FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Aflunov (which may affect more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Aflunov (som kan forekomme hos mere end 1 ud af 10 patienter) er hovedpine, muskelsmerter (myalgi), reaktioner på injektionsstedet (hævelse, smerte, hårdhed og rødme) samt træthed.
English: When a person is given the vaccine, the immune system recognises the virus parts in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når en person vaccineres, opfatter immunsystemet virusset i vaccinen som "fremmed" og danner antistoffer mod det.
English: It was noted that it is likely that a H5N1 strain of influenza will cause a pandemic in the future and Aflunov was shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Danish: Det blev bemærket, at det er sandsynligt, at en H5N1-stamme af influenzaen vil forårsage en pandemi i fremtiden, og at Aflunov har vist sig at producere tilstrækkelige antistoffer til at fremkalde en immunrespons og beskytte mod H5N1.
English: Aflunov has been shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Danish: Aflunov har vist sig at producere tilstrækkelige antistoffer til at fremkalde en immunrespons og beskytte mod H5N1.
English: Aflunov contains a flu strain called A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).
Danish: Aflunov indeholder en influenzastamme kaldet A/turkey/Turkey/1/2005 (H5N1)-lignende stamme (NIBRG-23) (forgrening 2.2.1).
English: For the full list of side effects of Aflunov, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Aflunov fremgår af indlægssedlen.
English: At the time of the initial marketing authorisation, two main studies using a strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Aflunov in healthy adults aged below and above 60 years.
Danish: På tidspunktet for den oprindelige markedsføringstilladelse var der opnået data fra to hovedstudier, som anvendte en stamme kaldet A/Vietnam/1194/2004 (H5N1)-lignende stamme (NIBRG-14), om vaccination af raske voksne i alderen under og over 60 år med Aflunov.
English: A third study, using a vaccine with strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23), was carried out in 343 adults aged below and above 60 years.
Danish: Et tredje studie, hvor der blev anvendt en vaccine med stammen A/turkey/Turkey/1/2005 (H5N1)lignende stamme (NIBRG-23), omfattede 343 voksne under og over 60 år.
English: Aflunov is a vaccine used in adults to protect against flu caused by the H5N1 (‘bird flu') strain of the influenza A virus.
Danish: Aflunov anvendes til voksne til beskyttelse mod influenza forårsaget af H5N1-stammen af influenzavirus A ("fugleinfluenza").
English: The study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years produced an acceptable antibody response.
Danish: I det første studie havde ca. 70 % af de voksne under 60 år og ca. 64 % af de voksne over 60 år opnået en acceptabel antistofrespons 21 dage efter den anden injektion.
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Danish: I det første studie havde ca. 90 % af personer under 60 år og ca. 80 % af personer på over 60 år tilstrækkelige antistoffer til at beskytte dem mod H5N1 21 dage efter den anden injektion.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aflunov 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 Aflunov.
English: How does Aflunov work?
Danish: Hvordan virker Aflunov?
English: What benefits of Aflunov have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Aflunov?
English: How is Aflunov used?
Danish: Hvordan anvendes Aflunov?
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people do not have immunity (protection) against it. Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus, an infection that can spread from birds to humans (a ‘zoonotic' infection).
Danish: Sundhedseksperter er bekymrede for, at H5N1-stammen af virusset i fremtiden kan forårsage en influenzapandemi, en infektion, som kan spredes fra fugle til mennesker (en "zoonotisk" infektion).
English: Package size bottle (HDPE)
Danish: Flaske (HDPE)
English: EU Number
Danish: Emballage
English: Date of first authorisation: 31 March 2009 Date of latest renewal: 16 January 2014
Danish: Dato for første tilladelse: 31. marts 2009 Dato for seneste fornyelse: 16. januar 2014.
English: Do not take Ribavirin Teva if any of the following apply to you or the child you are caring for.
Danish: Tag ikke Ribavirin Teva, hvis noget af følgende gælder for dig eller det barn, du har ansvar for.
English: Do not use this medicine if you notice any change in the appearance of the capsules.
Danish: Brug ikke dette lægemiddel, hvis du bemærker en ændring i udseendet af kapslerne.
English: − suicide,
Danish: - selvmord.
English: Poligono Industrial Malpica 50016 Zaragoza Spain
Danish: Poligono Industrial Malpica 50016 Zaragoza Spanien
English: The response to treatment in both of these trials is presented in Table 8.
Danish: Respons på behandlingen i begge disse undersøgelser er vist i Tabel 8.
English: Talk to your doctor if you or your child you are caring for
Danish: Tal med din læge, hvis du eller barnet du har ansvar for:
English: - If you have or develop severe kidney or liver problems, this treatment will be stopped.
Danish: - Hvis du har eller udvikler alvorlige nyre- eller leverlidelser, vil denne behandling blive stoppet
English: Girl or woman of childbearing age:
Danish: Piger eller kvinder i den fødedygtige alder:
English: - Depending upon the results of these tests, your doctor may change/adjust the number of capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
Danish: - Afhængigt af resultaterne af disse prøver, kan din læge ændre/tilpasse antallet af hårde kapsler, du eller barnet skal have, ordinere en anden pakningsstørrelse af dette lægemiddel, og/eller ændre varigheden af din behandling.
English: The use of Ribavirin Teva is contraindicated during pregnancy.
Danish: Anvendelsen af Ribavirin Teva er kontraindiceret under graviditet.
English: If it gets worse, your doctor will decide whether or not your Ribavirin Teva treatment needs to be changed.
Danish: Hvis den forværres, vil din læge beslutte, om din behandling med Ribavirin Teva skal ændres.
English: Do not take a double dose to make up for a forgotten dose
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among nonresponders.
Danish: Dette fald var signifikant blandt de responderende (-0,3 for Metavir og -1,2 for Ishak) og stabilt (-0,1 for Metavir og -0,2 for Ishak) blandt de ikke-responderende.
English: Steatosis was significantly improved in patients infected with HCV Genotype 3.
Danish: Steatose blev signifikant forbedret hos patienter, der var inficeret med HCV Genotype 3.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Danish: I alt 118 patienter blev inkluderet: 57 % mænd, 80 % kaukasiske og 78 % genotype 1, 64 % i alderen ≤12 år.
English: 4 capsulesb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Danish: 4 kapsler b Se venligst anbefalinger for dosering til voksne a: 1 morgen, 2 aften b: 2 morgen, 2 aften
English: HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
Danish: HCV-genotype og virusmængde ved baseline er prognostiske faktorer, som er kendt for at påvirke responsrater.
English: Ninety four of 107 children enrolled in the 5 year long-term follow up trial.
Danish: 94 af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast feeding”).
Danish: • er en mand, og din kvindelige partner er i den fødedygtige alder (se afsnittet "Graviditet og amning").
English: Elderly (≥ 65 years of age)
Danish: Ældre (≥ 65 år)
English: Ribavirin Teva capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Danish: Ribavirin Teva kapsler skal indtages oralt hver dag fordelt på to doser (morgen og aften) i forbindelse med et måltid.
English: This should be discussed with your doctor (see “Do not take Ribavirin Teva”).
Danish: Dette skal du tale med din læge om (se afsnittet ”Tag ikke Ribavirin Teva”).
English: Reminder: This medicine is used in combination with other medicines for hepatitis C virus infection.
Danish: Bemærk: Dette lægemiddel anvendes i kombination med andre lægemidler mod hepatitis C virus infektion.
English: ≥ 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Danish:  2 g/dl fald i hæmoglobin i løbet af en hvilken som helst 4 ugers periode under behandling (permanent dosisreduktion)
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 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid i øjeblikket, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen, og i syv måneder efter behandlingen er stoppet.
English: White, opaque and imprinted with blue ink.
Danish: Hvid, uigennemsigtig og mærket med blåt tryk.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Danish: Bemærk: For patienter, som vejer < 47 kg eller som ikke er i stand til at synke kapsler, er ribavirin oral opløsning tilgængelig og skal anvendes, hvis det skønnes nødvendigt.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin therapy:
Danish: Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af Ribavirin-behandling:
English: Method of administration Ribavirin capsules should be administered orally with food.
Danish: Administration Ribavirin-kapsler skal gives oralt sammen med mad.
English: Ribavirin Teva is a white, opaque, hard capsule imprinted with blue ink.
Danish: Ribavirin Teva er en hvid, uigennemsigtig, hård kapsel mærket med blåt tryk.
English: Ribavirin has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect.
Danish: Ribavirin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner; andre lægemidler anvendt i kombination kan imidlertid have en negativ virkning.
English: EU/1/09/509/001 - 84 capsules EU/1/09/509/002 - 112 capsules EU/1/09/509/003 - 140 capsules EU/1/09/509/004 - 168 capsules
Danish: EU/1/09/509/001 - 84 hårde kapsler EU/1/09/509/002 - 112 hårde kapsler EU/1/09/509/003 - 140 hårde kapsler EU/1/09/509/004 - 168 hårde kapsler
English: Ribavirin Teva must be used in combination therapy as described in section 4.1.
Danish: Ribavirin Teva skal altid anvendes i kombinationsbehandling som beskrevet i pkt 4.1.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults.
Danish: Den inkluderede population bestod hovedsageligt af børn med mild til moderat hepatitis C. I de to multicenterforsøg, svarede vedvarende virologiske responsrater hos børn og unge til dem, der sås hos voksne.
English: This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva may cause sleepiness, tiredness or confusion.
Danish: Dette lægemiddel påvirker ikke din evne til at køre bil eller betjene maskiner, men andre lægemidler anvendt i kombination med Ribavirin Teva kan gøre dig søvnig, træt eller forvirret.
English: Ribavirin Teva contains the active substance ribavirin.
Danish: Ribavirin Teva indeholder det aktive stof ribavirin.
English: Older people (≥ 65 years of age)
Danish: Ældre (i alderen ≥ 65 år)
English: Pancytopenia: Ribavirin Teva can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Danish: Pancytopeni: Ribavirin Teva kan medføre nedsat antal blodplader samt røde og hvide blodlegemer, når det anvendes sammen med peginterferon.
English: Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC)-aluminium blister packs
Danish: Ribavirin-kapsler er pakket i blisterpakninger, som består af polyvinylklorid (PVC)/polyethylen (PE)/polyvinylidenklorid (PVdC)-aluminiumblisterpakninger.
English: Capsule imprint Shellac
Danish: Kapselprægning Shellac
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Danish: Til børn og unge, som ikke kan sluge en hård kapsel, findes en oral opløsning af ribavirin.
English: Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Danish: Personer med nedsat nyrefunktion bør monitoreres mere omhyggeligt med hensyn til udvikling af anæmi.
English: Preclinical data: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Danish: Prækliniske data: - Fertilitet: I dyrestudier gav ribavirin reversible virkninger på spermatogenese (se pkt.
English: Paediatric population: No data are available in children below 3 years of age.
Danish: Der foreligger ingen data for børn under 3 år.
English: Ribavirin Teva is available in different pack sizes containing 84, 112, 140 or 168 capsules to be swallowed.
Danish: Ribavirin Teva fås i forskellige pakningsstørrelser indeholdende 84, 112, 140 eller 168 kapsler til at sluge.
English: - Teratogenicity: Significant teratogenic and/or embryocidal potential have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
Danish: - Teratogenicitet: Betydeligt teratogent og/eller embryocidt potentiale er vist for ribavirin i alle dyrearter, i hvilke tilstrækkelige undersøgelser er blevet udført, og forekommer ved så lave doser som en tyvendedel af den anbefalede humane dosis (se pkt.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm was observed in
Danish: 5.1) blev fald i niveau af absolut neutrofiltælling under 500 celler/mm3 observeret hos 4 % (8/194) af patienterne, og fald i blodplader under 50.000/mm3 blev observeret hos
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
Danish: Farmakoterapeutisk klassifikation: antivirale midler til systemisk brug, nukleosider og nukleotider, eksklusive reverse transcriptase-hæmmere, ATC-kode: J05AB04.
English: Do not store above 30oC
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Standard haematologic tests,blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Danish: Standard hæmatologiske tests, blodkemi (komplet blodtælling og differentialtælling, blodpladetal, elektrolytter, serumkreatinin, leverfunktionsundersøgelser, urinsyre) og graviditetstest skal udføres hos alle patienter før påbegyndelse af behandling.
English: If the child is weighing less than 47 kg or unable to swallow capsules an oral solution of ribavirin should be used.
Danish: Hvis barnet vejer under 47 kg eller ikke kan sluge kapslen, skal der anvendes en oral opløsning af ribavirin.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b .
Danish: a: p-værdi baseret på Cochran-Mantel Haenszel Chi square test. b: p-værdi baseret på chi-square test. c: forsøgspersoner < 75 kg fik 100 μg peginterferon alfa-2b/uge og forsøgspersoner ≥ 75 kg fik 150 μg peginterferon alfa-2b/uge.
English: Tell your doctor or pharmacist if you or the child you are caring for, are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with ribavirin may increase your risk of developing severe blood disorders.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller det barn du har ansvar for, bruger anden medicin eller har gjort det for nylig: - azathioprin er et lægemiddel, der undertrykker immunsystemet (immunsuppressivum), og anvendelse af denne medicin i kombination med ribavirin kan øge risikoen for at udvikle alvorlige blodsygdomme.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARVtreatment reassessed.
Danish: Patienter som udvikler leverdekompensation, skal seponere antihepatitis-behandlingen øjeblikkeligt, og ARV-behandlingen skal revurderes.
English: EU/1/09/509/001 (84 capsules) EU/1/09/509/002 (112 capsules) EU/1/09/509/003 (140 capsules) EU/1/09/509/004 (168 capsules)
Danish: EU/1/09/509/001 (84 hårde kapsler) EU/1/09/509/002 (112 hårde kapsler) EU/1/09/509/003 (140 hårde kapsler) EU/1/09/509/004 (168 hårde kapsler)
English: Patients whose dose of Ribavirin Teva is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Danish: Patienter, hvis dosis af Ribavirin Teva er reduceret til 600 mg dagligt får en 200 mg kapsel om morgenen og to 200 mg kapsler om aftenen.
English: In general, the adverse event profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of growth velocity of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Danish: Generelt svarede bivirkningsprofilen i den begrænsede undersøgte børn og unge-population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, da nedsat højdepercentil (gennemsnitlig percentilreduktion i væksthastighed på 9 percentil) og vægtpercentil (gennemsnitlig percentilreduktion på 13 percentil) blev observeret under behandling.
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Danish: Baseret på offentliggjorte data var enkeltdosis -farmakokinetikken for ribavirin ændret (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (kreatininclearance > 90 ml/minut).
English: d: Ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Danish: d: Ribavirindosis var 800 mg for patienter < 60 kg, 1.000 mg for patienter 60-75 kg og 1.200 mg for patienter > 75 kg.
English: − decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms),
Danish: - nedsættelse af skjoldbruskkirtlens funktion (hvilket kan gøre dig træt, depressiv, forøge din følsomhed for kulde samt andre symptomer),
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Danish: Et fem-årigt langtidsopfølgende observationsstudie indrullerede 97 pædiatriske patienter med kronisk hepatitis C, efter behandling i to af de tidligere nævnte multicenterstudier.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected with HIV.
Danish: Undersøgelse 2 (P02080) var en randomiseret, enkeltcenterundersøgelse, der omfattede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Danish: Farmakokinetikken for ribavirin og interferon alfa-2b (dosis-normaliseret) er ens hos voksne og børn eller unge.
English: If you forget to take Ribavirin Teva
Danish: Hvis du har glemt at tage Ribavirin Teva
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Teva must be discontinued immediately and appropriate medical therapy instituted.
Danish: I tilfælde af udvikling af akut overfølsomhedsreaktion (for eksempel urticaria, angioødem, bronkiekonstriktion, anafylaksi), skal Ribavirin Teva øjeblikkeligt seponeres og passende medicinsk behandling initieres.
English: There was no improvement in terms of fibrosis observed in this study.
Danish: Undersøgelsen viste ingen bedring i relation til fibrose.
English: The following side effects have been reported with the combination of ribavirin and an alpha interferon product in adults:
Danish: Følgende bivirkninger er blevet rapporteret med kombinationen af ribavirin og et alfa interferon produkt hos voksne:
English: A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 5.
Danish: Et givet antal bivirkninger tilskrevetinterferonbehandling, men som har været rapporteret i sammenhæng med hepatitis Cbehandling (i kombination med ribavirin) er også anført i Tabel 5.
English: Multiple-dose pharmacokinetic properties for ribavirin capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 10.
Danish: Flerdosis farmakokinetiske egenskaber for ribavirin-kapsler og interferon alfa-2b hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 10.
English: *AUC12 (ng.hr/mL) for Ribavirin; AUC0-24 (IU.hr/mL) for interferon alfa-2b
Danish: Ikke udført *AUC12 (ng.time/ml) for Ribavirin; AUC0-24 (IE.time/ml) for interferon alfa-2b
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/