FrancophonIA/ELRC3.0 huggingface dataset:
English: The physician is advised to discuss this issue with the patient, and based upon the condition of the disease and the tolerance of medication, give his recommendation in the individual case.
Danish: Lægen rådes til at diskutere dette med patienten og at give sin anbefaling i hvert enkelt tilfælde på grundlag af sygdomstilstand og tolerance over for lægemidlet.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8ºC when dilution is performed under controlled and validated aseptic conditions.
Danish: Der er påvist kemisk og fysisk stabilitet i op til 24 timer i køleskab (2-8 °C), hvis tilberedningen er foretaget under kontrollerede og validerede aseptiske forhold.
English: Samples of your urine and/or blood will be taken before each infusion of Vistide and used for testing kidney function.
Danish: Der vil blive taget urin- og/eller blodprøver før hver Vistide-infusion for at undersøge din nyrefunktion.
English: One of these patients experienced a minor transient change in renal function, while the other patient had no change in renal function (see section 4.4).
Danish: Den ene patient fik en mindre, forbigående ændring af nyrefunktionen, mens den anden ikke havde ændringer af nyrefunktionen (se pkt.
English: These medicines must be stopped at least 7 days before taking Vistide.
Danish: Behandling med disse former for medicin skal stoppes mindst 7 dage før, behandlingen med Vistide
English: It is not known whether Vistide is passed on to the baby in human milk.
Danish: Det vides ikke, om Vistide overføres til barnet via modermælken.
English: If you are taking zidovudine, you should discuss with your doctor whether to temporarily stop taking zidovudine or decrease the dose of zidovudine by 50% on days when Vistide and probenecid are given.
Danish: Hvis du får zidovudin, skal du tale med din læge om enten midlertidigt at ophøre med zidovudin eller nedsætte zidovudindosis med 50 % de dage, hvor du får Vistide og probenecid.
English: There are no studies of cidofovir on the fertility of men or women.
Danish: Der findes ingen undersøgelser af cidofovirs indflydelse på fertiliteten hos mænd og kvinder.
English: The mean values of total serum clearance, volume of distribution at steady-state and terminal elimination halflife were 138 (± 36) ml/h/kg, 388 (± 125) ml/kg and 2.2 (± 0.5) h, respectively.
Danish: Den gennemsnitlige totale serumclearance, fordelingsvolumen ved steady state og afsluttende eliminations halveringstid var hhv. 138 (± 36) ml/time/kg, 388 (± 125) ml/kg og 2,2 (± 0,5) time.
English: • The potential for interactions between Vistide and anti-HIV protease inhibitors has not been studied.
Danish: • Risikoen for, at Vistide og anti-HIV-proteasehæmmere påvirker hinanden, er ikke blevet undersøgt.
English: • If you cannot take the medicine probenecid because of a serious allergy to probenecid or other sulfa-containing medicines (e.g. sulfamethoxazole).
Danish: • Hvis du ikke kan tåle medicinen probenecid pga. alvorlig allergi over for probenecid eller anden sulfaholdig medicin (f.eks. sulfamethoxazol).
English: Male patients should be advised that cidofovir caused reduced testes weight and hypospermia in animals.
Danish: Mandlige patienter bør informeres om, at cidofovir har medført reduceret testikelvægt og hypospermi hos dyr.
English: The safety and efficacy of Vistide have not been established in patients with hepatic disease and therefore it should be used with caution in this patient population.
Danish: Vistides sikkerhed og virkning er ikke klarlagt hos patienter med leversygdom, og Vistide bør derfor anvendes med forsigtighed til disse patienter.
English: It must not be administered by other methods including intraocular injection (direct injection into the eye) or topically (on the skin).
Danish: Det må ikke indgives på anden måde, herunder injektion direkte i øjet (intraokulær injektion) eller på huden (topikalt).
English: Because many medicines are passed through to human milk, nursing mothers should stop Vistide or stop breast-feeding if they continue to receive
Danish: Da mange stoffer udskilles i modermælken, bør ammende kvinder ophøre med Vistide eller stoppe amningen, hvis de fortsætter med Vistide.
English: At the 4 cidofovir levels (12.5 to 100 µg/ml) tested, the percentage of damaged metaphases and number of aberrations per cell increased in a concentrationdependent manner.
Danish: På de 4 cidofovirniveauer (12,5 til 100 µg/ml), der blev undersøgt, forøgedes procentdelen af beskadigede metafaser og antallet af afvigelser pr. celle på en
English: Your treatment with Vistide may be stopped by your doctor if changes in kidney function occur.
Danish: Din læge kan stoppe behandlingen med Vistide, hvis der forekommer ændringer i nyrefunktionen.
English: No metabolites of cidofovir have been detected in serum or urine of patients.
Danish: Der er ikke påvist cidofovirmetabolitter i patienternes serum eller urin.
English: • headache, weakness/fatigue, chills and allergic reactions.
Danish: • hovedpine, svaghed/træthed, kulderystelser og allergiske reaktioner.
English: Peri- and post-natal development studies in which female rats received subcutaneous injections of cidofovir once daily at doses up to 1.0 mg/kg/day from day 7 of gestation through day 21 postpartum (approximately 5 weeks) resulted in no adverse effects on viability, growth, behaviour, sexual maturation or reproductive capacity in the offspring.
Danish: Peri- og postnatale udviklingsundersøgelser, hvor hunrotter fik subkutane injektioner af cidofovir 1 gang om dagen med doser på op til 1,0 mg/kg/dag fra drægtighedsperiodens 7. dag til den 21. dag efter fødslen (ca. 5 uger), medførte ikke bivirkninger vedrørende levedygtighed, vækst, adfærd, seksuel modning eller forplantningskapacitet hos afkommet.
English: From a microbiological point of view, the product must be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal Vistide anvendes umiddelbart efter rekonsitution.
English: In patients with normal renal function, 80 to 100% of the intravenous dose was recovered in the urine over 24 hours as unchanged cidofovir.
Danish: Hos patienter med normal nyrefunktion blev 80 til 100 % af den intravenøse dosis genfundet i urinen som uomdannet cidofovir inden for 24 timer.
English: Other Cidofovir should be considered a potential carcinogen in humans (see section 5.3).
Danish: Cidofovir skal betragtes som et potentielt carcinogen for mennesker (se pkt.
English: Antiviral activity is seen at concentrations significantly below those which cause cell death.
Danish: Antivirus-aktivitet er blevet iagttaget i koncentrationer, som er signifikant mindre end dem, der
English: Although not observed in clinical studies of cidofovir, such changes may occur in humans and cause infertility.
Danish: Selv om dette ikke er blevet iagttaget i kliniske undersøgelser med cidofovir, kan sådanne ændringer forekomme hos mennesket og forårsage infertilitet.
English: The most common side effect observed with Vistide is damage to the kidneys.
Danish: Den almindeligste bivirkning, der er set med Vistide, er nyreskader.
English: In patients exhibiting ≥ 2+ proteinuria, intravenous hydration should be performed and the test repeated.
Danish: Hos patienter, der har proteinuri ≥ 2+, bør der foretages intravenøs hydrering og testen bør gentages.
English: At the end of a one-hour infusion of cidofovir 5 mg/kg administered with concomitant oral probenecid, the mean (± SD) serum concentration of cidofovir was 19.6 (± 7.18) µg/ml.
Danish: Ved afslutningen af en infusion over 1 time af cidofovir 5 mg/kg, indgivet samtidig med oral probenecid, var den gennemsnitlige (± SD) cidofovir-serumkoncentration 19,6 (± 7,18) µg/ml.
English: In patients who develop allergic or hypersensitivity symptoms to probenecid (e.g., rash, fever, chills and anaphylaxis), prophylactic or therapeutic use of an appropriate antihistamine and/or paracetamol should be considered.
Danish: Hos patienter, som udvikler allergiske eller overfølsomhedssymptomer over for probenecid (f.eks. udslæt, feber, kuldegysninger og anafylaksi), bør den profylaktiske eller terapeutiske brug af et passende antihistamin og/eller paracetamol overvejes.
English: Viral resistance
Danish: Virus resistens
English: High flux haemodialysis has been shown to reduce the serum levels of cidofovir by approximately 75%.
Danish: Det er vist, at high-flux-hæmodialyse reducerer cidofovirs serumniveau med ca. 75 %.
English: Vistide should be administered by health care professionals adequately experienced in the care of AIDS patients.
Danish: Vistide bør administreres af sundhedspersonale med tilstrækkelig erfaring i behandling af aids-patienter.
English: If you get pain, redness or itching of the eye or changes in your vision, tell your doctor promptly.
Danish: Hvis du får smerter, rødmen eller kløe i øjnene eller ændringer af synet, skal du straks fortælle det til din læge.
English: 5 ml clear glass vials with a 5 ml nominal fill volume.
Danish: 5 ml gennemsigtige hætteglas med 5 ml nominel påfyldningsmængde.
English: Differential white blood cell counts should also be performed prior to each dose of cidofovir (see section 4.8).
Danish: Differentialtælling af hvide blodlegemer bør også foretages før hver cidofovirdosis (se pkt.
English: Preclinical animal studies demonstrated that nephrotoxicity was the major dose-limiting toxicity of cidofovir.
Danish: Prækliniske dyrestudier viste, at nefrotoksicitet var cidofovirs vigtigste dosisbegrænsende toksicitet.
English: • low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/fatigue and fever.
Danish: • nedsat antal hvide blodlegemer, hovedpine, kvalme, opkastning, protein i urinen, stigning i serumkreatinin (et mål for nyrefunktionen), hårtab, udslæt, mathed/træthed og feber.
English: Excess Vistide and all other materials used in the admixture preparation and administration should be placed in a leak-proof, puncture-proof container for disposal.
Danish: Overskydende Vistide og alle andre materialer, der bruges til tilberedning og administration af opløsningen, skal anbringes i en tæt, punkteringsfri beholder og destrueres.
English: A significantly increased foetal incidence of external, soft tissue and skeletal anomalies occurred in rabbits at 1.0 mg/kg/day, which was also maternally toxic.
Danish: En signifikant forøget føtal incidens af eksterne anomalier samt bløddels- og skeletanomalier forekom hos kaniner ved 1,0 mg/kg/dag, hvilket også var toksisk for moderdyret.
English: Probenecid tablets are given to lower the risk of kidney damage.
Danish: Probenecidtabletter gives for at nedsætte risikoen for nyreskader.
English: An increase in formation of micronucleated polychromatic erythrocytes was observed in vivo in mice receiving a high, toxic intraperitoneal dose of cidofovir (≥ 2,000 mg/kg).
Danish: Der blev iagttaget en forøgelse i dannelsen af mikronucleerede, polykromatiske erytrocytter in vivo hos mus, der fik en høj toksisk cidofovirdosis intraperitonealt (≥ 2.000 mg/kg).
English: The no-observable-effect doses for embryotoxicity were 0.5 mg/kg/day in rats and 0.25 mg/kg/day in rabbits.
Danish: Dosis for ingen observerbar effekt på embryotoksicitet var 0,5 mg/kg/dag for rotter og 0,25 mg/kg/dag for kaniner.
English: The major route of elimination of cidofovir was by renal excretion of unchanged drug by a combination of glomerular filtration and tubular secretion.
Danish: Cidofovirs vigtigste udskillelsesvej er nyreekskretion af det uomdannede lægemiddelstof ved en kombination af glomerulær filtration og tubulær sekretion.
English: Your doctor may instruct you to drink plenty of fluids before receiving Vistide.
Danish: Din læge kan bede dig om at drikke rigelig væske, inden du får Vistide.
English: Interactions of cidofovir/probenecid and anti-HIV drugs or drugs used to treat common chronic viral infections in this population, such as HCV- and HBV-related hepatitis, have not been investigated in clinical trials.
Danish: Interaktioner mellem cidofovir, probenecid og anti-HIV midler eller lægemidler til behandling af kroniske virale infektioner i disse populationer, f.eks. HCV og HBV-relateret hepatitis, er ikke blevet
English: Allergic reactions, with skin inflammation, itching, hives and, rarely, severe allergic reactions, and serious skin reaction have occurred.
Danish: Der er set allergiske reaktioner med betændelsestilstand i huden, kløe, nældefeber, og sjældent alvorlige allergiske reaktioner og alvorlige hudreaktioner er set.
English: Patients who can tolerate the additional fluid load may receive up to a total of 2 litres of 0.9% saline intravenously with each dose of cidofovir.
Danish: Patienter, som kan tolerere yderligere væskemængde, kan indgives op til i alt 2 liter 0,9 % natriumchlorid-infusionsvæske intravenøst med hver cidofovir-dosis.
English: If following hydration, a ≥ 2+ proteinuria is still observed, cidofovir therapy should be discontinued.
Danish: Hvis der stadig ses proteinuri ≥ 2+ efter hydrering, bør cidofovirbehandlingen stoppes.
English: Treatment with Vistide must not be initiated in patients with creatinine clearance ≤ 55 ml/min, or ≥ 2+ proteinuria (≥ 100 mg/dl), as the optimum induction and maintenance doses for patients with moderate to severe renal impairment are not known.
Danish: Behandling med Vistide må ikke initieres hos patienter med kreatininclearance ≤ 55 ml/min eller proteinuri ≥ 2+ (≥ 100 mg/dl), da den optimale induktions- og vedligeholdelsesdosis hos patienter med moderat til svær nyreinsufficiens ikke kendes.
English: The median times to retinitis progression in the two efficacy studies (GS-93-106 and GS-93-105), were 120 days and not reached for the treatment arms vs. 22 days and 21 days for the untreated (deferred treatment) arms, respectively.
Danish: Mediantiden for progressionen af retinitis i de 2 studier (GS-93-106 og GS-93-105) var for behandlingsgruppen 120 dage hhv. ikke opnået, hvorimod mediantiden var 22 hhv. 21 dage for
English: Cidofovir is active in vitro against HCMV, a member of the herpesviridae family.
Danish: In vitro er cidofovir aktiv over for HCMV, som er et medlem af herpesviridae-familien.
English: The finding of any glycosuria, proteinuria/aminoaciduria, hypouricemia, hypophosphatemia and/or hypokalemia, should prompt for the consideration of cidofovir-related Fanconi syndrome.
Danish: Ved tilfælde af glykosuri, proteinuri/aminosyreuri, hypourikæmi, hypofosfatæmi og/eller hypokaliæmi bør cidofovir-relateret Fanconis syndrom overvejes.
English: Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by ≥ 44 µmol/l (≥ 0.5 mg/dl), or if persistent proteinuria ≥ 2+ develops.
Danish: Behandlingen med cidofovir bør afbrydes og intravenøs hydrering tilrådes, hvis serumkreatinin stiger med ≥ 44 µmol/l (≥ 0,5 mg/dl) eller hvis der udvikles vedvarende proteinuri ≥ 2+.
English: Patients with AIDS are at high risk of developing CMV retinitis or other forms of CMV disease such as colitis (an inflammatory bowel disease).
Danish: Patienter med aids har stor risiko for at udvikle CMV-nethindebetændelse eller andre former for CMV-sygdomme såsom tyktarmsbetændelse.
English: Biochemical data support selective inhibition of HSV-1, HSV-2 and HCMV DNA polymerases by cidofovir diphosphate, the active intracellular metabolite of cidofovir.
Danish: Biokemiske data understøtter selektiv hæmning af HSV-1, HSV-2 og HCMV DNA-polymeraser af cidofovirdiphosphat, der er cidoforvirs aktive intracellulære metabolit.
English: Vistide should be used with caution in diabetic patients due to the potential increased risk of developing low pressure in the eye (ocular hypotony).
Danish: Vistide skal bruges med forsigtighed til diabetespatienter pga. den muligt forøgede risiko for udvikling af for lavt tryk i øjet (okulær
English: Adults:
Danish: Ældre:
English: Vistide should not be administered concurrently with medicinal products containing tenofovir disoproxil fumarate due to the risk of Fanconi syndrome (see section 4.5).
Danish: Vistide bør ikke administreres sammen med lægemidler, som indeholder tenofovirdisoproxilfumarat pga. risikoen for Fanconis syndrom (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Dose-independent kinetics were demonstrated with single doses of cidofovir given over the dose range 3 to 7.5 mg/kg.
Danish: Der blev vist dosisuafhængig kinetik med enkeltdoser af cidofovir, der blev givet i dosisområdet 3 til 7,5 mg/kg.
English: Studies have shown that cidofovir is clastogenic in vitro at 100 µg/ml and is embryotoxic in rats and rabbits.
Danish: Undersøgelser har vist, at cidofovir er klastogenetisk in vitro ved 100 µg/ml og embryotoksisk hos
English: Following in vitro selection of ganciclovir-resistant HCMV isolates, cross-resistance between ganciclovir and cidofovir was seen with ganciclovir-selected mutations in the HCMV DNA polymerase gene but not with mutations in the UL97 gene.
Danish: Efter in vitro-selektion af ganciclovirresistente HCMV-isolater, blev der iagttaget krydsresistens mellem ganciclovir og cidofovir med ganciclovirselekterede mutationer i HCMV DNA-polymerasegenet, men ikke med mutationer i UL97-genet.
English: Vistide must be given by a doctor or nurse with appropriate experience in treating people with AIDS.
Danish: Vistide skal indgives af en læge eller sygeplejerske med relevant erfaring i behandling af mennesker
English: Cidofovir diphosphate inhibits these viral polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma.
Danish: Cidofovirdiphosphat hæmmer disse viruspolymeraser ved koncentrationer, som er 1/8 til 1/600 af dem, der er nødvendige for at hæmme humane cellers DNA-polymeraser alfa, beta og gamma.
English: The active substance of Vistide 75 mg/ml is cidofovir.
Danish: Det aktive stof i Vistide 75 mg/ml er cidofovir.
English: The therapy should be prescribed by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør ordineres af en læge med erfaring i behandling af HIV-infektion.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation :
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: All clinical trials relevant to clinical efficacy evaluation were performed using probenecid concomitantly with cidofovir.
Danish: Alle kliniske undersøgelser med betydning for vurderingen af klinisk virkning blev udført med samtidig indgift af probenecid og cidofovir.
English: This medicinal product must not be mixed with other medicinal products or diluents except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation (S-9 fraction).
Danish: Cidofovir inducerede kromosomafvigelser i humane, perifere blodlymfocytter in vitro uden metabolisk aktivering (S-9 fraktion).
English: The fraction of the dose extracted during haemodialysis is 51.9 ± 11.0%.
Danish: Ved hæmodialyse udskilles 51,9 ± 11,0 % af dosis.
English: Although not observed in human studies of Vistide, such changes may occur in humans and cause infertility.
Danish: Selv om dette ikke er set i undersøgelser med Vistide hos mennesker, kan sådanne forandringer forekomme hos mennesker og medføre ufrugtbarhed.
English: Two grams of probenecid should be administered 3 hours prior to the cidofovir dose and one gram administered at 2 and again at 8 hours after completion of the 1 hour cidofovir infusion (for a total of 4 grams).
Danish: 2 gram probenecid skal indgives 3 timer før cidofovir og 1 gram indgives 2 timer og igen 8 timer efter afslutning af cidofovirinfusionen på 1 time (d.v.s. ialt 4 g).
English: No mutagenic response was elicited by cidofovir at dose levels up to 5 mg/plate, in the presence and absence of metabolic activation by rat liver S-9 fraction, in microbial assays involving Salmonella typhimurium for base pair substitutions or frameshift mutations (Ames) and Escherichia coli for reverse mutations.
Danish: Cidofovir fremkaldte ingen mutagen reaktion ved dosisniveauer på op til 5 mg/plade ved tilstedeværelsen af og uden metabolisk aktivering med rottelever-S-9 fraktion i mikrobiologiske assays, der omfatter Salmonellea typhimurium til basepar-substitutioner eller frameshift-mutationer (Ames) og Escherichia coli til omvendte mutationer.
English: The saline solution should be infused over a 1 hour period immediately before the Vistide infusion.
Danish: Saltvandsopløsningen skal infunderes i løbet af 1 time umiddelbart før Vistide-infusionen.
English: Women of childbearing potential have to use effective contraception during and after treatment with cidofovir.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under og efter behandling med cidofovir.
English: The safety of cidofovir has not been evaluated in patients receiving other known potentially nephrotoxic agents (e.g. tenofovir, aminoglycosides, amphotericin B, foscarnet, intravenous pentamidine, adefovir and vancomycin).
Danish: Cidofovirs sikkerhed er ikke undersøgt hos patienter, der behandles med andre lægemidler med kendt potentiel nefrotoksicitet (f.eks. tenofovir, aminoglykosider, amphotericin B, foscarnet, pentamidin i.v., adefovir og vancomycin).
English: For patients with evidence of decreased kidney function, your Vistide dose may be interrupted or stopped depending on your individual case.
Danish: Patienter, som får nedsat nyrefunktion, kan få afbrudt eller stoppet Vistide-behandlingen, afhængig af
English: Hearing impaired
Danish: Nedsat hørelse
English: Obtaining probenecid
Danish: Et probenecid
English: Patients receiving cidofovir should be advised to have regular follow-up ophthalmologic examinations for possible occurrence of uveitis/iritis and ocular hypotony.
Danish: Patienter, der får cidofovir, bør regelmæssigt få foretaget øjenundersøgelser, for at påvise evt. uveitis/iritis og okulær hypertoni.
English: CMV attacks the retina of the eye and may cause loss of vision, and eventually lead to blindness.
Danish: CMV angriber øjets nethinde og kan medføre synstab og med tiden blindhed.
English: The safety and efficacy of Vistide in children below 18 years of age have not been established.
Danish: Pædiatrisk population: Vistides sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: In order to reduce the potential for nausea and/or vomiting associated with administration of probenecid, patients should be encouraged to eat food prior to each dose of probenecid.
Danish: For at nedsætte risikoen for kvalme og/eller opkastning forbundet med indgivelse af probenecid, bør patienterne tilskyndes til at spise før hver probeneciddosis.
English: Cidofovir is a cytidine analogue with in vitro and in vivo activity against human cytomegalovirus (HCMV).
Danish: Cidofovir er en cytidinanalog med in vitro og in vivo-aktivitet over for human cytomegalovirus (HCMV).
English: Patients receiving cidofovir must have their serum creatinine and urine protein levels determined on specimens obtained within 24 hours prior to the administration of each dose of cidofovir.
Danish: Patienter, der behandles med cidofovir, skal have målt serumkreatinin og protein i urinen i prøver taget 24 timer inden hver cidofovirdosis.
English: There have been reports of leukopenia, hepatic necrosis, nephrotic syndrome, and aplastic anaemia.
Danish: Der er blevet rapporteret om leukopeni, hepatisk nekrose, nefrotisk syndrom og aplastisk anæmi.