FrancophonIA/ELRC3.0 huggingface dataset:
English: Probenecid is known to increase the exposure of many substances (e.g., paracetamol, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicyclic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine).
Danish: Probenecid er kendt for at øge tilgængeligheden af mange lægemidler (f.eks. paracetamol, aciclovir, angiotensin-converterende enzyminhibitorer, aminosalicylsyre, barbiturater, benzodiazepiner, bumetanid, clofibrat, methotrexat, famotidin, furosemid, NSAID, teofyllin og zidovudin).
English: Food should be taken before you are given Vistide.
Danish: Du bør spise, inden du får Vistide.
English: There have been reports of reduced white blood counts, liver toxicity, kidney toxicity and destruction of red blood cells.
Danish: Der er blevet rapporteret om nedsat antal hvide blodlegemer, påvirkninger af lever og nyrer og nedbrydning af røde blodlegemer.
English: Incorporation of cidofovir into viral DNA results in reductions in the rate of viral DNA synthesis.
Danish: Optagelse af cidofovir i virus-DNA medfører fald i virus-DNA-syntesens hastighed.
English: • inflammation of the eye, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath, diarrhoea and chills.
Danish: • betændelse i øjet, nedsat tryk i øjet, stakåndethed, vejrtrækningsproblemer, diarré og
English: In addition to probenecid, patients must receive a total of one litre of 0.9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir.
Danish: Udover probenecid skal patienterne indgives ialt 1 liter 0,9 % (normal) natriumchlorid-infusionsvæske intravenøst umiddelbart før hver cidofovirinfusion.
English: Cidofovir-selected mutants had a mutation in the DNA polymerase gene and were cross-resistant to ganciclovir, but susceptible to foscarnet.
Danish: Cidofovir-selekterede mutanter fik en mutation i DNA-polymerase-genet og var krydsresistente over for ganciclovir, men var modtagelige over for foscarnet.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
English: Nausea, vomiting
Danish: Kvalme, opkastning
English: In a 26-week intravenous toxicity study, a significant increase in incidence of mammary adenocarcinomas was seen in female rats and of Zymbal's gland carcinomas in male and female rats at subtherapeutic plasma levels of cidofovir.
Danish: I en 26 ugers intravenøs toksicitetsundersøgelse blev der iagttaget en signifikant stigning i forekomsten af mammaadenocarcinomer hos hunrotter og af Zymbals kirtelcarcinomer hos han- og hunrotter ved subterapeutiske plasmaniveauer af cidofovir.
English: Patients treated at 3.0 mg/kg, 5.0 mg/kg or 10 mg/kg without concomitant probenecid developed evidence of proximal tubular cell injury, including glycosuria, and decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Danish: Patienter, der blev behandlet med 3,0 mg/kg, 5,0 mg/kg eller 10,0 mg/kg uden samtidig indgift af probenecid, udviklede tegn på proksimal tubulær celleskade inklusive glycosuri og fald i serumfosfat, urinsyre og hydrogencarbonat samt stigninger i serumkreatinin.
English: CMV retinitis is an eye infection caused by a virus named cytomegalovirus (CMV).
Danish: CMV-nethindebetændelse er en øjeninfektion, der forårsages af en virus ved navn cytomegalovirus (CMV).
English: Prolonged antiviral effects of cidofovir are related to the half-lives of its metabolites; cidofovir diphosphate persists inside cells with a half-life of 17-65 hours and a cidofovir phosphate-choline adduct has a half-life of 87 hours.
Danish: Cidofovirs forlængede antivirale effekt er relateret til metabolitternes halveringstid; cidofovirdiphosphat bliver i cellerne med en halveringstid på 17-65 timer.
English: The recommended dose, frequency, or infusion rate must not be exceeded.
Danish: Den anbefalede dosis, doseringshyppighed eller infusionshastighed må ikke overskrides.
English: The safety and efficacy of Vistide have not been established for the treatment of CMV disease in patients over 60 years of age.
Danish: Vistides sikkerhed og virkning ved behandling af CMV-sygdom hos patienter over 60 år er ikke belyst.
English: If any of these apply to you, talk to your doctor.
Danish: Tal med din læge, hvis noget af dette gælder for dig.
English: Your doctor may also instruct you to drink plenty of fluids.
Danish: Din læge kan også bede dig om at drikke rigelig væske.
English: This medicinal product contains approximately 2.5 mmol (or 57 mg) sodium per vial which should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette lægemiddel indeholder ca. 2,5 mmol (svarende til 57 mg) natrium per hætteglas, hvilket bør tages i betragtning hos patienter på kontrolleret natriumdiæt.
English: To reduce the risk of kidney damage, you will receive intravenous fluids (normal saline) before each dose of Vistide and probenecid tablets before and after each dose of Vistide (see section 3 below for more information).
Danish: For at nedsætte risikoen for nyreskader vil du få intravenøse væsker (saltvandsopløsning) før hver Vistide-dosis og probenecid-tabletter før og efter hver Vistide-dosis (se pkt.
English: Breast-feeding should be discontinued during treatment with cidofovir.
Danish: Amning skal ophøre under behandling med cidofovir.
English: The container/closure components include: Type I clear borosilicate glass vials, Teflon faced grey butyl plug stoppers, and aluminium crimp seals with a flip off plastic tab.
Danish: Emballagens/lukningens bestanddele omfatter: Type I hætteglas af borosilicat, grå butyl gummipropper med teflon-belægning og aluminiumskapsler med flip off-plastgreb.
English: However, in case of difficulty in obtaining probenecid the local representative of the Marketing Authorisation Holder of Vistide should be contacted for information (see also sections 4.2 and 4.4).
Danish: Hvis det er vanskeligt at få leveret probenecid, kan den lokale repræsentant for indehaveren af markedsføringstilladelsen for Vistide kontaktes vedrørende information (se også
English: Hypersensitivity reactions, with dermatitis, pruritus, urticaria and, rarely, anaphylaxis, and Stevens-Johnson syndrome have occurred.
Danish: Der er forekommet overfølsomhedsreaktioner såsom dermatitis, pruritus, urticaria, og sjældent anafylaksi og StevensJohnsons-syndrom.
English: Patients receiving both drugs should be closely monitored for zidovudine induced haematological toxicity.
Danish: Patienter, der behandles med både cidofovir og zidovudin, bør nøje overvåges for zidovudininduceret hæmatologisk toksicitet.
English: Vistide is supplied as a sterile concentrate for solution for infusion in clear, glass vials containing 375 mg of the active ingredient, anhydrous cidofovir, formulated in 5 ml water for injections at a concentration of 75 mg/ml.
Danish: Vistide leveres som sterilt koncentrat til infusionsvæske, opløsning, i gennemsigtige hætteglas, der indeholder 375 mg vandfrit cidofovir i 5 ml vand til injektionsvæsker, således at koncentrationen er 75 mg/ml.
English: Personnel preparing the reconstituted solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs.
Danish: Personale, der tilbereder den rekonstituerede infusionsvæske, skal bære operationshandsker, sikkerhedsbriller og en lukket operationskittel med tætsluttende manchetter.
English: If you could get pregnant, you must use an effective method of contraception to stop you getting pregnant during treatment with Vistide
Danish: Hvis du kan blive gravid, skal du anvende sikker prævention under behandlingen med Vistide og i en måned derefter for at forhindre, at du bliver gravid.
English: It is recommended to discontinue potentially nephrotoxic agents at least 7 days before starting cidofovir.
Danish: Det anbefales, at potentielt nefrotoksiske lægemidler seponeres mindst 7 dage før behandling med
English: In a separate study, once weekly subcutaneous injections of cidofovir for 19 consecutive weeks resulted in mammary adenocarcinomas in female rats at doses as low as 0.6 mg/kg/week.
Danish: I en særskilt undersøgelse medførte subkutane injektioner af cidofovir 1 gang om ugen i 19 på hinanden følgende uger, mammaadenocarcinomer hos hunrotter ved doser på ned til 0,6 mg/kg/uge.
English: Probenecid may also cause other side effects including loss of appetite, sore gums, flushing, hair loss, dizziness, reduced red blood cell count and increased frequency of passing water (urinating).
Danish: Probenecid kan også give andre bivirkninger, f.eks. nedsat appetit, ømme gummer, rødmen, hårtab, svimmelhed, nedsat antal røde blodlegemer samt øget tendens til vandladning.
English: Cidofovir administration is contraindicated in patients unable to receive probenecid because of a clinically significant hypersensitivity to the active substance or medicinal product or to other sulfacontaining medicines.
Danish: Cidofovir er kontraindiceret til patienter, der ikke kan behandles med probenecid pga. klinisk signifikant overfølsomhed over for det aktive stof eller over for andre sulfapræparater.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Vistide til dig personligt.
English: Vistide is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Vistide bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender
English: HCMV strains resistant to ganciclovir may still be susceptible to cidofovir.
Danish: HCMV stammer, der er resistente overfor ganciclovir, kan stadig være følsomme overfor
English: Caution should be applied when considering cidofovir treatment of patients with diabetes mellitus due to the potential increased risk of developing ocular hypotony.
Danish: Cidofovir bør anvendes med forsigtighed, ved behandling af patienter med diabetes mellitus, pga. den potentielt forøgede risiko for udvikling af okulær hypotoni.
English: In vitro protein binding of cidofovir to plasma or serum protein was 10% or less over the cidofovir concentration range 0.25 to 25 µg/ml.
Danish: In vitro-proteinbinding af cidofovir til plasma eller serumprotein var 10 % eller mindre i cidofovirs
English: Additional reactions reported from post-marketing experience include kidney failure, damage to kidney tubule cells, inflammation of the pancreas and hearing impairment.
Danish: Andre bivirkninger rapporteret efter markedsføringen omfatter nyresvigt, beskadigelse af nyrernes tubulære celler, betændelse i bugspytkirtlen og nedsat hørelse.
English: Other types of IV set tubing and infusion bags have not been studied.
Danish: Andre typer infusionssæt og infusionsposer er ikke undersøgt.
English: Cidofovir enters cells by fluid-phase endocytosis and is phosphorylated to cidofovir monophosphate and subsequently to cidofovir diphosphate.
Danish: Cidofovir trænger ind i celler ved hjælp af væskefase-endocytose og fosforyleres til cidofovirmonophosphat og derefter til cidofovirdiphosphat.
English: Continued administration of cidofovir to patients with persistent ≥ 2+ proteinuria following intravenous hydration may result in further evidence of proximal tubular injury, including glycosuria, decreases in serum phosphate, uric acid and bicarbonate, and elevations in serum creatinine.
Danish: Fortsat indgift af cidofovir til patienter med vedvarende proteinuri ≥ 2+ efter intravenøs hydrering kan resultere i yderligere tegn på proksimal tubulær beskadigelse inklusive glycosuri, fald i serumfosfat, urinsyre og hydrogencarbonat og stigning i serumkreatinin.
English: In case of uveitis/iritis cidofovir should be discontinued if there is no response to treatment with a topical corticosteroid or the condition worsens, or if iritis/uveitis reoccurs after successful treatment.
Danish: I tilfælde af uveitis/iritis bør cidofovir seponeres, hvis der ikke responderes på behandling med topikal cortikosteroid eller hvis tilstanden forværres.
English: To lower the risk of kidney damage, probenecid tablets and intravenous fluids (saline solution) must be given on the day of each Vistide infusion.
Danish: For at nedsætte risikoen for nyreskader skal probenecidtabletter og intravenøse væsker (saltvandsopløsning) indgives på samme dag som hver Vistide-infusion.
English: Vistide must be diluted in 100 millilitres 0.9% (normal) saline prior to administration.
Danish: Vistide skal fortyndes i 100 ml 0,9 % (normal) natriumchlorid-infusionsvæske før administration.
English: Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis.
Danish: Cidofovir undertrykker HCMV-replikation ved selektiv hæmning af virus DNA-syntese.
English: Adverse reactions identified from post-marketing experience are included in italics.
Danish: Bivirkninger som er set efter markedsføring er anført i kursiv.
English: Vistide is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction.
Danish: Vistide er indiceret til behandling af CMV-retinitis hos voksne med erhvervet immundefektsyndrom (aids) uden nyreinsufficiens.
English: Each pack contains one 5 ml vial.
Danish: Hver pakning indeholder 1 5 ml hætteglas.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Daily intravenous administration of cidofovir during the period of organogenesis led to reduced fetal body weights when administered to pregnant rats at 1.5 mg/kg/day and to pregnant rabbits at 1.0 mg/kg/day.
Danish: Daglig intravenøs indgift af cidofovir ved organogenesen førte til nedsat fostervægt ved dosering til drægtige rotter på 1,5 mg/kg/dag og til drægtige kaniner på 1,0 mg/kg/dag.
English: Dyspnea
Danish: Dyspnø
English: If you drive or operate machinery, discuss this with your doctor to get their advice about stopping these activities based upon your disease and your tolerance of the medicine.
Danish: Hvis du kører bil eller motorcykel eller arbejder med maskiner, skal du drøfte dette med din læge, så du kan få hans/hendes råd om, hvorvidt du skal stoppe disse aktiviteter.
English: No adverse effects on fertility or general reproduction were seen following once weekly intravenous injections of cidofovir in male rats for 13 consecutive weeks at doses up to 15 mg/kg/week.
Danish: Der blev ikke iagttaget bivirkninger mht. fertilitet eller generel reproduktion efter 1 ugentlig intravenøs injektion af cidofovir til hanrotter i 13 uger med doser på op til 15 mg/kg/uge.
English: The preparation of Vistide reconstituted solution should be done in a laminar flow biological safety cabinet.
Danish: Rekonstitution af Vistide infusionsvæske bør ske i en LAFbænk (laminar air flow cabinet).
English: The chemical and physical stability of Vistide admixed with saline has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) or ethylene/propylene copolymer, and in PVC based vented IV administration sets.
Danish: Den kemiske og fysiske stabilitet af Vistide iblandet saltvand er blevet påvist i glasflasker, infusionsposer af polyvinylchlorid (PVC) eller ethylen/propylencopolymer samt i PVC-baserede i.v.-administrationssæt.
English: The formulation is pH-adjusted with sodium hydroxide (and hydrochloric acid if needed) and contains no preservatives.
Danish: Opløsningen er pH-justeret med natriumhydroxid (og saltsyre om nødvendigt) og
English: Concomitant use of probenecid is essential for reducing the pronounced nephrotoxicity of cidofovir to an extent that results in an acceptable benefit/risk balance of cidofovir therapy.
Danish: Samtidig indgift af probenecid er vigtig for at reducere den udtalte cidofovir-nefrotoksicit til et acceptabelt niveau mht. fordele og ulemper ved behandling med cidofovir.
English: Renal insufficiency [creatinine clearance ≤ 55 ml/min or ≥ 2+ proteinuria (≥ 100 mg/dl)] is a contraindication for the use of Vistide (see sections 4.3 and 4.4).
Danish: Nyreinsufficiens (kreatininclearance ≤ 55 ml/min eller proteinuri ≥ 2+ (≥ 100 mg/ml)) er kontraindikation for brug af Vistide (se også pkt.
English: Vistide is given by intravenous infusion (a drip into a vein).
Danish: Vistide indgives i en blodåre ved hjælp af et drop (en intravenøs infusion).
English: Vistide is an antiviral medicine which blocks the replication of CMV by interfering with viral DNA production.
Danish: Vistide er antivirusmedicin, som standser kopieringen af CMV, ved at gribe ind i produktionen af
English: Gilead Sciences, S.L.
Danish: España Gilead Sciences, S.L.
English: Renal and urinary disorders Very common
Danish: Nyrer og urinveje Meget almindelig
English: Vistide has been shown to cause damage in unborn animals and should not be used during pregnancy unless the potential benefits justify the risks to the foetus.
Danish: Hvis du bliver gravid, mens du får medicinen, skal du omgående fortælle din læge det. Vistide har vist sig at forårsage fosterskader hos dyr og bør ikke bruges under graviditet, medmindre de mulige fordele retfærdiggør de mulige risici for fostret.
English: The doctor or nurse will transfer the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution.
Danish: Lægen eller sygeplejersken overfører den relevante Vistide-dosis fra hætteglasset til en infusionspose, der indeholder 100 ml 0,9 % (normal) saltvandsopløsning.
English: Beginning two weeks after completion of induction treatment, the recommended maintenance dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once every two weeks.
Danish: To uger efter afslutning af startbehandlingen påbegyndes den anbefalede Vistidevedligeholdelsesdosis til patienter med normal nyrefunktion på 5 mg pr. kg legemsvægt, der gives
English: The recommended dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once weekly for two consecutive weeks.
Danish: Den anbefalede Vistide-dosis til patienter med normal nyrefunktion er 5 mg pr. kg legemsvægt, der gives 1 gang ugentlig i to på hinanden følgende uger.
English: See the package leaflet for further information.
Danish: 3 nedenfor for yderligere information).
English: Therefore before giving you probenecid your doctor should consult the current prescribing information regarding the safety of probenecid.
Danish: Din læge bør derfor rådføre sig med de nyeste produktoplysninger for probenecid angående probenecids sikkerhed, inden du får ordineret probenecid.
English: Renal insufficiency/Haemodialysis
Danish: Nyreinsufficiens/hæmodialyse
English: • In general, women with HIV should not breast-feed in order to avoid passing HIV to their
Danish: • For at undgå at HIV-smitten overføres til børnene gennem mælken, bør kvinder med HIV
English: Treatment for CMV retinitis is necessary to reduce the potential for blindness.
Danish: Behandlingen af CMV-nethindebetændelse er nødvendig for at nedsætte
English: Dose-dependent nephrotoxicity is the major dose-limiting toxicity related to administration of cidofovir (see section 4.8).
Danish: Dosisafhængig nefrotoksicitet er den væsentligste dosisbegrænsende toksicitet forbundet med indgift af cidofovir (se pkt.
English: Compatibility with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated.
Danish: Kompatibilitet med Ringer-opløsning, Ringer-laktat eller bakteriostatiske infusionsvæsker er ikke undersøgt.
English: Therefore, when co-prescribing cidofovir/probenecid with other agents, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) and the respective prescribing information of the other co-administered products for full information regarding drug interactions and other features of that product.
Danish: Når cidofovir og probenecid udskrives sammen med anden medicin, er det vigtigt, at lægen rådfører sig med det gældende produktresumé (eller anden passende reference) for probenecid, og tilsvarende produktinformation for det andet produkt for komplet information om interaktioner og andre vigtige forhold for det enkelte produkt.
English: The chemical stability of Vistide mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/propylene copolymer, and in PVC based vented IV administration sets.
Danish: Vistides kemiske stabilitet i saltvandsopløsning er blevet påvist i glasflasker, infusionsposer af enten polyvinylchlorid (PVC) eller ethylen/propylencopolymer og i PVC-baserede administrationssæt til intravenøst brug.
English: • You should not be given Vistide if you are breast-feeding.
Danish: • Du må ikke få Vistide, hvis du ammer.
English: Very common side effects possibly related to probenecid (These can affect more than 1 user in 10)
Danish: Meget almindelige bivirkninger, der muligvis er forbundet med probenecid (Disse kan forekomme hos flere end 1 bruger ud af 10)
English: Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir (see section 4.4).
Danish: Mandlige patienter bør tilrådes at anvende barriereprævention under og i tre måneder efter behandlingen med cidofovir (se pkt.
English: The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks.
Danish: Den anbefalede cidofovir-dosis er 5 mg/kg legemsvægt (givet som intravenøs infusion med konstant hastighed i løbet af 1 time) 1 gang ugentligt i 2 på hinanden følgende uger.
English: The following table lists adverse reactions possibly or probably related to probenecid based on clinical trial experience:
Danish: I nedenstående tabel er bivirkninger, der sandsynligvis eller muligvis kan relateres til probenecid,
English: Common side effects (These can affect 1 to 10 users in 100)
Danish: Almindelige bivirkninger (Disse kan forekomme hos mellem 1 og 10 brugere ud af 100)
English: Adverse reactions such as asthenia may occur during cidofovir therapy.
Danish: Bivirkninger såsom asteni kan forekomme under behandling med cidofovir.
English: Therefore, when coprescribing probenecid with cidofovir, it is important for prescribers to consult the current probenecid SmPC (or an appropriate drug reference source) for full information on the safety profile and other features of that product.
Danish: Når cidofovir og probenecid udskrives samtidig, er det derfor vigtigt, at lægen rådfører sig med det gældende produktresumé (eller anden passende reference) for probenecid for komplet information om sikkerhedsprofil og andre vigtige forhold for produktet.
English: Total
Danish: Generelt
English: Common side effects possibly related to probenecid (These can affect 1 to 10 users in 100)
Danish: Almindelige bivirkninger, der muligvis er forbundet med probenecid (Disse kan forekomme hos mellem 1 og 10 brugere ud af 100)
English: Vistide is contraindicated in patients with renal insufficiency (see section 4.2).
Danish: Vistide er kontraindiceret til patienter med nyreinsufficiens (se pkt.
English: Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfacontaining medication (see section 4.4 Prevention of nephrotoxicity).
Danish: Administration af cidofovir er kontraindiceret til patienter, der ikke kan behandles med probenecid eller andre sulfa-holdige lægemidler (se pkt.
English: Your doctor might instruct you to take other medicines such as anti-emetics (anti sickness medicines), antihistamines and/or paracetamol to decrease the side effects of probenecid.
Danish: Din læge kan muligvis anbefale dig, at tage anden medicin f.eks. midler mod opkastning, midler mod allergiske reaktioner og/eller paracetamol for at nedsætte
English: Very common side effects (These can affect more than 1 user in 10)
Danish: Meget almindelige bivirkninger (Disse kan forekomme hos flere end 1 bruger ud af 10)