FrancophonIA/ELRC3.0 huggingface dataset:
English: • the product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • Den produktinformation, der er foreslået af indehaverne af markedsføringstilladelse, er vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget.
English: If necessary, the dose can be increased by 25 mg every other week.
Danish: Dosen kan øges med 25 mg hver anden uge, hvis det er nødvendigt.
English: A starting dose of 10-25 mg in the evening are recommended for this patient population and although the dose may be increased depending on individual patient response and tolerability, doses above 100 mg should be used with caution.
Danish: En startdosis på 10-25 mg om aftenen anbefales hos denne patientgruppe, og selv om dosen kan øges afhængigt af den enkelte patients respons og tolerabilitet, bør doser over 100 mg anvendes med forsigtighed.
English: Its main metabolite, nortriptyline, is a more potent and selective norepinephrine reuptake inhibitor, although it still blocks serotonin uptake.
Danish: Dets hovedmetabolit, nortriptylin, er en mere potent og selektiv noradrenalingenoptagelseshæmmer, selv om den stadig blokerer serotonin-optaget.
English: • The committee considered the divergences identified in the notification for Saroten and associated names, as well as the remaining sections of the product information.
Danish: • Udvalget behandlede de divergenser, der er konstateret i anmeldelsen vedrørende Saroten og relaterede navne, samt de øvrige punkter i produktinformationen.
English: As part of the assessment of a previous PSUR procedure for amitriptyline (PSUSA/0000168/201501), the Lead Member, Greece, identified the need to harmonise the product information for the originator Saroten across the EU.
Danish: I forbindelse med vurderingen af en tidligere PSUR-procedure for amitriptylin (PSUSA/0000168/201501) konstaterede Grækenland i sin egenskab af ledende medlemsstat, at der var behov for at harmonisere produktinformationen for originalpræparatet, Saroten, i EU.
English: Therefore, due to the divergent national decisions taken by Member States concerning the authorisation of amitriptyline-containing products, Greece notified the Agency on 17 December 2015 of a referral under Article 30 of Directive 2001/83/EC for Saroten and associated names, in order to resolve divergences amongst the nationally authorized SmPCs for the above-mentioned product and thus to harmonise its divergent SmPCs across the EU.
Danish: På grund af de forskellige nationale beslutninger i medlemsstaterne vedrørende godkendelse af produkter indeholdende amitriptylin indgav Grækenland meddelelse til agenturet den 17. december 2015 om en officiel indbringelse af Saroten og relaterede navne i henhold til artikel 30 i direktiv 2001/83/EF for at løse divergenser mellem de nationalt godkendte produktresuméer for de førnævnte produkter og dermed harmonisere de divergerende produktresuméer i EU.
English: Section 4.5 of the SmPC on drug interactions was revised based on a review of the latest literature available.
Danish: 4.5 i produktresuméet vedrørende lægemiddelinteraktioner er blevet revideret på grundlag af en gennemgang af den nyeste tilgængelige litteratur.
English: Generally, patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions and in all cases the lowest effective dose should be used for the shortest duration required to treat the symptoms.
Danish: Generelt bør patienterne titreres individuelt til den dosis, der giver tilstrækkelig smertestillelse med tolerable bivirkninger, og doseringen bør i alle tilfælde være den laveste effektive dosis i den kortest mulige tid, som er nødvendig for at behandle symptomerne.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Saroten and associated names remains favourable, subject to the agreed changes to the product information.
Danish: CHMP konkluderede følgelig, at benefit/risk-forholdet for Saroten og relaterede navne fortsat er positivt under forudsætning af, at de vedtagne ændringer af produktinformationen gennemføres.
English: Saroten is available for oral use in film-coated tablets and modified-release capsules and tablets, with strengths including 10, 25, 50 and 75 mg.
Danish: Saroten fås til oral anvendelse som filmovertrukne tabletter og depotkapsler og -tabletter i styrkerne 10, 25, 50 og 75 mg.
English: The MAHs proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with the reference book Martindale (Martindale 2014).
Danish: Indehaverne af markedsføringstilladelse har foreslået harmoniserede dosisanbefalinger baseret på de kliniske undersøgelser og i overensstemmelse med referencebogen Martindale (Martindale 2014).
English: Moreover, the CHMP did not endorse a separate indication in nociceptive pain due to the insufficient evidence provided in relation to back pain and visceral pain.
Danish: Derudover støtter CHMP ikke en separat indikation for nociceptive smerter, da der ikke er fremlagt tilstrækkelig dokumentation relateret til rygsmerter og viscerale smerter.
English: In addition, section 4.9 of the SmPC focusing on the management of overdose has been streamlined.
Danish: 4.9 i produktresuméet vedrørende behandling af overdosering blevet strømlinet.
English: For the elderly patients over 65 years of age and patients with cardiovascular disease it is generally recommended to initiate treatment in the lower dose range as recommended for adult, as these populations are particularly susceptible to the known adverse reactions and in particular cardiac toxicity.
Danish: Med hensyn til ældre patienter over 65 år og patienter med hjerte-kar-sygdomme anbefales det generelt at indlede behandlingen med en lav voksendosis, da disse patientgrupper er særligt følsomme over for de kendte bivirkninger, herunder især hjertetoksicitet.
English: • The committee reviewed the totality of the data submitted by the MAHs as well as relevant available literature in support of the proposed harmonisation of the product information, the CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Saroten and associated names (see Annex I).
Danish: • Udvalget gennemgik samtlige data, som indehaverne af markedsføringstilladelse havde fremlagt, samt den relevante tilgængelige litteratur i forbindelse med den foreslåede harmonisering af produktinformationen, og CHMP anbefalede ændring af betingelserne for markedsføringstilladelse, idet produktinformationen er fastlagt i bilag III for Saroten og relaterede navne (se bilag I).
English: Finally, section 5.3 on preclinical safety data has been modified according to the most recent and relevant information from literature to reflect current knowledge with regards to cardiac toxicity, genotoxic potential, embryotoxicity and effect on fertility.
Danish: 5.3 vedrørende prækliniske sikkerhedsdata blevet ændret i overensstemmelse med de nyeste og mest relevante oplysninger fra litteraturen, så det afspejler den nyeste viden med hensyn til hjertetoksicitet, genotoksisk potentiale, embryotoksicitet og indvirkning på fertilitet.
English: Finally, based on current recommendations by national and international treatment guidelines and available literature, the use of amitriptyline for enuresis nocturna in children was restricted to third line therapy in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products.
Danish: Sluttelig anbefaler CHMP på grundlag af de aktuelle anbefalinger i nationale og internationale behandlingsvejledninger og den tilgængelige litteratur, at brugen af amitriptylin til behandling af enuresis nocturna (ufrivillig natlig vandladning) hos børn begrænses til tredjelinjebehandling hos børn i alderen 6 år og derover, når organisk patologi, herunder spina bifida og relaterede lidelser, er udelukket, og der ikke er opnået respons ved alle andre ikkemedicinske og medicinske behandlinger, herunder krampestillende midler og vasopressin-relaterede produkter.
English: The current SmPCs approved in the EU Member States differ significantly in the approved indications, posology and recommendations for use.
Danish: Der er store forskelle i de godkendte produktresuméer i EU-medlemsstaterne med hensyn til indikationer, dosering og anbefalet brug.
English: Amitriptyline has potent anticholinergic, antihistaminergic, and sedative properties and it potentiates the effects of catecholamines.
Danish: Amitriptylin har potente antikolinerge, antihistaminerge og sedative egenskaber, og det forstærker virkningen af katekolaminer.
English: Amitriptyline is a well-known tricyclic antidepressant with an established mechanism of action and use (Brunton 2011)1.
Danish: Amitriptylin er et velkendt tricyklisk antidepressivum med en klarlagt virkningsmekanisme og anvendelse (Brunton 2011).
English: Based on the drug reference Martindale (Martindale 2014) the recommended dose for nocturnal enuresis is 10 mg to 20 mg for children aged 6 to 10 years and 25 mg to 50 mg for children aged 11 years to 17 years.
Danish: Baseret på referencebogen Martindale (Martindale 2014) er den anbefalede dosis ved ufrivillig natlig vandladning 10-20 mg for børn i alderen 6-10 år og 25-50 mg for børn i alderen 11-17 år.
English: On review of all available data the recommended doses for the treatment of depression in adults is of 50 mg daily.
Danish: Efter gennemgang af alle tilgængelige data er den anbefalede dosis til behandling af depression hos voksne 50 mg dagligt.
English: A warning was added in section 4.4 of the SmPC on the risk of QT prolongation.
Danish: 4.4 i produktresuméet vedrørende risikoen for QT-forlængelse.
English: The recommended starting dose for the treatment of pain in the elderly and patients with cardiovascular disease is 10 mg to 25 mg in the evening.
Danish: Den anbefalede startdosis ved behandling af smerter hos ældre patienter og patienter med hjerte-karsygdomme er 10-25 mg om aftenen.
English: Based on the available clinical data of parenteral amitriptyline administration to depressed patients as well as on pharmacokinetic parameters the recommended dosage is 50 - 150 mg/day, given in 1 to 3 ampoules daily.
Danish: På grundlag af de tilgængelige kliniske data om parenteral administration af amitriptylin hos patienter med depression og på grundlag af de farmakokinetiske parametre er den anbefalede dosis 50150 mg/dag givet som 1-3 ampuller dagligt.
English: Taking into account current treatment guidelines and recent systematic reviews published in the literature, the CHMP endorsed an indication for amitriptyline in the treatment of major depressive disorder in adults.
Danish: Under hensyn til de aktuelle behandlingsvejledninger og nylige systematiske gennemgange i den publicerede litteratur støtter CHMP anvendelsen af amitriptylin til behandling af svær depression hos voksne.
English: The MAHs have performed an analysis of their databases and considered all available information in the literature including classical textbooks such as Martindale (Martindale 2014), in order to justify the inclusion of adverse drug reactions, for which a causal relationship is at least a reasonable possibility.
Danish: Indehaverne af markedsføringstilladelse har foretaget en analyse af deres databaser og overvejet alle tilgængelige oplysninger i litteraturen, herunder klassiske lærebøger som f.eks. Martindale (Martindale 2014), for at begrunde inklusionen af bivirkninger, for hvilke der er en rimelig mulighed for årsagssammenhæng.
English: Amitriptyline is a well-established product with a long standing use as antidepressant.
Danish: Amitriptylin er et veletableret produkt, der i mange år er blevet brugt som antidepressivt middel.
English: For the treatment of pain (neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine) in adults doses are in general lower than in depression, with doses rarely exceeding 100 mg. Dosing should start with 10mg at bedtime and then titrated in 1025mg increments every 3-7 days.
Danish: Ved behandling af smerter (neuropatiske smerter, forebyggende behandling af kronisk spændingshovedpine og migræne) hos voksne er dosis generelt lavere end ved depression, og den overstiger sjældent 100 mg. Doseringen bør starte med 10 mg ved sengetid og optitreres med 1025 mg ad gangen hver 3.-7. dag.
English: Although the use of amitriptyline in a broad indication in chronic pain was not agreed by the CHMP, the use of amitriptyline in the treatment of neuropathic pain in adults was considered supported by recent systematic reviews and meta-analysis of pharmacological treatments of this condition.
Danish: Selv om CHMP ikke støtter brugen af amitriptylin i en bred indikation ved kroniske smerter, anses brugen af amitriptylin til behandling af neuropatiske smerter hos voksne for at være dokumenteret i nylige systematiske gennemgange og meta-analyser af farmakologiske behandlinger af denne lidelse.
English: The package leaflet was amended in accordance with the changes made to the SmPC.
Danish: Indlægsseddel Indlægssedlen blev ændret i overensstemmelse med de foreslåede ændringer af produktresuméet.
English: In addition, the CHMP concluded that the totality of the data provided by the MAHs was supportive of a first line treatment for amitriptyline in the prophylactic treatment of chronic tension type headache (CTTH) and migrane in adults, although a specific indication in fibromyalgia was not agreed.
Danish: CHMP konkluderer desuden, at alle de data, som indehaverne af markedsføringstilladelse har fremlagt, understøtter brugen af amitriptylin som førstelinjebehandling ved profylaktisk behandling af kronisk spændingshovedpine og migræne hos voksne, men der er ikke enighed om at godkende en specifik indikation for fibromyalgi.
English: Amitriptyline is a tertiary amine that acts primarily as a serotonin-norepinephrine reuptake inhibitor.
Danish: Amitriptylin er en tertiær amin, der primært fungerer som en serotoninnoradrenalingenoptagelseshæmmer.
English: Section 5.1 was revised to include a short factual description of the mechanism of action and Section 5.2 was updated to include data supporting the pharmacokinetic properties, especially of the parenteral formulation have been presented and discussed.
Danish: 5.2 er blevet opdateret, så det omfatter data, der understøtter de farmakokinetiske egenskaber, især ved den parenterale formulering.
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC was updated based on the review and analysis of all the available data provided by MAHs including literature, and post marketing data from the MAH Global Safety database.
Danish: 4.6 i produktresuméet blevet opdateret på basis af den gennemgang og analyse af alle tilgængelige oplysninger, som indehaverne af markedsføringstilladelse fremlagde, herunder litteratur, samt data fra indehavernes globale sikkerhedsdatabase fremkommet efter markedsføring.
English: - Concomitant treatment with MAOIs (monoamine oxidase inhibitors) - Severe liver disease.
Danish: Enhver grad af hjerteblokade eller forstyrrelser af hjerterytmen og koronararterieinsufficiens - samtidig behandling med MAOI'er (monoaminoxidasehæmmere) - svær leversygdom - børn (under 6 år).
English: On the other hand, the evidence provided by the MAH on the use of amitriptyline in non-specific neuropathic conditions such as phantom pain, cancer neuropathy and HIV neuropathy was not considered adequate to support a specific indication in these pain categories.
Danish: kræft-neuropati og hiv-neuropati, er tilstrækkelig til at støtte en specifik indikation i disse smertekategorier.
English: The data supporting contraindications included in section 4.3 of the SmPC was discussed by the MAHs and the rationale provided for keeping them in the SmPC was agreed by the CHMP for the following ones:
Danish: 4.3 i produktresuméet, blev drøftet af indehaverne af markedsføringstilladelse, og CHMP er enig i rationalet for at bibeholde dem i produktresuméet, for så vidt angår følgende: - overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne - nyligt myokardieinfarkt.
English: Intravenous use vial (glass)
Danish: Intravenøs brug hætteglas (glas)
English: Concentrate for solution for infusion
Danish: Koncentrat til opløsning til infusion
English: 36 hours.
Danish: 36 timer.
English: Your surgeon will inform you about this.
Danish: Din kirurg vil informere dig om dette.
English: This level of efficacy is similar to that observed in the treated patients overall.
Danish: Dette efficacyniveau ligner det, der blev observeret hos de behandlede patienter generelt.
English: Although the risk is considered to be low and controlled in the manufacturing.
Danish: Risikoen betragtes imidlertid som lav og er kontrolleret i fremstillingen.
English: The product is implanted locally.
Danish: Produktet implanteres lokalt.
English: It will take several weeks to produce Holoclar.
Danish: Det vil tage adskillige uger at fremstille Holoclar.
English: On the second visit the surgeon will:
Danish: Ved det andet besøg vil kirurgen:
English: • Autologous means that they are your own cells.
Danish: • Autolog betyder, at det er dine egne celler.
English: Only a very small number of children have been treated so far, so it is not known whether the medicine is safe for use in children or how effective it may be.
Danish: Kun et meget lille antal børn er blevet behandlet indtil videre, så det vides ikke, om produktet er sikkert at anvende til børn eller hvor effektivt det er.
English: • Replace it with Holoclar
Danish: • Erstatte den med Holoclar
English: The surgeon will be informed as early in the process as possible and should hence select an alternative treatment for the patient.
Danish: Kirurgen vil blive informeret så tidligt som muligt i forløbet og skal derfor vælge en alternativ behandling for patienten.
English: Patient's Date of Birth:
Danish: Patientens fødselsdato:
English: Ask your doctor or pharmacist for advice.
Danish: Spørg din læge eller apotekspersonalet til råds.
English: Additional clinically-relevant parameters were evaluated as secondary efficacy assessments.
Danish: Yderligere klinisk relevante parametre blev evalueret som sekundære efficacyvurderinger.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/987/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/987/001
English: • The limbus is part of the eye.
Danish: • Limbus er en del af øjet.
English: See the educational material for further information.
Danish: Se undervisningsmaterialet for yderligere information.
English: <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: <1/1,000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The safety of Holoclar is demonstrated in the results obtained from the two retrospective clinical studies.
Danish: Holoclars sikkerhed er påvist i resultaterne, der blev opnået fra de to retrospektive kliniske studier.
English: EXPIRY DATE EXP : Day / Month / Year At time: Hour / Minute (CET)
Danish: UDLØBSDATO EXP: Dag/måned/år Klokken: Time/minut (CET)
English: If you have any of the following problems with your eyes, they should be treated before this medicine is used:
Danish: Hvis du har et af de følgende problemer med øjnene, skal de behandles, før dette lægemiddel anvendes:
English: Date of latest renewal: 11/12/2017
Danish: Dato for seneste fornyelse: 11/12/2017
English: Holoclar must be applied no later than 15 minutes after opening the primary container.
Danish: Holoclar skal anvendes senest 15 minutter efter åbning af den primære beholder.
English: A total of 75 (72.1%) treatments were reported with a successful outcome.
Danish: Der blev indberettet i alt 75 (72,1 %) behandlinger med et vellykket resultat.
English: When possible, concomitant eye problems should be corrected prior to Holoclar implantation.
Danish: Når det er muligt, skal samtidige øjenproblemer korrigeres før implantation af Holoclar.
English: Other cytotoxic agents must be avoided.
Danish: Andre cytotoksiske midler skal undgås.
English: Final CSR December
Danish: Endelig KSR, december
English: This is to protect it from contamination by bacteria.
Danish: Det er for at beskytte det mod forurening med bakterier.
English: The implantation must be followed by an appropriate monitoring schedule.
Danish: Implantationen skal efterfølges af en passende overvågningsplan.
English: Visit 2: Holoclar implantation
Danish: Besøg 2: Holoclar-implantation
English: Post-operative treatment
Danish: Post-operativ behandling
English: It is very important that you take all the medicines prescribed by your surgeon, otherwise Holoclar may not work.
Danish: Det er meget vigtigt, at du bruger alle lægemidler, der er ordineret af din kirurg, da Holoclar måske ellers ikke virker.
English: Transparent, circular sheet.
Danish: Gennemsigtig, rund skive.
English: Treatment with Holoclar is a two-step procedure.
Danish: Behandlingen med Holoclar er en procedure i 2 trin.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk.7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemgøre følgende foranstaltninger:
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable.>
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA <Ikke relevant.>
English: Very common: may affect more than 1 in 10 people • Inflammation of the eyelids (blepharitis)
Danish: Meget almindelig: kan påvirke flere end 1 ud af 10 personer • Betændelse i øjenlågene (blepharitis)
English: These new cells can replace the damaged cells in your eye.
Danish: Disse nye celler kan erstatte de beskadigede celler i øjet.
English: • Bleeding around the site of the operation where Holoclar was inserted
Danish: • Blødning rundt om indgrebsstedet, hvor Holoclar blev indsat
English: Holoclar could contain potentially infected biological material.
Danish: Holoclar kan indeholde potentielt inficeret biologisk materiale.
English: Although limited with regard to the number of subjects, data from both studies showed a success rate around 70% of treated cases in the elderly population.
Danish: Selvom studierne var begrænsede mht. antallet af forsøgspersoner, viste data fra begge studier en succesrate på omkring 70 % af de behandlede patienter hos den ældre population.
English: Holoclar is an autologous product and should under no circumstances be administered to anyone other than the donor patient.
Danish: Holoclar er et autologt produkt og må under ingen omstændigheder administreres til andre end donorpatienten.
English: When Holoclar is made, two ingredients from animals are used.
Danish: I fremstillingen af Holoclar anvendes der to indholdsstoffer fra dyr.
English: This is the case if the biopsy is not good enough to make Holoclar, the cells cannot be grown in the laboratory or the grown cells do not meet all the quality requirements.
Danish: Dette er tilfældet, hvis biopsien ikke er god nok til at fremstille Holoclar, cellerne ikke kan dyrkes i laboratoriet eller de dyrkede celler ikke opfylder alle kvalitetskrav.
English: Email: info@chiesi.com
Danish: E-mail: info@chiesi.com
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the corneal surface.
Danish: Mængden af celler, der skal administreres, afhænger af størrelsen (overflade i cm²) på corneas overflade.