FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of ARICLAIM while breastfeeding is not recommended.
Danish: Du bør ikke bruge ARICLAIM, mens du ammer.
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
Danish: • opkastning af blod eller sort, tjærefarvet afføring (på grund af blod i afføringen), mave-tarm
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Danish: Kapselskal: 30 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132) og Edible green ink.
English: Chest pain7
Danish: Myoclonus Akatisi7
English: If you stop taking ARICLAIM
Danish: Hvis du har taget for meget ARICLAIM
English: Ejaculation disorder
Danish: Nedsat nyrefunktion
English: Excipient(s) with known effect:
Danish: ARICLAIM indeholder: - Aktivt stof:
English: Very Rare mainly atrial fibrillation
Danish: Meget sjælden søvnkvalitet
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Danish: 60 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) og Edible white ink.
English: 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Danish: 98 hårde enterokapsler
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines., including medicines obtained without a prescription.
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Danish: Muskelstivhed Muskeltrækninger
English: Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv Muskuloskeletale smerter
English: Angio-neurotic oedema6
Danish: Leversvigt6 Ikterus6
English: What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
Danish: ARICLAIM er en hård enterokapsel.
English: Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Danish: ARICLAIM 30 mg hårde enterokapsler ARICLAIM 60 mg hårde enterokapsler
English: Hepatic failure6 Jaundice6
Danish: Angio ødem6
English: Syncope2
Danish: Kramper1
English: General disorders and administration site conditions Falls8
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Blurred vision Mydriasis Visual impairment
Danish: Svimmelhed Letargi Tremor Paræstesier
English: The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions:
Danish: Det aktive stof (duloxetin) i ARICLAIM bruges i andre lægemidler mod andre tilstande: • depression, angst og stressinkontinens
English: Weight decrease Weight increase
Danish: Nedsat leverfunktion
English: Common side effects (may affect up to 1 in 10 people)
Danish: • kvalme, mundtørhed Almindelige bivirkninger (kan ske hos op til 1 ud af 10 patienter)
English: * inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2
Danish: * Inducerer et virus-neutraliserende antistofrespons i kyllinger på ≥ 5,0 log2
English: The treatment duration was up to 2 years.
Danish: Behandlingsvarigheden var op til to år.
English: The timetable for the implementation of the agreement is set out in Annex III.
Danish: Tidsplanen for gennemførelse af aftalen er angivet i bilag III.
English: The first Marketing Authorisation in the EU was granted in France on 10 December 1982.
Danish: Den første markedsføringstilladelse i EU blev udstedt i Frankrig den 10. december 1982.
English: Spontaneous reports
Danish: Spontane indberetninger
English: • Respiratory events, mainly due to awareness of respiratory movements
Danish: • respiratoriske hændelser, der hovedsagelig skyldtes bevidsthed om vejrtrækningsbevægelser
English: Scientific conclusions and grounds for the revocation of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for tilbagekaldelse af markedsføringstilladelserne
English: In 50% of the cases, a neuropathy was also reported.
Danish: I 50 % af tilfældene blev der desuden indberettet om neuropati.
English: Data from clinical trials
Danish: Data fra kliniske undersøgelser
English: In addition, the PRAC noted that the mechanism of these 2 adverse reactions remains unknown.
Danish: Desuden bemærkede PRAC, at mekanismen bag disse to bivirkninger stadig ikke kendes.
English: Regarding weight loss, 795 cases were reported since launch, some of them severe.
Danish: Vedrørende vægttab blev der indberettet 795 tilfælde siden lanceringen, nogle af dem svære.
English: The mean time to onset for the cases reported was 5 months but time to onset was variable ranging from 15 days to 2,5 years.
Danish: Den gennemsnitlige tid til indsætten for de indberettede tilfælde var 5 måneder, men varierede fra 15 dage til 2,5 år.
English: Globally, an important proportion of cases had an outcome reported as not recovered or recovered with sequelae (489 cases out of the 2304 reported, i.e. 21.2%).
Danish: Totalt fik en betydelig andel af tilfældene et udfald, der blev indberettet som ikke restitueret, eller restitueret med sequelae (489 af de 2 304 indberettede tilfælde, dvs. 21,2 %).
English: No effect was nor observed on pulmonary functional status.
Danish: Der blev ikke iagttaget virkning på lungefunktionsstatus.
English: Almitrine containing medicinal products for oral use are currently authorised in 3 European Member States (France, Poland and Portugal) and only marketed in France and Poland (see Annex I for the list of almitrine containing medicinal products for oral use authorised in the EU).
Danish: Orale lægemidler indeholdende almitrin er på nuværende tidspunkt godkendt i tre EU-medlemsstater (Frankrig, Polen og Portugal) og markedsføres kun i Frankrig og Polen (bilag I indeholder en liste over orale lægemidler, der indeholder almitrin og er godkendt i EU).
English: In addition, France had concerns with regards to the benefit of almitrine in its approved indications.
Danish: Derudover havde Frankrig visse betænkeligheder vedrørende fordelen ved almitrin til de godkendte indikationer.
English: During the period September 2003 to December 2012, 20 cases of peripheral neuropathies were reported, suggesting that the risk minimisation measures are not able to prevent the occurrence of these reactions.
Danish: I perioden september 2003 til december 2012 blev der således indberettet 20 tilfælde af perifer neuropati, hvilket tyder på, at risikominimeringsforanstaltningerne ikke kan forhindre optræden af disse reaktioner.
English: Finally the PRAC noted that the current international consensus for the management of COPD and chronic hypoxemia (Global Initiative for Obstructive Lung Disease (GOLD) and other practical recommendation) does no longer refer to the use of almitrine.
Danish: Endelig bemærkede PRAC, at den nuværende internationale konsensus om behandlingen af KOL og kronisk hypoksæmi (Global Initiative for Obstructive Lung Disease (GOLD) og andre praktiske anbefalinger) ikke længere nævner anvendelsen af almitrin.
English: The NCAs should undertake timely actions allowing an appropriate switching of patients to other therapeutic alternatives.
Danish: De nationale kompetente myndigheder iværksætter rettidige tiltag med henblik på passende overgang af patienterne til andre behandlingsmuligheder.
English: This was supported by the fact that cases of peripheral neuropathy continued to be reported from September 2003 to November 2012 despite the implemented minimisation measures (recommendation for a sequential scheme of administration and dose adjustment initially, followed by contra-indications and warnings).
Danish: Dette var underbygget af det forhold, at der fra september 2003 til november 2012 fortsat blev indberettet tilfælde af perifer neuropati trods de iværksatte risikominimeringsforanstaltninger (anbefalinger om en sekventiel administrationsplan og initial dosisjustering, efterfulgt af kontraindikationer og advarsler).
English: The MAH has never performed trials or investigations to document/establish the mechanism of action of these adverse effects.
Danish: Indehaveren af markedsføringstilladelsen har aldrig udført forsøg eller undersøgelser til at dokumentere eller fastlægge virkningsmekanismen bag disse bivirkninger.
English: With regards to peripheral neuropathy, a total of 2304 cases of peripheral neuropathy have been spontaneously reported in patients exposed to almitrine since the launch of the product (from 1983 to December 2012).
Danish: Der er i alt spontant indberettet 2 304 tilfælde af perifer neuropati hos patienter, der blev eksponeret for almitrin siden produktets lancering (fra 1983 til december 2012).
English: The PRAC noted that weight loss reported led to almitrine discontinuation in 90,9% of the cases.
Danish: PRAC konstaterede, at det indberettede vægttab medførte seponering af almitrin i 90,9 % af tilfældene.
English: In November 2012 the French National Competent Authority considered that the above-mentioned major safety concerns were not fully controlled in clinical practice despite the risk minimisation measures in place.
Danish: I november 2012 nåede de kompetente franske nationale myndigheder frem til, at der trods de iværksatte risikominimeringsforanstaltninger ikke var fuld kontrol over ovennævnte sikkerhedsproblemer i klinisk praksis.
English: The PRAC noted that most cases of peripheral neuropathies reported from September 2003 to December 2012 were not recovered or recovered with sequelae.
Danish: PRAC konstaterede, at størstedelen af tilfældene af perifer neuropati indberettet fra september 2003 til december 2012 blev beskrevet som ikke restituerede eller restituerede med sequelae.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the revocation of the marketing authorisations of the marketing authorisations for all medicinal products referred to in Annex I.
Danish: I henhold til bestemmelserne i artikel 31 og 32 i direktiv 2001/83/EF anbefaler PRAC derfor tilbagekaldelse af markedsføringstilladelserne for alle lægemidler omhandlet i bilag I.
English: In view of the 11 above mentioned published clinical studies, it is acknowledged that efficacy results among clinical studies are contradictory and extrapolations not feasible.
Danish: På baggrund af de 11 ovennævnte publicerede kliniske undersøgelser erkendes det, at undersøgelsernes resultater vedrørende virkning er indbyrdes modstridende, og at ekstrapolationer ikke er mulige.
English: Consideration that long-term oxygen therapy can be discontinued, delayed or even avoided with almitrine is not based on scientific or clinical evidence.
Danish: Antagelsen af, at langtidsoxygenterapi kan seponeres, forsinkes eller endog undgås med almitrin, bygger ikke på videnskabelig eller klinisk evidens.
English: Concerns have also been raised with regards to the potential risks of hepatobilary disorders, skin disorders and cytopenia with the use of oral almitrine.
Danish: Der er endvidere rejst betænkelighed ved de potentielle risici for hepatobiliære sygdomme, hudsygdomme og cytopeni ved oral anvendelse af almitrin.
English: Hypoxemia alone is not sufficient to explain severe weight loss reported with almitrine.
Danish: Hypoksæmi er i sig selv ikke tilstrækkelig til at forklare det svære vægttab, der indberettes med almitrin.
English: A total of 11 published clinical studies which became available after the initial Marketing Authorisation were reviewed.
Danish: Der blev gennemgået i alt 11 publicerede kliniske undersøgelser, som var blevet tilgængelige efter den oprindelige markedsføringstilladelse.
English: Moreover, no data is available to support any benefit of almitrine in the restrictive indication proposed by the MAH (patient with PaO2: 55 mmHg< PaO2< 65 mmHg).
Danish: Endvidere foreligger der ingen data til støtte for en fordel ved almitrin til den indskrænkede indikation, der foreslås af indehaveren af markedsføringstilladelsen (patienter med PaO2: 55 mmHg< PaO2< 65 mmHg).
English: In the view of the negative benefit risk balance, patients will need to be switched to alternative therapies.
Danish: På baggrund af det negative benefit/risk-forhold bør patienterne overgå til andre behandlinger.
English: The decrease in reporting of peripheral neuropathy mentioned by the MAH, is probably mainly related to the decrease in sales over the last 10 years.
Danish: Det af markedsføringstilladelsesindehaveren omtalte fald i indberetningen af perifer neuropati beror formodentlig hovedsagelig på nedgangen i salget gennem de seneste ti år.
English: In published clinical studies with continuous administration1234567, peripheral neuropathies and weight loss were encountered when the study duration was longer than 3 months, indicating that the duration of continuous exposure have played a role in their development.
Danish: I de publicerede kliniske undersøgelser med kontinuerlig administration 1234567, forekom der perifer neuropati og vægttab, når undersøgelsens varighed var over tre måneder, hvilket tyder at varigheden af kontinuerlig eksponering har haft betydning for deres opståen på,
English: France has taken a number of national regulatory actions to minimise the risk of these adverse reactions associated with almitrine for oral use.
Danish: Frankrig har truffet en række nationale foranstaltninger til minimering af risikoen for sådanne bivirkninger forbundet med oral anvendelse af almitrin.
English: Overall summary of the scientific evaluation of Almitrine containing medicinal products for oral use by PRAC
Danish: Samlet resumé af PRAC's videnskabelige vurdering af orale lægemidler indeholdende almitrin
English: Spontaneous reports of peripheral neuropathies persist even after the introduction of sequential administration scheme.
Danish: Der bliver fortsat indberettet perifer neuropati selv efter indførelsen af den sekventielle behandlingsplan.
English: In France, almitrine containing medicinal products for oral use have been under close monitoring due to serious adverse reaction .
Danish: I Frankrig har orale lægemidler indeholdende almitrin været under tæt overvågning som følge af alvorlige bivirkninger.
English: The PRAC considered that many of the publications reported that a clinical benefit of oral almitrine could not be seen in terms of exacerbations or hospitalisation, exercise capacity, clinical outcome, survival, or quality of life.
Danish: PRAC tillagde det betydning, at mange af publikationerne angav, at der ikke kunne konstateres klinisk fordel af oralt almitrin hvad angår forværringer eller indlæggelser, fysisk kapacitet, klinisk udfald, overlevelse eller livskvalitet.
English: This adverse effect was also clearly recognised in the trials comparing almitrine at high doses to placebo.
Danish: Denne bivirkning er også klart blevet anerkendt i de undersøgelser, hvor almitrin i høje doser er blevet sammenlignet med placebo.
English: No benefit has been demonstrated when almitrine was used as an adjuvant of that intervention.
Danish: Der er ikke påvist nogen fordel af almitrin som adjuverende behandling til denne intervention.
English: The PRAC is of the opinion that almitrine cannot be considered as an alternative to LTOT for which reduction in mortality has been achieved.
Danish: PRAC er den opfattelse, at almitrin ikke kan anses for at være et alternativ til langtidsoxygenterapi, med hvilken der er opnået nedsat mortalitet.
English: Weight loss observed in patients with respiratory insufficiency is progressive.
Danish: Hos patienter med respirationsinsufficiens er det iagttagne vægttab progressivt.
English: 6 Marsac J. The assessment of Almitrine bismesylate in the long-term treatment of chronic obstructive bronchitis.
Danish: 6 Marsac J. The assessment of almitrin bismesylate in the long-term treatment of chronic obstructive bronchitis.
English: One of the proposed further risk minimisation measures by the MAH was a restricted indication in patients with PaO2 between 55 mmHg and 65 mmHg or as adjuvant treatment to Long Term Oxygen Therapy (LTOT).
Danish: En af de yderligere risikominimeringsforanstaltninger, der blev foreslået af indehaveren af markedsføringstilladelsen, var indskrænkning af indikationen til patienter med PaO2 mellem 55 mmHg og 65 mmHg eller som adjuverende behandling til langtidsoxygenterapi (LTOT).
English: However, the PRAC noted that weight loss reported with almitrine could occur faster and be more severe than what is commonly observed in chronic respiratory insufficiency.
Danish: PRAC bemærkede dog, at det vægttab, der blev indberettet med almitrin, kan tænkes at være hurtigere og sværere end det, der sædvanligvis iagttages ved kronisk respirationsinsufficiens.
English: Almitrine for oral use was studied in several clinical studies.
Danish: Oral anvendelse af almitrin har været genstand for flere kliniske undersøgelser.
English: PRAC noted that in the clinical trials with results in favour of almitrine, effect of almitrine could have been overestimated as a high rate of patients withdrew predominantly in the almitrine group as compared to placebo (Voisin and al, 1987 and in most of all the clinical trials).
Danish: PRAC bemærkede, at i de kliniske undersøgelser, hvor resultaterne er til fordel for almitrin, kan virkningen af almitrin være blevet overvurderet, da andelen af udtrædelser var højere i almitrin-gruppen end i placebogruppen (Voisin and al, 1987 samt størstedelen af alle de kliniske undersøgelser).
English: The doses of 100-200 mg of almitrine continuously were associated with a higher incidence of adverse effects and withdrawals compared to placebo.
Danish: Ved kontinuerlige doser på 100-200 mg almitrin var der højere forekomst af bivirkninger og udtrædelser end med placebo.
English: On 27 November 2012 France informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their consideration to review the benefit risk balance of almitrine for oral use in the treatment of chronic respiratory diseases resulting from the evaluation of data relating to pharmacovigilance.
Danish: Den 27. november 2012 underrettede Frankrig Det Europæiske Lægemiddelagentur om, at det i medfør af artikel 31 i direktiv 2001/83/EF overvejede at revurdere benefit/risk-forholdet for oral anvendelse af almitrin til behandling af kroniske luftvejssygdomme baseret på en vurdering af lægemiddelovervågningsdata.
English: Taken together, these clinical trials enrolled 2036 patients (1380 under almitrine, 656 under placebo).
Danish: Tilsammen omfattede disse kliniske undersøgelser 2 036 patienter (1 380 behandlet med almitrin, 656 med placebo).
English: The last trials, conducted with sequential treatment and following a double blind placebo controlled design, account for 366 patients.
Danish: De seneste undersøgelser blev udført med sekventiel behandling i et dobbeltblindet, placebokontrolleret design og omfatter 366 patienter.
English: An important proportion of cases seems to have been reported with an outcome as not recovered during the period from September 2003 to December 2012 (5 cases of the 7 reported).
Danish: At de tilfælde, der indberettet i perioden fra september 2003 til december 2012, synes en væsentlig del at være beskrevet som ikke restituerede (5 af de 7 indberettede tilfælde).
English: The first trials, conducted with non-sequential treatment, account for 1670 patients (1006 following a double blind, placebo controlled design).
Danish: De første undersøgelser, hvor der blev anvendt non-sekventiel behandling, omfatter 1 670 patienter (1 006 i dobbeltblindet, placebokontrolleret design).
English: However, no data supports the restrictive indication proposed by the MAH.
Danish: Der er imidlertid ingen data til støtte for den indskrænkede indikation, der foreslås af indehaveren af markedsføringstilladelsen.
English: Sequential treatment with low dose Almitrine bismesylate in hypoxaemic chronic obstructive airways disease.
Danish: Sequential treatment with low dose almitrin bismesylate in hypoxaemic chronic obstructive airways disease.
English: The reported reactions consisted mainly of peripheral neuropathy and weight loss.
Danish: De indberettede reaktioner bestod hovedsagelig af perifer neuropati og vægttab.
English: Even if occurrence of peripheral neuropathy in COPD patients with associated conditions could be considered as a confounding factor, the occurrence of cases with positive rechallenge with almitrine during the post-marketing experience is strongly in favour of a causal relationship between almitrine and peripheral neuropathies.
Danish: Selv om forekomsten af perifer neuropati hos KOL-patienter med tilknyttede sygdomme kan anses for en konfunderende faktor, tyder forekomsten af tilfælde fra erfaringerne efter markedsføring, hvor der var positiv reeksponering for almitrin, stærkt på en årsagssammenhæng mellem almitrin og perifer neuropati.
English: In addition to peripheral neuropathies with abnormal sensations in the lower limb or paraesthesia and weight loss up to -6%, in the publications reporting clinical studies with continuous administration, the following adverse events were also more frequent in the almitrine groups:
Danish: Ud over perifere neuropatier med abnorme føleindtryk i underekstremiteterne eller paræstesi og vægttab op til -6 % var følgende bivirkninger ligeledes hyppigere i almitrin-grupperne i de publicerede kliniske undersøgelser med kontinuerlig administration:
English: The PRAC considered the risk minimisations measures already implemented (reduction of the dose and implementation of a sequential treatment scheme) to mitigate the risk of neuropathies and weight loss.
Danish: PRAC gennemgik de tidligere iværksatte risikominimeringsforanstaltninger (dosisreduktion og en sekventiel behandlingsplan) til afbødning af risikoen for neuropati og vægttab.
English: Based on the data from clinical studies and post-marketing experience, the two main safety concerns with almitrine are peripheral neuropathy and weight loss.
Danish: Baseret på data fra kliniske undersøgelser og erfaringer efter markedsføring er de to vigtigste sikkerhedsproblemer ved almitrin perifer neuropati og vægttab.
English: Eur J Respir Dis 1983; 64(Suppl 126):323-330 (PE10377) 3 Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of Almitrine bismesylate in patients with chronic respiratory insufficiency.
Danish: Eur J Respir Dis 1983; 64(Suppl 126):323-330 (PE10377) 3 Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of almitrin bismesylate in patients with chronic respiratory insufficiency.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for almitrine containing products for oral administration (see Annex I).
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF som følge af lægemiddelovervågning af produkter til oral anvendelse af almitrin (se bilag I).
English: In addition to publications of clinical studies, the PRAC reviewed post marketing data provided by the MAH.
Danish: Foruden publikationer af kliniske undersøgelser gennemgik PRAC data efter markedsføring, som blev forelagt af indehaveren af markedsføringstilladelsen.
English: Overall, a significant number of cases with outcomes reported as not recovered or recovered with sequelae is not acceptable to the PRAC.
Danish: Totalt finder PRAC det uacceptabelt, at der er et betydeligt antal tilfælde med udfald, der indberettes som ikke restituerede eller restituerede med sequelae.
English: Besides, the PRAC also noted that the knowledge in physiopatholigical mechanism and management of COPD (including life expectancy in COPD) has been considerably improved.
Danish: Desuden bemærkede PRAC, at vi i dag ved væsentligt mere om patofysiologien og behandlingen af KOL (herunder den forventede levetid ved KOL).