger på hjertets fyldningstryk (preload), den kardiale flow rate og myokardiets iltforbrug.
English: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 Ireland
Danish: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 Irland
English: - Fatty lumps underneath skin.
Danish: Fedtknuder under huden.
English: Sufentanil has major influence on the ability to drive and use machines.
Danish: Sufentanil påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Tell the patient to touch their tongue to the roof of their mouth if possible.
Danish: Bed patienten sætte tungen mod ganen, hvis det er muligt.
English: Similar CST½ values were observed following both single and repeated administration, demonstrating that there is a predictable and consistent duration of action after multiple dosing of the sublingual tablet.
Danish: Der iagttoges samme CST½ -værdier efter både enkel og gentagen administration som tegn på, at virkningstiden er forudsigelig og konstant efter gentagen dosering af den sublinguale resoriblet.
English: Remove the white Lock from the green Pusher by squeezing the sides together and detaching from Pusher.
Danish: Fjern den hvide lås fra den grønne trykknap ved at klemme siderne sammen og løsne den fra trykknappen.
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazole, ritonavir) cannot be excluded.
Danish: Tilsvarende effekter kan ikke udelukkes med andre potente CYP3A4 hæmmere (f.eks. itraconazol og ritonavir).
English: After multiple administrations, a longer mean terminal half-life of 15.7 hours (range 2.4 to 42.7 hours) was observed, owing to the higher plasma concentrations of sufentanil achieved after repeated dosing and due to the possibility to quantify these concentrations over a longer time period.
Danish: Efter gentagen administration observeredes en længere gennemsnitlig terminal halveringstid på 15,7 timer (interval: 2,4 til 42,7 timer) som følge af de højere plasmakoncentrationer af sufentanil, der opnås efter gentagen dosering, og som følge af muligheden for at kvantificere disse koncentrationer over et længere tidsrum.
English: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Ireland.
Danish: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas, Dublin 11 Irland.
English: Ketoconazole, a potent CYP3A4 inhibitor, can significantly increase the systemic exposure to sublingual sufentanil (maximal plasma levels (Cmax) increase of 19%, overall exposure to the active substance (AUC) increase of 77% and prolong the time to reach maximum concentration by 41%.
Danish: Ketoconazol, der er en potent CYP3A4-hæmmer, kan medføre væsentligt øget systemisk eksponering for sublingualt sufentanil (maksimal plasmakoncentration (Cmax) forhøjet med 19 %, samlet eksponering for det aktive stof (AUC) forhøjet med 77 %, og tid til indtræden af maksimumkoncentration forlænget med 41 %).
English: The high lipophilicity of sufentanil allows it to be administered sublingually and achieve a rapid onset of analgesic effect.
Danish: Sufentanils høje lipofilicitet gør det muligt at administrere det sublingualt og opnå hurtig indsætten af analgetisk virkning.
English: Biotransformation takes place primarily in the liver and the small intestine.
Danish: Biotransformation finder fortrinsvis sted i leveren og tyndtarmen.
English: This may range from hypoventilation to respiratory arrest.
Danish: Denne kan spænde fra hypoventilation til respirationsstop.
English: There are no clinical data on the effects of sufentanil on fertility.
Danish: Der foreligger ingen kliniske data om virkningerne af sufentanil på fertiliteten.