FrancophonIA/ELRC3.0 huggingface dataset:
English: Absence of OS benefit: According to the applicant, the use of subsequent lines of therapy, that often included bevacizumab, may have confounded the result.
Danish: Manglende fordel i form af total overlevelse: Ifølge ansøgeren kan resultaterne være blevet konfunderet af efterfølgende behandlingsforløb, der ofte indbefattede bevacizumab.
English: Following the CHMP scientific conclusions adopted in 22 May 2014 that Avastin was not approvable in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma on the basis of the following grounds for the refusal of the Marketing Authorisation:
Danish: Efter CHMP's videnskabelige konklusioner af 22. maj 2014, om, at Avastin ikke kunne godkendes til behandling af voksne patienter med nydiagnosticeret glioblastom i kombination med strålebehandling og temozolomid, hvilket byggede på følgende begrundelse for afslag på ansøgningen om markedsføringstilladelse:
English: Thus, with the evidence provided, the efficacy of bevacizumab has not been convincingly demonstrated.
Danish: Den forelagte evidens godtgør således ikke på overbevisende måde virkningen af bevacizumab.
English: Overall conclusion on grounds for re-examination
Danish: Samlet konklusion om begrundelsen for fornyet overvejelse
English: Based on the arguments of the applicant and all the supporting data on safety and efficacy, the CHMP re-examined its initial opinion and in its final opinion concluded by majority decision that the efficacy of the above mentioned medicinal product is not sufficiently demonstrated, and, therefore maintains its recommendation for the refusal of the variation of the Marketing Authorisation for the above mentioned medicinal product.
Danish: Udvalget konkluderede i sin endelige udtalelse ved en flertalsafgørelse, at kvaliteten og virkningen af ovennævnte lægemiddel ikke er tilstrækkeligt påvist, og fastholder derfor sin anbefaling om afslag på ændringen af markedsføringstilladelsen.
English: Following the above CHMP opinion, the applicant requested re-examination and submitted on 22 July 2014 its detailed grounds for the request for re-examination of the CHMP opinion recommending the refusal of the granting of the marketing authorisation.
Danish: • i mangel af dokumenteret virkning er der ikke påvist et positivt benefit/risk-forhold, anmodede ansøgerne om fornyet overvejelse og indsendte den 22. juli 2014 en detaljeret begrundelse for anmodningen om fornyet overvejelse af CHMP's udtalelse, der anbefaler afslag på ansøgningen om markedsføringstilladelse.
English: Therefore, the CHMP has recommended the refusal of the variation of the marketing authorisation for Avastin in the treatment of adult patients with newly diagnosed glioblastoma in combination with radiotherapy and temozolomide.
Danish: CHMP anbefalede derfor afslag på ansøgninger om ændring af markedsføringstilladelsen for Avastin til behandling af voksne patienter med nydiagnosticeret glioblastom i kombination med strålebehandling og temozolomid.
English: The main efficacy issue was about the clinical relevance of the radiological endpoint PFS in the absence of a clinically relevant effect on OS. Antiangiogenic agents, especially those targeting vascular endothelial growth factor (VEGF), such as bevacizumab, can produce marked decrease in contrast enhancement and commonly result in high radiologic response rates.
Danish: Midler mod angiogenese, navnlig hæmmere af vaskulær endotelial vækstfaktor (VEGF) såsom bevacizumab, kan bevirke et markant fald i kontrastforøgelse og resulterer sædvanligvis i høje radiologiske responsrater.
English: The applicant concluded that despite the obvious flaws and biases of the exploratory survival analyses these analyses indicated a beneficial effect of bevacizumab.
Danish: Ansøgeren konkluderede, at de orienterende analyser af overlevelse viste gavnlig virkning af bevacizumab trods deres åbenbare fejl og skævheder.
English: Overall survival (OS) and progression-free survival (PFS) as assessed by the investigator were co-primary endpoints of the trial.
Danish: De ko-primære endepunkter i undersøgelsen var total overlevelse og progressionsfri overlevelse vurderet af investigator.
English: Therefore, the CHMP concluded on 22 May 2014 that the benefit/risk ratio of bevacizumab in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma was negative.
Danish: CHMP konkluderede derfor den 22. maj 2014, at benefit/risk-forholdet var negativt for bevacizumab til behandling af voksne patienter med nydiagnosticeret glioblastom i kombination med stråleterapi og temozolomid.
English: Other endpoints including corticosteroid use, and sign and symptoms of GMB also need special consideration in light of the nature of the mechanism of bevacizumab.
Danish: På baggrund af bevacizumabs mekanisme er der desuden behov for nærmere undersøgelse af andre endepunkter, herunder kortikosteroidforbrug og tegn og symptomer på glioblastoma multiforme.
English: The analysis OS showed no statistically significant difference in survival time between the bevacizumab arm and the placebo arm. Arguably, one-way cross-over after progression may hamper the detection of a difference in OS.
Danish: Analysen af total overlevelse viste ingen statistisk signifikant forskel i overlevelsestid mellem bevacizumab-armen og placeboarmen.
English: The MAH for Avastin applied for an extension of indication to include Avastin in combination with radiotherapy and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma.
Danish: Indehaveren af markedsføringstilladelsen for Avastin søgte om følgende udvidelse af indikationen: Behandling af nydiagnosticeret glioblastom hos voksne, kombineret med strålebehandling og temozolomid.
English: You will be carefully monitored if this is the case.
Danish: Du vil blive nøje overvåget hvis det er tilfældet.
English: • hands and feet
Danish: • hænder og fødder
English: Date of first authorisation: 15 June 2011 Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 15. juni 2011 Dato for seneste fornyelse: 26. maj 2016
English: Although they are rare, the symptoms can be severe.
Danish: Selvom de er sjældne, kan symptomerne være alvorlige.
English: n= number of subjects evaluated.
Danish: n= antal evaluerede forsøgspersoner.
English: ()) every 3 or 4 days for 12 weeks.
Danish: ) hver 3. eller 4. dag i 12 uger.
English: Adults and adolescents (12 years and above)
Danish: Voksne og unge (12 år og derover)
English: Therefore, Cinryze should be given to pregnant women only if clearly indicated.
Danish: Cinryze må derfor kun gives til gravide kvinder, hvis der er klart indiceret.
English: Local reactions at the injection site were uncommon.
Danish: Lokale reaktioner på injektionsstedet var ikke almindelige.
English: • voice-box (larynx), which may make breathing difficult
Danish: • strubehovedet (larynx), som kan gøre det svært at trække vejret
English: Your doctor will discuss with you the risks and benefits of taking this medicine.
Danish: Din læge vil diskutere risici og fordele ved at tage denne medicin med dig.
English: 1077 XX Amsterdam The Netherlands
Danish: 1077 XX Amsterdam Holland
English: Overall administration of Cinryze was well tolerated.
Danish: Overordnet set var administration af Cinryze veltolereret.
English: * Historically assigned potency values are expressed in in-house Units (U).
Danish: * Historisk tildelte værdier for styrken er udtrykt i interne enheder (E).
English: Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
Danish: Fortæl det straks til lægen, hvis du oplever nogle af de følgende symptomer, efter du tager denne medicin.
English: The continued need for regular prophylaxis with Cinryze should be reviewed on a regular basis.
Danish: Det fortsatte behov for regelmæssig profylakse med Cinryze skal vurderes regelmæssigt.
English: Work on the mat provided and wash your hands before performing the following procedures.
Danish: Udfør arbejdet på det medfølgende underlag, og vask hænder før de følgende procedurer udføres.
English: Two additional studies evaluated plasma levels in children (6-11 years).
Danish: To yderligere studier undersøgte plasmaniveauet hos børn (6-11 år).
English: Make sure all the powder is completely dissolved.
Danish: Sørg for, at alt pulveret er helt opløst.
English: • Additional risk minimisation measures Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Danish: • Yderligere risikominimeringsforanstaltninger Før præparatet markedsføres i det enkelte medlemsland, skal indehaveren af markedsføringstilladelsen nå til enighed om indholdet og formatet af uddannelsesmaterialet med den relevante nationale myndighed.
English: If there is no vacuum in the vial, do not use the product.
Danish: Hvis der ikke er vakuum i hætteglasset, må produktet ikke anvendes.
English: • Before you start treatment with Cinryze, it is important that you tell your doctor if you have, or have had, problems with your blood clotting (thrombotic events).
Danish: • Før du påbegynder behandling med Cinryze er det vigtigt, at du fortæller det til lægen, hvis du har eller har haft problemer med blodpropper (trombotiske hændelser).
English: None of these adverse reactions were severe, and none led to discontinuation of medicinal product.
Danish: Ingen af disse bivirkninger var alvorlige, og ingen førte til seponering af lægemidlet.
English: Prevention:
Danish: Forebyggelse:
English: Data collected in this registry should be reported to the CHMP at the time of PSUR submissions.
Danish: Data, som indsamles i dette register, skal rapporteres til CHMP på samme tidspunkt, hvor der indsendes PSUR.
English: A post-marketing registry should be set-up with the objective to gain additional information on the safety and the use of Cinryze in the EU.
Danish: Der skal oprettes et register for data efter markedsføring med det formål at opnå yderligere information om sikkerheden og brugen af Cinryze i EU.
English: Data supporting dosing recommendations in children less than 6 years old are very limited.
Danish: Data til understøttelse af doseringsanbefalinger hos børn under 6 år er meget begrænsede.
English: The main function of serpins is to regulate the activity of serine proteases.
Danish: Serpiners hovedfunktion er at regulere aktiviteten af serinproteaser.
English: Single Dose (1000 Units*)
Danish: Enkeltdosis (1000 enheder*)
English: No special investigations have been performed.
Danish: Der er ikke udført særlige studier.
English: Indication for treatment (acute attack or prophylaxis) Response to treatment
Danish: Indikation for behandling (akut anfald eller profylakse) Respons på behandling
English: Based upon an animal study there is a potential thrombogenic threshold at doses greater than 200 Units
Danish: Baseret på et dyreforsøg er der en potentiel trombogen tærskelværdi ved doser over 200 enheder
English: NL-1066 CX Amsterdam The Netherlands
Danish: NL-1066 CX Amsterdam Holland
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel.
English: This can include allergic-type reactions.
Danish: Dette kan blandt andre være allergilignende reaktioner.
English: Hypersensitivity reactions may have symptoms similar to angioedema attacks.
Danish: Overfølsomhedsreaktioner kan give symptomer, som ligner angioødem-anfald.
English: • face, eyelids, lips or tongue
Danish: • ansigt, øjenlåg, læber eller tunge
English: You or your carer might also administer Cinryze as an injection, but only after receiving adequate training.
Danish: Du eller din plejer kan også indgive Cinryze som en injektion, men kun efter at have modtaget tilstrækkelig træning.
English: Only frequencies based on reporting rates from clinical trials are used to assign frequency category.
Danish: Kun hyppigheder baseret på rapporteringshyppigheder fra kliniske studier er anvendt til at bestemme hyppighedskategorien.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: A leaflet providing detailed information on the key elements of the training that should be kept at home for further reference.
Danish: En brochure med detaljeret information om nøgleelementerne af træningen, som skal opbevares i hjemmet for yderligere reference.
English: Like all medicines, Cinryze can cause side effects, although not everybody gets them.
Danish: Cinryze kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No genotoxicity studies were performed as the active substance is unlikely to interact directly with DNA or other chromosomal material.
Danish: Der blev ikke udført genotoksiske studier, da det er usandsynligt, at det aktive stof vil indvirke direkte på DNA eller andet kromosommateriale.
English: Regular review of your/your carer's injection technique will be performed to ensure continued appropriate handling.
Danish: Regelmæssig gennemgang af din / din plejers injektionsteknik vil udføres for at sikre fortsat hensigtsmæssig behandling.
English: Patients with known risk factors for thrombotic events (including indwelling catheters) should be monitored closely.
Danish: Patienter med kendte risikofaktorer for trombose tilfælde (herunder centralt vene kateter) skal overvåges nøje.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature (15C - 25C).
Danish: Der er imidlertid blevet påvist kemisk og fysisk stabilitet under brug i 3 timer ved stuetemperatur (15 C - 25 C).
English: For 95% of attacks, clinical relief was observed and/or subjects were discharged to home within 4 hours.
Danish: Ved 95 % af anfaldene blev der observeret klinisk lindring, og/eller forsøgspersonerne blive udskrevet til hjemmet inden for 4 timer.
English: Symptoms may include stomach pains and swelling of the:
Danish: Symptomerne kan omfatte mavesmerter og hævelse af:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of general toxicity and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af generel toksicitet og reproduktionstoksicitet.
English: Technique of intravenous injection
Danish: Teknik for intravenøs injektion
English: Low serum C4 levels often correlate with HAE attacks.
Danish: Lave C4-niveauer i serum korrelerer ofte med HAE-anfald.
English: C1 inhibitor is a naturally occurring protein that is normally present in the blood.
Danish: C1-inhibitor er et naturligt forekommende protein, som normalt er til stede i blodet.
English: • If you are allergic to C1 inhibitor or any of the other ingredients of Cinryze (listed in section 6).
Danish: • hvis du er allergisk over for C1-inhibitor eller et af de øvrige indholdsstoffer i Cinryze (angivet i punkt 6).
English: Among reports of venous thrombosis, the most common underlying risk factor was presence of an indwelling catheter.
Danish: Blandt tilfældene af venøs trombose var den mest almindelige underliggende risikofaktor tilstedeværelsen af et centralt venekateter
English: Do not use Cinryze after the expiry date which is stated on the carton or vials after “EXP”.
Danish: Brug ikke Cinryze efter den udløbsdato, der står på kartonen eller hætteglassene efter EXP.
English: For 98% of procedures, no HAE attacks were reported within the 72 hours after the Cinryze dose.
Danish: For 98 % af procedurerne blev der ikke rapporteret nogen HAE-anfald inden for 72 timer efter Cinryzedosis.
English: • When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Danish: • Når medicin fremstilles fra humant blod eller plasma, tages der visse forholdsregler for at forhindre, at infektioner overføres til patienterne.
English: If you are injecting Cinryze yourself, always use it exactly as your doctor has instructed you.
Danish: Hvis du selv injicerer Cinryze, skal du altid bruge det nøjagtigt efter lægen anvisning.
English: The existence of a post marketing registry in which health care professionals are encouraged to enter patients
Danish: Eksistensen af et register med data efter markedsføring, hvor sundhedspersonale opfordres til at registrere patienter
English: If your doctor decides that you may be suitable for such home-treatment, he/she will give you detailed instructions.
Danish: Hvis din læge beslutter, at du kan være kandidat til hjemmebehandling, vil han/hun give dig udførlige instruktioner.
English: Potential risks associated with home-treatment are related to the administration itself as well as the handling of adverse reactions, particularly hypersensitivity.
Danish: Potentielle risici forbundet med hjemmebehandling er relateret til selve indgivelsen, såvel som behandlingen af bivirkninger, især overfølsomhed.
English: The Marketing Authorisation Holder (MAH) should ensure that all healthcare professionals who are expected to prescribe Cinryze are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, som forventes at ordinere Cinryze, forsynes med en uddannelsespakke.
English: The recommended dose of Cinryze for adults, adolescents, children, the elderly, or patients suffering from kidney or liver problems is as follows:
Danish: Den anbefalede dosis af Cinryze til voksne, unge, børn, ældre og patienter, der lider af nyre- eller leverproblemer, er følgende:
English: Both doses resulted in similar reduction of attack-frequency and showed clinical benefit regarding severity, duration, and requirement for acute treatment of attacks.
Danish: De 2 doser medførte samme reduktion af anfaldsfrekvens og viste en klinisk fordel for så vidt angår sværhedsgrad, varighed og behov for akut anfaldsbehandling.
English: The solvent is a clear, colourless solution.
Danish: Solvensen er en gennemsigtig, farveløs opløsning.
English: Very common side effects (may affect more than 1 in 10 people): headache, nausea.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer): hovedpine, kvalme.
English: No maternal or embryofoetal effects of treatment were observed in reproductive studies in rats at dose levels up to 28-times the recommended human dose (1000 IU) based on an average adult body weight of 70 kg.
Danish: Der blev ikke observeret nogen maternelle eller embryoføtale virkninger af behandlingen i reproduktionsstudier med rotter ved dosisniveauer op til 28 gange den anbefalede humane dosis (1000 IE), baseret på en gennemsnitlig kropsvægt for en voksen på 70 kg.
English: Adverse reactions reported in clinical studies and in postmarketing reports
Danish: Bivirkninger rapporteret i kliniske studier og efter markedsføring
English: It is unknown whether C1 inhibitor is excreted in human milk.
Danish: Det er ukendt, om C1-inhibitor udskilles i human mælk.
English: Cinryze based on body weight (see section 5.1).
Danish: Cinryze baseret på legemsvægt (se pkt.
English: The maximum serum concentration (Cmax) and area under the serum concentration-time curve (AUC) appeared to increase from the single to double dose, although the increase was not dose-proportional.
Danish: Den maksimale serumkoncentration (Cmax) og arealet under serum-koncentration/tidskurven (AUC) forekom forhøjet fra den enkelte til den dobbelte dosis, selvom denne forhøjelse ikke var dosis-proportional.
English: The very common adverse reactions observed following Cinryze infusion in clinical studies were headache and nausea.
Danish: Meget almindelige bivirkninger observeret efter en infusion med Cinryze i kliniske studier var hovedpine og kvalme.
English: Side effects in children and adolescents are expected to be similar to those in adults.
Danish: Det forventes, at bivirkningerne hos børn og unge svarer til bivirkningerne hos voksne.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Cinryze.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Cinryze.
English: B - 1000 Brussels Belgium medinfoeuceemea@shire.com
Danish: Belgien medinfoeuceemea@shire.com
English: Treatment with Cinryze resulted in elevation of C4 levels at 12 hours.
Danish: Behandling med Cinryze resulterer i en forhøjelse af C4-niveauer efter 12 timer.
English: Among 84 separate laryngeal HAE attacks, none required intubation following treatment with Cinryze.
Danish: Blandt 84 separate laryngeale HAE-anfald krævede ingen intubering efter behandling med Cinryze.
English: Batch number and dose received
Danish: Batchnummer og indgivet dosis
English: The expected consequence of metabolism of a glycoprotein is via degradation to small peptides and individual amino acids.
Danish: Det forventede resultat af en glykoprotein-metabolisme er via nedbrydning til små peptider og enkelte aminosyrer.
English: If you have a low amount of C1 inhibitor in your blood or your C1 inhibitor is not working properly, this can lead to swelling attacks (called angioedema).
Danish: Hvis du har et lavt indhold af C1-inhibitor i blodet, eller C1-inhibitoren ikke virker korrekt, kan det medføre anfald med hævelse (kaldet angioødem).
English: For subjects with >1 attack, the proportion of attacks responding within 4 hours after Cinryze dosing and the time to response was comparable regardless of the number of attacks treated.
Danish: Hos forsøgspersoner med >1 anfald, var andelen af anfald, der responderede inden for 4 timer efter Cinryze-dosering og tiden til respons sammenlignelig, uanset antallet af behandlede anfald.
English: In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
Danish: I tilfælde af anafylaktiske reaktioner eller shock skal akut medicinsk behandling initieres
English: Further information to be collected includes data on drug exposure, adverse drug reactions, frequency of attacks, long-term safety data, use in pregnant patients with outcome of pregnancies, as well as use in the paediatric population.
Danish: Yderligere information, der skal indsamles, omfatter data om lægemiddeleksponering, bivirkninger, anfaldshyppighed, langtids-sikkerhedsdata, brug til gravide patienter herunder udfaldet af graviditeten, samt brug i den pædiatriske population.
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også for hidtil ukendte eller nyopståede vira og andre patogener.
English: 6 to 11 years:
Danish: 6 til 11 år:
English: Do not reuse the transfer device.
Danish: Overførselsanordningen må ikke genbruges.
English: Store in original package in order to protect from light.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys.
English: The decision on the use of home- treatment for an individual patient should be made by the treating physician, who should ensure that appropriate training is provided and the use reviewed at intervals.
Danish: Beslutningen om at anvende hjemmebehandling for den enkelte patient skal foretages af den behandlende læge, som skal sikre, at den passende oplæring gives, og anvendelsen gennemgås med mellemrum.
English: It is important to tell your doctor if you think you have ever had an allergic reaction to any of the ingredients in Cinryze.
Danish: Det er vigtigt at fortælle det til lægen, hvis du mener du tidligere har haft en overfølsomhedsreaktion over for nogle af indholdsstofferne i Cinryze.