FrancophonIA/ELRC3.0 huggingface dataset:
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: Mean (SEM) observed FVC change from baseline (mL) over time, studies INPULSIS-1 and INPULSIS-2 pooled bid = twice daily
Danish: Middelværdi for observeret ændring i FCV over tid fra baseline (ml), samlet for studierne INPULSIS-1 og INPULSIS-2
English: Vomiting led to discontinuation in 0.8% of the patients.
Danish: Kvalme resulterede i seponering af nintedanib hos 2,0 % af patienterne, og opkastning resulterede i seponering hos 0,8 % af patienterne.
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelsen
English: Dose adjustments
Danish: Dosisjusteringer
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg nintedanib (as esilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 100 mg nintedanib (som esilat).
English: Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Danish: Andel af FVC-respondere ved uge 52 i studierne INPULSIS-1, INPULSIS-2 og de samlede data - behandlede
English: Renal function
Danish: Leverfunktion
English: Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Danish: Hver bløde kapsel indeholder 100 mg nintedanib (som esilat) Hjælpestof, som behandleren skal være opmærksom på Hver 100 mg bløde kapsel indeholder 1,2 mg sojalecithin.
English: Do not take two capsules together if you have forgotten to take your earlier dose.You should take your next 150 mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.
Danish: Tag din næste dosis Ofev på 150 mg efter planen på det næste fastlagte tidspunkt og i den dosis, som lægen eller apotekspersonalet har anbefalet.
English: The treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily).
Danish: Behandlingen kan genoptages med en reduceret dosis (100 mg to gange dagligt) eller den fulde dosis (150 mg to gange dagligt).
English: Headache
Danish: Hjerte
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg nintedanib (as esilate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 150 mg nintedanib (som esilat).
English: Cytochrome (CYP)-enzymes
Danish: CYP-enzymer
English: Ofev treatment may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily).
Danish: Behandlingen med Ofev kan genoptages med den fulde dosis (150 mg to gange dagligt) eller med en reduceret dosis (100 mg to gange dagligt).
English: Ofev treatment may be resumed at a reduced dose (100 mg twice daily) or at the full dose (150 mg twice daily).
Danish: Behandlingen med Ofev kan genoptages med en reduceret dosis (100 mg to gange dagligt) eller den fulde dosis (150 mg to gange dagligt).
English: Vascular disorders
Danish: Venøs tromboemboli
English: Triglycerides, medium-chain, hard fat, soya lecithin (E322) (see section 2) Capsule shell: Gelatin, glycerol (85%), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Danish: Gelatine, glycerol (85 %), titandioxid (E171), jernoxid, rød (E172), jernoxid, gul (E172)
English: Hepatic function
Danish: Nedsat leverfunktion
English: Vomiting
Danish: Amning
English: Ofev 150 mg soft capsules nintedanib
Danish: Ofev 150 mg bløde kapsler nintedanib
English: 6.1 List of excipients
Danish: 6.1 Hjælpestoffer
English: Ofev 100 mg soft capsules nintedanib
Danish: Ofev 100 mg bløde kapsler nintedanib
English: What you need to know before you take Ofev 3.
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Ofev Sådan skal du tage Ofev Bivirkninger
English: In case of renal impairment/failure, therapy adjustment should be considered (see section 4.2 Dose adjustments).
Danish: Justering af behandlingen bør overvejes i tilfælde af nedsat nyrefunktion/-svigt (se pkt.
English: Bleeding (see section 4.4)
Danish: Blødning (se pkt.
English: A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events.
Danish: I INPULSIS-studierne blev en patient utilsigtet eksponeret over for en dosis på 600 mg dagligt i 21 dage i alt. En ikke-alvorlig bivirkning (nasopharyngitis) opstod og forsvandt i løbet af perioden med den forkerte dosering uden forekomst af andre indberettede bivirkninger.
English: NAME OF THE MEDICINAL PRODUCT Ofev 150 mg capsules nintedanib
Danish: LÆGEMIDLETS NAVN Ofev 150 mg kapsler nintedanib
English: NAME OF THE MEDICINAL PRODUCT Ofev 100 mg capsules nintedanib
Danish: LÆGEMIDLETS NAVN Ofev 100 mg kapsler nintedanib
English: NAME OF THE MEDICINAL PRODUCT Ofev 150 mg soft capsules nintedanib
Danish: LÆGEMIDLETS NAVN Ofev 150 mg bløde kapsler nintedanib
English: Haemorrhage
Danish: Udslæt
English: Renal failure (see section 4.4)
Danish: Nyresvigt (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules nintedanib
Danish: LÆGEMIDLETS NAVN Ofev 100 mg bløde kapsler nintedanib
English: Ofev 150 mg capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Danish: Ofev 150 mg kapsler er brune, uigennemsigtige, aflange kapsler af blød gelatine med Boehringer Ingelheims logo og tallet “150” præget med sort på den ene side.
English: Breast-feeding
Danish: FVCrespondere
English: Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Danish: Ofev 150 mg bløde kapsler er brune, uigennemsigtige, aflange kapsler af blød gelatine med Boehringer Ingelheims logo og tallet “150” præget med sort på den ene side.
English: Posology
Danish: Oddsratio
English: Ofev 100 mg capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Danish: Ofev 100 mg kapsler er ferskenfarvede, uigennemsigtige, aflange kapsler af blød gelatine med Boehringer Ingelheims logo og tallet “100” præget med sort på den ene side.
English: Method of administration
Danish: Systemorganklasse
English: Ofev 100 mg soft capsules are peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Danish: Ofev 100 mg bløde kapsler er ferskenfarvede, uigennemsigtige, aflange kapsler af blød gelatine med Boehringer Ingelheims logo og tallet “100” præget med sort på den ene side.
English: Nintedanib may cause foetal harm in humans (see section 5.3).
Danish: Nintedanib kan forårsage fosterskader hos mennesker (se pkt.
English: Swallow the whole capsules with water and do not chew or crush the capsules.
Danish: Du skal synke kapslerne hele sammen med vand.
English: NAME OF THE MEDICINAL PRODUCT Ofev 100 mg soft capsules
Danish: LÆGEMIDLETS NAVN Ofev 100 mg bløde kapsler Ofev 150 mg bløde kapsler
English: Liver enzyme elevations (see section 4.4) were reported in 13.6% of nintedanib treated patients.
Danish: 4.4) hos 13,6 % af de patienter, der blev behandlet med nintedanib.
English: DATE OF REVISION OF THE TEXT
Danish: Oversigt over indlægssedlen
English: Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Danish: Tel: +31 (0) 800 22 55 889
English: This summary was last updated in 08-2013.
Danish: Dette sammendrag blev sidst ajourført i 08- 2013.
English: EMA/123532/2013 EMEA/H/C/002500
Danish: EMEA/H/C/002500
English: It can be used in patients with the following forms of the disease:
Danish: Det kan anvendes til patienter med følgende former af sygdommen:
English: Regular blood tests are needed to find the correct daily dose.
Danish: Der skal regelmæssigt tages blodprøver for at finde frem til den korrekte daglige dosis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pheburane on 31 July 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pheburane den 31. juli 2013.
English: The full EPAR for Pheburane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pheburane 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 Pheburane.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pheburane.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de frembringer samme mængde af det aktive stof i kroppen.
English: Pheburane may be a life-long treatment unless the patient has a successful liver transplant.
Danish: Pheburane kan være en livslang behandling, medmindre patienten har fået en vellykket levertransplantation.
English: Pheburane is available as granules (483 mg/g).
Danish: Pheburane fås som granulat (483 mg/g).
English: The daily dose of Pheburane is adjusted for each patient individually and depends on the patient's diet, height and weight.
Danish: Den daglige dosis af Pheburane tilpasses den enkelte patient og afhænger af patientens kost, højde og vægt.
English: The Committee recommended that Pheburane be approved for use in the EU.
Danish: Udvalget anbefalede, at Pheburane godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Pheburane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pheburane?
English: These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver.
Danish: Disse patienter kan ikke udskille kvælstofholdige affaldsstoffer, fordi de mangler visse enzymer, som normalt findes i leveren.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Pheburane granules are available at a lower strength and contain different excipients (inactive ingredients) to mask the unpleasant taste of the active substance.
Danish: Det betyder, at det svarer til et "referencelægemiddel", der indeholder det samme aktive stof, men Pheburane granulat fås i en lavere styrke og med forskellige hjælpestoffer (inaktive indholdsstoffer) til maskering af det aktive stofs ubehagelige smag.
English: Other information about Pheburane
Danish: Andre oplysninger om Pheburane
English: It can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Danish: Det udleveres kun efter recept, og behandling bør overvåges af en læge med erfaring i behandling af patienter med forstyrrelser i urinstofcyklus.
English: What are the benefits and risks of Pheburane?
Danish: Hvilke fordele og risici er der forbundet med Pheburane?
English: Pheburane is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Danish: Pheburane anvendes til patienter, der mangler ét eller flere af følgende enzymer: carbamylphosphatsyntetase, ornithintranscarbamylase eller argininosuccinatsyntetase.
English: The granules can be sprinkled onto food immediately before being swallowed or placed in the mouth and swallowed immediately with a drink.
Danish: Granulatet kan blandes i maden, umiddelbart før det synkes eller placeres i munden, eller det kan synkes sammen med væske.
English: It is not intended to provide practical advice on how to use Pheburane.
Danish: Det er ikke en praktisk vejledning i, hvordan Pheburane bør anvendes.
English: Pheburane is a ‘hybrid medicine'.
Danish: Pheburane er et "hybridt lægemiddel".
English: It is used to treat patients who have urea cycle disorders.
Danish: Det anvendes til behandling af patienter, der lider af forstyrrelser i urinstofcyklus.
English: Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death.
Danish: Patienter med forstyrrelser i urinstofcyklus kan ikke udskille ammoniak, som derfor kan forekomme i høje koncentrationer i kroppen, hvilket kan medføre alvorlige problemer, bl.a. invaliditet, hjerneskade og død.
English: What is Pheburane and what is it used for?
Danish: Hvad er Pheburane, og hvad anvendes det til?
English: The daily dose of Pheburane should be divided into equal amounts and given with each meal.
Danish: Den daglige dosis Pheburane skal deles i lige store mængder, der indtages med hvert måltid.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Pheburane, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Pheburane, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Pheburane is used with a special low-protein diet to reduce the intake of nitrogen.
Danish: Pheburane anvendes sammen med en særlig lavproteindiæt for at begrænse indtagelsen af kvælstof.
English: • 'early-onset' disease in patients who show a complete lack of one or more of these enzymes within the first month of life;
Danish: • "tidlig sygdomsdebut" hos patienter, hvor ét eller flere af disse enzymer mangler fuldstændigt, inden for den første måned efter fødslen
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Pheburane has been shown to have comparable quality and to be bioequivalent to Ammonaps.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Pheburane er påvist til at være af sammenlignelig kvalitet og til at være bioækvivalent med Ammonaps.
English: For more information about treatment with Pheburane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pheburane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The reference medicine for Pheburane is Ammonaps.
Danish: Referencelægemidlet for Pheburane er Ammonaps.
English: Because Pheburane is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pheburane er et hybridt lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: In the body, waste nitrogen is in the form of ammonia, which is toxic when it accumulates, especially for the brain.
Danish: Kvælstofholdige affaldsstoffer findes i kroppen i form af ammoniak, der er giftigt, når det ophobes, navnlig for hjernen.
English: Therefore, the CHMP's view was that, as for Ammonaps, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Ammonaps.
English: • 'late-onset' disease in patients who show a partial lack of one or more of these enzymes after the age of one month and have had high blood ammonia levels that affected the brain's activity.
Danish: • "sen sygdomsdebut" hos patienter, der er over en måned gamle og delvis mangler ét eller flere enzymer, og som i blodet har haft højt ammoniakindhold, der har påvirket hjerneaktiviteten.
English: Why is Pheburane approved?
Danish: Hvorfor blev Pheburane godkendt?
English: Studies in patients have been limited to tests to determine that Pheburane is bioequivalent to the reference medicine, Ammonaps.
Danish: Undersøgelser hos patienter har været begrænset til test for at fastslå, at Pheburane er bioækvivalent med referencelægemidlet Ammonaps.
English: This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Danish: Det får kvælstofindholdet i kroppen til at falde, hvilket nedsætter produktionen af ammoniak.
English: Pheburane is a medicine that contains the active substance sodium phenylbutyrate.
Danish: Pheburane er et lægemiddel, der indeholder det aktive stof natriumphenylbutyrat.
English: Eating protein brings nitrogen into the body, which is then transformed into ammonia.
Danish: Indtagelse af protein tilfører kroppen kvælstof, som herefter omdannes til ammoniak.
English: The active substance in Pheburane, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Danish: Det aktive stof i Pheburane, natriumphenylbutyrat, omdannes i kroppen til et andet stof kaldet phenylacetat.
English: Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys.
Danish: Phenylacetat bindes til aminosyren glutamin, som indeholder kvælstof, hvorved der dannes et stof, som kan udskilles gennem nyrerne.
English: For practical information about using Pheburane, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pheburane, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Pheburane sodium phenylbutyrate
Danish: EPAR - sammendrag for offentligheden natriumphenylbutyrat
English: How is Pheburane used?
Danish: Hvordan anvendes Pheburane?
English: How has Pheburane been studied?
Danish: Hvordan blev Pheburane undersøgt?
English: How does Pheburane work?
Danish: Hvordan virker Pheburane?
English: Strength
Danish: Styrke
English: Pharmaceutical Form
Danish: Lægemiddelform Administration Emballage
English: Pack size
Danish: Paknings-størrelse
English: EU Number
Danish: MF (EU)-nummer (Særnavn) Navn
English: It was considered that this should be reflected in the product information.
Danish: Der blev taget stilling til, at dette burde afspejles i produktinformationen.
English: All these products are restricted to ‘prescription only' status.
Danish: Alle disse produkter er begrænset til statussen "receptpligtig".
English: CHMP opinion
Danish: CHMP's udtalelse
English: The PRAC adopted a recommendation on 17 March 2016 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Danish: PRAC har den 17. marts 2016 vedtaget en anbefaling, der efterfølgende er blevet vurderet af CHMP, jf. artikel 107k i direktiv 2001/83/EF.
English: Exacerbations and comorbidities contribute to the overall severity in individual patients [Global Initiative for Obstructive Lung Disease (GOLD), 2015].
Danish: Eksacerbationer og komorbiditeter bidrager til den samlede sværhedsgrad hos den individuelle patient [The Global Initiative for Obstructive Lung Disease (GOLD), 2015].
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CHMP sig anbefalingens overordnede konklusioner og begrundelser.
English: However ICSs are an important therapeutic option for certain patient groups as established in some treatment guidelines (GOLD report, 2015).
Danish: ICS'er er dog en vigtig terapeutisk mulighed for visse patientgrupper, som det fremgår af nogle behandlingsretningslinjer (GOLD report, 2015).
English: Episodes of acute worsening of these symptoms (exacerbations) often occur.
Danish: Der forekommer ofte episoder med akut forværring af disse symptomer (eksacerbationer).
English: Grounds for PRAC recommendation
Danish: Begrundelser for PRAC's anbefaling
English: Since the results of the TORCH study were published in 2007, a number of large meta-analyses of pooled data have been conducted.
Danish: Da resultaterne af TORCH-studiet blev offentliggjort i 2007, blev der gennemført en lang række metaanalyser af de samlede data.
English: The therapeutic effect of inhaled corticosteroids is considered to be the result of suppression of airway inflammation, but the airway effects of ICS in COPD are complex and the mechanism of action is not completely understood (Finney et al., 2014, Jen et al., 2012).
Danish: Den terapeutiske virkning af inhalerede kortikosteroider anses for at være resultatet af suppression af luftvejsinfektion, men ICS's virkning på luftvejene ved KOL er kompleks, og virkningsmekanismen ikke fuldt klarlagt (Finney et al., 2014, Jen et al., 2012).
English: ICS-containing products authorised across the EU for the treatment of COPD includes the active substances beclomethasone, fluticasone propionate, fluticasone furoate, budesonide and flunisolide.
Danish: ICS-holdige produkter, der er godkendt på tværs af EU til behandling af KOL, inkluderer de aktive stoffer beclomethason, fluticasonpropionat, fluticasonfuroat, budesonid og flunisolid.
English: Estimates based on the data provided suggest a patient exposure in the tens of millions across ICS as a class.
Danish: Estimater baseret på foreliggende data indikerer en patienteksponering på mere end ti millioner på tværs af ICS'er, som klasse betragtet.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for inhaled corticosteroids (ICS)-containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease (COPD);
Danish: • PRAC tog stilling til den procedure, der i medfør af artikel 31 i direktiv 2001/83/EF var foranlediget af lægemiddelovervågningsdata for lægemidler, der indeholder kortikosteroider (ICS) indiceret til behandling af kronisk obstruktiv lungesygdom (KOL).
English: On 27 April 2015 the European Commission therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of ICS containing medicinal products indicated in the treatment of COPD and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Danish: På baggrund af disse lægemiddelovervågningsdata indledte Europa-Kommissionen derfor den 27. april 2015 en indbringelsesprocedure i medfør af artikel 31 i direktiv 2001/83/EF, og bad PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for ICS-holdige lægemidler indiceret til behandling af KOL og fremsætte en anbefaling om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: Chronic obstructive pulmonary disease (COPD) is characterised by persistent, usually progressive, airflow limitation associated with an enhanced inflammatory response in the airways and the lungs.
Danish: Kronisk obstruktiv lungesygdom (KOL) er karakteriseret ved vedvarende, almindeligvis tiltagende luftvejsobstruktion forbundet med et øget inflammatorisk respons i luftveje og lunger.
English: It is considered mechanistically plausible that a higher dose of corticosteroid could cause a greater degree of immunosuppression in the lung and lead to a higher risk of pneumonia, but this has not been demonstrated conclusively across all studies.
Danish: Det betragtes som værende mekanistisk muligt, at en højere dosis kortikosteroid kan forårsage en højere grad af immunsuppresion i lungerne og føre til en højere risiko for lungebetændelse, men dette er ikke blevet påvist definitivt på tværs af alle studier.
English: Inhaled corticosteroid (ICS) medicinal products are widely used in the treatment of COPD, as a monocomponent or in combination with a long-acting beta2 adrenergic agonist (LABA).
Danish: Der bruges i vid udstrækning inhalerede kortikosteroider (ICS) til behandling af KOL, både som enkelt stof eller i kombination med en langtidsvirkende beta2-adrenerg agonist (LABA).