FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are given <Product name> repeatedly your doctor will monitor the ability of your blood to clot, bleeding time and other functions.
Danish: Hvis du får <Produktnavn> gentagne gange, skal din læge overvåge dit blods evne til at størkne, blødningstid og andre funktioner.
English: Because of the risk of allergic (anaphylactic/anaphylactoid) reactions, you will be monitored closely to detect early signs of an allergic reaction when you receive this medicine.
Danish: På grund af risikoen for allergiske (anafylaktiske/anafylaktoide) reaktioner, vil du blive overvåget tæt for at opdage tidlige tegn på en allergisk reaktion, når du får denne medicin.
English: This will be done especially if you have problems with your lungs or with your heart or circulation.
Danish: Dette vil især ske, hvis du har problemer med dine lunger, dit hjerte eller med kredsløbet.
English: There is a lack of robust long term safety data in patients undergoing surgical procedures and in patients with trauma.
Danish: Der mangler solide langsigtede sikkerhedsdata for patienter, der har gennemgået kirurgiske indgreb, og for patienter med traumer.
English: • are critically ill (e.g. you need to stay in an intensive care unit)
Danish: • er kritisk syg (f.eks. hvis du er indlagt på en intensivafdeling)
English: Section 4.4 Special warnings and precautions for use
Danish: Afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: What you need to know before you use <Product name>
Danish: Det skal du vide, før du begynder at bruge <Produktnavn>
English: The first 10-20 ml should be infused slowly and under careful monitoring of the patient so that any anaphylactoid reaction can be detected as early as possible.
Danish: De første 10-20 ml skal infunderes langsomt og under nøje overvågning af patienten, så en anafylaktoid reaktion kan opdages så tidligt som muligt.
English: Therefore it is not recommended to use this medicine in children.
Danish: Derfor anbefales denne medicin ikke til børn.
English: (see sections 4.2, 4.3 and 4.4)
Danish: 4.2, 4.3 og 4.4).
English: Package Leaflet <This medicine is subject to additional monitoring.
Danish: Indlægsseddel < Dette lægemiddel er underlagt supplerende overvågning.
English: The dosage must be adjusted carefully, particularly in patients with pulmonary and cardiocirculatory problems.
Danish: Doseringen skal justeres omhyggeligt, særligt hos patienter med lunge- og hjertekredsløbsproblemer.
English: Use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h.
Danish: Brug af hydroxyethylstivelse (HES) skal begrænses til den initiale fase af volumenerstatningen med et maksimalt tidsinterval på 24 timer.
English: Monitoring of renal function in patients is recommended for at least 90 days.
Danish: Det anbefales at monitore patienternes nyrefunktion i mindst 90 dage.
English: - hyperkalaemia [only applicable to products containing potassium]
Danish: - hyperkalæmi [kun for præparater, der indeholder kalium]
English: Section 4.8 Undesirable effects [This following wording should be reflected in this section]
Danish: Afsnit 4.8 Bivirkninger [Følgende ordlyd skal afspejles i dette afsnit]
English: Discontinue the use of HES at the first sign of coagulopathy.
Danish: HES skal seponeres ved første tegn på koagulopati.
English: In addition your doctor may need to monitor your kidney function for up to 90 days.
Danish: Der kan endvidere være behov for at overvåge din nyrefunktion i op til 90 dage.
English: [This section should be amended to include the following contraindications]
Danish: [Dette afsnit skal ændres for at inkludere følgende kontraindikationer]
English: I. Summary of Product Characteristics <This medicinal product is subject to additional monitoring.
Danish: I. Produktresumé < Dette lægemiddel er underlagt supplerende overvågning.
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Danish: Behandlingen skal være styret af kontinuerlig hæmodynamisk monitorering, så infusionen stoppes, så snart passende hæmondynamiske mål er nået.
English: • suffer from bleeding in the brain (intracranial or cerebral bleeding)
Danish: • har en blødning i hjernen (intrakraniel blødning eller hjerneblødning)
English: What <Product name> is and what it is used for [This section should be amended to include the below wording] <Product name> is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone.
Danish: Virkning og anvendelse [Dette afsnit skal ændres for at inkludere nedenstående ordlyd] <Produktnavn> er et bloderstatningspræparat, som anvendes til at genoprette blodvolumenet, når du har mistet blod, og andre produkter kaldet krystalloider er vurderet ikke at være tilstrækkelige alene.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: • problems with your heart or circulation
Danish: • problemer med dit hjerte eller kredsløb
English: Hepatic injury < frequency not known (cannot be estimated from the available data)> Renal injury < frequency not known (cannot be estimated from the available data)>
Danish: Leverskade <frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data)> Nyreskade <frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data)>
English: - severe hypernatraemia or severe hyperchloraemia - severely impaired hepatic function
Danish: - svær hypernatriæmi eller svær hyperkloræmi - alvorligt nedsat leverfunktion
English: Severe haemodilution resulting from high doses of HES solutions must also be avoided in the treatment of hypovolaemic patients.
Danish: Alvorlig hæmodilution som følge af høje doser af HES-infusionsvæske skal også undgås ved behandling af hypovolæmiske patienter.
English: Section 4.1 Therapeutic indications [The wording of this section should be read as below] Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Danish: Afsnit 4.1 Terapeutiske indikationer [Ordlyden i dette afsnit skal lyde som nedenstående] Behandling af hypovolæmi ved akut blodtab, når krystalloider alene ikke vurderes at være tilstrækkelige (se pkt.
English: If the doctor detects first signs of kidney impairment he/she will stop giving you this medicine.
Danish: Hvis lægen opdager de første tegn på nedsat nyrefunktion, vil han/hun stoppe med at give dig medicinen.
English: The nursing staff will also take measures to observe your body's fluid balance, blood salt level, and kidney function.
Danish: Sundhedspersonalet vil træffe foranstaltninger for at observere din væskebalance, saltniveauet i dit blod samt din nyrefunktion.
English: How to use <Product name>
Danish: Sådan skal du bruge <Produktnavn>
English: In case of an impairment of the ability of your blood to clot, your doctor will stop giving you this medicine.
Danish: Hvis blodets evne til at størkne bliver forringet, vil din læge stoppe med at give dig denne medicin.
English: Serum electrolytes, fluid balance and renal function should be monitored closely.
Danish: Serumelektrolytter, væskebalance og nyrefunktion skal monitoreres nøje.
English: [This section should be amended to reflect the following wording]
Danish: [Dette afsnit skal ændres for at afspejle følgende ordlyd]
English: (see section 4.2)
Danish: (angivet i punkt 6)
English: If you are undergoing open heart surgery and you are on a heart-lung machine to assist in pumping your blood during the surgery, the administration of this solution is not recommended.
Danish: Hvis du får foretaget en åben hjerteoperation, og du har en hjerte-lunge-maskine til at hjælpe med at pumpe blodet rundt i kroppen under operationen, frarådes det, at du får denne infusionsvæske.
English: • suffer from serious generalised infection (sepsis)
Danish: • har en alvorlig infektion i blodet (sepsis)
English: • problems with your kidneys
Danish: • problemer med dine nyrer
English: If impaired kidney function occurs during therapy:
Danish: Hvis nedsat nyrefunktion forekommer under behandlingen:
English: Because of the risk of allergic (anaphylactoid) reactions, the patient should be monitored closely and the infusion instituted at a low rate (see section 4.8).
Danish: På grund af risikoen for allergiske (anafylaktoide) reaktioner skal patienten monitoreres tæt og infusionen indgives med lav hastighed (se pkt.
English: The indication for volume replacement with HES has to be considered carefully, and haemodynamic monitoring is required for volume and dose control.
Danish: Indikationen for volumenerstatning med HES skal overvejes nøje, og hæmodynamisk monitorering er påkrævet for at kontrollere volumen og dosis (se også pkt.
English: See section 4.8 for how to report adverse reactions.>
Danish: 4.8, hvordan bivirkninger indberettes.>
English: - hypersensitivity to the active substances or to any of the other excipients listed in section 6.1 - sepsis - burns - renal impairment or renal replacement therapy - intracranial or cerebral haemorrhage - critically ill patients (typically admitted to the intensive care unit) - hyperhydration - pulmonary oedema - dehydration
Danish: - sepsis - forbrændinger - nedsat nyrefunktion eller nyreerstatningsterapi - intrakraniel blødning eller hjerneblødning - kritisk sygdom (typisk krævende indlæggelse på intensivafdeling) - hyperhydrering - lungeødem - dehydrering
English: • have severe problems with your blood clotting
Danish: • har alvorlige problemer med dit blods størkning
English: <Product name> is contraindicated if you have kidney impairment or of kidney injury requiring dialysis.
Danish: Du må ikke få <Produktnavn>, hvis du har nedsat nyrefunktion eller nyreskade, som kræver dialyse.
English: Particular caution should be exercised when treating patients with impaired hepatic function or in patients with blood coagulation disorders.
Danish: Særlig forsigtighed skal udvises ved behandling af patienter med nedsat leverfunktion eller koagulationsforstyrrelser.
English: Section 4.2 Posology and method of administration
Danish: Afsnit 4.2 Dosering og indgivelsesmåde
English: Paediatric population: Data are limited in children therefore it is recommended not to use HES products in this population.
Danish: Pædiatrisk population: Der foreligger begrænsede data for børn og derfor anbefales brugen af HES-præparater ikke til denne population (se pkt.
English: Data are limited in children therefore it is recommended not to use HES products in this population.
Danish: Der foreligger begrænsede data for børn og derfor anbefales brugen af HES-præparater ikke til denne population.
English: • have kidney impairment or receive dialysis
Danish: • har nedsat nyrefunktion eller er i dialyse
English: • have fluid in the lungs (pulmonary oedema)
Danish: • har væske i lungerne (lungeødem)
English: Possible side effects [This section should be amended to include the below wording]
Danish: Bivirkninger [Dette afsnit skal ændres for at inkludere nedenstående ordlyd]
English: • have severe liver disease
Danish: • har en alvorlig leversygdom
English: • are dehydrated
Danish: • har væskemangel (er dehydreret)
English: • have severe heart failure
Danish: • har alvorligt hjertesvigt
English: The use of HES must be discontinued at the first sign of renal injury.
Danish: HES skal seponeres ved det først tegn på nyreskade.
English: HES products are contraindicated in patients with renal impairment or renal replacement therapy (see section 4.3).
Danish: HES-præparater er kontraindiceret til patienter med nedsat nyrefunktion eller i nyreerstatningsterapi (se pkt.
English: In patients undergoing open heart surgery in association with cardiopulmonary bypass the use of HES products is not recommended due to the risk of excess bleeding.
Danish: HES-præparater frarådes til patienter, som gennemgår åben hjertekirurgi i forbindelse med kardiopulmonal bypass, på grund af risiko for øget blødning.
English: • suffer from burn injury
Danish: • har forbrændingsskader
English: • Liver injury
Danish: • Leverskade
English: • blood clotting (coagulation) disorders
Danish: • forstyrrelser i størkningen af dit blod (koagulationen)
English: • have severely impaired liver function
Danish: • har alvorligt nedsat leverfunktion
English: Intravenous Use vial (glass)
Danish: Intravenøs anvendelse Hætteglas (glas)
English: Powder for solution for infusion
Danish: Pulver til infusionsvæske, opløsning
English: Immediate packaging Pack size
Danish: Pakningsstørrelse
English: is approved in all EU Member States except Latvia, Malta and Slovenia.
Danish: er godkendt i alle EU-medlemslande, undtagen Letland, Malta og Slovenien.
English: National approval was obtained in most of the European countries.
Danish: Der blev indhentet national godkendelse i de fleste EU-lande.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • udvalget behandlede indbringelsen i medfør af artikel 30 i direktiv 2001/83/EF
English: Additional data in this population need to be submitted in the future via the appropriate regulatory procedure.
Danish: Yderligere data for denne population skal i fremtiden indsendes ved at følge den relevante lovbestemte procedure.
English: and associated names is considered to be favourable.
Danish: og relaterede navne kan anses for at være gunstigt.
English: There were no major discrepancies between the existing wordings in the individual Member States.
Danish: Der var ingen større afvigelser mellem ordlyden i de eksisterende udgaver anvendt i de enkelte medlemslande.
English: was first approved in United Kingdom on 15 June 1988, which marks its International Birth Date (IBD).
Danish: blev først godkendt i Det Forenede Kongerige den 15. juni 1988, hvilket markerer datoen for dets internationale godkendelse (IBD).
English: The information on pregnancy and breastfeeding was different in the individual Member States.
Danish: Oplysninger om graviditet og amning var forskellige i de enkelte medlemslande.
English: QUALITY - MODULE 3
Danish: KVALITET - MODUL 3
English: and associated names (see Annex I)
Danish: og relaterede navne (se bilag I)
English: Some of the studies are conducted predominantly in adults, but also included children.
Danish: Nogle af undersøgelserne er primært blevet gennemført med voksne, men har også omfattet børn.
English: These additions to the safety information were considered relevant and were accepted by the CHMP.
Danish: Disse tilføjelser til sikkerhedsoplysningerne blev anset for relevante og accepteret af CHMP.
English: The majority of these studies were open-label controlled studies.
Danish: Størstedelen af disse undersøgelser var ikke-blindede kontrollerede undersøgelser.
English: In addition the wording on precautions of handling the product has been harmonised.
Danish: Endvidere er ordlyden af forsigtighedsforanstaltningerne ved håndtering af produktet blevet harmoniseret.
English: Ten clinical studies were conducted during the period from 1986 till 1996 in patients with AIDS.
Danish: I perioden fra 1986 til 1996 blev der gennemført ti kliniske undersøgelser hos patienter med AIDS.
English: The CHMP agreed on a common wording.
Danish: CHMP blev enig om en fælles ordlyd.
English: In most of the studies efficacy of ganciclovir 2.5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
Danish: I de fleste af undersøgelserne blev effektiviteten af ganciclovir 2,5 mg/kg, 5 mg/kg, 6 mg/kg i.v.
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 menneskelige virus omfatter humant cytomegalovirus (HCMV), herpes-simplex virus-1 og -2 (HSV-1 og HSV-2), human herpesvirus -6, -7 og -8 (HHV-6, HHV-7, HHV-8), Epstein-Barr virus (EBV), varicel-zoster virus (VZV) og hepatitis B virus.
English: On 15 September 2014 the European Commission on behalf of all marketing authorisation holders presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics, labelling and package leaflet of the medicinal products, Cymevene i.v.
Danish: Den 15. september 2014 præsenterede Europa-Kommissionen på vegne af alle indehavere af markedsføringstilladelsen en indbringelse i medfør af artikel 30 i direktiv 2001/83/EF for det Europæiske Lægemiddelagentur, med henblik på at harmonisere det nationale produktresumé, etikettering og indlægsseddel på lægemidlet Cymevene i.v.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee;
Danish: • det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaverne af markedsføringstilladelsen, er vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Danish: Baseret på gennemgangen af data vedtog CHMP et harmoniseret Modul 3.
English: Cymevene is indicated for use in adults and adolescents from 12 years of age.
Danish: Cymevene er beregnet til brug hos voksne og unge fra 12 år.
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: Derfor bør ganciclovir ikke anvendes hos gravide, medmindre det kliniske behov for behandling af disse kvinder vejer tungere end den potentielle teratogene risiko for fosteret.
English: Overall summary of the scientific evaluation of Cymevene i.v.
Danish: Samlet resumé af den videnskabelige vurdering af Cymevene i.v.
English: The labelling was reviewed during this procedure and changes were introduced, mainly to align with the QRD template.
Danish: Under denne procedure blev mærkningen revurderet og ændringer implementeret, primært for at opnå overensstemmelse med QRD-modellen.
English: The only strength of 500 mg is available.
Danish: Lægemidlet er kun tilgængeligt i en styrke på 500 mg.
English: The inclusion criteria regarding the age of eligible patients in ganciclovir studies are variable.
Danish: Inklusionskriterierne vedrørende alderen af de patienter, der kan udvælges til undersøgelser med ganciclovir, kan variere.
English: Grounds for the variation to the terms of the marketing authorisation(s)
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen(-tilladelserne)
English: Results of these studies demonstrated beneficial effect on progression of disease, relapse of CMV infections and incidence of the disease.
Danish: Resultaterne af disse undersøgelser viste en positiv effekt på sygdommens fremskriden, tilbagefald af CMV-infektioner og tilfælde af sygdommen.
English: Consideration should be given to official guidance on the appropriate use of antiviral agents.
Danish: Officielle retningslinjer for forsvarlig brug af antivirale stoffer bør følges.
English: contains ganciclovir, a synthetic analogue of 2'-deoxyguanosine which inhibits replication of herpes viruses.
Danish: indeholder ganciclovir, en syntetisk analog til 2'-deoxyguanosin, der hæmmer replikation af herpesvirus.
English: Cymevene must only be given by intravenous infusion over 1 hour.
Danish: Cymevene må kun gives ved intravenøs infusion gennem én time.
English: Safety and efficacy data from valganciclovir studies conducted in children were also presented as relevant to the safety and efficacy of ganciclovir (clinical use of valganciclovir, the pro-drug of ganciclovir, has been approved in EU for paediatric SOT recipients for prevention of CMV disease.)
Danish: Data for sikkerhed og effektivitet fra undersøgelser med valganciclovir hos børn blev også fremlagt som relevante for sikkerhed og effektivitet ved ganciclovir (klinisk brug af valganciclovir, prodrug af ganciclovir, er blevet godkendt i EU til pædiatriske SOT-patienter til forebyggelse af CMVsygdommen).
English: Therefore, breastfeeding must be discontinued during treatment with ganciclovir.
Danish: Derfor skal amning indstilles under behandling med ganciclovir.
English: doses used for 2 weeks (induction treatment) and later 5 mg/kg or 6 mg/kg maintenance doses were evaluated for treatment of CMV retinitis in AIDS patients.
Danish: doser anvendt i 2 uger (induktionsbehandling), og senere blev konsolideringsdoser på 5 mg/kg eller 6 mg/kg evalueret til behandling af CMV retinitis hos AIDSpatienter.
English: The safety of ganciclovir for use in pregnant women has not been established.
Danish: Sikkerheden omkring anvendelse af ganciclovir under graviditet er ikke fastlagt.
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, hvorvidt ganciclovir udskilles i brystmælk, men risikoen for at ganciclovir udskilles med brystmælken og forårsager alvorlige skadelige reaktioner hos det ammende barn, kan ikke udelukkes.
English: Before the introduction of HAART, approximately 30% of patients with AIDS experienced CMV retinitis, making CMV prophylaxis necessary.
Danish: Før HAART blev introduceret oplevede ca. 30 % af AIDS-patienterne retinitis med CMV, hvilket gjorde CMV-profylakse nødvendig.
English: In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity.
Danish: I dyreforsøg blev ganciclovir kædet sammen med reproduktionstoksicitet og teratogenicitet.
English: In conclusion, based on the assessment of the MAH's proposals and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of product information documents of Cymevene i.v.
Danish: Afsluttende, på grundlag af vurderingen af markedsføringstilladelsesindehaverens forslag og besvarelser og efter udvalgets drøftelser, vedtog CHMP et harmoniseret sæt produktinformationsdokumenter for Cymevene i.v.
English: The medicinal product is available in vials of 10 ml as powder for concentrate for solution for infusion.
Danish: Lægemidlet fås i hætteglas på 10 ml som et pulver til koncentreret infusionsvæskeopløsning.
English: Caution regarding the need to administer Cymevene by intravenous infusion over 1 hour and the hazards associated with other routes or rates of administration were provided.
Danish: Sikkerhedsregler vedrørende behovet for at indgive Cymevene ved intravenøs infusion gennem én time og farer forbundet med at anvende andre indgivelsesveje og -hastigheder blev stillet til rådighed.
English: In patients with AIDS prevention of CMV disease is no longer recommended because the highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with AIDS.
Danish: Forebyggelse af CMV-sygdommen hos AIDS-patienter anbefales ikke længere, eftersom den højaktive antiretrovirale terapi (HAART) har reduceret risikoen for CMV-sygdommen hos patienter med AIDS.
English: Special dosage instructions for patients with renal impairment, older people and paediatric patients are provided.
Danish: Specielle indikationer om dosis til patienter med nyreinsufficiens, ældre personer og pædiatriske patienter er stillet til rådighed.
English: The high pH of ganciclovir can result in severe tissue irritation if the product is given by intramuscular or subcutaneous injection and toxicity may be increased if intravenous administration is rapid.
Danish: Ganciclovirs høje pH-værdi kan forårsage alvorlig vævsirritation, hvis produktet indgives ved intramuskulær eller subkutan injektion, og toksiciteten kan øges, hvis den intravenøse indgivelse sker hurtigt.
English: the CHMP was of the opinion that the benefit/risk ratio of Cymevene i.v.
Danish: var CHMP af den opfattelse, at benefit/risk-forholdet for Cymevene i.v.