FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon ≥1/1,000 and <1/100 Rare
Danish: ≥1/10.000 til <1/1.000 Meget sjælden <1/10.000 Ikke kendt
English: Zalviso is to be administered in a hospital setting only.
Danish: Zalviso må kun administreres i hospitalsregie.
English: EU/1/15/1042/001 1 cartridge of 40 sublingual tablets EU/1/15/1042/002 10 cartridges of 40 sublingual tablets each EU/1/15/1042/003 20 cartridges of 40 sublingual tablets each
Danish: EU/1/15/1042/001 1 patron a 40 sublinguale resoribletter EU/1/15/1042/002 10 patroner a 40 sublinguale resoribletter EU/1/15/1042/003 20 patroner a 40 sublinguale resoribletter
English: Zalviso 15 micrograms sublingual tablets
Danish: Zalviso 15 mikrogram resoribletter, sublinguale
English: Respiratory depression caused by sufentanil can be reversed by opioid antagonists.
Danish: Hæmmet respiration forårsaget af sufentanil er reversibelt med opioidantagonister.
English: Sufentanil as a µ-opioid receptor agonist may slow the gastrointestinal motility.
Danish: Sufentanil kan som µ-opioid receptoragonist nedsætte den gastrointestinale motilitet.
English: The sublingual tablets are supplied in cartridges; each cartridge contains 40 sublingual tablets.
Danish: De sublinguale resoribletter leveres i patroner, som hver indeholder 40 sublinguale resoribletter.
English: Concomitant use of Zalviso and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Danish: Samtidig brug af Zalviso og sedativa såsom benzodiazepiner eller lignende stoffer, kan føre til sedation, respirationsdepression, koma og dødsfald.
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Danish: Sufentanil metaboliseres hos mennesker primært af cytokrom P450-3A4-enzymsystemet (se pkt.
English: Dizziness Headache Sedation
Danish: Svimmelhed Hovedpine Sedation
English: Two local tolerance studies were conducted in the hamster cheek pouch with the sufentanil sublingual tablets.
Danish: Der er gennemført to studier af lokal tolerance af sufentanil sublinguale resoribletter i hamsteres kindposer.
English: 1 cartridge of 40 sublingual tablets 10 cartridges of 40 sublingual tablets each 20 cartridges of 40 sublingual tablets each
Danish: 10 patroner med hver 40 sublinguale resoribletter 20 patroner med hver 40 sublinguale resoribletter
English: EU/1/15/1042/004 2 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/005 3 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/006 5 x 20 cartridges of 40 sublingual tablets each
Danish: EU/1/15/1042/004 2 x 20 patroner a 40 sublinguale resoribletter EU/1/15/1042/005 3 x 20 patroner a 40 sublinguale resoribletter EU/1/15/1042/006 5 x 20 patroner a 40 sublinguale resoribletter
English: Annex IV
Danish: BILAG IV
English: The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Danish: Samtidig brug af Zalviso med sedativa såsom benzodiazepiner eller lignende stoffer øger risikoen for sedation, respirationsdepression, koma og dødsfald på grund af den additive CNS-hæmmende virkning.
English: After removing from the sachet, the cartridge should be placed into the Zalviso administration device immediately.
Danish: Når patronen er taget ud af posen, skal den omgående placeres i Zalviso doseringsudstyret.
English: Maximum concentrations of sufentanil are achieved approximately 50 minutes after a single dose; this is shortened to approximately 20 minutes following repeat dosing.
Danish: Maksimale koncentrationer af sufentanil nås cirka 50 minutter efter en enkelt dosis.
English: No special population studies were performed using sufentanil sublingual tablets in hepatic and renal impaired patients.
Danish: Der er ikke gennemført særlige populationsstudier med sufentanil sublinguale resoribletter hos patienter med nedsat lever- eller nyrefunktion.
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: Tilsvarende CST½-værdier sås efter både enkelt og gentagen administration.
English: Before you start using Zalviso, your doctor or nurse will show you how to use the Zalviso administration device.
Danish: Sådan tager du de sublinguale resoribletter med doseringsudstyret Før du begynder at tage Zalviso, viser din læge eller sygeplejerske dig, hvordan du skal bruge Zalviso doseringsudstyret.
English: No special population studies were performed using sufentanil sublingual tablets in elderly patients.
Danish: Der er ikke gennemført særlige populationsstudier med sufentanil sublinguale resoribletter hos ældre.
English: Serotonergic agents
Danish: Serotonerge mideler
English: Therefore, Zalviso should be used with caution in such patients (see section 4.4).
Danish: Derfor skal Zalviso anvendes med forsigtighed hos disse patienter (se pkt.
English: Sufentanil as a µ-opioid receptor agonist may cause spasm of the sphincter of Oddi.
Danish: Sufentanil kan som µ-opioid receptoragonist forårsage spasme i sfincter Oddi.
English: Respiratory arrest
Danish: Åndedrætsstop
English: Concomitant use of Zalviso and sedating medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
Danish: Samtidig brug af Zalviso og beroligende medicin såsom benzodiazepiner eller lignende medicin øger risikoen for døsighed, vejrtrækningsbesvær (respirationsdepression), koma og kan være livstruende.
English: Constipation Dyspepsia
Danish: Konstipation Dyspepsi
English: Contains sunset yellow FCF Aluminium Lake (E110), contains sodium.
Danish: Indeholder sunset yellow FCF aluminium lake (E110), indeholder natrium.
English: Grünenthal Norway AS C.J. Hambros Plass 2C 0164 Oslo
Danish: Grünenthal Norway AS C.J. Hambros Plass 2C N-0164 Oslo Tlf: +47 22996054
English: Sufentanil should be used with caution in patients who may be particularly susceptible to the cerebral effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Danish: Sufentanil bør anvendes med forsigtighed af patienter, som kan være særligt modtagelige for cerebrale virkninger af CO2-retention.
English: When patients titrated themselves to analgesic effect with Zalviso, plasma sufentanil concentrations averaged 60-100 pg/ml over two days of use, with no effect based on age or body mass index (BMI), or mild to moderate renal or liver impairment.
Danish: Når patienter titrerede sig selv til analgetisk virkning med Zalviso, nåede sufentanils plasmakoncentrationer gennemsnitligt 60-100 pg/ml efter to dages brug.
English: Zalviso is only to be taken in a hospital setting.
Danish: Zalviso må kun tages i et medicinsk overvåget miljø.
English: Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium Lake (E110).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver sublingual resoriblet indeholder 0,074 mg sunset yellow FCF aluminium lake (E110).
English: Zalviso sublingual tablets contain the azo colouring agent sunset yellow FCF Aluminium Lake (E110), which may cause allergic reactions.
Danish: Zalviso sublinguale resoribletter indeholder azo-farvestoffet sunset yellow FCF aluminium lake (E110), som kan forårsage allergiske reaktioner.
English: Zalviso sublingual tablets are available in pack sizes of 1, 10 and 20 cartridges and in multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Danish: Zalviso sublinguale resoribletter fås i pakningsstørrelser med 1, 10 og 20 patroner og i multipakninger med 40 (2 pakninger a 20), 60 (3 pakninger a 20) og 100 (5 pakninger a 20) patroner, svarende til henholdsvis 40, 400, 800, 1600, 2400 og 4000 sublinguale resoribletter.
English: What Zalviso looks like and contents of the pack Zalviso sublingual tablets are orange-coloured flat-faced tablets with rounded edges.
Danish: Zalviso sublinguale resoribletter er orangefarvede resoribletter med flad overside og afrundede kanter.
English: Respiratory depression
Danish: Hæmmet respiration
English: 1 cartridge of 40 sublingual tablets
Danish: 1 patron a 40 sublinguale resoribletter
English: Zalviso is available in pack sizes of 1 and 10, 20 cartridges and multipacks containing 40 (2 packs of 20), 60 (3 packs of 20) and 100 (5 packs of 20) cartridges, equivalent to 40, 400, 800, 1,600, 2,400 and 4,000 sublingual tablets, respectively.
Danish: Zalviso fås i pakningsstørrelser med 1 og 10, 20 patroner og multipakninger med 40 (2 pakninger a 20), 60 (3 pakninger a 20) og 100 (5 pakninger a 20) patroner, svarende til henholdsvis 40, 400, 800, 1600, 2400 og 4000 sublinguale resoribletter.
English: Sufentanil passes into breast milk and can cause side effects in the breast-fed child. Breastfeeding is not recommended when you take Zalviso.
Danish: Sufentanil udskilles i modermælk og kan give bivirkninger hos det ammede barn.
English: Tel.: +49-241-569-0
Danish: Tlf.: +49-241-569-0
English: Check with your doctor if you are not sure.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: Sufentanil is excreted in human milk when applied intravenously; therefore caution is advised when Zalviso is administered to breast-feeding women.
Danish: Sufentanil udskilles i human mælk, når det gives intravenøst.
English: If you take more Zalviso than you should
Danish: Hvis du har taget for mange Zalviso
English: Very common ≥1/10 Common
Danish: Hyppigheden er defineret som følger: Meget almindelig ≥1/10 Almindelig ≥1/100 til <1/10 Ikke almindelig ≥1/1.000 til <1/100 Sjælden
English: confusion, dizziness, headache, drowsiness, increased heart rate, high blood pressure, low blood pressure, constipation, indigestion, itching of the skin, involuntary muscle cramps, muscle twitching, difficulty passing urine.
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 personer): forvirring, svimmelhed, hovedpine, døsighed, øget hjerterytme, højt blodtryk, lavt blodtryk, forstoppelse, fordøjelsesbesvær, hudkløe, ufrivillige muskelkramper, muskelsammentrækninger, vandladningsbesvær.
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Danish: Sufentanil kan forårsage hæmmet respiration (se pkt.
English: Involuntary muscle spasms
Danish: Muskelspasmer Muskeltrækninger*
English: 800 sublingual tablets (20 cartridges of 40 sublingual tablets each).
Danish: 800 sublinguale resoribletter (20 patroner a 40 sublinguale resoribletter) Del af multipakning, må ikke sælges separat.
English: Zalviso sublingual tablets are to be self-administered by the patient in response to pain using the Zalviso administration device.
Danish: Patienten skal ved smerter egenadministrere Zalviso sublinguale resoribletter med Zalviso doseringsudstyr.
English: EU/1/15/1042/006
Danish: EU/1/15/1042/001 EU/1/15/1042/002 EU/1/15/1042/003 EU/1/15/1042/004 EU/1/15/1042/005 EU/1/15/1042/006
English: Multipack: 1600 sublingual tablets [40 (2 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 2400 sublingual tablets [60 (3 packs of 20) cartridges of 40 sublingual tablets each] Multipack: 4000 sublingual tablets [100 (5 packs of 20) cartridges of 40 sublingual tablets each]
Danish: Multipakning: 1600 sublinguale resoribletter [40 (2 pakninger a 20) patroner a 40 sublinguale resoribletter]
English: Deutschland Grünenthal GmbH Zieglerstr.
Danish: Deutschland Grünenthal GmbH Zieglerstraße 6
English: Do not crush, chew, or swallow the tablet.
Danish: Resoribletten må ikke knuses, tygges eller synkes.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Danish: Sufentanil kan forårsage dosisafhængig respirationshæmning.
English: One cartridge is packed in a sachet including an oxygen absorber.
Danish: Hver patron ligger i en pose med en iltabsorber.
English: - If you have any further questions, ask your doctor or nurse.
Danish: Er du i tvivl, så spørg lægen.
English: Miosis disturbances
Danish: Synsforstyrrelser Miose
English: Excipients
Danish: Mundtørhed
English: Apnoea
Danish: Amning
English: Nausea Vomiting
Danish: Nyrer og urinveje
English: What Zalviso is and what it is used for What you need to know before you take Zalviso How to take Zalviso
Danish: Det skal du vide, før du begynder at tage Zalviso Sådan skal du tage Zalviso Bivirkninger
English: Hyperhidrosis Rash
Danish: Abstinenssyndrom
English: Date of first authorisation: 12 May 2016
Danish: Dato for første markedsføringstilladelse: 12. maj 2016
English: The relevance for humans is not known.
Danish: Relevansen for mennesker er ukendt.
English: Not everyone will end up on the same maintenance dose.
Danish: Ikke alle ender med at få den samme vedligeholdelsesdosis.
English: There was no significant treatment effect from baseline to Week 26.
Danish: Der var ingen signifikant behandlingsvirkning fra baseline til uge 26.
English: Uptravi can be used on its own if the patient is not a candidate for these medicines.
Danish: Uptravi kan anvendes alene, hvis patienten ikke er kandidat til disse lægemidler.
English: • Myocardial infarction within the last 6 months.
Danish: • Myokardieinfarkt inden for de sidste 6 måneder.
English: The exposure to selexipag was up to 4.2 years.
Danish: Eksponeringen for selexipag var op til 4,2 år.
English: Every patient with PAH is different.
Danish: Hver patient med PAH er forskellig.
English: Otherwise, fertility parameters were not affected.
Danish: Ellers var fertilitetsparametre ikke påvirket.
English: Do not give this medicine to children under 18 years of age, because Uptravi has not been tested in children.
Danish: Giv ikke dette lægemiddel til børn under 18 år, da Uptravi ikke er blevet afprøvet hos børn.
English: Exercise capacity was evaluated as a secondary endpoint.
Danish: Motionskapaciteten blev vurderet som et sekundært endepunkt.
English: In the placebo group, little change in median values was apparent.
Danish: I placebogruppen blev der set en lille ændring i medianværdierne.
English: Paediatric population (< 18 years)
Danish: Pædiatrisk population (< 18 år)
English: The absolute bioavailability of selexipag in humans is approximately 49%.
Danish: Den absolutte biotilgængelighed af selexipag hos mennesker er ca. 49 %.
English: A risk to the suckling child cannot be excluded.
Danish: En risiko hos det ammede barn kan ikke udelukkes.
English: Absolute risk reduction
Danish: Absolut risikoreduktion
English: • Information about the safe and effective use of Uptravi in lay language.
Danish: • Oplysninger om sikker og effektiv brug af Uptravi i lægmandssprog.
English: The mechanisms are rodent-specific.
Danish: Mekanismerne er gnaver-specifikke.
English: Uptravi should be used with caution in this age group.
Danish: Uptravi bør anvendes med forsigtighed i denne aldersgruppe.
English: You should take each dose with a glass of water, preferably during a meal.
Danish: Du skal tage hver dosis med et glas vand, helst i forbindelse med et måltid.
English: The Controlled Access System should include three key principles that will be incorporated within each system in all Member States.
Danish: Det kontrollerede adgangssystem bør omfatte tre nøgleprincipper, som skal implementeres i det enkelte system i alle medlemslande- Det gælder:
English: There are no data from the use of selexipag in pregnant women.
Danish: Der er ingen data fra anvendelse af selexipag til gravide kvinder.
English: 17.9% of patients were ≥ 65 and 1.1% ≥ 75 years of age.
Danish: 17,9 % af patienterne var ≥ 65 og 1,1 % ≥ 75 år.
English: All events were confirmed by an independent adjudication committee, blinded to treatment allocation.
Danish: Alle hændelser blev bekræftet af en uafhængig bedømmelseskomité, der var blindet over for behandlingstildelingen.
English: Patients with an event
Danish: Patienter med en hændelse
English: The volume of distribution of selexipag at steady state is 11.7 L.
Danish: Selexipags fordelingsvolumen ved steady state er 11,7 l.
English: The majority of these reactions are of mild to moderate intensity.
Danish: Størstedelen af disse reaktioner er af mild til moderat sværhedsgrad.
English: In the event of overdose, supportive measures must be taken as required.
Danish: I tilfælde af overdosering skal der iværksættes understøttende tiltag efter behov.
English: Mild, transient nausea was the only reported consequence.
Danish: Mild, forbigående kvalme er den eneste følgevirkning, der er indberettet.
English: The safety and efficacy of Uptravi in children aged 0 to less than 18 years have not yet been established.
Danish: Uptravis sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
English: ↓When should you step down?
Danish: ↓Hvornår skal jeg nedtrappe?
English: Swallow the tablets whole with a glass of water.
Danish: Tabletterne skal synkes hele med et glas vand.
English: Specific drug-drug interaction studies with hormonal contraceptives have not been conducted.
Danish: Der er ikke udført specifikke interaktionsstudier med hormonelle kontraceptiva.
English: There are no clinical data available.
Danish: Der foreligger ingen kliniske data.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet.
English: Please remember to dispose of unused tablets (see section 5).
Danish: Husk at bortskaffe ikke anvendte tabletter (se afsnit 5).
English: Nasopharyngitis (of non-infectious origin)
Danish: Nasopharyngitis (af ikke-infektiøs årsag)
English: PAH-specific therapies
Danish: PAH-specifikke behandlinger
English: Caution is required when administering these medicinal products concomitantly with Uptravi.
Danish: Der skal udvises forsigtighed ved administration af disse lægemidler samtidig med Uptravi.
English: Relative risk reduction (99% CI)
Danish: Relativ risikoreduktion (99 % CI)
English: For example, painkillers such as paracetamol may help treat pain and headache.
Danish: For eksempel kan smertestillende midler såsom paracetamol være en hjælp til behandling af smerter og hovedpine.
English: Treatment should be initiated in the evening.
Danish: Behandlingen bør startes om aftenen.
English: Each step usually lasts about 1 week.
Danish: Hvert trin varer som regel omkring 1 uge.
English: Uptravi is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension, also called PAH.
Danish: Uptravi er et lægemiddel, der tages hver morgen og aften til behandling af pulmonal arteriel hypertension, også kaldet PAH.
English: • Severe coronary heart disease or unstable angina.
Danish: • Svær koronarhjertesygdom eller ustabil angina.
English: At the start of treatment, you will take the lowest dose.
Danish: I starten af behandlingen vil du få den laveste dosis.
English: Stepping down to a lower dose due to side effects
Danish: Nedtrapning til en lavere dosis på grund af bivirkninger
English: • The move to the maintenance dose (titration phase);
Danish: • Skiftet til vedligeholdelsesdosen (titreringsfase).
English: Time to PAH-related death or hospitalisation for PAH was assessed as a secondary endpoint.
Danish: Tiden til PAH-relateret død eller hospitalisering pga. PAH blev vurderet som et sekundært endepunkt.
English: These reactions are more frequent during the up-titration phase.
Danish: Disse reaktioner er hyppigere i optitreringsfasen.
English: How should you step up your dose?
Danish: Hvordan optrapper jeg min dosis?
English: • Decompensated cardiac failure if not under close medical supervision.
Danish: • Dekompenseret hjertesvigt, hvis dette ikke er under tæt medicinsk overvågning.
English: Do not use Uptravi after the expiry date, which is stated on the carton and on the blister after “EXP.” The expiry date refers to the last day of that month.
Danish: Brug ikke Uptravi efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Table 1 Summary of outcome events
Danish: Tabel 1 Opsummering af udfaldsrelaterede hændelser
English: Except for the active metabolite, none of the circulating metabolites in human plasma exceed 3% of the total drug-related material.
Danish: Med undtagelse af den aktive metabolit overstiger ingen af de cirkulerende metabolitter i human plasma 3 % af det totale lægemiddelrelaterede materiale.
English: Approximately 1%, 46%, 53%, and 1% of patients were in WHO FC I, II, III and IV, respectively, at baseline.
Danish: Cirka hhv. 1 %, 46 %,53% og 1 % af patienterne var i WHO-funktionsklasse II, III og IV ved baseline.
English: You may experience side effects not only during the titration period when your dose is being increased, but also later after taking the same dose for a long time.
Danish: Du kan få bivirkninger, ikke alene i titreringsperioden hvor dosis øges, men også senere efter lang tids brug af samme dosis.
English: A no-observed-adverse-effect level was not established.
Danish: NOAEL (no-observed-adverse-effect-level) blev ikke klarlagt.
English: Isolated cases of overdose up to 3,200 micrograms were reported.
Danish: Der er rapporteret om enkeltstående tilfælde af overdosering op til 3.200 mikrogram.
English: Read all of this leaflet carefully before taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Efficacy in patients with PAH
Danish: Virkning hos patienter med PAH
English: When you move to your maintenance dose
Danish: Når du overgår til din vedligeholdelsesdosis
English: Suddenly stopping your treatment with Uptravi might lead to your symptoms getting worse.
Danish: Brat ophør af behandlingen med Uptravi kan resultere i, at dine symptomer bliver forværrede.
English: It relieves the symptoms of PAH and improves the course of the disease.
Danish: Det lindrer symptomerne på PAH og forbedrer sygdomsforløbet.
English: Your doctor will tell you to increase your dose in steps, usually every week but the interval between increases could be longer.
Danish: Lægen vil anvise, at du øger din dosis i trin, som regel hver uge, men intervallet mellem stigningerne kan være længere.
English: However, not every patient will reach this dose, because different patients require different doses.
Danish: Det er dog ikke alle patienter, der når denne dosis, da den påkrævede dosis varierer fra patient til patient.
English: = intravenous; PAH = pulmonary arterial hypertension; s.c. = subcutaneous.
Danish: = intravenøs; PAH = pulmonal arteriel hypertension; s.c. = subkutan.
English: • The identification and maintenance of a list of all Uptravi prescribers;
Danish: • Identifikation og vedligeholdelse af en liste over alle personer, der ordinerer Uptravi.
English: i.v./s.c.
Danish: Indledning af i.v./s.c.
English: The most common side effects (may affect more than 1 in 10 people) you may experience while taking Uptravi are:
Danish: De mest almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer), du kan få, når du tager Uptravi, er:
English: Pain-associated events have frequently been treated with analgesics (such as paracetamol).
Danish: Smerterelaterede hændelser er ofte blevet behandlet med analgetika (såsom paracetamol).
English: Notes:
Danish: Noter:
English: Prior to the launch of Uptravi in each Member State, the MAH must agree on the content and format of the Controlled Access System with the National Competent Authority.
Danish: Inden lancering af Uptravi i det enkelte medlemsland skal indehaveren af markedsføringstilladelsen aftale indholdet og formatet af det kontrollerede adgangssystem med de nationale kompetente myndigheder.
English: Each step usually lasts about 1 week, unless your doctor or nurse instructs you otherwise.
Danish: Hvert trin varer som regel omkring 1 uge, medmindre lægen eller sundhedspersonalet anviser noget andet.