FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism behind these events is not known (see sections 4.3, 4.4 and 4.5 of the telbivudine SPC).
Danish: Mekanismen bag disse hændelser er ikke kendt (se punkterne 4.3, 4.4 og 4.5 i produktresumeet for telbivudin).
English: Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Danish: Pure red cell aplasia, en tilstand, hvor kroppen er ophørt med eller har nedsat produktion af røde blodlegemer, er blevet rapporteret.
English: Patients with advanced disease may require a daily dose of 5 million IU.
Danish: Patienter med fremskreden sygdom kan have behov for en daglig dosis på 5 millioner IE.
English: Your doctor has prescribed IntronA specifically for you and your current condition; do not share this medicine with anyone else.
Danish: Din læge har ordineret IntronA specielt til dig og din nuværende tilstand; del ikke denne medicin med andre.
English: • Genotype 1: The recommended duration of treatment is one year.
Danish: • Genotype 1: Den anbefalede behandlingsvarighed er et år.
English: Growth and development (children and adolescents):
Danish: Vækst og udvikling (børn og teenagere):
English: The treatment is to be temporarily discontinued during and after surgery.
Danish: Behandlingen bør afbrydes midlertidigt under og efter kirurgi.
English: 6 IU/kg/day for 3 months.
Danish: 6 IE/kg/dag i 3 måneder.
English: Duration of treatment for children and adolescents
Danish: Varighed af behandling for børn og unge
English: Moderate and usually reversible pancytopenia has been reported.
Danish: Der er set moderat og sædvanligvis reversibel pancytopeni.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3 Genotype 4
Danish: Alle genotyper Genotype 1 Genotype 2 Genotype 3 Genotype 4
English: Volume (mL)
Danish: Mængde (ml)
English: Use IntronA exactly as prescribed by your doctor.
Danish: Anvend IntronA nøjagtigt som foreskrevet af din læge.
English: Check with your doctor immediately if you have any of these symptoms.
Danish: Kontakt straks din læge, hvis du har et af disse symptomer.
English: All patients in these trials received 3 MIU of IntronA three times a week.
Danish: Alle patienter i disse undersøgelser fik 3 MIE IntronA tre gange om ugen.
English: In studies in pregnant animals, interferons have sometimes caused miscarriage.
Danish: I undersøgelser på drægtige dyr har interferoner undertiden forårsaget abort.
English: This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Danish: Dette forårsager svær anæmi, og symptomer herpå vil omfatte usædvanlig træthed og mangel på energi.
English: One dose of IntronA is given on each scheduled day.
Danish: En dosis af IntronA gives på hver fastlagt dag.
English: Clinical experience indicates that a haematological and cytogenetic major/minor response is obtainable in the majority of patients treated.
Danish: Klinisk erfaring indikerer, at et hæmatologisk og cytogenetisk større/mindre respons er opnåeligt hos størstedelen af behandlede patienter.
English: - if you are a man who is taking ribavirin, do not have sex with a pregnant woman unless you use a condom.
Danish: - hvis du er en mand, der tager ribavirin, så hav ikke samleje med en gravid kvinde, medmindre du bruger kondom.
English: The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Danish: Den optimale behandlingsvarighed med IntronA alene er endnu ikke fuldstændig fastsat, men en behandling på mellem 12 og 18 måneder anbefales.
English: Insert the needle into the pinched skin at an angle of 45° to 90°.
Danish: Stik kanylen ind i den sammenklemte hud i en vinkel på 45 til 90.
English: b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Danish: b: n = antallet af respondenter/antal patienter med given genotype, og fastsat behandlingsvarighed.
English: It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Danish: Det anbefales, at patienter behandles med IntronA alene i mindst 3 til 4 måneder, hvorefter HCV-RNA status bør bestemmes.
English: IntronA must be used with caution in fertile men.
Danish: IntronA skal anvendes med forsigtighed hos fertile mænd.
English: The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
Danish: Den sædvanlige begyndelsesdosis for hver sygdom angives nedenfor, men de individuelle doser kan variere, og lægen kan ændre din dosis på grund af dit specielle behov:
English: • Genotype 2/3: The recommended duration of treatment is 24 weeks.
Danish: • Genotype 2/3: Den anbefalede behandlingsvarighed er 24 uger.
English: With your other hand hold the syringe as you would a pencil.
Danish: Hold sprøjten med din anden hånd, som du ville holde en blyant.
English: IntronA is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: IntronA må kun anvendes under graviditet, hvis den mulige gavn berettiger den potentielle risiko for fosteret.
English: Check with your doctor if you think you are getting an infection.
Danish: Spørg din læge til råds, hvis du tror, at du er ved at få en infektion.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Danish: Du kunne overveje at bede et familiemedlem eller en nær ven hjælpe dig med at være opmærksom på tegn på depression eller ændringer i din opførsel.
English: Need for adequate hydration
Danish: Behovet for tilstrækkelig hydrering
English: - when receiving IntronA, you may temporarily have a greater risk of getting an infection.
Danish: - når du får IntronA, kan du midlertidigt have en større risiko for at få en infektion.
English: IntronA is given either daily (5 or 7 times a week), or three times a week, every other day, for example on Monday, Wednesday, and Friday.
Danish: IntronA gives enten dagligt (5 eller 7 gange ugentligt), eller tre gange ugentlig, hveranden dag, for eksempel mandag, onsdag og fredag.
English: - if you have psoriasis, it may get worse during treatment with IntronA.
Danish: - hvis du har psoriasis, kan den forværres under behandling med IntronA.
English: Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
Danish: Skønt den optimale (minimale) dosis for opnåelse af den fulde kliniske virkning er ukendt, skal patienterne behandles med de anbefalede doser, dog med dosisreduktion ved toxicitet som angivet.
English: This can be discussed with your doctor.
Danish: Du kan diskutere dette med din læge.
English: Some children did not reach their projected height within 10-12 years after completing treatment.
Danish: Nogle børn nåede ikke den forventede højde inden for 10-12 år efter behandlingen.
English: Appropriate dose form and strength must be selected.
Danish: Hensigtsmæssig formulering og styrke skal vælges.
English: Authorized Representative: BD, Laagstraat 57, B-9140 Temse, Belgium
Danish: Autoriseret repræsentant: BD, Laagstraat 57, B-9140 Temse, Belgien
English: Patients with psoriasis and sarcoidosis
Danish: Patienter med psoriasis eller sarcoidosis
English: If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Danish: Hvis du selv injicerer denne medicin, vil du blive instrueret i at tilberede og indgive injektionen.
English: Genotype 1  2 million copies/mL Genotype 1 > 2 million copies/mL
Danish: Genotype 1  2 millioner kopier/ml Genotype 1 > 2 millioner kopier/ml
English: Sodium chloride M-cresol
Danish: Natriumchlorid M-cresol
English: The following side effects have been reported:
Danish: Følgende bivirkninger er blevet rapporteret
English: Hold the IntronA vial upright without touching the cleaned top of the vial with your hands.
Danish: Hold IntronA hætteglasset lodret uden at røre den rensede top af hætteglasset med dine hænder.
English: Pyrexia and fatigue were often reversible within 72 hours of interruption or cessation of treatment.
Danish: Feber og træthed var ofte reversible inden for 72 timer efter afbrydelse eller ophør af behandlingen.
English: - if you have poor kidney or liver function.
Danish: - hvis du har dårlig nyre- eller leverfunktion.
English: Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Danish: Hvis det er muligt, bør barnet behandles efter pubertetens vækstspurt for at reducere risikoen for væksthæmning.
English: IntronA should be given alone mainly in case of intolerance or contraindication to ribavirin.
Danish: IntronA bør hovedsageligt gives alene i tilfælde af intolerance eller kontraindikation for ribavirin.
English: A major cytogenetic response is defined by < 34 % Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34 %, but < 90 % Ph+ cells in the marrow.
Danish: Et større cytogenetisk respons er defineret som < 34 % Ph+ leukæmiske celler i knoglemarven, mens et mindre respons er  34 %, men < 90 % Ph+ celler i marven.
English: Driving and using machines Do not drive or use machines if you become drowsy, tired, or confused from using this medicine.
Danish: Kør ikke bil og betjen ikke værktøj eller maskiner, hvis du bliver døsig, træt eller forvirret af denne medicin.
English: These undesirable effects have also been reported with IntronA alone.
Danish: Disse bivirkninger er også rapporteret med IntronA alene.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid nu, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandling, og i 7 måneder efter behandlingen er stoppet.
English: - if you have advanced decompensated (uncontrolled) liver disease.
Danish: - hvis du har fremskreden ubehandlet (ukontrolleret) leversygdom.
English: Contact your doctor or pharmacist if needed.
Danish: Kontakt din læge eller apoteket efter behov.
English: Do not use IntronA - if you are allergic to interferon or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke IntronA - hvis du er allergisk over for interferon eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: IntronA is usually intended for subcutaneous use.
Danish: IntronA er sædvanligvis beregnet til subkutan anvendelse.
English: 462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study.
Danish: 462 patienter fuldendte mindst 5 års langtidsopfølgning, og kun 12 vedvarende respondenter ud af 492 fik tilbagefald under denne undersøgelse.
English: Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
Danish: Din læge vil undersøge dit blod for at sikre, at antallet af hvide blodlegemer (celler, som bekæmper infektion) og røde blodlegemer (celler, som bærer jern og ilt), blodplader (blodstørkningsceller) og andre laboratorieværdier er på acceptable niveauer.
English: Be sure to tell your doctor if you are taking the Chinese herbal medicine shosaikoto.
Danish: Det er vigtigt at fortælle din læge, hvis du tager den kinesiske urtemedicin shosaikoto.
English: Interferon alfa-2b treatment is to be restarted at 50 % of the previous dose.
Danish: Interferon alfa-2b behandlingen bør genstartes med 50 % af den tidligere dosis.
English: If you have them, you may have had a serious allergic reaction to IntronA.
Danish: Hvis du har dem, kan du have fået en alvorlig allergisk reaktion over for IntronA.
English: If you are scheduled to inject this medicine every day, and you accidentally missed a full day's dose, continue treatment at the usual dose the following day.
Danish: Hvis du skal injicere dette lægemiddel hver dag, og du ved et uheld kommer til at springe en hel dagsdosis over, så fortsæt behandling med den sædvanlige dosis næste dag.
English: For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC.)
Danish: For pædiatriske patienter, der vejer < 47 kg eller ikke kan synke kapsler, se produktresume for ribavirin oral opløsning.)
English: If you have the impression that the effect of IntronA is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener, at virkningerne af IntronA er for kraftige eller for svage, bør du tale med din læge eller apoteket herom.
English: If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Danish: Hvis du er usædvanligt tynd, så brug kun låret eller ydersiden af overarmen til injektion.
English: if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Danish: - hvis du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere.
English: Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Danish: Tyve (21%) ud af 97 børn havde en > 15 percentilreduktion i højdepercentilen, hvoraf 10 ud af de 20 børn havde en > 30 percentilreduktion i deres højdepercentil fra starten af behandlingen til slutningen af langtidsopfølgningen (op til 5 år).
English: Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking IntronA in combination with ribavirin.
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter eller hos partnere af mandlige patienter, der får IntronA i kombination med ribavirin.
English: Loss of consciousness has occurred very rarely, mostly in elderly patients treated at high doses.
Danish: Tab af bevidsthed er forekommet meget sjældent, for det meste hos ældre patienter, behandlet med høje doser.
English: Toxicity was demonstrated in monkeys given 100 x 10
Danish: Toksicitet blev påvist i aber, der fik 100 x 10
English: Growth rate decrease (height and/or weight decrease for age)
Danish: Nedsat væksthastighed (mindre højde og/eller vægt end alderssvarende)
English: - Epilepsy and/or compromised central nervous system (CNS) function (see section 4.4).
Danish: - Epilepsi og/eller kompromitteret centralnervesystem (CNS) funktion (se pkt.
English: IntronA will add to the effects of substances that slow down your nervous system, possibly causing drowsiness.
Danish: IntronA vil forøge virkningerne af stoffer, der hæmmer dit nervesystem, muligvis ved at forårsage døsighed.
English: Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Danish: Pulmonal arteriel hypertension - en sygdom, der medfører svær forsnævring af blodkarrene i lungerne med deraf følgende højt blodtryk i de blodkar, der fører blodet fra hjertet til lungerne.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa-2b on growth, development, sexual maturation, and behaviour.
Danish: Ingen undersøgelser er blevet udført i unge dyr med henblik på at undersøge virkningen af behandling med interferon alfa-2b på vækst, udvikling, seksuel modning og opførsel.
English: If you are prescribed IntronA in combination with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur: - if you are a girl or a woman of childbearing age, you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Danish: Hvis du har fået foreskrevet IntronA i kombination med ribavirin, kan ribavirin være yderst skadelig for et ufødt barn, og både kvindelige og mandlige patienter skal derfor tage særlige forholdsregler i deres seksuelle aktivitet, hvis der er nogen mulighed for, at en graviditet kan opstå: - hvis du er en pige eller kvinde i den fødedygtige alder, skal du have en negativ graviditetstest før behandling, hver måned under behandling og i 4 måneder efter behandlingen er stoppet.
English: Laboratory Tests
Danish: Laboratorieundersøgelser
English: Please make sure to select an appropriate dose form and strength.
Danish: Vær sikker på at vælge en hensigtsmæssig formulering og styrke.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Danish: Du bør børste dine tænder omhyggeligt to gange dagligt og få foretaget regelmæssige tandeftersyn.
English: If you forget to use IntronA
Danish: Hvis du har glemt at tage IntronA
English: §, hyperuricemia, increased appetite
Danish: §, hyperurikæmi, øget appetit
English: Examine the solution prior to administration: it should be clear and colourless.
Danish: Undersøg den færdigtilberedte opløsning før indgift: den skal være klar og farveløs.
English: CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Danish: CHOP-lignende regimer anbefales, men klinisk erfaring findes kun med CHVP (kombination af cyclophosphamid, doxorubicin, teniposid og prednisolon).
English: Some people get depressed when taking IntronA alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender IntronA alene eller i kombinationsbehandling med ribavirin, og i nogle tilfælde har personer haft tanker om at true andre mennesker på livet, selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: - if you have a history of autoimmune disease, or have had an organ transplant and are taking medicine that suppresses your immune system (your immune system helps protect you from infection).
Danish: - hvis du tidligere har haft autoimmun sygdom, eller har fået en organtransplantation og anvender medicin, der undertrykker dit immunsystem (dit immunsystem hjælper med at beskytte dig mod infektioner).
English: 6 IU/kg/day for 3 months caused no remarkable toxicity.
Danish: 6IE/kg/dag i 3 måneder forårsagede ingen mærkbar toksicitet.
English: - if you have cirrhosis or other liver problems (other than hepatitis B or C).
Danish: - hvis du har skrumpelever eller andre leversygdomme (ud over hepatitis B eller C).
English: IntronA increases the risk of liver decompensation and death in patients with cirrhosis.
Danish: IntronA øger risikoen for leverdekompensation og død hos patienter med cirrose.
English: *AUC12 (ng.hr/mL) for ribavirin; AUC0-24 (IU.hr/mL) for IntronA
Danish: *AUC12 (ng.time/ml) for ribavirin; AUC0-24 (IE.time/ml) for IntronA
English: In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Danish: Hos voksne patienter, som modtager interferon i kombination med ribavirin, er den opnåede vedvarende responsrate 47 %.
English: As maintenance therapy in patients who have achieved objective remission (more than 50 % reduction in myeloma protein) following initial induction chemotherapy.
Danish: Som vedligeholdelsesbehandling hos patienter, som har opnået objektiv remission (mere end 50 % reduktion i myeloid protein) efter initial induktionskemoterapi.
English: The increased response rate to the combination of IntronA + ribavirin, compared with IntronA alone, is maintained across all subgroups.
Danish: Den øgede responsrate ved kombinationen af IntronA + ribavirin, sammenlignet med IntronA alene, er opretholdt på tværs af alle undergrupper.
English: This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested.
Danish: Denne dosering fastholdes, med mindre sygdommen progredierer hurtigt, eller hvis der opstår alvorlig intolerance.
English: What IntronA contains
Danish: IntronA indeholder
English: Pharmacotherapeutic group: interferon alfa-2b, ATC code: L03A B05
Danish: Farmakoterapeutisk klassifikation: interferon alfa-2b, ATC-kode: L03A B05
English: Long-term efficacy data
Danish: Langtidsdata
English: This means that IntronA is injected with a short needle into the fatty tissue just under the skin.
Danish: Dette betyder, at IntronA injiceres med en kort kanyle i fedtvævet lige under huden.
English: Do not use this medicine after the expiry date which is stated on the package.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker dog ikke forekomsten af hepatiske hændelser hos patienter med cirrose (herunder hepatocellulært karcinom).
English: For most patients with hairy cell leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
Danish: For de fleste patienter med hårcelleleukæmi kan ses normalisering af en eller flere hæmatologiske variable inden for en til to måneders IntronA-behandling.
English: IntronA treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved.
Danish: IntronA-behandling bør afbrydes efter 8 til 12 ugers behandling, hvis ikke mindst en partiel hæmatologisk remission eller en klinisk betydningsfuld cytoreduktion er opnået.
English: No other medicinal product can be infused concomitantly with IntronA.
Danish: Intet andet lægemiddel må infunderes samtidig med IntronA.
English: Within the 5 years follow-up post-treatment period, the children had a mean height of th percentile, which was below the median of the normative population and less than their mean baseline height (48
Danish: Inden for de 5 års opfølgning efter behandlingsperioden havde børnene en gennemsnitlig højde på 44. percentil, hvilket var under medianen af den normative population og mindre end deres gennemsnitlige baseline-højde (48. percentil).
English: if you have received an organ transplant, either kidney or liver, interferon treatment may increase the risk of rejection.
Danish: hvis du har fået foretaget en organtransplantation, enten af nyre eller lever, kan interferonbehandling øge risikoen for afstødning.
English: The pharmacokinetics of IntronA and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Danish: Farmakokinetikken for IntronA og ribavirin (dosis-normaliseret) er ens hos voksne og børn eller unge.
English: Your doctor may prescribe a different dose of IntronA alone or in combination with other medicines (e.g., cytarabine, ribavirin).
Danish: Din læge kan ordinere en anden dosis af IntronA alene eller i kombination med andre lægemidler (såsom cytarabin, ribavirin).
English: Children and adolescents are particularly prone to develop depression when being treated with IntronA and ribavirin.
Danish: Børn og teenagere er særligt udsatte for at udvikle depression, når de behandles med IntronA og ribavirin.
English: Tell your doctor if you are taking theophylline or aminophylline for asthma, and about all other medicines you are taking, or have taken recently, even those not prescribed, as the dose of some medicines may have to be adjusted while you are treated with IntronA.
Danish: Fortæl din læge, om du anvender theophyllin eller aminophyllin for astma, og om al anden medicin, du anvender, eller for nylig har anvendt, også hvis der er tale om ikke-receptpligtige lægemidler, idet dosis af visse lægemidler eventuelt skal justeres, mens du behandles med IntronA.