FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor about the risks and benefits of taking Zeffix during your pregnancy.
Danish: Tal med lægen omkring risici og fordele ved at tage Zeffix under graviditeten.
English: • other medicines containing lamivudine, used to treat HIV infection (sometimes called the AIDS virus)
Danish: • andre lægemidler indeholdende lamivudin, der bruges til behandling af hiv-infektion (nogle gange kaldet aids-virus)
English: Remove the applicator from the adapter.
Danish: Fjern applikatoren fra tilpasningsstykket.
English: The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.
Danish: Den orale applikator er vedlagt til nøjagtig afmåling af den foreskrevne dosis oral opløsning.
English: Reduction of erythrocytes and neutrophil counts were identified as the effects most likely to be of clinical relevance.
Danish: Reduktion i erytrocyt- og neutrofiltal blev identificeret som de virkninger, der mest sandsynligt var af klinisk relevans.
English: Undetectable HBV DNA
Danish: Udetekterbar HBV-DNA
English: Keep it safely.
Danish: Opbevar det sikkert.
English: Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.
Danish: Andre lægemidler (f.eks. ranitidin, cimetidin) udskilles kun delvist ved denne mekanisme og har vist sig ikke at interagere med lamivudin.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Danish: Efter oral administration er gennemsnitstiden (tmax) til maksimale serumkoncentrationer (Cmax) omkring en time.
English: Leave the adapter in the bottle.
Danish: Lad tilpasningsstykket blive siddende i flasken.
English: YMDD1 Non-YMDD1
Danish: Ikke-YMDD1
English: ULN = Upper limit of normal.
Danish: ULN = Upper limit of normal (øvre normale grænse).
English: No patients in either group progressed to cirrhosis.
Danish: Ingen patienter i begge grupper udviklede cirrose.
English: Renal clearance accounts for about 70 % of lamivudine elimination.
Danish: Renal clearance er ansvarlig for omkring 70 % af eliminationen af lamivudin.
English: Oral solution:
Danish: Oral opløsning:
English: The total amount of lamivudine ingested by a breastfed infant is very low and is therefore likely to result in exposures exerting a sub-optimal antiviral effect.
Danish: Den totale mængde lamivudin indtaget af et ammet spædbarn er meget lav og resulterer derfor sandsynligvis i en grad af påvirkning, der medfører en suboptimal antiviral effekt.
English: Zeffix can be taken with or without food.
Danish: Zeffix kan tages med eller uden mad.
English: See the diagram and instructions after section 6 of this leaflet for how to measure and take a dose of medicine.
Danish: Se illustrationen og vejledningen efter punkt 6 i denne indlægsseddel, der viser hvordan du skal afmåle en dosis og tage lægemidlet.
English: Creatinine clearance ml/min
Danish: Kreatininclearance ml/min
English: When lamivudine was discontinued, the majority of patients (70 %) had a return of viral replication.
Danish: Når lamivudin blev seponeret, fik hovedparten af patienterne (70 %) et tilbagevenden af virusreplikation.
English: Co-administration of lamivudine with food resulted in a delay of tmax and a lower Cmax (decreased by up to 47 %).
Danish: Administration af lamivudin sammen med mad resulterer i en forsinket tmax og en lavere Cmax (nedsat med op til 47 %).
English: The formation of further viral DNA is blocked by incorporation of lamivudine-TP into the chain and subsequent chain termination.
Danish: Dannelsen af yderligere viralt DNA blokeres ved inkorporering af lamivudin-TP i kæden og efterfølgende afslutning af kæden.
English: Date of latest renewal: 23 June 2014
Danish: Dato for første markedsføringstilladelse: 29. juli 1999 Dato for seneste fornyelse: 23. juni 2014
English: Use the oral applicator supplied with the pack to measure your dose accurately (see also Section 3).
Danish: Brug den orale applikator, der er vedlagt i pakningen, til nøjagtig afmåling af dosis (se også punkt 3).
English: If you are planning to change your HIV treatment, discuss this change with your doctor first.
Danish: Hvis du planlægger at ændre din hivbehandling, skal du tale med lægen først.
English: 7 Put the applicator into your mouth, placing the tip of the applicator against the inside of your cheek.
Danish: 7 Tag applikatoren i munden, og hold applikatorens spids mod indersiden af din kind.
English: Lamivudine was not genotoxic in vivo at doses that gave plasma concentrations around 60-70 times higher than the anticipated clinical plasma levels.
Danish: Lamivudin var ikke genotoksisk in vivo ved doser, der medførte plasmakoncentrationer omkring 60-70 gange højere end de forventede kliniske plasmakoncentrationer.
English: How to measure the dose and take the medicine
Danish: Sådan skal du afmåle en dosis og tage lægemidlet
English: Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80 and 85 %.
Danish: Lamivudin absorberes godt fra mave-tarmkanalen, og oral biotilgængelighed hos voksne er normalt 80-85 %.
English: Transmission of hepatitis B
Danish: Transmission af hepatitis B
English: During treatment with Zeffix patients should be monitored regularly.
Danish: Patienter i behandling med Zeffix bør undersøges regelmæssigt.
English: See section 3 for more information about how to take Zeffix.
Danish: Se punkt 3 for mere information om, hvordan du skal tage Zeffix.
English: Push the adapter (B) firmly into the neck of the bottle, as far as it will go.
Danish: Tryk tilpasningsstykket (B) så langt ned i flaskehalsen som muligt.
English: For example, if your dose is 20 ml, you need to take 2 applicator-fulls of medicine.
Danish: Hvis din dosis f.eks. er 20 ml, skal du tage to fulde applikatorer (2 x 10 ml) med medicin.
English: At the end of 5 years, all patients had HBV DNA levels that were undetectable or lower than pre-treatment levels.
Danish: Ved afslutningen af de 5 år havde alle patienter HBV-DNA niveauer der var udetekterbare eller lavere end præ-behandlingsniveauer.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage den, så snart du husker det, og derefter fortsætte din behandling som før.
English: However, the extent (based on the AUC) of lamivudine absorbed was not influenced, therefore lamivudine can be administered with or without food.
Danish: Omfanget af absorptionen af lamivudin påvirkes dog ikke (baseret på AUC), derfor kan lamivudin tages med eller uden mad.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructoseintolerance, glukose-galactose malabsorption eller sucrase-isomaltaseinsufficiens bør ikke tage denne medicin.
English: Table 3: Post-treatment ALT Elevations in 2 Placebo-Controlled Studies in Adults
Danish: Tabel 3: Post-behandling ALAT-stigninger i to placebokontrollerede studier hos voksne
English: When you stop taking Zeffix your doctor will monitor you for at least four months to check for any problems.
Danish: Når du stopper med at tage Zeffix, vil lægen følge dig i mindst 4 måneder for at holde øje med eventuelle problemer.
English: Swallow the tablet whole, with some water.
Danish: Tabletten skal synkes hel med vand.
English: It is also only a weak inhibitor of mammalian DNA polymerases alpha and beta.
Danish: Det er ligeledes kun en svag hæmmer af mammale DNA alfa- og beta-polymeraser.
English: Belgique/Belgien
Danish: België/Belgique/Belgien
English: 2 Hold the bottle.
Danish: 2 Hold fast om flasken.
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you're taking Zeffix.
Danish: Husk at informere lægen eller apotekspersonalet, hvis du begynder at tage et nyt lægemiddel, mens du tager Zeffix.
English: If you get any side effects
Danish: Hvis du får bivirkninger
English: Patients should be informed that malaise and fatigue have been reported during treatment with lamivudine.
Danish: Patienter skal informeres om, at utilpashed og træthed har været rapporteret under behandling med lamivudin.
English: Duration of treatment The optimal duration of treatment is unknown.
Danish: Behandlingsvarighed Den optimale behandlingsvarighed er ukendt.
English: Not all pack-sizes may be available in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i dit land.
English: Immunosuppressive treatments
Danish: Immunsupprimerende behandlinger
English: The results of long term carcinogenicity studies with lamivudine in rats and mice did not shown any carcinogenic potential.
Danish: Resultaterne fra langtidskarcinogenicitetsstudier med lamivudin hos rotter og mus viste intet karcinogent potentiale.
English: When doses below 100 mg are required Zeffix oral solution should be used (see Table 1 below).
Danish: Ved behov for doser under 100 mg daglig bør der anvendes Zeffix oral opløsning (se tabel 1 nedenfor).
English: Consider more frequent monitoring of HBV viral load when chronic co-administration cannot be avoided.
Danish: Overvej hyppigere overvågning af HBV virusmængde, når vedvarende samtidig administration ikke kan undgås.
English: Due to the marginal liver function in these patients, hepatitis reactivation at discontinuation of lamivudine or loss of efficacy during treatment may induce severe and even fatal decompensation.
Danish: Som følge af den marginale leverfunktion hos disse patienter kan reaktivering af hepatitis ved seponering af lamivudin eller ophørt effekt under behandlingen inducere alvorlig og endda fatal dekompensation.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
Danish: • lægemidler (oftest opløsninger), der indeholder sorbitol og andre sukkeralkoholer (som f.eks. xylitol, mannitol, lactitol eller maltitol), hvis de anvendes regelmæssigt
English: • a worsening of liver disease after Zeffix is stopped or during treatment if the hepatitis B virus becomes resistant to Zeffix.
Danish: • forværring af leversygdom, efter behandlingen med Zeffix er stoppet eller under behandlingen, hvis hepatitis B-virus bliver resistens over for Zeffix.
English: The active substance is lamivudine.
Danish: Det aktive stof er lamivudin.
English: Delta hepatitis or hepatitis C
Danish: Delta-hepatitis og hepatitis C
English: In non-controlled studies, where lamivudine was administered prior to and during transplantation, effective HBV DNA suppression and ALT normalisation was demonstrated.
Danish: I ikke-kontrollerede studier, hvor lamivudin blev administreret før og under transplantation, blev der påvist effektiv suppression af HBV-DNA og normalisering af ALAT.
English: Don't stop taking Zeffix without your doctor's advice, as there is a risk of your hepatitis getting worse.
Danish: Stop ikke med at tage Zeffix uden lægens anvisning, da der er en risiko for, at din hepatitis forværres.
English: The neurological disorders might be transient or permanent.
Danish: Det er uvist, om disse neurologiske forstyrrelser er forbigående eller vedvarende.
English: You need to keep taking it every day to control your infection and stop your illness getting worse.
Danish: Du skal tage Zeffix hver dag for at få kontrol over din infektion og for at forhindre, at din sygdom forværres.
English: In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported.
Danish: Hos patienter med hiv-infektion er der rapporteret om tilfælde af pancreatitis og perifer neuropati (eller paræstesi).
English: Currently available data are described in sections 4.4 and 5.1 but no recommendation on a posology can be made.
Danish: 4.4 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Exacerbations of hepatitis
Danish: Forværring af hepatitis
English: Hepatitis B infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hepatitis B-infektion spredes ved seksuel kontakt med nogen, der har infektionen, eller ved overførsel af inficeret blod (f.eks. ved at dele kanyler).
English: In patients with chronic hepatitis B there was no observed difference in incidence of these events between placebo and lamivudine treated patients.
Danish: Hos patienter med kronisk hepatitis B blev der ikke observeret nogen forskel i forekomsten af disse hændelser mellem patienter i placebo- og lamivudinbehandling.
English: If you accidentally take too much, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Danish: Hvis du ved et uheld har taget for meget, skal du kontakte lægen, apoteket eller nærmeste skadestue for nærmere rådgivning.
English: Experience in patients with decompensated liver disease Placebo controlled studies have been regarded as inappropriate in patients with decompensated liver disease, and have not been undertaken.
Danish: Erfaring med patienter med dekompenseret leversygdom Placebokontrollerede studier betragtes som upassende hos patienter med dekompenseret leversygdom og er ikke gennemført.
English: Other side effects Other side effects have occurred in a very small number of people but their exact frequency is unknown
Danish: Andre bivirkninger er set hos et meget lille antal personer, og deres nøjagtige hyppighed kendes ikke.
English: The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim.
Danish: Muligheden for interaktioner med andre samtidigt indgivne lægemidler bør overvejes, særligt hvis deres udskillelse primært sker ved aktiv renal sekretion via det organiske kationiske transportsystem, f.eks. trimethoprim.
English: The frequency categories assigned to the adverse reactions are mainly based on experience from clinical trials including a total of 1,171 patients with chronic hepatitis B receiving lamivudine at 100mg.
Danish: Kategoriseringen af bivirkningsfrekvenserne er primært baseret på erfaringer fra kliniske studier, herunder i alt 1.171 patienter med kronisk hepatitis B, der fik 100 mg lamivudin.
English: Synthetic yellow and red iron oxides
Danish: Syntetisk gul og rød jernoxid
English: Hepatitis B is a virus which infects the liver, causes long term (chronic) infection, and can lead to liver damage.
Danish: Hepatitis B er en virus, som inficerer leveren og forårsager langvarig (kronisk) infektion, hvilket kan medføre leverskader.
English: The bottle contains 240 ml of lamivudine solution (5 mg/ml).
Danish: Flasken indeholder 240 ml lamivudinopløsning (5 mg/ml).
English: In a retrospective study to determine the factors associated with HBV DNA breakthrough, 159 Asian HBeAg-positive patients were treated with lamivudine and followed up for a median period of almost 30 months.
Danish: I et retrospektivt studie til bestemmelse af de faktorer, der er forbundet med fremkomst af HBV-DNA, blev 159 asiatiske HBeAg-positive patienter behandlet med lamivudin og fulgt i en medianperiode på næsten 30 måneder.
English: Data is available from an extended treatment study in HBeAg negative patients (NUCAB3017) treated with lamivudine.
Danish: Data er tilgængelige fra et udvidet behandlingsstudie med HBeAg-negative patienter (NUCAB3017), der blev behandlet med lamivudin.
English: The solution is clear, colourless to pale yellow in colour with strawberry/banana flavouring.
Danish: Opløsningen er klar, farveløs til svagt gul og med jordbær/banansmag.
English: Zeffix also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).
Danish: Zeffix indeholder også konserveringsmidler (parahydroxybenzoater), som kan give allergiske reaktioner (kan optræde efter behandlingen).
English: HIV co-infection
Danish: Samtidig infektion med hiv
English: Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats (see section 5.3).
Danish: Dyrestudier med lamivudin viste øget forekomst af tidlig død af embryoner hos kaniner, men ikke hos rotter (se pkt.
English: 3 Insert the applicator (C) firmly into the adapter.
Danish: 3 Stik applikatoren (C) godt ned i tilpasningsstykket.
English: Most events have been self-limiting, however some fatalities have been observed.
Danish: De fleste tilfælde var selvbegrænsende, men der er dog observeret få letale tilfælde.
English: Don't take a double dose to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: Patients should be advised that therapy with lamivudine has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore, appropriate precautions should still be taken.
Danish: Patienter bør orienteres om, at behandling med lamivudin ikke har vist sig at forebygge risikoen for overførsel af hepatitis B-virus til andre, og der bør derfor fortsat tages passende forholdsregler.
English: This population primarily consisted of children with minimal hepatitis B. A dose of 3 mg/kg once daily (up to a maximum of 100 mg daily) was used in children aged 2 to 11 years and a dose of 100 mg once daily in adolescents aged 12 years and above.
Danish: Gruppen bestod primært af børn med minimal hepatitis B. En dosering på 3 mg/kg 1 gang daglig (op til maksimum 100 mg daglig) blev anvendt til børn i alderen 2-11 år, mens en dosering på 100 mg 1 gang daglig blev givet til unge på 12 år og derover.
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Danish: For zidovudin ses en beskeden stigning i Cmax (28 %), når det gives sammen med lamivudin, men den samlede eksposition (AUC) ændres ikke signifikant.
English: Table 1: Dosage of Zeffix in patients with decreased renal clearance.
Danish: Tabel 1: Dosering af Zeffix til patienter med nedsat renal clearance.
English: Continued lamivudine treatment for an additional 2 years in patients who had failed to achieve HBeAg seroconversion in the initial 1 year controlled studies resulted in further improvement in bridging fibrosis.
Danish: Fortsat lamivudin behandling i yderligere 2 år hos patienter, som ikke opnåede HBeAg-serokonversion i de initiale 1 års kontrollerede studier, resulterede i yderligere forbedring i brofibrose.
English: Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored more frequently as appropriate.
Danish: Patienter, som udvikler tegn på leverinsufficiens under eller efter behandlingsophør, bør undersøges hyppigere, som det er hensigtsmæssigt.
English: The clinical status of the patient and the adverse reaction profile of lamivudine should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Patientens kliniske status og bivirkningsprofilen for lamivudin skal tages i betragtning, når patientens evne til at føre motorkøretøj eller betjene maskiner vurderes.
English: Side effects thought to be caused by Zeffix
Danish: Bivirkninger, der kan være forårsaget af Zeffix
English: The likelihood of metabolic substance interactions with lamivudine is low due to the small (5-10 %) extent of hepatic metabolism and the low plasma protein binding.
Danish: Sandsynligheden for metaboliske stofinteraktioner med lamivudin er lav på grund af begrænset (5-10 %) levermetabolisme og lav plasmaproteinbinding.
English: Laboratory parameters to be monitored should include (as a minimum) serum ALT, bilirubin, albumin, blood urea nitrogen, creatinine, and virological status: HBV antigen/antibody, and serum HBV DNA concentrations when possible.
Danish: De laboratorieparametre, som skal undersøges, bør (som et minimum) omfatte serum-ALAT, bilirubin, albumin, blod karbamid nitrogen, kreatinin og virologisk status: HBV-antigen/antistof og serumkoncentrationer af HBV-DNA, hvor det er muligt.
English: Zeffix contains sugar and preservatives
Danish: Zeffix indeholder sukker og konserveringsmidler
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: The pack also includes a polyethylene applicator-adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Danish: Pakningen indeholder desuden et tilpasningsstykke af polyethylen samt en 10 ml oral applikator bestående af et kammer af polypropylen (med angivelse af ml) og et stempel af polyethylen.
English: This should lead to a reduction in liver damage and an improvement in your liver function.
Danish: Derved kan leverskaden mindskes og leverfunktionen forbedres.
English: Lamivudine has been administered to children (2 years and above) and adolescents with compensated chronic hepatitis B. However, due to limitations of the data, the administration of lamivudine to this patient population is not currently recommended (see section 5.1).
Danish: Lamivudin er blevet givet til børn (fra og med 2 år) og unge med kompenseret kronisk hepatitis B. På grund af begrænsninger i data, kan administration af lamivudin ikke på nuværende tidspunkt anbefales til denne patientgruppe (se pkt.
English: A side effect which may show up in blood tests is: • a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Danish: En bivirkning, som kan vise sig i blodprøver, er: • nedsat antal af de celler, der er involveret, når blod størkner (trombocytopeni).
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Danish: Da lamivudin kan fjernes ved dialyse, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, selvom dette ikke er undersøgt.
English: In patients with compensated liver disease, these increases in serum ALT were generally not accompanied by an increase in serum bilirubin concentrations or signs of hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom blev disse stigninger i serum-ALAT generelt set ikke ledsaget af stigning i serum-bilirubin-koncentrationen eller tegn på dekompenseret leversygdom.
English: The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged substance.
Danish: Sandsynligheden for metaboliske interaktioner er lav som følge af begrænset metabolisme og plasmaproteinbinding og næsten fuldstændig renal elimination af uomdannet lægemiddelstof.
English: Lamivudine has been administered to children and adolescents with compensated CHB in a placebo controlled study of 286 patients aged 2 to 17 years.
Danish: Lamivudin er blevet givet til børn og unge med kompenseret CHB i et placebo-kontrolleret studie af 286 patienter i alderen fra 2 år til 17 år.
English: The pack includes an oral applicator with ml graduations and an applicator-adapter, which should be fitted to the bottle before use.
Danish: Pakningen indeholder en applikator med angivelse af ml og et tilpasningsstykke, som skal sættes på flasken inden brug.
English: The majority of lamivudine is excreted unchanged in the urine via glomerular filtration and active secretion (organic cationic transport system).
Danish: Hovedparten af lamivudin udskilles uomdannet i urinen via glomerulær filtration og aktiv sekretion (via det organiske kationiske transportsystem).
English: Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased lamivudine exposure by about 40 %.
Danish: Administration af trimethoprim/sulfamethoxazol 160 mg/800 mg øger lamivudin-eksponeringen med ca. 40 %.
English: HBeAg seroconversion
Danish: HBeAg-serokonversion