FrancophonIA/ELRC3.0 huggingface dataset:
English: After treatment discontinuation the health-care professional has to remove the cartridge from the device and any unused and/or not completely empty cartridges have to be disposed by the health-care professional in accordance with local laws and requirements for controlled substances.
Danish: Efter seponering af behandlingen skal sundhedspersonalet fjerne patronen fra udstyret, og eventuelle ubrugte og/eller ikke helt tomme patroner skal bortskaffes af sundhedspersonalet i overensstemmelse med lokale love og regler for kontrollerede stoffer.
English: Sufentanil may cause hypotension, especially in hypovolemic patients.
Danish: Sufentanil kan forårsage hypotension, særligt hos hypovolæmiske patienter.
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 et antal inaktive metabolitter med oxidativ N- og O-dealkylering som de primære eliminationsveje.
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Danish: Afhængigt af den enkelte patients sensitivitet afgøres det kliniske billede af graden af hæmmet respiration.
English: Clearance is not affected by race, sex, renal parameters, hepatic parameters, or concomitant CYP3A4 substrates.
Danish: Clearance påvirkes ikke af race, køn, nyrefunktionstal, leverfunktion eller samtidige CYP3A4-substrater.
English: Immeuble Eurêka 19 rue Ernest Renan CS 90001
Danish: Laboratoires Grünenthal SAS Immeuble Eurêka 19 rue Ernest Renan CS 90001
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 distributionsvolumen efter intravenøs administration af sufentanil er cirka 14 liter, og distributionsvolumen ved steady state er cirka 350 liter.
English: The health-care professional should take into consideration the ability (e. g. visual or cognitive) of the patient to use the device appropriately.
Danish: Sundhedspersonalet bør tage patientens evne (f.eks. visuel eller kognitiv) til at betjene udstyret med i betragtning.
English: - Other medicines which are also taken sublingually (medicines that are placed under the tongue where they dissolve) or medicines which dilute or take effect in your mouth (e.g. nystatin, a liquid or pastilles you hold in your mouth to treat fungus infections), as the effect on Zalviso has not been studied.
Danish: - Andre lægemidler, som også tages sublingualt (lægemidler, der placeres under tungen), eller lægemidler, som opløses eller virker i munden (f.eks. nystatin, en væske eller pastiller, du holder i munden til behandling af svampeinfektioner), da deres påvirkning af Zalviso ikke er undersøgt.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to / are provided with the following items:
Danish: Indehaveren (MAH) vil sikre, at efter diskussioner og aftale med de nationale, ansvarlige myndigheder i hver enkelt medlemsstat, hvor Zalviso markedsføres, informeres alle læger, som forventes at ordinere Zalviso, via en informationsskrivelse om adgang til/udleveres til dem følgende oplysninger:
English: In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Danish: I denne henseende anbefales det på det kraftigste at informere patienter og omsorgspersoner om at være opmærksomme på disse symptomer (se pkt.
English: Each sublingual tablet contains 0.013 mg sodium.
Danish: Hver sublingual resoriblet indeholder 0,013 mg natrium.
English: It is only prescribed by physicians who are experienced in the use of strong pain killers like Zalviso and know the effects it may have on you, in particular on your breathing (see “Warnings and precautions” above).
Danish: Det ordineres kun af læger med erfaring i brug af stærke, smertestillende midler som Zalviso, og som kender den virkning, det kan have på dig, særligt på din vejrtrækning (se “Advarsler og forsigtighedsregler” ovenfor).
English: This may range from hypoventilation to respiratory arrest.
Danish: Det kan være fra hypoventilation til åndedrætsstop.
English: Prior to launch of Zalviso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden markedsføring i hver enkelt medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) træffe aftale med den nationale, ansvarlige myndighed om uddannelsesprogrammets indhold og format, herunder kommunikationsmedier, fordelingskanaler og alle andre aspekter i programmet.
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, en potent CYP3A4-inhibitor, kan signifikant øge den systemiske eksponering for sublingual sufentanil (maksimal stigning i plasmaniveauer (Cmax) på 19 %, samlet 77 % øget eksponering for det aktive stof (AUC) og forlænge tiden til maksimal koncentration med 41 %.
English: Analgesia induced by sufentanil is thought to be mediated via activation of µ-opioid receptors primarily within the CNS to alter processes affecting both the perception of and the response to pain.
Danish: Analgesi induceret af sufentanil menes at blive medieret via aktivering af µ-opioid-receptorer, primært i CNS, for at ændre processer, der påvirker både følelsen af og responsen på smerte.
English: Adverse reactions identified either from clinical studies or from post-marketing experience with other medicinal products containing sufentanil are summarised in the table below.
Danish: Bivirkninger, påvist enten under kliniske studier eller efter markedsføringen med andre lægemidler, der indeholder sufentanil, er opsummeret i skemaet nedenfor.
English: Buccal administration study showed an increased bioavailability of 78 % when the tablets were placed in front of the front lower teeth.
Danish: Studiet med buccal administration viste en forøget biotilgængelighed på 78 %, når resoribletterne blev placeret foran fortænderne i undermunden.
English: Somnolence Paraesthesia Ataxia* Dystonia* Hyperreflexia*
Danish: Somnolens Paræstesi Ataksi* Dystoni* Hyperrefleksi*
English: In clinical trials approximately 30 % of enrolled patients were 65 to 75 years of age.
Danish: I kliniske forsøg var cirka 30 % af de inkluderede patienter i alderen 65-75 år.
English: Patients reported in all the 3 Phase III trials a clinically meaningful pain relief within the first hour of treatment with Zalviso (pain intensity difference to baseline and total pain response >1 NRS).
Danish: Patienter berettede i alle 3 fase III-forsøg en klinisk betydende smertelindring inden for den første times behandling med Zalviso (smerteintensitetsforskel i forhold til baseline og total smerterespons >1 NRS).
English: Pharmacotherapeutic group: Opioid anaesthetics, ATC Code: N01AH03
Danish: Farmakoterapeutisk klassifikation: opoide anæstetika, ATC-kode: N01AH03.
English: The pharmacokinetics of sufentanil after sublingual administration can be described as a threecompartment model with first-order absorption.
Danish: Sufentanils farmakokinetik efter sublingual administration kan beskrives som en trekammer-model med førsteordens absorption.
English: This route of administration results in higher absolute bioavailability by avoiding intestinal and first-pass liver 3A4 enzyme metabolism.
Danish: Administrationsvejen resulterer i højere absolut biotilgængelighed ved at undgå metabolisering i tarmene og first pass-metabolisering af 3A4-enzymet i leveren.
English: The Ames test revealed no mutagenic activity of sufentanil.
Danish: Ames-testen viste ingen mutagen aktivitet af sufentanil.
English: On the basis of the scientific conclusions for sufentanil the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing sufentanil is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for sufentanil er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder sufentanil, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: After 48 hours more than half of the subjects in the Zalviso group had a relevant pain reduction (30 % responder rate) in these trials (visceral pain 60 %, nociceptive pain 54.9 %).
Danish: Efter 48 timer havde mere end halvdelen af forsøgspersonerne i Zalviso-gruppen relevant smertereduktion (30 % responderrate) i disse studier (visceral smerte 60 %, nocireceptiv smerte 54,9 %).
English: Cardiovascular stability is also the result of minimal effects on cardiac preload, cardiac flow rate and myocardial oxygen consumption.
Danish: Kardiovaskulær stabilitet skyldes også minimale virkninger af kardialt preload, kardial strømningshastighed (flow rate) og myokardialt iltforbrug.
English: The duration of the concomitant use should be limited (see section 4.4).
Danish: Varigheden af samtidig brug bør begrænses (se pkt.
English: Do not take Zalviso: - if you are allergic to sufentanil or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Zalviso: - hvis du er allergisk over for sufentanil eller et af de øvrige indholdsstoffer i sufentanil (angivet i afsnit 6).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystemanført i Appendiks V.
English: The safety and efficacy of Zalviso in children aged below 18 years have not been established.
Danish: Zalvisos sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: The cartridge should be used only with the Zalviso administration device, consisting of a controller and a dispenser to ensure the proper use of this system.
Danish: Patronen må kun bruges sammen med Zalviso doseringsudstyr, der består af en kontrolenhed og en dispenser for at sikre korrekt brug af systemet.
English: There is limited pharmacokinetic data available in children after intravenous sufentanil administration.
Danish: Der er begrænsede farmakokinetiske data for børn efter intravenøs administration af sufentanil.
English: Patients who were treated with Zalviso between 48 and 72 hours in the three controlled trials used a wide range of the available 216 doses, with a mean of 49 doses/patient (range of 8-153 doses) with the majority of patients (69.7 %) using between 24 to 72 doses.
Danish: Patienter, der blev behandlet med Zalviso mellem 48 og 72 timer i de tre kontrollerede undersøgelser, anvendte et bredt spektrum af de tilgængelige 216 doser, med en middelværdi på 49 doser/patient (interval på 8-153 doser) med et flertal af patienter (69,7 %), der anvendte mellem 24 og 72 doser.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking or after the treatment with Zalviso.
Danish: Patienter bør rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever somnolens, svimmelhed eller synsforstyrrelser, mens de tager eller efter behandling med Zalviso.
English: What you need to know before you take Zalviso
Danish: Det skal du vide, før du begynder at tage Zalviso
English: D-52078 Aachen GERMANY
Danish: D-52078 Aachen Tyskland
English: Patients on chronic opioid therapy or opioid addicts may require higher analgesic doses than the Zalviso administration device can deliver.
Danish: Patienter, der får kronisk, opiod terapi eller er opiumafhængige, kan have behov for højere analgetiske doser, end Zalviso doseringsudstyret kan administrere.
English: Warnings and precautions Talk to your doctor or nurse before taking Zalviso.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du tager Zalviso.
English: This should be considered when prescribing or administering sufentanil where there is concern about an increased risk of misuse, abuse or diversion.
Danish: Dette bør tages i betragtning ved ordination eller administration af sufentanil, hvor der er mistanke om øget risiko for misbrug eller anvendelse på anden måde end den foreskrevne.
English: After multiple administrations, a longer mean terminal half-life of up to 18 hours was determined, 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 flere administrationer blev en længere middelterminal halveringstid bestemt på op til 18 timer på grund af de højere plasmakoncentrationer af sufentanil, derblev nået efter gentagen dosering, og på grund af muligheden for at bestemme disse koncentrationer over en længere periode.
English: The maximum amount of sublingual sufentanil that can be delivered via the Zalviso administration device over an hour is 45 micrograms (3 doses).
Danish: Den maksimale mængde sublingual sufentanil, der kan administreres via Zalviso doseringsudstyr i en time, er 45 mikrogram (3 doser).
English: As demonstrated in the active-controlled trial, the average time between Zalviso doses was approximately double as long as compared to intravenous morphine patient-controlled analgesia (approximately 80 minutes compared to approximately 45 minutes) over the first 48 hours.
Danish: Som påvist i studiet med aktiv kontrol var den gennemsnitlige tid mellem doserne af Zalviso cirka dobbelt så lang sammenlignet med patientkontrolleret smertelindring med intravenøs morfin (cirka 80 minutter sammenlignet med cirka 45 minutter) i løbet af de første 48 timer.
English: Sufentanil has been shown to induce opioid-like effects in a variety of laboratory animals (dogs, rats, guinea pigs, hamsters) at doses above those inducing analgesia and in two repeat-dose studies with sufentanil sublingual tablets administered buccally in Golden Syrian hamster.
Danish: Det er blevet påvist, at sufentanil inducerer opioid-lignende effekter hos et udvalg af laboratoriedyr (hunde, rotter, marsvin, hamstere) ved doser over dem, der inducerer analgesi, og i to studier med gentagen dosis med sufentanil sublinguale resoribletter, administreret buccalt hos syrisk guldhamster.
English: Some adverse reactions were not observed in the clinical trials with Zalviso.
Danish: Nogle bivirkninger blev ikke observeret i de kliniske forsøg med Zalviso.
English: Analgesic plasma concentrations of sufentanil may provoke nausea and vomiting by irritation of the chemoreceptor trigger zone.
Danish: Sufentanils analgetiske plasmakoncentrationer kan give kvalme og opkastning på grund af irritation af kemoreceptortriggerzonen.
English: Carcinogenicity studies have not been conducted on sufentanil.
Danish: Der er ikke udført carcinogenicitetsstudier med sufentanil.
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (see section 2 “What you need to know before you take Zalviso”)
Danish: - De øvrige indholdsstoffer er mannitol (E421), calciumhydrogenphosphat (vandfrit), hypromellose, croscarmellosenatrium, stearinsyre, magnesiumstearat, sunset yellow FCF aluminium lake (E110) (se afsnit 2 “Det skal du vide, før du begynder at tage Zalviso”)
English: After prolonged use of other substances with µ-opioid receptor activity, symptoms of withdrawal were observed after abrupt interruption of the treatment.
Danish: Efter længere tids anvendelse af andre stoffer med µ-opioid receptor-aktivitet sås abstinenssymptomer efter brat seponering af behandlingen.
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: Det kan være nødvendigt at gentage administration af antagonister, da den hæmmede respiration kan vare længere end antagonistens virkning (se pkt.
English: Monoamine Oxidase Inhibitors must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Danish: Monoaminoxidase-hæmmere må ikke tages i 2 uger før eller samtidig med, at der gives Zalviso.
English: Therefore, Zalviso should be used with caution in patients at risk of ileus.
Danish: Derfor bør Zalviso anvendes med forsigtighed hos patienter med risiko for ileus.
English: Patients should not eat or drink and minimize talking for 10 minutes after each dose of Zalviso.
Danish: Patienter bør ikke spise eller drikke og tale så lidt som muligt i 10 minutter efter hver dosis Zalviso.
English: Calcium hydrogen phosphate, anhydrous Hypromellose
Danish: Calciumhydrogenfosfat, vandfrit Hypromellose
English: Due to the limited number of patients with moderate to severe hepatic impairment, a potential effect of hepatic dysfunction as covariate on clearance may not have been detected.
Danish: På grund af det begrænsede antal patienter med moderat til svært nedsat leverfunktion er en mulig effekt af dårlig leverfunktion som covariat ved clearance måske ikke blevet registreret.
English: Grünenthal Denmark ApS Arne Jacobsens Allé 7 2300 København S Tlf: +45 88883200
Danish: Grünenthal Denmark ApS Arne Jacobsens Allé 7 DK-2300 København S Tlf: +45 88883200
English: Low doses of intravenous sufentanil associated with likely vagal (cholinergic) activity cause mild bradycardia and mildly reduced systemic vascular resistance without significantly lowering blood pressure (see section 4.4).
Danish: Lave doser af intravenøs sufentanil i forbindelse med sandsynlig (kolinerg) vagusaktivitet forårsager mild bradykardi og let nedsat systemisk, vaskulær modstand uden at sænke blodtrykket signifikant (se pkt.
English: In case you experience any of the above mentioned side effects, stop taking Zalviso and tell your doctor or nurse immediately.
Danish: Hvis du oplever nogle af ovennævnte bivirkninger, skal du stoppe med at tage Zalviso og straks fortælle det til lægen eller sygeplejersken.
English: Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Danish: Andre symptomer, der kan forekomme, er bevidstløshed, koma, kardiovaskulært shock og muskelstivhed.
English: Zalviso should not be used during pregnancy or if you are a woman of childbearing potential not using contraception.
Danish: Zalviso må ikke anvendes under graviditet, eller hvis du er en kvinde i den fødedygtige alder og ikke anvender prævention.
English: Zalviso is provided in a polycarbonate cartridge, each of which contains 40 sublingual tablets and is packed in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Danish: Zalviso leveres i en patron af polycarbonat, som hver indeholder 40 sublinguale resoribletter pakket i polyesterfilm/LDPE/aluminiumfolie/LDPE-pose med en iltabsorber.
English: Marketing Authorisation Holder and Manufacturer Grünenthal GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller Grünenthal GmbH
English: Before use, the health-care professional should ensure that the patients have been appropriately instructed on how to operate the Zalviso administration device to self-administer tablets as needed to manage their pain post-operatively.
Danish: Før brug skal sundhedspersonalet sikre, at patienterne er korrekt instrueret i betjening af Zalviso doseringsudstyr til egenadministration af resoribletter efter behov for at håndtere postoperative smerter.
English: The sublingual tablets measure 3 mm in diameter.
Danish: De sublinguale resoribletter måler 3 mm i diameter.
English: The duration of activity may be prolonged in patients with severe hepatic and renal impairment.
Danish: Aktivitetens varighed kan være forlænget hos patienter med svært nedsat lever- eller nyrefunktion.
English: Very rare Not known Cannot be estimated from the available data
Danish: Kan ikke estimeres ud fra eksisterende data
English: These medicines must not be taken in the 2 weeks before or at the same time as Zalviso is given.
Danish: Disse lægemidler må ikke tages i 2 uger før eller samtidig med Zalviso.
English: Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Danish: Hver sublingual resoriblet indeholder 15 mikrogram sufentanil (som citrat).
English: Pharmacokinetic data from intravenous sufentanil administration did not reveal age related differences.
Danish: Farmakokinetiske data fra intravenøs administration af sufentanil viste ingen aldersrelaterede forskelle.
English: You should not drive or operate machinery if you experience any of these symptoms whilst or after being treated with Zalviso.
Danish: Du bør ikke føre motorkøretøj eller betjene maskiner, hvis du oplever nogen af disse symptomer, mens du er i behandling med Zalviso.
English: Therefore, Zalviso should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Danish: Derfor bør Zalviso anvendes med forsigtighed hos patienter med galdevejssygdom, herunder akut pancreatitis.
English: Sedating medicinal products such as benzodiazepines or related substances
Danish: Sedativa såsom benzodiazepiner eller lignende stoffer
English: The most serious side effects are severe breathing problems like slow and shallow breathing, which may even lead to stopping breathing or inability to breathe.
Danish: De mest alvorlige bivirkninger er svære åndedrætsproblemer som langsomt og overfladisk åndedræt, som kan føre til åndedrætsstop eller manglende evne til at trække vejret.
English: Hypersensitivity* Anaphylactic shock
Danish: Overfølsomhed* Anafylaktisk shock
English: In the placebo-controlled Phase 3 trials, approximately 20 % of enrolled patients were elderly (≥ 75 years of age) and approximately 30 % of enrolled patients were 65 to 75 years of age.
Danish: I placebokontrollerede fase III-studier var cirka 20 % af de inkluderede patienter ældre (≥ 75 år), og cirka 30 % af de inkluderede patienter var i alderen 65-75 år.
English: After a single dose, the median CST½ was 2.2 hours, increasing to a median value of 2.5 h after multiple dosing: the sublingual delivery route thus substantially extends the duration of action associated with intravenous sufentanil administration (CST½ of 0.14 hours).
Danish: Efter en enkeltdosis var middel CST½ 2,2 timer, som steg til en middelværdi på 2,5 t efter flere doser; den sublinguale administrationsvej forlænger således væsentligt virkningstiden, sammenlignet med intravenøs administration af sufentanil (CST½ på 0,14 timer).
English: Zalviso affects your ability to drive or use machines as it may cause sleepiness, dizziness or visual disturbances.
Danish: Zalviso påvirker evnen til at føre motorkøretøj eller anvende maskiner, da det kan forårsage søvnighed, svimmelhed eller synsforstyrrelser.
English: Sufentanil is a synthetic, potent opioid with highly selective binding to µ-opioid receptors.
Danish: Sufentanil er et syntetisk, potent opioid med stærkt selektiv binding til µ-opioid-receptorer.
English: No special population studies were performed using Zalviso in the elderly.
Danish: Der er ikke gennemført særlige populationsstudier med Zalviso hos ældre.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet
Danish: • Produktresumé (SmPC) og indlægsseddel
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 stoffet sublingualt og opnå en hurtigt indsættende, analgetisk virkning.