FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Teva is being used alone or with other treatments, and how the patient responds to treatment.
Danish: Dosis og antallet af doser afhænger af den type tumor, der behandles, hvorvidt patienten er blevet behandlet tidligere, hvorvidt Temozolomide Teva anvendes alene eller med andre behandlinger, og hvordan patienten reagerer på behandlingen.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Danish: • Voksne og børn på tre år og derover med ondartet gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma, hvor svulsten er kommet tilbage eller er blevet værre efter standardbehandling.
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 Temozolomide Teva.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Temozolomide Teva skal anvendes.
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Danish: Det anvendes til behandling af ondartede gliomer (hjernesvulster) hos følgende patientgrupper:
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Teva.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of malignant glioma).
Danish: • Voksne med nydiagnosticeret glioblastoma multiforme (en aggressiv form for hjernesvulst).
English: For more information about treatment with Temozolomide Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Temozolomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temozolomide Teva er identisk med et «referencelægemiddel», som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: Temozolomide Teva is used on its own in these patients.
Danish: Temozolomide Teva anvendes alene hos disse patienter.
English: Temozolomide Teva is used first with radiotherapy and then on its own;
Danish: Temozolomide Teva anvendes først sammen med radioterapi og herefter alene.
English: Temozolomide Teva should be used with caution in patients with severe liver problems or with kidney problems.
Danish: Temozolomide Teva bør anvendes med forsigtighed hos patienter med alvorlige leverproblemer eller med nyreproblemer.
English: Temozolomide Teva should be taken without food.
Danish: Temozolomide Teva skal tages uden for måltiderne.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Teva has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Teva er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Teva.
Danish: Det kan også være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temozolomide Teva.
English: In the body, temozolomide is converted to another compound called MTIC.
Danish: I kroppen omdannes temozolomid til et andet stof, kaldet MTIC.
English: Other information about Temozolomide Teva
Danish: Andre oplysninger om Temozolomide Teva
English: Treatment with Temozolomide Teva should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temozolomide Teva skal ordineres af en læge med erfaring i behandling af hjernetumorer.
English: The active substance in Temozolomide Teva, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Danish: Det aktive stof i Temozolomide Teva, temozolomid, tilhører en gruppe af lægemidler mod kræft kaldet alkylerende midler.
English: The Committee recommended that Temozolomide Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Teva.
English: Temozolomide Teva is a ‘generic medicine'.
Danish: Temozolomide Teva er et «generisk lægemiddel».
English: Because Temozolomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Temozolomide Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Temodal.
English: What are the benefits and risks of Temozolomide Teva?
Danish: Hvilken fordel og risiko er der forbundet med Temozolomide Teva?
English: Because Temozolomide Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temozolomide Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
English: Temozolomide Teva is a medicine that contains the active substance temozolomide.
Danish: Temozolomide Teva er et lægemiddel, der indeholder det aktive stof temozolomid.
English: Temozolomide Teva temozolomide
Danish: Temozolomide Teva temozolomid
English: Why has Temozolomide Teva been approved?
Danish: Hvorfor blev Temozolomide Teva godkendt?
English: Temozolomide Teva is a cancer medicine.
Danish: Temozolomide Teva er et lægemiddel mod kræft.
English: What is Temozolomide Teva?
Danish: Hvad er Temozolomide Teva?
English: How has Temozolomide Teva been studied?
Danish: Hvordan blev Temozolomide Teva undersøgt?
English: How is Temozolomide Teva used?
Danish: Hvordan anvendes Temozolomide Teva?
English: What is Temozolomide Teva used for?
Danish: Hvad anvendes Temozolomide Teva til?
English: How does Temozolomide Teva work?
Danish: Hvordan virker Temozolomide Teva?
English: Date of first authorisation: 30 July 2007 Date of latest renewal: 30 July 2012
Danish: Dato for første markedsføringstilladelse: 30. juli 2007 Dato for seneste fornyelse: 30. juli 2012
English: The following combinations are not recommended:
Danish: Følgende kombinationer anbefales ikke:
English: Stimulants (analeptics) must not be used.
Danish: Stimulanter (analeptika) må ikke anvendes.
English: The tablet may be taken with or without food.
Danish: Tabletten kan tages med eller uden mad.
English: As much as possible of the amount administered should be removed before the next instillation.
Danish: Så meget som muligt af den administrerede mængde bør fjernes før den næste skylning.
English: Increased doses may ultimately produce toxicity.
Danish: Øgede doser kan i sidste ende forårsage toksicitet.
English: Risks of abuse
Danish: Risiko for misbrug
English: Patients should be informed that most people do not experience drowsiness.
Danish: Patienterne bør oplyses om, at de fleste mennesker ikke oplever døsighed.
English: Apnoea is treated with respiratory assistance.
Danish: Apnø behandles med respiratorisk assistance.
English: Aerinaze is also contraindicated in patients with:
Danish: Aerinaze er også kontraindiceret hos patienter med:
English: The recommended dosage and the duration of treatment should not be exceeded.
Danish: Den anbefalede dosis og behandlingsvarighed bør ikke overskrides.
English: Patients should be carefully monitored.
Danish: Patienterne skal overvåges tæt.
English: • changes in the way the heart beats
Danish: • ændringer i måden hjertet slår
English: If you suddenly stop treatment, depression may occur.
Danish: Hvis du stopper behandlingen pludseligt, kan depression forekomme.
English: Distribution Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Danish: Distribution Desloratadin bindes moderat (83 %-87 %) til plasmaproteiner.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret som meget almindelig (≥1/10), almindelig (≥1/100 til ≤1/10), ikke almindelig (≥1/1.000 til ≤1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (≤1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Therefore Aerinaze should be used with caution in patients above 60 years of age.
Danish: Aerinaze bør derfor anvendes med forsigtighed til patienter over 60 år.
English: In the event of overdose, symptomatic and supportive treatment immediately should be started and maintained it for as long as necessary.
Danish: I tilfælde af overdosering skal symptomatisk og støttende behandling startes øjeblikkeligt og vedligeholdes så længe som nødvendigt.
English: Do not take this medicine for more than 10 days continuously unless your doctor tells you to do so.
Danish: Tag ikke dette lægemiddel i mere end 10 dage i træk, med mindre lægen siger det.
English: The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
Danish: Behandlingsvarigheden bør holdes så kort som muligt, og behandlingen bør ikke fortsætte, efter symptomerne er forsvundet.
English: If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule.
Danish: Hvis du glemmer at tage din dosis til tiden, så tag den så hurtigt som muligt og fortsæt med din sædvanlige dosering.
English: Not known: frequency cannot be estimated from the available data • abnormal behaviour
Danish: Ikke kendt: Hyppigheden kan ikke estimeres ud fra forhåndenværende data
English: The half-life for desloratadine is 27.4 hours.
Danish: Halveringstiden for desloratadin er 27,4 timer.
English: There were no significant differences in the efficacy of Aerinaze tablets across subgroups of patients defined by gender, age, or race.
Danish: Der var ingen signifikante forskelle i virkningen af Aerinaze-tabletter i forskellige subgrupper af patienter defineret ved køn, alder eller race.
English: Do not take tablets more often than recommended.
Danish: Tag ikke tabletter oftere end anbefalet.
English: What Aerinaze is
Danish: Hvad Aerinaze er
English: If you forget to take Aerinaze
Danish: Hvis du har glemt at tage Aerinaze
English: • sugar in urine
Danish: • sukker i urinen
English: Keep the blisters in the outer carton in order to protect from light.
Danish: Opbevares i den ydre karton for at beskytte mod lys.
English: Adults and adolescents 12 years of age and over The recommended dose is one tablet twice daily with a glass of water, with or without food.
Danish: Brug til børn og unge i alderen 12 år og ældre Den anbefalede dosis er én tablet to gange daglig med et glas vand med eller uden mad.
English: Do not take more tablets than recommended on the label.
Danish: Tag ikke flere tabletter end anbefalet på etiketten.
English: In case of alkalinisation of the urine, a partial resorption takes place.
Danish: I tilfælde af alkalisk urin sker en partiel resorption.
English: The active substance and its metabolite are excreted in urine; 55-75 % of the administered dose is excreted unchanged.
Danish: Den aktive substans og dens metabolit udskilles i urin: 55-75 % af den administrerede dosis udskilles i uomdannet stand.
English: In adults, tap water can be used.
Danish: Hos voksne kan postevand anvendes.
English: Continuous use can lead to tolerance resulting in an increased risk of overdosing.
Danish: Kontinuert brug kan føre til tolerance, som medfører en øget risiko for overdosering.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: If you are scheduled to have surgery, your doctor may advise you to stop taking Aerinaze 24 hours beforehand.
Danish: Hvis det er planlagt, at du skal opereres, vil din læge måske anbefale dig at stoppe behandlingen med Aerinaze 24 timer i forvejen.
English: The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
Danish: Tabletten kan tages med et helt glas vand, men skal sluges hel (uden at knuse, dele eller tygge den).
English: After emergency treatment, medical monitoring of the patient should be continued.
Danish: Efter akut behandling skal patienten fortsat monitoreres medicinsk.
English: Desloratadine does not readily penetrate the central nervous system.
Danish: Desloratadin penetrerer ikke centralnervesystemet nemt.
English: Adsorption of active substance remaining in the stomach may be attempted by administration of active charcoal suspended in water.
Danish: Adsorption af den aktive substans i maven kan forsøges ved administration af aktivt kul suspenderet i vand.
English: No pre-clinical studies have been performed with Aerinaze.
Danish: Der er ikke udført prækliniske studier med Aerinaze.
English: Abnormal behaviour, aggression
Danish: Unormal adfærd, aggression
English: The combination was not more toxic than their individual components, and observed effects were generally related to the pseudoephedrine sulphate component.
Danish: Kombinationen var ikke mere toksisk end de enkelte komponenter, og de observerede virkninger var generelt relaterede til pseudoephedrinsulfatdelen.
English: Continuous use may lead to taking more Aerinaze than the recommended dose to get the desired effect, resulting in an increased risk of overdosing.
Danish: Fortsat brug kan føre til at tage mere Aerinaze end den anbefalede dosis for at få den ønskede virkning, hvilket kan medføre øget risiko for overdosering.
English: The interaction with Aerinaze and alcohol has not been studied.
Danish: Interaktionen mellem Aerinaze og alkohol er ikke undersøgt.
English: Symptoms of overdose are mostly of a sympathomimetic nature.
Danish: Symptomer på overdosering er overvejende af sympatomimetisk karakter.
English: Some patients may present a toxic psychosis with delusions and hallucinations.
Danish: Nogle patienter kan udvise toksisk psykose med vrangforestillinger og hallucinationer.
English: If signs and symptoms such as pyrexia, erythema or many small pustules are observed, administration of Aerinaze should be discontinued and appropriate measures taken if needed.
Danish: Hvis der observeres tegn og symptomer såsom pyreksi, erytem eller mange små pustler, skal administration af Aerinaze seponeres og passende forholdsregler skal træffes efter behov.
English: The following side effects have been seen in studies:
Danish: De følgende bivirkninger er set i kliniske undersøgelser:
English: Treatment of the pseudoephedrine sulphate overdose is symptomatic and supportive.
Danish: Behandling af pseudoephedrinsulfat-overdosering er symptomatisk og støttende.
English: These subjects had a Cmax concentration about 3-fold higher at approximately 7 hours with a terminal phase half-life of approximately 89 hours.
Danish: Disse personer havde ca. 3 gange så høj en Cmax koncentration i ca. 7 timer med en terminalfase-halveringstid på ca. 89 timer.
English: Adverse reactions considered by investigators to be causally related to Aerinaze are listed below by System Organ Class.
Danish: Bivirkninger, som af investigatorer er anset for at være relateret til Aerinaze, fremgår af listen nedenfor i henhold til systemorganklasse.
English: Caution should be exercised in the following patient groups:
Danish: Der skal udvises forsigtighed med følgende patientgrupper:
English: Desloratadine has demonstrated antiallergic properties from in vitro studies.
Danish: Desloratadin har vist antiallergiske egenskaber i in vitro-undersøgelser.
English: Aerinaze with alcohol
Danish: Brug af Aerinaze sammen med alkohol
English: Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced by the body.
Danish: Antihistaminer reducerer allergiske symptomer ved at forhindre virkningen af et stof kaldet histamin, som dannes i kroppen.
English: The apparent half-life of pseudoephedrine sulphate is 7.9 hours.
Danish: Den tilsyneladende halveringstid for pseudoephedrinsulfat er 7,9 timer.
English: • weight increased, increased appetite
Danish: • vægtforøgelse, øget appetit
English: This medicine is for oral use.
Danish: Lægemidlet er til oral anvendelse.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne præsenteret efter faldende sværhedsgrad.
English: Posology The recommended dose of Aerinaze is one tablet twice a day.
Danish: Dosering Anbefalet Aerinaze-dosis er 1 tablet 2 gange dagligt.
English: Swallow the tablet whole with water.
Danish: Sluges hele med vand.
English: It has an indirect sympathomimetic effect due primarily to the release of adrenergic mediators from the post-ganglionic nerve endings.
Danish: Det har en indirekte sympatomimetisk virkning primært p.g.a. frigørelsen af adrenerge mediatorer fra de postganglionære nerveender.
English: • tricyclic antidepressants and other antihistamines.
Danish: • tricykliske antidepressiva og andre antihistaminer.
English: Athletes taking Aerinaze may have positive doping-tests.
Danish: Sportsudøvere, som tager Aerinaze, kan få positive dopingprøver.
English: Very rarely: the following other side effects reported during the marketing of desloratadine, may affect up to 1 in 10,000 people
Danish: Meget sjældne bivirkninger: følgende øvrige bivirkninger, der er indberettet under markedsføringen af desloratadin, kan berøre op til 1 ud af 10.000 personer
English: Cardiovascular and general effects
Danish: Kardiovaskulære og generelle virkninger
English: Use in children and adolescents Do not give this medicine to children less than 12 years of age.
Danish: Børn og unge Giv ikke dette lægemiddel til børn under 12 år.
English: Palpitation, supraventricular extrasystoles
Danish: Palpitation, supraventrikulære ekstrasystoler
English: • anorexogenics or amphetamine-type psychostimulants
Danish: • anoreksika eller amfetaminlignende psykostimulanter
English: • urinary retention,
Danish: • urinretention,
English: Pharmacodynamic effects The pharmacodynamic effects of Aerinaze tablets are directly related to that of its components.
Danish: Farmakodynamisk virkning Aerinaze tabletternes farmakodynamiske virkning er direkte relateret til komponenternes.
English: Short acting barbiturates, diazepam or paraldehyde may be administered to control seizures.
Danish: Korttidsvirkende barbiturater, diazepam eller paraldehyd kan administreres for at kontrollere anfald.
English: • painful or difficult urination
Danish: • smertefuld eller vanskelig vandladning
English: • increased sugar in blood
Danish: • øget blodsukker
English: Agitation, anxiety, irritability
Danish: Agitation, angst, irritabilitet
English: • hyperthyroidism,
Danish: • hyperthyreoidism,
English: When Aerinaze should be used
Danish: Hvornår Aerinaze skal anvendes
English: Taking Aerinaze is not recommended if you are pregnant.
Danish: Du må ikke tage Aerinaze, hvis du er gravid.
English: In a single dose pharmacokinetic study with Aerinaze, plasma concentration of desloratadine can be detected within 30 minutes of administration.
Danish: I en enkeltdosis-farmakokinetisk undersøgelse med Aerinaze blev plasmakoncentration af desloratadin målt inden for 30 minutter fra administration.
English: These effects may be more likely to occur in adolescents from 12 years old, elderly patients, or in cases of overdose (see section 4.9).
Danish: Sandsynligheden for disse virkninger er størst hos unge fra 12 år, ældre patienter eller i tilfælde af overdosering (se pkt.
English: Stop taking Aerinaze at least 48 hours before you have any skin tests since antihistamines may influence the result of the skin test.
Danish: Stop brugen af Aerinaze mindst 48 timer før du får foretaget hudtests, da antihistaminer kan påvirke resultatet af hudtesten.
English: At the recommended dose, this medicine is not expected to affect your ability to drive or use machines.
Danish: Ved den anbefalede dosis forventes det ikke, at dette lægemiddel vil påvirke din evne til at køre bil eller arbejde med maskiner.
English: Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermia blanket.
Danish: Hyperpyrexi, i særdeleshed hos børn, kan nødvendiggøre behandling med svampe med lunkent vand eller hypotermitæppe.
English: Certain conditions may make you unusually sensitive to the decongestant pseudoephedrine sulphate contained in this medicine.
Danish: Særlige tilstande kan gøre dig usædvanligt følsom over for dekongestanten pseudoephedrinsulfat, som findes i dette lægemiddel.
English: 2220 Heist-op-den-Berg Belgium
Danish: 2220 Heist-op-den-Berg Belgien
English: • Patients with hypertension
Danish: • patienter med hypertension
English: Speak with your doctor, pharmacist or nurse regarding whether you can drink alcohol while taking Aerinaze.
Danish: Tal med lægen, apoteket eller sundhedspersonalet om, hvorvidt du kan drikke alkohol, når du tager Aerinaze.
English: The rate of excretion is accelerated and the duration of action decreased in acidic urine (pH5).
Danish: Udskillelseshastigheden øges, og virkningsvarigheden nedsættes i sur urin (pH5).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apoteket eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Aerinaze has no or negligible influence on the ability to drive and use machines.
Danish: Aerinaze påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Other adverse reactions reported for desloratadine during the post-marketing period are listed hereunder.
Danish: Andre bivirkninger, som er rapporteret for desloratadin efter markedsføring, er nævnt nedenfor.
English: Desloratadine is not removed by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.
Danish: Desloratadin kan ikke fjernes ved hæmodialyse, og det vides ikke, om det elimineres ved peritoneal dialyse.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the combination of desloratadine and pseudoephedrine sulphate in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (under 300 graviditeter) fra anvendelse af kombinationen af desloratadin og pseudoephedrinsulfat til gravide kvinder.
English: • bromocriptine
Danish: • bromocriptin
English: Caution should also be exercised in patients being treated with other sympathomimetics (see section 4.5).
Danish: Der skal også udvises forsigtighed med patienter i behandling med andre sympatomimetika (se pkt.
English: Common: the following may affect up to 1 in 10 people
Danish: Almindelige bivirkninger: følgende kan berøre op til 1 ud af 10 personer