FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Danish: Patienter med kronisk hepatitis B eller C behandlet med antiviral kombinationsbehandling har øget risiko for alvorlige og potentielt fatale leverpåvirkninger.
English: Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Danish: Vægt og metaboliske parametre: Vægtstigning og forhøjede lipider og glucose i blodet kan forekomme under antiretroviral behandling.
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: Ranitidine eliminated only in part by renal organic cation transport system.
Danish: Ranitidin elimineres kun delvist via det renale organisk kation transportsystem.
English: If you're breast-feeding, or thinking about breast-feeding:
Danish: Hvis du ammer eller planlægger at amme:
English: Potential to slightly decrease zidovudine plasma concentrations through UGT induction.
Danish: Risiko for moderat nedsat plasmakoncentration af zidovudin på grund af induktion af UGT.
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/mm
Danish: Disse optræder hyppigere ved høj dosering (1200- 1500 mg/dag) og hos patienter med fremskreden hiv-sygdom (specielt ved ringe knoglemarvsreserve forud for behandlingen) og især hos patienter med CD4-celletal under 100/mm (se pkt.
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: Interactions involving binding site displacement are not anticipated with Lamivudine/Zidovudine Teva.
Danish: Interaktioner, der involverer fortrængning af bindingssted, forventes ikke med Lamivudin/Zidovudin ”Teva”.
English: People may be more likely to get this condition:
Danish: Du har risiko for at få denne sygdom:
English: The median (range) lamivudine and zidovudine tmax values were 0.75 (0.50-2.00) hours and 0.50 (0.25-2.00) 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: • a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
Danish: • lavt antal røde blodceller (anæmi) eller lavt antal hvide blodceller (neutropeni eller leukopeni)
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 forsøg har vist, at lamivudin plus zidovudin forsinker fremkomsten af zidovudin-resistente isolater hos personer, som ikke før har været i antiretroviral behandling.
English: Very common: Nausea
Danish: Meget almindelig: kvalme
English: Tell your doctor.
Danish: Kontakt lægen.
English: Separate administration of Lamivudine/Zidovudine Teva and clarithromycin by at least 2 hours
Danish: Administration af Lamivudin/Zidovudin Teva og clarithromycin skal ske med mindst 2 timers interval.
English: Haematological adverse reactions: Anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
Danish: Hæmatologiske bivirkninger: Anæmi, neutropeni og leukopeni (som regel sekundært til neutropeni) kan forventes at forekomme hos patienter, der behandles med zidovudin.
English: In general, lamivudine pharmacokinetics in paediatric patients are similar to adults.
Danish: Generelt er lamivudins farmakokinetik ens hos pædiatriske patienter og voksne.
English: Depending on the overall condition of the patient, blood tests may be performed less often, for example every one to three months.
Danish: Blodprøver kan derfor tages sjældnere afhængig af patientens almene tilstand, f.eks. med 1-3 måneders mellemrum.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Danish: Hos patienter med leverinsufficiens, herunder kronisk aktiv hepatitis, ses oftere abnorm leverfunktion i forbindelse med den antiretrovirale behandling, og disse patienter skal kontrolleres ifølge standardpraksis.
English: Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine and zidovudine-containing products.
Danish: Patienter skal undersøges regelmæssigt for tegn på lipoatrofi under behandling med zidovudin og lægemidler, som indeholder zidovudin.
English: It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV'.
Danish: Det er vigtigt, at du læser oplysningerne under 'Andre mulige bivirkninger ved kombinationsbehandling af hiv' senere under dette punkt.
English: Signs of lactic acidosis include:
Danish: Symptomerne på laktacidose omfatter:
English: In the present case, the use in pregnant women of zidovudine, with subsequent treatment of the newborn infants, has been shown to reduce the rate of maternal-foetal transmission of HIV.
Danish: Anvendelse af zidovudin hos gravide har, som det er nu, vist, at efterfølgende behandling af nyfødte spædbørn nedsætter hyppigheden af maternal-føtal transmission af hiv.
English: The dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling and supported by data from clinical studies using the individual components lamivudine and zidovudine.
Danish: Doseringsanbefalingerne til børn mellem 14 kg og 30 kg er overvejende baseret på farmakokinetisk udregning, dog med understøttende data fra kliniske studier med de individuelle indholdsstoffer; lamivudin og zidovudin.
English: Peripheral blood lymphocytes from AIDS patients receiving zidovudine treatment have also been observed to contain higher numbers of chromosome breakages.
Danish: Lymfocytter i perifert blod fra aids-patienter i behandling med zidovudin har ligeledes vist højere hyppighed af kromosombrud.
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 cellelinjer og over for forskellige celleforstadier i knoglemarven in vitro.
English: Talk to your doctor immediately.
Danish: Kontakt straks lægen.
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: Lamivudine/Zidovudine Teva is available in aluminium blisters or HDPE containers containing 60 tablets.
Danish: Lamivudin/Zidovudin Teva findes i aluminiumblistere eller HDPE-beholdere indeholdende 60 tabletter.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS
English: Zidovudine and stavudine maintain their antiretroviral activities against lamivudine-resistant HIV-1.
Danish: Zidovudin og stavudin beholder deres antivirale aktivitet overfor lamivudin-resistent hiv-1.
English: If Lamivudine/Zidovudine Teva 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 Lamivudin/Zidovudin “Teva” 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: Their main modes of action are as chain terminators of viral reverse transcription.
Danish: Den primære virkningsmekanisme er at afslutte kæden i virus revers transskriptionen.
English: To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Danish: For optimal optagelse af dosis bør tabletterne synkes hele.
English: If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink and take all the dose immediately.
Danish: Hvis du har synkebesvær, kan du knuse tabletten og opblande den i lidt mad eller væske og indtage hele mængden straks.
English: • dapsone, to prevent pneumonia and treat skin infections
Danish: • dapson til forebyggelse af lungebetændelse og behandling af hudinfektioner.
English: Lamivudine/Zidovudine Teva helps to control your condition.
Danish: Lamivudin/Zidovudin Teva hjælper til med at holde din sygdom under kontrol.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Danish: Autoimmune sygdomme (som f.eks. Graves' sygdom og autoimmun hepatitis) er også blevet rapporteret i forbindelse med immunreaktivering; dog er den rapporterede tid til frembrud mere variabel, og frembrud kan forekomme mange måneder efter behandlingsstart.
English: In patients with early HIV disease haematological adverse reactions are infrequent.
Danish: Hos patienter med hiv-infektion i tidligt stadium er hæmatologiske bivirkninger sjældne.
English: Hepatic impairment: Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation.
Danish: Nedsat leverfunktion: Begrænsede data fra patienter med cirrose tyder på, at der kan forekomme akkumulering af zidovudin hos patienter med nedsat leverfunktion på grund af nedsat glucuronidering.
English: Lamivudine/Zidovudine Teva contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine.
Danish: Lamivudin/Zidovudin Teva indeholder to aktive stoffer, der bruges til at behandle hiv-infektioner: lamivudin og zidovudin.
English: The active ingredients of Lamivudine/Zidovudine Teva 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 Lamivudin/Zidovudin Teva kan eventuelt hæmme cellulær DNAreplikation og zidovudin er vist at være carcinogent transplacentalt i ét dyrestudie (se pkt.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Danish: De hyppigst rapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
English: Administration of crushed tablets with a small amount of semi-solid food or liquid would not be expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter the clinical effect.
Danish: Administration af knuste tabletter sammen med lidt væske eller halvflydende føde forventes ikke at have indflydelse på kvaliteten af tabletten.
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: Zidovudine concentrations are increased in patients with advanced renal failure.
Danish: Koncentrationen af zidovudin er øget hos patienter med fremskreden nyresvigt.
English: • chest pain; disease of the heart muscle (cardiomyopathy)
Danish: • brystsmerter, sygdom i hjertemuskulaturen (kardiomyopati)
English: When these signs occur, Lamivudine/Zidovudine Teva should be stopped and your HIV treatment changed.
Danish: Hvis der ses tegn på lipoatrofi, skal behandlingen med Lamivudin/Zidovudin Teva stoppes og din hiv-behandling ændres.
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 lægemidler.
English: White opaque HDPE containers with white opaque polyethylene child resistant screw cap with Aluminium seal.
Danish: Hvide uigennemsigtige high density polyethylene (HDPE)-beholdere med hvide uigennemsigtige børnesikrede låg af polyethylen og med aluminium forsegling.
English: No Lamivudine/Zidovudine Teva dosage adjustment necessary, unless patient has renal impairment (See Section
Danish: Dosisjustering ikke nødvendig for Lamivudin/Zidovudin Teva, medmindre patienten har nedsat nyrefunktion (se pkt.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du har glemt at tage Lamivudin/Zidovudin Teva Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det. Fortsæt derefter behandlingen som før.
English: • ribavirin or injections of ganciclovir to treat viral infections
Danish: • ribavirin eller ganciclovir-injektioner, mod virusinfektioner
English: Tablet film-coat Hypromellose 3cP Hypromellose 6cP Polysorbate 80
Danish: Hypromellose 6cP Polysorbat 80
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 lamivudine 100 mg SmPC.
Danish: Leversygdom: Hvis lamivudin anvendes samtidigt til behandling af såvel hiv som HBV, kan der findes yderligere information i produktresuméet for lamivudin 100 mg vedrørende behandling af hepatitis B med lamivudin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BLISTER PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - BLISTERPAKNING
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 over for lamivudin og det kliniske respons af behandling, hvor lamivudin er indeholdt, undersøges forsat.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Danish: In vitro-data tyder på, at på trods af fremkomsten af M184V har lamivudin stadig antiretroviral aktivitet (formentlig på grund af svækkede vira).
English: Renal impairment: Lamivudine and zidovudine concentrations are increased in patients with renal impairment due to decreased clearance.
Danish: Nedsat nyrefunktion: Koncentrationen af lamivudin og zidovudin er øget hos patienter med nedsat nyrefunktion som følge af nedsat clearance.
English: Lamivudine/Zidovudine Teva is therefore contraindicated in these patients (see section 4.4).
Danish: Lamivudin/Zidovudin “Teva” er derfor kontraindiceret hos disse patienter (se pkt.
English: Lamivudine/Zidovudine Teva contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Lamivudine/Zidovudine Teva.
Danish: Lamivudin/Zidovudin Teva” indeholder lamivudin og zidovudin, og derfor er interaktioner, påvist individuelt for disse, relevante for Lamivudin/Zidovudin Teva”.
English: Therefore patients should remain under close clinical observation by physicians experienced in the treatment of HIV infection.
Danish: De bør derfor følges tæt af læger med erfaring i behandling af hiv-infektion.
English: Lamivudine and zidovudine are nucleoside analogues which have activity against HIV.
Danish: Lamivudin og zidovudin er nukleosidanaloge stoffer, der er aktive mod hiv.
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Danish: Data fra patienter med moderat til svært nedsat leverfunktion viser, at farmakokinetikken af lamivudin ikke påvirkes nævneværdigt ved dysfunktion af leveren.
English: Nervous system disorders Common: Headache, insomnia Very rare: Peripheral neuropathy (or paraesthesiae)
Danish: Almindelig: hovedpine, søvnløshed Meget sjælden: perifer neuropati (eller paræstesi).
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Lamivudine (160 mg/800 mg once daily for 5 days/300 mg single dose)
Danish: Trimethoprim/ sulfamethoxazol (sulfa/trim) / lamivudin (160 mg / 800 mg én gang daglig i 5 dage / 300 mg enkeltdosis)
English: There is limited experience of overdosage with lamivudine/zidovudine.
Danish: Der er begrænset erfaring med overdosering med Lamivudin/Zidovudin “Teva”.
English: • wind (flatulence)
Danish: • luft i tarmene (flatulens)
English: Tell your doctor or pharmacist if any of the side effects get severe or troublesome, or if you notice any side effects not listed in this leaflet.
Danish: Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller hvis du får bivirkninger, som ikke er nævnt her.
English: It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: For at undgå overførsel af hiv anbefales det, at hiv-inficerede mødre under ingen omstændigheder ammer deres spædbørn.
English: Limited data from clinical trials do not indicate a significantly increased risk of adverse reactions to zidovudine with cotrimoxazole (see interaction information above relating to lamivudine and cotrimoxazole), aerosolised pentamidine, pyrimethamine and acyclovir at doses used in prophylaxis.
Danish: Begrænsede data fra kliniske studier tyder ikke på en signifikant øget risiko for bivirkninger af zidovudin med sulfa/trim (se oplysningerne ovenfor om interaktioner mellem lamivudin og sulfa/trim), pentamidin som inhalation, pyrimethamin og profylaktiske doser af aciclovir.
English: Your doctor should monitor for signs of lipoatrophy.
Danish: Lægen vil undersøge dig for tegn på lipoatrofi.
English: • feeling depressed or anxious, not being able to concentrate, feeling drowsy
Danish: • nedtrykthed eller angst, nedsat koncentrationsevne, døsighed
English: Some people taking Lamivudine/Zidovudine Teva or other combination treatments for HIV are more at risk of serious side effects.
Danish: Nogle patienter, der tager Lamivudin/Zidovudin Teva eller andre kombinationsbehandlinger mod hiv, har større risiko for at få bivirkninger end andre.
English: Both lamivudine and zidovudine are excreted in breast milk at similar concentrations to those found in serum.
Danish: Amning: Både lamivudin og zidovudin udskilles i mælk i mængder svarende til koncentrationerne målt i serum.
English: For patients co-infected with hepatitis who are being treated with lamivudine containing medicinal products such as Lamivudine/Zidovudine Teva 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 Lamivudin/Zidovudin Teva, bør det vurderes, om der er en risiko for recidiv af hepatitis ved seponering af lamivudin.
English: Dosage adjustments in patients with haematological adverse reactions: Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/dl or 5.59 mmol/l or the neutrophil count falls below 1.0 x 109/l (see sections 4.3 and 4.4).
Danish: Dosisjustering hos patienter med hæmatologiske bivirkninger: Dosisjustering af zidovudin kan være nødvendig, hvis hæmoglobinniveauet falder under 9 g/dl eller 5,59 mmol/l, eller neutrofiltallet falder under 1,0 x 109 /l (se pkt.
English: Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Zidovudine
Danish: Trimethoprim/ sulfamethoxazol (sulfa/trim) / zidovudin
English: OPA/Alu/PVC Aluminium blisters
Danish: Blisterpakning: OPA7Alu/PVC aluminiumblisterpakninger
English: Additionally dosage adjustment of zidovudine may be required if severe anaemia or myelosuppression occurs during treatment with Lamivudine/Zidovudine Teva, or in patients with preexisting bone marrow compromise e.g. haemoglobin <9 g/dl (5.59 mmol/l) or neutrophil count <1.0 x 10
Danish: Yderligere kan dosisjustering af zidovudin være nødvendig, hvis der opstår svær anæmi eller myelosuppression under behandling med Lamivudin/Zidovudin “Teva” 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: • fluconazole or flucytosine, to treat fungal infections such as candida
Danish: • fluconazol og flucytosin mod svampeinfektioner som candida.
English: A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at humanequivalent exposures.
Danish: En transplacental genotoksicitetsundersøgelse udført på aber sammenlignede zidovudin alene med kombinationen af zidovudin og lamivudin i human-ækvivalente doser.
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Danish: Lamivudin/Zidovudin Teva kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Teva Pharmaceuticals Slovakia s.r.o.
Danish: Slovenská republika Teva Pharmaceuticals Slovakia s.r.o.
English: No antagonistic effects in vitro were seen with lamivudine and other antiretrovirals (tested agents: abacavir, didanosine and nevirapine).
Danish: Der blev ikke observeret nogen antagonistisk effekt ved lamivudin og andre antiretrovirale lægemidler in vitro (lægemidler testet: abacavir, didanosin og nevirapin).
English: As Lamivudine/Zidovudine Teva contains lamivudine and zidovudine, the type and severity of adverse reactions associated with each of the compounds may be expected.
Danish: Da Lamivudin/Zidovudin “Teva” indeholder lamivudin og zidovudin, kan typen og sværhedsgraden af bivirkninger forbundet med hvert af stofferne forventes.
English: Based on these data lamivudine/zidovudine may be administered with or without food.
Danish: Ud fra disse data kan lamivudin/zidovudin gives med og uden mad.
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 undersøgelser har vist, at lamivudin i kombination med zidovudin kan reducere hiv-1-virus byrden samt øge CD4-celletallet.
English: Metabolism and nutrition disorders Rare: Lactic acidosis in the absence of hypoxaemia, anorexia
Danish: Metabolisme og ernæring Sjælden: laktacidose uden samtidig hypoxæmi, anoreksi.
English: Physicians should refer to the individual prescribing information for these medicinal products.
Danish: Lægen bør referere til den individuelle produktinformation, som foreligger for disse lægemidler.