FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of 100 mg tablets (dose 10 mg/kg)
Danish: Antal 100 mg tabletter (dosis 10 mg/kg)
English: Kuvan 100 mg soluble tablets
Danish: Kuvan 100 mg opløselige tabletter.
English: Caution is recommended during concomitant use of Kuvan with all medicinal products that cause vasodilation, including those administered topically, by affecting nitric oxide (NO) metabolism or action including classical NO donors (e.g. glyceryl trinitrate
Danish: Der bør derfor udvises forsigtighed ved samtidig behandling med Kuvan og lægemidler, der kan medføre vasodilatation (inklusive topikale lægemidler) via nitrogenoxids (NO) metabolisme eller virkning.
English: After dissolving the powder in water, the solution must be clear, colourless to yellow.
Danish: Når pulveret er opløst i vandet, skal opløsningen være klar og have en farveløs til gullig nuance.
English: Rhinorrhoea
Danish: Hypofenylalaninæmi
English: This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Danish: Dette skal tages i betragtning ved administration af patienter, som har et allerede eksisterende forkortet QTinterval (f.eks. patienter med familiært kort QT-syndrom).
English: Physician-supervised restriction of dietary phenylalanine intake prior to and throughout pregnancy is the first choice of treatment in this patient group.
Danish: For denne patientgruppe er førstevalgsbehandlingen forud for og under graviditet diætbehandling med reduktion af fenylalaninindtagelsen under vejledning fra en læge.
English: Each tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Danish: Hver tablet indeholder 100 mg sapropterindihydrochlorid (svarende til 77 mg sapropterin).
English: Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Danish: Hver opløselig tablet indeholder 100 mg sapropterindihydrochlorid (svarende til 77 mg sapropterin).
English: Convulsions disorders
Danish: Krampesygdomme
English: Number of 100 mg sachets (dose 10 mg/kg)
Danish: Antal 100 mg breve (dosis 10 mg/kg)
English: After dissolving Kuvan powder in water, the solution must be clear, colourless to yellow.
Danish: Når Kuvan pulveret er opløst i vandet, skal opløsningen være klar med en farveløs til gullig nuance.
English: Table 4: 20 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Danish: Tabel 4: doseringstabel for 20 mg/kg dagligt til børn, der vejer op til 20 kg Vægt (kg) Samlet dosis (mg/dag)
English: Number of 100 mg sachets (dose 20 mg/kg)
Danish: Antal 100 mg breve (dosis 20 mg/kg)
English: Table 3: 10 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Danish: Tabel 3: Doseringstabel for 10 mg/kg dagligt til børn, der vejer op til 20 kg Vægt (kg) Samlet dosis (mg/dag)
English: Table 2: 5 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Danish: Tabel 2: Doseringstabel for 5 mg/kg dagligt til børn, der vejer op til 20 kg Vægt (kg) Samlet dosis (mg/dag)
English: Table 1: 2 mg/kg per day dosing table for children weighing up to 20 kg Weight (kg) Total dose (mg/day)
Danish: Tabel 1: doseringstabel for 2 mg/kg dagligt til børn, der vejer op til 20 kg Vægt (kg) Samlet dosis (mg/dag)
English: Each sachet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).
Danish: Hvert brev indeholder 100 mg sapropterindihydrochlorid (sapropterin dihydrochloride) (svarende til 77 mg sapropterin).
English: Headache
Danish: Amning
English: Renal or hepatic impairment
Danish: Nervesystemet Meget almindelig: Hovedpine
English: Each sachet contains 1.6 mmol (62.7 mg) potassium.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hvert brev indeholder 1,6 mmol (62,7 mg) kalium.
English: What Kuvan is and what it is used for What do you need to know before you take Kuvan How to take Kuvan
Danish: Det skal du vide, før du begynder at tage Kuvan Sådan skal du tage Kuvan Bivirkninger
English: Powder for dispersion for infusion
Danish: Pulver til infusionsvæske, dispersion
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse hætteglas (glas) 100 mg
English: Safety was not assessed in this study.
Danish: Sikkerheden blev ikke undersøgt i dette studie.
English: (listed in section 6)
Danish: (angivet i punkt 6)
English: This is to check the dose you are having is right for you.
Danish: Det sker for at kontrollere, om den dosis, du får, er den rigtige for dig.
English: • If you have two infusions a day, this will continue for up to 21 days.
Danish: • Hvis du får 2 infusioner om dagen, vil dette fortsætte i op til 21 dage.
English: • what you are using the medicine for.
Danish: • hvad du får medicinen for.
English: There were no deaths secondary to CMV.
Danish: Der var ingen dødsfald sekundært til CMV.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Denne produktinformation kan efterfølgende opdateres hvis relevant af de kompetente myndigheder i medlemsstaterne, i samarbejde med referencemedlemsstaten i overensstemmelse med betingelserne i kapitel 4 i afsnit III i direktiv 2001/83/EF procedurer.
English: No studies have been conducted in adults older than 65 years of age.
Danish: Der er ikke udført studier hos voksne over 65 år.
English: • how well your kidneys are working
Danish: • hvor godt dine nyrer virker
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis det sker, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: Powder: Does not require any special storage conditions.
Danish: Pulver: Kræver ikke særlige opbevaringsforhold.
English: There were 9 deaths during the study, 3 in the ganciclovir group and 6 in the control group.
Danish: Der var 9 dødsfald i løbet af studiet, 3 i ganciclovir-gruppen og 6 i kontrolgruppen.
English: The overall incidence of CMV was 16% (15/92 patients).
Danish: Den samlede forekomst af CMV var 16% (15/92 patienter).
English: Of these, 25 received ganciclovir and 17 received no treatment.
Danish: Ud af disse fik 25 ganciclovir, og 17 fik ingen behandling.
English: No specific information available
Danish: Der foreligger ingen specifik information.
English: No deaths were related to study medication.
Danish: Ingen af dødsfaldene var relateret til studiemedicinen.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Candida infections including oral candidiasis.
Danish: Candida-infektioner, inklusive oral candidiasis
English: • hallucinations - hearing or seeing things that are not real.
Danish: • hallucinationer - hvor man hører eller ser ting, der ikke er der.
English: * The frequencies of these adverse reactions are derived from post-marketing experience, all other frequency categories are based on the frequency recorded in clinical trials.
Danish: *Hyppigheden for disse bivirkninger stammer fra erfaringer efter markedsføring, mens alle andre hyppighedskatagorier er baseret på den hyppighed, der er registreret i kliniske studier.
English: • blood poisoning (sepsis)
Danish: • blodforgiftning (sepsis)
English: For females: 0.85 x male value
Danish: Kvinder: 0,85 x værdien for mænd
English: This medicinal product is authorised in the Member States of the EEA under the following names: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: <{Medlemslandets navn}><{Lægemidlets navn} <{Medlemslandets navn}><{Lægemidlets navn}
English: See Serious side effects at the top of section 4 for more information.
Danish: Se ”Alvorlige bivirkninger” øverst i afsnit 4 for mere information.
English: Read all of this leaflet carefully before you start using this medicine - because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: This is called an intravenous infusionand it will usually take one hour.
Danish: Det kaldes en intravenøs infusion og tager som regel 1 time.
English: • you are having radiotherapy.
Danish: • du får strålebehandling.
English: The recommended dosage, frequency and infusion rates should not be exceeded.
Danish: De anbefalede doser, doseringsfrekvenser og infusionshastigheder må ikke overskrides.
English: You should not become pregnant while using this medicine.
Danish: Du må ikke blive gravid, mens du får denne medicin.
English: This belongs to a group called anti-viral medicines.
Danish: Stoffet tilhører en gruppe af lægemidler, der kaldes antivirale lægemidler.
English: Cymevene should not be mixed with other intravenous products.
Danish: Cymevene bør ikke blandes med andre intravenøse lægemidler.
English: Cymevene can cause some serious side effects that you need to tell your doctor about straight away.
Danish: Cymevene kan forårsage alvorlige bivirkninger, som du straks skal fortælle lægen om.
English: It should not be used after the expiry date which is stated on the carton.
Danish: Må ikke anvendes efter den udløbsdato, der står på pakningen.
English: Children and adolescents There is limited information on how safe or effective Cymevene is in children under 12 years.
Danish: Børn og unge Der er begrænset information om, hvor sikkert og effektivt Cymevene er til børn under 12 år.
English: Antiviral treatment consisted of either:
Danish: Den antivirale behandling bestod af:
English: The study included 21 infants with normal hearing at birth who developed late-onset hearing loss.
Danish: Studiet inkluderede 21 spædbørn med normal hørelse ved fødslen, som udviklede sent indsættende høretab.
English: A total of 38.5% of subjects were spared antiviral medications beyond their initial postoperative prophylaxis.
Danish: I alt 38,5% af patienterne fik ikke yderligere antiviral behandling ud over den initiale postoperative profylakse.
English: • hands or feet feeling weak or numb, which may affect your balance
Danish: • hænder og fødder føles svage eller følelsesløse, hvilket kan påvirke balancen
English: It is used in adults and adolescents 12 years and older.
Danish: Det bruges til voksne og unge over 12 år.
English: Do not use Cymevene if any of the above apply to you.
Danish: Du må ikke få Cymevene, hvis noget af ovenstående gælder for dig.
English: Cymevene may temporarily or permanently stop men from producing sperm.
Danish: Cymevene kan midlertidigt eller permanent stoppe mænds sædproduktion.
English: The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Danish: Infusionen skal gives i en vene med tilstrækkelig blodgennemstrømning, helst via plastikkanyle.
English: None of the children required a cochlear implant and hearing loss improved in 83% of ears affected by hearing loss at baseline.
Danish: Ingen af børnene havde behov for cochlea-implantat, og høretabet forbedredes på 83% af de ører, der var påvirket ved baseline.
English: • The virus can affect anyone, but it is a particular problem in people with a weak immune system.
Danish: • Virusset kan ramme alle, men er særligt et problem hos dem, der har et svagt immunforsvar, hvor
English: Time to onset of CMV infection was comparable in both groups.
Danish: Tid til indtræden af CMV-infektion var sammenlignelig grupperne imellem.
English: • your age
Danish: • din alder
English: Side effects in children and adolescents The following side effects are more likely in children:
Danish: Bivirkninger hos børn og unge Følgende bivirkninger er hyppigere hos børn:
English: • You will usually start by having one or two infusions every day.
Danish: • Du vil normalt få 1 eller 2 infusioner om dagen til at starte med.
English: The risk of neutropenia is not predictable on the basis of the number of neutrophils before treatment.
Danish: Risko for neutropeni kan ikke forudsiges ud fra neutrofilocyttallet inden behandling.
English: The dose of Cymevene varies from one patient to another.
Danish: Dosis af Cymevene er forskellig fra patient til patient.
English: For the first 2 weeks these blood tests will be done often.
Danish: I de første 2 uger vil der blive taget blodprøver ofte, herefter vil der gå længere tid imellem.
English: You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Cymevene.
Danish: Du kan føle dig søvnig, svimmel, forvirret eller usikker, og du kan miste balancen eller få kramper, mens du er i behandling med Cymevene.
English: Ganciclovir is a potential carcinogen.
Danish: Ganciclovir er potentielt karcinogent.
English: The fraction of ganciclovir removed during a single dialysis session varied from 50% to 63%.
Danish: Den andel af ganciclovir, der fjernes ved en enkelt dialyse-session, varierer fra 50% til 63%.
English: Caution should be exercised in the handling of Cymevene.
Danish: Der skal udvises forsigtighed ved håndtering af Cymevene.
English: The possibility of viral resistance should be considered in patients who repeatedly achieve a poor clinical response or experience continuous viral excretion during treatment.
Danish: Muligheden for viral resistens skal overvejes hos patienter, der gentagne gange oplever dårligt klinisk respons eller vedvarende viral udskillelse under behandling.
English: • eye infection (conjunctivitis)
Danish: • øjeninfektion (konjunktivitis)
English: Preparation of the reconstituted concentrate
Danish: Fremstilling af det rekonstituerede koncentrat:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY}
Danish: <Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}> <Dato for seneste fornyelse: {DD måned ÅÅÅÅ}>
English: The safety of ganciclovir for use in pregnant women has not been established.
Danish: Ganciclovirs sikkerhed ved anvendelse til gravide kvinder er ikke undersøgt.
English: Cymevene will be given to you by a doctor or nurse.
Danish: Du vil få Cymevene af en læge eller sygeplejerske.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold inden brug brugerens ansvar.
English: The benefits of treatment should be carefully considered in each case and should clearly outweigh the risks (see section 4.2).
Danish: Fordelene ved behandling bør omhyggeligt overvejes i hvert enkelt tilfælde og bør klart opveje risiciene (se pkt.
English: Of the 100 patients enrolled, 42 met all study criteria and had both baseline and 6-month follow up audiometric evaluations.
Danish: Ud af de 100 inkluderede patienter opfyldte 42 alle studiekriterier og blev evalueret audiometrisk ved såvel baseline som ved 6-måneders opfølgningen.
English: Neutropenia was the only side effect reported and it was not necessary to discontinue treatment in any patient.
Danish: Neutropeni var den eneste rapporterede bivirkning, og seponering var ikke nødvendig hos nogen patienter.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel dig personligt.
English: This is because it may affect the unborn baby.
Danish: Det skyldes, at medicinen kan skade det ufødte barn.
English: Tests and checks
Danish: Prøver og undersøgelser
English: LIST OF EXCIPIENTS This medicinal product contains sodium.
Danish: LISTE OVER HJÆLPESTOFFER Dette lægemiddel indeholder natrium.
English: Refer to treatment guidelines.
Danish: Der henvises til retningslinjer for behandling.
English: Neutropenia was the only severe adverse drug reaction observed during the study and although none of the children required treatment cessation, 4 required granulocyte colony-stimulating factor (G-CSF) treatment to maintain absolute neutrophil counts > 400 cells/mm3.
Danish: Neutropeni var den eneste svære bivirkning, der blev observeret under studiet, og selvom seponering ikke var nødvendig hos nogen af børnene, havde 4 behov for behandling med granulocytkolonistimulerende faktor (G-CSF) for at opretholde et absolut neutrofiltal >400 celler/mm3.
English: Neutropenia also occurs more often in paediatric patients, but there is no correlation between neutropenia and infectious adverse reactions in the paediatric population.
Danish: Neutropeni ses ligeledes oftere hos børn, men der er ingen korrelation mellem neutropeni og infektionsrelaterede bivirkninger i den pædiatriske population.
English: Ganciclovir was effective with a toxicity profile similar to that seen in adults.
Danish: Ganciclovir var effektivt med en toksicitetsprofil svarende til den, der ses hos voksne.
English: Such an effect is also anticipated during concomitant administration of intravenous ganciclovir and probenecid.
Danish: En sådan effekt forventes også ved samtidig administration af intravenøs ganciclovir og probenecid.
English: Cymevene solutions are alkaline (pH ~11).
Danish: Cymevene-opløsninger er basiske (pH ~11).
English: Antiviral Activity
Danish: Antiviral aktivitet
English: 4.5 Interaction with other medicinal products and other forms of interaction Pharmacokinetic interactions
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Patients with low baseline platelet counts (< 100,000 /mL) have an increased risk of developing thrombocytopenia.
Danish: Patienter med lavt trombocyttal ved baseline (<100.000/ml) har øget risiko for at udvikle trombocytopeni.
English: It is also used to prevent CMV infection after an organ transplant or during chemotherapy.
Danish: Det bruges også til at forebygge CMV-infektion efter organtransplantation eller under kemobehandling.
English: • infertility in men - see ‘Fertility' section
Danish: • barnløshed hos mænd - se afsnittet ‘Frugtbarhed'
English: Neutropenia usually occurs during the first or second week of induction therapy and following administration of a cumulative dose of ≤ 200 mg / kg.
Danish: Neutropeni opstår sædvanligvis inden for den første eller anden uge efter, behandlingen er påbegyndt, og efter en kumulativ dosis på ≤200 mg/kg.
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Danish: <MM/ÅÅÅÅ> <{DD/MM/ÅÅÅÅ}> <{DD måned ÅÅÅÅ}>
English: The range of exposures was comparable to those observed in adults.
Danish: Eksponeringsintervallet var sammenligneligt med det, der ses hos voksne.
English: At intravenous doses of 5 and 10 mg/kg/day, an increase in the AUC of didanosine ranging from 38% to 67% has been observed.
Danish: Ved intravenøse doser på 5 og 10 mg/kg/dag ses 38% til 67% stigning i didanosins AUC.
English: Serum creatinine (µmol/L)
Danish: Serumcreatinin (µmol/l)
English: Based on patient weight the appropriate volume should be removed with a syringe from the vial and further diluted into an appropriate infusion solution.
Danish: Baseret på patientens vægt trækkes det relevante volumen op af hætteglasset med en sprøjte og fortyndes yderligere til en egnet infusionsvæske.
English: Sensitive human viruses include human cytomegalovirus (HCMV), herpes-simplex virus-1 and -2 (HSV-1 and HSV-2), human herpes virus -6, -7 and -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), and hepatitis B virus.
Danish: Følsomme humane vira inkluderer humant cytomegalovirus (HCMV), herpes simplex virus-1 og -2 (HSV-1 og HSV-2), humant herpesvirus-6, -7 og -8 (HHV-6, HHV-7, HHV-8), EpsteinBarr-virus (EBV), varicella zoster-virus (VZV) samt hepatitis B-virus.
English: Other adverse drugs reactions are presented in the table below.
Danish: Andre bivirkninger er angivet i tabellen nedenfor.
English: • The other ingredients are sodium hydroxide and hydrochloric acid.
Danish: • Øvrige indholdsstoffer: natriumhydroxid og saltsyre.
English: Ganciclovir penetrates the cerebrospinal fluid, where concentrations observed reach 24%−67% of the plasma concentrations.
Danish: Ganciclovir passerer over i cerebrospinalvæsken, hvor de observerede koncentrationer ligger på 24-67% af plasmakoncentrationen.
English: • low white blood cell counts.
Danish: • lavt antal hvide blodlegemer.
English: In a randomised, controlled study, 100 neonates (≤1 month of age) with symptomatic congenital CMV
Danish: I et randomiseret, kontrolleret studie fik 100 nyfødte (≤1 måned) med symptomatisk kongenital CMV
English: • you have had problems with your blood cell counts caused by medicines in the past
Danish: • du tidligere har haft problemer med antallet af blodlegemer i forbindelse med medicin
English: If you or your partner becomes pregnant while using Cymevene, talk to your doctor straight away.
Danish: Hvis du eller din partner bliver gravid, mens du er i behandling med Cymevene, skal du straks kontakte lægen.
English: Ganciclovir must be administered by intravenous infusion over 1 hour at a concentration not exceeding 10 mg/mL.
Danish: Ganciclovir skal administreres ved intravenøs infusion over 1 time i en koncentration på maksimalt 10 mg/ml.
English: If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with plain water.
Danish: Hvis der opstår kontakt, skal det berørte område vaskes grundigt med sæbe og vand og øjne skylles grundigt med almindeligt vand.
English: Caution:
Danish: Advarsel:
English: The volume of distribution of intravenously administered ganciclovir is correlated to body weight.
Danish: Fordelingsvolumen for intravenøst administreret ganciclovir er korreleret til kropsvægt.
English: Cymevene should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.
Danish: Cymevene må ikke anvendes af gravide kvinder, medmindre fordelene for moderen opvejer den mulige risiko for det ufødte barn.
English: Forty-three patients were considered high-risk for CMV and 79 were routine-risk.
Danish: 43 patienter vurderedes at være i høj risiko for CMV og 79 i den almindelige risikogruppe.
English: In patients with normal renal function, more than 90% of the intravenously administered ganciclovir dose is recovered unchanged in the urine within 24 hours.
Danish: Hos patienter med normal nyrefunktion kan mere end 90% af den intravenøst administrerede ganciclovirdosis genfindes uomdannet i urinen inden for 24 timer.
English: The in vitro antiviral activity, measured as IC50 of ganciclovir against CMV, is in the range of 0.08 µM (0.02 µg/ml) to 14 µM (3.57 µg/ml).
Danish: In vitro antiviral aktivitet, målt som IC50 for ganciclovir mod CMV, er inden for området 0,08 µM (0,02 µg/ml) til 14 µM (3,57 µg/ml).
English: Plasma protein binding was 1%−2% over ganciclovir concentrations of 0.5 and 51 µg/mL.
Danish: Plasmaproteinbindingen er 1%-2% ved ganciclovirkoncentrationer på 0,5-51 µg/ml.
English: Patients with impaired renal function are at increased risk of toxicity (especially haematological toxicity).
Danish: Patienter med nedsat nyrefunktion har øget risiko for toksicitet (særligt hæmatologisk toksicitet).
English: Creatinine clearance (mL/min)
Danish: Creatininclearance (ml/min)
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB06.
Danish: Farmakoterapeutisk gruppe: Antivirale midler til systemisk brug, direkte virkende antivirale midler, nukleosider og nukleotider eksklusive revers-transkriptase-hæmmere, ATC-kode: J05AB06.
English: Aseptic technique should be used throughout to reconstitute lyophilised Cymevene.
Danish: Der skal anvendes aseptisk teknik gennem hele processen ved rekonstituering af lyofiliseret Cymevene.
English: All children received intravenous ganciclovir 5 mg/kg twice daily for 2 weeks following transplantation.
Danish: Alle børnene fik intravenøs ganciclovir 5 mg/kg 2 gange dagligt i 2 uger efter transplantationen.