FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium dihydrogen phosphate dihydrate
Danish: Dinatriumphosphat, vandfri Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: How to store Shingrix
Danish: Sådan får du Shingrix
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Posology
Danish: personår
English: GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
Danish: Tηλ: + 30 210 68 82 100
English: Traceability
Danish: Opbevaring
English: Efficacy against Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) In two phase III, placebo-controlled, observer-blind efficacy studies of Shingrix:
Danish: Virkning mod Herpes zoster (HZ) og postherpetisk neuralgi (PHN)
English: 1 Injection set = injection syringe + 2 injection needles + cleansing swab.
Danish: 1 Injektionssæt = injektionssprøjte + 2 kanyler + renseserviet.
English: Strength Pharmaceutical form
Danish: Lægemiddelform Administrati on
English: Immediate Packaging
Danish: injektionssæt
English: Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
Danish: Oral anvendelse Blister (PVC/PVdC /Al) 100 x 1 kapsler (enhedsdosis)
English: Blister (PVC/PVdC/Alu) 50 x 1 tablets
Danish: 500 mg Filmovertrukket tablet Oral anvendelse Blister (PVC/PVdC /Al) 50 x 1 tabletter (enhedsdosis)
English: (unit dose)
Danish: (Særnavn) Navn
English: Route of administration
Danish: Pakningsstørrelse
English: Feraccru received a marketing authorisation valid throughout the EU on 18 February 2016.
Danish: Feraccru fik en markedsføringstilladelse med gyldighed i hele EU den 18. februar 2016.
English: Further information on Feraccru can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Feraccru findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach.
Danish: Den anbefalede dosis er én kapsel to gange dagligt, morgen og aften, på tom mave.
English: Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.
Danish: Behandlingens varighed afhænger af jernmanglens sværhedsgrad, men sædvanligvis er det nødvendigt med mindst 12 ugers behandling.
English: As for all medicines, data on the use of Feraccru are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Feraccru løbende overvåget.
English: Other information about Feraccru
Danish: Andre oplysninger om Feraccru
English: For more information about using Feraccru, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Feraccru, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Feraccru (ferric maltol) EMA/162888/2018
Danish: Feraccru (ferrimaltol) EMA/162888/2018
English: In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
Danish: Endvidere opnåede ca. 65 % af de patienter, der fik Feraccru, et normalt hæmoglobinniveau sammenholdt med 10 % af de patienter, der fik placebo.
English: Side effects reported with Feraccru are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Feraccru vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Feraccru is available as capsules (30 mg).
Danish: Feraccru fås som kapsler (30 mg).
English: What measures are being taken to ensure the safe and effective use of Feraccru?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Feraccru?
English: The European Medicines Agency decided that Feraccru's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Feraccru opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Feraccru and why it is authorised in the EU
Danish: En oversigt over Feraccru og hvorfor det er godkendt i EU
English: Severe side effects include abdominal pain, constipation and diarrhoea.
Danish: Svære bivirkninger er mavesmerter, forstoppelse og diarré.
English: Feraccru is effective at increasing haemoglobin levels in patients with iron deficiency and anaemia, (defined as haemoglobin levels lower than 12 g/dl for women and 13 g/dl for men).
Danish: Feraccru er effektivt til at øge hæmoglobinniveauet hos patienter med jernmangel og anæmi (defineret som hæmoglobin under 12 g/dl for kvinder og 13 g/dl for mænd).
English: The safety profile of Feraccru is considered acceptable, with side effects that are mostly mild to moderate in intensity and in line with those of other iron preparations.
Danish: Sikkerhedsprofilen for Feraccru anses for acceptabel med bivirkninger, der hovedsageligt er lette til moderate og svarer til bivirkningerne ved andre jernpræparater.
English: Why is Feraccru authorised in the EU?
Danish: Hvorfor blev Feraccru godkendt i EU?
English: This helps correct reduced production of haemoglobin (the oxygen-carrying pigment in red blood cells), anaemia (low levels of red blood cells) and any symptoms of the condition.
Danish: Dette medvirker til at korrigere nedsat dannelse af hæmoglobin (det iltbærende pigment i røde blodlegemer), anæmi (lavt antal røde blodlegemer) og eventuelle symptomer på denne tilstand.
English: What is Feraccru and what is it used for?
Danish: Hvad er Feraccru, og hvad anvendes det til?
English: Data on how the medicine is absorbed in the body show that Feraccru can also have an effect on patients with iron deficiency who have not already developed anaemia.
Danish: Data om, hvordan lægemidlet optages i kroppen, viser, at Feraccru også kan have en virkning hos patienter, der har jernmangel uden allerede at have udviklet anæmi.
English: When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency.
Danish: Når det tages gennem munden, optages det af tarmcellerne, hvorefter jernet frigives fra stoffet og transporteres og opbevares i kroppen, så jernindholdet hos patienter med jernmangel bliver normalt.
English: Feraccru (ferric maltol)
Danish: Feraccru (ferrimaltol)
English: What are the risks associated with Feraccru?
Danish: Hvilke risici er der forbundet med Feraccru?
English: Feraccru must not be used in patients with iron overload disorder (haemachromatosis) or in patients receiving repeated blood transfusions.
Danish: Feraccru må ikke anvendes hos patienter, der lider af jernoverbelastning (hæmokromatose) eller får gentagne blodtransfusioner.
English: In a study of 128 patients, those taking Feraccru for 12 weeks had their haemoglobin levels increase on average from 11.0 to 13.2 g/dl whereas in patients taking placebo (a dummy treatment)
Danish: I et studie med 128 patienter fik de patienter, der blev behandlet med Feraccru i 12 uger, forøget deres gennemsnitlige hæmoglobinniveau fra 11,0 til 13,2 g/dl, mens det forblev på ca. 11,1 g/dl hos
English: The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity.
Danish: De hyppigste bivirkninger ved Feraccru (som kan forekomme hos op til 1 ud af 10 personer) er symptomer i tarmen, såsom mavesmerter, tarmluft (flatulens), forstoppelse (konstipation), maveubehag og oppustethed samt diarré.
English: Feraccru contains the active substance ferric maltol.
Danish: Feraccru indeholder det aktive stof ferrimaltol.
English: Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.
Danish: Feraccru er et jernholdigt lægemiddel, der anvendes til behandling af jernmangel hos voksne.
English: How is Feraccru used?
Danish: Hvordan anvendes Feraccru?
English: Feraccru has been shown to be effective in increasing haemoglobin levels in patients with iron deficiency anaemia.
Danish: Feraccru er påvist at være effektivt til at forøge hæmoglobinindholdet hos patienter med jernmangelanæmi.
English: For the full list of side effects of Feraccru, see the package leaflet.
Danish: Den fuldstændige liste over bivirkningerne ved Feraccru fremgår af indlægssedlen.
English: The active substance in Feraccru, ferric maltol, is an iron-containing compound.
Danish: Det aktive stof i Feraccru, ferrimaltol, indeholder jern.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Feraccru have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Feraccru.
English: What benefits of Feraccru have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Feraccru?
English: How does Feraccru work?
Danish: Hvordan virker Feraccru?
English: Iron is an essential building block for haemoglobin and the body can produce more haemoglobin and correct anaemia once iron stores are replenished.
Danish: Kroppen producerer derfor mere hæmoglobin, når jernbeholdningerne er fyldt op, så anæmien afhjælpes.
English: For [indication*]
Danish: Mod [indikation*]
English: The warning should read as follows:
Danish: Advarslen skal fremstå som følger:
English: Patient card text
Danish: Tekst på patientkort
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktrinformationen kan efterfølgende opdateres af medlemsstaternes kompetente myndigheder, i samarbejde med referencemedlemsstaten, hvor det er relevant, i overensstemmelse med bestemmelserne i kapitel 4, afsnit III i direktiv 2001/83/EF.
English: Take/Use [depending on formulation] only once a week
Danish: Tages/anvendes [afhængig af formulering] kun én gang ugentligt
English: If you have any questions, please talk to your doctor or pharmacist before you take this medicine.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet, inden du tager dette lægemiddel.
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante punkter i produktinformationen er resultatet af referralproceduren.
English: The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.
Danish: Den ordinerende læge skal sikre sig, at patienten eller dennes omsorgsperson vil være i stand til at overholde doseringsregimet med én ugentligt dosis.
English: Any recommendations to split the dose should be deleted from the SmPC.
Danish: Eventuelle anbefalinger om at opdele dosis skal slettes fra produktresuméet.
English: Please read section 3 of this leaflet very carefully.
Danish: Læs afsnit 3 i denne indlægsseddel meget nøje.
English: On blisters the wording should be printed repeatedly in one or more (e.g. on multilingual packages) rows depending on readability.
Danish: På blisterstrips skal ordlyden skrives gentagne gange på en eller flere (f.eks. på flersprogede pakninger) rækker afhængigt af læsbarheden.
English: Always show this card to health care professionals not familiar with your methotrexate treatment to alert them about your once weekly use (e.g. on hospital admission, change of care).
Danish: Vis altid dette kort til sundhedspersoner, som ikke er bekendt med din methotrexat-behandling, for at advisere dem om din indtagelse én gang ugentligt (f.eks. ved hospitalsindlæggelse, ændring af pleje).
English: Dosage errors in the use of <product name> (methotrexate) can result in serious adverse reactions, including death.
Danish: Doseringsfejl under brug af <Særnavn> (methotrexat) kan resultere i alvorlige bivirkninger, herunder dødsfald.
English: Amendments to relevant sections of the product information
Danish: Ændringer til relevante punkter i produktinformationen
English: {For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below} Summary of product characteristics
Danish: {Alle produkter i Bilag I skal have ændret ordlyden i den eksisterende produktinformation (indsætning, ændring eller sletning af tekst) for at afspejle den aftalte ordlyd som angivet nedenfor} Produktresumé
English: On other immediate packaging it should be implemented once only in a prominent place.}
Danish: På øvrig indre emballage skal den kun implementeres én gang på et fremtrædende sted.}
English: Annex III Amendments to relevant sections of the product information
Danish: Bilag III Ændringer til relevante punkter i produktinformationen
English: IF YOU USE METHOTREXATE FOR ONE OF THE ABOVE MENTIONED INDICATIONS, YOU SHOULD ONLY TAKE METHOTREXATE ONCE A WEEK Write here in full the day of the week for intake: ______________ Do not take more than the prescribed dose.
Danish: HVIS DU BRUGER METHOTREXAT MOD EN AF OVENNÆVNTE LIDELSER (INDIKATIONER), MÅ DU KUN TAGE METHOTREXAT ÉN GANG UGENTLIGT Skriv tydeligt ugedagen for indtagelse her: ______________ Tag ikke mere end den dosis, som lægen har ordineret.
English: Take only once a week on ……………………………………………………….
Danish: Må kun tages én gang ugentligt hver ……………………………………………………….
English: {For parenteral formulations (solution for injection in prefilled syringes or pens), the warning should be implemented once in a prominent place of the immediate packaging if space allows.}
Danish: {På parenterale formuleringer (injektionsvæske, opløsning, i fyldte injektionssprøjter eller injektionspenne), skal advarslen implementeres én gang på et fremtrædende sted på den indre emballage, såfremt pladsen tillader det.}
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING 7.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INTERMEDIÆRE EMBALLAGE 7.
English: • Parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease)
Danish: • Parenterale formuleringer af methotrexat-holdige lægemidler med mindst en indikation, der kræver behandling én gang ugentligt (f.eks. reumatologiske/dermatologiske sygdomme eller Crohns sygdom)
English: (include weekday of intake in full)
Danish: (skriv tydeligt hvilken ugedag lægemidlet skal tages)
English: • All methotrexate-containing medicinal products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease): {Any reference to dividing the dose for indications requiring treatment once a week should be removed from the package leaflet.}
Danish: • Alle methotrexat-holdige lægemidler med mindst én indikation, der kræver behandling én gang ugentligt (f.eks. reumatologiske/dermatologiske sygdomme eller Crohns sygdom): {Enhver henvisning til opdeling af dosis til indikationer, der kræver behandling én gang ugentligt, skal fjernes fra indlægssedlen.}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 7.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 7.
English: OTHER SPECIAL WARNING(S), IF NECESSARY {For oral formulations, a warning e.g. in red should be implemented on the immediate packaging.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER {For orale formuleringer skal der implementeres en advarsel f.eks. med rødt på den indre emballage.
English: OTHER SPECIAL WARNING(S), IF NECESSARY {For parenteral formulations, a warning e.g. in red should be implemented once in a prominent place on the intermediate packaging.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER {For parenterale formuleringer skal der implementeres en advarsel f.eks. med rødt på et fremtrædende sted på den intermediære emballage.
English: • Oral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week: {The following wording should be included on the outer packaging}
Danish: • Orale formuleringer af methotrexat-holdige lægemidler kun med indikationer, der kræver behandling én gang ugentligt: {Følgende ordlyd skal fremstå på den ydre emballage}
English: • Parenteral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week and oncologic indication:
Danish: • Parenterale formuleringer af methotrexat-holdige lægemidler med mindst én indikation, der kræver behandling én gang ugentligt og onkologisk indikation:
English: The warning should read as follows:}
Danish: {Der skal inkluderes en advarselsboks i dette afsnit som følger:}
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 7.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 7.
English: • All oral formulations of methotrexate-containing medicinal products with at least one indication requiring once weekly dosing: {The following wording should be reflected:}
Danish: • Alle orale formuleringer af methotrexat-holdige lægemidler med mindst en indikation, der kræver dosering én gang ugentligt: {Følgende ordlyd skal afspejles:}
English: For [indication*] take/use [depending on formulation] only once a week *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Danish: Mod [indikation*] tages/anvendes [afhængig af formulering] kun én gang ugentligt *[Indikation] skal indsættes af indehaverne af markedsføringstilladelserne i grupperede termer, f.eks. colitis, artritis, psoriasis, hvor det er relevant.
English: • Parenteral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week:
Danish: • Parenterale formuleringer af methotrexat-holdige lægemidler udelukkende med indikationer, der kræver behandling én gang ugentligt:
English: OTHER SPECIAL WARNING(S), IF NECESSARY A framed warning should be placed at the front of the outer package in a clearly visible place, e.g. after the information on the name and the active substance; the letters should be of appropriate size; the respective wording and frame should be in red colour on a white background, but ensuring that it contrasts with the rest of the packaging.
Danish: Den respektive ordlyd og ramme skal fremstå i rødt på en hvid baggrund, men det skal sikres, at advarslen står i kontrast til resten af emballagen.
English: • All methotrexate-containing products only with indications requiring treatment once a week: {The warning should read as follows:}
Danish: • Alle methotrexat-holdige lægemidler udelukkende med indikationer, der kræver behandling én gang ugentligt: {Advarslen skal fremstå som følger}:
English: For [indication*] use only once a week *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Danish: Mod [indikation*] - må kun anvendes én gang ugentligt *[Indikation] skal indsættes af indehaverne af markedsføringstilladelserne i grupperede termer, f.eks. colitis, artritis, psoriasis, hvor det er relevant.
English: • Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week:
Danish: • Orale formuleringer af methotrexat-holdige lægemidler med mindst én indikation, der kræver behandling én gang ugentligt:
English: • All methotrexate-containing products with at least one indication requiring treatment once a week: {The warning should read as follows:}
Danish: • Alle methotrexat-holdige lægemidler med mindst én indikation, der kræver behandling én gang ugentligt: {Advarslen skal fremstå som følger}:
English: • All methotrexate-containing medicinal products with at least one indication requiring once weekly dosing: {This section should be amended as follows (new text underlined, deleted text strikethrough):} Only physicians with experience in the various properties of the medicinal product and its mode of action should prescribe methotrexate.
Danish: • Alle methotrexat-holdige lægemidler med mindst en indikation, der kræver dosering én gang ugentligt: {Dette punkt skal ændres som følger (ny tekst, der skal tilføjes i produktinformationen, er understreget.
English: • All parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease) {This section should include the following wording:} Important warning about the dosage of <product name> (methotrexate) In the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis, etc.)>, <product name> (methotrexate) must only be used once a week.
Danish: Vigtig advarsel om dosering af <Særnavn> (methotrexat) Ved behandlingen af <indikation(er), der kræver dosering én gang ugentligt, f.eks. rheumatoid arthritis, psoriasis, etc.)>, må <Særnavn> (methotrexat) kun bruges én gang ugentligt.
English: • Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week: {This section should include the following wording:} THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS WHO USE A METHOTREXATECONTAINING MEDICINE FOR <INDICATIONS INSERTED BY THE MAHS IN GROUPED TERMS, E.G. COLITIS, ARTHRITIS, PSORIASIS, AS PER INDICATIONS LISTED IN PACKAGE LEAFLET>.
Danish: DETTE PATIENTKORT ER KUN TIL PATIENTER, DER BRUGER ET METHOTREXAT-HOLDIGT LÆGEMIDDEL MOD <INDIKATIONER INDSÆTTES AF INDEHAVERNE AF MARKEDSFØRINGSTILLADELSERNE I GRUPPEREDE TERMER, F. EKS: TYKTARMSBETÆNDELSE (COLITIS), GIGT (ARTRITIS), PSORIASIS, IFØLGE INDIKATION SOM ANFØRT I INDLÆGSSEDDEL>.
English: Take only once a week on …………………………………………………….. (include weekday of intake in full) *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Danish: Må kun tages én gang ugentligt hver …………………………………………………….. (skriv tydeligt hvilken ugedag lægemidlet skal tages) *[Indikation] skal indsættes af indehaverne af markedsføringstilladelserne i grupperede termer, f.eks. colitis, artritis, psoriasis, hvor det er relevant.
English: • All methotrexate-containing medicinal products with at least one indication requiring once weekly dosing:
Danish: • Alle methotrexat-holdige lægemidler med mindst en indikation, der kræver dosering én gang
English: Use only once a week on …………………………………………………………….. (include weekday of use in full)
Danish: Må kun anvendes én gang ugentligt hver …………………………………………………………….. (skriv tydeligt hvilken ugedag lægemidlet skal tages)
English: Section 3: How to use <product name> {A boxed warning should be included in this section as follows:} Important warning about the dose of <product name> (methotrexate): Use <product name> only once a week for the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis etc.>.
Danish: <Særnavn> må kun bruges én gang om ugen til behandling af <indikation(er), som kræver dosering én gang ugentligt, f. eks. leddegigt, psoriasis osv.> [Brug] af for meget af <Særnavn> (methotrexat) kan have dødeligt udfald.
English: • methotrexate-containing products with at least one indication requiring treatment once a week:
Danish: • Methotrexat-holdige lægemidler med mindst én indikation, der kræver behandling én gang