FrancophonIA/ELRC3.0 huggingface dataset:
English: A 3-month study in mice with pegaspargase at doses up to 500 U/kg intraperitoneal or intramuscular resulted in slight hepatocellular changes only at the highest intraperitoneal dose.
Danish: I et 3-måneders studie med pegaspargase i doser på højst 500 U/kg administreret intraperitonealt (i.p) eller intramuskulært (i.m.)
English: In Study AALL07P4, PK parameters after a single 2,500 U/m2 IV dose during Induction were calculated by noncompartmental PK analysis from sequential plasma samples and are depicted in Table 3 (see section 5.1).
Danish: I studiet AALL07P4 blev (FK)-parametre beregnet efter en enkelt intravenøs dosis på 2.500 E/m2 under induktion ved brug af en nonkompartmental FK-analyse fra sekventielle plasmaprøver.
English: The powder must therefore be handled and administered with particular care.
Danish: Pulveret skal derfor håndteres og administreres med særlig omhu.
English: Very common (may affect more than 1 in 10 people) - Changes in the function of the pancreas; - Weight loss; - Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism); - Loss of appetite, general weakness, vomiting, diarrhoea, nausea; - Increased blood sugar levels.
Danish: Meget almindelige (kan ses hos flere end 1 ud af 10 patienter) - Ændringer i bugspytkirtlens funktion - Vægttab - Smerter i benet (hvilket kan være et symptom på en blodprop), brystsmerter eller åndenød
English: Rare: Hepatic necrosis, jaundice, cholestasis, hepatic failure Immune system disorders Very common: Hypersensitivity, urticaria, anaphylactic reaction Not known: Toxic epidermal necrolysis*
Danish: Meget almindelig: overfølsomhed, urticaria, anafylaktisk reaktion Ikke kendt: toksisk epidermal nekrolyse*
English: Oncaspar was administered intramuscularly at a dose of 2,500 Units/m2 BSA on Day 3 of the 4-week Induction phase and on Day 3 of each of two 8-week
Danish: Oncaspar blev administreret intramuskulært med en dosis på 2.500 enheder/m2 BSA på dag 3 i induktionsfasen på 4
English: Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Danish: Oncaspar 750 E/ml injektions-/infusionsvæske, opløsning pegaspargase
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate heptahydrate Sodium chloride
Danish: Natriumdihydrogenfosfatmonohydrat Dinatriumfosfatheptahydrat Natriumchlorid
English: Event-Free Survival (EFS) for the Oncaspar and native E. coli L-asparaginase arms are summarised in Table 2, Study CCG-1962 was not designed to evaluate differences in EFS rates.
Danish: Studiet CCG-1962 var ikke designet til at evaluere forskellene i tallene for EFS.
English: These results indicate that, when Oncaspar 2,500 U/m2 BSA is administered as single and repeated doses every two weeks, clinically relevant asparaginase activity is sustained over the entire dosing interval (i.e., two weeks).
Danish: Disse resultater indikerer, at en klinisk relevant asparaginaseaktivitet vedvarer i hele doseringsintervallet(dvs. to uger), når Oncaspar 2.500 E/m2 BSA administreres som en enkelt dosis gentaget hver anden uge.
English: The percentage of patients in the Oncaspar arm with evaluable Low End-Induction MRD (<0.001 detectable disease) at Day 32 was 87.9% (80/91).
Danish: Procentdelen af patienter i Oncaspar-gruppen med evaluerbar MRD ved induktion i den lave ende (< 0,001 detekterbar sygdom)
English: Servier Italia S.p.A. Tel: + 39 (06) 669081
Danish: Tel: +39 06 669081
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml powder for solution for injection/infusion.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Oncaspar 750 E/ml pulver til injektions-/infusionsvæske, opløsning.
English: The solution must therefore be handled and administered with particular caution.
Danish: Opløsningen skal derfor håndteres og administreres med særlig forsigtighed.
English: Asparaginase antibodies
Danish: Asparaginaseantistoffer
English: (CCG-1962) and IV (AALL07P4) provides maintenance of L-asparagine depletion for approximately two weeks following dosing.
Danish: På baggrund af resultater fra disse to studier vil en dosis af Oncaspar på 2.500 E/m2 BSA administreret intramuskulært (CCG-1962) og intravenøst (AALL07P4) opretholde depletering af L-asparagin i cirka to uger efter dosering.
English: A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).
Danish: Kvinder i den fødedygtige alder skal anvende en anden metode end orale kontraceptiva (se pkt.
English: First-Line (ALL patients non-hypersensitive to native E. coli L-asparaginase) The safety and efficacy of Oncaspar was evaluated in an open-label, multicentre, randomised, active-controlled study (StudyCCG-1962).
Danish: Oncaspars sikkerhed og virkning blev evalueret i et åbent, randomiseret, aktivt kontrolleret multicenterstudie (studiet CCG-1962).
English: Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962) Oncaspar native E. coli L-asparaginase
Danish: Skema 2: Hændelsesfri overlevelsesrate efter 3, 5 og 7 år (studiet CCG-1962 )
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml solution for injection/infusion.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Oncaspar 750 E/ml injektions-/infusionsvæske, opløsning.
English: EXP After reconstitution, the solution should be used immediately.
Danish: Efter rekonstitution skal opløsningen anvendes straks.
English: The solution must therefore be handled and administered with particular care.
Danish: Opløsningen skal derfor håndteres og administreres med særlig omhu.
English: A total of 166 patients were enrolled in this study; 54 patients were randomised to treatment with 2,500 U/m2 BSA Oncaspar and 111 patients were randomised to the investigational pegylated asparaginase product.
Danish: 54 patienter blev randomiseret til behandling med 2.500 E/m2 BSA Oncaspar,
English: Oncaspar was administered intravenously at the dose of 2,500 Units/m
Danish: Oncaspar blev administreret intravenøst med en dosis på 2.500 enheder/m2 BSA i løbet af faserne induktion,
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion.
Danish: LÆGEMIDLETS NAVN Oncaspar 750 E/ml pulver til injektions-/infusionsvæske, opløsning.
English: Delayed Intensification (DI) phases.
Danish: 6 doser i løbet af hver af de efterfølgende intensifikationsfaser.
English: Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Danish: Tel: +31 (0)71 5246700
English: th th percentiles).
Danish: † Median (10., 90. percentiler).
English: Common: Hepatotoxicity, fatty liver
Danish: Almindelig: hepatotoksicitet, fedtlever Sjælden: hepatisk nekrose, gulsot, cholestase, leversvigt
English: 2,500 U/m
Danish: 4.5 og 4.6).
English: 14 October 2016 EMA/656265/2016 EMEA/H/C/004003
Danish: 14. oktober 2016 EMA/656265/2016 EMEA/H/C/004003
English: It was to be used in patients whose disease had come back after previous treatment.
Danish: Lægemidlet skulle bruges hos patienter, hvis sygdom vender tilbage efter tidligere behandling.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Zemfirza og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: What was Zemfirza expected to be used for?
Danish: Hvad forventedes Zemfirza anvendt til?
English: What is Zemfirza?
Danish: Hvad er Zemfirza?
English: The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP).
Danish: CHMP satte spørgsmålstegn ved pålideligheden af undersøgelsesresultaterne efter en rutinemæssig inspektion af undersøgelsescentrene, der viste, at undersøgelsen ikke var udført helt efter god klinisk praksis (GCP).
English: Zemfirza is a cancer medicine that contains the active substance cediranib.
Danish: Zemfirza er et kræftlægemiddel, der indeholder det aktive stof cediranib.
English: The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse af 456 patienter med æggestokkræft, der var kommet tilbage mindst 6 måneder efter én tidligere behandling med platinbaseret terapi.
English: On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer.
Danish: Den 19. september 2016 meddelte AstraZeneca AB officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Zemfirza til behandling af æggestokkræft tilbage.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zemfirza could not have been approved for the treatment of ovarian cancer.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Zemfirza ikke kunne godkendes til behandling af æggestokkræft.
English: The main measure of effectiveness was the length of time patients lived without their disease getting worse (progression-free survival).
Danish: Det primære mål for virkningen var varigheden af den progressionsfri overlevelse (den tid, patienterne lever uden forværring af sygdommen).
English: By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.
Danish: Ved at blokere for VEGF-receptorerne forventes dette lægemiddel at nedsætte blodforsyningen til kræftcellerne og derved bremse væksten og spredningen af kræften.
English: Withdrawal of the marketing authorisation application for Zemfirza (cediranib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Zemfirza (cediranib)
English: In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period.
Danish: I undersøgelsen blev Zemfirza sammenlignet med placebo (et uvirksomt stof) og givet sammen med platinbaserede lægemidler i starten af behandlingen og efterfølgende alene som vedligeholdelsesbehandling i en periode.
English: The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors.
Danish: Det aktive stof i Zemfirza, cediranib, blokerer for aktiviteten af de såkaldte "vaskulær endotelial vækstfaktor (VEGF)-receptorer".
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at det ikke var påvist, at fordelene ved Zemfirza opvejede risiciene, og anmodede virksomheden om at fremskaffe flere oplysninger.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review.
Danish: I sit brev til agenturet oplyste virksomheden, at den trak sin ansøgning tilbage på grund af de udestående spørgsmål, der stadig ikke var besvaret på dette sene stadie af gennemgangen.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza.
Danish: Virksomheden har informeret CHMP om, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Zemfirza.
English: In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.
Danish: Den bedring i progressionsfri overlevelse, der sås ved brug af Zemfirza, blev desuden vurderet at være beskeden, og lægemidlets bivirkninger ansås for at være problematiske, navnlig diarré og træthed, der fik mange patienter til at ophøre med behandlingen.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Zemfirza?
English: Zemfirza was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer.
Danish: Zemfirza blev udpeget som lægemiddel til sjældne sygdomme den 29. juli 2014 til behandling af æggestokkræft.
English: These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells.
Danish: Disse receptorer findes i stort antal på blodkarrenes celler og er involveret i udviklingen af nye blodkar, der forsyner kræftcellerne med næring.
English: Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen).
Danish: Det var meningen, at Zemfirza skulle anvendes til behandling af kvinder med kræft i æggestokkene, herunder kræft i æggelederne, der forbinder æggestokkene til livmoderen, og kræft i bughinden.
English: How does Zemfirza work?
Danish: Hvordan virker Zemfirza?
English: Kit - 48 months.
Danish: Kit: 48 måneder.
English: These revealed no remarkable findings.
Danish: Disse afslørede ingen bemærkelsesværdige resultater.
English: Do not
Danish: Må hverken
English: You produce many different kinds of antibodies.
Danish: Du producerer mange forskellige antistoffer.
English: Calculate the percent free technetium as follows:
Danish: Beregn procentindholdet af frit technicium på følgende måde:
English: This dose of radioactivity is safe and will be gone from the body in about 24
Danish: Denne dosis af radioaktivitet er sikker og vil være borte fra din krop i løbet af ca. 24 timer.
English: This helps your doctor make a diagnosis and evaluate the extent of your illness.
Danish: Dette hjælper din læge med at stille en diagnose og vurdere omfanget af din sygdom.
English: Alternative techniques which do not involve ionising radiation should be considered.
Danish: Alternative teknikker som ikke involverer ioniserende stråling bør overvejes.
English: The radiolabelled product should not contain more than 10% free technetium.
Danish: Det radioaktivt mærkede produkt må ikke indeholde mere end 10% frit technicium.
English: These values were calculated according to Medical Internal Radiation Dosimetry.
Danish: Disse værdier er kalkuleret i overensstemmelse med Medical Internal Radiation Dosimetry.
English: Pharmacokinetic studies were performed after the intravenous administration of the product.
Danish: Farmakokinetiske studier blev udført efter intravenøs administration af produktet.
English: There are, as yet, limited data on safety following repeated use.
Danish: Der er endnu kun begrænsede data om sikkerhed i forbindelse med gentagen administration.
English: • It is possible to have a serious allergic reaction to LeukoScan.
Danish: • Du kan muligvis få en alvorlig allergisk reaktion over for LeukoScan.
English: Higher doses may be justified in some clinical circumstances.
Danish: Højere doser kan være nødvendige i visse kliniske tilfælde.
English: Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine.
Danish: Din læge bør derfor holde dig under observation i en kort periode, efter at du har fået denne medicin.
English: Some side effects, although not common, have been reported.
Danish: Nogen bivirkninger, som dog ikke er almindeligt forekommende, er blevet rapporteret.
English: If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to
Danish: Hvis din læge beslutter, at give det til dig igen efter flere uger eller mange måneder, skal dit blod først testes for at se, om du har udviklet en allergi overfor
English: 4.4 Special warnings and special precautions for use Safety and diagnostic accuracy in persons under 21 years of age have not been established.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Sikkerheden og den diagnostisk nøjagtighed hos personer under 21 år, er ikke blevet fastslået.
English: In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
Danish: In vitro er en positiv binding til lymfocytter på op til 2-6% blevet påvist.
English: HAMA titers should be determined before repeated administration of LeukoScan.
Danish: HAMA titeren skal bestemmes før gentagen administration af LeukoScan.
English: These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging
Danish: Disse fordele var også ledsaget af en væsentlig reduktion (85,.4%) i antallet af patienter, som ville have behov for andre diagnostiske undersøgelser.
English: It is produced in mice and purified so that it can be used in humans.
Danish: Det er produceret i mus og renfremstillet, så det kan anvendes til mennesker.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Danish: Enhver kvinde med udeblevet menstruation skal antages at være gravid indtil man har bevist det modsatte.
English: The doctor can also determine how much disease there is.
Danish: Lægen kan også afgøre, hvor udbredt sygdommen er.
English: For instructions for preparation see section 6.6.
Danish: For instruktion vedrørende anvendelsen se afsnit 6.6.
English: Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal)
Danish: Databehandling med filtreret tilbageprojektion og rekonstruktion i tre planer (transaksial, koronal og
English: Patients have been given four times the amount you will receive with no adverse reactions.
Danish: Patienter har fået fire gange den mængde, de vil blive udsat for uden bivirkninger.
English: 4.5 Interactions with other medicinal products and other forms of interaction Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics.
Danish: 4.5 Interaktioner med andre lægemidler og andre former for interaktion Formelle lægemiddelinteraktionsstudier er ikke blevet udført, men ingen lægemiddelinteraktion er blevet beskrevet til dato, inklusiv patienter, der modtager antibiotika.
English: The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Danish: Den færdige opløsning har en pH på 4,5-5,5 og må kun bruges til intravenøs anvendelse.
English: This material will then be injected into your vein.
Danish: Dette stof vil herefter blive indsprøjtet i en af dine vener.
English: Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12).
Danish: Før indgivelse skal opløsningen inspiceres visuelt for partikler og misfarvning, og der skal udføres kvalitetskontrol (se afsnit 12).
English: % Free Technetium = Activity in top half of strip × 100
Danish: % frit technicium = Aktivitet i den øverste halvdel af strimlen x 100 Total aktivitet
English: It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction.
Danish: Der skal dog gøres opmærksom på at disse studier ikke belyste spørgsmål om genotoksicitet, karcinogent potentiale eller eventuel reproduktionstoksicitet.
English: The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis.
Danish: Størrelsen af disse stigninger blev af forskerne vurderet som værende uden klinisk konsekvens for den individuelle patient.
English: Human Anti-mouse Antibody (HAMA)
Danish: Human antimus antistof (HAMA)
English: Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self
Danish: Postmarketingerfaringerne udgør i dag mere end 70.000 solgte hætteglas med 2 rapporter om
English: These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Danish: Disse inkluderer en lille stigning i antallet af visse hvide blodlegemer, der kaldes eosinofile celler (men uden nogen tydelige symptomer), og udslæt.
English: Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject.
Danish: Indgivelse af LeukoScan til unge personer bør kun foretages, efter de mulige risici og fordele er blevet overvejet.
English: Immunoscintigraphy should be performed one to eight hours after injection.
Danish: Immunoscintigrafi bør foretages en til otte timer efter indgivelse.
English: LeukoScan is contraindicated in pregnancy.
Danish: LeukoScan er kontraindiceret under graviditet.
English: Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes.
Danish: Tilsæt det fremstillede eluat til det blybeskyttede hætteglas, ryst og lad mærkningsreaktionen forløbe i ti minutter.
English: Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Danish: Farmakoterapeutisk gruppe: Diagnostisk radioaktivt lægemiddel.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Danish: For hver patient må udsættelse for ioniserende stråling retfærdiggøres på baggrund af forventet fordel.
English: Like all medicines, LeukoScan can cause side effects, although not everybody gets them.
Danish: LeukoScan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Reconstituted and radiolabelled material - 4 hours.
Danish: Rekonstitueret og radiomarkeret materiale: 4 timer.
English: Radiolabelling must take place immediately after reconstitution of product.
Danish: Radiomarkering skal udføres umiddelbart efter produktet er rekonstitueret.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt inden Du begynder at bruge medicinen.
English: There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Danish: Der var ingen væsentlig forskel i detektion af tilstedeværelse eller fravær af osteomyelitis 1-2 timer eller 5-8 timer efter indsprøjtning.
English: Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Danish: Billedeoptagelse i analog og/eller digital mode og med en matrix på mindst 128 x 128 anbefales.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Danish: Udsættelse for ioniserende stråling er forbundet med kræftfremkaldelse og en mulighed for udvikling af arvelige defekter.
English: When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Danish: Når væskefronten er 1 cm fra strimlens øverste kant, tages den op, skæres i to halvdele, og hver halvdel placeres i et separat glasrør.