FrancophonIA/ELRC3.0 huggingface dataset:
English: • pancreatitis - signs are severe stomach pain which spreads into your back.
Danish: • betændelse i bugspytkirtlen - tegn på dette kan være voldsomme mavesmerter, der spreder sig til ryggen.
English: (72) x (0.011 x serum creatinine [micromol/L])
Danish: Mænd: (140 - alder [år]) x (vægt [kg]) (72) x (0,011 x serum-creatinin [mikromol/l])
English: Toxicity may be enhanced when ganciclovir is co-administered with other drugs known to be myelosuppressive or associated with renal impairment (such as dapsone, pentamidine, flucytosine, vincristine, vinblastine, doxorubicin, amphotericin B, mycophenolate mofetil, trimethoprim/sulphamethoxazole, and hydroxyurea) as well as nucleoside analogues (including zidovudine).
Danish: Toksiciteten kan forstærkes, hvis ganciclovir administreres sammen med andre lægemidler, der vides at være myelosupprimerende eller forbundne med nedsat nyrefunktion (fx dapson, pentamidin, flucytosin, vincristin, vinblastin, doxorubicin, amphotericin B, mycofenolatmofetil, trimethoprim/sulfamethoxazol og hydroxyurinstof) såvel som nukleosidanaloger (inklusive zidovudin).
English: For storage conditions after reconstitution and after dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: • you have kidney problems - your doctor will need to give you a lower dose and check your blood cell counts more often during treatment
Danish: • du har problemer med nyrerne - lægen vil give dig en lavere dosis og tage flere blodprøver under behandlingen
English: • kidney or liver problems
Danish: • nyre- eller leverproblemer
English: INFORMATION IN BRAILLE Justification for not including Braille accepted [To be completed nationally]
Danish: INFORMATION I BRAILL-SKRIFT <Fritaget fra krav om brailleskrift> [Udfyldes nationalt]
English: - Intravenous ganciclovir 5 mg/kg daily for 6 weeks followed by oral valganciclovir 17 mg/kg twice daily for 6 weeks then daily until 1 year of age, or - Oral valganciclovir 17 mg/kg twice daily for 12 weeks then daily for 9 months.
Danish: - Intravenøs ganciclovir 5 mg/kg dagligt i 6 uger efterfulgt af oral valganciclovir 17 mg/kg 2 gange dagligt i 6 uger, herefter dagligt indtil 1 årsalderen, eller - Oral valganciclovir 17 mg/kg 2 gange dagligt i 12 uger, herefter dagligt i 9 måneder.
English: • fever, chills or night sweats
Danish: • feber, kulderystelser eller nattesved
English: Ganciclovir was associated with a decrease in the detection of CMV by culture or polymerase chain reaction.
Danish: Ganciclovir var forbundet med et fald i detektion af CMV ved dyrkning eller polymerasekædereaktion (PCR).
English: • imipenem/cilastatin - used for bacterial infections,
Danish: • imipenem/cilastatin - anvendes til bakterieinfektioner
English: Other medicines and Cymevene Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Cymevene Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • changes in blood cell counts.
Danish: • ændringer i blodtallene.
English: By one year after baseline, 5/24 ganciclovir recipients and 13/19 control patients had worsening hearing (p < 0.01).
Danish: 1 år efter baseline havde 5/24 ganciclovirbehandlede patienter og 13/19 kontrolpatienter dårligere hørelse (p<0,01).
English: As dosage modifications are recommended in patients with renal impairment, serum creatinine or estimated creatinine-clearance levels should be monitored.
Danish: Dosisjustering anbefales til patienter med nedsat nyrefunktion, og derfor bør serum-creatinin eller estimeret creatininclearance monitoreres.
English: Infusion concentrations greater than 10mg/mL are not recommended.
Danish: Koncentration over 10 mg/ml i infusionsvæsken frarådes.
English: • The virus can affect any part of the body.
Danish: • Virusset kan ramme alle dele af kroppen, også nethinden bag i øjet.
English: • trimethoprim, trimethoprim/sulfamethoxazole, dapsone - used for bacterial infections,
Danish: • trimethoprim, trimethoprim/sulfamethoxazol, dapson - anvendes til bakterieinfektioner
English: Exposure as measured by mean AUC0−∞ on Days 1 and 14 were 19.4 ± 7.1 and 24.1 ± 14.6 µg.h/mL, respectively, and the corresponding Cmax values were 7.59 ± 3.21 µg/mL (Day 1) and 8.31 ± 4.9 µg/mL (Day 14).
Danish: Eksponeringen, målt ved gennemsnitligt AUC0−∞ på dag 1 og 14, var henholdsvis 19,4 ± 7,1 og 24,1 ± 14,6 µg∙t/ml, og de tilsvarende Cmax-værdier var 7,59 ± 3,21 µg/ml (dag 1) og 8,31 ± 4,9 µg/ml (dag 14).
English: Viral resistance to ganciclovir can arise by selection of mutations in the viral kinase gene (UL97) responsible for ganciclovir monophosphorylation and/or the viral polymerase gene (UL54).
Danish: Viral resistens mod ganciclovir kan opstå ved selektion af mutationer i det virale kinasegen (UL97), der er ansvarligt for ganciclovir-monofosforylering og/eller det virale polymerasegen (UL54).
English: Therefore, patients taking probenecid and Cymevene should be closely monitored for ganciclovir toxicity.
Danish: Patienter, der får probenecid samtidig med Cymevene, bør derfor monitoreres omhyggeligt for ganciclovirtoksicitet.
English: Viruses containing mutations in the UL97 gene are resistant to ganciclovir alone, whereas viruses with mutations in the UL54 gene are resistant to ganciclovir but may show cross-resistance to other antivirals that also target viral polymerase.
Danish: Vira med mutationer i UL97-genet er kun resistente over for ganciclovir, mens vira med mutationer i UL54-genet er resistente over for ganciclovir og kan være krydsresistente over for andre antivirale midler, der også er rettet mod viral polymerase.
English: In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase, UL97.
Danish: I CMV-inficerede celler fosforyleres ganciclovir initialt til ganciclovirmonophosphat af den virale proteinkinase UL97.
English: Twenty-one of 25 ganciclovir recipients had improved hearing or maintained normal hearing from baseline to 6 months compared with 10/17 control patients (84% and 59%, respectively p = 0.06).
Danish: 21 af de 25 ganciclovirbehandlede patienter havde forbedret eller fortsat normal hørelse efter 6 måneder i forhold til baseline sammenlignet med 10/17 kontrolpatienter (henholdsvis 84% og 59%, p = 0,06).
English: Mean values for the steady state volume of distribution (0.7 L/kg) and systemic clearance (3.15 ± 0.47 mL/min/kg at 4 mg/kg and 3.55 ± 0.35 mL/min/kg at 6 mg/kg) were comparable to those observed in adults with normal renal function.
Danish: Gennemsnitlige værdier for fordelingsvolumen ved steady state (0,7 l/kg) og systemisk clearance (3,15 ± 0,47 ml/min/kg ved 4 mg/kg og 3,55 ± 0,35 ml/min/kg ved 6 mg/kg) var sammenlignelige med værdierne hos voksne med normal nyrefunktion.
English: None of the ganciclovir recipients had worsening hearing from baseline to 6 months, compared with 7 control patients (p < 0.01).
Danish: Ingen af de ganciclovirbehandlede patienter havde dårligere hørelse efter 6 måneder i forhold til baseline sammenlignet med 7 kontrolpatienter (p<0,01).
English: Cymevene should be used with caution in patients with pre-existing haematological cytopenia or a history of drug-related haematological cytopenia and in patients receiving radiotherapy.
Danish: Cymevene bør anvendes med forsigtighed hos patienter med allerede eksisterende cytopeni eller med lægemiddelrelateret cytopeni i anamnesen samt til patienter i strålebehandling.
English: Tell your doctor straight away if you notice any of the serious side effects above.
Danish: Kontakt straks lægen, hvis du bemærker én eller flere af ovenstående alvorlige bivirkninger.
English: • feeling depressed, anxious, confused or having abnormal thoughts
Danish: • depression, uro, forvirring eller unormale tanker
English: After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir.
Danish: Efter rekonstitution med 10 ml vand til injektionsvæsker indeholder hver ml 50 mg ganciclovir.
English: • serious kidney problems shown in tests
Danish: • alvorlige nyreproblemer, påvist i laboratorieprøver
English: During intermittent haemodialysis, estimates for the clearance of ganciclovir ranged from 42−92 mL/min, resulting in intra-dialytic half-lives of 3.3−4.5 hours.
Danish: Ved intermitterende hæmodialyse spændte estimater for ganciclovir-clearance fra 42 til 92 ml/min, hvilket giver en intradialytisk halveringstid på 3,3-4,5 timer.
English: Based upon animal studies where aspermatogenesis was induced at ganciclovir systemic exposures below therapeutic levels, it is considered likely that ganciclovir causes inhibition of human spermatogenesis.
Danish: På baggrund af dyrestudier, hvor aspermatogenese induceres ved systemisk ganciclovir-eksponering under terapeutisk niveau, er det sandsynligt, at ganciclovir kan hæmme den humane spermatogenese.
English: Men If you are a man whose female partner could get pregnant - use a barrier method of contraception (such as condoms) while you are using Cymevene.
Danish: Hvis din partner kan blive gravid, skal du bruge en barrieremetode (f.eks. kondom), mens du er i behandling med Cymevene.
English: Precaution to be taken before handling or administering the medicinal product: Since ganciclovir is considered a potential teratogen and carcinogen in humans, caution should be taken in its handling (see section 6.6).
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet: Da ganciclovir potentielt er teratogent og karcinogent hos mennesker, skal der tages forholdsregler, når det håndteres (se pkt.
English: In a retrospective analysis, the safety and efficacy of ganciclovir was compared to valganciclovir in 92 paediatric kidney and/or liver transplant patients (7 months -18 years of age, median age 9 years).
Danish: En retrospektiv analyse sammenlignede sikkerheden og virkningen af ganciclovir og valganciclovir hos 92 nyre- og/eller levertransplanterede børn (i aldersgruppen 7 måneder -18 år, medianalder 9 år).
English: Talk to your doctor, pharmacist or nurse before using Cymevene if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Cymevene, hvis:
English: Cymevene and associated names (see Annex I) 500 mg powder for concentrate for solution for infusion.
Danish: Cymevene og relaterede navne (se bilag I) 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: • feeling agitated or nervous
Danish: • rastløs uro eller nervøsitet
English: Add a volume of 100ml of diluent to the reconstituted solution.
Danish: Tilsæt 100 ml infusionsvæske til det rekonstituerede koncentrat.
English: During the course of the study, 29/46 ganciclovir-treated patients had neutropenia, compared with 9/43 control patients (p < 0.1).
Danish: I løbet af studiet oplevede 29/46 patienter i ganciclovir-gruppen neutropeni sammenlignet med 9/43 kontrolpatienter (p<0,1).
English: The duration of maintenance treatment should be determined on an individual basis, local treatment guidelines should be consulted.
Danish: Varigheden af vedligeholdelsesbehandlingen skal vurderes individuelt i overensstemmelse med lokale vejledninger.
English: Hepatic function abnormal Blood alkaline phosphatase increased Aspartate aminotransferase increased
Danish: Unormal leverfunktion Forhøjet alkalisk fosfatase i blodet Forhøjet aspartat-aminotransferase Forhøjet alanin-aminotransferase
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG ADMINISTRATIONSVEJ
English: Dose modifications for patients with renal impairment:
Danish: Dosisjusteringer til patienter med nedsat nyrefunktion:
English: Therefore, breastfeeding must be discontinued during treatment with ganciclovir (see section 4.3).
Danish: Amning skal derfor ophøre under behandling med ganciclovir (see pkt.
English: • flucytosine, amphotericin B - used for fungal infections,
Danish: • flucytosin, amphotericin B - anvendes til svampeinfektioner
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal tages hensyn til dette hos patienter på natrium- eller saltfattig diæt.
English: • mycophenolate mofetil - used after an organ transplant,
Danish: • mycophenolatmofetil - anvendes efter organtransplantationer
English: Increased haematological monitoring may be warranted in patients with renal impairment.
Danish: Hyppigere hæmatologisk monitorering kan være nødvendig hos patienter med nedsat nyrefunktion.
English: Pharmacokinetics of intravenous ganciclovir were also studied in infants and children with normal renal function and aged 9 months−12 years.
Danish: Farmakokinetikken for intravenøs ganciclovir er også undersøgt hos spædbørn og børn 9 måneder -12 år med normal nyrefunktion.
English: The reconstituted solution should be checked carefully to ensure that the product is in solution and practically free from visible particles prior to dilution with compatible solvent.
Danish: Det rekonstituerede koncentrat skal omhyggeligt kontrolleres for at sikre, at pulveret er opløst, og at koncentratet fremstår klart og stort set uden synlige partikler, inden den fortyndes med en forligelig infusionsvæske.
English: Sodium chloride, dextrose 5%, Ringer's or lactated Ringer's solutions are determined chemically or physically compatible with Cymevene.
Danish: Natriumchloridinfusionsvæske, glucoseinfusionsvæske 5%, Ringer-infusionsvæske og Ringer-lactatinfusionsvæske er dokumenteret kemisk og fysisk forligelige med Cymevene.
English: In animal studies ganciclovir was found to be mutagenic, teratogenic, aspermatogenic, carcinogenic and to impair fertility.
Danish: Ganciclovir er i dyrestudier vist at være mutagent, teratogent, aspermatogent og karcinogent samt at nedsætte fertiliteten.
English: From a microbiological point of view, the Cymevene infusion solution should be used immediately.
Danish: Ud fra en mikrobiologiske betragtning bør Cymevene infusionsvæske anvendes straks.
English: • you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine
Danish: • du er allergisk over for ganciclovir, valganciclovir eller et af de øvrige indholdsstoffer i Cymevene
English: Therefore, adverse drug reactions reported with intravenous or oral ganciclovir or with valganciclovir are included in the table of adverse reactions.
Danish: Derfor er alle de bivirkninger, der er rapporteret med intravenøs og oral ganciclovir samt med valganciclovir, inkluderet i bivirkningstabellen.
English: Other antiretrovirals
Danish: Andre antiretrovirale lægemidler
English: Ganciclovir should not be used concomitantly with imipenem-cilastatin unless the potential benefits outweigh the potential risks (see section 4.5).
Danish: Ganciclovir bør ikke anvendes sammen med imipenem-cilastatin, medmindre de potentielle fordele opvejer de potentielle risici (se pkt.
English: Cymevene may affect fertility.
Danish: Cymevene kan påvirke frugtbarheden.
English: • vincristine, vinblastine, doxorubicin - used for cancer,
Danish: • vincristin, vinblastin, doxorubicin - anvendes til behandling af kræft
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)
Danish: Natriumhydroxid (til pH-justering).
English: • probenecid - used for gout,
Danish: • probenecid - anvendes til urinsur gigt
English: Single-dose glass vials of 10 mL with fluoro-resin laminated rubber stopper and aluminum closure with flip-off cap.
Danish: Enkeltdosis-hætteglas (glas) med 10 ml fluor-resin-lamineret gummiprop og aluminiumshætte, der kan vippes af.
English: Intravenous ganciclovir exhibits linear pharmacokinetics over the range of 1.6−5.0 mg/kg.
Danish: Linearitet/non-linearitet Intravenøs ganciclovir udviser lineær farmakokinetik i dosisintervallet 1,6-5,0 mg/kg.
English: For patients with severe leucopenia, neutropenia, anaemia and/or thrombocytopenia it is recommended to consider the use of treatment with haematopoietic growth factors and/or the interruption of ganciclovir therapy (see sections 4.2 and 4.8).
Danish: For patienter med svær leukopeni, neutropeni, anæmi og/eller trombocytopeni anbefales det at overveje brug af hæmatopoietiske vækstfaktorer og/eller at afbryde behandlingen med ganciclovir (se pkt.
English: What Cymevene is
Danish: Hvad er Cymevene
English: Ganciclovir is removed by haemodialysis, therefore haemodialysis may be of benefit in reducing drug exposure in patients who receive an overdose of ganciclovir (see section 5.2).
Danish: Ganciclovir fjernes ved hæmodialyse og derfor kan hæmodialyse være gavnligt til at reducere eksponereringen hos patienter, der har fået en overdosis ganciclovir (se pkt.
English: These drugs should not be used concomitantly unless the potential benefits outweigh the potential risks (see section 4.4).
Danish: Disse lægemidler bør ikke anvendes sammen, medmindre de potentielle fordele opvejer de potentielle risici (se pkt.
English: The pharmacokinetic characteristics of ganciclovir were the same after single and multiple (q12h) 5 mg/kg intravenous doses.
Danish: De farmakokinetiske karakteristika for ganciclovir var de samme efter en enkelt dosis og efter gentagne doser (hver 12. time) af 5 mg/kg intravenøst.
English: Severe leucopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow depression have been observed in patients treated with ganciclovir.
Danish: Der er observeret svær leukopeni, neutropeni, anæmi, trombocytopeni, pancytopeni og knoglemarvsdepression hos patienter behandlet med ganciclovir.
English: In a prospective study, 36 severely immunocompromised paediatric patients (6 months - 16 years of age) with HIV and CMV infection received intravenous ganciclovir at a dose of 5 mg/kg per day for 2 days followed by oral ganciclovir for a median of 32 weeks.
Danish: I et prospektivt studie fik 36 svært immunkompromitterede pædiatriske patienter (6 måneder - 16 år) med HIV- og CMV-infektion intravenøs ganciclovir i en dosis på 5 mg/kg per dag i 2 dage efterfulgt af oral ganciclovir i en medianperiode på 32 uger.
English: In patients treated with ganciclovir the most serious and common adverse drug reactions are haematological reactions and include neutropenia, anaemia and thrombocytopenia.
Danish: De alvorligste og hyppigst forekommende bivirkninger hos patienter behandlet med ganciclovir er hæmatologiske bivirkninger og omfatter neutropeni, anæmi og trombocytopeni.
English: Injection site reactions occur commonly in patients receiving ganciclovir.
Danish: Reaktioner ved injektionsstedet er hyppigt forekommende hos patienter behandlet med ganciclovir.
English: Therefore, women of child bearing potential must be advised to use effective contraception during treatment and for at least 30 days thereafter.
Danish: Fertile kvinder skal derfor informeres om at anvende effektiv prævention under behandlingen og i mindst 30 dage efter, behandlingen er afsluttet.
English: Male patients must be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir unless it is certain that the female partner is not at risk of pregnancy (see sections 4.4 and 5.3).
Danish: Mandlige patienter skal informeres om at anvende barriere-prævention under behandlingen og i mindst 90 dage efter, behandlingen med ganciclovir er afsluttet, medmindre det er sikkert, at den kvindelige partner ikke risikerer graviditet (se pkt.
English: Mean Ganciclovir Plasma half-life (hours)
Danish: Gennemsnitlig plasmahalveringtid for ganciclovir (timer)
English: • urine infection - signs include fever, passing urine more often, pain when passing urine
Danish: • urininfektion - tegn på dette kan være feber, hyppig vandladning, smerter ved vandladning
English: In a Phase III, randomised, controlled study, 100 neonates (3-33 days of age, median age 12 days) with severe symptomatic congenital CMV with CNS involvement, received either intravenous ganciclovir 6 mg/kg twice daily for 6 weeks (n = 48) or no antiviral treatment (n = 52).
Danish: I et randomiseret, kontrolleret fase III-studie fik 100 nyfødte (alder 3-33 dage; medianalder 12 dage) med svær, symptomatisk kongenital CMV med CNS-påvirkning enten intravenøs ganciclovir 6 mg/kg 2 gange dagligt i 6 uger (n = 48) eller ingen antiviral behandling (n = 52).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE Pulver til koncentrat til infusionsvæske, opløsning.
English: Ganciclovir IV
Danish: Ganciclovir i.v.
English: Agranulocytosis* Aplastic anaemia* Granulocytopenia*
Danish: Trombocytopeni Leukopeni Pancytopeni Knoglemarvssvigt Agranulocytose* Aplastisk anæmi* Granulocytopeni*
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: PRODUKTRESUMÈ, ETIKETTERING OG INDLÆGSSEDDEL
English: If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to.
Danish: Hvis du er gravid eller har mistanke om, at du er gravid, skal du spørge lægen til råds, før du får dette lægemiddel.
English: • your blood counts
Danish: • dine blodprøver
English: If you have any kidney or blood problems your doctor might suggest a smaller dose of Cymevene and check your blood cell counts more often during treatment.
Danish: Hvis du har problemer med nyrerne eller blodtallene Hvis du har problemer med nyrerne eller blodtallene, vil lægen måske foreslå en lavere dosis af Cymevene og tage lidt flere blodprøver i løbet af behandlingen.
English: Neutropenia Anaemia.
Danish: Neutropeni Anæmi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas indeholder 500 mg ganciclovir (som ganciclovirnatrium).
English: In a retrospective study, 122 paediatric liver transplantation recipients (16 days - 18 years of age, median age 2.5 years) received a minimum of 14 days of intravenous ganciclovir 5 mg/kg twice a day followed by pre-emptive CMV PCR monitoring.
Danish: I et retrospektivt studie fik 122 levertransplanterede børn (16 dage - 18 år, medianalder 2,5 år) mindst 14 dages intravenøs ganciclovir 5 mg/kg 2 gange dagligt, efterfulgt af præventiv monitorering af CMV ved PCR.
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Danish: Ud fra en mikrobiologiske betragtning bør det rekonstituerede koncentrat anvendes straks.
English: The mean systemic clearance ranged from 2.64 ± 0.38 mL/min/kg (N = 15) to 4.52 ± 2.79 mL/min/kg (N = 6) and renal clearance ranged from 2.57 ± 0.69 mL/min/kg (N = 15) to 3.48 ± 0.68 mL/min/kg (N = 20), corresponding to 90%−101% of administered ganciclovir.
Danish: Gennemsnitlig systemisk clearance ligger i området 2,64 ± 0,38 ml/min/kg (n = 15) til 4,52 ± 2,79 ml/min/kg (n = 6), og den renale clearance ligger i området 2,57 ± 0,69 ml/min/kg (n = 15) til 3,48 ± 0,68 ml/min/kg (n = 20), svarende til 90%-101% af administreret ganciclovir.
English: • swollen stomach
Danish: • udspilet mave
English: NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN {Cymevene og relaterede navne (Se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
English: • pentamidine - used for parasite or lung infections,
Danish: • pentamidin - anvendes til behandling af parasitter eller lungeinfektioner
English: Also do this for at least 30 days after Cymevene has been stopped.
Danish: Du skal fortsætte med at bruge prævention i mindst 30 dage, efter du er holdt op med at få Cymevene.
English: • liver and kidney problems shown in tests
Danish: • lever- og nyreproblemer, påvist i laboratorieprøver
English: • you are breast-feeding (see Breast-feeding subsection).
Danish: • du ammer (se underafsnittet ”Amning”).