FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d.d., Novo mesto on 27 September 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zalasta til KRKA, d.d., Novo mesto den 27. september 2007.
English: It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘orodispersible' tablets (5, 7.5, 10, 15 and 20 mg).
Danish: Det fås som runde, gule tabletter (2,5, 5, 7,5, 10, 15 og 20 mg) og som runde, gule smeltetabletter (5, 7,5, 10, 15 og 20 mg).
English: The full EPARs for the reference medicines can also be found on the EMEA's website.
Danish: Den fuldstændige EPAR for referencelægemidlerne findes også på EMEA's websted.
English: Other information about Zalasta:
Danish: Andre oplysninger om Zalasta:
English: The Committee recommended that Zalasta be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zalasta.
English: The full EPAR for Zalasta can be found here.
Danish: Den fuldstændige EPAR for Zalasta findes her.
English: The recommended starting dose of Zalasta depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Den anbefalede startdosis af Zalasta afhænger af, hvilken sygdom der behandles: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZALASTA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ZALASTA EPAR - sammendrag for offentligheden
English: Zalasta is used to treat adults with schizophrenia.
Danish: Zalasta anvendes til behandling af voksne med skizofreni.
English: Zalasta is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Zalasta anvendes ligeledes til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: Zalasta is a ‘generic medicine'.
Danish: Zalasta er et ‘generisk lægemiddel'.
English: Zalasta is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Zalasta er også effektivt i fastholdelsen af den kliniske bedring ved fortsat behandling af patienter, der har vist initial behandlingsrespons.
English: What are the benefit and risk of Zalasta?
Danish: Hvilken fordel og risiko er der forbundet med Zalasta?
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Danish: Det kan også anvendes til at forebygge recidiverende episoder (når symptomerne vender tilbage) hos voksne med bipolar sygdom (en psykisk lidelse, hvor patienten svinger mellem højt humør og depression), der har vist initial behandlingsrespons.
English: The active substance in Zalasta, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof i Zalasta, olanzapin, er et antipsykotisk lægemiddel.
English: Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i.e. that the medicines produce the same levels of the active substance in the body).
Danish: Da Zalasta er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlerne (dvs. at lægemidlerne producerer samme mængder af det aktive stof i kroppen).
English: This means that Zalasta is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Danish: Det betyder, at Zalasta er identisk med ‘referencelægemidler', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Zyprexa og Zyprexa Velotab.
English: Zalasta is a medicine containing the active substance olanzapine.
Danish: Zalasta er et lægemiddel, som indeholder det aktive stof olanzapin.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zalasta has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Zalasta i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Zyprexa og Zyprexa Velotab.
English: Because Zalasta is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Danish: Da Zalasta er et generisk lægemiddel, som er bioækvivalent med referencelægemidlerne, anses benefit/risk-forholdet for at være det samme som for referencelægemidlerne.
English: Why has Zalasta been approved?
Danish: Hvorfor blev Zalasta godkendt?
English: What is Zalasta?
Danish: Hvad er Zalasta?
English: What is Zalasta used for?
Danish: Hvad anvendes Zalasta til?
English: How has Zalasta been studied?
Danish: Hvordan blev Zalasta undersøgt?
English: How is Zalasta used?
Danish: Hvordan anvendes Zalasta?
English: How does Zalasta work?
Danish: Hvordan virker Zalasta?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis on 16 September 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ventavis den 16. september 2003.
English: It is given six to nine times a day.
Danish: Lægemidlet skal indtages seks til ni gange dagligt.
English: The recommended dose is 2.5 or 5 micrograms.
Danish: Den anbefalede dosis er 2,5 eller 5 mikrogram.
English: As the company had supplied the additional information requested at the time of authorisation, the ‘exceptional circumstances' ended on 26 August
Danish: Idet virksomheden på tidspunktet for udstedelse af tilladelsen havde tilvejebragt de yderligere nødvendige oplysninger, ophørte de "særlige omstændigheder" den 26. august 2013.
English: The full EPAR for Ventavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ventavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Ventavis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ventavis.
English: The main measure of effectiveness was the number of patients who had responded to treatment after 12 weeks.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, som havde reageret på behandlingen efter 12 uger.
English: By dilating these blood vessels, the blood pressure is reduced and symptoms are improved.
Danish: Ved at udvide disse blodkar nedsættes blodtrykket, og symptomerne bedres.
English: A risk management plan has been developed to ensure that Ventavis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ventavis anvendes så sikkert som muligt.
English: Ventavis was significantly more effective than placebo: 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).
Danish: Ventavis er væsentlig mere effektiv end placebo: 17 % af de patienter, der fik Ventavis, reagerede på behandling (17 ud af 101) sammenlignet med 5 % af de patienter, der fik placebo (5 ud af 102).
English: If the patient has liver or kidney problems, the time between doses should be at least three to four hours.
Danish: Hvis patienten har lever- eller nyreproblemer, skal der være et interval på mindst tre til fire timer mellem hver dosis.
English: The dose should be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Danish: Dosis bør herefter nedsættes til 2,5 mikrogram igen, hvis patienten ikke kan tåle den høje dosis.
English: 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.
Danish: En "reaktion" blev defineret som en kombination af en 10 % 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.
English: Ventavis is a medicine that contains the active substance iloprost.
Danish: Ventavis er et lægemiddel, der indeholder det aktive stof iloprost.
English: Other information about Ventavis
Danish: Andre oplysninger om Ventavis
English: For more information about treatment with Ventavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ventavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients should start with the low dose of 2.5 micrograms for the first inhalation, and if the first dose is well tolerated, the second and consecutive doses should be 5 micrograms.
Danish: Patienterne skal starte med den lave dosis på 2,5 mikrogram ved den første inhalation, og hvis denne dosis tåles godt, bør den anden og de efterfølgende doser være på 5 mikrogram.
English: Pulmonary hypertension is abnormally high blood pressure in the arteries of the lungs.
Danish: Pulmonal hypertension er unormalt højt blodtryk i lungearterierne.
English: Treatment with Ventavis should be started and monitored by a doctor experienced in the treatment of pulmonary hypertension.
Danish: Behandling med Ventavis skal indledes og overvåges af en læge, som har erfaring med behandling af pulmonal hypertension.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ventavis.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ventavis skal anvendes.
English: What measures are being taken to ensure the safe and effective use of Ventavis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ventavis?
English: Ventavis was originally authorised under ‘exceptional circumstances' because, as the disease is rare, limited information was available at the time of approval.
Danish: Ventavis blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun fandtes begrænsede tilgængelige oplysninger om Ventavis, fordi sygdommen er sjælden.
English: 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.
Danish: Lægemidlet indgives ved hjælp af en såkaldt "dosimetrisk" nebulisator, der standser automatisk, når den korrekte dosis er blevet indgivet.
English: The CHMP decided that Ventavis's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ventavis opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Ventavis.
English: ‘Primary' means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘class' reflects the severity of the symptoms caused by the disease: ‘class III' involves marked limitation of physical activity.
Danish: "Primær" betyder, at det høje blodtryk ikke er forårsaget af nogen anden sygdomstilstand i hjerte eller lunger, og "klassen" afspejler sværhedsgraden af de symptomer, sygdommen forårsager: "Klasse III" omfatter markant begrænsning af den fysiske aktivitet.
English: Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Danish: Ventavis anvendes til behandling af voksne patienter med primær pulmonal hypertension (klasse III) for at forbedre den fysiske kapacitet (evnen til at udføre fysisk aktivitet) og symptomerne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ventavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ventavis, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Ventavis 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.
Danish: Ventavis må ikke anvendes hos 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.
English: The most common side effects with Ventavis (seen in more than 1 patient in 10) are headache, vasodilation (blood vessels becoming wider causing flushing or reddening of the face), bleeding episodes, chest pain and discomfort, peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), pain in the jaw and contraction of the jaw muscles, and cough.
Danish: De hyppigste bivirkninger ved Ventavis (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, vasodilation (blodkarrene udvides og forårsager rødmen af ansigtet), blødningsepisoder, brystsmerter og ubehag, perifert ødem (hævelse, især af ankler og fødder), kvalme, kæbesmerter og sammentrækning af kæbemusklerne samt hoste.
English: Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adults with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Danish: Ventavis er blevet sammenlignet med placebo (en virkningsløs 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.
English: Ventavis is given by inhalation using a nebuliser (a special machine that changes the solution into an aerosol that the patient can breathe in).
Danish: Ventavis indgives ved inhalation via en nebulisator (et specielt apparat, hvori opløsningen omdannes til aerosol, som patienten kan indånde).
English: 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).
Danish: Ventavis er en inhaleret formulering af iloprost, som er et stof, der i høj grad ligner prostacyclin - et naturligt forekommende molekyle, som får blodkarrene til at udvide sig (dilatere).
English: However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.
Danish: Ved gennemgangen af de forskellige patientgrupper i denne undersøgelse viste det sig dog, at behandling med Ventavis kun havde gavnlig virkning hos patienter med primær pulmonal hypertension (klasse III).
English: Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs that causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Danish: Pulmonal hypertension er en invaliderende sygdom, der består i svær konstriktion (forsnævring) af blodkarrene i lungerne, hvilket medfører et meget højt blodtryk i de blodkar, der fører blodet fra højre side af hjertet til lungerne.
English: It is available as a solution for inhalation using a nebuliser.
Danish: Det fås som en opløsning, der inhaleres ved hjælp af en nebulisator.
English: For the full list of all side effects reported with Ventavis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ventavis fremgår af indlægssedlen.
English: What is the risk associated with Ventavis?
Danish: Hvilken risiko er der forbundet med Ventavis?
English: What is Ventavis?
Danish: Hvad er Ventavis?
English: Why has Ventavis been approved?
Danish: Hvorfor blev Ventavis godkendt?
English: What is Ventavis used for?
Danish: Hvad anvendes Ventavis til?
English: What benefit has Ventavis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ventavis?
English: How has Ventavis been studied?
Danish: Hvordan blev Ventavis undersøgt?
English: How is Ventavis used?
Danish: Hvordan anvendes Ventavis?
English: How does Ventavis work?
Danish: Hvordan virker Ventavis?
English: Date of first authorisation: 03 May 1996 Date of latest renewal: 29 May 2006
Danish: Dato for første markedsføringstilladelse: 3. maj 1996 Dato for seneste fornyelse: 29. maj 2006
English: Puregon is usually not effective in such cases.
Danish: Puregon virker normalt ikke i sådanne tilfælde.
English: Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
Danish: Bivirkninger, som kun er rapporteret én gang, er listet som almindelig, fordi en enkeltstående rapport forhøjer frekvensen til over 1%.
English: Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Danish: Behandling med Puregon og hCG skal vare i mindst 3 til 4 måneder, før der kan forventes nogen forbedring af spermatogenesen.
English: Single-dose administration of Puregon to rats induced no toxicologically significant effects.
Danish: Enkeltdosis-administration af Puregon til rotter har ikke induceret toksikologisk signifikante virkninger.
English: Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).
Danish: Begrænset til kvinder med induceret ovulation (Puregon, n = 76; u-FSH, n = 42).
English: Clinical experience with Puregon is based on up to three treatment cycles in both indications.
Danish: Klinisk erfaring med Puregon er baseret på op til 3 behandlingscykli ved begge indikationer.
English: This may be of particular relevance when switching between the pen-injector and a conventional syringe within one treatment cycle.
Danish: Dette kan have særlig relevans når der skiftes mellem pennen og en almindelig sprøjte inden for samme behandlingscyklus.
English: Your doctor will check the effects of the treatment regularly to be able to choose the correct dose of Puregon from day to day.
Danish: Din læge vil vurdere effekten af din behandling regelmæssigt for at være i stand til at vælge den rette dosis Puregon fra dag til dag.
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Puregon induced no toxicologically significant effects.
Danish: I gentagne dosisforsøg på rotter (2 uger) og hunde (13 uger), med doser op til 100 gange større end den maksimale humane dosis, har Puregon ikke induceret toksikologisk signifikante virkninger.
English: Self-administration of Puregon should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Danish: Selvadministration af Puregon bør kun foretages af patienter, som er velmotiverede, er blevet tilstrækkeligt oplært, og som har adgang til ekspertbistand.
English: Due to the relatively long elimination half-life, repeated administration of the same dose will lead to plasma concentrations of FSH that are approximately 1.5-2.5 times higher than after single dose administration.
Danish: På grund af den relativt lange eliminationshalveringstid vil gentagen administration af den samme dosis medføre FSHplasmakoncentrationer, som er ca. 1,5-2,5 gange højere end efter administration af en enkelt dosis.
English: • Puregon may contain traces of streptomycin and/or neomycin.
Danish: • Puregon kan indeholde spor af streptomycin og/eller neomycin.
English: Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Danish: Behandling med Puregon skal initieres under supervision af en læge, som har erfaring med behandling af fertilitetsproblemer.
English: Puregon contains a recombinant FSH.
Danish: Puregon indeholder rekombinant FSH.
English: The use of Puregon during pregnancy is not indicated.
Danish: Anvendelse af Puregon er ikke indiceret under graviditet.
English: Puregon may affect milk production.
Danish: Puregon kan påvirke mælkeproduktionen.
English: The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Danish: Sprøjtens rumfang skal være tilstrækkeligt lille, til at den ordinerede dosis kan gives med rimelig nøjagtighed.
English: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations:
Danish: Voksne kvinder: Puregon er indiceret til behandling af kvindelig infertilitet i følgende kliniske situationer:
English: These side effects are not considered to be related to the use of Puregon, but to Assisted Reproductive Technology (ART) or subsequent pregnancy.
Danish: Disse bivirkninger anses ikke for at være relateret til behandlingen med Puregon, men til den kunstige befrugtning (assisteret reproduktionsbehandlingsteknologi - ART) eller den efterfølgende graviditet.
English: There are no significant pharmacokinetic differences between intramuscular and subcutaneous administration of Puregon.
Danish: Der er ingen signifikante farmakokinetiske forskelle mellem intramuskulær og subkutan administration af Puregon.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Puregon.
Danish: Sygdomme, som kontraindicerer graviditet, skal også evalueres, før behandling med Puregon påbegyndes.
English: Talk to your doctor before using Puregon if you:
Danish: Kontakt lægen, før du tager Puregon, hvis du:
English: The active substance is follitropin beta.
Danish: Aktivt stof: follitropin beta.
English: Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated).
Danish: Klinisk brug af Puregon via intramuskulær eller subkutan administration kan resultere i lokale reaktioner ved injektionsstedet (3% af alle behandlede patienter).
English: Treatment with Puregon, just as pregnancy itself, may increase the risk of having a blood clot (thrombosis).
Danish: Behandling med Puregon kan ligesom graviditet øge risikoen for blodpropper (trombose).
English: To prevent painful injections and minimise leakage from the injection site Puregon should be slowly administered intramuscularly or subcutaneously.
Danish: For at forhindre smertefuld injektion og minimere udsivning fra injektionsstedet bør Puregon indgives langsomt, enten intramuskulært eller subkutant.
English: Children There is no relevant use of PUREGON in children.
Danish: Børn Det er ikke relevant at anvende Puregon hos børn.
English: Subcutaneous injection of Puregon may be carried out by patient or partner, provided that proper instructions are given by the physician.
Danish: Subkutan injektion af Puregon kan udføres af patienten selv eller dennes partner, forudsat de har modtaget fyldestgørende instruktioner af lægen.