FrancophonIA/ELRC3.0 huggingface dataset:
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
English: The administration device will make you wait 20 minutes between doses to prevent you from taking more Zalviso than you should.
Danish: Doseringsudstyret er konstrueret, så du skal vente 20 minutter mellem doserne, for at forhindre, at du tager for mange Zalviso.
English: The dispensed sublingual tablet should dissolve under the tongue and should not be crushed, chewed, or swallowed.
Danish: Den dispenserede sublinguale resoriblet skal opløses under tungen og må ikke knuses, tygges eller synkes.
English: The active substance of Zalviso is sufentanil, which belongs to a group of strong pain-relieving medicines called opioids.
Danish: Det aktive stof i Zalviso er sufentanil, som tilhører gruppen af stærke, smertestillende lægemidler, kaldet opioider.
English: If these start to develop, tell a doctor or nurse immediately.
Danish: Hvis dette sker, skal du straks fortælle det til en læge eller sygeplejerske.
English: Clinical trials have shown that sufentanil administered intravenously causes less respiratory depression when compared with equianalgesic doses of fentanyl.
Danish: Kliniske studier har vist, at sufentanil administreret intravenøst forårsager mindre hæmmet respiration i sammenligning med ækvianalgetiske doser af fentanyl.
English: Direct effects of sufentanil on myocardial function were not observed.
Danish: Der er ikke observeret nogen direkte effekt af sufentanil på myokardiefunktionen.
English: However if your doctor prescribes Zalviso together with sedating medicines the duration of concomitant treatment should be limited by your doctor.
Danish: Hvis din læge ordinerer Zalviso sammen med beroligende medicin, bør din læge begrænse varigheden af den samtidig behandling.
English: Efficacy of Zalviso for patient-controlled analgesia was demonstrated in 3 Phase III clinical trials in acute post-surgical nociceptive and visceral pain (post-surgical pain following major abdominal or orthopaedic surgery): 2 trials were double-blind placebo-controlled (Zalviso N = 430 patients; placebo N = 161 patients) and 1 was an open-label active-controlled (Zalviso N = 177 patients; morphine N = 180 patients) trial.
Danish: Effekten af Zalviso ved patientkontrolleret analgesi er påvist i 3 kliniske fase III-forsøg ved akut, postoperativ nociceptiv og visceral smerte (postoperativ smerte efter større abdominale eller ortopædiske operationer): 2 studier var dobbeltblindede og placebokontrollerede (Zalviso n = 430 patienter; placebo n = 161 patienter), og 1 var et åbent studie med aktiv kontrol (Zalviso n = 177 patienter; morfin n = 180 patienter).
English: Zalviso should only be prescribed by physicians who are experienced in the management of opioid therapy, particularly opioid adverse reactions such as respiratory depression (see section 4.4).
Danish: Zalviso må kun ordineres af læger, der er erfarne og trænede i håndteringen af opioid terapi, især opioide bivirkninger, f.eks. respirationsdepression (se afsnit 4.4).
English: Heart rate increased Heart rate decreased*
Danish: Øget hjerterytme Nedsat hjerterytme*
English: The fully charged Zalviso administration device will operate without recharging for up to 72 hours.
Danish: Fuldt opladet Zalviso doseringsudstyr fungerer i 72 timer uden genopladning.
English: 1932 Sint-Stevens-Woluwe België/Belgique/Belgien Tél/Tel: + 32 (0)2 290 52 00 beinfo@grunenthal.com
Danish: B-1932 Sint-Stevens-Woluwe België/Belgique/Belgien Tél/Tel: + 32 (0)2 290 52 00 beinfo@grunenthal.com
English: Clinically relevant plasma levels are largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50 % of Cmax after discontinuation of dosing (context sensitive halftime or CST½) rather than by the terminal half-life.
Danish: Klinisk relevante plasmaniveauer bestemmes primært af tiden, det tager plasmakoncentrationen af sufentanil at falde fra Cmax til 50 % af Cmax efter seponering (CST½), frem for den terminale halveringstid.
English: Only limited data are available for the use of Zalviso in such patients.
Danish: Der foreligger kun begrænsede data om brugen af Zalviso hos sådanne patienter.
English: High doses of intravenously administered sufentanil are known to cause muscle rigidity, probably as a result of an effect on the substantia nigra and the striate nucleus.
Danish: Man ved, at høje doser af intravenøst administreret sufentanil kan forårsage muskelstivhed, sandsynligvis som følge af en effekt på substantia nigra og corpus striatum.
English: DE-52078 Aachen Tel: + 49 241 569-1111 service@grunenthal.com
Danish: D-52078 Aachen Tel: + 49 241 569-1111 service@grunenthal.com
English: A significantly higher proportion of patients (78.5 %) rated the method of pain control as “good” or “excellent” with Zalviso than with intravenous morphine patient-controlled analgesia method (65.5 %) (primary endpoint at 48 hours; P = 0.007).
Danish: En signifikant højere patientandel (78,5 %) vurderede smertekontrolmetoden som “god” eller “udmærket” med Zalviso end med patientkontrolleret analgesi med intravenøs morfin (65,5 %) (primært effektmål ved 48 timer; p = 0,007).
English: Campus 21, Liebermannstraße A01/501 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
Danish: Campus 21, Liebermannstraße A01/501 A-2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
English: In the micronucleus test in female rats, single intravenous doses of sufentanil as high as 80 µg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations.
Danish: I mikrokernetesten hos hunrotter viste enkelte, intravenøse doser af sufentanil helt op til 80 µg/kg (cirka 2,5 gange maksimal human, intravenøs dosis) ingen strukturelle kromosommutationer.
English: - Significant respiratory depression.
Danish: Signifikant hæmmet respiration.
English: Tell your doctor or nurse before treatment if you: - are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath).
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du: - lider af en sygdom, der påvirker din vejrtrækning (f.eks. astma, hvæsende åndedræt eller stakåndethed).
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 dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: www.ema.europa.eu
English: Mean absolute bioavailability after a single sublingual administration of Zalviso relative to a oneminute intravenous sufentanil infusion of 15 micrograms was 59 %.
Danish: Den gennemsnitlige, absolutte biotilgængelighed efter en enkelt, sublingual administration af Zalviso i forhold til én et-minuts intravenøs infusion af 15 mikrogram sufentanil var 59 %.
English: However, there was a statistically significant lower percentage of patients who experienced oxygen desaturation episodes following the administration of Zalviso sublingual tablets (19.8 %) with the administration device than in the IV PCA morphine group (30.0 %).
Danish: Der sås imidlertid en statistisk signifikant lavere procentdel af patienter, som oplevede episoder med iltafmætning efter administration af Zalviso sublinguale resoribletter (19,8 %) med doseringsudstyret end i gruppen med patientkontrolleret smertelindring med intravenøs morfin (30,0 %).
English: 40 sublingual tablets
Danish: 40 sublinguale resoribletter
English: The instructions for setting up the Zalviso administration device by a healthcare professional must be followed carefully.
Danish: Instruktionerne til sundhedspersonalet om opsætning af Zalviso doseringsudstyret skal følges nøje.
English: No pharmacokinetic data exist for the Zalviso in paediatric patients.
Danish: Der foreligger ingen farmakokinetiske data for brug af Zalviso til pædiatriske patienter.
English: The sublingual tablets are taken using the Zalviso administration device, which is a system that delivers a single dose upon activation.
Danish: De sublinguale resoribletter tages ved hjælp af Zalviso doseringsudstyr, der er et system, som frigiver en enkeltdosis efter aktivering.
English: Zalviso is placed under the tongue using the Zalviso administration device.
Danish: Zalviso placeres under tungen med Zalviso doseringsudstyret.
English: In the event of repeated maximal usage by the patient, one cartridge will last for a period of 13 hours 20 minutes.
Danish: Ved gentagen maksimal brug holder en patron i 13 timer og 20 minutter.
English: Reproductive toxicity has been shown in animal studies (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: Sufentanil should be used with caution in patients with brain tumours.
Danish: Sufentanil bør anvendes med forsigtighed hos patienter med hjernetumorer.
English: The tablets dissolve under your tongue and should not be crushed, chewed, or swallowed.
Danish: Resoribletten opløses under tungen og må ikke knuses, tygges eller synkes.
English: Superiority over placebo was demonstrated in the Phase III placebo-controlled trials for the primary endpoint time-weighted sum of pain intensity difference from baseline over 48 hours (SPID48; P 0.001), and the secondary endpoints, time-weighted SPID (P 0.004), total pain relief (TOTPAR; P 0.004), and patients global assessment (P 0.007) over 24, 48 and 72 hours.
Danish: Zalviso viste sig at være bedre end placebo i de placebokontrollerede fase III-studier i det primære effektmål, tidsvægtet sum af forskel i smerteintensitet fra baseline i 48 timer (SPID48; p 0,001), og de sekundære effektmål, tidsvægtet SPID (p 0,004), fuld smertelindring (TOTPAR); p 0,004), og patienters samlede vurdering (p 0,007) i 24, 48 og 72 timer.
English: However, symptoms of overdose include severe breathing problems like slow and shallow breathing, loss of conciousness, extreme low blood pressure, collapse and muscle rigidity.
Danish: Symptomer på en overdosis omfatter imidlertid svære åndedrætsproblemer som langsomt og overfladisk åndedræt, bevidstløshed, ekstremt lavt blodtryk, kollaps og muskelstivhed.
English: Only limited data are available for the use of sufentanil in such patients.
Danish: Der foreligger kun begrænsede data om brugen af sufentanil hos sådanne patienter.
English: Zalviso is used to treat acute moderate to severe pain after an operation in adults.
Danish: Zalviso anvendes til behandling af akutte, moderate til svære smerter hos voksne efter en operation.
English: The respiratory effects of sufentanil should be assessed by clinical monitoring, e. g. respiratory rate, sedation level and oxygen saturation.
Danish: Sufentanils respiratoriske virkning bør evalueres med klinisk overvågning, f.eks. åndedrætshastighed, sedationsniveau og iltmætning.
English: In the Phase III active-controlled trial, the magnitude of decrease in oxygen saturation was comparable between Zalviso and i.v.
Danish: I fase III-forsøget med aktiv kontrol var formindskelsens størrelse i iltmætning sammenlignelig mellem Zalviso and i.v.-patientkontrollerede morfingrupper.
English: The Zalviso administration device is designed to deliver a single sufentanil 15 micrograms sublingual tablet, on a patient-controlled as needed basis, with a minimum of 20 minutes (lockout interval) between doses, over a period of up to 72 hours, which is the maximum recommended treatment duration.
Danish: Zalviso doseringsudstyr er designet til at administrere en enkelt 15 mikrogram sufentanil sublingual resoriblet på patientkontrolleret basis efter behov, med minimum 20 minutter (låst interval) mellem doserne, over en periode på 72 timer, som er den maksimale, anbefalede behandlingsvarighed.
English: Ask the medical staff how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: - Medicines for the treatment of depression known as Monoamine Oxidase Inhibitors (MAOIs).
Danish: Lægemidler til behandling af depression kaldet monoaminoxidase-hæmmere (MAOI'er).
English: Gastrointestinal effects of sufentanil comprise decreased propulsive motility, reduced secretion and increased muscle tone (up to spasms) of the sphincters of the gastrointestinal tract (see section 4.4).
Danish: Sufentanils gastrointestinale virkning omfatter reduceret motilitet, reduceret sekretion og øget muskeltonus (herunder spasmer) i mave-tarmkanalens sfinctere (se pkt.
English: Patients should only drive and use machines if sufficient time has elapsed after the last administration of Zalviso.
Danish: Patienter bør kun føre motorkøretøj eller betjene maskiner, hvis der er forløbet tilstrækkelig tid efter seneste indgivelse af Zalviso.
English: The Zalviso administration device should not be used if any component is visibly damaged.
Danish: Zalviso doseringsudstyret må ikke anvendes, hvis dele af udstyret er synligt beskadiget.
English: Based on the population pharmacokinetic analysis for Zalviso in patients and healthy volunteers (N = 700), which included 13 patients with moderate and 6 patients with severe hepatic impairment, hepatic function was not identified as a significant covariate for clearance.
Danish: Baseret på den populationsfarmakokinetiske analyse af Zalviso hos patienter og raske forsøgspersoner (n = 700), der omfattede 13 patienter med moderat og 6 patienter med svært nedsat leverfunktion, var leverfunktion ikke identificeret som en signifikant covariat for clearance.
English: - Medicines for the treatment of depression known as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Danish: - Lægemidler til behandling af depression kaldet serotonin-genoptagelseshæmmere (SSRI'er) og serotonin-noradrenalin-genoptagelseshæmmere (SNRI'er).
English: Analgesic doses of Zalviso resulted in respiratory depressive effects in some patients in the clinical trials.
Danish: Analgetiske doser af Zalviso kan hos nogle patienter virke respirationshæmmende i de kliniske forsøg.
English: Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Danish: Zalviso er indiceret til behandling af akutte, moderate til svære postoperative smerter hos voksne patienter.
English: After single administration of a 15 micrograms sufentanil sublingual tablet, mean terminal phase halflives in the range of 6 to 10 hours have been observed.
Danish: Efter enkeltadministration af en 15 mikrogram sufentanil sublingual resoriblet sås middelterminalfasehalveringstider i intervallet 6 til 10 timer.
English: Other medicines and Zalviso Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zalviso Fortæl det til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Patients were treated using the Zalviso dosing regimen of 15 micrograms sufentanil sublingually as needed with a minimum 20 minute lock-out interval over a period of 72 hours.
Danish: Patienter blev behandlet efter et Zalviso-doseringsskema med 15 mikrogram sufentanil sublingualt efter behov med låst minimum 20 minutters interval i en periode på 72 timer.
English: Sufentanil acts as a full agonist in µ-opioid receptors.
Danish: Sufentanil fungerer som en fuld agonist i µ-opioid-receptorer.
English: Their frequencies were established based on data from intravenous administration of sufentanil: common - muscle twitching; uncommon - hypersensitivity, apathy, nervousness, ataxia, dystonia, hyperreflexia, heart rate decreased and dry skin.
Danish: Deres hyppigheder blev bestemt ud fra data fra intravenøs administration af sufentanil: almindelig - muskeltrækninger; ikke almindelig - overfølsomhed, apati, nervøsitet, ataksi, dystoni, hyperrefleksi, nedsat hjerterytme og tør hud.
English: Sufentanil overdose is manifested by an exaggeration of its pharmacological effects.
Danish: Symptomerne på overdosering af sufentanil er en forstærkning af den farmakologiske virkning.
English: Patients at higher risk are those with respiratory impairment or reduced respiratory reserve.
Danish: Patienter med nedsat respirationsfunktion eller respiratorisk reserve har højere risiko.
English: Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Danish: Samtidig administration af sufentanil og et serotonergt middel som f.eks. selektive serotoningenoptagelseshæmmere (SSRI'er), serotonin-noradrenalinin-genoptagelseshæmmere (SNRI'er) eller monoaminoxidase-hæmmere (MAOI'er) kan øge risikoen for serotoninsyndrom, som er en potentielt livstruende tilstand.
English: Confusional state Apathy* Nervousness*
Danish: Apati* Nervøsitet*
English: A population pharmacokinetic analysis of plasma sufentanil concentrations following usage of Zalviso in patients and healthy volunteers (N = 700), which included 75 patients with moderate and 7 patients with severe renal impairment, did not identify renal function as a significant covariate for clearance.
Danish: En populationsfarmakokinetisk analyse af plasmasufentanil-koncentrationer efter brug af Zalviso hos patienter og raske forsøgspersoner (n = 700), der omfattede 75 patienter med moderat og 7 patienter med svært nedsat nyrefunktion, identificerede ikke nyrefunktion som en signifikant covariat for clearance.
English: Zalviso should be administered with caution to patients with moderate to severe hepatic or severe renal impairment (see section 4.4).
Danish: Zalviso skal administreres med forsigtighed til patienter med moderat til svært nedsat lever- eller nyrefunktion (se afsnit 4.4).
English: Breastfeeding is not recommended when sufentanil is administered, due to the risk of opioid effects or toxicity in the breastfed newborns/infants (see section 4.9).
Danish: Det anbefales at undlade at amme under behandling med sufentanil på grund af risiko for opioid virkning eller toksicitet hos den ammede nyfødte/spædbarnet (se pkt.
English: For instructions on the setup and handling of the Zalviso administration device before administration, see section 6.6.
Danish: 6.6 for instruktioner i opsætning og håndtering af Zalviso doseringsudstyr før administration.
English: After your treatment the medical staff will take the Zalviso administration device and dispose of any unused tablets accordingly.
Danish: Efter behandlingen tager sundhedspersonalet Zalviso doseringsudstyret og bortskaffer eventuelle ubrugte resoribletter.
English: The concomitant use of CNS depressants including barbiturates, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression.
Danish: Samtidig brug af sedativa, herunder barbiturater, neuroleptika eller andre opioider, halogengasser eller andre ikke-selektive sedativa (f.eks. alkohol) kan forstærke en hæmmet respiration.
English: You should only drive and use machines if sufficient time as elapsed after your last dose of Zalviso.
Danish: Du bør kun føre motorkøretøj eller betjene maskiner, hvis der er forløbet tilstrækkelig lang tid efter seneste dosis Zalviso.
English: Secondary pharmacodynamics effects
Danish: Sekundær farmakodynamisk virkning
English: However, due to the limited number of patients with severe renal impairment studied, Zalviso should be used with caution in such patients (see section 4.4).
Danish: På grund af det begrænsede antal undersøgte patienter med svært nedsat nyrefunktion skal Zalviso dog anvendes med forsigtighed hos sådanne patienter (se pkt.
English: Frequency not known (frequency cannot be estimated from the available data): severe allergic reactions (anaphylactic shock), convulsion (fits), coma, small pupil size, redness of the skin, withdrawal syndrome.
Danish: Hyppighed ikke kendt (hyppighed kan ikke estimeres ud fra forhåndenværende data): svære allergiske reaktioner (anafylaktisk shock), krampeanfald (anfald), koma, små pupiller, rødme af huden, abstinenssyndrom.
English: Zalviso sublingual tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Danish: Zalviso sublinguale resoribletter indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. lægemidlet er i det væsentlige natrium-frit.
English: Do not use the device if any component is visibly damaged.
Danish: Doseringsudstyret må ikke anvendes, hvis dele er synligt beskadiget.
English: To be used only with the Zalviso administration device.
Danish: Må kun anvendes sammen med Zalviso doseringsudstyr.
English: How to take Zalviso
Danish: Sådan skal du tage Zalviso
English: Zalviso sublingual tablets of 3 mm diameter are orange-coloured flat-faced tablets with rounded edges.
Danish: Zalviso sublinguale resoribletter, 3 mm i diameter, er orangefarvede resoribletter med flad overside og afrundede kanter.
English: Repeat-dose toxicity
Danish: Gentagen dosistoksicitet
English: Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances
Danish: Risiko forbundet med samtidig brug af sedativa såsom benzodiazepiner eller lignende stoffer.
English: Primary pharmacodynamics effects
Danish: Primær farmakodynamisk virkning
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Danish: Sufentanil metaboliseres primært af det humane cytokrom P450-3A4-enzym.
English: Patients with moderate to severe hepatic or severe renal impairment should be monitored carefully for symptoms of sufentanil overdose (see section 4.9).
Danish: Patienter med moderat til svært nedsat leverfunktion eller svært nedsat nyrefunktion skal nøje overvåges for symptomer på en overdosis af sufentanil (se pkt.
English: Sufentanil may obscure the clinical course of patients with head injury.
Danish: Sufentanil kan bevirke, at det kliniske forløb for en patient med kranietraume bliver uklart.
English: The most serious adverse reaction of sufentanil is respiratory depression, potentially leading to apnoea and respiratory arrest (see section 4.4).
Danish: Den alvorligste bivirkning af sufentanil er hæmmet respiration, der potentielt kan føre til apnø og åndedrætsstop (se pkt.
English: Croscarmellose sodium Stearic acid
Danish: Croscarmellosenatrium Stearinsyre
English: Sublingual use.
Danish: Sublingual anvendelse.
English: Uncommon side effects (may affect up to 1 in 100 people): allergic reactions, lack of interest or emotion, nervousness, sleepiness, abnormal sensation of the skin, problems coordinating muscle movements, muscle contractions, exaggeration of reflexes, vision disturbances, decreased heart rate, dry mouth, excessive sweating, rash, dry skin, chills, weakness.
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100): allergiske reaktioner, manglende interesse eller følelser, nervøsitet, søvnløshed, unormale fornemmelser i huden, problemer med at koordinere muskelbevægelser, muskelsammentrækninger, overdrevne reflekser, synsforstyrrelser, nedsat hjerterytme, mundtørhed, øget sved produktion, udslæt, tør hud, kulderystelser, svækkelse.
English: Zalviso 15 micrograms sublingual tablets Sufentanil
Danish: Zalviso 15 mikrogram resoribletter, sublinguale Sufentanil
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: The Zalviso sublingual tablets are to be self-administered using the Zalviso administration device which should only be actuated by the patient in response to pain (see section 6.6).
Danish: Zalviso sublinguale resoribletter skal egenadministreres med Zalviso doseringsudstyr, som kun må aktiveres af patienten som respons på smerte (se pkt.
English: Zalviso is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Zalviso bør ikke anvendes under graviditet og til kvinder i den fertile alder, som ikke anvender sikker prævention.