FrancophonIA/ELRC3.0 huggingface dataset:
English: Herpes zoster in immunocompetent adults 500 mg three times daily for 7 days ≥ 60
Danish: Herpes zoster hos immunkompetente voksne 500 mg 3 gange daglig i 7 dage ≥ 60
English: Commitments to be undertaken by the MAH were agreed.
Danish: Indehaveren af markedsføringstilladelsens forpligtelser blev fastlagt.
English: − the treatment of first and recurrent episodes of genital herpes in immunocompetent adults
Danish: • behandling af primær og recidiverende herpes genitalis hos immunkompetente voksne
English: FamciclovirSandoz 500 mg Filmtabletten
Danish: Famciclovir-Sandoz 500 mg Filmtabletten
English: Suppression of recurrent genital herpes in immunocompromised adults 500 mg twice daily.
Danish: Suppression af recidiverende herpes genitalis hos immunkompromitterede voksne 500 mg 2 gange daglig
English: 500 mg once daily for 7 days 250 mg once daily for 7 days Haemodialysis patients 250 mg following each dialysis during 7 days
Danish: 250 mg 1 gang daglig i 7 dage Hæmodialysepatienter 250 mg efter hver dialyse i 7 dage
English: FamciclovirSandoz 250 mg Filmtabletten
Danish: Famciclovir-Sandoz 250 mg Filmtabletten
English: Herpes zoster in immunocompromised adults 500 mg three times daily for ten days.
Danish: Herpes zoster hos immunkompromitterede voksne 500 mg 3 gange dagligt i 10 dage.
English: Use in patients with renal impairment In patients with impaired renal function dose adjustment is necessary (see sections 4.2 and 4.9).
Danish: Anvendelse hos patienter med nedsat nyrefunktion Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Herpes zoster in immunocompetent adults 500 mg three times daily for seven days.
Danish: Herpes zoster hos immunkompetente voksne 500 mg 3 gange dagligt i 7 dage.
English: Since 4 h haemodialysis resulted in up to 75% reduction in plasma penciclovir concentrations, famciclovir should be administered immediately following dialysis.
Danish: Famciclovir skal administreres umiddelbart efter dialyse, da 4 timers hæmodialyse reducerede plasmakoncentrationen af penciclovir med op til 75 %.
English: SUPPRESSION OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT AND IMMUNOCOMPROMISED ADULTS
Danish: SUPPRESSION AF RECIDIVERENDE GENITAL HERPES HOS IMMUNKOMPETENTE OG IMMUNKOMPROMITTEREDE VOKSNE
English: 500 mg twice daily for 10 days
Danish: 500 mg 2 gange daglig i 10 dage
English: − the treatment of recurrent episodes of genital herpes in immunocompromised adults
Danish: − behandling af recidiverende genital herpes hos immunkompromitterede voksne
English: 500 mg three times daily for 10 days
Danish: 500 mg 3 gange daglig i 10 dage
English: POSSIBLE SIDE EFFECTS
Danish: Ikke almindelige bivirkninger
English: 500 mg three times daily for 7 days
Danish: 500 mg 3 gange daglig i 7 dage
English: • Severe blistering of the skin or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (these could be signs of a serious allergic skin reaction, for frequency see below).
Danish: • Voldsom blæredannelse på hud eller slimhinder på læber, øjne, mund, næsen eller kønsdelene
English: If you are pregnant or think you may be, tell your doctor.
Danish: Fortæl det til din læge, hvis du er gravid eller tror, at du er det. Famvir må ikke tages under graviditet, medmindre det er strengt nødvendigt.
English: Genital herpes in immunocompetent adults - first episode of genital herpes 250 mg three times daily for 5 days ≥ 40
Danish: Herpes genitalis hos immunkompetente voksneprimær herpes genitalis 250 mg 3 gange daglig i 5 dage ≥ 40
English: General characteristics
Danish: Generelle karakteristika
English: No dose adjustment is recommended for patients with mild and moderate hepatic impairment (see sections 4.2 and 4.4).
Danish: Der kræves ingen dosisjustering hos patienter med mild til moderat nedsat leverfunktion (se pkt.
English: − the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults
Danish: − suppression af recidiverende genital herpes hos immunkompetente og immunkompromitterede voksne.
English: 500 mg twice daily for 7 days
Danish: 500 mg 2 gange daglig i 7 dage
English: 250 mg once daily
Danish: 250 mg 1 gang daglig
English: No differences in efficacy outcomes were noted between the 250mg and 500mg doses of famciclovir.
Danish: Der påvistes ingen effektforskelle mellem famciclovir-dosen på 250 mg og dosen på 500 mg. Alle doser af famciclovir var veltolererede, og der var ingen forskelle i hverken arten eller forekomsten af bivirkninger mellem de forskellige doser.
English: Herpes zoster in immunocompromised adults 500 mg three times daily for 10 days
Danish: Herpes zoster hos immunkompromitterede voksne 500 mg 3 gange daglig i 10 dage ≥ 60
English: is effective and safe in suppressing recurrent HSV outbreaks in HIV-infected patients.
Danish: Sammenfattende er famciclovir 500 mg BID effektivt og sikkert ved suppression af recidiverende HSV-udbrud hos hivinficerede patienter.
English: 500 mg once daily
Danish: 500 mg 1 gang daglig
English: What Famvir looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: 250 mg twice daily
Danish: 250 mg 2 gange dalig
English: please tell your doctor or pharmacist.
Danish: Fortæl det til din læge, hvis du ammer.
English: Famciclovir Sandoz
Danish: Famciclovir Sandoz 250 mg
English: Rash, pruritus.
Danish: Udslæt, kløe.
English: Patients with renal impairment on haemodialysis
Danish: Patienter med nedsat nyrefunktion i hæmodialyse
English: • Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden
English: 125 mg twice daily for 5 days 125 mg once daily for 5 days Haemodialysis patients 125 mg following each dialysis during 5 days
Danish: Hæmodialysepatienter 125 mg efter hver dialyse i 5 dage
English: 125 mg once daily
Danish: 125 mg 1 gange daglig i 5 dage
English: Suppression of recurrent genital herpes in immunocompromised adults
Danish: Suppression af recidiverende herpes genitalis hos immunkompromitterede voksne.
English: 125 mg twice daily
Danish: 125 mg 2 gange daglig 125 mg 1 gang daglig
English: Use in patients with hepatic impairment
Danish: Anvendelse hos patienter med nedsat leverfunktion
English: Dizziness, somnolence.
Danish: Svimmelhed, døsighed.
English: Famciclovir has not been studied in patients with severe hepatic impairment.
Danish: Der er ingen studier af indgift af famciclovir til patienter med alvorlig nedsat leverfunktion (se pkt.
English: Kύπρος Γ.Α.Σταμάτης & Σια Λτδ.
Danish: Κύπρος Γ.Α.Σταμάτης & Σια Λτδ.
English: Some of them might be serious
Danish: Nogle af dem kan være alvorlige.
English: The number of serious infections was too low to draw definitive conclusions.
Danish: Antallet af alvorlige infektioner var for lavt til at drage endelige konklusioner.
English: Infusion 2 (2 weeks later)
Danish: Infusion 2 (2 uger senere)
English: In rare cases, some of these infections were fatal.
Danish: I sjældne tilfælde var nogle af disse infektioner dødelige.
English: * All patients in this analysis had a minimum of 120 weeks of follow-up.
Danish: *Alle patienter i denne analyse havde mindst 120 ugers opfølgning.
English: Adults over 55 years old and elderly population
Danish: Voksne over 55 år og ældre
English: There have been no studies performed with other routes of administration.
Danish: Der er ikke gennemført studier med andre administrationsveje.
English: The primary analysis is based on all events accrued.
Danish: Den primære analyse er baseret på alle opsamlede hændelser.
English: · Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP)
English: In most cases these are mild reactions but some serious reactions can happen.
Danish: I de fleste tilfælde er reaktionerne milde, men der kan forekomme alvorlige reaktioner.
English: Delayed or Missed Doses
Danish: Forsinkede eller manglende doser
English: The symptoms can appear suddenly within a few hours, or slowly over several days.
Danish: Symptomerne kan komme pludseligt, inden for få timer eller langsommere over flere dage.
English: See section 4.5 and 5.1 for further information about vaccinations.
Danish: 4.5 og 5.1 for yderligere information om vaccinationer.
English: Effect on the immune system :
Danish: Virkning på immunsystemet:
English: You must not be given Ocrevus:
Danish: Du må ikke få Ocrevus:
English: Your blood B-cells will gradually increase to normal levels.
Danish: B-cellerne i blodet vil gradvist stige til det normale niveau.
English: Demographic and baseline characteristics were well balanced across the two treatment groups.
Danish: Demografi- og baseline-karakteristika var velbalancerede på tværs af de to behandlingsgrupper.
English: A risk to neonates and infants cannot be excluded.
Danish: En risiko for nyfødte og spædbørn kan ikke udelukkes.
English: · It is important to continue your treatment for as long as you and your doctor decide that it is helping you.
Danish: • Det er vigtigt, at du fortsætter behandlingen så længe du og lægen har besluttet, at du har gavn af den.
English: Disease history at screening
Danish: Sygdomshistorie ved screening
English: This can take from six months to two and a half years, or up to several years in rare cases.
Danish: Det kan tage fra 6 måneder til 2½ år, og i sjældne tilfælde op til flere år.
English: They will watch you closely while you are being given this medicine.
Danish: De vil følge dig tæt, mens du får denne medicin.
English: · you have cancer or if you have had cancer in the past.
Danish: • du har en kræftsygdom eller tidligere har haft kræft.
English: Patients over 55 years of age were not studied.
Danish: Patienter over 55 år blev ikke undersøgt.
English: · Some side effects can be related to having low B cells.
Danish: • Nogle bivirkninger kan være relateret til at have lavt antal B-celler.
English: The terminal elimination half-life of ocrelizumab was 26 days.
Danish: Den terminale elimination halveringstid for ocrelizumab var 26 dage.
English: · low levels of a type of white blood cell (neutropenia)
Danish: • lave antal af en bestemt type hvide blodlegemer (neutropeni)
English: · Keep this leaflet.You may need to read it again.
Danish: Du kan få brug for at læse den igen.
English: Age 18-55 years, EDSS of 3.0 to 6.5
Danish: Alder 18-55 år, EDSS på 3,0 til 6,5
English: Patients should follow standard breast cancer screening per local guidelines.
Danish: Patienter skal følge standard brystkræft screening per lokale retningslinjer.
English: Please see section 4.2 for populations not studied.
Danish: 4.2 for populationer, der ikke er undersøgt.
English: It is recommended that the product is used immediately after dilution.
Danish: Det anbefales, at produktet anvendes straks efter fortynding.
English: There is a limited amount of data from the use of Ocrevus in pregnant women.
Danish: Der er begrænsede data vedrørende brug af Ocrevus hos gravide kvinder.
English: In addition, innate immunity and total T-cell numbers are not affected.
Danish: Derudover påvirkes den naturlige immunitet og det totale antal af T-celler ikke.
English: This is because Ocrevus may lower blood pressure.
Danish: Det er fordi Ocrevus kan sænke blodtrykket.
English: The studies enrolled patients with active disease.
Danish: Studierne inkluderede patienter med aktiv sygdom.
English: Ocrevus treatment may further increase the risk of severe pneumonia in these patients.
Danish: Ocrevus behandling kan yderligere øge risikoen for alvorlig pneumoni hos disse patienter.
English: This is in case you get any side effects.
Danish: Dette er i tilfælde af, at du får nogle bivirkninger.
English: Disposal of unused/expired medicines
Danish: Bortskaffelse af ubrugt/udløbet lægemiddel
English: The capacity of B-cell reconstitution and preexisting humoral immunity are preserved.
Danish: B-cellernes evne til at gendannes og allerede eksisterende humoral immunitet bevares.
English: Treatment of severely immunocompromised patients
Danish: Behandling af svært immunkompromitterede patienter
English: · Diseases that affect your immune system: if you have another disease which affects the immune system.
Danish: • Sygedomme, som påvirker dit immunsystem: hvis du har en anden sygdom, som påvirker immunsystemet.
English: Ocrevus will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Danish: Ocrevus vil blive givet til dig af en læge eller sygeplejerske, der har erfaring med brugen af denne behandling.
English: What is Multiple Sclerosis
Danish: Hvad er multipel sclerose
English: The symptoms disappear or improve between relapses but damage may build up and lead to permanent disability.
Danish: Symptomerne forsvinder eller forbedres mellem attakkerne men skaderne kan ophobe sig og medføre blivende handicap.
English: A hypersensitivity reaction could also occur (acute allergic reaction to medicinal product).
Danish: Der kan også forekomme overfølsomhedsreaktioner (akut allergisk reaktion overfor lægemidlet).
English: · Talk to your doctor before vaccinating your baby.
Danish: • Tal med lægen før vaccination af dit spædbarn.
English: Patients with baseline score < 2 were not included in analysis.
Danish: Patienter med en baseline-score <2 blev ikke inkluderet i analysen.
English: Do not wait until your next planned infusion.
Danish: Vent ikke til næste planlagte dosis.
English: No formal pharmacokinetic study has been conducted.
Danish: Der er ikke gennemført formelle farmakokinetiske studier.
English: · you are taking medicines for high blood pressure.
Danish: • du får medicin mod forhøjet blodtryk.
English: In the controlled period of the clinical trials, the incidence of non-melanoma skin cancers was low and there was no imbalance between treatment groups.
Danish: I den kontrollerede periode af de kliniske studier var forekomsten af non-melanom hudkræft lav, og der var ikke ubalance mellem behandlingsgrupperne.
English: You may not be able to receive Ocrevus.
Danish: Du kan muligvis ikke få Ocrevus.
English: · This medicine is to be stored in a refrigerator (2oC - 8oC).
Danish: • Dette lægemiddel skal opbevares i køleskab (2oC-8oC).
English: See section 4.4 ‘Treatment of severely immunocompromised patients' for information about the use of immunosuppressants before, during or after Ocrevus treatment.
Danish: 4.4 "Behandling af svært immunkompromitterede patienter" for information om brug af immunosuppressive midler før, under eller efter Ocrevus behandling.
English: 300 mg in 250 mL
Danish: 300 mg i 250 ml
English: It is a type of protein called a ‘monoclonal antibody'.
Danish: Det er en type protein, der kaldes monoklonalt antistof.
English: Animal studies (embryo-foetal toxicity) do not indicate teratogenic effects.
Danish: Dyrestudier (embryo-føtal toksicitet) har ikke vist tegn på teratogen virkning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 8 January 2018
Danish: Dato for første markedsføringstilladelse: 8. januar 2018
English: MRI evidence should be used to confirm inflammatory activity in all patients.
Danish: MRI skal anvendes til at bekræfte inflammatorisk aktivitet hos alle patienter.
English: Within each System Organ Class, the adverse reactions are presented in order of decreasing frequency.
Danish: Inden for de enkelte systemorganklasser præsenteres bivirkningerne efter faldende frekvens.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Begrundelse for ikke at inkludere brailleskrift er accepteret.
English: Non-confirmatory p-value; hierarchical testing procedure terminated before reaching endpoint.
Danish: 6 Ikke-bekræftende p-værdi; hierakisk testprocedure fastlagt inden endepunkt nås.
English: It will be given as an infusion into a vein (intravenous infusion or IV infusion).
Danish: Det gives som en infusion i en vene (intravenøs infusion eller IV infusion).
English: Cough, catarrh
Danish: Hoste, katar
English: Ocrevus should be avoided during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Danish: Ocrevus skal undgås under graviditet med mindre den potentielle gavn for moderen opvejer den potientielle risiko for fostret.
English: It is unknown whether ocrelizumab/metabolites are excreted in human milk.
Danish: Det vides ikke om ocrelizumab/metabolitter udskilles i human mælk.
English: Multiple Sclerosis (MS) affects the central nervous system, especially the nerves in the brain and spinal cord.
Danish: Multipel sclerose påvirker centralnervesystemet, særligt nerverne i hjernen og rygmarven.
English: After you stop Ocrevus treatment, you may still experience side effects until your B-cells return to normal.
Danish: Når du holder op med at få Ocrevus, kan du stadig opleve bivirkninger, indtil dine B-celler vender tilbage til det normale niveau.
English: The following side effects have been reported with Ocrevus:
Danish: Følgende bivirkninger er indberettet efter brug af Ocrevus:
English: The treatment interval of 6 months (with a minimum of 5 months) for Ocrevus should be maintained between doses (see Table 1).
Danish: Behandlingsintervallet på 6 måneder (med et minimum på 5 måneder) for Ocrevus skal opretholdes mellem doseringerne (se Tabel 1).
English: This reduced rate should be maintained for at least 30 minutes.
Danish: Den reducerede hastighed skal fortsætte i mindst 30 minutter.
English: Mean number of relapses in the last year
Danish: Gennemsnitligt antal attakker inden for det sidste år
English: Pharmacokinetics in Special Populations
Danish: Farmakokinetik i særlige populationer
English: Treatment with Ocrevus resulted in a decrease in total immunoglobulins over the controlled period of the studies, mainly driven by reduction in IgM.
Danish: Behandling med Ocrevus medførte fald i total-immunoglobuliner under kontrolperioden i studierne, primært drevet af reduktion i IgM.
English: An increase in incidence was observed between years 3 and 4 of treatment due to basal cell carcinoma, which was not observed in subsequent years.
Danish: En stigning i forekomsten blev observeret mellem 3. og 4. år af behandlingen på grund af basalcellekarcinom, som ikke blev observeret i de efterfølgende år.
English: · To get the full benefit of Ocrevus, it is important that you receive each infusion when it is due.
Danish: • For at få fuldt udbytte af Ocrevus, er det vigtigt, at du får alle infusioner til tiden.
English: Contraception for women
Danish: Prævention for kvinder
English: Ocrevus contains sodium
Danish: Ocrevus indeholder natrium
English: · Do not use Ocrevus if you are pregnant unless you have discussed this with your doctor.
Danish: • Du må ikke få Ocrevus, hvis du er gravid, med mindre du har aftalt det med lægen.
English: · Before you start treatment with Ocrevus and before subsequent infusions, your doctor may ask you to have a blood test to verify your immune system because infections may occur more frequently in case of severe problems with your immune system.
Danish: • Inden du begynder behandling med Ocrevus og inden de efterfølgende infusioner, kan din læge bede dig om at få taget en blodprøve til at kontrollere dit immunsystem, fordi infektioner kan forekomme oftere i tilfælde af alvorlige problemer med dit immunsystem.
English: Antibodies work by attaching to specific targets in your body.
Danish: Antistoffer virker ved at binde sig til bestemte celler inde i kroppen.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ocrelizumab, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for ocrelizumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: Considering the first report of hepatitis B reactivation published for ocrelizumab and described in the previous PSUR, the PRAC recommended a minor revision of the statements in section 4.4 of the SmPC on the risk of hepatitis B reactivation.
Danish: I betragtning af den første rapport om hepatitis B-reaktivering, der blev offentliggjort for ocrelizumab og beskrevet i den foregående PSUR, anbefalede PRAC en mindre revision af udsagnene i afsnit 4.4 i produktresuméet om risikoen for hepatitis B-genaktivering.
English: In PPMS, patients with swallowing difficulties are at a higher risk of aspiration pneumonia.
Danish: Ved PPMS er patienter med synkebesvær i højere risiko for aspirationspneumoni.
English: Baseline characteristics
Danish: Baseline-karakteristika
English: · you have ever had hepatitis B or are a carrier of the hepatitis B virus.
Danish: • du har haft hepatitis B eller er bærer af hepatitis B-virus.
English: This is because the immune cells that Ocrevus targets also help to fight infection.
Danish: Det er fordi de immunceller, som Ocrevus er rettet mod også hjælper med at bekæmpe infektioner.
English: Pharmacotherapeutic group: selective immunosuppressants group, ATC code: L04AA36.
Danish: Farmakoterapeutisk klassifikation: selektive immunsupprimerende midler, ATC-kode: L04AA36.
English: The safety and timing of vaccination should be discussed with the infant's physician (see section 4.6).
Danish: Sikkerhed og planlægning af vaccination skal diskuteres med spædbarnets læge (se pkt.
English: Physicians should take prompt action for patients presenting with pneumonia.
Danish: Læger bør handle hurtigt overfor patienter med pneumoni.
English: The course of both neonatal infections could have potentially been impacted by B-cell depletion.
Danish: Forløbet af begge neonatale infektioner kunne potentielt være påvirket af lavt B-celle-niveau.
English: Clinical trial data have shown an association between decreased levels of IgG (and less so for IgM or IgA) and serious infections.
Danish: Kliniske data har vist en sammenhæng mellem et fald i niveauet af IgG (samt et mindre fald for IgM eller IgA) og alvorlige infektioner.
English: An increase in the rate of serious infections was observed in RMS between Years 2 and 3, but not in subsequent years.
Danish: En stigning i antallet af alvorlige infektioner blev observeret i attakvis multipel sclerose mellem 2. og 3. år, men ikke i de efterfølgende år.
English: See section 4.4 and section 4.8 (subsection ‘Description of selected adverse reactions') for further details.
Danish: 4.8 (underafsnittet: ‘Beskrivelse af udvalgte bivirkninger') for yderligere detaljer.
English: The final drug concentration after dilution is approximately 1.2 mg/mL.
Danish: Den endelige lægemiddelkoncentration efter fortynding er ca. 1,2 mg/ml.
English: Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg ocrelizumab every six months after they become 55 and older.
Danish: Patienter, der deltager i de igangværende kliniske studier, fortsætter med at blive doseret med 600 mg ocrelizumab hver 6. måned efter at de er blevet 55 år og ældre.
English: Event-driven (Minimum 120 weeks and 253 confirmed disability progression events) (Median follow-up time: Ocrevus 3.0 years, Placebo 2.8 years
Danish: Hændelsesdrevet (mindst 120 uger og 253 bekræftede hændelser af handicapudvikling) (Median for opfølgning: Ocrevus 3,0 år; placebo 2,8 år
English: Individual benefit risk should be considered in patients with known risk factors for malignancies and in patients who are being actively monitored for recurrence of malignancy.
Danish: En individuel afvejning af fordele og ulemper skal overvejes hos patienter med kendte risikofaktorer for maligniteter og hos patienter, der aktivt monitoreres for recidiv af malignitet.
English: Before your Ocrevus treatment, your doctor will check if you are at risk of hepatitis B infection.
Danish: Inden du behandles med Ocrevus, vil lægen derfor kontrollere, om du er i risiko for hepatitis B-infektion.
English: Relative Increase (Pooled Analysis1) Relative Increase (Individual Studies
Danish: Relativ stigning (poolet analyse1) Relativ stigning (individuelle studier2)
English: · Ocrevus will be given to you by a doctor or a nurse.
Danish: • Ocrevus gives af en læge eller sygeplejerske.