FrancophonIA/ELRC3.0 huggingface dataset:
English: Be sure to ventilate or air the room in which you have taken your Ventavis treatment.
Danish: Sørg for at ventilere eller udlufte det rum, hvor du har taget Ventavis.
English: Elderly Pharmacokinetics in elderly patients have not been investigated.
Danish: Ældre Der er ingen tilgængelige farmakokinetiske data for ældre patienter.
English: You may also experience a decrease or an increase in blood pressure, bradycardia (reduced heart rate), tachycardia (increased heart rate), vomiting, diarrhoea or limb pain.
Danish: Du kan også få et fald eller stigning i blodtrykket, bradykardi (nedsat puls), takykardi (forhøjet puls), opkastning, diaré eller smerter i arme eller ben.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Blødning*§
English: Because iloprost is extensively metabolised by the liver, the plasma levels of the active substance are influenced by changes in hepatic function.
Danish: Da iloprost metaboliseres ekstensivt i leveren, bliver medikamentets plasmaniveauer påvirket af ændringer i leverfunktionen.
English: In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.
Danish: I tilfælde af forværring af svigt i den højre hjertehalvdel bør det overvejes at overføre patienten til anden medicinsk behandling.
English: Genotoxic potential, tumourigenicity
Danish: Genotoksicitet, tumorigenicitet
English: Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension.
Danish: Ventavis bør kun ordineres/initieres og monitoreres af en læge med erfaring i behandlingen af pulmonal hypertension.
English: • If you suffer from pulmonary hypertension, avoid getting pregnant as pregnancy may lead to a worsening of your condition and may even endanger your life.
Danish: • Hvis du lider af for højt blodtryk i lungerne (pulmonal hypertension), skal du undgå at blive gravid, da graviditet kan forværre din situation og endda blive livstruende.
English: − Pulmonary hypertension due to venous occlusive disease.
Danish: - Pulmonal hypertension forårsaget af okklusiv venesygdom.
English: You should use the green baffle plate to obtain the optimal droplet size for the administration of Ventavis.
Danish: Brug den grønne prelplade for at få den optimale dråbestørrelse til administration af Ventavis.
English: − Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage
Danish: - Tilstande hvor Ventavis' virkning på trombocytterne kunne forøge risikoen for blødning (f.eks.
English: A mean increase in the 6-minute walk test of 44.7 metres from a baseline mean value of 329 metres vs. a change of -7.4 metres from a baseline mean value of 324 metres in the placebo group (no data imputation for death or missing values) was observed in the subgroup of 49 patients with primary pulmonary hypertension receiving treatment of inhaled iloprost for 12 weeks (46 patients in the placebo group).
Danish: en ændring på -7,4 meter fra baselinemiddelværdien på 324 meter i placebo-gruppen (ingen databeregninger for død eller manglende værdier) i undergruppen på 49 patienter med primær pulmonal hypertension, som fik behandling med inhaleret iloprost i 12 uger (46 patienter i placebogruppen).
English: Ventavis therapy should only be initiated by a physician experienced in treatment of pulmonary hypertension.
Danish: Behandling med Ventavis bør kun påbegyndes af en læge med erfaring i behandling af pulmonal hypertension.
English: Always take Ventavis exactly as your doctor has told you.
Danish: Brug altid Ventavis nøjagtigt efter lægens anvisning.
English: 3 minutes
Danish: 3 måneder.
English: When using the Breelib nebuliser please follow the instructions for use provided with the device.
Danish: Ved brug af Breelib-nebulisatoren bedes man følge brugsanvisningen, som følger med systemet.
English: Just before you start to inhale, break the glass ampoule and pour the solution into the medication chamber following the instructions for use of the nebuliser.
Danish: Lige inden du begynder at inhalere, skal du knække spidsen af glasampullen og hælde opløsningen over i medicineringskammeret ved at følge instruktionerne til nebulisatoren.
English: When iloprost at the concentration of 10 microgram/ml is administered via inhalation in patients with pulmonary hypertension or healthy volunteers (iloprost dose at the mouthpiece: 5 microgram: inhalation time in between 4.6 - 10.6 min), mean peak serum concentrations of about 100 to 200 picogram/ml were observed at the end of inhalation session.
Danish: Når iloprost i koncentrationen 10 mikrogram/ml indgives via inhalation hos patienter med pulmonal hypertension eller raske frivillige (iloprost-dosis ved mundstykket: 5 mikrogram: inhalationstid fra 4,6-10,6 min), blev der observeret gennemsnitlige serum-spidskoncentrationer på omkring 100 til 200 pikogram/ml ved afslutningen af inhalationsbehandlingen.
English: § see section “Description of selected adverse reactions”
Danish: ”Beskrivelse af udvalgte bivirkninger”
English: • The other ingredients are trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
Danish: • Øvrige indholdsstoffer: Trometamol, ethanol, natriumchlorid, saltsyre til pH-justering og vand til injektionsvæsker.
English: The nebulising device delivers 5 microgram iloprost at the mouthpiece.
Danish: Nebulisatoren leverer 5 mikrogram iloprost ved mundstykket.
English: If your doctor decides to further increase the dose up to 5 microgram, again dosing intervals of 3 - 4 hours should be chosen initially and shortened depending on how you tolerate the treatment.
Danish: Hvis din læge beslutter at øge dosis til 5 mikrogram, skal der igen i første omgang vælges et mellemrum på 3-4 timer mellem doserne, og derefter kan afstanden afkortes afhængigt af, hvor godt du tåler behandlingen.
English: During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.
Danish: Under inhalationsbehandlingerne bør man undgå at anvende ansigtsmasker, men kun mundstykket.
English: Newborns, infants and pregnant women should not be subjected to Ventavis in the room air.
Danish: Nyfødte, spædbørn og gravide kvinder må ikke udsættes for Ventavis i indåndingsluften.
English: Hypotension, an increase of blood pressure, bradycardia or tachycardia, vomiting, diarrhoea and limb pain might also be possible.
Danish: Potentielt kan hypotension, blodtryksstigning, bradykardi eller takykardi, opkastning, diaré samt ekstremitetssmerter også forekomme.
English: Breelib is a small handheld, battery-powered, breath activated, vibrating mesh technology system.
Danish: Breelib er et lille håndholdt, batteridrevet vibrerende system med netteknologi, der aktiveres ved hjælp af vejrtrækningen.
English: • 90 (3x30) ampoules
Danish: • 90 (3x30) ampuller
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (forekommer hos flere end 1 ud af 10 personer):
English: Ampoules with 2 ml nebuliser solution (for the use of Venta-Neb):
Danish: Ampuller med 2 ml opløsning til nebulisator (til brug sammen Venta-Neb):
English: Breelib nebuliser:
Danish: Breelib-nebulisator:
English: In a small, randomised, 12-week double-blinded, placebo-controlled study (the STEP trial), 34 patients treated with bosentan 125 mg twice per day for at least 16 weeks who were in stable haemodynamic conditions before enrolment, tolerated the addition of inhaled iloprost at the concentration of 10 microgram/ml (up to 5 microgram 6 to 9 times per day during waking hours).
Danish: I et lille, randomiseret, 12-ugers dobbeltblindet, placebokontrolleret studie (STEP-studiet) tålte 34 patienter, som havde fået 125 mg bosentan to gange dagligt i mindst 16 uger, og som var i en stabil hæmodynamisk tilstand inden rekrutteringen, tilføjelse af inhaleret iloprost i koncentrationen 10 mikrogram/ml (op til 5 mikrogram 6-9 gange pr. dag i de vågne timer).
English: Ventavis contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Danish: Ventavis indeholder en mindre mængde ethanol (alkohol), mindre end 100 mg pr. dosis.
English: Skin and eye contact, oral ingestion
Danish: Hud- og øjenkontakt, oral indtagelse
English: • The nebuliser turns Ventavis solution into a mist which you breathe in through your mouth.
Danish: • Nebulisatorerne omdanner Ventavis-opløsningen til aerosoler, som indåndes gennem munden.
English: Ventavis10 microgram/ml is available in the following packs:
Danish: Ventavis 10 mikrogram/ml fås i følgende pakker indeholdende:
English: • 300 (10x30) ampoules.
Danish: • 300 (10x30) ampuller.
English: • throat irritation
Danish: • Irritation i halsen
English: A careful monitoring of the patients taking anticoagulants or other inhibitors of platelet aggregation according to common medical practice is recommended.
Danish: Omhyggelig monitorering i overensstemmelse med almindelig praksis af patienter, der tager antikoagulantia eller andre hæmmere af trombocytaggregation anbefales.
English: Symptoms can include chest pain, - a heart attack within the last six months, - a weak heart (decompensated cardiac failure) which is not under close medical observation, - severe unstable heartbeat, - a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension),
Danish: Symptomerne kan omfatte smerter i brystet, - har haft et hjerteanfald inden for de sidste seks måneder, - et svagt hjerte (dekompenseret hjertesvigt), som ikke er under nøje lægelig overvågning, - alvorligt ustabilt hjerteslag, - fejl i hjerteklapperne (medfødt eller erhvervet), så hjertet arbejder dårligt (ikke relateret til forhøjet blodtryk i lungerne),
English: Thereafter, dosing intervals may be shortened cautiously based on individual tolerability.
Danish: Derefter kan doseringsintervallerne forsigtigt afkortes, men skal være baseret på den enkelte patients tolerabilitet over for lægemidlet.
English: Symptoms can include swelling of feet and ankles, shortness of breath, palpitations, urinating more frequently at night or oedema.
Danish: Symptomerne kan omfatte hævede fødder og ankler, kortåndethed, hjertebanken eller hyppigere vandladning om natten eller vand i kroppen (ødem).
English: Data with intravenously administered iloprost indicated that the elimination is reduced in patients with renal failure requiring dialysis.
Danish: Data fra intravenøst indgivet iloprost viste, at eliminationen er reduceret hos patienter med dialysekrævende nyreinsufficiens.
English: Room ventilation
Danish: Udluftning af rummet
English: The table below provides a summary of the user instructions of the I-Neb for Ventavis:
Danish: Nedenstående tabel giver en oversigt over brugervejledningen til I-Neb ved brug sammen med Ventavis:
English: Initially, doses of 2.5 microgram iloprost should be administered using Ventavis 10 microgram/ml with dosing intervals of 3-4 hours (corresponds to administration of max. 6 times per day).
Danish: Som start bør der administreres doser på 2,5 mikrogram iloprost med Ventavis 10 mikrogram/ml med doseringsintervaller på 3-4 timer (hvilket svarer til højst 6 gange administration pr. dag).
English: The measured MMAD of the aerosol droplets was 2.6 micrometres.
Danish: Den målte MMAD for aerosoldråberne var 2,6 mikrometer.
English: If you tolerate this dose well, your next inhalation will be with Ventavis 20 microgram/ml (ampoule with yellow and red rings).
Danish: Hvis du kan tåle denne dosis, vil din næste inhalation være med Ventavis 20 mikrogram/ml (ampul med gule og røde ringe).
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: forekommer hos flere end 1 ud af 10 personer
English: Since iloprost inhibits platelet function its use with the following substances may enhance iloprostmediated platelet inhibition, thereby increasing the risk of bleeding:
Danish: Da iloprost hæmmer trombocytternes funktion, kan dets anvendelse sammen medfølgende stoffer forstærke den iloprost-medierede hæmning af trombocytterne og dermed øge risikoen for blødning:
English: There is no need to alter the dose in patients with mild or moderate kidney problems (patients with a creatinine clearance > 30 ml/min).
Danish: Der er ikke nødvendigt at ændre dosis hos patienter med lette eller moderate nyreproblemer (patienter med en kreatinin-clearance på >30 ml/min).
English: No clinical trial data are available comparing directly in intra-patient observations the acute haemodynamic response after intravenous to that after inhaled iloprost.
Danish: Der er ingen tilgængelige data fra observationer af patienter i kliniske forsøg, der direkte sammenligner den akutte hæmodynamiske respons efter intravenøs og inhaleret administration af iloprost.
English: 2.5 microgram 5 microgram
Danish: 2,5 mikrogram 5 mikrogram
English: What you need to know before you use Ventavis Do not use Ventavis
Danish: Det skal du vide, før du begynder at bruge Ventavis Brug ikke Ventavis:
English: • widening of the blood vessels (vasodilatation).
Danish: • Udvidelse af blodkarrene.
English: Cmax and AUC (0-tlast) after inhalation of 5 microgram iloprost administered as Ventavis 20 microgram/ml using the Breelib were 77% and 42%, respectively higher compared to inhalation of the same dose using Ventavis 10 microgram/ml and the I-Neb AAD system.
Danish: Cmax og AUC (0-tlast) efter inhalation af 5 mikrogram iloprost, der blev administreret som Ventavis 20 mikrogram/ml med Breelib, var hhv. 77 % og 42 % højere sammenlignet med inhalation af den samme dosis med Ventavis 10 mikrogram/ml og I-Neb AAD-systemet.
English: Tetranor-iloprost is pharmacologically inactive as shown in animal experiments.
Danish: Som vist i dyreforsøg er tetranor-iloprost farmakologisk inaktiv.
English: The measured MMAD of the aerosol droplets was 2.1 micrometres.
Danish: Den målte MMAD for aerosoldråberne var 2,1 mikrometer.
English: Ventavis 20 microgram/ml is double the concentration of Ventavis 10 microgram/ml.
Danish: Ventavis 20 mikrogram/ml er dobbelt så koncentreret som Ventavis 10 mikrogram/ml.
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol measured using I-Neb nebulising systems equipped with power level 10 disc was similar between Ventavis 20 microgram/ml (golden programme) and Ventavis 10 microgram/ml (purple programme) nebuliser solutions (i.e.: around 2 micrometres) but with faster delivery when using Ventavis 20 microgram/ml.
Danish: Den målte Mass Median Aerodynamic Diameter (MMAD) for aerosoldråben målt med I-Neb nebulisatorudstyr med en disk på styrken 10 var den samme i Ventavis 20 mikrogram/ml (gyldent program) og Ventavis 10 mikrogram/ml (lilla program) (dvs. omkring 2 mikrometer), men med højere tilførselshastighed, når Ventavis 20 mikrogram/ml blev anvendt.
English: • 168 (4x42) ampoules
Danish: • 168 (4x42) ampuller
English: If you cannot tolerate inhalation of Ventavis 20 microgram/ml talk to your doctor who may decide that you should take Ventavis 10 microgram/ml (1 ml ampoule).
Danish: Hvis du ikke kan tåle inhalationen af Ventavis 20 mikrogram/ml, skal du tale med lægen, som kan beslutte, at du skal tage Ventavis 10 mikrogram/ml (1 ml-ampul).
English: Ventavis 20 microgram/ml is available in the following packs: - Pack containing 30 ampoules or 42 ampoules for use with the Breelib and I-Neb nebuliser.
Danish: Ventavis 20 mikrogram/ml fås i følgende pakker: - Pakke med 30 ampuller eller 42 ampuller til brug med Breelib- eller I-Neb-nebulisatoren.
English: Your doctor will supervise your treatment if switching from Ventavis 10 microgram /ml to Ventavis 20 microgram/ml to monitor how well you tolerate the higher concentration.
Danish: Din læge vil overvåge din behandling, hvis der skiftes fra Ventavis 10 mikrogram/ml til Ventavis 20 mikrogram/ml for at holde øje med, hvor godt du tåler den højere dosis.
English: - poor blood flow to the heart muscles (severe coronary heart disease or unstable angina).
Danish: - dårlig blodtilførsel til hjertet (alvorlig hjertesygdom eller ustabil angina pectoris).
English: When using the I-Neb AAD system the following instructions need to be followed.
Danish: De følgende anvisninger skal følges ved brug af I-Neb AAD-systemet.
English: Common: may affect up to 1 in 10 people
Danish: Almindelig: forekommer hos op til 1 ud af 10 personer
English: • 30 ampoules
Danish: • 30 ampuller
English: Diarrhoea Vomiting Mouth and tongue irritation including pain
Danish: Mund- og tungeirritation herunder smerter
English: For further details please refer to the instruction manual of the nebuliser device or ask your doctor.
Danish: Læs brugervejledningen for nebulisatoren for at få yderligere oplysninger, eller spørg din læge.
English: Continuous intravenous/subcutaneous infusion of iloprost up to 26 weeks in rodents and non-rodents did not cause any organ toxicity at dose levels which exceeded the human therapeutic systemic exposure between 14 and 47 times (based on plasma levels).
Danish: Kontinuerlig intravenøs/subkutan infusion af iloprost i op til 26 uger hos gnavere og ikke-gnavere forårsagede ikke organtoksicitet ved dosisniveauer, som overskred den humane, terapeutiske, systemiske dosis mellem 14 og 47 gange (baseret på plasmaniveauer) Kun forventede farmakologiske virkninger som hypotension, rødmen af huden, dyspnø og forøget tarmmotilitet blev observeret.
English: 30 AMPOULES WITH 2 ML 90 AMPOULES WITH 2 ML 90 (3 x 30) AMPOULES WITH 2 ML 100 AMPOULES WITH 2 ML 300 AMPOULES WITH 2 ML 300 (10 x 30) AMPOULES WITH 2 ML
Danish: 30 AMPULLER MED 2 ML 90 AMPULLER MED 2 ML 90 (3 x 30) AMPULLER MED 2 ML 100 AMPULLER MED 2 ML 300 AMPULLER MED 2 ML 300 (10 x 30) AMPULLER MED 2 ML
English: If a dose up to 5 microgram iloprost is indicated, again dosing intervals of 3-4 hours should be chosen initially and shortened according to individual tolerability.
Danish: Hvis en dosis op til 5 mikrogram iloprost er indiceret, skal der igen startes med doseringsintervaller på 3-4 timer, som efterfølgende kan afkortes i overensstemmelse med den enkelte patients tolerabilitet over for lægemidlet.
English: Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis 10 microgram/ml.
Danish: Derudover har Venta-Neb, en bærbar, ultrasonisk, batteridrevet nebulisator, også vist sig at være egnet til administration af Ventavis 10 mikrogram/ml.
English: Pain in jaw/trismus
Danish: Kæbesmerter/trismus
English: 2.5 mcg red red
Danish: 2,5 mikrogram rød rød
English: Close supervision by the treating physician is necessary if switching from Ventavis 10 microgram/ml to Ventavis 20 microgram/ml to control the acute tolerance relating to faster delivery rate of iloprost with the double concentration.
Danish: Nøje tilsyn fra den behandlende læge er nødvendigt, hvis der skiftes fra Ventavis 10 mikrogram/ml til Ventavis 20 mikrogram/ml, for at kontrollere den akutte tolerance i forbindelse med den hurtigere tilførselshastighed af iloprost med den dobbelte koncentration.
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: • or other inhibitors of platelet aggregation, such as acetylsalicylic acid, non-steroidal anti-inflammatory medicinal products, non-selective phosphodiesterase inhibitors like pentoxifylline, selective phosphodiesterase 3 (PDE3) inhibitors like cilostazol or anagrelide, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, like o abciximab, o eptifibatide, o tirofiban, defibrotide.
Danish: • eller andre hæmmere af trombocytaggregation som f.eks. - acetylsalicylsyre, - non-steroide anti-inflammatoriske lægemidler, - non-selektive phosphodiesterasehæmmere, som f.eks. pentoxifyllin - selektive phosphodiesterase 3 (PDE3)-hæmmere, som f.eks. cilostazol eller anagrelid - ticlopidin, - clopidogrel, - glycoprotein IIb/IIIa-antagonister, som f.eks. o abciximab, o eptifibatid, o tirofiban - defibrotid.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH 1 ML
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER AMPUL MED 1 ML
English: • diarrhoea
Danish: • Diaré
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC11
Danish: Farmakoterapeutisk klassifikation: Antitrombosemidler, trombocytaggregationshæmmere eksklusive Heparin
English: Other medicines and Ventavis
Danish: Brug af anden medicin sammen med Ventavis
English: Part of a multipack containing 300 ampoules with 2 ml.
Danish: Del af en multipakning indeholdende 300 ampuller med 2 ml.
English: • 90 ampoules
Danish: • 90 ampuller
English: Ampoules with 1 ml nebuliser solution (for the use of Breelib or I-Neb AAD):
Danish: Ampuller med 1 ml opløsning til nebulisator (til brug sammen med Breelib eller I-Neb AAD):
English: Part of a multipack containing 90 ampoules with 2 ml.
Danish: Del af en multipakning indeholdende 90 ampuller med 2 ml.
English: • Bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing (see also section 2 “Warnings and precautions”)
Danish: • Bronkospasme (pludselig sammentrækning af musklerne i bronkierne i lungerne) og hvæsende vejrtrækning (se også pkt.
English: Any Ventavis solution remaining in the nebuliser after inhalation must be thrown away.
Danish: Eventuelle rester af Ventavis-opløsning i nebulisatoren efter din inhalation skal bortskaffes.
English: • Breelib nebuliser
Danish: • Breelib-nebulisator
English: In the iloprost group, the mean change from baseline after 12 weeks of treatment in the 6-minute walking distance was an increase of 22 metres (-3.3 metres in the placebo group, no data imputation for death or missing values).
Danish: I iloprost-gruppen var middelændringen fra baseline i den 6 minutters gangtest en øgning på 22 meter efter 12 ugers behandling (-3,3 meter i placebo-gruppen.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (forekommer hos op til 1 ud af 10 personer):
English: Depending on your individual needs, Ventavis can be used for long term treatment.
Danish: Ventavis kan anvendes til langvarig behandling, afhængigt af individuelle behov.
English: Ventavis 10 microgram/ml is provided in colourless ampoules, containing either 1 ml or 2 ml nebuliser solution.
Danish: Ventavis 10 mikrogram/ml leveres i farveløse ampuller indeholdende enten 1 ml eller 2 ml nebulisatoropløsning.
English: This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 5 micrograms iloprost of the Ventavis 20 microgram/ml nebuliser solution (1 ml ampoule with yellow and red rings).
Danish: Nebulisatoren monitorerer vejrtrækningsmønsteret for at bestemme den aerosol-pulseringstid, der er nødvendig for at afgive den forudindstillede dosis på 5 mikrogram iloprost af Ventavis 20 mikrogram/ml inhalationsvæske, opløsning (1 ml-ampul med gule og røde ringe).
English: Hepatic impairment Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
Danish: Nedsat leverfunktion Eliminationen af iloprost reduceres hos patienter med hepatisk dysfunktion (pkt.
English: How to inhale
Danish: Sådan skal du inhalere
English: • Medicines used to treat high blood pressure or heart disease, such as beta blockers, nitro-vasodilators,
Danish: • Medicin, der anvendes til behandling af for højt blodtryk eller hjertesygdom, som f.eks.
English: • Inhibition of platelet aggregation, platelet adhesion and release reaction
Danish: • Hæmning af trombocytaggregation, trombocytadhæsion og release-reaktion