FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine.
Danish: Samtidig behandling, specielt akut behandling, med potentielt nefrotoksiske eller myelosuppressive lægemidler (f.eks. systemisk pentamidin, dapson, pyrimethamin, sulfa/trim, amphotericin B, flucytosin, ganciclovir, interferon, vincristin, vinblastin og doxorubicin) kan også øge risikoen for bivirkninger af zidovudin.
English: Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V mutations.
Danish: Flerstof antiretroviralbehandling hvor lamivudin er indeholdt har vist sig, at være effektiv hos antiretroviral-naïve patienter, såvel som hos patienter der er smittet med virus der indeholder M184Vmutationer.
English: Treatment with zidovudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Danish: Behandling med zidovudin bør stoppes, hvis der opstår symptomatisk hyperlaktatæmi og metabolisk acidose/laktacidose, fremadskridende hepatomegali eller hurtigt stigende aminotransferaseniveauer.
English: These occurred more frequently at higher zidovudine dosages (1200-1500 mg/day) and in patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease.
Danish: Det ses hyppigere ved høje doser zidovudin (1.200-1.500 mg/dag) og hos patienter med dårlig knoglemarvsreserve forud for behandlingen, særligt ved fremskreden hiv-infektion.
English: A small amount of the ingredients in Combivir can also pass into your breast-milk.
Danish: Indholdsstofferne i Combivir kan også udskilles i små mængder i mælken.
English: In reproductive toxicity studies lamivudine has demonstrated evidence of causing an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in man, but not in the rat even at very high systemic exposure.
Danish: I reproduktionstoksicitetsstudier har lamivudin vist tegn på at forårsage en øget forekomst af tidlig fosterdød hos kaniner ved relativt lave systemiske koncentrationer sammenlignet med dem, der opnås hos mennesker, men ikke hos rotter selv ved meget høje systemiske koncentrationer.
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Danish: Kliniske end-point data indikerer, at lamivudin i kombination med zidovudin medfører en signifikant reduktion af risici for forværring af sygdommen og dødeligheden.
English: Combivir contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Combivir.
Danish: Combivir indeholder lamivudin og zidovudin, og derfor er interaktioner, påvist individuelt for disse, relevante for Combivir.
English: Combivir film-coated tablets are provided in cartons, containing blister packs or bottles with a child resistant-closure.
Danish: Combivir filmovertrukne tabletter findes i æsker indeholdende blisterpakninger eller beholdere med børnesikret låg.
English: This conclusion is based on the physiochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Danish: Dette er baseret på fysisk-kemiske og farmakokinetiske data og forudsætter, at patienten opblander hele tabletten og at hele mængden indtages straks.
English: • if you are seriously overweight (especially if you are a woman) Talk to your doctor if any of these apply to you.
Danish: • hvis du er svært overvægtig (særligt hvis du er kvinde).
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Danish: M184V-mutanter udviser markant reduceret følsomhed over for lamivudin, og udviser mindsket viral replikationskapacitet in vitro.
English: The usual dose of Combivir is one tablet twice a day.
Danish: Den sædvanlige dosis er 1 tablet 2 gange daglig.
English: If gastrointestinal intolerance occurs in patients weighing 21-30 kg, an alternative dosing schedule with one-half tablet taken thrice daily can be applied in attempt to improve tolerability.
Danish: Hvis der opstår gastrointestinal intolerance hos børn der vejer 21-30 kg, kan der anvendes en alternativ doseringsanbefaling på én halv tablet 3 gange daglig i et forsøg på at forbedre tolerancen.
English: • pyrimethamine, to treat malaria and other parasitic infections
Danish: • pyrimethamin mod malaria eller andre parasitære infektioner
English: The active ingredients of Combivir may inhibit cellular DNA replication and zidovudine has been shown to be transplacental carcinogen in one animal study (see section 5.3).
Danish: De aktive indholdsstoffer i Combivir kan eventuelt hæmme cellulær DNA-replikation og zidovudin er vist at være carcinogent transplacentalt i ét dyrestudie (se pkt.
English: Zidovudine is well absorbed from the gut and at all dose levels studied in adults and children, the bioavailability was between 60-74% with a mean of 65%.
Danish: Zidovudin absorberes godt fra tarmen, og ved alle undersøgte doser var biotilgængeligheden 60-74 % med en middelværdi på 65 %.
English: • tablet film-coat; hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
Danish: • Filmovertræk: Hypromellose, titandioxid, macrogol 400 og polysorbat 80.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Danish: Hiv-1-resistens over for lamivudin involverer udviklingen af M184V-aminosyreændringer tæt ved den aktive del af viral revers-transkriptase (RT).
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Danish: Krydsresistens overført af M184V TR er begrænset indenfor klassen af nucleosidinhibitorer af antivirale stoffer.
English: Sími: +354 535 7000
Danish: Simi: + 354 535 7000
English: Lamivudine-TP and zidovudine-TP have selective inhibitory activity against HIV-1 and HIV-2 replication in vitro; lamivudine is also active against zidovudine-resistant clinical isolates of HIV.
Danish: Lamivudin-TF og zidovudinTF har en selektiv hæmmende effekt overfor hiv-1- og hiv-2-replikationen in vitro; lamivudin er også aktivt mod zidovudinresistente kliniske hiv-isolater.
English: Cartons containing white high density polyethylene (HDPE) bottle with a child-resistant closure.
Danish: Kartoner indeholdende hvide high density polyethylene (HDPE) beholdere med børnesikret låg.
English: Very common : Headache
Danish: Meget almindelig: Hovedpine
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:18 March 1998
Danish: Dato for første markedsføringstilladelse: 18. marts 1998
English: INFORMATION IN BRAILLE combivir
Danish: INFORMATION I BRAILLE-SKRIFT combivir
English: For these patients and for patients, who are unable to swallow tablets, oral solutions of lamivudine and zidovudine are available.
Danish: Til børn og til patienter, der ikke kan sluge en tablet, findes der en oral opløsning af både lamivudin og zidovudin.
English: Subjects receiving lamivudine and zidovudine with or without additional concomitant antiretroviral therapies and who already present with the M184V mutant virus also experience a delay in the onset of mutations that confer resistance to zidovudine and stavudine (Thymidine Analogue Mutations; TAMs).
Danish: Også hos personer, der får lamivudin og zidovudin med eller uden tillæg af samtidig antiretroviral behandling, og som allerede har virus med M184V-mutationer, ses der senere fremkomst af mutationer, der medfører resistens over for zidovudin og stavudin (Thymidine Analogue Mutations: TAMs).
English: Dosages of 180 mg/m2 four times daily in children produced similar systemic exposure (24 hour AUC 40.0 h µM or 10.7 h µg/ml) as doses of 200 mg six times daily in adults (40.7 h µM or 10.9 h µg/ml).
Danish: Doseringer til børn på 180 mg/m2 4 gange daglig giver samme systemiske eksponering (24 timers AUC: 40,0 timer x µM eller 10,7 timer x µg/ml) som doser på 200 mg 6 gange daglig til voksne (40,7 timer x µM eller 10,9 timer x µg/ml).
English: As Combivir contains lamivudine and zidovudine, the type and severity of adverse reactions associated with each of the compounds may be expected.
Danish: Da Combivir indeholder lamivudin og zidovudin, kan typen og sværhedsgraden af bivirkninger forbundet med hvert af stofferne forventes.
English: Based on these data Combivir may be administered with or without food.
Danish: Ud fra disse data kan Combivir gives med og uden mad.
English: • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.
Danish: • øget niveau af bilirubin (stof, der dannes i leveren) i blodet, hvilket kan medføre gulfarvning af huden.
English: Abacavir maintains its antiretroviral activities against lamivudineresistant HIV-1 harbouring only the M184V mutation.
Danish: Abacavir beholder den antiretrovirale aktivitet overfor lamivudin-resistent hiv-1, der kun har M184V-mutationen.
English: • if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).
Danish: • hvis du har et meget lavt antal røde blodceller (anæmi) eller et meget lavt antal hvide blodceller (neutropeni).
English: No Combivir dosage adjustment necessary, unless patient has renal impairment (See Section 4.2).
Danish: Dosisjustering ikke nødvendig for Combivir, medmindre patienten har nedsat nyrefunktion (se pkt.
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Danish: Kliniske studier har vist, at lamivudin plus zidovudin forsinker fremkomsten af zidovudin-resistente isolater hos personer, som ikke før har været i antiretroviral behandling.
English: Lamivudine and zidovudine have been widely used as components of antiretroviral combination therapy with other antiretroviral agents of the same class (NRTIs) or different classes (PIs, nonnucleoside reverse transcriptase inhibitors).
Danish: Lamivudin og zidovudin er i vid udstrækning blevet anvendt som komponent i antiretroviral kombinationsbehandling i kombination med andre antiretrovirale stoffer fra den samme gruppe (NRTI'er) eller fra andre grupper (PI'er, non-nukleosid revers transkriptase inhibitorer).
English: Cartons containing opaque polyvinyl chloride/foil blister packs.
Danish: Kartoner indeholdende uigennemsigtig polyvinylchlorid/folie-blisterpakninger.
English: In these patients, lamivudine and zidovudine should be taken as separate formulations according to the prescribed dosing recommendations for these products.
Danish: Til disse børn skal lamivudin og zidovudin gives hver for sig i henhold til foreskrevne doseringsanbefalinger for disse produkter.
English: Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2).
Danish: Combivir er indiceret til antiretroviral kombinationsbehandling af Human Immundefekt Virus (hiv) infektion (se pkt.
English: If Combivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication for 4 months is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Danish: Hvis behandling med Combivir afbrydes hos patienter inficeret med hepatitis B-virus, bør såvel leverfunktion som markører for HBV-replikationen monitoreres periodisk i fire måneder, da seponering af lamivudin kan medføre akut forværring af hepatitis.
English: Mitochondrial dysfunction following exposure in utero: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Mitokondriel dysfunktion efter eksponering in utero: Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i variende grad, hvilket er mest udtalt for stavudin, didanosin og zidovudin.
English: In any case, initiation of susceptible NRTI's should always be preferred to maintenance of lamivudine therapy.
Danish: Behandling med andre NRTI'er vil under alle omstændigheder være at foretrække frem for at fortsætte behandling med lamivudin.
English: White to off-white, capsule-shaped film-coated scored tablets engraved with “GXFC3” on both sides.
Danish: Hvide til råhvide, kapselformede filmovertrukne tabletter med delekærv, der er præget ”GXFC3” på begge sider.
English: Cssmax levels were 4.45 µM (1.19 µg/ml) following a dose of 120 mg zidovudine (in solution)/m2 body surface area and 7.7 µM (2.06 µg/ml) at 180 mg/m2 body surface area.
Danish: Cssmax -niveauet var 4,45 µM (1,19 µg/ml) efter en dosis på 120 mg zidovudin (i opløsning) pr. m2 legemsoverflade, og 7,7 µM (2,06 µg/ml) ved en dosis på 180 mg/m2 legemsoverflade.
English: Very common : Nausea
Danish: Meget almindelig: Kvalme
English: For children who weigh less than 14 kg lamivudine and zidovudine (the ingredients of Combivir) should be taken separately.
Danish: Børn, der vejer under 14 kg, skal have lamivudin og zidovudin (de aktive stoffer i Combivir) som to separate lægemidler.
English: Therefore as dosage adjustment of these may be necessary it is recommended that separate preparations of lamivudine and zidovudine be administered to patients with reduced renal function (creatinine clearance ≤50 ml/min).
Danish: Da dosisjustering derfor kan være nødvendig, anbefales det, at lamivudin og zidovudin gives som særskilte præparater til patienter med nedsat nyrefunktion (kreatininclearance ≤ 50 ml/min).
English: When possible, avoid chronic coadministration of Combivir with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Danish: Undgå så vidt muligt vedvarende administration af Combivir sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer eller monosaccharidalkoholer (f.eks. xylitol, mannitol, lactitol og maltitol).
English: Other possible side effects of combination therapy for HIV Combination therapy such as Combivir may cause other conditions to develop during HIV treatment.
Danish: Andre bivirkninger ved kombinationsbehandling af hiv Kombinationsbehandling som Combivir kan forårsage andre sygdomme under behandlingen af hiv.
English: The median (range) lamivudine and zidovudine tmax values were 0.75 (0.50-2.00) hours and 0.50 (0.252.00) hours respectively.
Danish: De gennemsnitlige tmax-værdier (intervaller) var for lamivudin 0,75 (0,50-2,00) timer og for zidovudin 0,50 (0,25-2,00) timer.
English: These occurred more frequently at higher dosages (1200-1500 mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment), and particularly in patients with CD4 cell counts less than 100/mm3 (see section 4.4).
Danish: Disse optræder hyppigere ved høj dosering (1.2001.500 mg/dag) og hos patienter med fremskreden hiv-infektion (specielt ved ringe knoglemarvsreserve forud for behandlingen), og især hos patienter med CD4+-celletal under 100/mm3 (se pkt.
English: Liver disease: If lamivudine is being used concomitantly for the treatment of HIV and HBV, additional information relating to the use of lamivudine in the treatment of hepatitis B infection is available in the Zeffix SmPC.
Danish: Leversygdom: Hvis lamivudin anvendes samtidigt til behandling af såvel hiv som HBV, kan der findes yderligere information i produktresuméet for Zeffix vedrørende behandling af hepatitis B med lamivudin.
English: Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in vitro.
Danish: Lamivudin udviser lav cytotoksicitet over for lymfocytter i perifert blod, over for etablerede lymfocyt og monocyt-makrofage cellelinier og over for forskellige celleforstadier i knoglemarven in vitro.
English: Some people taking Combivir or other combination treatments for HIV are more at risk of serious side effects.
Danish: Nogle patienter, der tager Combivir eller andre kombinationsbehandlinger mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: If you get any symptoms of infection while you are taking Combivir: Tell your doctor immediately.
Danish: Hvis du får symptomer på en infektion, mens du tager Combivir:
English: Some people taking Combivir develop a condition called lactic acidosis, together with an enlarged liver.
Danish: Nogle patienter, der tager Combivir, får en sygdom, der kaldes laktacidose, samt forstørret lever.
English: • dapsone, to prevent pneumonia and treat skin infections
Danish: • dapson til forebyggelse af lungebetændelse og behandling af hudinfektioner
English: Microcrystalline cellulose (E460), sodium starch glycollate, colloidal silicon dioxide, magnesium stearate
Danish: Mikrokrystallinsk cellulose (E460), natriumstivelsesglycolat, kolloid silica, magnesiumstearat.
English: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Danish: • manglende dannelse af nye røde blodceller i knoglemarven (pure red cell aplasi).
English: They are white to off-white, capsuleshaped scored tablets marked with the code GXFC3 on both sides.
Danish: Tabletterne er hvide til råhvide, kapselformede og med delekærv, præget med koden GXFC3 på begge sider.
English: Combivir was shown to be bioequivalent to lamivudine 150 mg and zidovudine 300 mg given as separate tablets, when administered to fasting subjects.
Danish: Combivir viste sig at være bioækvivalent med lamivudin 150 mg og zidovudin 300 mg givet som særskilte tabletter, når det blev givet til fastende individer.
English: Neither lamivudine nor zidovudine are mutagenic in bacterial tests, but consistent with other nucleoside analogues, inhibit cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Danish: Hverken lamivudin eller zidovudin var mutagene i bakterieforsøg, men i analogi med andre nukleosidanaloger hæmmer de cellulær DNA-replikation i in vitro test med celler fra pattedyr, såsom i lymfetesten udført på mus..
English: • fluconazole or flucytosine, to treat fungal infections such as candida
Danish: • fluconazol og flucytosin mod svampeinfektioner som candida
English: Combivir and similar medicines may cause side effects in unborn babies.
Danish: Combivir og lignende medicin kan give fosteret bivirkninger.
English: For patients co-infected with hepatitis who are being treated with lamivudine containing medicinal products such as Combivir and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Danish: Hos patienter, som også er smittet med hepatitis, og som bliver gravide under behandling med et lægemiddel, der indeholder lamivudin, såsom Combivir, bør det vurderes, om der er en risiko for recidiv af hepatitis ved seponering af lamivudin.
English: Take special care with Combivir
Danish: Vær ekstra forsigtig med at tage Combivir
English: Additionally dosage adjustment of zidovudine may be required if severe anaemia or myelosuppression occurs during treatment with Combivir, or in patients with pre-existing bone marrow compromise e.g. haemoglobin <9 g/dl (5.59 mmol/l) or neutrophil count <1.0 x 109/l (see section 4.2).
Danish: Yderligere kan dosisjustering af zidovudin være nødvendig, hvis der opstår svær anæmi eller myelosuppression under behandling med Combivir eller hos patienter med forud eksisterende knoglemarvspåvirkning (f.eks. hæmoglobin < 9 g/dl (5,59 mmol/l) eller neutrofiltal < 1,0 x 109/l) (se pkt.
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea Rare: Pancreatitis, rises in serum amylase
Danish: Almindelig: Kvalme, opkastning, mavesmerter eller -kramper, diarré Sjælden: Pancreatitis, stigning i serum amylase
English: Their main modes of action are as chain terminators of viral reverse transcription.
Danish: Den primære virkningsmekanisme er at afslutte kæden i hiv revers-transskriptionen.
English: Adults and adolescents weighing at least 30 kg: the recommended dose of Combivir is one tablet twice daily.
Danish: Voksne og unge, der vejer mindst 30 kg: Den anbefalede dosis Combivir er 1 tablet 2 gange daglig.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 150 mg lamivudin og 300 mg zidovudin.
English: The relationship between in vitro susceptibility of HIV to lamivudine and zidovudine and clinical response to lamivudine/zidovudine containing therapy remains under investigation.
Danish: Forholdet mellem in vitro følsomheden af hiv overfor lamivudin og det kliniske respons af behandling hvor lamivudin er indeholdt undersøges forsat.
English: • ribavirin or injections of ganciclovir to treat viral infections
Danish: • Ribavirin eller ganciclovir-injektioner, mod virusinfektioner
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesiae)
Danish: Almindelig: Hovedpine, søvnløshed Meget sjælden: Perifer neuropati (eller paræstesi)
English: Intravenous studies with lamivudine and zidovudine showed that the mean apparent volume of distribution is 1.3 and 1.6 l/kg respectively.
Danish: Distribution: I studier med intravenøst administreret lamivudin og zidovudin var det gennemsnitlige tilsyneladende fordelingsvolumen 1,3 henholdsvis 1,6 l/kg.
English: • tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide
Danish: • Tabletkerne: Mikrokrystallinsk cellulose, natriumstivelsesglycolat (glutenfri), magnesiumstearat,
English: The usual starting dose of Combivir is one half tablet (½) taken in the morning and one half tablet (½) taken in the evening.
Danish: Den sædvanlige startdosis er en halv (½) tablet om morgenen og en halv (½) tablet om aftenen.
English: These thymidine analogue mutations alone do not cause high-level cross-resistance to any of the other nucleosides, allowing for the subsequent use of any of the other approved reverse transcriptase inhibitors.
Danish: Disse thymidin analog mutationer forårsager alene ikke høj krydsresistens overfor de andre nucleosider.
English: Hertfordshire, SG12 0DJ, United Kingdom or
Danish: Hertforshire SG12 0DJ,
English: In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral load and increase CD4 cell count.
Danish: Kliniske studier har vist, at lamivudin i kombination med zidovudin kan reducere hiv-1-virus byrden samt øge CD4-celletallet.
English: Metabolism and nutrition disorders Very Rare: Lactic acidosis
Danish: Metabolisme og ernæring Meget sjælden: Laktacidose
English: For situations where discontinuation of therapy with one of the active substances of Combivir, or dose reduction is necessary separate preparations of lamivudine and zidovudine are available in tablets/capsules and oral solution.
Danish: Hvis det bliver nødvendigt at seponere eller reducere dosis af et af de aktive indholdsstoffer i Combivir, findes lamivudin og zidovudin hver for sig som tabletter/kapsler og oral opløsning.
English: Both of these belong to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: Begge disse aktive stoffer tilhører en gruppe af midler rettet mod retrovirus, der kaldes nukleosidanalog revers transkriptasehæmmere (NRTI'er).