FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, clinical results at week 104 in telbivudine-treated patients were consistent with those at week 52, demonstrating durability of efficacy responses for telbivudine-treated patients with continued treatment.
Danish: Der blev demonstreret varig effekt hos patienter i fortsat telbivudinbehandling, idet kliniske resultater, i uge 104 hos patienter behandlet med telbivudin, var i overensstemmelse med dem, der blev observeret efter 52 uger
English: ALT normalisation n/N (%)
Danish: ALAT normalisering n/N (%)
English: Ishak fibrosis score ≤ 1 (no or minimal fibrosis) was observed in
Danish: Knodells nekroinflammatorisk score ≤3 (ingen eller minimal nekroinflammation) blev observeret hos
English: Cmax (g/ml) AUC0-∞ (g•h/ml) CLRENAL (ml/min)
Danish: AUC0-∞ (g•t/ml)
English: Each ml contains 20 mg telbivudine.
Danish: Hver ml indeholder 20 mg telbivudin.
English: Dry the cup with a clean tissue and place it back over the cap of the bottle.
Danish: Tør koppen med et rent stykke køkkenrulle og sæt den tilbage på låget.
English: Cases of rhabdomyolysis have been reported during post-marketing use of telbivudine (see section 4.8).
Danish: Post-marketing er der rapporteret tilfælde af rabdomyolyse ved brug af telbivudin (se pkt.
English: Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily.
Danish: Voksne Den anbefalede dosis Sebivo er 30 ml, svarende til 600 mg, 1 gang dagligt.
English: Mean HBV DNA reduction from baseline (log10 copies/ml) ± SEM % Patients HBV DNA undetectable by PCR
Danish: udgangsværdi (log10 kopier/ml) ± SEM % patienter med ikke målbart HBV-DNAved PCR
English: Excipient with known effect: A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: En dosis på 600 mg (30 ml) oral opløsning indeholder ca. 47 mg natrium.
English: If you experience any of these symptoms during your treatment with Sebivo, call your doctor immediately.
Danish: Kontakt straks din læge, hvis du oplever nogen af disse symptomer under behandling med Sebivo.
English: In the pooled analysis from NV-02B-007 (GLOBE) and NV-02B-015, by 104 weeks of treatment grade 3 or4 CK elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients (n = 847) and 4.0% of lamivudine-treated patients (n = 846).
Danish: CK-forhøjelser af grad 3 eller 4 (>7x ULN) forekom i den samlede analyse fra NV-02B-007 (GLOBE) og NV-02B-015, af 104 ugers behandlingsvarighed hos 12,6 % af de telbivudin-behandlede patienter (n=847) og hos 4,0 % af de lamivudin-behandlede patienter (n=846).
English: Before pouring any solution into the cup, please check the position of the 5 and 10 ml marks to avoid any potential waste or spillage.
Danish: For at undgå spild bør du tjekke, hvor målestregerne for 5 ml og 10 ml er på doseringskoppen, inden du hælder opløsningen op i koppen.
English: Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
Danish: Hos patienter, der behandles med telbivudin, er perifer neuropati blevet rapporteret med frekvensen ikke almindelig.
English: Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily.
Danish: Voksne Den anbefalede dosis Sebivo er 600 mg (1 tablet) 1 gang dagligt.
English: Study CLDT600A2303 - Clinical results over 208 weeks Study CLDT600A2303 was an open-label 104-week extension study in patients with compensated chronic hepatitis B who were previously treated with telbivudine for 2 years including patients from studies NV-02B-007 (GLOBE) and NV-02B-015, providing efficacy and safety data after 156 and 208 weeks of continuous telbivudine therapy.
Danish: CLDT600A2303-studiet - Kliniske resultater over 208 uger CLDT600A2303-studiet var et åbent 104-ugers forlængelsesstudie hos patienter med kompenseret kronisk leversygdom B, der tidligere var behandlet med telbivudin i 2 år, inklusiv patienter fra studierne NV-02B-007 (GLOBE) og NV-02B-015.
English: The combination of telbivudine with any interferon alfacontaining product is contraindicated (see section 4.3).
Danish: Samtidig behandling af telbivudin med enhvert præparat, der indeholder interferon alfa, er kontraindiceret (se pkt.
English: Table 2 Adverse reactions
Danish: Tabel 2 Bivirkninger
English: Telbivudine should be administered after haemodialysis.
Danish: Telbivudin skal administreres efter hæmodialyse.
English: Hold the syringe above the cup.
Danish: Hold sprøjten over doseringskoppen.
English: Each film-coated tablet contains 600 mg telbivudine.
Danish: Hver filmovertrukket tablet indeholder 600 mg telbivudin.
English: HBV DNA undetectability n/N (%)
Danish: Ikke målbart HBV-DNA n/N (%)
English: In general, caution must be exercised when prescribing Sebivo to older patients in view of the greater frequency of decreased renal function due to concomitant disease or concomitant use of other medicinal products.
Danish: I betragtning af den højere frekvens af nedsat nyrefunktion forårsaget af samtidig sygdom eller samtidig brug af andre lægemidler skal der generelt udvises forsigtighed, når Sebivo ordineres til ældre.
English: Cross-resistance has been observed among HBV nucleoside analogues (see section 4.4).
Danish: Der er set krydsresistens hos HBV-nukleosidanaloger.
English: Telbivudine 600 mg (n = 199)
Danish: Telbivudin 600 mg (n=199)
English: ALT normalisation HBeAg seroconversion HBeAg loss
Danish: HBeAgserokonvertering HBeAg-tab
English: Therefore, the combination of telbivudine with pegylated or standard interferon alfa is contraindicated (see section 4.3).
Danish: Derfor er samtidig behandling af telbivudin med pegyleret eller standard interferon alfa kontraindiceret (se pkt.
English: One ml contains 20 mg telbivudine.
Danish: En ml indholder 20 mg telbivudin.
English: One tablet contains 600 mg telbivudine.
Danish: En tablet indeholder 600 mg telbivudin.
English: Sebivo 20 mg/ml [folding box only]
Danish: Sebivo 20 mg/ml [kun karton]
English: Lamivudine 100 mg (n = 386)
Danish: Lamivudin 100 mg (n=386)
English: The recommended dose of Sebivo is one 600 mg tablet once a day.
Danish: Den anbefalede dosis Sebivo er 1 tablet á 600 mg 1 gang dagligt.
English: Lamivudine 100 mg (n = 207)
Danish: Lamivudin 100 mg (n=207)
English: The NV-02B-007 (GLOBE) study is a randomised, double-blind, multinational phase III study of telbivudine compared to lamivudine for a treatment period of 104 weeks in 1,367 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative patients.
Danish: NV-02B-007 (GLOBE)-studiet er et randomiseret, dobbeltblindet, multinationalt fase III-studie af telbivudin sammenlignet med lamivudin i en behandlingsperiode på 104 uger.
English: Telbivudine 600 mg (n = 222)
Danish: Telbivudin 600 mg (n=222)
English: Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.
Danish: Resultatet af disse tests er afgørende for, hvor tit du skal tage Sebivo - derfor vil din læge måske råde dig til at ændre det. - hvis du lider af levercirrose (en alvorlig lidelse, der forårsager ”ardannelse” på leveren).
English: Table 4 Summary of post-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV02B-015 studies
Danish: Tabel 4 Opsummering af ALAT-stigning efter behandling - data fra de poolede studier NV02B-007 (GLOBE) og NV-02B-015
English: You may need to take Sebivo less frequently if you have kidney problems.
Danish: Hvis du har nyreproblemer, skal du muligvis ikke tage Sebivo så tit.
English: Lamivudine 100 mg (n = 224)
Danish: Lamivudin 100 mg (n=224)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Sebivo Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Telbivudine 600 mg (n = 458)
Danish: Telbivudin 600 mg (n=458)
English: Lamivudine 100 mg (n = 463)
Danish: Lamivudin 100 mg (n=463)
English: HBV DNA at week 24
Danish: Baseline til uge 24
English: Before pouring any solution into the cup, please check the position of the appropriate graduation to avoid any potential waste or spillage.
Danish: For at undgå spild, skal du tjekke, hvor den korrekte målestreg er i doseringskoppen, inden du hælder opløsningen op i koppen.
English: Sebivo 20 mg/ml oral solution
Danish: Sebivo 20 mg/ml oral opløsning
English: Discard the solution left in the cup into the sink.
Danish: 10. Smid opløsningen fra koppen i vasken.
English: Table 3 Summary of on-treatment ALT flares - Pooled NV-02B-007 (GLOBE) and NV-02B015 studies
Danish: Tabel 3 Opsummering af ALAT-stigninger under behandling - data fra de poolede studier NV-02B-007 (GLOBE) og NV-02B-015
English: Each tablet contains 600 mg telbivudine.
Danish: Hver tablet indeholder 600 mg telbivudin.
English: Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/min, including patients on haemodialysis.
Danish: Justering af dosisinterval anbefales derfor hos patienter med kreatininclearance <50 ml/min, herunder patienter i hæmodialyse.
English: Telbivudine 600 mg (n = 384)
Danish: Telbivudin 600 mg (n=384)
English: Rinse the cup and syringe with clean water.
Danish: Rengør doseringskoppen og sprøjten med vand.
English: If you are on a controlled sodium diet, ask your doctor for advice.
Danish: Spørg din læge til råds, hvis du er på en kontrolleret natrium diæt.
English: Genotypic analysis of 203 evaluable sample pairs with HBV DNA ≥ 1,000 copies/ml at week 104 (NV-02B-007 (GLOBE)) demonstrated that the primary mutation associated with telbivudine resistance was rtM204I, often associated with mutations rtL180M and rtL80I/V and infrequently with rtV27A, rtL82M, rtV173L, rtT184I and rtA200V.
Danish: Telbivudinresistens var ofte forbundet med mutationerne rtL180M og rtL801/V og sjældent med mutationerne rtV27A, rtL82M, rtV173L, rtT184I og rtA200V.
English: Telbivudine 20 mg/ml oral solution
Danish: Telbivudin 20 mg/ml oral opløsning
English: For full instructions on how to take Sebivo, see section “Instructions for use” at the end of this leaflet.
Danish: Se afsnittet 'Brugsanvisning' sidst i denne indlægsseddel for yderligere information om, hvordan du tager Sebivo.
English: Sebivo 600 mg film-coated tablets
Danish: Sebivo 600 mg filmovertrukne tabletter
English: While you are taking Sebivo, make sure you do not run out of Sebivo.
Danish: Hold ikke op med Sebivo, medmindre din læge siger det. Sørg for ikke at løbe tør for Sebivo, mens du er i behandling med Sebivo.
English: Numbness, tingling, pain and/or burning sensation in the arms and/or legs or around the mouth Pain in lower back or hip that may radiate into the leg (sciatica) Taste disturbance
Danish: Ikke almindelige (kan forekomme hos 1 ud af 100 patienter) - Ledsmerter - Vedvarende nedsat muskelkraft eller muskelsmerter (myopati/myositis), muskelkramper - Ryg, nakke og smerte i siden Følelsesløshed, prikken, smerte og/eller brændende fornemmelse i armene og/eller benene eller rundt om munden Smerte i nedre del af ryg eller hofte som sommetider kan mærkes ned i benet (iskias) Smagsforstyrrelser - Man føler sig skidt tilpas (utilpashed)
English: Malaise
Danish: Laktatacidose
English: What Sebivo is and what it is used for What you need to know before you take Sebivo How to take Sebivo
Danish: Det skal du vide, før du begynder at tage Sebivo Sådan skal du tage Sebivo Bivirkninger
English: Telbivudine 600 mg film-coated tablet
Danish: Telbivudin 600 mg filmovertrukne tabletter
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Tabeloversigt over bivirkninger
English: 300 copies/ml to < 3 log10 copies/ml ≥ 3 log10 copies/ml 82/190 (43) 54/190 (28) 23/188 (12) 106/184 (58) 90/190 (47)
Danish: CLRENAL (ml/min) 126,7±48,3 83,3±20,0 43,3±20,0 11,7±6,7
English: Combination of telbivudine with pegylated or standard interferon alfa (see sections 4.4 and 4.5).
Danish: Samtidig behandling af telbivudin med pegyleret eller standard interferon alfa (se pkt.
English: Sebivo 20 mg/ml oral solution telbivudine
Danish: Sebivo 20 mg/ml oral opløsning Telbivudin
English: Sebivo 20 mg/ml oral solution Telbivudine
Danish: Sebivo 20 mg/ml oral opløsning telbivudin
English: Sebivo 600 mg film-coated tablets Telbivudine
Danish: Sebivo 600 mg filmovertrukne tabletter telbivudin
English: Sebivo 600 mg film-coated tablets telbivudine
Danish: Sebivo 600 mg filmovertrukne tabletter Telbivudin
English: Renally impaired patients on haemodialysis
Danish: Patienter med nedsat nyrefunktion i hæmodialyse
English: HBeAg-positive < 300 copies/ml
Danish: HBeAg-positiv <300 kopier/ml 300 kopier/ml til <3 log10 kopier/ml ≥3 log10 kopier/ml HBeAg-negativ <300 kopier/ml
English: Other medicines and Sebivo
Danish: Hvis du har taget for mange Sebivo-tabletter
English: This request was based on the following reasons:
Danish: Anmodningen tog udgangspunkt i følgende:
English: The final opinion was converted into a Decision by the European Commission on 19 November 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 19. november 2008.
English: - There are other alternative treatments available for the above-mentioned indication.
Danish: - Der er tilgængelige alternativer til behandling af ovennævnte indikation.
English: The referral procedure started on 20 September 2007.
Danish: Indbringelsesproceduren blev indledt den 20. september 2007.
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 24 July 2008.
Danish: * Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 24. juli 2008.
English: Written explanations were provided by the Marketing Authorisation Holder by 25 February and 20 June 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 25. februar og den 20. juni 2008.
English: - Pyelonephritis is often associated with bacteraemia.
Danish: - Pyelonefritis forbindes ofte med bakteriæmi.
English: The Rapporteur and Co-Rapporteur appointed were: Dr. Ondřej Slanař and Dr. Pieter Neels, respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. Ondřej Slanař og dr. Pieter Neelsy.
English: The same objections are obviously valid for the oral treatment of uncomplicated pyelonephritis.
Danish: Samme indvendinger gør sig selvsagt også gældende for peroral behandling af ukompliceret pyelonefritis.
English: - Complicated pyelonephritis can be treated orally or intravenously (according to local treatment policy and diagnostic criteria used for defining complicated infection).
Danish: - Kompliceret pyelonefritis kan behandles peroralt eller intravenøst (afhængigt af den lokale behandlingspolitik og de diagnostiske kriterier, der anvendes til bestemmelse af en kompliceret infektion).
English: 13 January 2009 EMEA/660192/2008 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL Norfloxacin containing medicinal products International non-proprietary name (INN): norfloxacin BACKGROUND INFORMATION *
Danish: 13. januar 2009 EMEA/CHMP/89938/2009 UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31 Lægemidler indeholdende norfloxacin Internationalt fællesnavn (INN): norfloxacin BAGGRUNDSOPLYSNINGER *
English: On 14 September 2007, Belgium referred the matter to the EMEA under Article 31 of Directive 2001/83/EC and asked the CHMP to give its opinion on whether the marketing authorisations for oral formulations of medicinal products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the re-assessment of norfloxacin benefit/risk balance.
Danish: Den 14. september 2007 indbragte Belgien en sag for EMEA i henhold til artikel 31 i direktiv 2001/83/EF og anmodede CHMP om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for perorale formuleringer af lægemidler indeholdende norfloxacin til behandling af akut eller kronisk kompliceret eller ukompliceret pyelonefritis skulle opretholdes, ændres, suspenderes eller trækkes tilbage i hele Den Europæiske Union efter revurderingen af benefit/risk-forholdet for norfloxacin.
English: Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP concluded that for oral formulations of norfloxacin containing medicinal products the benefit does not outweigh the risk in acute or chronic complicated pyelonephritis, and therefore adopted an opinion on 24 July 2008 recommending the variation of the Marketing Authorisations by removing the therapeutic indication “acute and chronic complicated pyelonephritis” from the Product Information for the norfloxacin containing medicinal products taken orally.
Danish: På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporterne fra rapportørerne konkluderede CHMP, at fordelene ved de perorale formuleringer af lægemidler indeholdende norfloxacin ikke opvejer risiciene til behandling af akut eller kronisk kompliceret pyelonefritis, og vedtog en udtalelse den 24. juni 2008, hvori det anbefaledes at ændre markedsføringstilladelserne ved at fjerne den terapeutiske indikation “akut og kronisk kompliceret pyelonefritis” fra produktoplysningerne for lægemidler indeholdende norfloxacin til peroral indtagelse.
English: Norfloxacin containing medicinal products, which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Danish: Lægemidler, der indeholder norfloxacin, og som kun er tilgængelige i en peroral formulering, giver ikke tilstrækkelige serumniveauer til behandling af samtidig bakteriæmi.
English: Second generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
Danish: Andengenerationsfluoroquinoloner såsom ciprofloxacin, ofloxacin og levofloxacin giver højere serumkoncentrationer og langt bedre fordeling i væv end norfloxacin.
English: Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
Danish: Norfloxacin er et bredspektret, baktericidt quinolonderivat, der er indiceret til behandling af akut eller kronisk kompliceret eller ukompliceret pyelonefritis fremkaldt af bakterier, som er følsomme over for norfloxacin.
English: In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
Danish: Ved peroral behandling virker andengenerations-fluoroquinoloner bedre end norfloxacin, fordi de giver højere serum- og vævsniveauer.
English: A positive change indicates improvement.
Danish: En positiv ændring indikerer forbedring.
English: In addition, a post-hoc definition of response is provided in the same table.
Danish: Ydermere er en post-hoc definition af respons vist i samme tabel.
English: You may require medical attention.
Danish: Du kan have brug for lægehjælp.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppighed kan ikke beregnes ud fra tilgængelige data)
English: It is not known if this occurs in humans.
Danish: Det vides ikke, om dette er tilfældet hos mennesker.
English: • Seeing things that are not there (hallucinations)
Danish: • Ser ting, der ikke er der i virkeligheden (hallucinationer)
English: • Treatment usually starts with a low dose.
Danish: • Behandlingen starter normalt med en lav dosis.
English: The in vivo micronucleus test was negative.
Danish: In vivo micronucleus-testen var negativ.
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Danish: Hovedmetabolitten NAP226-90 viste heller ikke genotoksisk potentiale.
English: Patients with Clinically Significant Response (%) Intent to Treat
Danish: Patienter med klinisk signifikant respons (%) Intention to Treat
English: They also have some additional side effects:
Danish: De får også visse andre bivirkninger:
English: • Your doctor will slowly increase your dose depending on how you respond to treatment.
Danish: • Din læge vil gradvist øge din dosis afhængigt af, hvordan du reagerer på behandlingen.
English: No target organ toxicity was observed.
Danish: Der blev ikke observeret nogen mål-organtoksicitet.
English: Use of scopolamine as an antidote is not recommended.
Danish: Anvendelse af scopolamin som antidot kan ikke anbefales.
English: Individual response to rivastigmine cannot be predicted.
Danish: Individuelt respons på rivastigmin kan ikke forudsiges.
English: Your doctor will tell you what dose of Nimvastid to take.
Danish: Din læge vil fortælle dig, hvilken dosis Nimvastid du skal tage.
English: No safety margins to human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
Danish: Der blev ikke fundet nogen human sikkerhedsmargin i dyreforsøgene på grund af følsomheden af de anvendte dyremodeller.
English: Rivastigmine is rapidly and completely absorbed.
Danish: Rivastigmin absorberes hurtigt og fuldstændigt.
English: Protein binding of rivastigmine is approximately 40%.
Danish: Proteinbinding af rivastigmin er ca. 40%.
English: If this applies to you, tell your doctor and do not take Nimvastid.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke tage Nimvastid.
English: Your doctor will also monitor your weight whilst you are taking this medicine.
Danish: Din læge vil også holde øje med din vægt, så længe du tager denne medicin.
English: - if you have a low body weight.
Danish: hvis din kropsvægt er meget lav.
English: Patients with Alzheimer's disease may lose weight.
Danish: Patienter med Alzheimers sygdom kan tabe sig.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kraven for fremsendelse af periodiske, opdaterede sikkerhedsindberetningar for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: • To benefit from your medicine, take it every day.
Danish: • Du skal tage medicinen hver dag for at få gavn af den.
English: Dosing recommendations to titrate according to individual tolerability must be closely followed.
Danish: Dosisanbefalingerne vedrørende titrering i henhold til individuel tolerance skal følges nøje.
English: Dissolve the tablet in the mouth and swallow it with or without water.
Danish: Opløs tabletten i munden og synk den med eller uden vand.
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Danish: Den gennemsnitlige aktuelle dagsdosis for responderende i 6-12 mg gruppen, der svarede til denne definition, var 9,3 mg.
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Danish: Absolut biotilgængelighed efter en 3 mg dosis er ca. 36%±13%.
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Danish: Der kan foregå vedligeholdelsesbehandling så længe, der er terapeutiske fordele for patienten.
English: Caution is recommended in treating patients predisposed to such diseases.
Danish: Der tilrådes derfor forsigtighed ved behandling af patienter, der er prædisponerede for sådanne sygdomme.
English: If you find you have forgotten to take your dose of Nimvastid, wait and take the next dose at the usual time.
Danish: Hvis du finder ud af, at du har glemt at tage en dosis Nimvastid, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
English: Such events appeared to occur particularly after dose increments or high doses of rivastigmine.
Danish: Sådanne hændelser synes at forekomme særligt efter dosisstigninger eller høje doser af rivastigmin.