FrancophonIA/ELRC3.0 huggingface dataset:
English: Due date neurologic or psychiatric symptoms as well as in paediatric patients, the MAH should conduct and submit the results of an open label, prospective study to investigate the clinical course of hepatic, neurological and psychiatric disease from the time of initiation of treatment with trientine dihydrochloride up to 24 months of therapy.
Danish: PAES: For yderligere at karakterisere virkningen af trientindihydrochlorid i behandlingen af Wilsons sygdom hos patienter med overvejende lever-, neurologiske eller psykiatriske symptomer samt hos pædiatriske patienter skal indehaveren af markedsføringstilladelsen gennemføre og indsende resultaterne af et ublindet, prospektivt studie, der undersøger det kliniske forløb af lever-, neurologisk og psykiatrisk sygdom fra tidspunktet for iværksættelse af behandling med trientindihydrochlorid op til 24 måneders behandling.
English: In cases up to 20 g of trientine base there were no apparent adverse effects reported.
Danish: Der blev ikke rapporteret tydelige bivirkninger i tilfælde med op til 20 g trientin base.
English: Cufence 200 mg hard capsules
Danish: Cufence 200 mg hårde kapsler
English: Cufence 200 mg hard capsules trientine
Danish: Cufence 200 mg hårde kapsler trientin
English: There is no evidence that calcium and magnesium antacids alter the efficacy of trientine but it is recommended to separate their administration (see section 4.5).
Danish: Der er ingen evidens for, at calcium- og magnesiumantacida ændrer trientins virkning, men de bør gives på forskellige tidspunkter (se pkt.
English: Use within 3 months after first opening the bottle.
Danish: Anvendes senest 3 måneder efter anbrud.
English: The dose should be adjusted according to clinical response; 400 - 1,000 mg have been used at initiation of therapy.
Danish: 400-1.000 mg har været anvendt ved behandlingens start (se pkt.
English: How to take Cufence
Danish: Sådan skal du tage Cufence
English: If you become pregnant whilst taking Cufence, talk to your doctor.
Danish: Tal med lægen, hvis du bliver gravid, mens du tager Cufence.
English: All effects were reversible with the exception of the lung findings; however the dose levels where these effects were observed are far in excess of those used clinically.
Danish: De dosisniveauer, hvor disse virkninger blev observeret, er dog langt højere end de klinisk anvendte doser.
English: Uncommon: Anaemia Uncommon: Aplastic anaemia Uncommon: Sideroblastic anaemia
Danish: Ikke almindelig: Anæmi Ikke almindelig: Aplastisk anæmi
English: Cufence is indicated for the treatment of Wilson's disease in patients intolerant to D-Penicillamine therapy, in adults, adolescents and children aged 5 years or older.
Danish: Cufence er indiceret til behandling af Wilsons sygdom hos voksne, unge og børn i alderen 5 år og derover, som ikke tåler behandling med D-penicillamin.
English: Unabsorbed trientine is bound to intestinal copper and eliminated through faecal excretion.
Danish: Uabsorberet trientin bindes til intestinalt kobber og udskilles gennem fæces.
English: < 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: (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Capsule shell:
Danish: Kapslens skal:
English: Therefore, the recommended dose in patients with renal impairment is the same as for adults.
Danish: Den anbefalede dosis til patienter med nedsat leverfunktion er derfor den samme som til voksne.
English: Patients primarily presenting hepatic symptoms The recommended dose in patients primarily presenting hepatic symptoms is the same as the recommended adult dose.
Danish: Den anbefalede dosis til patienter primært med leversymptomer er den samme som den anbefalede dosis til voksne.
English: Other medicines and Cufence
Danish: Brug af anden medicin sammen med Cufence
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det eller de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: What Cufence looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: If you take more Cufence than you should
Danish: Hvis du har taget for meget Cufence
English: Date of first authorisation: 29 March 2017
Danish: Dato for første markedsføringstilladelse: 29. marts 2017
English: From the date of notification of the Commission Decision*
Danish: Fra datoen for kundgørelse af Kommissionens afgørelse*
English: Unopened bottle 15 months.
Danish: Uåbnet flaske 15 måneder
English: *Referral EMEA/H/A-31/1463
Danish: * Indbringelsesprocedure EMEA/H/A-31/1463
English: It may cause allergic reactions (possibly delayed).
Danish: Det kan udløse allergiske reaktioner (eventuelt forsinkede).
English: The doctor will decide whether any treatment is needed.
Danish: Lægen vil afgøre, om behandling er nødvendig.
English: Children, adolescents and elderly
Danish: Børn, unge og ældre
English: % of dose to be administered
Danish: % af dosis, som skal administreres
English: Opportunistic infections (sometimes fatal)
Danish: Opportunistiske infektioner (undertiden dødelige)
English: However, a risk cannot be completely excluded and there is no information regarding higher methotrexate doses.
Danish: En risiko kan dog ikke udelukkes helt og der findes ingen oplysninger om højere methotrexatdoser.
English: (See renal function monitoring)
Danish: (Se monitorering af nyrefunktionen)
English: Never change the dose on your own.
Danish: Du må aldrig selv ændre dosis.
English: Do not use Jylamvo if you are trying to become pregnant.
Danish: Brug ikke Jylamvo, hvis du prøver på at blive gravid.
English: After the desired treatment outcome is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Danish: Når det ønskede behandlingsresultat er opnået, bør dosis gradvis nedsættes til den lavest mulige effektive vedligeholdelsesdosis.
English: • Alcohol abuse
Danish: • Alkoholmisbrug
English: Jylamvo must not be administered.
Danish: Jylamvo må ikke administreres.
English: Therefore you must ensure that you are taking effective contraception for the whole of this period (see also section "Warnings and precautions").
Danish: Du skal derfor bruge effektiv prævention i hele denne periode (se også punktet "Advarsler og forsigtighedsregler").
English: Most adverse reactions are reversible if they are detected early.
Danish: De fleste bivirkninger er reversible, hvis de opdages tidligt.
English: Vitamin products
Danish: Vitaminprodukter
English: During treatment
Danish: Under behandlingen
English: It is not known if methotrexate is present in semen.
Danish: Det vides ikke, om methotrexat er til stede i sæd.
English: You must talk to a doctor if you do not feel better or if you feel worse
Danish: Kontakt lægen, hvis du ikke får det bedre, eller hvis du får det værre.
English: Other tests may possibly be performed before and after treatment.
Danish: Der kan blive taget andre prøver før og efter behandlingen.
English: For the oncology indication recommendations in published protocols should also apply.
Danish: For den onkologiske indikation bør man desuden følge anbefalingerne i publicerede protokoller.
English: Never take a double dose to make up for a forgotten dose but continue with the prescribed dose.
Danish: Tag aldrig en dobbeltdosis som erstatning for den glemte dosis, men fortsæt med den ordinerede dosis.
English: Before the beginning of treatment
Danish: Før behandlingen påbegyndes
English: • A statement about the responsibility of the prescribing physician to determine which patients may be suitable for home or self-administration of Jylamvo.
Danish: • en redegørelse vedrørende den ordinerende læges ansvar for at afgøre, hvilke patienter der kan være egnede til hjemme- eller selvadministration af Jylamvo.
English: Teratogenicity - Reproductive risk
Danish: Teratogenicitet - Reproduktiv risiko
English: Jylamvo is for use in the following indications:
Danish: Jylamvo er indiceret ved følgende indikationer:
English: Female patients of reproductive potential must be counselled regarding pregnancy prevention and planning.
Danish: Kvindelige patienter med reproduktivt potentiale skal rådgives om graviditetsforebyggelse og planlægning.
English: Mutagenic and carcinogenic potential
Danish: Mutagent og karcinogent potentiale
English: Peak serum concentrations are attained within 1-2 hours.
Danish: Maksimal serumkoncentration nås inden for 1‐2 timer.
English: Ensure that the patient is sitting up or standing before giving the medicine.
Danish: Patienten skal sidde eller stå, før medicinen gives.
English: The tests below must be conducted weekly in the first two weeks, then every two weeks for a month; thereafter, depending on the leucocyte count and the stability of the patient, at least once a month during the next six months and then at least every three months.
Danish: Nedenstående undersøgelser skal udføres ugentligt de første to uger, derefter hver anden uge i en måned; derefter - afhængigt af leukocyttal og stabiliteten af patientens tilstand - mindst én gang om måneden de næste seks måneder, og derefter mindst hver tredje måned.
English: Such abnormalities should return to normal within two weeks, after which, treatment may be resumed at the discretion of the doctor.
Danish: Sådanne abnormiteter bør normaliseres inden for to uger, hvorefter behandlingen kan genoptages efter lægens skøn.
English: There is a suspected mutagenic effect in humans.
Danish: Der er mistanke om en mutagen virkning hos mennesker.
English: Contains E214 and E219.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder E214 og E219.
English: • Severe, acute or chronic infections such as tuberculosis and HIV
Danish: • Svære, akutte eller kroniske infektioner, såsom tuberkulose og HIV
English: 1 can be reversible - see 4.4
Danish: 1 kan være reversibelt ‐ se pkt.
English: If, one week later, appropriate laboratory tests are normal, treatment may be initiated.
Danish: Hvis relevante laboratorieprøver er normale en uge senere, kan behandling initieres.
English: Response to treatment can be expected after approximately 4-8 weeks.
Danish: Respons på behandlingen kan forventes efter ca. 4‐8 uger.
English: You will possibly also have an X-ray of your chest.
Danish: Du vil muligvis også få taget et røntgenbillede af brystkassen.
English: The following side effects have also been reported:
Danish: Derudover er følgende bivirkninger rapporteret:
English: Teratogenic effects have been observed in four species (rats, mice, rabbits, cats).
Danish: Der er set teratogene virkninger hos fire arter (rotter, mus, kaniner og katte).
English: Medical staff and patients must be clearly instructed.
Danish: Der skal gives klare anvisninger til sundhedspersonale og patienter.
English: The patient card shall contain the following key elements:
Danish: Patientkortet skal indeholde følgende nøgleelementer:
English: Such side effects cannot be excluded when methotrexate is used to treat other diseases.
Danish: Disse bivirkninger kan ikke udelukkes, når methotrexat anvendes til at behandle andre sygdomme.
English: Anyone handling methotrexate should wash their hands before and after administering a dose.
Danish: Alle, der håndterer methotrexat, bør vaske hænder før og efter administration af en dosis.
English: This can result in an increased risk of adverse reactions, although in several studies this was only observed in individual patients.
Danish: Dette kan øge risikoen for bivirkninger, men dette er dog kun set hos enkelte patienter i mange studier.
English: Methotrexate is approximately 50% bound to serum proteins.
Danish: Methotrexat er ca. 50 % bundet til serumproteiner.
English: In this case, treatment with methotrexate must be discontinued until the symptoms have disappeared.
Danish: I så fald skal behandlingen med methotrexat afbrydes, indtil symptomerne er forsvundet.
English: Prior to launch of Jylamvo in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før markedsføring af Jylamvo i de enkelte medlemsstater skal indehaveren af markedsføringstilladelsen aftale indhold og form af informationsmaterialet, herunder kommunikationsmedier, distribution og alle øvrige aspekter af programmet, med den relevante nationale myndighed.
English: • Concurrent vaccination with live vaccines
Danish: • Samtidig vaccination med levende vacciner
English: For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial.
Danish: For psoriasispatienter er nødvendigheden af en leverbiopsi før og under behandling kontroversiel.
English: Tabulated list of adverse reactions Frequencies in the table are defined according to the MedDRA convention:
Danish: Tabel over bivirkninger Hyppighederne i tabellen er angivet i henhold til MedDRA-konventionen:
English: This medicine is not recommended in children under 3 years of age as there is insufficient experience in this age group
Danish: Dette lægemiddel frarådes til børn under 3 år, da der ikke er tilstrækkelig erfaring hos denne aldersgruppe.
English: How to take the medicine
Danish: Hvordan lægemidlet skal tages
English: Patients with JIA should always be referred to a rheumatology unit specialising in the treatment of children/adolescents.
Danish: Patienter med JIA bør altid henvises til en reumatologisk afdeling, der er specialiseret i behandling af børn/unge.
English: These effects appear to be reversible after discontinuation of therapy in most cases.
Danish: Disse virkninger synes at være reversible efter seponering af behandlingen i de fleste tilfælde.
English: Do not interrupt or stop the treatment with Jylamvo without first discussing this with your doctor.
Danish: Du må ikke afbryde eller stoppe behandlingen med Jylamvo uden først at have talt med lægen.
English: • Inform on serious adverse effects that may be fatal and on the symptoms of overdose and steps to be taken should symptoms arise to enable the patient to seek medical help in time
Danish: • oplyse om alvorlige bivirkninger, der kan være dødelige og om symptomer på overdosering og skridt, der skal tages, hvis der skulle opstå symptomer, for derved at gøre det muligt for patienten at søge rettidig lægehjælp
English: The mean terminal half-life is 6-7 hours and demonstrates considerable variations (3-17 hours).
Danish: Den gennemsnitlige terminale halveringstid er 6‐7 timer, dog med betydelig variation (3‐17 timer).
English: There is a pronounced enterohepatic circulation.
Danish: Der er udtalt enterohepatisk cirkulation.
English: In rhesus monkeys, no malformations comparable to those seen in humans occurred.
Danish: Hos rhesusaber forekom ikke misdannelser, som er sammenlignelige med dem, der ses hos mennesker.
English: Caution: This medicine can affect your capacity to react and your ability to drive.
Danish: Bemærk: Dette lægemiddel kan påvirke din reaktionsevne og evne til at føre motorkøretøj.
English: Keep to the dose exactly and follow your doctor's instructions exactly on when to take the medicine.
Danish: Overhold dosen nøjagtigt, og følg nøje lægens anvisninger for, hvornår du skal tage lægemidlet.
English: This event may also be associated with vasculitis and other comorbidities.
Danish: Denne bivirkning kan også være forbundet med vaskulitis og andre komorbiditeter.
English: Response to treatment can generally be expected after approximately 4-8 weeks.
Danish: Respons på behandlingen kan sædvanligvis forventes efter ca. 4‐8 uger.
English: Patients with rheumatological or dermatological diseases must be informed unequivocally that treatment is to be taken just once a week and not daily.
Danish: Patienter med reumatologiske eller dermatologiske sygdomme skal informeres grundigt om, at behandlingen kun skal tages én gang om ugen og ikke dagligt.
English: If you want to become pregnant, you should speak with your doctor, who may refer you for specialist advice before the planned start of treatment.
Danish: Hvis du ønsker at blive gravid, skal du tale med lægen, som vil henvise dig til specialistrådgivning før behandlingens planlagte påbegyndelse.
English: For contraception advice for men see section 4.6.
Danish: For rådgivning om prævention til mænd se punkt 4.6.
English: If you become pregnant during treatment or suspect you might be pregnant, speak to your doctor as soon as possible.
Danish: Hvis du bliver gravid under behandlingen eller mistænker, at du måske er gravid, skal du tale med lægen hurtigst muligt.
English: Your doctor must carry out investigations and laboratory tests in order to detect these effects as early as possible.
Danish: Lægen skal udføre undersøgelser og laboratorieprøver for, at sådanne bivirkninger kan opdages så tidligt som muligt.
English: In psoriasis, cell proliferation of the epithelium is markedly increased compared with normal skin.
Danish: Ved psoriasis er celleproliferation i epitel markant øget i forhold til normal hud.
English: Because of the possibility of severe or even fatal toxic reactions, patients should be extensively informed by the treating doctor of the risks involved (including early signs and symptoms of toxicity) and the recommended safety measures.
Danish: På grund af risikoen for svære eller endog dødelige toksiske reaktioner skal lægen informere patienterne grundigt om de mulige risici (herunder tidlige symptomer på toksicitet) og de anbefalede sikkerhedsforanstaltninger.
English: • The need to inform patients and relatives/carers about the once weekly dosing;
Danish: • behovet for at oplyse patienter og pårørende/omsorgspersoner om doseringen én gang ugentligt
English: • Guide for healthcare professionals
Danish: • vejledning til sundhedspersoner
English: • Reminder that patients who use methotrexate for an indication requiring a weekly dosing schedule to take the product only once weekly and to write the day of the week for intake on the card
Danish: • påmindelse om, at patienter, der bruger methotrexat til en sygdomstilstand, som kræver en ugentlig doseringsplan, kun skal tage produktet én gang ugentligt og skrive ugedagen for indtagelse på kortet
English: The duration of the treatment is determined by the treating physician.
Danish: Behandlingsvarigheden fastlægges af den behandlende læge.
English: Particular caution is also required in the presence of inactive chronic infections (e.g. herpes zoster, tuberculosis, hepatitis B or C) as it is possible that activation of these infections may occur.
Danish: Særlig forsigtighed er desuden påkrævet ved inaktive kroniske infektioner (f.eks. herpes zoster, tuberkulose, hepatitis B eller C), da disse infektioner muligvis kan blive aktiveret.
English: In non-oncologic indications, the absence of pregnancy must be confirmed before Jylamvo is used.
Danish: I ikke-onkologiske indikationer skal fraværet af graviditet bekræftes, før Jylamvo anvendes.
English: After distribution, it collects predominantly in the liver, kidneys and spleen in the form of polyglutamates, which can be retained for weeks or months.
Danish: Efter fordeling findes det primært i lever, nyrer og milt som polyglutamater, der kan tilbageholdes i uger eller måneder.
English: This should also be considered during simultaneous administration of haematotoxic medicinal products.
Danish: Dette bør ligeledes overvejes ved samtidig administration af hæmatotoksiske lægemidler.
English: An overdose of methotrexate can cause serious reactions.
Danish: En overdosis af methotrexat kan medføre alvorlige reaktioner.
English: Higher dosages should be given parenterally.
Danish: Højere doser bør gives parenteralt.
English: Use in children under 3 years of age is not recommended as insufficient data on efficacy and safety are available for this patient group
Danish: Anvendelse hos børn under 3 år frarådes, da der ikke foreligger tilstrækkelige data om virkning og sikkerhed hos denne patientgruppe.
English: If Jylamvo comes into contact with skin, eyes or nose, you should wash the affected area with water and soap.
Danish: Hvis Jylamvo kommer i kontakt med huden, øjnene eller næsen, skal det pågældende område vaskes med vand og sæbe.
English: The medicinal product can be taken with or without food.
Danish: Lægemidlet kan indtages sammen med eller uden føde.
English: 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)
Danish: Ikke almindelig (≥1/1 000 til < 1/100) Sjælden (≥1/10 000 til <1/1 000) Meget sjælden (<1/10 000)
English: If serum creatinine levels are increased, the dose should be reduced.
Danish: Hvis serumkreatinin er forhøjet, bør dosis nedsættes.
English: In each individual case the benefit of treatment must be weighed up against the possible risk to the foetus.
Danish: Fordelene ved behandling skal i hvert enkelt tilfælde opvejes mod den mulige risiko for fostret.
English: • Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over
Danish: • Vedligeholdelsesbehandling af akut lymfoblastær leukæmi (ALL) hos voksne, unge og børn på 3 år og derover.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (herunder cyster og polypper)
English: Ask your doctor for advice.
Danish: Spørg lægen.
English: Depending on the individual activity of the disease and tolerability by the patient, the dose may be increased gradually by 2.5 mg (1.25 ml) per week.
Danish: Alt efter sygdommens aktivitet hos den enkelte patient og patientens tolerance kan dosis gradvis øges med 2,5 mg (1,25 ml) om ugen.
English: • Information on treatment with Jylamvo, administration and posology.
Danish: • oplysninger om behandling med Jylamvo, administration og dosering.
English: • Active rheumatoid arthritis in adult patients.
Danish: • Aktiv reumatoid artritis hos voksne.
English: Further research is needed to establish whether serial liver function tests or determinations of propeptide of type III collagen are appropriate for detecting hepatotoxicity.
Danish: Yderligere forskning er nødvendig for at fastlægge, om serielle leverfunktionsprøver eller bestemmelser af type III-kollagen-propeptid er egnet til at påvise hepatotoksicitet.
English: In some cases the ability to drive or use machines may be affected.
Danish: Undertiden kan evnen til at føre motorkøretøj eller betjene maskiner være påvirket.
English: The doctor may increase the dose if the used dose is not effective but tolerated well.
Danish: Lægen kan øge dosis, hvis du tåler den anvendte dosis, men den ikke er effektiv.
English: Interstitial alveolitis/ pneumonia (can be fatal)
Danish: Interstitiel alveolitis/pneumoni (kan være dødelig)
English: • Detailed description regarding strength of the solution and the dose volumes to help clarify the appropriate dose of the oral solution.
Danish: • detaljeret beskrivelse vedrørende styrken af opløsningen og dosisvolumener til præcisering af den korrekte dosis oral opløsning
English: Methotrexate can cause serious (sometimes life-threatening) side effects.
Danish: Methotrexat kan medføre alvorlige (undertiden livstruende) bivirkninger.
English: The half-life may be prolonged up to four-fold in patients with a third distribution compartment (pleural effusion, ascites).
Danish: Halveringstiden kan være op til firedoblet hos patienter med et tredje fordelingsrum (pleura-effusion, ascites).
English: Approximately 5-20% of methotrexate and 1-5% of 7-hydroxymethotrexate is eliminated in the bile.
Danish: Ca. 5‐20 % af methotrexat og 1‐5% af 7‐hydroxymethotrexat udskilles i galden.
English: This means that the medicine can cause genetic mutations.
Danish: Det vil sige, at lægemidlet kan forårsage mutationer i generne.