FrancophonIA/ELRC3.0 huggingface dataset:
English: You need to know about important signs and symptoms to look out for while you are taking Lamivudine Teva Pharma B.V..
Danish: Du bør kende til vigtige tegn og symptomer, som du skal holde øje med, mens du tager Lamivudin Teva Pharma B.V.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in lamivudine exposure at therapeutic doses.
Danish: Interaktion med trimethoprim øger ekspositionen af lamivudin med 40 % ved terapeutiske doser.
English: Children from three months of age: As an accurate dosage cannot be achieved with the 300 mg nonscored tablet formulation in this patient population, it is recommended that the Lamivudine Teva Pharma B.V. 150 mg scored tablet formulation is used and the corresponding recommended dosage instructions are followed.
Danish: Børn fra 3 måneder: Da der ikke kan opnås præcis dosering med 300 mg tabletter uden delekærv i denne patientpopulation, anbefales det at anvende Lamivudin Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: helbreder ikke hiv-infektionen fuldstændig, men nedsætter mængden af virus i kroppen og bevarer den på et lavt niveau.
English: -1.6% (95% CI -8.4% to +5.2%), p=0.65 Week 96
Danish: -1,6 % (95 % CI -8,4 % til +5,2 %), p=0,65
English: 1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial (COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 5.1).
Danish: 1.206 hiv-inficerede patienter i alderen 3 måneder til 17 år blev inkluderet i ARROW-studiet (COL105677); heraf fik 669 patienter abacavir og lamivudin enten som én daglig dosis eller som 2 daglige doser (se pkt.
English: It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: tilhører en gruppe af midler rettet mod retrovirus, der kaldes nukleosidanalog revers transkriptasehæmmere (NRTI'er).
English: Treatment with Lamivudine Teva Pharma B.V. should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Danish: bør stoppes omgående, hvis kliniske tegn, symptomer eller unormale laboratoriefund tyder på udvikling af pancreatitis.
English: Very rare: Peripheral neuropathy (or paraesthesia).
Danish: Almindelige: Hovedpine, søvnløshed Meget sjælden: Perifer neuropati (eller paræstesi)
English: Plasma HIV-1 RNA <80 c/mL Risk difference (once daily-twice daily)
Danish: Plasma hiv-1-RNA < 80 kopier/ml Risikodifference (én gang daglig vs. to gange daglig)
English: Children weighing ≥20 kg to <25 kg: The recommended dose is 225 mg daily.
Danish: Børn, der vejer ≥ 20 kg til < 25 kg: Den anbefalede dosis er 225 mg daglig.
English: If Lamivudine Teva Pharma B.V. is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis (see lamivudine 100 mg SmPC).
Danish: afbrydes hos hiv-patienter med hepatitis Bvirus infektion, bør der foretages periodisk monitorering af både leverfunktionen og markører for HBV-replikationen, idet seponeringen af lamivudin kan medføre akut forværrelse af hepatitis (se også i produktresumeet for lamivudin 100 mg).
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor about the risks and benefits to you and your baby of taking Lamivudine Teva Pharma B.V.. Lamivudine Teva Pharma B.V. and similar medicines may cause side effects in unborn babies.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du tale med lægen om risici og fordele ved Lamivudin Teva Pharma B.V.
English: Children weighing 14 kg to <20 kg: The recommended dose is 150 mg daily.
Danish: Børn, der vejer 14 kg til < 20 kg: Den anbefalede dosis er 150 mg daglig.
English: Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase in peak plasma levels.
Danish: Gives zidovudin samtidigt, øges ekspositionen af zidovudin med 13 %, og den maksimale plasmakoncentration øges med 28 %.
English: Paediatric population: In a study performed in paediatric patients (see section 5.1 ARROW study), lower rates of virologic suppression and more frequent viral resistance were reported in children receiving an oral solution of lamivudine as compared to those receiving the tablet formulation.
Danish: 5.1 ARROW studie) blev der rapporteret lavere virologisk responsrater og hyppigere viral resistens hos børn, der fik oral opløsning af lamivudin sammenlignet med dem, der fik tabletformuleringen.
English: When possible, avoid chronic coadministration of Lamivudine Teva Pharma B.V. with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol,
Danish: sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer eller monosaccaharidalkoholer (f.eks. xylitol, mannitol,
English: Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.
Danish: er indiceret som del af en antiretroviral kombinationsbehandling til behandling af Human Immundefekt Virus (hiv)-inficerede voksne og børn.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Not everyone responds to treatment with Lamivudine Teva Pharma B.V. in the same way.
Danish: Ikke alle reagerer ens på behandlingen med Lamivudin Teva Pharma B.V.
English: Talk to your doctor if any of these apply to you.
Danish: Kontakt lægen, hvis noget af ovenstående gælder for dig.
English: Lamivudine Teva Pharma B.V. contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
Danish: indeholder natrium Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. det er i det væsentlige natrium-frit.
English: Once Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Danish: Én gang daglig Plasma hiv-1 RNA < 80 kopier/ml: n/N (%)
English: Twice Daily Plasma HIV-1 RNA <80 c/ml: n/N (%)
Danish: To gange daglig Plasma hiv-1 RNA < 80 kopier/ml: n/N (%)
English: Very rare: Pure red cell aplasia.
Danish: Meget sjælden: Ren erytrocyt aplasi
English: Lamivudine 8 mg/kg OnceDaily Dosing Geometric Mean (95% Cl)
Danish: Lamivudin 8 mg/kg én gang daglig Geometrisk gennemsnit (95 % CI)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ } Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also active against zidovudine-resistant clinical isolates of HIV.
Danish: Trifosfatet hæmmer selektivt replikationen af hiv-1 og hiv-2 in vitro.
English: Respiratory, thoracic and mediastinal disorders Common: Cough, nasal symptoms.
Danish: Luftveje, thorax og mediastinum Almindelige: Hoste, symptomer fra næsen
English: Keep in touch with your doctor, and do not stop taking Lamivudine Teva Pharma B.V. without your doctor's advice.
Danish: Hold kontakt med lægen, og stop ikke med at tage Lamivudin Teva Pharma B.V.
English: Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of lamivudine in plasma are 1.2 µg/ml (24%) and 0.09 µg/ml (27%), respectively.
Danish: Ved en terapeutisk dosis på 150 mg 2 gange daglig er den gennemsnitlige (CV) steady state Cmax og Cmin i plasma for lamivudin henholdsvis 1,2 μg/ml (24 %) og 0,09 μg/ml (27 %).
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia.
Danish: Blod og lymfesystem Ikke almindelige: Neutropeni og anæmi (begge af og til alvorlige), trombocytopeni
English: • if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for lamivudin eller et af de øvrige indholdsstoffer i Lamivudin Teva
English: If you forget to take Lamivudine Teva Pharma B.V.
Danish: Hvis du har glemt at tage Lamivudin Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or HDPE containers containing 30 tablets.
Danish: er tilgængelig i aluminiumblistere indeholdende 20, 30, 60, 80, 90, 100 og 500 tabletter eller HDPE-beholdere indeholdende 30 tabletter.
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets EU/1/09/596/008 20 tablets (blister) EU/1/09/596/009 30 tablets (blister) EU/1/09/596/010 60 tablets (blister) EU/1/09/596/011 90 tablets (blister) EU/1/09/596/012 100 tablets (blister) EU/1/09/596/013 500 tablets (blister) EU/1/09/596/014 30 tablets (bottle) EU/1/09/596/016 80 tablets(blister)
Danish: 300 mg filmovertrukne tabletter EU/1/09/596/008 20 tabletter (blister) EU/1/09/596/009 30 tabletter (blister) EU/1/09/596/010 60 tabletter (blister) EU/1/09/596/011 90 tabletter (blister) EU/1/09/596/012 100 tabletter (blister) EU/1/09/596/013 500 tabletter (blister) EU/1/09/596/014 30 tabletter (beholder) EU/1/09/596/016 80 tabletter (blister)
English: Musculoskeletal and connective tissue disorders Common: Arthralgia, muscle disorders.
Danish: Knogler, led, muskler og bindevæv Almindelige: Artralgi, muskelforstyrrelser Sjælden: Rhabdomyolyse
English: Lamivudine Teva Pharma B.V. is available in aluminium blisters containing 20, 30, 60, 80, 90, 100 and 500 tablets or HDPE containers containing 60 tablets.
Danish: er tilgængelig i aluminiumblistere indeholdende 20, 30, 60, 80, 90, 100 og 500 tabletter eller HDPE-beholdere indeholdende 60 tabletter.
English: This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4).
Danish: Denne dosis kan gives som 150 mg 2 gange dagligt eller 300 mg 1 gang dagligt (se pkt.
English: Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea.
Danish: Almindelige: Kvalme, opkastning, mavesmerter eller -kramper, diarré Sjældne: Pancreatitis, stigning i serumamylase
English: Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
Danish: I akutte dyrestudier resulterede indgift af meget høje doser lamivudin ikke i organtoksicitet.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets EU/1/09/596/001 20 tablets (blister) EU/1/09/596/002 30 tablets (blister) EU/1/09/596/003 60 tablets (blister) EU/1/09/596/004 90 tablets (blister) EU/1/09/596/005 100 tablets (blister) EU/1/09/596/006 500 tablets (blister) EU/1/09/596/007 60 tablets (bottle) EU/1/09/596/015 80 tablets (blister)
Danish: 150 mg filmovertrukne tabletter EU/1/09/596/001 20 tabletter (blister) EU/1/09/596/002 30 tabletter (blister) EU/1/09/596/003 60 tabletter (blister) EU/1/09/596/004 90 tabletter (blister) EU/1/09/596/005 100 tabletter (blister) EU/1/09/596/006 500 tabletter (blister) EU/1/09/596/007 60 tabletter (beholder) EU/1/09/596/015 80 tabletter (blister)
English: In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 10.31 (6.26, 17.0) µg•h/mL in the once-daily dosing and 9.24 (4.66, 18.3) µg•h/mL in the twice-daily dosing.
Danish: I PENTA 15-studiet er lamivudins geometriske gennemsnits-AUC (0-24) (95 % CI) i plasma for de fire patienter under 12 måneder, som skiftede fra 2 daglige doser til én daglig dosis (se pkt.
English: Opportunistic infections: Patients receiving Lamivudine Teva Pharma B.V. or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
Danish: Opportunistiske infektioner: Patienter kan fortsat udvikle opportunistiske infektioner eller andre komplikationer af hiv-infektionen, selv om de får Lamivudin Teva Pharma B.V.
English: Children weighing at least 14 kg and less than 20 kg The usual dose of Lamivudine Teva Pharma B.V. is 150 mg a day.
Danish: Børn, der vejer mindst 14 kg og mindre end 20 kg Den sædvanlige dosis er 150 mg daglig.
English: 300 mg or
Danish: 300 mg
English: Grey, diamond shaped, biconvex film-coated tablet - engraved with “L 300” on one side and plain on the other
Danish: Grå, ruderformet, bikonveks filmovertrukket tablet - præget med "L 300" på den ene side og ingenting på den anden side.
English: maltitol).
Danish: (BMI)).
English: Due to similarities, Lamivudine Teva Pharma B.V. should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Danish: ikke administreres sammen med andre cytidinanaloger såsom emtricitabin.
English: Children weighing at least 20 kg and less than 25 kg The usual dose of Lamivudine Teva Pharma B.V. is 225 mg a day.
Danish: Børn, der vejer mindst 20 kg og mindre end 25 kg Den sædvanlige dosis er 225 mg daglig.
English: Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets: 60 ml container of 30 film-coated tablets.
Danish: 300 mg filmovertrukne tabletter: 60 ml beholder a 30 filmovertrukne tabletter.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Light grey, diamond shaped, biconvex film-coated tablet with approx. 14.5 mm length and 7.0 mm width - engraved with “L 150” and breakline on one side and breakline on the other.
Danish: Lysegrå, ruderformede, bikonvekse, filmovertrukne tabletter med en længde på ca. 14,5 mm og en bredde på ca. 7,0 mm - præget med "L 150" og delekærv på den ene side og delekærv på den anden side.
English: Moreover, Lamivudine Teva Pharma B.V. should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Danish: ikke tages sammen med andre lægemidler, der indeholder lamivudin (se pkt.
English: Light grey, diamond shaped, biconvex film-coated tablet - engraved with “L 150” and breakline on one side and breakline on the other.
Danish: Lysegrå, ruderformet, bikonveks filmovertrukket tablet - præget med "L 150" og delekærv på den ene side og delekærv på den anden side.
English: If you get any symptoms of infection while you are taking Lamivudine Teva Pharma B.V.: Tell your doctor immediately.
Danish: Hvis du får symptomer på en infektion, mens du tager Lamivudin Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. is used to treat HIV (human immunodeficiency virus) infection in adults and children.
Danish: bruges til behandling af hiv-infektioner (humant immun defektvirus) hos voksne og børn.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets: 50 ml container of 60 film-coated tablets.
Danish: 150 mg filmovertrukne tabletter: 50 ml beholder a 60 filmovertrukne tabletter.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg of lamivudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 300 mg lamivudin.
English: The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral administration was approximately 0.12.
Danish: 2-4 timer efter peroral indgift var det gennemsnitlige forhold mellem lamivudinkoncentrationen i cerebrospinalvæsken og plasma ca. 0,12.
English: In neonates one week of age, lamivudine oral clearance was reduced when compared to paediatric patients and is likely to be due to immature renal function and variable absorption.
Danish: Hos 1 uge gamle spædbørn var den orale lamivudinclearance reduceret sammenlignet med pædiatriske patienter.
English: Other possible side effects of combination therapy for HIV Combination therapy including Lamivudine Teva Pharma B.V. may cause other conditions to develop during HIV treatment.
Danish: Andre mulige bivirkninger ved kombinationsbehandling af hiv Kombinationsbehandling som Lamivudin Teva Pharma B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg of lamivudine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 150 mg lamivudin.
English: Drug Interactions: Lamivudine Teva Pharma B.V. should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Danish: må ikke tages sammen med andre lægemidler, der indeholder lamivudin eller emtricitabin (se pkt.
English: It is metabolised intracellularly to the active moiety, lamivudine 5'-triphosphate.
Danish: Lamivudin metaboliseres intracellulært til den aktive del lamivudin 5′-trifosfat, hvis primære virkningsmekanisme er at afslutte kæden i hiv-revers transkription.
English: Talk to your doctor or pharmacist before taking Lamivudine Teva Pharma B.V..
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Lamivudin Teva Pharma B.V.
English: What you need to know before you take Lamivudine Teva Pharma B.V. Do not take Lamivudine Teva Pharma B.V.
Danish: Det skal du vide, før du begynder at tage Lamivudin Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Grey, diamond shaped, biconvex film-coated tablet with approx. 18.0 mm length and 8.0 mm widthengraved with “L 300” on one side and plain on the other
Danish: Grå, ruderformede, bikonvekse, filmovertrukne tabletter med en længde på ca. 18,0 mm og en bredde på ca. 8,0 mm - præget med "L 300" og delekærv på den ene side og uden delekærv på den anden side.
English: Uncommon: Transient elevations in liver enzymes (AST, ALT).
Danish: Ikke almindelige: Midlertidige stigninger af leverenzymer (ASAT, ALAT) Sjælden: Hepatitis
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine Teva Pharma B.V. or other medicines you are taking, or an effect of the HIV disease itself.
Danish: Når du bliver behandlet for hiv, kan det være svært at afgøre, om dine symptomer skyldes Lamivudin Teva Pharma B.V.
English: Some people taking Lamivudine Teva Pharma B.V. or other combination treatments for HIV are more at risk of serious side effects.
Danish: eller andre kombinationsbehandlinger mod hiv, har større risiko for at få alvorlige bivirkninger end andre.
English: Rare: Rhabdomyolysis.
Danish: hedder lamivudin.
English: These medicines should not be used with Lamivudine Teva Pharma B.V.:
Danish: Følgende lægemidler må ikke tages sammen med Lamivudin Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets lamivudine
Danish: 150 mg filmovertrukne tabletter lamivudin
English: 150 mg once daily
Danish: 150 mg 1 gang daglig
English: Children (weighing less than 25 kg)
Danish: Voksne, unge og børn (som vejer mindst 25 kg):
English: INFORMATION IN BRAILLE Lamivudine Teva Pharma B.V. 300 mg
Danish: INFORMATION I BRAILLESKRIFT Lamivudin Teva Pharma B.V.
English: If you take more Lamivudine Teva Pharma B.V. than you should Accidentally taking too much Lamivudine Teva Pharma B.V. is unlikely to cause any serious problems.
Danish: Der vil sandsynligvis ikke opstå alvorlige problemer, hvis du ved et uheld tager for meget Lamivudin Teva Pharma B.V.
English: Skin and subcutaneous tissue disorders Common: Rash, alopecia.
Danish: Hud og subkutane væv Almindelige: Udslæt, hårtab Sjælden: Angioødem
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets lamivudine
Danish: 300 mg filmovertrukne tabletter lamivudin
English: The active ingredient in Lamivudine Teva Pharma B.V. is lamivudine.
Danish: Det aktive stof i Lamivudin Teva Pharma B.V.
English: How to take Lamivudine Teva Pharma B.V.
Danish: Sådan skal du tage Lamivudin Teva Pharma B.V.
English: Iron oxide yellow Iron oxide black
Danish: Gul jernoxid Sort jernoxid
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Lamivudine Teva Pharma B.V. 300mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tabletbeholder - Lamivudin Teva Pharma B.V.
English: A 10 mg/mL oral solution may be the most appropriate formulation to achieve the recommended dose in children with renal impairment aged at least 3 months and weighing less than 25kg.
Danish: Til børn over 3 måneder og med en vægt på mindre end 25 kg med nedsat nyrefunktion er en 10 mg/ml oral opløsning sandsynligvis den bedst egnede lægemiddelform til at opnå den anbefalede dosis.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - LAMIVUDINE TEVA PHARMA B.V. 300 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - LAMIVUDIN TEVA PHARMA B.V.
English: Dosing according to weight bands is recommended for Lamivudine Teva Pharma B.V. tablets.
Danish: Børn (som vejer under 25 kg): Dosering af Lamivudin Teva Pharma B.V.-tabletter ud fra vægtgrupper anbefales.
English: How to store Lamivudine Teva Pharma B.V.
Danish: Behandling med Lamivudin Teva Pharma B.V.
English: Other medicines and Lamivudine Teva Pharma B.V.
Danish: Brug af anden medicin sammen med Lamivudin Teva Pharma B.V.
English: Excipient(s)
Danish: Hjælpestof(fer)
English: Lamivudine Teva Pharma B.V. 150 mg film-coated tablets Each film-coated tablet contains 150 mg lamivudine.
Danish: Hver filmovertrukket tablet indeholder 150 mg lamivudin.
English: Lamivudine Teva Pharma B.V. 300 mg film-coated tablets Each film-coated tablet contains 300 mg lamivudine.
Danish: Hver filmovertrukket tablet indeholder 300 mg lamivudin.
English: Kyprolis received a marketing authorisation valid throughout the EU on 19 November 2015.
Danish: Kyprolis fik en markedsføringstilladelse med gyldighed i hele EU den 19. november 2015.
English: Each infusion lasts 10 or 30 minutes, according to the dose.
Danish: Hver infusion varer i 10 eller 30 minutter, afhængigt af dosen.
English: After the first week the dose is increased if the side effects are manageable.
Danish: Efter den første uge øges dosen, hvis bivirkningerne er håndterbare.
English: It is given in four-week treatment cycles, on days 1, 2, 8, 9, 15 and 16 of each cycle.
Danish: Det gives i behandlingscyklusser a fire uger på dag 1, 2, 8, 9, 15 og 16 i hver cyklus.
English: The dose is calculated using the patient's height and weight.
Danish: Dosen afhænger af patientens højde og vægt.
English: Other information about Kyprolis
Danish: Andre oplysninger om Kyprolis
English: It is given to adults who have received at least one previous treatment for their cancer.
Danish: Det anvendes hos voksne, der har fået mindst én forudgående kræftbehandling.
English: As for all medicines, data on the use of Kyprolis is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Kyprolis løbende overvåget.
English: Kyprolis must not be used in women who are breastfeeding.
Danish: Kyprolis må ikke anvendes hos kvinder, der ammer.
English: What measures are being taken to ensure the safe and effective use of Kyprolis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kyprolis?