FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues.
Danish: Der foreligger rapporter om mitokondriel dysfunktion hos hiv-negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller efter fødslen.
English: For patients who are being treated with lamivudine and subsequently become pregnant consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
Danish: Hos patienter, som bliver gravide under behandling med lamivudin, bør det vurderes, om der er en risiko for tilbagevenden af hepatitis ved ophør med lamivudin.
English: In patients followed for up to 16 weeks after discontinuation of treatment at one year, post-treatment ALT elevations were observed more frequently in patients who had received lamivudine than in patients who had received placebo.
Danish: Hos patienter, der blev fulgt op til 16 uger efter ophør med behandlingen på 1 år, så man en hyppigere forekomst af forhøjet ALAT efter behandling hos de patienter, som havde fået lamivudin i forhold til de patienter, som fik placebo.
English: In patients with YMDD mutant HBV, 41/82 (50 %) patients had improvement in liver inflammation and 40/56 (71 %) patients without YMDD mutant HBV had improvement.
Danish: Hos patienter med YMDD-mutation-HBV udviste 41/82 (50 %) patienter forbedring af leverinflammation og 40/56 (71 %) patienter uden YMDD-mutation-HBV udviste forbedring.
English: Some lateonset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Danish: Der foreligger rapporter med senreaktioner i form af neurologiske forstyrrelser (hypertoni, kramper, usædvanlig opførsel).
English: Other medicines and Zeffix
Danish: Brug af anden medicin sammen med Zeffix
English: Check with your doctor if you think this applies to you.
Danish: Kontakt lægen, hvis du mener dette gælder for dig.
English: The dosage should, therefore, be reduced for patients with a creatinine clearance of < 50 ml/minute.
Danish: Dosis bør derfor nedsættes til patienter med kreatininclearance under 50 ml/min.
English: PHARMACEUTICAL FORM AND CONTENTS Each bottle contains 240 ml oral solution
Danish: Hver flaske indeholder 240 ml oral opløsning
English: Discard one month after first opening.
Danish: Kasseres 1 måned efter første åbning af flasken.
English: In elderly patients the pharmacokinetic profile of lamivudine suggests that normal ageing with accompanying renal decline has no clinically significant effect on lamivudine exposure, except in patients with creatinine clearance of < 50 ml/min (see section 4.2).
Danish: Hos ældre patienter tyder den farmakokinetiske profil af lamivudin på, at normal ældning med ledsagende nedsættelse af nyrefunktionen ikke har nogen klinisk signifikant effekt på ekspositionen af lamivudin undtagen hos patienter med kreatininclearance under 50 ml/min (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 July 1999
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Experience in CHB patients with advanced fibrosis or cirrhosis In a placebo-controlled study in 651 patients with clinically compensated chronic hepatitis B and histologically confirmed fibrosis or cirrhosis, lamivudine treatment (median duration 32 months) significantly reduced the rate of overall disease progression (34/436, 7.8 % for lamivudine versus 38/215, 17.7 % for placebo, p=0.001), demonstrated by a significant reduction in the proportion of patients having increased Child-Pugh scores (15/436, 3.4 % versus 19/215, 8.8 %, p=0.023) or developing hepatocellular carcinoma (17/436, 3.9 % versus 16/215, 7.4 %, p=0.047).
Danish: Erfaring med CHB patienter med fremskreden fibrose eller cirrose I et placebokontrolleret studie med 651 patienter, med klinisk kompenseret kronisk hepatitis B og histologisk bekræftet fibrose eller cirrose, reducerede lamivudin behandling (middelvarighed 32 måneder) signifikant hyppigheden af overordnet sygdomsprogression, (34/436, 7,8 % for lamivudin versus 38/215, 17,7 % for placebo, p=0.001), demonstreret ved en signifikant reduktion i andelen af patienter, der havde øget ChildPugh scores (15/436, 3,4 % versus 19/215, 8,8 %, p=0.023) eller udviklende hepatocellulær carcinoma (17/436, 3,9 % versus 16/215, 7,4 %, p=0.047).
English: Zidovudine had no effect on the pharmacokinetics of lamivudine (see section 5.2).
Danish: Zidovudin har ingen indvirkning på farmakokinetikken af lamivudin (se pkt.
English: • difficulty swallowing or breathing Contact a doctor immediately if you get these symptoms.
Danish: Kontakt omgående lægen, hvis du får disse symptomer.
English: Each film-coated tablet contains 100 mg of lamivudine.
Danish: Hver filmovertrukken tablet indeholder 100 mg lamivudin.
English: • an increase in the level of an enzyme produced in the muscles(creatine phosphokinase) which may be a sign that body tissue is damaged.
Danish: • stigning i indholdet af enzymer, som dannes i musklerne (kreatinfosfokinase), som kan være tegn på ødelæggelse af muskelvæv.
English: In patients who have YMDD mutant HBV, a switch to or addition of an alternative agent without cross resistance to lamivudine based on therapeutic guidelines should be considered (see section 5.1).
Danish: Hos patienter, som har YMDD-mutation-HBV, bør skift til eller tilføjelse af et alternativt lægemiddel uden krydsresistens over for lamivudin overvejes, baseret på terapeutiske retningslinjer (se pkt.
English: Blood and lymphatic system disorders Not known
Danish: Blod og lymfesystem
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Danish: Studier hos patienter med nedsat nyrefunktion viser, at eliminationen af lamivudin påvirkes ved dysfunktion af nyrerne.
English: Data obtained in patients with hepatic impairment, including those with end-stage liver disease awaiting transplant, show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Danish: Data fra patienter med nedsat leverfunktion, herunder patienter med terminal leversygdom som afventer transplantation, viser, at farmakokinetikken af lamivudin ikke påvirkes signifikant ved dysfunktion af leveren.
English: For the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive treatment with lamivudine or the combination lamivudine-zidovudine, the dose of lamivudine prescribed for HIV infection (usually 150 mg/twice daily in combination with other antiretrovirals) should be maintained.
Danish: Ved behandling af patienter, der er co-inficeret med hiv, som bliver eller planlægger at blive behandlet med lamivudin eller kombinationen lamivudin-zidovudin, skal den dosis, der er udskrevet til hiv-infektionen (sædvanligvis 150 mg 2 gange daglig i kombination med andre antiretrovirale lægemidler) beholdes.
English: Adults The recommended dosage of Zeffix is 100 mg once daily.
Danish: Voksne Den anbefalede dosis Zeffix er 100 mg én gang daglig.
English: Addition of 10 mg adefovir dipivoxil once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ml.
Danish: Tilføjelse af 10 mg adefovirdipivoxil én gang dagligt til den eksisterende behandling med 100 mg lamivudin i 52 uger medførte en medianreduktion i HBV-DNA på 4,6 log10 kopier/ml.
English: Talk to your doctor if any of these apply to you.
Danish: Kontakt lægen, hvis noget af dette gælder for dig.
English: How much to take The usual dose of Zeffix is 20 ml (100 mg lamivudine) once a day.
Danish: Den sædvanlige dosis Zeffix er 20 ml (100 mg lamivudin) én gang daglig.
English: First dose of Zeffix oral solution
Danish: Initialdosis Zeffix oral opløsning
English: In a double-blind study in CHB patients with YMDD mutant HBV and compensated liver disease (NUC20904), with a reduced virological and biochemical response to lamivudine (n=95), the addition of adefovir dipivoxil 10 mg once daily to ongoing lamivudine 100mg for 52 weeks resulted in a median decrease in HBV DNA of 4.6 log10 copies/ml compared to a median increase of 0.3 log10 copies/ml in those patients receiving lamivudine monotherapy.
Danish: I et dobbeltblindet studie med CHB patienter med YMDD-mutation-HBV og kompenseret leversygdom (NUC20904) og med et reduceret virologisk og biokemisk respons over for lamivudin (n=95) resulterede tilføjelse af adefovirdipivoxil 10 mg 1 gang daglig til igangværende behandling med lamivudin 100 mg i 52 uger i et gennemsnitligt fald i HBV-DNA på 4.6 log10 kopier/ml sammenlignet med en gennemsnitlig stigning på 0,3 log10 kopier/ml hos patienter, der fik lamivudin monoterapi.
English: Don't take this medicine after the expiry date shown on the carton and blister.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på æsken og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Artificial strawberry flavour Artificial banana flavour Purified water
Danish: Syntetisk jordbærsmagsstof Syntetisk banansmagsstof Vand, renset
English: 10 Close the bottle tightly with the cap.
Danish: 10 Luk flasken godt med låget.
English: Zeffix 5 mg/ml oral solution lamivudine
Danish: Zeffix 5 mg/ml oral opløsning Lamivudin
English: There have been reports of mitochondrial dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Danish: Der foreligger rapporter om mitokondriel dysfunktion hos hiv-negative spædbørn, som har været eksponeret for nukleosidanaloger in utero og/eller efter fødslen (se pkt.
English: In some patients the development of YMDD mutant HBV can lead to exacerbation of hepatitis, primarily detected by serum ALT elevations and re-emergence of HBV DNA (see section 4.2).
Danish: Hos nogle patienter kan udviklingen af YMDD-mutation-HBV medføre en forværring af hepatitis, primært konstateret via stigninger i serum-ALAT, samt tilbagevendende forekomst af HBV-DNA (se pkt.
English: Discard one month after first opening
Danish: EXP Kasseres 1 måned efter første åbning af flasken
English: - Baseline ALT  1 x ULN2 - Baseline ALT > 2 x ULN
Danish: - Baseline ALAT > 2 x ULN
English: Contains amongst others: sugar (sucrose), preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
Danish: Indeholder blandt andet: sukker (saccharose), konserveringsmidler: methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216)
English: The other ingredients are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol, sodium citrate, artificial strawberry flavour, artificial banana flavour, purified water.
Danish: De øvrige indholdsstoffer er: saccharose, methylparahydroxybenzoat (E218), propylparahydroxybenzoat (E216), citronsyre, propylenglycol, natriumcitrat, syntetisk jordbær- og banansmagsstof og renset vand.
English: Sucrose 20 % w/v (4 g/20 ml) Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Saccharose 20 % w/v (4 g/20 ml) Methylparahydroxybenzoat (E218) 1,5 mg/ml Propylparahydroxybenzoat (E216) 0,18 mg/ml Alle hjælpestoffer er anført under pkt.
English: 6 Turn the bottle the right way up.
Danish: 6 Vend flasken rigtigt.
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Danish: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 finland.tuoteinfo@gsk.com
English: How much to take The usual dose of Zeffix is one tablet (100 mg lamivudine) once a day.
Danish: Den sædvanlige dosis Zeffix er 1 tablet (100 mg lamivudin) én gang daglig.
English: In patients with the mutant, 4/26 (15 %) patients showed improvement in necroinflammatory score and 8/26 (31 %) patients worsened compared to pretreatment.
Danish: Hos patienter med mutation udviste 4/26 (15 %) patienter forbedring i nekroinflammatorisk score og 8/26 (31 %) patienter udviste forværring sammenlignet med præbehandling.
English: Keep in touch with your doctor, and don't stop taking Zeffix without your doctor's advice.
Danish: Hold kontakt til lægen og afbryd ikke behandlingen med Zeffix uden lægens anvisning.
English: INFORMATION IN BRAILLE zeffix 5 mg/ml
Danish: zeffix 5 mg/ml
English: Do not stop treatment with Zeffix without your doctor's advice.
Danish: Stop ikke med at tage Zeffix uden lægens anvisning.
English: ALT  3 x baseline value†
Danish: ALAT ≥ 2 x baseline-værdien ALAT ≥ 3 x baseline-værdien†
English: • In patients with HBeAg negative CHB (pre-core mutant) without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Danish: • Hos patienter med HBeAg-negativ CHB (præ-core mutant) uden cirrose, skal behandling i hvert tilfælde gives indtil HBs-serokonversion eller indtil der ses tegn på tab af effekt.
English: • In patients with HBeAg positive chronic hepatitis B (CHB) without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg seroconversion or there is loss of efficacy (see section 4.4).
Danish: • Hos patienter med HBeAg-positiv kronisk hepatitis B (CHB) uden cirrose skal behandling altid gives i mindst 6-12 måneder, efter HBeAg-serokonversion (bortfald af HBeAg og HBV-DNA med HBeAbdetektion) er bekræftet, for at mindske risikoen for virologisk tilbagefald.
English: Sucrose (20 % w/v) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Citric acid (anhydrous) Propylene glycol
Danish: Saccharose (20 % w/v) Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Citronsyre (vandfri) Propylenglycol
English: Placental transfer of lamivudine has been shown to occur in humans.
Danish: Det er vist, at lamivudin overføres via moderkagen hos mennesker.
English: The mean lamivudine CSF/serum concentration ratio 2-4 hours after oral administration was approximately 0.12.
Danish: 2-4 timer efter oral administration var det gennemsnitlige forhold mellem koncentrationen af lamivudin i cerebrospinalvæsken og serum ca. 0,12.
English: * Zeffix oral solution containing 5 mg/ml lamivudine.
Danish: * Zeffix oral opløsning med lamivudin 5 mg/ml.
English: However, unless the patient has renal impairment, no dosage adjustment of lamivudine is necessary.
Danish: Dosisjustering af lamivudin er dog ikke nødvendig, medmindre patienten har nedsat nyrefunktion.
English: INFORMATION IN BRAILLE zeffix 100 mg
Danish: zeffix 100 mg
English: Experience in patients with HBeAg positive CHB and compensated liver disease In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 1618 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
Danish: Erfaring med patienter med HBeAg-positiv CHB og kompenseret leversygdom I kontrollerede studier viste 1 års behandling med lamivudin signifikant suppression af HBV-DNAreplikation [34-57 % af patienterne var under assay detektionsgrænserne, (Abbott Genostics solution hybridization assay, LLOD < 1,6 pg/ml)}, normaliseret ALAT-niveau (40-72 % af patienterne), induceret HBeAg-serokonversion (tab af HBeAg og HBeAb-detektion med HBV-DNA tab [ved konventionel assay], 16-18 % af patienterne), forbedret histologi (38-52 % af patienterne havde ≥ 2 points fald i Knodell histologisk aktivitets index [HAI]), og reduceret fibroseudviklinger (hos 3-17 % af patienterne) og udvikling til cirrose.
English: Experience in patients with HBeAg positive CHB and compensated liver disease In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 1618 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
Danish: Erfaring med patienter med HBeAg-positiv CHB og kompenseret leversygdom I kontrollerede studier viste 1 års behandling med lamivudin signifikant suppression af HBV-DNAreplikation (34-57 % af patienterne var under assay detektionsgrænserne (Abbott Genostics solution hybridization assay, LLOD < 1,6 pg/ml)], normaliseret ALAT-niveau (40-72 % af patienterne), induceret HBeAg-serokonversion (bortfald af HBeAg og HBeAb-detektion med HBV-DNA bortfald [ved konventionel assay], 16-18 % af patienterne), forbedret histologi (38-52 % af patienterne havde ≥ 2 points fald i Knodell histologisk aktivitets index [HAI]), og reduceret fibroseudvikling (hos 3-17 % af patienterne) og udvikling til cirrose.
English: • if you have ever had other types of liver disease, such as hepatitis C
Danish: Du skal derfor være opmærksom på en øget risiko: hvis du nogensinde har haft andre typer leversygdom, såsom hepatitis C hvis du er svært overvægtig (især hvis du er en kvinde).
English: Exacerbations of hepatitis, primarily detected by serum ALT elevations, have been reported ‘ontreatment' and following lamivudine withdrawal.
Danish: 4.4) Forværring af hepatitis, hovedsagelig set ved stigninger i serum ALAT, er rapporteret under behandling og ved stop af behandling med lamivudin.
English: • skin rash or ‘hives' anywhere on the body
Danish: • kramper og muskelsmerter • udslæt eller nældefeber på et hvilket som helst sted på kroppen.
English: Tell your doctor or pharmacist if you're 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 eller har gjort det for nylig.
English: In patients without YMDD mutant HBV, 14/22 (64 %) showed improvement in necroinflammatory score and 1/22 (5 %) patients worsened compared to pre-treatment.
Danish: Hos patienter uden YMDDmutation HBV udviste 14/22 (64 %) forbedring i nekroinflammatorisk score og 1/22 (5 %) patienter udviste forværring sammenlignet med præ-behandling.
English: Zeffix 100 mg film-coated tablets lamivudine
Danish: Zeffix 100 mg filmovertrukne tabletter Lamivudin
English: Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see section decompensated liver disease in combination with a second agent without cross-resistance to lamivudine (see section 4.2).
Danish: Påbegyndelse af behandling med lamivudin bør kun overvejes, når anvendelse af et alternativt antiviralt lægemiddel med en højere genetisk barriere over for resistens ikke er tilgængeligt eller egnet (se pkt.
English: Don't push too hard and squirt the liquid into the back of your throat, or you may choke.
Danish: For kraftig sprøjten bag til i halsen kan medføre risiko for kvælning.
English: YMDD mutant HBV status
Danish: Status for YMDD-mutationHBV
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Zeffix.
Danish: Hvis du ammer, eller overvejer at amme: Kontakt lægen, før du tager Zeffix.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Danish: Læs indlægssedlen inden brug Oral anvendelse
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Exacerbations on treatment
Danish: Forværring under behandling
English: • cladribine, used to treat hairy cell leukaemia Tell your doctor if you're being treated with any of these.
Danish: • cladribin, der bruges til behandling af hårcelleleukæmi.
English: Dose reduction in patients with a creatinine clearance of < 50 ml/min is necessary (see section 4.2).
Danish: Dosisreduktion er nødvendig til patienter med kreatininclearance under 50 ml/minut (se pkt.
English: Each ml of the oral solution contains 5 mg lamivudine
Danish: Hver ml af den orale opløsning indeholder 5 mg lamivudin
English: Limited data in patients undergoing liver transplantation show that impairment of hepatic function does not impact significantly on the pharmacokinetics of lamivudine unless accompanied by renal dysfunction.
Danish: Ifølge begrænsede data fra patienter, som fik levertransplantation påvirker nedsat leverfunktion ikke farmakokinetikken af lamivudin nævneværdigt, medmindre den er ledsaget af nedsat nyrefunktion.
English:  Use a condom when you have oral or penetrative sex.  Don't risk blood transfer - for example, don't share needles.
Danish: For at beskytte andre personer mod at blive smittet med hepatitis B:  Brug kondom ved oralsex, analsex eller samleje  Undgå overførsel af blod - lad f.eks. være med at dele nåle.
English: 4 Turn the bottle upside down.
Danish: 4 Vend flasken på hovedet.
English: Glaxo Wellcome Operations Priory Street
Danish: Glaxo Wellcome Operations
English: ALT elevations (see section 4.4)
Danish: Meget almindelig Stigninger i ALAT (se pkt.
English: You must not stop taking Zeffix without consulting your doctor.
Danish: Stop aldrig med at tage Zeffix uden først at spørge lægen til råds.
English: Don't stop taking Zeffix
Danish: Hvis du holder op med at tage Zeffix
English: NAME OF THE MEDICINAL PRODUCT Zeffix 5 mg/ml oral solution Lamivudine
Danish: Indlægsseddel: Information til brugeren Zeffix 5 mg/ml oral opløsning lamivudin
English: Each ml of oral solution contains 5 mg of lamivudine.
Danish: Hver ml af den orale opløsning indeholder 5 mg lamivudin.
English: Microcrystalline cellulose
Danish: Cellulose, mikrokrystallinsk Natriumstivelsesglycolat Magnesiumstearat
English: Thrombocytopenia Metabolism and nutrition disorders Very rare
Danish: Frekvens ikke kendt Thrombocytopeni
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Danish: Spontan forværring af kronisk hepatitis B er forholdsvist almindeligt og er karakteriseret ved kortvarige stigninger i serum-ALAT.
English: Zeffix is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Danish: Det tilhører en gruppe af lægemidler kaldet nukleosidanalog revers transkriptase-hæmmere (NRTI'er).
English: Don't store above 25 °C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: However, the proportion of patients who had post-treatment elevations associated with bilirubin elevations was low and similar in both treatment arms (see Table 3 in section 5.1).
Danish: Andelen af patienter, der efter behandlingsophør fik stigninger associeret med stigning i bilirubinniveau, var dog lille og ens i de to behandlingsarme.