FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH's argument that the literature on the originator product is relevant for their product on the basis of the submitted pharmaceutical data is not considered scientifically valid by CHMP.
Danish: CHMP finder ikke videnskabeligt holdepunkt for markedsføringstilladelsesindehaverens argumentation om, at litteraturen om det oprindelige lægemiddel er relevant for det ansøgte lægemiddel på grundlag af de forelagte farmaceutiske data.
English: Based on the pharmacokinetic study results used to bridge Loraxin to the published literature, there is a potential for difference in exposure after Loraxin administration as compared to the product Clarityn, and the MAH has not adequately justified why this potential difference in exposure is unlikely to have a clinically significant difference in efficacy or safety.
Danish: Resultaterne af den farmakokinetiske undersøgelse, der er anvendt til at forbinde Loraxin med den offentliggjorte faglitteratur, giver mulighed for en potentiel forskel i eksponering efter administration af henholdsvis Loraxin og Clarityn.
English: On the basis of the bibliographic data submitted, taken together with the pharmaceutical, pharmacokinetic and clinical documentation, the MAH failed to establish the relevance of these data to demonstrate safety and efficacy of Loraxin.
Danish: Indehaveren af markedsføringstilladelsen har ikke godtgjort relevansen af den forelagte bibliografiske oversigt kombineret med den farmaceutiske, farmakokinetiske og kliniske dokumentation med henblik på at påvise sikkerheden og virkningen af Loraxin.
English: Whereas
Danish: Sver
English: Although the 90% confidence interval of the AUCt (0.884-1.035) and Cmax (0.822-0.989) of the metabolite desloratadine were within the acceptance interval, the CHMP considered that the pharmacokinetic data did not support the submitted bibliographic data since the evaluation of bioequivalence should in principle be based upon measured concentrations of the parent compound (in this case loratadine and not desloratadine).
Danish: For metabolitten desloratadin var 90-%-sikkerhedsintervallet for AUCt ([0,884-1,035]) og Cmax ([0,822-0,989]) inden for acceptintervallet.
English: As it could not be established whether a potentially lower or higher exposure to loratidine compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature would constitute any efficacy or safety concerns, the CHMP therefore maintained its concern that this is a potential serious risk to public health.
Danish: Det kunne ikke fastslås, om der var anledning til betænkelighed vedrørende sikkerhed eller virkning på grund af potentielt lavere eller højere eksponering for loratadin i forhold til eksponeringen fra det lægemiddel, der blev anvendt i de kliniske hovedundersøgelser, der er beskrevet i den forelagte bibliografiske oversigt.
English: The median age was 64 years.
Danish: Gennemsnitsalderen var 64 år.
English: ● if you are pregnant.
Danish: ● hvis du er gravid.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes øjeblikkeligt.
English: These results have been confirmed through an independent radiological review.
Danish: Disse resultater er blevet bekræftet ved en uafhængig radiologisk gennemgang.
English: In addition, an independent review of the primary endpoint was also conducted.
Danish: En uafhængig gennemgang af det primære endepunkt blev også udført.
English: System organ class (SOC)
Danish: Systemorganklasse (SOC)
English: You will be treated with Zirabev once every 2 or 3 weeks.
Danish: Du vil blive behandlet med Zirabev én gang hver 2. eller 3. uge.
English: * if specified, the frequency has been derived from clinical trial data
Danish: * Hvis frekvens angives, er den udledt af data fra kliniske studier
English: There were no complete responses and 2 partial responses (MacDonald criteria).
Danish: Der var ingen komplette respons og 2 delvise respons (Macdonald-kriterier).
English: A total of 452 patients were randomised to receive either:
Danish: I alt blev 452 patienter randomiseret til at få enten:
English: * primary analysis
Danish: * primær analyse
English: ● Your doctor should record the brand name and batch number of your medication.
Danish: ● Din læge skal angive handelsnavnet og batchnummeret på din medicin.
English: This does not necessarily mean that these side effects were strictly caused by bevacizumab.
Danish: Det betyder ikke at disse bivirkninger nødvendigvis kun skyldes bevacizumab.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden ogbetingelserne under brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C - 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: a patients with measurable disease at baseline
Danish: a patienter med målbar sygdom ved baseline
English: *Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Danish: *Samlet overlevelsesanalyse ved klinisk cut-off 31. januar 2007 ** Primær analyse ved klinisk cut-off 31. januar 2006 I forhold til kontrolarmen
English: Objective response rate (ORR) Patients included in analysis Rate
Danish: Objektiv responsrate (ORR) Patienter inkluderet i analysen Rate
English: When Zirabev is injected directly into the eye (unapproved use), the following side effects may occur:
Danish: Hvis Zirabev injiceres direkte i øjet (ikke-godkendt brug), kan følgende bivirkninger forekomme:
English: ● you may develop a severe migraine.
Danish: ● Du kan få svær migræne.
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Danish: Hvis du skal opereres, hvis du har fået foretaget en større operation indenfor de sidste 28 dage, eller hvis du har et sår efter en operation, som ikke er helet, må du ikke få denne medicin.
English: Observed in pediatric population only
Danish: Kun observeret i den pædiatriske population
English: These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Danish: Disse klinisk signifikante bivirkninger er derfor inkluderet i Tabel 2 under kolonnen ”Frekvens ikke kendt”.
English: Bevacizumab vs. No Bevacizumab
Danish: Bevacizumab vs. ingen Bevacizumab
English: The adverse reactions listed in this section fall into the following frequency categories: 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); not known (cannot be estimated from the available data).
Danish: Bivirkninger, som er opsummeret i dette afsnit, er delt ind i følgende frekvenskategorier: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Danish: Termerne repræsenterer grupperede bivirkninger, der beskriver et medicinsk koncept frem for en enkelttilstand eller den foretrukne term i MedDRA (Medical Dictionary for Regulatory Activities).
English: Prior hormonal therapy for the treatment of metastatic disease was allowed.
Danish: Tidligere hormonbehandling af metastatisk sygdom var tilladt.
English: Table 6 Treatment regimens in trial NO16966 (mCRC)
Danish: Tabel 6 Behandlingsregimer i studie NO16966 (mCRC)
English: Elderly patients No dose adjustment is required in the elderly.
Danish: Ældre patienter: Dosisjustering er ikke nødvendig hos ældre.
English: Zirabev may also cause changes in laboratory tests carried out by your doctor.
Danish: Zirabev kan også forårsage ændringer i de laboratorieundersøgelser, som din læge foretager.
English: intravenous bolus injection immediately after leucovorin
Danish: intravenøs bolusinjektion umiddelbart efter leucovorin
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Danish: Alvorlige bivirkninger med ikke kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data) omfatter:
English: ● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Danish: ● hvis du får svært forhøjet blodtryk, der kræver behandling med blodtryksmedicin,
English: Common Uncommon Rare Very rare Frequency not known
Danish: Almindelig Ikke almindelig Sjælden Meget sjælden Frekvens ikke kendt
English: Zirabev may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Danish: Zirabev kan skade det ufødte barn, da det kan standse dannelsen af nye blodkar.
English: Low albumin and high tumour burden are generally indicative of disease severity.
Danish: Generelt er lavt albumin og høj tumorbyrde indikativ for sygdommens sværhedsgrad.
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Danish: Den samlede gennemsnitsalder var 59,4 år, 56,6 % af patienterne havde en ECOG-performancestatus på 0, 43 % havde en status på 1 og 0,4 % havde en status på 2.
English: ● if you undergo surgery.
Danish: ● hvis du skal opereres.
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Zirabev treatment.
Danish: Hvis du har forhøjet blodtryk, som ikke er velbehandlet med blodtrykssænkende medicin, skal du kontakte din læge, fordi det er vigtigt at sikre, at dit blodtryk er under kontrol, før du starter i behandling med Zirabev.
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
Danish: Som forud planlagt blev inklusionen i arm 3 standset, så snart sikkerheden af bevacizumab med IFL-regimet var dokumenteret og blev anset for acceptabel.
English: ● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Danish: ● Denne medicin kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier).
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab treatment.
Danish: ● En sjælden neurologisk bivirkning kaldet posteriort reversibelt encefalopati- syndrom (PRES) har været knyttet til bevacizumabbehandling.
English: ● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Danish: ● Risikoen for at udvikle blodpropper i arterierne (en type blodkar) kan øges, hvis du er over 65 år, hvis du har sukkersyge, eller hvis du tidligere har haft blodpropper i arterierne.
English: Zirabev is for single-use only, as the product contains no preservatives.
Danish: Zirabev er udelukkende til engangsbrug, da produktet ikke indeholder konserveringsmidler.
English: In all clinical trials, bevacizumab was administered as an intravenous infusion.
Danish: I alle kliniske studier blev bevacizumab administreret som en intravenøs infusion.
English: Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Danish: Fortæl straks din læge, hvis du er gravid, bliver gravid under behandling med denne medicin eller har planer om at blive gravid.
English: You should discuss this with your doctor.
Danish: Du bør tale med din læge om det.
English: Before you are given Zirabev or while you are being treated with Zirabev:
Danish: Før du får Zirabev, eller imens du bliver behandlet med Zirabev:
English: Best overall response - Primary analysis
Danish: Bedste samlede respons - primær analyse
English: Caution should be taken when treating these patients with Zirabev.
Danish: Der skal iagttages forsigtighed, når disse patienter behandles med Zirabev.
English: ● your doctor will decide when you should be given your next dose of Zirabev.
Danish: ● Din læge beslutter, hvornår du skal have den næste dosis Zirabev.
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Danish: Patienter med nylig pulmonal blødning/hæmoptyse (> 2,5 ml rødt blod) bør ikke behandles med Zirabev.
English: Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Danish: Fremstiller Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Danish: Blandt de 110 patienter randomiseret til arm 3 (5-FU/FA + bevacizumab) inden lukning af denne arm, var den mediane samlede overlevelse 18,3 måneder og den mediane progressionsfri overlevelse var 8,8 måneder.
English: Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Danish: Nasal septumperforation (ikke kendt) Pulmonal hypertension (ikke kendt) Dysfoni (almindelig)
English: Caution should be exercised when Zirabev and intravenous bisphosphonates are administered simultaneously or sequentially.
Danish: Der bør udvises forsigtighed, når Zirabev og intravenøse bisfosfonater administreres samtidigt eller sekventielt.
English: Do not stop treatment with Zirabev unless you have discussed this with your doctor.
Danish: Stop ikke behandlingen med Zirabev før, du har diskuteret det med din læge.
English: Assessment of bevacizumab metabolism in rabbits following a single intravenous dose of
Danish: Vurdering af bevacizumabs metabolisme hos kaniner efter en intravenøs enkeltdosis af
English: The dose of Zirabev needed depends on your body weight and the kind of cancer to be treated.
Danish: Dosis af Zirabev afhænger af din legemsvægt og af den type kræft, der skal behandles.
English: ● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
Danish: ● svært forhøjet blodtryk, som ikke kan kontrolleres med blodtrykssænkende medicin, eller hvis blodtrykket pludseligt stiger alvorligt,
English: ● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Danish: ● Denne medicin kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk.
English: Before initiating Zirabev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med Zirabev bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: Zirabev contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Danish: Zirabev indeholder det aktive stof bevacizumab, som er et humaniseret monoklonalt antistof (et slags protein, som normalt laves af immunsystemet, og som hjælper med at beskytte kroppen mod infektioner og kræft).
English: ● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Zirabev, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Danish: ● hvis du behøver invasiv tandbehandling (fx tandudtrækning) eller en tandoperation, skal du fortælle din tandlæge, at du er i behandling med Zirabev, især hvis du også bliver eller er blevet behandlet med bisfosfonater, som injektion i blodet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
Danish: EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
Danish: Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse Followup-analyse blev udført ved data cut-off 7. marts 2014; alle p-værdier er kun vist for oplysende formål
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Danish: *Bevacizumab er et rekombinant humaniseret monoklonalt antistof, som fremstilles ved dna-teknologi i ovarieceller fra kinesiske hamstere.
English: Your doctor will prescribe a dose of Zirabev that is right for you.
Danish: Din læge vil ordinere den dosis Zirabev, som passer til dig.
English: ● This medicine may cause bleeding, especially tumour-related bleeding.
Danish: ● Denne medicin kan forårsage blødning, især tumor-relateret blødning.
English: Zirabev infusions should not be administered or mixed with glucose solutions.
Danish: Infusionsvæsker med Zirabev bør ikke administreres eller blandes med glucoseopløsninger.
English: Zirabev use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Danish: Det frarådes at anvende Zirabev til børn og unge under 18 år, da sikkerheden og fordelene ved Zirabev ikke er fastlagt hos denne patientgruppe.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab treated patients.
Danish: Der blev rapporteret dødelig udgang i ca. en tredjedel af de alvorlige tilfælde af gastrointestinal perforation, hvilket svarer til 0,2-1 % af alle bevacizumabbehandlede patienter.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Zirabev:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Zirabev:
English: bevacizumab was combined with two chemotherapy regimens:
Danish: Bevacizumab blev kombineret med to kemoterapiregimer:
English: Sodium hydroxide (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til justering af pH-værdien) Vand til injektionsvæsker
English: Patients were treated until disease progression.
Danish: Patienterne blev behandlet indtil sygdomsprogression.
English: Difference in response rates
Danish: Forskel i responsrater
English: Fistulae have also been reported in post-marketing experience.
Danish: Fistler er også rapporteret efter markedsføring.
English: In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Danish: I de fleste af de kliniske studier med bevacizumab blev patienter med præ-eksisterende CHF af NYHA (New York Heart Association) klasse II-IV ekskluderet, og derfor findes der ingen data for risikoen for CHF i denne population.
English: No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Zirabev og polyvinylchlorid- eller polyolefinposer.
English: There is evidence suggesting that all Grade (US National Cancer Institute- Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Danish: Der er evidens for, at alle grader af proteinuri (US National Cancer Institute-Common Terminology Criteria for Adverse Event [NCI-CTCAE v.3]) kan være relateret til dosis.
English: Name and address of the manufacturer of the biological active substance Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
Danish: Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
English: Zirabev should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Danish: Zirabev skal seponeres permanent, hvis en klinisk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med standard antihypertensionsbehandling, eller hvis patienten udvikler hypertensiv krise eller hypertensiv encefalopati.
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
Danish: Resultaterne for den primære analyse og followup-analysen er præsenteret for bevacizumabbehandling og forsøgsbehandling i henholdsvis tabel 14 og 15.
English: ● Zirabev can increase the risk of developing a weak heart.
Danish: ● Zirabev kan øge risikoen for at udvikle et svagt hjerte.
English: ● any severe bleeding.
Danish: ● svær blødning.
English: The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in Table 4.
Danish: Virkningsresultaterne af bevacizumab i kombination med IFL-kemoterapi fremgår af tabel 4.
English: Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of bevacizumab and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Danish: Dosisreduktion af IFN alfa-2a syntes ikke at påvirke effekten af kombinationen af bevacizumab og IFN alfa-2a, baseret på antal hændelser i tidsrummet for progressionsfri overlevelse, som er vist ved en undergruppeanalyse.
English: In the bevacizumab-containing arms, patients could receive bevacizumab as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
Danish: I bevacizumab-armen kunne patienter få bevacizumab som enkeltstofbehandling hver 3. uge indtil sygdomsprogression eller indtil uacceptabel toksicitet.
English: A high proportion of patients (approximately 62%) went on to receive a variety of nonprotocol specified anti- cancer therapies, which may have impacted the analysis of overall survival.
Danish: En stor del af patienterne (omkring 62 %) fik derefter forskellige anticancerbehandlinger uden for protokollen, hvilket kan have haft indflydelse på den samlede overlevelse.
English: Depending on the dose prescribed for you, some or all of the contents of the Zirabev vial will be diluted with sodium chloride solution before use.
Danish: Afhængig af den dosis, som er foreskrevet til dig, vil en del af indholdet i hætteglasset med Zirabev eller hele indholdet blive fortyndet med natriumchloridopløsning (saltvandsopløsning) før anvendelsen.
English: Your doctor should advise you about using contraception during treatment with Zirabev and for at least 6 months after the last dose of Zirabev.
Danish: Din læge bør vejlede dig om anvendelsen af prævention under behandlingen med Zirabev og i mindst 6 måneder efter sidste dosis Zirabev.
English: ● It is possible that Zirabev may cause bleeding in and around your brain.
Danish: ● Det er muligt, at Zirabev kan forårsage blødning i og omkring hjernen.
English: ● if you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Danish: ● hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer (angivet i afsnit 6).