natgillin/translations-raw huggingface dataset:
Patienterne skal starte med den lave dosis på 2, 5 mikrogram ved den første inhalation, fulgt af 5, 0 mikrogram ved den anden.
Patients should start with the low dose of 2.5 micrograms for the first inhalation, followed by 5.0 micrograms for the second.
Dosis kan herefter nedsættes til 2, 5 mikrogram igen, hvis patienten ikke kan tåle den høje dosis.
The dose can then be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Lægemidlet indgives ved hjælp af en såkaldt ” dosimetrisk ” nebulisator, der standser automatisk, når den korrekte dosis er blevet indgivet.
The medicine must be given using a type of nebuliser known as a ‘ dosimetric’ nebuliser, which stops automatically when the correct dose has been delivered.
Lægemidlet skal indtages seks til ni gange dagligt.
It is taken six to nine times a day.
Dosis bør være lavere for patienter med leverproblemer.
Doses are lower if the patient has liver problems.
Pulmonal hypertension er en invaliderende sygdom, der består i svær konstriktion (forsnævring) af blodkarrene i lungerne.
Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Det medfører et højt blodtryk i de blodkar, der fører blodet fra højre side af hjertet til lungerne.
It causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Ventavis er en inhaleret formulering af iloprost, et stof, der i høj grad ligner
Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Reproduction is authorised provided the source is acknowledged. prostacyclin, som er et naturligt forekommende molekyle, der får blodkarrene til at udvide sig (dilatere).
Reproduction is authorised provided the source is acknowledged.
Ventavis er blevet sammenlignet med placebo (en uvirksom behandling) i en undersøgelse af 203 voksne patienter med stabil pulmonal hypertension (klasse III eller IV), som enten var primær eller forårsaget af en anden tilstand.
Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adult patients with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Det vigtigste mål for virkningen var antallet af patienter, som havde responderet på behandling efter 12 uger. ” Respons ” blev defineret som en kombination af en 10 procents forbedring af den fysiske kapacitet (som blev målt ved at undersøge, hvor langt patienten kunne gå på seks minutter) og en bedring af patientens tilstand (en mindskelse af sygdommens alvorlighed med mindst én klasse) uden en forværring af den pulmonale hypertension eller død.
A ‘ response’ was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient ’ s condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
Ventavis er væsentlig mere effektivt end placebo:
Ventavis was significantly more effective than placebo:
17% af patienterne, der fik Ventavis, responderede på behandling (17 ud af 101) sammenlignet med 5% af de patienter, der fik placebo (5 ud af 102).
17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
De hyppigste bivirkninger ved Ventavis (som optræder hos flere end 1 ud af 10 patienter) er vasodilatation (blodkarrene udvides og forårsager rødmen af ansigtet), hypotension (lavt blodtryk) og hoste.
The most common side effects with Ventavis (seen in more than 1 patient in 10) are vasodilation (blood vessels becoming wider causing flushing or reddening of the face), hypotension (low blood pressure) and cough.
Den fuldstændige liste over de indberettede bivirkninger ved Ventavis fremgår af indlægssedlen.
For the full list of all side effects reported with Ventavis, see the Package Leaflet.
Ventavis bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for iloprost eller et eller flere af de øvrige indholdsstoffer.
Ventavis should not be used in people who may be hypersensitive (allergic) to iloprost or any of the other ingredients.
Det må ikke anvendes af patienter, som har risiko for blødninger, som har visse hjerteproblemer, som for nylig har haft et slagtilfælde, eller hvis pulmonale hypertension er forårsaget af en blokeret eller forsnævret vene.
It must not be used in patients who are at risk of bleeding, who have certain heart problems, who have recently had a stroke, or whose pulmonary hypertension is caused by a blocked or narrow vein.
Ventavis må heller ikke anvendes af kvinder, som er gravide eller ammer.
It must also not be used in women who are pregnant or breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, på trods af, at der kun forelå en begrænset mængde oplysninger, at fordelene ved Ventavis er større end risiciene til behandling af patienter med primær pulmonal hypertension, klassificeret som NYHA funktionsklasse III, for at forbedre den fysiske kapacitet og symptomer.
The Committee for Medicinal Products for Human Use (CHMP) decided that, despite the limited data available, Ventavis’ s benefits are greater than its risks for the treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Udvalget anbefalede udstedelse af en markedsføringstilladelse for Ventavis.
The Committee recommended that Ventavis be given marketing authorisation.
Ventavis er blevet godkendt under ” særlige omstændigheder ”, da det ikke har været muligt at indhente fyldestgørende oplysninger om lægemidlet, da sygdommen er sjælden.
Ventavis has been authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Hvilke oplysninger afventes der stadig for Ventavis?
Which information is still awaited for Ventavis?
Virksomheden, som fremstiller Ventavis, skal udføre yderligere undersøgelser med henblik på at indsamle data om langtidsanvendelse af lægemidlet.
The company that makes Ventavis will carry out further studies to collect data on the long-term use of the medicine.
Andre oplysninger om Ventavis:
Other information about Ventavis:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ventavis til Bayer Schering Pharma AG den 16. september 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis to Bayer Schering Pharma AG on 16 September 2003.
Markedsføringstilladelsen blev fornyet den16. september 2008.
The marketing authorisation was renewed on 16 September 2008.
Registreringen af udpegelsen af Ventavis som lægemiddel til sjældne sygdomme kan ses her.
The record of Ventavis’ s designation as an orphan medicine is available here.
Den fuldstændige EPAR om Ventavis findes her.
The full EPAR for Ventavis can be found here.
30 ampuller
Packaging
300 ampuller
Package size
Inhalationsvæske til nebulisator, opløsning
Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis Ventavis
Inhalationsvæske til nebulisator, opløsning
Nebuliser solution Nebuliser solution Nebuliser solution Nebuliser solution Nebuliser solution Nebuliser solution Nebuliser solution Nebuliser solution
Inhalationsvæske til nebulisator, opløsning
Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use Inhalation use
Inhalationsvæske til nebulisator, opløsning
ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass) ampoule (glass)
10 x 30 ampuller
30 ampoules 100 ampoules 300 ampoules 30 ampoules 168 ampoules 90 ampoules 3 x 30 ampoules 10 x 30 ampoules
Ventavis 10 mikrogram/ ml inhalationsvæske til nebulisator, opløsning
Ventavis 10 microgram/ ml nebuliser solution
1 ml vandig opløsning indeholder 10 mikrogram iloprost (som iloprosttrometamol).
1 ml solution contains 10 micrograms iloprost (as iloprost trometamol).
Hver ampul med 1 ml indeholder 10 mikrogram iloprost.
Each ampoule with 1 ml contains 10 micrograms iloprost.
Hver ampul med 2 ml indeholder 20 mikrogram iloprost.
Each ampoule with 2 ml contains 20 micrograms iloprost.
Ethanol 96% 0, 81 mg pr. ml.
Ethanol 96% 0,81 mg per ml.
Inhalationsvæske til nebulisator, opløsning Klar, farveløs opløsning
Clear, colourless solution.
Til behandling af patienter med primær pulmonal hypertension, klassificeret som NYHA funktionel klasse III, for at forbedre arbejdsevnen og mindske sygdomssymptomerne.
Treatment of patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Ventavis bør kun ordineres/ initieres og monitoreres af en læge med erfaring i behandlingen af pulmonal hypertension.
Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension.
Ventavis er indiceret til inhalation ved forstøvning (se pkt.
Ventavis is intended for inhalation use by nebulisation (see section 6.6).
6. 6).
Adults
Voksne Dosis pr. inhalationsbehandling:
• Dose per inhalation session:
Den anbefalede dosis er 2, 5 mikrogram eller 5, 0 mikrogram inhaleret iloprost (indgivet via nebulisatorens mundstykke) begyndende med en lav dosis på 2, 5 mikrogram ved første inhalation efterfulgt af 5, 0 mikrogram ved anden inhalation.
The recommended dose is 2.5 micrograms or 5.0 micrograms of inhaled iloprost (as delivered at the mouthpiece of the nebuliser), starting with the low dose of 2.5 microgram for the first inhalation, followed by 5.0 micrograms for the second inhalation.
Hvis dosis på 5, 0 mikrogram tolereres dårligt, skal dosis nedsættes til 2, 5 mikrogram.
In case of poor tolerability of the 5.0 microgram dose, the dose should be reduced to 2.5 micrograms.
To nebulisatorsystemer, HaloLite og Prodose, der anvender trykluft, har vist sig at være egnede nebulisatorer til administration af Ventavis.
Two compressed air nebuliser systems, HaloLite and Prodose, have been shown to be suitable nebulisers for the administration of Ventavis.
I begge systemer var Mass Median Aerodynamic Diameter (MMAD) af aerosoldråben med iloprost mellem 2, 6 og 2, 7 mikrometer.
With both systems the mass median aerodynamic diameter of the aerosol droplet (MMAD) with iloprost was between 2.6 and 2.7 micrometres.
Til hver inhalationsbehandling skal indholdet af én ampul med 2 ml Ventavis nebulisatoropløsning overføres til nebulisatorkammeret umiddelbart inden brug.
For each inhalation session the content of one ampoule containing 2 ml of Ventavis nebuliser solution will be transferred into the nebuliser medication chamber immediately before use.
HaloLite og Prodose er dosimetriske systemer.
HaloLite and Prodose are dosimetric systems.
De standser automatisk, efter at den forudindstillede dosis er blevet givet.
They stop automatically after the pre-set dose has been delivered.
Inhalationstiden afhænger af patientens vejrtrækningsmønster.
The inhalation time depends on the patient ’ s breathing pattern.
System
Device
Dosis iloprost ved
Dose of iloprost at
mundstykket
Estimated inhalation time
(hyppighed på
mouthpiece
15 vejrtrækninger pr. minut)
(frequency of 15 breaths per minute)
2, 5 mikrogram
2.5 micrograms
4 til 5 min
4 to 5 min
8 til 10 min
8 to 10 min
Til en dosis på 5 mikrogram iloprost ved mundstykket anbefales det at fuldføre to inhalationscykler med et forudindstillet doseringsprogram på 2, 5 mikrogram med påfyldning af én ampul med 2 ml Ventavis nebulisatoropløsning, som har to farvede ringe (hvid - lyserød).
For a dose of 5 micrograms iloprost at mouthpiece it is recommended to complete two inhalation cycles with 2.5 micrograms pre-set dose program with a filling of one ampoule containing 2 ml Ventavis nebuliser solution, which shows two coloured rings (white – pink).
Derudover har Venta- Neb, en bærbar, ultrasonisk, batteridrevet nebulisator, også vist sig at være egnet til administration af Ventavis.
Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis.
Den målte MMAD for aerosoldråberne var 2, 6 mikrometer.
The measured MMAD of the aerosol droplets was 2.6 micrometres.
Til hver inhalationsbehandling skal indholdet af en ampul med 2 ml Ventavis nebulisatoropløsning, og som viser to farvede ringe (hvid - lyserød) overføres til nebulisatorkammeret umiddelbart inden brug.
For each inhalation session, the content of one ampoule containing 2 ml Ventavis nebuliser solution and showing two coloured rings (white – pink) will be transferred into the nebuliser medication chamber immediately before use.
Der kan anvendes to programmer:
Two programs can be operated:
5, 0 mikrogram aktivt stof på mundstykket 25 inhalationscyklusser.
5.0 micrograms active substance on the mouth piece 25 inhalation cycles.
2, 5 mikrogram aktivt stof på mundstykket 10 inhalationscyklusser.
2.5 micrograms active substance on the mouth piece 10 inhalation cycles.
Valget af det forud indstillede program foretages af lægen.
The selection of the pre set program is made by the physician.
Venta- Neb giver patienten besked på at inhalere ved hjælp af et visuelt og akustisk signal.
Venta-Neb prompts the patient to inhale by an optical and an acoustic signal.
Yderligere information findes i brugervejledningen til Venta- Neb nebulisatoren.
For details refer to the instruction manual of the Venta-Neb nebuliser.
Estimeret inhalationstid
Estimated Inhalation time
2, 5 mikrogram 5 mikrogram
5 micrograms
I- Neb AAD- systemet er et transportabelt, håndholdt, vibrerende nebulisatorsystem med netteknologi.
The I-Neb AAD System is a portable, hand-held, vibrating mesh technology nebuliser system.
I- Neb AAD - nebulisatoren har også vist sig at være velegnet til administrering af Ventavis.
The I-Neb AAD nebuliser has also been shown to be suitable for the administration of Ventavis.
Den målte MMAD for aerosoldråberne var 2, 1 mikrometer.
The measured MMAD of the aerosol droplets was 2.1 micrometres.
Nebulisatoren monitorerer vejrtrækningsmønsteret for at bestemme den aerosol- pulseringstid, der er nødvendig for at afgive den forudindstillede dosis på 2, 5 eller 5 mikrogram iloprost.
This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 2.5 or 5 micrograms iloprost.
Den forudindstillede dosis, som I- Neb AAD- systemet giver, kontrolleres af medicineringskammeret i kombination med en kontroldisk.
The pre-set dose provided by the I-Neb AAD system is controlled by the medication chamber in combination with a control disc.
Der er to forskellige farvekodede medicineringskamre.
There are two different colour coded medication chambers.
For hvert medicineringskammer er der en tilsvarende farvekodet kontroldisk.
For each medication chamber there is a corresponding colour coded control disc:
Til dosis på 2, 5 mikrogram anvendes medicineringskammeret (350 mikroliter) med den røde pal sammen med den røde kontroldisk.
For the 2.5 micrograms dose the medication chamber (350 microliter) with the red latch is used together with the red control disc.
Til dosis på 5 mikrogram anvendes medicineringskammeret (650 mikroliter) med den lilla pal sammen med den lilla kontroldisk.
For the 5 micrograms dose the medication chamber (650 microliter) with the purple coloured latch is used together with the purple control disc.
Til hver inhalationsbehandling med I- Neb AAD overføres indholdet af en ampul med 1 ml Ventavis, som har tre farvede ringe (lyserød - rød - rød), til det relevante nebulisator- medicineringskammer umiddelbart før brug.
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis, showing three coloured rings (pink – red- red), will be transferred into the appropriate nebuliser medication chamber immediately before use.
Estimeret inhalationstid
Inhalation time
5. 2), bør patienter, der er stabliseret på en nebulisator, ikke skifte til en anden nebulisator uden tilsyn fra den behandlende læge.
Since the I-Neb nebuliser has been shown to produce an aerosol with slightly different physical characteristics to those of HaloLite, Prodose and VentaNeb devices and a faster delivery of the solution (see section 5.2), patients stabilized on one nebuliser should not switch to another nebuliser without supervision by the treating physician.
Effekten af og tolerabiliteten over for inhaleret iloprost, når den administreres med andre nebulisatorsystemer, som giver andre forstøvningskarakteristika af iloprost- opløsningen, er ikke blevet påvist.
The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established.
Daglig dosis:
• Daily dose:
Behandlingens varighed:
• Duration of treatment:
Behandlingens varighed afhænger af patientens kliniske status og bør vurderes og bestemmes af lægen.
The duration of treatment depends on clinical status and is left to the physician’ s discretion.
5. 2).
Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
Som start bør der administreres doser på 2, 5 mikrogram med doseringsintervaller på mindst 3 timer (hvilket svarer til højst 6 gange administration pr. dag).
Initially, doses of 2.5 micrograms should be administered with dosing intervals of at least 3 hours (corresponds to administration of max.
Hvis en yderligere forøgelse af dosis op til 5 mikrogram er indiceret, skal der igen startes med doseringsintervaller på mindst 3 timer, som efterfølgende kan afkortes i overensstemmelse med den enkelte patients tolerabilitet over for lægemidlet.
If a further increase in the dose up to 5.0 micrograms is indicated, again dosing intervals of at least 3 hours should be chosen initially and shortened according to individual tolerability.
En yderligere uønsket akkumulation af lægemidlet efter flere dages behandling er ikke sandsynlig, da administrationen af lægemidlet afbrydes om natten.
A further undesired accumulation of the medicinal product following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
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).
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).
Patienter med en kreatinin clearance på ≤ 30 ml/ min blev ikke undersøgt i de kliniske studier.
Patients with a creatinine clearance of ≤ 30 ml/ min were not investigated in the clinical trials.
Der er ingen erfaring med brugen af Ventavis hos børn og unge.
There is no experience with Ventavis in children or adolescents.
− Overfølsomhed over for det (de) aktive stof( fer) eller over for et eller flere af hjælpestofferne. − Tilstande hvor Ventavis' s virkning på trombocytterne kunne forøge risikoen for blødning (f. eks. aktiv peptisk ulcus, traume, intrakraniel blødning). − Alvorlig koronar hjertesygdom eller ustabil angina;
− Hypersensitivity to the active substance or to any of the excipients. − Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e. g. active peptic ulcers, trauma, intracranial haemorrhage). − Severe coronary heart disease or unstable angina; − Myocardial infarction within the last six months; − Decompensated cardiac failure if not under close medical supervision;
4. 6)..
4 − Severe arrhythmias; cerebrovascular events (e. g. transient ischaemic attack, stroke) within the last 3 months. − Pulmonary hypertension due to venous occlusive disease. − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. − Pregnancy and lactation (see section 4.6).
Den pulmonale vasodilatatoriske effekt af inhaleret iloprost er kortvarig (mellem én til to timer).
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
Patienter, som oplever synkoper i forbindelse med pulmonal hypertension, bør undgå usædvanlig anstrengelse, f. eks. under motion.
Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
4. 8).
The occurrence of a nocturnal or exertional syncope reflects therapeutic gaps and/ or insufficient efficiency, and the need to adapt and/ or change the therapy should be considered (see section 4.8).
4. 8 Bivirkninger).
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8 Undesirable effects).
Hos patienter med lavt systemisk blodtryk skal der udvises omhu for at undgå yderligere hypotension.
In patients with low systemic blood pressure, care should be taken to avoid further hypotension.
Brugen af Ventavis bør ikke påbegyndes hos patienter med systolisk arteriel hypotension mindre end 85 mmHg.
Ventavis should not be initiated in patients with systolic arterial hypotension less than 85 mmHg.
Hvis der forekommer tegn på pulmonalt ødem, når inhaleret iloprost administreres hos patienter med pulmonal hypertension, bør muligheden for en associeret pulmonal veno- okklusiv sygdom overvejes.
Should signs of pulmonary oedema occur when inhaled iloprost is administered in patients with pulmonary hypertension, the possibility of associated pulmonary veno-occlusive disease should be considered.
Behandlingen bør afbrydes.
The treatment should be stopped.
I tilfælde af afbrydelse af Ventavis behandlingen er risikoen for rebound effekt ikke formelt udelukket.
In case of interruption of Ventavis therapy, the risk of rebound effect is not formally excluded.
Patienten bør monitoreres omhyggeligt, når behandlingen med inhaleret iloprost standses, og en alternativ behandling bør overvejes hos kritisk syge patienter.
Careful monitoring of the patient should be performed, when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.
Eliminationen af iloprost reduceres hos patienter med hepatisk dysfunktion og hos patienter med dialysekrævende nyreinsufficiens (se pkt.
Iloprost elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2).
4. 2).
A cautious initial dose titration using dosing intervals of at least 3 hours is recommended (see section 4.2).
Det kan ikke udelukkes, at dette også er relevant for mennesker i forlænget Ventavis behandling.
It cannot be excluded that this is also relevant to man on prolonged Ventavis therapy.
For at minimere utilsigtet udsættelse anbefales det at anvende Ventavis med nebulisatorer med inhalationsudløste systemer (HaloLite/ Prodose) og at sørge for god ventilation i rummet.
To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalation- triggered systems (HaloLite/ Prodose), and to keep the room well ventilated.
Ventavis inhalationsopløsning til nebulisatorer bør ikke komme i kontakt med hud og øjne; oral indtagelse af Ventavis- opløsning bør undgås.
Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.
Iloprost kan forøge virkningen af vasodilatatorer og anti- hypertensive midler.
Iloprost may increase the effect of vasodilatators and antihypertensive agents.