FrancophonIA/ELRC3.0 huggingface dataset:
English: On 13 December 2018, following a review of medicines containing the painkiller metamizole, EMA recommended that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the EU market.
Danish: Den 13. december 2018, efter en gennemgang af lægemidler, der indeholder det smertestillende middel metamizol, anbefalede EMA, at den maksimale daglige dosis af lægemidlet og kontraindikationerne for at anvende lægemidlet til kvinder, der er gravide eller ammer, bør harmoniseres for alle produkter på EU-markedet.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20 March 2019.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende afgørelse med gyldighed i alle EU's medlemsstater den 20. marts 2019.
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker.
English: The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used.
Danish: Der var stort set intet i gennemgangen, der tydede på problemer i forbindelse med tidlig graviditet, og enkeltdoser i de første 6 måneder kan godtages, hvis der ikke kan anvendes andre smertestillende midler.
English: • EMA has recommended changes to the product information of metamizole, to ensure that advice on the maximum daily doses and warnings not to use the medicine during the last 3 months of pregnancy or during breastfeeding are consistent across the EU.
Danish: • EMA har anbefalet ændring af produktinformationen for metamizol for at sikre, at anbefalingerne vedrørende de maksimale daglige doser og advarsler om ikke at anvende lægemidlet i de sidste 3 måneder af graviditeten eller ved amning er overensstemmende i hele EU.
English: It has been used for many decades in the EU by mouth, as suppositories or by injection, to treat severe pain and fever that cannot be controlled with other treatments.
Danish: Det har været anvendt i mange årtier i EU og tages gennem munden, som stikpiller eller ved injektion for at behandle alvorlige smerter og feber, som ikke kan kontrolleres med andre behandlinger.
English: The recommendation addressed inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.
Danish: Anbefalingen vedrørte uoverensstemmelser i produktinformationen for metamizolholdige lægemidler, som markedsføres i mange EU-medlemsstater til behandling af svære smerter og feber, som ikke kan kontrolleres med andre behandlinger.
English: • EMA has completed a review of the painkiller metamizole, used in many EU countries to treat severe pain and fever that cannot be controlled with other treatments.
Danish: • EMA har afsluttet en gennemgang af det smertestillende middel metamizol, som anvendes i mange EU-lande til behandling af svære smerter og feber, som ikke kan kontrolleres med andre behandlinger.
English: However, there was some evidence of effects on the kidneys and circulation of the fetus if the medicine were used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period.
Danish: Der foreligger dog nogen evidens for indvirkninger på nyrerne og kredsløbet hos fostre, hvis lægemidlet anvendes inden for de sidste 3 måneder af graviditeten.
English: Treatment should start at the lowest recommended dose and only be increased if needed.
Danish: Behandlingen bør begynde med den laveste anbefalede dosis og kun øges, hvis der er behov for det. Ved indsprøjtning bør den samlede daglige dosis ikke overstige 5.000 mg.
English: If given by injection the total daily dose should not exceed 5,000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.
Danish: Doser til yngre patienter bør baseres på deres kropsvægt.
English: This summary was last updated in 04-2015.
Danish: Dette sammendrag blev sidst ajourført i 04-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristempa on 13 April 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ristempa den 13. april 2015.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere oplysninger findes i resuméet af risikostyringsplanen.
English: What is Ristempa and what is it used for?
Danish: Hvad er Ristempa, og hvad anvendes det til?
English: Other information about Ristempa
Danish: Andre oplysninger om Ristempa
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Danish: Filgrastim har været markedsført i andre lægemidler i EU i en årrække.
English: This is a summary of the European public assessment report (EPAR) for Ristempa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ristempa.
English: Patients can inject themselves if they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne, hvis de har fået passende instruktion.
English: The full EPAR and risk management plan summary for Ristempa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Ristempa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Ristempa is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ristempa anvendes så sikkert som muligt.
English: The company that makes Neulasta has agreed that its scientific data can be used for Ristempa (‘informed consent').
Danish: Virksomheden, som fremstiller Neulasta, har indvilget i, at dens videnskabelige oplysninger må anvendes for Ristempa ("informeret samtykke").
English: Why is Ristempa approved?
Danish: Hvorfor blev Ristempa godkendt?
English: This medicine is the same as Neulasta, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Neulasta, som i forvejen er godkendt i EU.
English: What measures are being taken to ensure the safe and effective use of Ristempa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ristempa?
English: It is not intended to provide practical advice on how to use Ristempa.
Danish: Det er ikke en praktisk vejledning i, hvordan Ristempa bør anvendes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ristempa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ristempa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What are the risks associated with Ristempa?
Danish: Hvilke risici er der forbundet med Ristempa?
English: The most common side effects with Ristempa (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Ristempa (som optræder hos mere end 1 ud af 10 patienter) er smerter i knogler og muskler, hovedpine og kvalme.
English: Ristempa contains the active substance pegfilgrastim.
Danish: Ristempa indeholder det aktive stof pegfilgrastim.
English: Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia.
Danish: Ristempa var lige så effektivt som filgrastim til at afkorte varigheden af svær neutropeni.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristempa, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ristempa, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Ristempa can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Ristempa fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af blodkræft eller blodsygdomme.
English: Ristempa has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Danish: Ristempa er blevet undersøgt i to hovedundersøgelser med 467 patienter med brystkræft, som var i behandling med cytotoksisk kemoterapi.
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when neither medicine is used.
Danish: I begge undersøgelser havde patienterne svær neutropeni i ca. 1,7 dage under den første behandlingsserie med kemoterapi, sammenholdt med ca. 5-7 dage, når ingen af lægemidlerne blev anvendt.
English: Ristempa is a medicine used in cancer patients to help with some of the side effects of their treatment.
Danish: Ristempa er et lægemiddel, der anvendes hos kræftpatienter for at modvirke nogle af bivirkningerne af deres behandling.
English: It is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Danish: Det gives som en enkelt injektion af 6 mg under huden da. 24 timer efter afslutningen af hver behandlingsserie med kemoterapi.
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Danish: Da pegfilgrastim er pegyleret, udskilles lægemidlet langsommere af kroppen, så det ikke behøver gives så ofte.
English: How is Ristempa used?
Danish: Hvordan anvendes Ristempa?
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Ristempa fremgår af indlægssedlen.
English: For more information about treatment with Ristempa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ristempa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Ristempa, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF), that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Ristempa, pegfilgrastim, er filgrastim, der nøje svarer til det menneskelige protein granulocytkolonistimulerende faktor (G CSF) og er bundet til det kemiske stof polyethylenglycol (dvs. det er pegyleret).
English: In both studies, a single injection of Ristempa was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Danish: I begge undersøgelser blev en enkelt injektion af Ristempa sammenlignet med flere daglige injektioner af filgrastim i hver af fire behandlingsserier med kemoterapi.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Danish: Virkningen blev hovedsagelig bedømt på varigheden af svær neutropeni i den første behandlingsserie med kemoterapi.
English: Ristempa is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Danish: Ristempa anvendes til at nedsætte varigheden af neutropeni og forekomsten af neutropeni med feber.
English: It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).
Danish: Det kan heller ikke anvendes hos patienter med myelodysplastisk syndrom, en sygdom, som bevirker produktion af for mange hvide blodlegemer og kan udvikle sig til leukæmi.
English: Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Danish: Filgrastim stimulerer knoglemarven til at danne flere hvide blodlegemer, og stigningen i hvide blodlegemer modvirker neutropeni.
English: What benefits of Ristempa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ristempa?
English: For practical information about using Ristempa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ristempa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg pegfilgrastim.
Danish: Ristempa fås som injektionsvæske i fyldte sprøjter, der indeholder 6 mg pegfilgrastim.
English: Ristempa cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells).
Danish: Ristempa kan ikke anvendes hos patienter med en særlig type kræft, der udgår fra de hvide blodlegemer (kronisk myeloid leukæmi).
English: How does Ristempa work?
Danish: Hvordan virker Ristempa?
English: Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections.
Danish: Dette medfører infektioner pga. lavt indhold af neutrofile, der er en type hvide blodlegemer, som bekæmper infektionerne.
English: Up to 9 days from the date of manufacture.
Danish: Indtil 9 dage efter fremstillingsdatoen.
English: Non carrier added (n.c.a.)
Danish: No carrier added (n.c.a.)
English: Date of first authorisation: 6 July 2016
Danish: Dato for første markedsføringstilladelse: 06 juli 2016
English: In some patients more than one cell line may be affected.
Danish: Hos nogle patienter kan mere end én cellelinje blive berørt.
English: Time points for measurements were 5 minutes, 1 hour, 12 hours, 2 days, 7 days and 28 days.
Danish: Måletidspunkterne var 5 minutter, 1 time, 12 timer, 2 dage, 7 dage og 28 dage.
English: These are duplicates of those identified in the literature.
Danish: Disse er duplikater af dem, der er beskrevet i litteraturen.
English: The PRAC therefore recommends that the Product Information should be updated accordingly.
Danish: PRAC anbefaler derfor, at produktinformationen opdateres i overensstemmelse hermed.
English: This could potentially result in osteosarcomas.
Danish: Dette kan potentielt medføre osteosarkom.
English: Duration of the procedure
Danish: Procedurens varighed
English: 2 mL vial: EU/1/16/1105/001 10 mL vial: EU/1/16/1105/002
Danish: 2 ml hætteglas: EU/1/16/1105/001 10 ml hætteglas: EU/1/16/1105/002
English: Dose reduction may be necessary in affected patients.
Danish: Det kan være nødvendigt at reducere dosis hos de berørte patienter.
English: This radiation is used to treat certain diseases.
Danish: Strålingen anvendes til behandling af visse sygdomme.
English: Activity may be measured using an ionisation chamber.
Danish: Aktiviteten kan måles med et ioniseringskammer.
English: The specific activity of the medicinal product at ART is indicated on the label and always greater than 3,000 GBq/mg.
Danish: Den specifikke aktivitet af lægemidlet ved ART er angivet på etiketten og er altid højere end 3.000 GBq/mg.
English: Before use, packaging and radioactivity should be checked.
Danish: Før brug skal emballage og radioaktivitet kontrolleres.
English: Effective Dose (mSv/MBq)
Danish: Effektiv dosis (mSv/MBq)
English: Radiation protection
Danish: Strålingsbeskyttelse
English: Individual benefit/risk justification
Danish: Individuel begrundelse for benefit/risk-forholdet
English: The following nuclear reaction is ongoing in the irradiation:
Danish: Følgende kernereaktion finder sted ved bestrålingen:
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Danish: Modtagelse, opbevaring, anvendelse, overførsel og bortskaffelse skal ske i overensstemmelse med de relevante bestemmelser og/eller påkrævede tilladelser fra den relevante officielle organisation.
English: The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect.
Danish: Den administrerede aktivitet skal i alle tilfælde være så lav som rimeligt mulig til at opnå den nødvendige diagnostiske virkning.
English: (GBq: GigaBecquerel is the unit in which radioactivity is measured).
Danish: (GBq: GigaBecquerel er måleenheden for radioaktivitet).
English: The use of television monitor systems to monitor the patients is recommended.
Danish: Brug af udstyr til videoovervågning af patienterne anbefales.
English: You will be asked to stop breast-feeding.
Danish: Du vil blive bedt om at holde op med at amme.
English: It has to be used in combination with other medicines (carrier medicines).
Danish: Det skal bruges i kombination med bærerstoffer (andre lægemidler).
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Danish: De pågældende vil drage særlig omsorg for, at præparatet anvendes sikkert, og vil holde dig orienteret om, hvad de foretager sig.
English: In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Danish: I alle tilfælde må det sikres, at risiciene ved strålingen er mindre end ved selve sygdommen.
English: The surface dose rates and the accumulated dose depend on many factors.
Danish: Overfladedosishastighed og akkumuleret dosis afhænger af mange faktorer.
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Danish: Der er strenge lovbestemmelser for anvendelse, håndtering og bortskaffelse af radioaktive lægemidler.
English: Before the use of 177Lu-labelled medicinal products, pregnancy should be excluded using an adequate/validated test.
Danish: Før anvendelse af 177Lu-mærkede lægemidler bør graviditet udelukkes ved en passende/valideret prøve.
English: Usual precautions regarding sterility and radioactivity should be respected.
Danish: Sædvanlige forholdsregler vedrørende sterilitet og radioaktivitet skal overholdes.
English: The generally accepted threshold for discharge of the treated patient from the hospital is 20 µSv/h.
Danish: Den almindeligt accepterede grænse for udskrivning af en behandlet patient fra hospital er 20 µSv/time.
English: In most countries, the exposure limit for hospital staff is set the same as for the general public at 1 mSv/year.
Danish: I de fleste lande er eksponeringsgrænsen for hospitalsansatte den samme som for den almindelige befolkning, dvs. 1 mSv/år.
English: Store in the original package in order to avoid unnecessary radiation exposure.
Danish: Opbevares i den originale pakning for at undgå unødig eksponering for stråling.
English: Activity measurements using an ionization chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated.
Danish: Aktivitetsmålinger med ioniseringskammer er meget følsomme for geometriske forhold og skal derfor udføres under tilstrækkeligt validerede geometriske betingelser.
English: Management should be in accordance with local protocols.
Danish: Fremgangsmåden bør ske i henhold til de lokale protokoller.
English: Adequate shielding is mandatory.
Danish: Tilstrækkelig afskærmning er obligatorisk.
English: Tel: + 49-89-289 139-08 info@itg-garching.de
Danish: Tlf.: + 49-89-289 139-08 info@itg-garching.de
English: Further precautions with respect to relatives, carers and hospital staff are provided in section 6.6.
Danish: Yderligere forholdsregler for pårørende, omsorgsgivere og hospitalspersonale er anført i pkt.
English: The PRAC is of the view that although the number of identified cases is limited, the exposure to date is relatively low, and the association with tumour lysis syndrome is biologically plausible.
Danish: PRAC vurderer, at selvom antallet af identificerede tilfælde er begrænset, er eksponeringen til dato relativt lav, og forbindelsen med tumorlysesyndrom er biologisk plausibel.
English: In case of extravasation, infusion of the medicinal product should be immediately ceased, and the nuclear medicine physician and the radiopharmacist should be promptly informed.
Danish: I tilfælde af ekstravasation bør infusionen af lægemidlet straks ophøre, og en nuklearmedicinsk læge og radiofarmaceut bør straks informeres.
English: In cats, no pharmacological effects on respiration and cardiovascular function were observed up to a cumulative intravenous dose of 10 mg/kg.
Danish: Hos katte er der ikke iagttaget farmakologiske virkninger på respiration og kardiovaskulær funktion ved en kumulativ intravenøs dosis på op til 10 mg/kg.
English: The intraperitoneal LD50 in mice was found to be approximately 315 mg/kg.
Danish: Den intraperitoneale LD50 hos mus er bestemt til ca. 315 mg/kg.
English: This should be taken into account when considering the benefit/risk, especially in patients with possible risk factors like prior exposure to chemotherapeutic agents (such as alkylating agents).
Danish: Dette bør tages i betragtning ved vurderingen af fordele/risici, især hos patienter med mulige risikofaktorer såsom tidligere eksponering for kemoterapeutiske midler (f.eks. alkyleringsmidler).
English: Your doctor will perform blood tests to monitor you for this syndrome.
Danish: Lægen vil tage blodprøver for at overvåge dig for dette syndrom.
English: Withdrawals should be performed under aseptic conditions.
Danish: Udtagning skal ske under aseptiske forhold.
English: Reported symptoms include flushing and diarrhoea associated with hypotension.
Danish: De indberettede symptomer omfatter flushing og diarré i forbindelse med hypotension.
English: The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as indicated by the customer and can be within 0 to 7 days starting from the day of manufacture.
Danish: ART er klokken 12:00 middag på den planlagte dato for radioaktiv mærkning, som er angivet af kunden, og kan være fra 0 til 7 døgn efter fremstillingsdatoen.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Danish: Præparatet må kun håndteres og gives til dig af personale, der er oplært i og kvalificeret til at anvende det på sikker måde.
English: This dose is approximately 7 orders of magnitude lower than the intraperitoneal LD50 in mice and more than 5 orders of magnitude lower than the NOEL observed in cats.
Danish: Denne dosis er ca. 7 størrelsesordener lavere end den intraperitoneale LD50 hos mus og mere end 5 størrelsesordner lavere end den iagttagne NOEL hos katte.
English: Red Marrow Osteogenic Cells Skin
Danish: Rød knoglemarv Osteogene celler Hud