FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Ibandronic acid Accord work?
Danish: Hvordan virker Ibandronsyre Accord?
English: This should be discussed with your doctor.
Danish: Dette bør diskuteres med din læge.
English: (see section 6, further information).
Danish: 6, yderligere oplysninger).
English: Do not have sex with a pregnant woman unless you use a condom.
Danish: Hav ikke samleje med en gravid kvinde, med mindre du anvender et kondom.
English: • are older than 65 years or if you have problems with your kidneys.
Danish: • er ældre end 65 år, eller hvis du har problemer med dine nyrer.
English: Case by case benefit/risk assessment in children:
Danish: Case by case fordel/risiko vurdering hos børn:
English: 3 tablets a
Danish: 3 tabletter a
English: The attempt to harm yourself has also been reported in adults, children, and adolescents.
Danish: Forsøg på at gøre skade på sig selv er også blevet rapporteret hos voksne, børn og unge.
English: You should tell your doctor if you have suffered from any other serious illness in the past.
Danish: Du bør fortælle det til lægen, hvis du tidligere har lidt af en anden alvorlig sygdom.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Danish: Dit blod vil derfor blive undersøgt regelmæssigt for at sikre, at HIV-infektionen ikke bliver værre.
English: Sustained response was assessed by the response rate six months
Danish: Vedvarende respons blev vurderet som responsraten seks måneder efter
English: Some children did not reach their projected height within 1-5 years after completing treatment.
Danish: Nogle børn nåede ikke den forventede højde inden for 1-5 år efter behandlingen.
English: Dose to be administered
Danish: Dosis som skal administreres
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Danish: Ansøgningen er baseret på et referencelægemiddel, for hvilket der ikke er blevet identificeret nogen sikkerhedsanliggender, der kræver yderligere risikominimeringsaktiviteter.
English: Reminder: If your doctor's instructions are different from the amounts in the below table,
Danish: Bemærk: Hvis din læges instruktioner er forskellige fra antallet i nedenstående tabel, skal
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Danish: Den absolutte biotilgængelighed er imidlertid omkring 45 %-65 %, hvilket synes at skyldes first pass-metabolisme.
English: Discontinue combination therapy when the below test value is reported:** < 8.5 g/dl
Danish: Afbryd kombinationsbehandling, når testværdien nedenunder rapporteres:** < 8,5 g/dl
English: < 12 g/dl after 4 weeks of dose reduction
Danish: < 12 g/dl efter 4 ugers dosisreduktion
English: Biopartners GmbH Kaiserpassage 11 D-72764 Reutlingen Germany
Danish: Biopartners GmbH Kaiserpassage 11 D-72764 Reutlingen Tyskland
English: Dose modifications were required in 30 % of patients, most
Danish: Dosisjusteringer var nødvendige hos 30 % af patienterne, mest
English: Another approximately 4 % had a transient decrease below the lower limit of normal.
Danish: Omtrent 4 % havde et forbigående fald under den nedre normalgrænse.
English: If you have any questions about the dose, ask your doctor.
Danish: Hvis du har spørgsmål om dosis, så spørg din læge.
English: Read across on the same line to see how many tablets to take.
Danish: Læs på tværs af linjen for at se, hvor mange hårde kapsler du skal tage.
English: Please refer also to the relevant product information for antiretroviral medicinal products.
Danish: Se venligst også produktinformationen for de pågældende antiretrovirale lægemidler.
English: Based on the results of clinical trials, it is recommended that patients be treated for at least six months.
Danish: Det anbefales på baggrund af resultater fra kliniske undersøgelser, at patienter behandles i mindst seks måneder.
English: You or your caregiver should call your doctor immediately if you have any of these symptoms.
Danish: Du eller din plejer bør kontakte din læge omgående, hvis du oplever nogle af disse symptomer.
English: The response to treatment in both of these trials is presented in Table 7.
Danish: Respons på behandlingen i begge af disse undersøgelser er vist i Tabel 7.
English: Children 3 years of age and older and adolescents:
Danish: Børn i alderen 3 år eller ældre samt unge:
English: This will lessen the possibility for ribavirin to be left in the woman's body.
Danish: Dette vil reducere risikoen for at ribavirin efterlades i kvindens krop.
English: As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
Danish: Da kompliance kan være af betydning for behandlingens udfald, bør den indtagne dosis være så tæt som muligt på den anbefalede standarddosis.
English: Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Danish: Ribavirin var aktiv i Balb/3T3 in vitro Transformation Assay.
English: You should tell your doctor if you or your child you are caring for:
Danish: Du bør fortælle din læge, hvis du eller dit barn, som du har ansvar for:
English: There are no data on long term effects on sexual maturation.
Danish: Der er ingen langtidsdata af effekten på kønsmodningen.
English: This appears to be due to reduction of apparent clearance in these patients.
Danish: Dette synes at være forårsaget af en reduktion af målelig clearance hos disse patienter.
English: The usual dose, according to how much the patient weighs, is shown in the table below: Look for the line that shows how much the adult or child/adolescent weighs.
Danish: Den normale dosis, alt efter hvor meget patienten vejer, er vist i tabellen nedenfor: Kig på den linje, der viser, hvor meget voksne eller et barn/en ung vejer.
English: • have any severe medical conditions that leave you very weak, including severe kidney disease.
Danish: • har nogle alvorlige medicinske tilstande, som gør dig meget svag, herunder alvorlig nyresygdom.
English: MIU = million international units; TIW = three times a week.
Danish: MIU = millioner internationale enheder; TIW = tre gange ugentligt.
English: EU/1/10/626/001 (84 film-coated tablets) EU/1/10/626/002 (112 film-coated tablets) EU/1/10/626/003 (140 film-coated tablets) EU/1/10/626/004 (168 film-coated tablets)
Danish: EU/1/10/626/001 (84 filmovertrukne tabletter) EU/1/10/626/002 (112 filmovertrukne tabletter) EU/1/10/626/003 (140 filmovertrukne tabletter) EU/1/10/626/004 (168 filmovertrukne tabletter)
English: • have had any previous severe heart problems, or have had any problems with the heart in the last 6 months.
Danish: • har haft nogle tidligere alvorlige problemer med hjertet, eller har haft nogle problemer med hjertet inden for de sidste 6 måneder.
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Danish: Hertil kommer, at 98 % (51/52) med normale ALAT niveauer ved opfølgningsuge 24 havde normal ALAT-niveau ved deres sidste
English: This should be discussed with your doctor (see section “Do not take Ribavirin BioPartners”).
Danish: Dette bør diskuteres med din læge (se afsnittet "Brug ikke Ribavirin BioPartners").
English: The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out.
Danish: En mulig negativ indflydelse af reduktion af ribavirin-dosis på effekt-resultater kunne ikke udelukkes.
English: A dominant lethal assay in rats was negative, indicating that if mutations occurred in rats they were not transmitted through male gametes.
Danish: En dominant letal test hos rotter var negativ, hvilket tyder på, at hvis mutationer forekom i rotter, blev de ikke overført via mandlige
English: All patients should have a baseline eye examination.
Danish: Alle patienter bør ved baseline have foretaget en undersøgelse af øjnene.
English: Standard blood tests will be taken to check your blood, kidney and liver function.
Danish: Standard blodundersøgelser vil blive taget for at tjekke dit blod samt nyre- og leverfunktion.
English: Packs of 84, 112, 140 and 168 film-coated tablets.
Danish: Pakninger á 84, 112, 140 og 168 filmovertrukne tabletter.
English: Ribavirin BioPartners can be very damaging to your unborn baby (embryo).
Danish: Ribavirin BioPartners kan være meget skadeligt for dit ufødte barn (embryotoksicitet)
English: The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10) Common
Danish: Hyppigheden af mulige bivirkninger er defineret ved hjælp af den følgende konvention: Meget almindelig (påvirker flere end 1 af 10 brugere) Almindelig
English: - Depending upon the results of these tests, your doctor may change/adjust the number of tablets you or the child you are caring for take, prescribe a different pack size of Ribavirin BioPartners, and/or change the length of time to take this treatment.
Danish: Afhængigt af resultaterne af disse undersøgelser, kan din læge ændre/tilpasse antallet af tabletter, du eller barnet skal have, ordinere en anden pakningsstørrelse af Ribavirin BioPartners, og/eller ændre varigheden af din behandling.
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 non-responders.
Danish: Dette fald var signifikant blandt de responderende (-0,3 for Metavir og -1,2 for Ishak) og stabile (-0,1 for Metavir og -0,2 for Ishak) blandt de ikke-responderende.
English: • are an adult who has or had a severe nervous or mental disorder, confusion, unconsciousness,
Danish: • • er en voksen, som har eller har haft alvorlige nervøs eller psykisk lidelse, forvirring,
English: - Patients with severe, debilitating medical conditions.
Danish: Patienter med alvorlige svækkende sygdomstilstande.
English: have suffered from autoimmune disease in the past, or suffer from autoimmune hepatitis, or are taking other medicines that suppress your immune system (that protects you against infection and some diseases).
Danish: • tidligere har lidt af autoimmun sygdom eller lider af autoimmun hepatitis, eller tager anden medicin, der undertrykker dit immunsystem (som beskytter dig mod infektion og visse sygdomme)
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: The choice of combination regimen is based on the characteristics of the patient.
Danish: Valg af kombinationsbehandling baseres på patientens karakteristika.
English: Note: For patients who weigh < 47 kg, or are unable to swallow tablets, 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 tabletter, er en oral opløsning af ribavirin tilgængelig, som skal anvendes hvis hensigtsmæssigt.
English: Do not use Ribavirin BioPartners after the expiry date which is stated on the carton.
Danish: Brug ikke Ribavirin BioPartners efter den udløbsdato, der står på kartonen.
English: Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Danish: Ribavirin ophobes intracellulært og udskilles meget langsomt fra kroppen.
English: The following side effects have been reported with children and adolescents taking ribavirin and
Danish: De følgende bivirkninger er blevet rapporteret hos børn og unge, som tager ribavirin og
English: If it gets worse, your doctor will decide whether or not your Ribavirin BioPartners treatment needs to be changed.
Danish: Hvis den bliver værre, vil din læge beslutte, om det er nødvendigt at ændre din behandling med Ribavirin BioPartners eller ej.
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus.
Danish: Hvis graviditet forekommer under behandling eller inden for fire måneder efter ophørt behandling, skal patienten informeres om den betydelige teratogene risiko ved ribavirin for fosteret.
English: Nucleoside analogs: Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Danish: Nukleosidanaloger: Anvendelse af nukleosid-analoger, alene eller i kombination med andre nukleosider, har resulteret i lactacidose.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 April 2010
Danish: Dato for første markedsføringstilladelse: 6. april 2010
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Danish: I klinisk undersøgelse C/I98-580 blev 1.530 naive patienter behandlet i et år med et af følgende
English: The reversibility of growth inhibition is uncertain.
Danish: Reversibiliteten af væksthæmningen er uvis.
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
English: do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Danish: Derfor, kør ikke bil og betjen ikke værktøj eller maskiner, hvis du føler dig træt, søvnig eller desorienteret af denne behandling.
English: Population pharmacokinetic analysis was performed using sparsely sampled serum concentration values from four controlled clinical trials.
Danish: Populationsfarmakokinetisk analyse blev udført ved hjælp af spredte, indsamlede serumkoncentrationsværdier fra fire kontrollerede kliniske undersøgelser.
English: Do not use Ribavirin BioPartners without advice of your doctor or pharmacist if you notice any change in the appearance of the tablets.
Danish: Brug ikke Ribavirin BioPartners uden at rådføre dig med din læge eller på apoteket, hvis du bemærker en ændring i udseendet af tabletterne.
English: Psychiatric and Central Nervous System (CNS):
Danish: Psykiatrisk og centralnervesystem (CNS):
English: - With zidovudine or stavudine, it is not certain if Ribavirin BioPartners will change the way these medicines work.
Danish: Med zidovudin eller stavudin er det ikke sikkert at Ribavirin BioPartners vil ændre den måde, disse lægemidler virker på.
English: When deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition.
Danish: Ved beslutning om ikke at udsætte behandlingen til barnet er voksen, er det vigtigt at betænke at kombinationsterapien forårsagede en væksthæmning.
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Danish: Dette udelukker imidlertid ikke forekomsten af hepatiske tilfælde hos patienter med cirrhosis (inklusive hepatocarcinoma).
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 vil måske overveje at bede et familiemedlem eller en tæt ven hjælpe dig med at være opmærksom på tegn på depression eller
English: If any of the following apply to you or your child you are caring for, do not take Ribavirin BioPartners, and tell your doctor if you:
Danish: Hvis noget af følgende sker for dig eller dit barn, du har ansvar for, skal du ikke tage Ribavirin BioPartners, og fortæl din læge, hvis du:
English: Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Danish: Enhver patient, som klager over forringet syn eller tab af syn, skal omgående have foretaget en komplet øjenundersøgelse.
English: Adults: ≥ 12 g/dl (females); ≥ 13 g/dl (males) Children and adolescents: ≥ 11 g/dl (females); ≥ 12 g/dl (males)
Danish: Voksne: ≥ 12 g/dl (kvinder); ≥ 13 g/dl (mænd) Børn og unge: ≥ 11 g/dl (kvinder); ≥ 12 g/dl (mænd)
English: - Blood tests will be done regularly to help your doctor to know if this treatment is working.
Danish: Blodundersøgelser vil blive foretaget regelmæssigt for at hjælpe din læge til at vide, om
English: Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Danish: Effekten af disse kovarianser på ribavirinclearance synes at være af begrænset klinisk betydning på grund af den kraftige restvariabilitet, der ikke tages
English: Elderly patients (≥ 65 years of age): Specific pharmacokinetic evaluations for elderly subjects have not been performed.
Danish: Ældre patienter (i alderen ≥ 65 år): Specifikke farmakokinetikundersøgelser hos ældre personer er ikke blevet udført.
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Danish: Ribavirin absorberedes hurtigt efter oral administration af en enkelt dosis (gennemsnitlig Tmax = 1,5 timer), efterfulgt af hurtig fordeling og forlængede eliminationsfaser (enkeltdosis halveringstid for absorption, distribution og elimination er hhv. 0,05, 3,73 og 79 timer).
English: Ribavirin: Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Danish: Ribavirin: Ribavirin er embryotoksisk, teratogent eller begge dele ved doser et godt stykke under den anbefalede humane dosis i alle dyrearter, i hvilke undersøgelser er blevet udført.
English: The use of Ribavirin BioPartners is contraindicated during pregnancy.
Danish: Anvendelsen af Ribavirin BioPartners er kontraindiceret under graviditet.
English: - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Danish: Anamnese med allerede eksisterende alvorlig hjertesygdom, inklusive ustabil eller ukontrolleret hjertesygdom, i de foregående seks måneder (se pkt.
English: Ribavirin BioPartners stops the multiplication of many types of viruses, including hepatitis C virus.
Danish: Ribavirin BioPartners stopper mangfoldiggørelsen af mange former for virus, heriblandt hepatitis C virus.
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Ribavirin and for seven months after treatment.
Danish: Selvom resultater fra omkring 300 prospektivt fulgte graviditeter med paternal eksposition for ribavirin ikke har vist en øget risiko for misdannelse sammenlignet med den almindelige population, og heller intet specifikt mønster af misdannelser, skal mandlige patienter ellerderes kvindelige partnere i fertil alder rådes til at anvende effektiv kontraception under behandling med Ribavirin og i syv måneder efter behandling.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 5 dated 27 April 2009 presented in Module 1.8.2 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen (version 5 dateret 27. april 2009, Modul 1.8.2), er på plads og fungerer, før
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Danish: Hvis du gør det, så husk at skylle din mund omhyggeligt bagefter.
English: Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 3).
Danish: Vejledninger for dosisjustering blev udviklet i kliniske undersøgelser (se Dosisjusteringsvejledninger, Tabel 3).
English: Ribavirin BioPartners is available in different pack sizes containing 84, 112, 140 or 168 film-coated tablets.
Danish: Ribavirin BioPartners fås i forskellige pakningsstørrelser indeholdende 84, 112, 140 eller 168
English: 2 tablets in the morning and 2 tablets in the evening 2 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 3 tablets in the evening 3 tablets in the morning and 4 tablets in the evening
Danish: 2 tabletter om morgenen og 2 tabletter om aftenen 2 tabletter om morgenen og 3 tabletter om aftenen 3 tabletter om morgenen og 3 tabletter om aftenen 3 tabletter om morgenen og 4 tabletter om aftenen
English: For children and adolescents weighing less than 47 kg a solution formulation is available.
Danish: Til børn og unge, der vejer mindre end 47 kg, er en opløsning tilgængelig.
English: Liver function: Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Danish: Leverfunktion: Enhver patient, der udvikler betydelig påvirkning af leverfunktionen under behandling, skal følges nøje.
English: It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Danish: Det anbefales, at de patienter, som har allerede eksistende hjerteproblemer, skal have taget elektrokardiogram før og under behandlingsforløbet.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Danish: Patienter bør børste deres tænder omhyggeligt to gange dagligt og få regelmæssige tandeftersyn.
English: Anti-thyroid antibody positive Injury, poisoning and procedural complications
Danish: Positiv anti-thyroid antistof Traumer, forgiftninger og behandlingskomplikationer
English: Use in the elderly (≥ 65 years of age): There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Danish: Anvendelse hos ældre (≥ 65 år): Der synes ikke at være en signifikant aldersrelateret effekt på ribavirins farmakokinetik.
English: Subjects 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: Your doctor has determined the correct dose of Ribavirin BioPartners based on how much you or the child
Danish: Din læge har bestemt den korrekte dosis af Ribavirin BioPartners på basis af din eller barnets
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: Ribavirin clinical trials in children and adolescents:
Danish: Ribavirin i kliniske undersøgelser hos børn og unge:
English: All patients in selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Danish: Alle patienter i valgte kronisk hepatitis C-undersøgelser fik foretaget en leverbiopsi før inklusion, men i visse tilfælde (eksempelvis patienter med genotype 2 og 3) kan behandling være mulig uden histologisk bekræftelse.
English: Ribavirin BioPartners film-coated tablets are packaged in blisters consisting of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) and aluminium foil.
Danish: Ribavirin BioPartners filmovertrukne tabletter er pakket i blisterpakninger, som består af polyvinylklorid (PVC)/polyvinylidenklorid (PVdC) og aluminiumfolie.