FrancophonIA/ELRC3.0 huggingface dataset:
English: In the iloprost group, the median daily inhaled dose was 30 microgram (range 12.5 to 45 microgram/day).
Danish: I iloprost-gruppen var den gennemsnitlige dosis, der blev inhaleret dagligt, 30 mikrogram (område 12,5 til 45 mikrogram/dag).
English: Symptoms of overdoses are mainly related to the vasodilatory effect of iloprost.
Danish: Symptomerne på overdosering er hovedsageligt relateret til iloprosts vasodilaterende virkning.
English: No disturbance of postnatal development and reproductive performance was seen in the offspring that were raised, indicating that the observed retardation in rats was compensated during the postnatal development.
Danish: Der sås ingen forstyrrelser i den postnatale udvikling eller i forplantningsevnen hos det afkom, der blev opfostret, hvilket tyder på, at den observerede hæmning hos rotter blev kompenseret under den postnatale udvikling.
English: • mouth and tongue irritation including pain
Danish: • Irritation i mund og tunge, herunder smerter
English: In a chronic inhalation study in rats over 26 weeks, the highest achievable dose of 48.7 microgram/kg/day was identified as ‘no observed adverse effect level' (NOAEL).
Danish: I et kronisk inhalationsstudie med rotter over 26 uger blev den opnåelige dosis på 48,7 mikrogram/kg/dag observeret som et nul-effekt-niveau (NOAEL) (no observed adverse effect level).
English: For administration with the Venta-Neb.
Danish: Til administration med Venta-Neb.
English: If you swallow it accidentally, drink plenty of water and tell your doctor.
Danish: Hvis du kommer til at synke medicinen, så drik rigeligt med vand og kontakt din læge.
English: Your doctor will consider changing your treatment.
Danish: Din læge vil overveje, om din behandling skal ændres.
English: A cautious initial dose titration using dosing intervals of 3-4 hours is recommended (see section 4.2).
Danish: Forsigtig initial dosistitrering med doseringsintervaller på 3-4 timer anbefales (se pkt.
English: Contents of the pack and other information What Ventavis contains:
Danish: Pakningsstørrelser og yderligere oplysninger Ventavis indeholder:
English: The rate of responders to iloprost was 16.8% (17/101) and the rate of responders in the placebo group was 4.9% (5/102) (p=0.007).
Danish: Målopfyldelsen på iloprost var 16,8 % (17/101) og for placebo-gruppen 4,9 % (5/102) (p=0,007).
English: One inhalation session with Breelib will usually last about 3 minutes.
Danish: En inhalationsbehandling med Breelib varer som regel 3 minutter.
English: (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
Danish: aktiv peptisk ulcus, traume, intrakraniel blødning).
English: The duration of treatment depends on clinical status and is left to the physician's discretion.
Danish: Behandlingens varighed afhænger af patientens kliniske status og bør vurderes og bestemmes af lægen.
English: Peripheral oedema§
Danish: Perifert ødem§
English: − Severe coronary heart disease or unstable angina.
Danish: - Alvorlig koronar hjertesygdom eller ustabil angina.
English: • For the inhalation you should use a mouthpiece to prevent Ventavis coming into contact with your skin.
Danish: • Ved inhalering skal du anvende et mundstykke for at undgå, at Ventavis kommer i kontakt med din hud.
English: Although, clinical studies have not been conducted, in vitro studies investigating the inhibitory potential of iloprost on the activity of cytochrome P450 enzymes revealed that no relevant inhibition of drug metabolism via these enzymes by iloprost is to be expected.
Danish: Selv om der ikke er udført kliniske studier, viste in vitro-studier, der undersøger iloprosts potentielle hæmmende virkning på cytokrom-P450-enzymernes aktivitet, at iloprost ikke forventes at have nogen relevant hæmmende effekt på lægemiddelmetabolisme via disse enzymer.
English: For administration with the Breelib.
Danish: For administration med Breelib.
English: Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs.
Danish: Når aerosolerne indåndes, føres Ventavis til lungerne, hvor det kan virke mest effektivt i arterien mellem hjertet og lungerne.
English: • 42 ampoules.
Danish: • 42 ampuller.
English: Gender Gender is not of clinical relevance to the pharmacokinetics of iloprost.
Danish: Køn Køn er ikke af klinisk relevans i forbindelse med iloprosts farmakokinetik.
English: Patients with diseases of the respiratory tract
Danish: Patienter med respirationssygdomme
English: For administration with the Breelib or the I-Neb.
Danish: Til administration med Breelib eller I-Neb.
English: Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered.
Danish: Hvis patientens tilstand forværres ved denne behandling bør intravenøs behandling med prostacyklin overvejes.
English: Talk to your doctor, pharmacist or nurse before using Ventavis:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Ventavis:
English: Interruption of the inhalation session, monitoring and symptomatic measures are recommended.
Danish: Det anbefales at afbryde inhalationsbehandlingen, overvåge patienten og tage symptomatiske forholdsregler.
English: You may be gradually introduced to the prescribed dose or be prescribed a lower dose of Ventavis than for other patients (see section 3.
Danish: Du kan blive trappet gradvist op til den ordinerede dosis, eller du kan få ordineret en lavere dosis af Ventavis end andre patienter (se pkt.
English: Bleeding events (mostly epistaxis and haemoptysis) were very common as expected in this patient population with a high proportion of patients taking anticoagulant co-medication.
Danish: Blødning (mest epistaxis og hæmoptyse) var meget almindelig som forventet i denne patientgruppe, hvor en stor del af patienterne samtidig tager antikoagulantia.
English: 4.2 Posology and method of administration Drug product
Danish: 4.2 Dosering og administration Lægemiddel
English: The baseline 6-minute walk test values reflected a moderate exercise limitation: in the iloprost group the mean was 332 metres (median value: 340 metres) and in the placebo group the mean was 315 metres (median value: 321 metres).
Danish: Den 6 minutters baseline-gangtest viste en moderat motionsindskrænkning: i iloprost-gruppen var middelværdien 332 meter (median: 340 meter), og i placebo-gruppen var middelværdien 315 meter (median 321 meter).
English: • If you are pregnant, think you might be or are planning to have a baby, tell your doctor straight away.
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du straks fortælle det til lægen.
English: If you get any side effects talk to your doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge.
English: Only patients who are maintained at the 5 microgram dose and who have repeatedly experienced extended inhalation times with Ventavis 10 microgram/ml, which could result in incomplete inhalation, may be considered suitable for switching to Ventavis 20 microgram/ml.
Danish: Kun de patienter, som holdes på 5 mikrogram-dosis, og som gentagne gange har oplevet forlængede inhalationstider med Ventavis 10 mikrogram/ml, hvilket kan medføre ufuldstændig inhalation, kan anses for egnede til at skifte over til Ventavis 20 mikrogram/ml.
English: Ventavis is intended for inhalation use by nebulisation.
Danish: Ventavis er beregnet til inhalation via en nebulisator.
English: He/she may consider adjusting your dose or changing your treatment.
Danish: Din læge kan overveje at justere dosis eller ændre din behandling.
English: Caution is recommended in case of co-administration of Ventavis with other antihypertensive or vasodilatating agents as dose adjustment might be required.
Danish: Det anbefales at udvise forsigtighed, hvis Ventavis gives sammen med andre antihypertensiva eller vasodilaterende stoffer, da justering af dosis kan være nødvendigt.
English: It is not known whether Ventavis passes into human milk.
Danish: Det er ukendt, om Ventavis udskilles i mælken hos mennesker.
English: Women with pulmonary hypertension (PH) should avoid pregnancy as it may lead to life-threatening exacerbation of the disease.
Danish: Kvinder med pulmonal hypertension bør undgå en graviditet, da det kan føre til livstruende forværring af sygdommen.
English: The use of Ventavis is not recommended in patients with unstable pulmonary hypertension, with advanced right heart failure.
Danish: Brugen af Ventavis anbefales ikke til patienter med ustabil pulmonal hypertension, med fremskreden svigt af højre hjertehalvdel.
English: • Follow carefully any instructions that come with the nebuliser.
Danish: • Følg nøje eventuelle instruktioner, der fulgte med nebulisatoren.
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol is between 1 and 5 micrometers.
Danish: Aerosolens MMAD (Mass Median Aerodynamic Diameter) er 1-5 mikrometer.
English: There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
Danish: Der er ikke behov for dosistilpasning hos patienter med en kreatinin clearance >30 ml/min (som bestemt ud fra serum kreatinin ved brug af Cockroft- og Gault-formlen).
English: One inhalation session will usually last about 4 to 10 minutes with I-Neb AAD depending on the prescribed dose.
Danish: En inhalationsbehandling varer normalt 4 til 10 minutter med I-Neb AAD, afhængigt af den ordinerede dosis.
English: Further in vitro studies suggest that metabolism of iloprost in the lungs is similar after intravenous administration or inhalation.
Danish: Desuden antyder in vitro-studier, at metaboliseringen af iloprost i lungerne er nogenlunde ens efter intravenøs indgivelse og inhalation.
English: A potential risk to the breast-feeding child cannot be excluded and it is preferable to avoid breast-feeding during Ventavis therapy.
Danish: En potentiel risiko for det ammede barn kan ikke udelukkes, og det er bedst at lade være med at amme under Ventavis-behandling.
English: No studies to investigate the metabolism of iloprost were performed following inhalation of Ventavis.
Danish: Der er ikke udført studier for at undersøge iloprosts metabolisme efter inhalation af Ventavis.
English: The occurrence of peripheral oedema can be related to the deterioration of the disease or insufficient effectiveness of the product.
Danish: Perifert ødem kan skyldes en forværring af sygdommen eller utilstrækkelig effektivitet af produktet.
English: A dermal sensitisation (maximisation test) and an antigenicity study in guinea pigs showed no sensitising potential.
Danish: En sensibilisering af huden (maksimeringstest) og et antigenicitetsstudie med marsvin viste intet sensibiliseringspotentiale.
English: Packages containing:
Danish: Pakker indeholdende:
English: In acute toxicity studies, single intravenous and oral doses of iloprost caused severe symptoms of intoxication or death (intravenous) at doses about two orders of magnitude above the intravenous therapeutic dose.
Danish: I studier omhandlende akut toksicitet forårsagede intravenøse og orale enkeltdoser af iloprost alvorlige symptomer på intoksikation eller død (intravenøse) ved doser i en størrelsesorden på cirka to gange den intravenøse terapeutiske dosis.
English: Other people might accidentally be exposed to Ventavis through the room air.
Danish: Andre personer kan komme til at indånde Ventavis gennem luften i rummet.
English: The dose of Ventavis and the duration of treatment that is right for you depend on your individual condition.
Danish: Den rigtige dosis Ventavis og behandlingens varighed afhænger af din tilstand.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne vises inden for hvert hyppighedsområde efter faldende alvorlighed.
English: Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma.
Danish: Desuden er udbyttet ved at anvende Ventavis ikke blevet påvist hos patienter med samtidig kronisk obstruktiv lungesygdom (KOL) og svær astma.
English: Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain.
Danish: Hyppigt observerede symptomer efter overdosering er svimmelhed, hovedpine, flushing, kvalme, kæbe- eller rygsmerter.
English: • If you experience difficulty breathing, cough up blood, and/or sweat excessively these may be signs that you have water in the lungs (lung oedema).
Danish: • Hvis du har vejrtrækningsbesvær, hoster blod op og/eller sveder kraftigt, kan det være tegn på, at du har væske i lungerne (lungeødem).
English: No study has been performed with Ventavis in children with pulmonary hypertension.
Danish: Der er ikke foretaget studier med Ventavis hos børn med pulmonal hypertension.
English: In addition to local effects resulting from administration of iloprost by inhalation such as cough, adverse reactions with iloprost are related to the pharmacological properties of prostacyclins.
Danish: Foruden lokale virkninger, der forekommer som resultat af indtagelse af iloprost ved inhalation, er bivirkninger fra iloprost som f.eks. hoste, relateret til de farmakologiske egenskaber af prostacycliner.
English: Fatal cases included cerebral and intracranial haemorrhage.
Danish: Letale tilfælde inkluderede cerebral og intrakraniel blødning.
English: To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalationtriggered systems (such as Breelib or I-Neb), and to keep the room well ventilated.
Danish: For at minimere utilsigtet udsættelse anbefales det at anvende Ventavis med nebulisatorer med inhalationsudløste systemer (som f.eks. Breelib, I-Neb) og at sørge for god ventilation i rummet.
English: • 2 ml ampoules for the use with Venta-Neb: Pack containing 30, 90, 100 or 300 ampoules.
Danish: • 2 ml ampuller med Venta-Neb: - Pakke med 30, 90, 100 eller 300 ampuller.
English: − Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
Danish: - Alvorlig arytmi - Cerebrovaskulære hændelser (f.eks. transient iskæmisk anfald, slagtilfælde) inden for de sidste
English: If you stop taking Ventavis
Danish: Hvis du holder op med at tage Ventavis
English: If you forget to use Ventavis
Danish: Hvis du har glemt at bruge Ventavis
English: A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost at the concentration of 10 microgram/ml: N=101; placebo n=102) with stable pulmonary hypertension.
Danish: Et randomiseret, dobbelt-blindt, multi-center, placebo-kontrolleret fase III-forsøg (studie RRA02997) er foretaget med 203 voksne patienter (inhaleret iloprost i koncentrationen 10 mikrogram/ml: N=101; placebo n=102) med stabil pulmonal hypertension.
English: The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Danish: De alvorligste bivirkninger var hypotension, blødning og bronkospasmer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON WITHOUT BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE EMBALLAGE UDEN BLUE BOX
English: In embryo- and foetotoxicity studies in rats continuous intravenous administration of iloprost led to anomalies of single phalanges of the forepaws in a few foetuses/pups without dose dependence.
Danish: I embryo- og føtotoksicitetsstudier hos rotter førte kontinuerlig intravenøs administration af iloprost til anomalier af enkelt-falankser i forpoterne hos nogle fostre/unger uafhængigt af dosis.
English: As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
Danish: Som forventet for prostacycliner fremkaldte iloprost hæmodynamiske virkninger (vasodilatation, rødmen af huden, hypotension, hæmning af trombocytfunktionen, respirationsbesvær) samt generelle tegn på intoksikation som f.eks. apati, gangforstyrrelser samt posturale ændringer.
English: The table below provides a summary of the user instructions of the I-Neb:
Danish: Nedenstående tabel giver en oversigt over brugervejledningen for I-Neb:
English: One inhalation session with Venta-Neb will usually last about 4 to 10 minutes depending on the prescribed dose.
Danish: En inhalationsbehandling med Venta-Neb varer normalt 4 til 10 minutter, afhængigt af den ordinerede dosis.
English: • Swelling, mainly of the ankles and legs, due to fluid retention (peripheral oedema) is a very common symptom of the illness itself but can also occur during treatment with Ventavis.
Danish: • Hævelse primært af ankler og ben på grund af vand i kroppen (perifert ødem) er et meget almindeligt symptom på selve sygdommen, men kan også optræde under behandlingen med Ventavis.
English: Iloprost may increase the effects of vasodilatators and antihypertensive agents and then favour the risk of hypotension (see section 4.4).
Danish: Iloprost kan øge virkningen af vasodilatorer og antihypertensive midler og dermed øge risikoen for hypotension (se pkt.
English: First dosing with 2.5 microgram should be done even if patients had already been stable on 5 microgram inhaled with an alternative device (see section 4.2).
Danish: Den første administration af 2,5 mikrogram gælder også, selvom patienten allerede var stabil ved 5 mikrogram inhaleret med et andet system (se pkt.
English: Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8).
Danish: Inhalation af Ventavis kan indebære risiko for udløsning af bronkospasmer, specielt hos patienter med bronkial hyperaktivitet (se pkt.
English: In order to ensure that you receive the prescribed dose, check the colour of the medication chamber and the colour of the control disc.
Danish: For at sikre, at du får den ordinerede dosis, skal du kontrollere farven på medicineringskammeret og farven på kontroldisken.
English: No disturbance of post-natal development and reproductive performance was seen in animals exposed during lactation.
Danish: Der sås ingen forstyrrelser i den postnatale udvikling eller i forplantningsevnen hos dyr, der blev eksponeret for iloprost under diegivning.
English: After each inhalation session, any solution remaining in the nebuliser should be discarded.
Danish: Efter hver inhalationsbehandling skal eventuel opløsning, der er tilbage i nebulisatoren, kasseres.
English: Use dosing intervals of 3 - 4 hours (this corresponds to a maximum of 6 administrations per day).
Danish: Tag en ny dosis hver 3.-4. timer (dette svarer til et maksimum på 6 doser pr. dag).
English: Physicians should be alerted to the presence of concomitant conditions or medicinal products that might increase the risk of hypotension and syncope (see section 4.5).
Danish: Lægen bør være opmærksom på andre samtidigt forekommende sygdomstilstande eller lægemidler, der kan øge risikoen for hypotension og synkope (se pkt.
English: Therefore, the same dosing recommendations as in patients with hepatic impairment (see above) are to be applied.
Danish: Derfor gælder der samme dosisanbefaling som for patienter med nedsat leverfunktion (se ovenfor).
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Danish: Dette lægemiddel indeholder en mindre mængde ethanol (alkohol), mindre end 100 mg pr. dosis.
English: Estimated inhalation time
Danish: Estimeret inhalationstid
English: To minimize accidental exposure it is recommended to keep the room well ventilated.
Danish: For at minimere utilsigtet eksponering anbefales det at holde rummet velventileret.
English: Direct vasodilatation of the pulmonary arterial bed occur with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.
Danish: Der forekom direkte vasodilatation af det pulmonale arterieleje med konsekutiv signifikant forbedring af det pulmonale arterietryk, den pulmonale vaskulære modstand og hjertets minutvolumen så vel som iltmætningen i blandet venøst blod.
English: • if you are at risk of bleeding- for example, if you have an active ulcer of the stomach or of the first part of the small intestine (duodenal ulcers), if you have suffered a physical injury (trauma), if you are at risk of bleeding within the skull,
Danish: • hvis du har risiko for blødning - hvis du f.eks. har et aktivt sår i maven eller i øverste del af tyndtarmen (sår på tolvfingertarmen), hvis du har pådraget dig en fysisk skade (traume), eller hvis du har risiko for blødninger i kraniet,
English: Switching to the Breelib nebuliser
Danish: Skift til Breelib-nebulisatoren
English: • 300 ampoules.
Danish: • 300 ampuller.
English: • fast heartbeat (tachycardia)
Danish: • Hurtig puls (takykardi)
English: The increased occurrence of syncope can be related to the deterioration of the disease or insufficient effectiveness of the product (see section 4.4).
Danish: En øget forekomst af synkope kan skyldes en forværring af sygdommen eller utilstrækkelig effektivitet af produktet (se pkt.
English: This system generates droplets by ultrasound, which forces the solution through a mesh.
Danish: Systemet genererer dråber via ultralyd, som presser opløsningen igennem et net.
English: For each inhalation session the content of one opened ampoule of Ventavis has to be transferred completely into the medication chamber immediately before use.
Danish: Til hver inhalationsbehandling skal alt indholdet af én åben ampul Ventavis overføres til medicineringskammeret umiddelbart inden brug.
English: Women of childbearing potential should use effective contraceptive measures during treatment with Ventavis.
Danish: Fertile kvinder bør anvende sikker kontraception under behandlingen med Ventavis.
English: Patients initiating Ventavis treatment or switching from an alternative device to Breelib should be closely supervised by the treating physician to ensure that dose and speed of inhalation are well tolerated.
Danish: Patienter, der påbegynder behandling med Ventavis, eller som skifter fra et andet system til Breelib, bør overvåges nøje af den behandlende læge for at sikre, at patienterne tolererer dosis og inhalationshastighed godt.
English: • Bleeding events (mostly nosebleed (epistaxis) and coughing up blood (haemoptysis)) may very commonly occur, especially if you are also taking blood-thinning medicines (anticoagulants).
Danish: • Blødning (oftest næseblod (epistaxi) og ophostning af blod (hæmoptyse)) kan være meget almindeligt forekommende, især hvis du også tager blodfortyndende medicin (antikoagulantia).
English: General disorders and administration site condition
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Cmax and AUC (0-tlast) of iloprost after inhalation with Breelib were, however, still in the range of values observed with Ventavis 10 microgram/ml using other inhalers across different studies.
Danish: Cmax og AUC (0-tlast) for iloprost efter inhalation med Breelib viste imidlertid stadigvæk værdier inden for det område, der blev observeret med Ventavis 10 mikrogram/ml med andre inhalatorer på tværs af forskellige studier.
English: The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Danish: Dosis pr. inhalationsbehandling bør administreres 6 til 9 gange dagligt efter patientens behov og tolerabilitet.
English: Syncope§ (see section 4.4) Hypotension*
Danish: 4.4) Hypotension*
English: As you repeatedly experience extended inhalation treatment times with Ventavis 10 microgram/ml (1 ml ampoule with white and yellow rings), your doctor decided to switch to Ventavis 20 microgram/ml.
Danish: Da du gentagne gange har oplevet forlængede inhalationstider under behandlingen med Ventavis 10 mikrogram/ml (1 ml-ampul med hvide og gule ringe), har din læge besluttet at skifte til Ventavis 20 mikrogram/ml.