FrancophonIA/ELRC3.0 huggingface dataset:
English: A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).
Danish: Immunforsvaret kan svækkes af andre sygdomme (for eksempel AIDS) eller af medicin (for eksempel kemobehandling eller immunsupprimerende lægemidler).
English: Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in patients who have a weak immune system.
Danish: Cymevene anvendes til at behandle sygdomme, der skyldes et virus, der kaldes cytomegalovirus (CMV) hos patienter, som har et svagt immunforsvar.
English: • low blood pressure, which may make you feel dizzy or faint
Danish: • lavt blodtryk, som kan få dig til at føle dig svimmel eller besvime
English: In these people the CMV virus can lead to a serious disease.
Danish: CMV kan forårsage alvorlig sygdom.
English: Other potential drug interactions
Danish: Andre potentielle lægemiddelinteraktioner
English: Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of herpes viruses both in vitro and in vivo.
Danish: Ganciclovir er en syntetisk analog af 2'-deoxyguanosin, der hæmmer replikation af herpesvira, både in vitro og in vivo.
English: • sight problems or eye pain
Danish: • problemer med synet eller smerter i øjet
English: Such results are consistent with the positive mouse carcinogenicity study with ganciclovir.
Danish: Dette er konsistent med de positive karcinogenicitetsstudier med ganciclovir hos mus.
English: However, the rates of certain adverse reactions, such as pyrexia and abdominal pain, which may be characteristic of the paediatric population, occur more often in paediatric than in adult patients.
Danish: Visse bivirkninger, fx pyreksi og abdominalsmerter, som kan være karakteristiske for den pædiatriske population, ses dog oftere hos børn end hos voksne.
English: • didanosine, stavudine, zidovudine or any other medicines used for HIV.
Danish: • didanosin, stavudin, zidovudin og alle andre lægemidler til behandling af HIV.
English: - Treatment of disease progression: Any patient, in whom CMV disease progresses, either while on maintenance treatment or because treatment with ganciclovir has been withdrawn, may be re-treated using the induction treatment regimen.
Danish: Behandling af sygdomsprogression: Patienter, der oplever CMV-sygdomsprogression, enten under vedligeholdelsesbehandling, eller fordi behandlingen med ganciclovir er seponeret, kan genbehandles ved at gentage initialbehandlingsregimet.
English: As a consequence, pharmacokinetic interactions with protease inhibitors and non-nucleoside reverse transcriptase inhibitors are not anticipated.
Danish: Derfor forventes ingen farmakokinetiske interaktioner med proteasehæmmere og non-nukleosid-reverstranskriptasehæmmere.
English: Asymptomatic CMV infection was detected by PCR in 34.4% of subjects and was more likely in high-risk than in routine-risk recipients (58.1% vs. 21.8%, p = 0.0001).
Danish: Asymptomatisk CMV-infektion blev påvist ved PCR hos 34,4% af patienterne og var mere sandsynlig i højrisiko-gruppen end i den almindelige risikogruppe (58,1% vs. 21,8%; p = 0,0001).
English: Currently available paediatric data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: This has been shown to occur in HSV- and HCMV-infected cells, with half-lives of 18 and 6−24 hours, respectively, after removal of extracellular ganciclovir.
Danish: Dette er vist at forekomme i HSV- og HCMV-inficerede celler med halveringstider på henholdsvis 18 og 6−24 timer, efter ekstracellulært ganciclovir er fjernet.
English: This adverse reaction has only been reported in studies in AIDS patients treated with Cymevene for CMV retinitis.
Danish: Denne bivirkning har kun været rapporteret i studier med AIDS-patienter behandlet med Cymevene for CMV-retinitis.
English: Infants who received ganciclovir had improved neurodevelopmental outcomes at 6 and 12 months compared with those who did not receive antiviral treatment.
Danish: Spædbørn, der blev behandlet med ganciclovir, havde bedre neurologisk udvikling ved måned 6 og 12 sammenlignet med de spædbørn, der ikke fik antiviral behandling.
English: Three subjects developed acute rejection within 6 months of detection of CMV, but CMV was preceded by rejection in 13 subjects.
Danish: 3 patienter udviklede akut afstødning inden for 6 måneder efter påvisning af CMV, men hos 13 patienter fandt afstødning sted inden CMV.
English: Formal safety studies with ganciclovir have not been conducted in children under 12 years of age but based on experience with valganciclovir, a pro-drug of ganciclovir, the overall safety profile of the active drug is similar in paediatric and adult patients.
Danish: Der er ikke gennemført formelle sikkerhedsstudier med ganciclovir hos børn under 12 år, men baseret på erfaringer med valganciclovir, et prodrug til ganciclovir, er den overordnede sikkerhedsprofil for det aktive stof ens hos voksne og børn.
English: It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be excluded.
Danish: Det vides ikke, om ganciclovir udskilles i human mælk, men det kan ikke udelukkes, at ganciclovir udskilles i mælken og forårsager alvorlige bivirkninger hos det ammede barn.
English: Decreased appetite Anorexia
Danish: Appetitløshed Anoreksi Vægttab
English: In patients with mild, moderate, and severe renal impairment, mean systemic clearances of 2.1, 1 and 0.3 mL/min/kg were observed.
Danish: Hos patienter med let, middelsvært og svært nedsat nyrefunktion er der set gennemsnitlig systemisk clearance på henholdsvis 2,1; 1 og 0,3 ml/min/kg.
English: Didanosine plasma concentrations were found to be consistently raised when given with ganciclovir.
Danish: Plasmakoncentrationen af didanosin var vedvarende forhøjet, når det blev givet sammen med ganciclovir.
English: Oral ganciclovir is no longer available but adverse reactions reported with its use can also be expected to occur in patients receiving intravenous ganciclovir.
Danish: Oral ganciclovir er ikke længere tilgængeligt, men de bivirkninger, der er rapporteret ved brug af dette, kan også forventes at forekomme hos patienter, der behandles intravenøst med ganciclovir.
English: - Maintenance treatment: For immunocompromised patients at risk of relapse maintenance therapy may be given.
Danish: Vedligeholdelsesbehandling: Der kan gives vedligeholdelsesbehandling til immunkompromitterede patienter med risiko for recidiv.
English: Caution should therefore be used when prescribing Cymevene to patients with known hypersensitivity to aciclovir or penciclovir (or to their prodrugs, valaciclovir or famciclovir respectively).
Danish: Der skal derfor udvises forsigtighed, når Cymevene ordineres til patienter med kendt overfølsomhed over for aciclovir eller penciclovir (eller deres prodrugs, henholdsvis valaciclovir og famciclovir).
English: Therapy should not be initiated if the absolute neutrophil count is less than 500 cells/µL or the platelet count is less than 25,000 cells/µL or the haemoglobin is less than 8 g/dL (see sections 4.2 and 4.8).
Danish: Behandling bør ikke påbegyndes, hvis det absolutte neutrofiltal er under 500 celler/µl, trombocytter er under 25.000 celler/µl, eller hæmoglobin er under 8 g/dl (se pkt.
English: It is recommended that complete blood counts including platelet counts be monitored during therapy.
Danish: Det anbefales, at der udføres komplet blodtælling, inklusive trombocytter, under behandlingen.
English: However, ganciclovir readily diffuses across the human placenta.
Danish: Ganciclovir passerer dog i udstrakt grad den humane placentabarriere.
English: INSTRUCTIONS FOR USE AND HANDLING
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Clinical studies have been limited to evaluation of efficacy in patients with CMV infection.
Danish: De kliniske studier har udelukkende evalueret effekten hos patienter med CMV-infektion.
English: During the first 14 days of administration it is recommended that white blood cell count (preferably as a differential test) is conducted every second day; in patients with low baseline neutrophil levels (< 1000 neutrophils/µl), those who developed leucopenia during previous therapy with other myelotoxic substances, and those with renal impairment, this monitoring should be performed daily.
Danish: I de første 14 dage af behandlingen anbefales det at monitorere hvide blodlegemer hver 2. dag (helst som differentialtest); hos patienter med lave neutrofilværdier (<1000 neutrofiler/µl) ved baseline, patienter, der tidligere har udviklet leukopeni under behandling med myelotoksiske midler, og hos patienter med nedsat nyrefunktion bør denne monitorering udføres dagligt.
English: Patients with iatrogenic immunosuppression due to treatment with immunosuppressive drugs are at greater risk of thrombocytopenia than patients with AIDS (see section 4.4).
Danish: Patienter med iatrogen immunsuppression på grund af behandling med immunsuppressive midler har større risiko for trombocytopeni end patienter med AIDS (se pkt.
English: Severe thrombocytopenia may be associated with potentially life-threatening bleeding.
Danish: Alvorlig trombocytopeni kan være forbundet med livstruende blødninger.
English: Male infertility
Danish: Mandlig infertilitet
English: Cymevene contains sodium
Danish: Cymevene indeholder natrium
English: Do not use bacteriostatic water for injection containing parabens (para-hydroxybenzoates), since these are incompatible with Cymevene.
Danish: Brug ikke bakteriostatisk vand til injektionsvæsker indeholdende parabener (parahydroxybenzoater), da disse er uforligelige med Cymevene.
English: - Gastrointestinal toxicity: abdominal pain, diarrhoea, vomiting - Neurotoxicity: generalised tremor, convulsion
Danish: - Gastrointestinal toksicitet: abdominalsmerter, diarré, opkastning - Neurotoksicitet: generaliseret tremor, kramper
English: Therefore, ganciclovir should not be used in pregnant women unless the clinical need for treatment of the woman outweighs the potential teratogenic risk to the foetus.
Danish: Ganciclovir bør derfor ikke anvendes til gravide kvinder, medmindre kvindens kliniske behov for behandling opvejer den potentielle teratogene risiko for fostret.
English: Twelve subjects (9.8%) developed CMV disease (8 high-risk vs. 4 routine-risk, p = 0.03).
Danish: 12 patienter (9,8%) udviklede CMV-sygdom (8 i højrisikogruppen vs. 4 i den almindelige risikogruppe, p = 0,03).
English: Prior to initiation of ganciclovir treatment, patients should be advised of the potential risks to the foetus.
Danish: Inden påbegyndelse af behandling med ganciclovir skal patienterne informeres om den potientielle risiko for fostret.
English: Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections.
Danish: Kemisk og fysisk stabilitet er påvist for det rekonstituerede koncentrat i 12 timer ved 25 °C efter opløsning i vand til injektionsvæsker.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Danish: Ansvaret vedrørende opbevaringstid og opbevaringsforhold i brug ligger hos brugeren, hvis infusionsvæsken ikke anvendes straks, og opbevaringstiden bør ikke være længere end 24 timer ved 2 oC til 8 oC, medmindre rekonstitution og fortynding er foregået under kontrollerede og validerede aseptiske forhold.
English: A retrospective study investigated the effect of antiviral treatment on late-onset hearing loss in infants with congenital CMV infection (4-34 months of age, mean age 10.3±7.8 months, median age 8 months).
Danish: Et retrospektivt studie undersøgte effekten af antiviral behandling på sent indsættende høretab hos spædbørn med kongenital CMV-infektion (aldersgruppe 4-34 måneder, gennemsnitsalder 10,3±7,8 måneder, medianalder 8 måneder).
English: • After that the doctor may prescribe the infusion once a day.
Danish: • Efter de 21 dage vil lægen måske ordinere det 1 gang om dagen.
English: • you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir - these are other medicines used for viral infections
Danish: • du er allergisk over for aciclovir, valaciclovir, penciclovir eller famciclovir - dette er andre lægemidler mod virusinfektioner
English: Tell your doctor straight away if you notice any of the following serious side effects - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:
Danish: Kontakt straks lægen, hvis du bemærker én eller flere af følgende alvorlige bivirkninger - lægen kan vælge at stoppe behandlingen med Cymevene, og du kan have brug for akut behandling:
English: Look out for these while you are taking Cymevene - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:
Danish: Hold øje med disse, mens du får Cymevene - lægen kan vælge at stoppe din behandling med Cymevene, og du kan få brug for akut behandling:
English: Ganciclovir is predominantly eliminated by renal excretion via glomerular filtration and active tubular secretion of unchanged ganciclovir.
Danish: Ganciclovir elimineres primært renalt via glomerulær filtration og aktiv tubulær sekretion af uomdannet ganciclovir.
English: Children treated before 2004 then received oral ganciclovir 30 mg/kg/dose up to 1 g/dose three times daily (n = 41), while children treated after 2004 received valganciclovir up to 900 mg once daily (n = 51).
Danish: Børn behandlet før 2004 fik herefter oral ganciclovir 30 mg/kg/dosis, op til 1 g/dosis, 3 gange dagligt (n = 41), mens børn behandlet efter 2004 fik valganciclovir op til 900 mg 1 gang dagligt (n = 51).
English: Half-lives in subjects without renal impairment ranged from 2.73 ± 1.29 (N = 6) to 3.98 ± 1.78 hours (N = 8).
Danish: Halveringstid hos patienter med nedsat nyrefunktion ligger i området 2,73 ± 1,29 (n = 6) til 3,98 ± 1,78 timer (n = 8).
English: Therapeutic guidelines should be consulted.
Danish: Behandlingsvejledninger bør følges.
English: Patients treated with ganciclovir and didanosine, medicines known to be myelosuppressive or affecting renal function, should be closely monitored for signs of added toxicity (see section 4.5).
Danish: Patienter behandlet med ganciclovir og didanosin, lægemidler, der vides at være myelosupprimerende eller påvirke nyrefunktionen, skal omhyggeligt monitoreres for tegn på øget toksicitet (se pkt.
English: The steady state volume of distribution has a range of 0.54−0.87 L/kg.
Danish: Fordelingsvolumen ved steady state er 0,54-0,87 l/kg.
English: Although ganciclovir recipients had fewer delays and more normal neurological outcomes, most were still behind what would be considered normal development at 6 weeks, 6 months, or 12 months of age.
Danish: Selvom de ganciclovirbehandlede spædbørns udvikling i mindre grad var forsinket, og deres neurologiske resultater var tættere på normalen, var de flestes udvikling stadig forsinket i forhold til normalen ved 6 ugers-, 6 måneders- og 12 måneders-alderen.
English: Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible.
Danish: På grund af ligheder i den kemiske struktur mellem ganciclovir og aciclovir og penciclovir er der risiko for krydsallergi mellem disse lægemidler.
English: This medicinal product contains 2 mmol (43mg) sodium per 500 mg dose.
Danish: Dette lægemiddel indeholder 2 mmol (43 mg) natrium per 500 mg dosis.
English: The pharmacokinetic properties of ganciclovir have been evaluated in HIV- and CMV-seropositive patients, patients with AIDS and CMV retinitis, and in solid organ transplant patients.
Danish: Ganciclovirs farmakokinetiske egenskaber er undersøgt hos HIV- og CMV-seropositive patienter, patienter med AIDS og CMV-retinitis samt organtransplanterede patienter.
English: The total plasma clearance of ganciclovir is linearly correlated with creatinine clearance.
Danish: Den totale plasma-clearance af ganciclovir er lineært korreleret med creatininclearance.
English: • The active substance is ganciclovir.
Danish: • Aktivt indholdsstof: ganciclovir.
English: There was no clinically significant effect on ganciclovir concentrations.
Danish: Der ses ingen klinisk signifikant påvirkning af ganciclovirkoncentrationen.
English: The virustatic activity of ganciclovir is a result of the inhibition of viral DNA synthesis by: (1) competitive inhibition of incorporation of deoxyguanosine triphosphate into DNA by DNA polymerase, and (2) incorporation of ganciclovir triphosphate into viral DNA, causing termination of, or very limited, viral DNA elongation.
Danish: Ganciclovirs virustatiske aktivitet er resultat af hæmningen af den virale DNA-syntese ved: (1) kompetitiv hæmning af inkorporering af deoxyguanosintriphosphat i DNA ved DNA-polymerase og (2) inkorporering af ganciclovirtriphosphat i viralt DNA medførende terminering eller i meget begrænset omfang elongering.
English: Ganciclovir should therefore be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers.
Danish: Ganciclovir bør derfor anses som værende potentielt teratogent og karcinogent hos mennesker med risiko for at forårsage fosterskader og cancer.
English: Draw 10 mL of water for injection into a syringe, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
Danish: Træk 10 ml vand til injektionsvæsker op i en sprøjte, stik nålen gennem midten af gummiproppen og injicér vandet langsomt i hætteglasset med nålen pegende mod hætteglassets væg.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Det er særligt vigtigt, at du fortæller lægen eller apotekspersonalet det, hvis du tager følgende lægemidler:
English: Estimates of ganciclovir clearance for continuous dialysis were lower (4.0−29.6 mL/min) but resulted in greater removal of ganciclovir over a dose interval.
Danish: Estimater for ganciclovir-clearance ved kontinuerlig dialyse er lavere (4,0-29,6 ml/min), men medfører, at mere ganciclovir fjernes over et dosisinterval.
English: Cymevene contains the active substance ganciclovir.
Danish: Cymevene indeholder det aktive stof ganciclovir.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Danish: ANVENDELSMÅDE OG ADMINISTRATIONSVEJ Til intravenøs anvendelse efter rekonstitution og fortynding.
English: Ganciclovir causes impaired fertility and teratogenicity in animals.
Danish: Ganciclovir forårsager nedsat fertilitet og teratogenicitet hos dyr.
English: Probenecid given with oral ganciclovir resulted in statistically decreased renal clearance of ganciclovir, and led to clinically significant increased exposure.
Danish: Samtidig administration af probenecid og oral ganciclovir har medført et statistisk signifikant fald i den renale clearance af ganciclovir og medført klinisk signifikant øget eksponering.
English: Further phosphorylation occurs by several cellular kinases to produce ganciclovir triphosphate, which is then slowly metabolised intracellularly.
Danish: Yderligere fosforylering finder sted ved hjælp af flere cellulære kinaser til ganciclovirtriphosphat, der herefter langsomt metaboliseres intracellulært.
English: Mean Cmax was 5.5 ± 6 µg/mL at 4 mg/kg and 7.0 ± 1.6 µg/mL at 6 mg/kg.
Danish: Gennemsnitligt Cmax var 5,5 ± 6 µg/ml ved 4 mg/kg og 7,0 ± 1,6 µg/ml ved 6 mg/kg.
English: Vials of Cymevene are supplied in packs of 1 or 5.
Danish: Hætteglas med Cymevene fås i pakninger med 1 eller 5 stk.
English: As a result of the potential for reproductive toxicity and teratogenicity, women of childbearing potential must be advised to use effective contraception during and for at least 30 days after treatment.
Danish: På grund af potentiel reproduktionstoksicitet og teratogenicitet skal fertile kvinder informeres om at anvende effektiv prævention under behandlingen og i mindst 30 dage efter, behandlingen er afsluttet.
English: Patients should be closely monitored for didanosine toxicity (see section 4.4).
Danish: Patienterne bør monitoreres tæt for didanosintoksicitet (se pkt.
English: • you have low white blood cell, red blood cell or platelet counts - your doctor will do blood tests before you start and during your treatment
Danish: • du har et lavt antal hvide blodlegemer, røde blodlegemer eller blodplader - du vil få taget en blodprøve før og under behandlingen
English: Dermatitis Night sweats Pruritus
Danish: Dermatitis Nattesved Pruritus
English: After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer's or lactated Ringer's solution for injection) :
Danish: Efter fortynding med infusionsvæsker (natriumchlorid 0,9%, glucose 5%, Ringers opløsning eller Ringer-lactat):
English: Mutagenicity, teratogenicity, carcinogenicity, fertility, and contraception
Danish: Mutagenicitet, teratogenicitet, karcinogenicitet, fertilitet og prævention
English: How often you will have Cymevene and how long you keep using it will also vary.
Danish: Det er også forskelligt, hvor tit man skal have Cymevene, og hvor længe behandlingen skal fortsætte.
English: • low red blood cell counts shown in tests
Danish: • lavt antal røde blodlegemer, påvist i laboratorieprøver
English: The pharmacokinetics of intravenous ganciclovir were investigated in neonates aged 2−49 days following doses of 4 mg/kg (N = 14) and 6 mg/kg (N = 13).
Danish: Farmakokinetikken for intravenøs ganciclovir er undersøgt hos nyfødte 2-49 dage efter doser på 4 mg/kg (n = 14) og 6 mg/kg (n = 13).
English: Cymevene contains 43 mg of sodium in each 500mg dose.
Danish: Cymevene indeholder 43 mg natrium i hver 500 mg dosis.
English: As the phosphorylation is largely dependent on the viral kinase, phosphorylation of ganciclovir occurs preferentially in virus-infected cells.
Danish: Da fosforylering i stor udstrækning er afhængig af den virale kinase, finder fosforyleringen af ganciclovir primært sted i virusinficerede celler.
English: • abnormal thoughts or feelings, losing contact with reality
Danish: • unormale tanker eller følelser, manglende realitetssans
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 - 8°C (do not freeze).
Danish: Der er vist kemisk og fysisk i-brug-holdbarhed i 24 timer ved 2-8 °C (må ikke fryses).
English: Ganciclovir is not metabolised to a significant extent.
Danish: Biotransformation Ganciclovir metaboliseres ikke i betydelig grad.
English: Only limited data are available in neonates or infants with HIV/AIDS or symptomatic congenital CMV infection treated with valganciclovir or ganciclovir, however the safety profile appears to be consistent with the known safety profile of valganciclovir/ganciclovir.
Danish: Data for nyfødte og spædbørn med HIV/AIDS eller symptomatisk medfødt CMV-infektion behandlet med valganciclovir eller ganciclovir er begrænsede, dog synes sikkerhedsprofilen at svare til den kendte sikkerhedsprofil for valganciclovir/ganciclovir.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: 6.6 for vejledning i rekonstitution af lægemidlet inden administration.
English: Since Cymevene is considered a potential teratogen and carcinogen in humans, caution should be observed in its handling.
Danish: Da Cymevene vurderes at være potentielt teratogent og karcinogent hos mennesker, skal der udvises forsigtighed ved håndtering.
English: If you stop using Cymevene Do not stop using Cymevene without talking to your doctor.
Danish: Hold ikke op med at få Cymevene uden at have talt med lægen.
English: disease with CNS involvement received 6 weeks of intravenous ganciclovir 6 mg/kg every 12 hours or no treatment.
Danish: sygdom med CNS-påvirkning 6 ugers behandling med intravenøs ganciclovir 6 mg/kg hver 12. time eller ingen behandling.