FrancophonIA/ELRC3.0 huggingface dataset:
English: • 7 tablets (7 blisters each with 1 tablet)
Danish: • 7 tabletter (7 blisterkort hver med 1 tablet)
English: Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased venetoclax Cmax by 2.3-fold and AUC∞ by 6.4-fold.
Danish: Samtidig administration af ketoconazol, en potent CYP3A-, P-gp- og BCRP-hæmmer, 400 mg én gang dagligt i 7 dage hos 11 tidligere behandlede patienter med NHL øgede venetoclax-Cmax 2,3 gange og -AUC∞ 6,4 gange.
English: • urinary tract infection
Danish: • urinvejsinfektion/blærebetændelse
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (5-dages pakning)
English: Post-titration dose for venetoclax monotherapy
Danish: Venetoclax-dosis i monoterapi efter titrering
English: TTR, months, median (range)
Danish: Median TTR, måneder
English: The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Danish: Venclyxto 10 mg-tabletter De filmovertrukne tabletter leveres i æsker med 10 eller 14 tabletter (i blistre med 2 tabletter).
English: 17p deletion and/or TP53 mutation status ORR, % (95% CI)
Danish: Status for 17p-deletion og/eller TP53-mutation
English: OS, % (95% CI)
Danish: OS % (95% KI)
English: Concomitant use of venetoclax with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase and for other toxicities (see section 4.5).
Danish: Dosisændring i forbindelse med brug af CYP3A-hæmmere Samtidig brug af venetoclax og potente eller moderate CYP3A-hæmmere øger venetoclax-eksponeringen og kan øge risikoen for tumorlysesyndrom ved behandlingsstart og i dosistitreringsfasen og for anden toksicitet (se pkt.
English: Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other.
Danish: Bleggul, aflang og bikonveks tablet, 17,2 mm lang og 9,5 mm bred, præget med V på den ene side og 100 på den anden.
English: What Venclyxto is and what it is used for What Venclyxto is
Danish: Virkning og anvendelse Hvad er Venclyxto?
English: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Danish: Beige, aflang og bikonveks tablet, 14 mm lang og 8 mm bred, præget med V på den ene side og 50 på den anden.
English: Urinary tract infection Upper respiratory tract infection
Danish: Urinvejsinfektion Infektioner i de øvre luftveje
English: Anti-hyperuricaemic agents
Danish: Midler mod hyperurikæmi
English: A larger dose reduction may occur at the discretion of the physician.
Danish: Lægen kan vurdere, at en større dosisreduktion er påkrævet.
English: България АбВи ЕООД
Danish: AbbVie UAB
English: Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Danish: Venclyxto 50 mg filmovertrukket tablet er beige, aflang, 14 mm lang, præget med V på den ene side og 50 på den anden.
English: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Danish: Venclyxto 50 mg-tabletter De filmovertrukne tabletter leveres i æsker med 5 eller 7 tabletter (i blistre med 1 tablet).
English: • the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
Danish: • dosis øges til 50 mg (én 50 mg-tablet) én gang dagligt i 7 dage.
English: If a moderate CYP3A inhibitor must be used, the initiation dose of venetoclax and the doses for the titration phase (see section 4.2) should be reduced by at least 50%.
Danish: Hvis det er nødvendigt at anvende en moderat CYP3A-hæmmer, skal startdosis af venetoclax og doserne i titreringsfasen (se pkt.
English: Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Danish: Venclyxto 10 mg filmovertrukne tabletter Venclyxto 50 mg filmovertrukne tabletter Venclyxto 100 mg filmovertrukne tabletter
English: Venclyxto 100 mg film-coated tablets 3 years.
Danish: Venclyxto 100 mg filmovertrukne tabletter 3 år.
English: Low white blood cell count (neutropenia) (very common - may affect more than 1 in 10 people) Your doctor will check your blood count during treatment with Venclyxto.
Danish: Lavt antal hvide blodlegemer (neutropeni) (meget almindelig bivirkning - kan forekomme hos flere end 1 ud af 10 personer)
English: • fits or seizures
Danish: • kvalme eller opkastning
English: DOR, months, median (95% CI)
Danish: Median DOR, måneder (95 % KI)
English: - you are taking a herbal medicine called St. John's wort, used for depression.
Danish: - hvis du tager naturlægemidlet perikon mod depression.
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Du må ikke stoppe behandlingen med Venclyxto, medmindre lægen siger, du skal.
English: • 10 tablets (5 blisters each with 2 tablets)
Danish: • 10 tabletter (5 blisterkort hver med 2 tabletter)
English: Film-coated tablet 14 film-coated tablets
Danish: Filmovertrukne tabletter 14 filmovertrukne tabletter
English: • 14 tablets (7 blisters each with 2 tablets)
Danish: • 14 tabletter (7 blisterkort hver med 2 tabletter)
English: PFS, months, median (95% CI)
Danish: Median PFS, måneder (95 % KI)
English: If you have problems taking this medicine, talk to your doctor.
Danish: Kontakt lægen, hvis du har problemer med at tage dette lægemiddel.
English: Pneumonia Upper respiratory tract infection
Danish: Pneumoni Infektioner i de øvre luftveje
English: Concomitant use of venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities (see section 4.4).
Danish: Hvis samtidig brug af en P-gp- eller BCRP-hæmmer er nødvendig, skal patienterne monitoreres nøje for tegn på toksicitet (se pkt.
English: Film-coated tablet 7 film-coated tablets
Danish: Filmovertrukne tabletter 7 filmovertrukne tabletter
English: The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
Danish: Venetoclax sikkerhed og virkning blev vurderet i et åbent multicenterstudie med en enkelt gruppe (M13-982) hos 107 tidligere behandlede patienter med kronisk lymfatisk leukæmi med 17p-deletion.
English: Venclyxto 50 mg film-coated tablets 2 years.
Danish: Venclyxto 50 mg filmovertrukne tabletter 2 år.
English: Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase (see sections 4.2 and 4.5).
Danish: Samtidig brug af potente CYP3A-hæmmere ved behandlingsstart og i dosistitreringsfasen (se pkt.
English: Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other.
Danish: Venclyxto 100 mg filmovertrukket tablet er bleggul, aflang, 17,2 mm lang, præget med V på den ene side og 100 på den anden.
English: Venclyxto 10 mg film-coated tablets 2 years.
Danish: Venclyxto 10 mg filmovertrukne tabletter 2 år.
English: The recommended dose of venetoclax in combination with rituximab is 400 mg once daily (see section 5.1 for details of the combination regimen).
Danish: Venetoclax-dosis i kombination med rituximab efter titrering Den anbefalede venetoclax-dosis i kombination med rituximab er 400 mg en gang dagligt (se pkt.
English: Venclyxto 100 mg tablets
Danish: Venclyxto 100 mg-tabletter
English: Film-coated tablet 10 film-coated tablets
Danish: Filmovertrukne tabletter 10 filmovertrukne tabletter
English: • the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
Danish: • dosis øges til 400 mg (fire 100 mg-tabletter) én gang dagligt i 7 dage.
English: How to take Venclyxto
Danish: Sådan skal du tage Venclyxto
English: Each film-coated tablet contains 50 mg venetoclax
Danish: Hver filmovertrukket tablet indeholder 50 mg venetoclax.
English: Each film-coated tablet contains 10 mg venetoclax
Danish: Hver filmovertrukket tablet indeholder 10 mg venetoclax.
English: Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Danish: Venclyxto 10 mg filmovertrukket tablet er bleggul, rund, 6 mm i diameter, præget med V på den ene side og 10 på den anden.
English: Each film-coated tablet contains 100 mg venetoclax
Danish: Hver filmovertrukket tablet indeholder 100 mg venetoclax.
English: Film-coated tablet 5 film-coated tablets
Danish: Filmovertrukne tabletter 5 filmovertrukne tabletter
English: - you are taking any of the medicines listed below when you start your treatment and while your dose is gradually being increased (usually over 5 weeks).
Danish: - hvis du tager et eller flere af de lægemidler, der er anført nedenfor, når du starter behandlingen, og mens din dosis gradvist øges (normalt en periode på 5 uger), da der kan opstå alvorlige og livstruende bivirkninger, hvis Venclyxto tages sammen med disse lægemidler:
English: How Venclyxto works
Danish: Hvordan virker Venclyxto?
English: Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
Danish: Filmovertræk Gul jernoxid (E172) Polyvinylalkohol (E1203) Titandioxid (E171) Macrogol 3350 (E1521) Talcum (E553b)
English: • the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
Danish: • dosis øges til 200 mg (to 100 mg-tabletter) én gang dagligt i 7 dage.
English: Venclyxto 10 mg film-coated tablet Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other.
Danish: Venclyxto 10 mg filmovertrukket tablet Bleggul, rund og bikonveks tablet, 6 mm i diameter, præget med V på den ene side og 10 på den anden.
English: In the MURANO study, neutropenia was reported in 61% (all grades) of patients on the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia.
Danish: I MURANO-studiet, blev neutropeni rapporteret hos 61% (alle grader) af patienterne i venetoclax + rituximab-armen.
English: Venclyxto 50 mg tablets venetoclax
Danish: Venclyxto 50 mg tabletter venetoclax
English: Gastrointestinal disorders
Danish: Galdesyre-kompleksdannere
English: AbbVie UAB Tel: +370 5 205 3023
Danish: Tel: +370 5 205 3023
English: Venclyxto 100 mg tablets venetoclax
Danish: Venclyxto 100 mg tabletter venetoclax
English: Venclyxto 10 mg tablets venetoclax
Danish: Venclyxto 10 mg tabletter venetoclax
English: • the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
Danish: • dosis øges til 100 mg (én 100 mg-tablet) én gang dagligt i 7 dage.
English: Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5).
Danish: Patienterne skal monitoreres meget nøje for tegn på toksicitet (se pkt.
English: Venclyxto 100 mg film-coated tablets:
Danish: Venclyxto 100 mg filmovertrukne tabletter:
English: • higher level of potassium
Danish: • forhøjet kalium
English: • Venclyxto 50 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)
Danish: • Venclyxto 50 mg filmovertrukne tabletter: gul jernoxid (E172), rød jernoxid (E172), sort jernoxid (E172), polyvinylalkohol (E1203), titandioxid (E171), macrogol 3350 (E1521), talcum (E553b)
English: Venclyxto 50 mg film-coated tablets:
Danish: Venclyxto 50 mg filmovertrukne tabletter:
English: Venclyxto 10 mg film-coated tablets
Danish: Venclyxto 10 mg filmovertrukne tabletter
English: Venclyxto 10 mg film-coated tablets:
Danish: Venclyxto 10 mg filmovertrukne tabletter:
English: Venclyxto 100 mg film-coated tablet
Danish: Venclyxto 100 mg filmovertrukket tablet
English: • Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Danish: • Venclyxto 100 mg filmovertrukne tabletter: gul jernoxid (E172), polyvinylalkohol (E1203), titandioxid (E171), macrogol 3350 (E1521), talcum (E553b).
English: Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax.
Danish: Venclyxto 50 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 50 mg venetoclax.
English: At baseline, 46.6% of patients had one or more nodes ≥5 cm, and
Danish: Ved baseline havde 46,6% af patienterne en eller flere lymfeknuder ≥5 cm og 67,6% havde ALC ≥25 x 109/l.
English: Concomitant use of venetoclax with strong CYP3A inhibitors at initiation and during the dose-titration phase is contraindicated (see sections 4.3, 4.4, and 4.5).
Danish: Samtidig brug af venetoclax og potente CYP3A-hæmmere er kontraindiceret ved behandlingsstart og i dosistitreringsfasen (se pkt.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: • Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Danish: • Venclyxto 10 mg filmovertrukne tabletter: gul jernoxid (E172), polyvinylalkohol (E1203), titandioxid (E171), macrogol 3350 (E1521), talcum (E553b).
English: • Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax.
Danish: • Venclyxto 50 mg filmovertrukne tabletter: Hver filmovertrukket tablet indeholder 50 mg venetoclax.
English: Venclyxto 50 mg film-coated tablet
Danish: Venclyxto 50 mg filmovertrukket tablet
English: Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax.
Danish: Venclyxto 10 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 10 mg venetoclax.
English: • Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax.
Danish: • Venclyxto 10 mg filmovertrukne tabletter: Hver filmovertrukket tablet indeholder 10 mg venetoclax.
English: Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high absolute lymphocyte count [ALC ≥25 x 109/l]) are at greater risk of TLS when initiating venetoclax.
Danish: Patienter med stor tumorbyrde (f.eks. lymfeknuder med en diameter ≥ 5 cm eller et højt absolut lymfocyttal
English: • Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.
Danish: • Venclyxto 100 mg filmovertrukne tabletter: Hver filmovertrukket tablet indeholder 100 mg venetoclax.
English: Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax.
Danish: Venclyxto 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg venetoclax.
English: Concomitant use of preparations containing St. John's wort (see sections 4.4 and 4.5).
Danish: Samtidig anvendelse af præparater, der indeholder perikon (se pkt.
English: Venclyxto 100 mg film-coated tablets venetoclax
Danish: Venclyxto 100 mg filmovertrukne tabletter venetoclax
English: Venclyxto 10 mg film-coated tablets venetoclax
Danish: Venclyxto 10 mg filmovertrukne tabletter venetoclax
English: NR (16.4, NR)
Danish: 4.4 og 4.5).
English: Venclyxto 50 mg film-coated tablets
Danish: Venclyxto 50 mg filmovertrukne tabletter
English: Venclyxto 50 mg film-coated tablets venetoclax
Danish: Venclyxto 50 mg filmovertrukne tabletter venetoclax
English: Dose modifications for tumour lysis syndrome
Danish: Dosisændring ved tumorlysesyndrom
English: It is important to follow all of the instructions in the ‘how to take' section of the leaflet.
Danish: Det er vigtigt, at du følger anvisningerne i punktet "Sådan skal du tage Venclyxto".
English: • abdominal pain and distension
Danish: • mavesmerter og udspilet mave
English: Hazard ratio (95% CI)
Danish: Samlet overlevelsee Antal hændelser (%) Hazard-ratio (95% KI)
English: 50 mg 100 mg 200 mg 400 mg
Danish: 200 mg
English: 8 (8 x 1) vials
Danish: 8 (8 x 1) hætteglas
English: [The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required.
Danish: [Nedenstående formulering skal erstatte den tidligere formulering] Titrering på ugentligt basis anbefales, hvis højere doser er påkrævet.
English: Note: These amendments are to be incorporated to the valid summary of product characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure.
Danish: Bemærk: Disse ændringer skal indføres i det gældende produktresumé, etikettering og indlægsseddel og er de endelige versioner, der blev opnået under koordinationsgruppens procedure.
English: Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone.
Danish: Nogle patienter kan have gavn af højere doser op til maksimalt 60 mg/30 mg oxycodon.
English: The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
Danish: Den gennemsnitlige daglige dosis i det pivotale studie var 20 mg/10 mg oxycodonhydrochlorid/naloxonhydrochlorid.
English: Annex III Amendments to the summary of product characteristics
Danish: Bilag III Ændringer til produktresuméet
English: 4.2 Posology and method of administration
Danish: Dosering og indgivelsesmåde
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Danish: • Bioækvivalens med et EU-referencelægemiddel er blevet påvist på grundlag af relevante data i henhold til kravene i artikel 10 i direktiv 2001/83/EF (f.eks. en bioækvivalensundersøgelse udført med EU-referencelægemidlet).
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Danish: For at kunne ophæve suspenderingen af markedsføringstilladelserne i bilag IB skal de kompetente myndigheder sikre, at nedenstående betingelser er opfyldt af indehaveren af markedsføringstilladelsen
English: Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen/-tilladelserne
English: Date of first authorisation: 5 September 2017
Danish: Dato for første markedsføringstilladelse: 5. september 2017
English: No special requirements.
Danish: Ingen særlige krav.
English: 24 months.
Danish: 24 måneder
English: These measures will help protect the environment.
Danish: Dette vil medvirke til at skåne miljøet.
English: These findings were not reversible.
Danish: Disse forandringer var ikke reversible.
English: Not known (frequency cannot be estimated from available data)
Danish: Ikke kendt (hyppigheden kan ikke beregnes ud fra forhåndenværende data):
English: Your symptoms may initially get worse after starting the treatment.
Danish: Dine symptomer kan i begyndelsen blive værre efter påbegyndelse af behandlingen.
English: Polyvinyl alcohol.
Danish: Polyvinylalkohol.
English: Children ≥ 5 years
Danish: Børn ≥ 5 år
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000), meget sjælden (< 1/10 000) eller ikke kendt (kan ikke beregnes af forhåndenværende data).
English: Cuprior is for oral use.
Danish: Cuprior er til oral brug.
English: Not known: urticaria.
Danish: Ikke kendt: urticaria.
English: This medicine is for long-term use.
Danish: Dette lægemiddel er til langtidsbehandling.
English: Your doctor will tell you how many tablets you should take and how often in the day.
Danish: Lægen vil fortælle dig, hvor mange tabletter du skal tage og hvor ofte i løbet af dagen.
English: The pharmaceutical form is not suitable for administration to children < 5 years.
Danish: Lægemiddelformen er ikke egnet til administration til børn < 5 år.
English: Not known: duodenitis, colitis (including severe colitis).
Danish: Ikke kendt: duodenitis, colitis (herunder svær colitis).
English: EU/1/17/1199/001 72 film-coated tablets EU/1/17/1199/002 96 film-coated tablets
Danish: EU/1/17/1199/001 72 filmovertrukne tabletter EU/1/17/1199/002 96 filmovertrukne tabletter
English: Just take your next dose at its regularly scheduled time.
Danish: Tag blot næste dosis til den planlagte tid.
English: Titanium dioxyde (E171).
Danish: Titandioxid (E171).
English: Common: nausea.
Danish: Almindelig: kvalme.
English: However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.
Danish: Det har imidlertid ikke kunnet fastslås, om reaktionen skyldtes trientin eller den forudgående penicillamin-behandling.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan desuden indberette bivirkninger direkte gennem det nationale indberetningssystem, der er anført i Appendiks V. Ved at indberette bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not stop your treatment without the advice of your doctor even if you feel better because Wilson's disease is a life-long condition.
Danish: Stop ikke behandlingen, medmindre lægen har sagt, at du skal gøre det, også selv om du føler dig bedre, da Wilsons sygdom er en livsvarig sygdom.
English: The absorption of trientine following oral administration is low and variable in patients with Wilson disease.
Danish: Absorptionen af trientin efter oral administration er lav og varierende hos patienter med Wilsons sygdom.
English: Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
Danish: Behandlingen bør kun initieres af speciallæger med erfaring i behandling af Wilsons sygdom.
English: The following side effects have been reported:
Danish: Der er indberettet følgende bivirkninger:
English: This means that the small amounts of copper from food and drink build up to excessive levels and can lead to liver damage and problems in the nervous system.
Danish: Det medfører, at små mængder kobber fra mad og drikke ophobes i for store mængder og kan forårsage leverskade og problemer i nervesystemet.
English: You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Danish: Du og din læge skal gennemdrøfte de mulige fordele ved behandlingen og tage alle mulige risici i betragtning.
English: The dose that you will take is usually lower than for an adult and depends on your age and body weight.
Danish: Den dosis, du skal have, er sædvanligvis lavere end til en voksen og afhænger af din alder og din legemsvægt.
English: Glycerol monocaprylocaprate (Type I).
Danish: Glycerol monocaprylocaprat (Type I).
English: In particular, you must tell your doctor if you are already taking iron supplements or if you take indigestion remedies (medicines that reduce discomfort after eating).
Danish: Navnlig skal du fortælle lægen, om du allerede får jerntilskud eller får lægemidler mod fordøjelsesbesvær (lægemidler, der mindsker ubehaget efter måltider).
English: EU/1/17/1199/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/17/1199/001
English: No dose adjustment is required in elderly patients.
Danish: Der behøves ingen dosisjustering hos ældre patienter.
English: Cuprior should only be used in pregnancy after careful consideration of the benefits compared with the risks of treatment in the individual patient.
Danish: Cuprior bør kun anvendes ved graviditet efter nøje vurdering af behandlingens fordele i forhold til risiciene hos den enkelte patient.