FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Danish: Ribavirins farmakokinetik er ændret hos patienter med nedsat nyrefunktion som følge af en reduktion af den tilsyneladende kreatininclearance hos disse patienter (se pkt.
English: - anti-Human Immunodeficiency Virus (HIV) medicines - [nucleoside reverse transcriptase inhibitor (NRTI), and/or combined anti-retroviral therapy (cART)]: Taking this medicine in combination with an alpha interferon and an anti-HIV medicine may increase the risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Danish: - medicin mod hiv (humant immundefekt virus - [nukleosid revers transkriptasehæmmer (NRTI) og/eller anti-retroviral kombinationsbehandling (cART)]: - Dette lægemiddel i kombination med alfa interferon og anti-hiv-medicin kan øge risikoen for mælkesyreacidose, leversvigt og udvikling af blodabnormiteter (reduktion i antallet af røde blodlegemer, der transporterer ilt, visse hvide blodlegemer der bekæmper infektioner og blodkoagulerende celler kaldet blodplader).
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received ribavirin 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 3
Danish: Børn og unge i alderen 3 til 16 år med kompenseret kronisk hepatitis C og påviselig HCV-RNA (målt hos et centralt laboratorium ved brug af en forskningsbaseret RT-PCR-analyse) blev inkluderet i to multicenterundersøgelser og fik Ribavirin 15 mg/kg pr. dag plus interferon alfa-2b 3 MIE/m2 tre gange om ugen i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: - Genotoxicity: Ribavirin induces genotoxicity (see section 5.3).
Danish: - Genotoksicitet: Ribavirin bevirker genotoksicitet (se pkt.
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Danish: Lungeinfiltration٭, pneumoni٭, interstitial pneumonitis٭
English: Pharma B.V. must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: ikke initieres, før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
English: Mitochondrial toxicity and lactic acidosis: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Danish: Mitokondriel toksicitet og mælkesyreacidose: Der bør udvises forsigtighed hos hiv-positive personer, som samtidig er inficeret med HCV, og som får behandling med nukleosid revers transcriptasehæmmer (NRTI) (især ddI og d4T) og kombineret interferon alfa-2b/ribavirin-behandling.
English: During combination therapy for up to 48 weeks with interferon alfa2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Danish: Under kombinationsbehandlingen i op til 48 uger med interferon alfa-2b og ribavirin, blev væksthæmning observeret, som medførte reduceret sluthøjde hos nogle patienter.
English: Dose modification for adverse reactions Dose modification for adults
Danish: Dosisjustering ved bivirkninger Dosisjustering for voksne
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Danish: Bakterieinfektion (inklusive sepsis), svampeinfektion, influenza, luftvejsinfektion, bronkitis, herpes simplex, sinuitis, otitis media, rhinitis, urinvejsinfektion
English: Tablet core; Calcium hydrogen phosphate anhydrous, croscarmellose sodium, povidone, magnesium stearate.
Danish: Tabletkerne: Calciumhydrogenphosphat, vandfri, croscarmellosenatrium, povidon, magnesiumstearat.
English: Reminder: Please read the “Do not take” section of the Package leaflet for the other medicines used in combination before you begin combination treatment with this medicine.
Danish: Bemærk: Læs afsnittet "Tag ikke" i indlægssedlerne for de andre lægemidler, som anvendes sammen med dette lægemiddel.
English: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia
Danish: Hæmolytisk anæmi, leukopeni, thrombocytopeni, lymfadenopati, lymfopeni
English: This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva Pharma B.V. 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 Pharma B.V.
English: However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with peginterferon alfa-2b or interferon alfa-2b.
Danish: Responsrater i denne undersøgelse blev imidlertid vist også at være afhængige af dosis af ribavirin givet i kombination med peginterferon alfa-2b eller interferon alfa-2b.
English: Depression, insomnia, emotional liability
Danish: Depression, søvnløshed, emotionel labilitet
English: Haemoglobin: Patients with History of Stable Cardiac Disease
Danish: Hæmoglobin: Patienter med stabil hjertesygdom i anamnesen
English: Rhabdomyolysis*, myositis*
Danish: Rabdomyolyse٭, myositis٭
English: Teva Denmark A/S Tlf: +45 44 98 55 11
Danish: Tlf: +45 44 98 55 11
English: Neuralgia, lethargy, psychomotor hyperactivity
Danish: Neuralgia, sløvhed, psykomotorisk hyperaktivitet
English: The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa-2b or peginterferon alfa-2b.
Danish: De bivirkninger, som er angivet i dette afsnit, er primært rapporteret fra kliniske studier og/eller som bivirkninger fra spontane rapporter, når ribavirin blev brugt i kombination med interferon alfa-2b eller peginterferon alfa-2b.
English: Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Danish: Co-inficerede patienter, der får både antiretroviral (ARV) og antihepatitis behandling, bør monitoreres tæt.
English: When deciding not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to consider that this combination therapy induced a growth inhibition that may be irreversible in some patients.
Danish: Når der skal træffes en beslutning om ikke at udsætte kombinationsbehandling med peginterferon alfa2b eller interferon alfa-2b til barnet er voksent, er det vigtigt at være opmærksom på, at denne kombinationsbehandling forårsager en væksthæmning, som kan være irreversibel hos nogle patienter.
English: Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted.
Danish: Misdannelser af kranium, gane, øje, kæbe, lemmer, skelet og mave-tarmkanal blev registreret.
English: Ribavirin Teva Pharma B.V. 200 mg film-coated tablets are light-pink to pink, (debossed with “93” on one side and “7232” on the other).
Danish: 200 mg filmovertrukne tabletter er lys pink til pink, (præget med "93" på den ene side og "7232" på den anden side).
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Danish: Ved kombinationsbehandling i op til 48 uger med pegyleret interferon alfa-2b og ribavirin, blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt.
English: • Dental and periodontal disorders: Dental and gum disorders have been reported in patients receiving ribavirin in combination with (peg)interferon alfa-2b.
Danish: • Tand- og tandkødssygdomme: Tand- og tandkødssygdomme er set hos patienter, som er blevet behandlet med ribavirin og (peg)interferon alfa-2b samtidig.
English: Pigmentation disorder, dermatitis atopic, skin exfoliation
Danish: Pigmenteringsforstyrrelse, atopisk dermatitis, hudeksfoliation
English: Table 4 Dosage Modification for Renal Impairment in Adult Patients
Danish: Tabel 4 Dosisjustering for voksne patienter med nedsat nyrefunktion
English: Haemolysis: Ribavirin Teva Pharma B.V. can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Danish: Derudover er følgende bivirkninger forekommet hos patienter, der tager Ribavirin Teva Pharma B.V: Hæmolyse: Ribavirin Teva Pharma B.V kan medføre nedbrydning af røde blodlegemer, hvilket forårsager anæmi, som kan svække din hjertefunktion eller forværre symptomerne på hjertesygdom.
English: Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Danish: Desuden refererer SPC'et for peginterferon alfa2b og interferon alfa-2b til bivirkninger, der kan tilskrives interferonmonoterapi.
English: Ninety four of 107 children enrolled in the
Danish: 94 af 107 børn blev inkluderet i det opfølgende 5-årige langtidsstudie.
English: • Inability to achieve full adult height may occur in some children and adolescents
Danish: • Nogle børn og unge opnår ikke fuld voksenhøjde
English: Usual daily Ribavirin Teva Pharma B.V. dose
Danish: Normal daglig Ribavirin Teva Pharma B.V.-dosis
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicine and peginterferon alfa-2b may increase your risk of worsening liver function combined antiretroviral therapy (cART) and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Danish: Hvis du er en voksen patient med både HCV- og hiv-infektion, der får anti-HIV behandling, kan samtidig indtagelse af dette lægemiddel og peginterferon alfa-2b øge din risiko for forværring af leverfunktionen antiretroviral kombinationsbehandling (cART) og øge risikoen for mælkesyreacidose, leverskader og udvikling af unormaliteter af blodet (nedsat antal røde blodlegemer, der transporterer ilt, visse hvide blodlegemer, der bekæmper infektion og celler, som får blodet til at størkne og som kaldes blodplader) (NRTI).
English: Co-infected patients with advanced liver disease receiving cART may be at increased risk of worsening liver function.
Danish: - Patienter med både hiv- og HCV-infektion med fremskreden leversygdom, der tager (cART), kan have øget risiko for forværring af leverfunktionen.
English: Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Danish: Dette kan muligvis føre til en akkumulering af 6-methylthioinosinmonofosfat (6-MTIMP), som har været forbundet med myelotoksicitet hos patienter, som behandles med azathioprin.
English: Ribavirin Teva Pharma B.V. 400 mg film-coated tablets are light-pink to pink, (debossed with “R” on one side and “400” on the other).
Danish: 400 mg filmovertrukne tabletter er lys pink til pink, (præget med "R" på den ene side og "400" på den anden side).
English: For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Danish: Bivirkningerne, der har været rapporteret i undersøgelserne med en hyppighed > 5 % var: oral candidiasis (14 %), pådraget lipodystrofi (13 %), nedsat CD4-lymfocytter (8 %), nedsat appetit (8 %), øget gammaglutamyltransferase (9 %), rygsmerte (5 %), øget amylase i blodet (6 %), øget mælkesyre i blodet (5 %), cytolytisk hepatitis (6 %), øget lipase (6 %) og smerte i lemmerne (6 %).
English: Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Danish: Patienter med samtidig HCV/hiv-infektion og fremskreden cirrose, som får antiretroviral kombinationsbehandling (cART), kan have en øget risiko for nedsat leverfunktion og død.
English: • Ribavirin (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Danish: • Ribavirin (1.000/1.200 mg/dag) + interferon alfa-2b (3 MIE tre gange om ugen) (n = 505).
English: A reduction in haemoglobin concentrations by > 4 g/dL was observed in 30 % of patients treated with ribavirin and peginterferon alfa-2b and 37 % of patients treated with ribavirin and interferon alfa-2b.
Danish: Et fald i hæmoglobinkoncentration på > 4 g/dl blev set hos 30 % af patienter behandlet med ribavirin og peginterferon alfa-2b og 37 % af patienter behandlet med ribavirin og interferon alfa-2b.
English: SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and nonpegylated, with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Danish: SVR efter behandling af kronisk HCV med interferon alfa-2b (pegyleret eller non-pegyleret, med eller uden ribavirin) resulterer i langtidsclearance af virus, hvilket medfører resolution af leverinfektion og klinisk 'helbredelse' af kronisk HCV.
English: Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa-2b when compared to patients receiving ribavirin in combination with interferon alfa-2b.
Danish: Hæmatologiske unormaliteter blev rapporteret mere hyppigt hos patienter, der modtog ribavirin i kombination med peginterferon alfa-2b sammenlignet med patienter, der modtog ribavirin i kombination med interferon alfa-2b.
English: Cardiovascular
Danish: Kardiovaskulært
English: An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients.
Danish: Hos nogle patienter blev der også observeret forhøjet urinsyre og indirekte bilirubin forbundet med hæmolyse.
English: Diabetes mellitus, hypertriglyceridemia*
Danish: Diabetes mellitus, hypertriglyceridæmi٭
English: Nucleoside analogues
Danish: Nukleosidanaloger
English: Ribavirin Dose (daily)
Danish: Ribavirin-dosis (daglig)
English: The combination of Ribavirin Teva Pharma B.V. with interferon alfa-2b is used to treat patients 3 years of age and older who have chronic hepatitis C (HCV) infection.
Danish: med interferon alfa-2b er anvendt til at behandle patienter i alderen 3 år og ældre, som har kronisk hepatitis C (HCV) infektion.
English: Hepatomegaly, jaundice, hyperbilirubinemia*
Danish: Leverforstørrelse, gulsot, hyperbilirubinæmi٭
English: Reminder: Please read the “Other medicines” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V. before you begin combination treatment with this medicine.
Danish: Bemærk: Læs afsnittet ”Brug af anden medicin” i indlægssedlen for de andre lægemidler, der anvendes sammen med Ribavirin Teva Pharma B.V, før du begynder kombinationsbehandlingen med dette lægemiddel.
English: Ribavirin may be used in combination with interferon alfa-2b (see section 4.4).
Danish: Ribavirin kan bruges i kombination med interferon alfa-2b (se pkt.
English: • Ribavirin (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514).
Danish: • Ribavirin (1.000/1.200 mg/dag) + peginterferon alfa-2b (1,5 mikrogram/kg/uge i en måned efterfulgt af 0,5 mikrogram/kg/uge i 11 måneder) (n = 514).
English: Ribavirin Teva Pharma B.V. is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3-years of age or older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b.
Danish: er indiceret til behandling af kronisk hepatitis C (HCV)-infektion hos voksne, børn i alderen 3 år og ældre og unge og skal udelukkende anvendes som en del af en kombinationsbehandling med interferon alfa-2b.
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Danish: Kvinder: Amenorre, menorragi, menstruationsforstyrrelser, dysmenorre, brystsmerte, ovarielidelse, vaginallidelse.
English: Please refer to the corresponding Summary of Product Characteristics (SmPC) of medicinal products used in combination with Ribavirin Teva Pharma B.V. for prescribing information particular to that product and for further dosage recommendations on co-administration with Ribavirin Teva Pharma B.V..
Danish: Der henvises til produktresuméerne (SmPC) for de lægemidler, som anvendes i kombination med Ribavirin Teva Pharma B.V, for yderligere information vedrørende ordination af disse specifikke lægemidler og for yderligere anbefalinger vedrørende dosering ved administration sammen med Ribavirin Teva Pharma B.V.
English: This medicine in combination with an alpha interferon product may also cause: aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy,
Danish: Dette lægemiddel i kombination med et alfa interferonprodukt kan også forårsage: - aplastisk anæmi, pure red cell aplasi (en tilstand, hvor kroppen er ophørt med eller har nedsat produktionen af røde blodlegemer).
English: The active substance is Ribavirin.
Danish: indeholder det aktive stof ribavirin.
English: is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Danish: er beregnet til anvendelse, i kombination med interferon alfa-2b, til behandling af børn og unge i alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C af alle typer, med undtagelse af genotype 1, uden leverdekompensation, og som er positive med hensyn til HCV-RNA.
English: Ribavirin (800 mg/day) + interferon alfa2b (3 MIU TIW)
Danish: Ribavirin (800 mg/dag) + interferon alfa2b (3 MIE TIW)
English: Hypotension, hypertension, flushing
Danish: Hypotension, hypertension, ansigtsrødme
English: Headache, dizziness, dry mouth, concentration impaired
Danish: Hovedpine, svimmelhed, mundtørhed, nedsat koncentration
English: Patients were randomized to receive either ribavirin (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or ribavirin (800 -1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Danish: Patienterne blev randomiseret til enten at modtage ribavirin (800-1.200 mg/dag baseret på vægt) plus peginterferon alfa-2b (100 eller 150 μg/uge baseret på vægt) eller ribavirin (800-1.200 mg/dag baseret på vægt) plus interferon alfa-2b (3 MIE TIW).
English: Alopecia, rash
Danish: Alopeci, udslæt
English: Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin.
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med HCV-behandling, henvises der til de tilsvarende SmPC'er for opmærksomhed på og håndtering af toksiciteter, der er specifikke for det enkelte præparat og potentialet for overlappende toksiciteter med ribavirin.
English: Please refer to the corresponding SmPC of medicinal products used in combination with Ribavirin Teva Pharma B.V..
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Ribavirin Teva Pharma B.V.
English: Nephrotic syndrome*
Danish: Nefrotisk syndrom٭
English: SVR after treatment of chronic HCV with non-pegylated interferon alfa-2b with ribavirin results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Danish: SVR efter behandling af kronisk HCV med ikke-pegyleret interferon alfa-2b med ribavirin resulterede i langtids-clearance af virus, som resulterede i opløsning af leverinfektion og klinisk 'helbredelse' af kronisk HCV.
English: • Severe eye disorders
Danish: • Svære øjensygdomme
English: If you forget to take Ribavirin Teva Pharma B.V.
Danish: Hvis du har glemt at tage Ribavirin Teva Pharma B.V.
English: Ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Danish: Ribavirin (1.000/1.200 mg) + interferon alfa-2b (3 MIE)
English: Female: dysmenorrhoea
Danish: Kvinder: Dysmenorre
English: Volume of distribution is approximately 5,000 l. Ribavirin does not bind to plasma proteins.
Danish: Ribavirin bindes ikke til plasmaproteiner.
English: Haematological abnormalities in HCV/HIV co-infected patients:
Danish: Hæmatologiske unormaliteter hos patienter med samtidig HCV/hiv-infektion:
English: Periodontal disorder, dental disorder, tongue pigmentation
Danish: Parodontal lidelse, dental lidelse, pigmentering af tungen
English: In HCV/HIV co-infected patients receiving cART, the following other side effects have occurred with the combination of ribavirin and peginterferon alfa-2b (not listed above in adults side effects): appetite decreased, back pain, CD4 lymphocytes decreased, defective metabolism of fat, hepatitis, limb pain, oral candidiasis (oral thrush), various laboratory blood values abnormalities.
Danish: Hos HCV/HIV co-inficerede patienter, der fik cART, er nedenstående supplerende bivirkninger forekommet ved kombinationen af ribavirin og peginterferon alfa-2b (ikke listet oven for for bivirkninger hos voksne): - nedsat appetit, - rygsmerter, - nedsat antal CD4-lymfocytter, - ufuldkommen fedtomsætning, - leverbetændelse, - smerte i lemmer, - svamp i mundhulen (trøske), - unormale laboratorieblodværdier
English: Iron oxide red
Danish: Rød jernoxid
English: Hyperthyroidism, virilism
Danish: Hypertyreoidisme, virilisering