FrancophonIA/ELRC3.0 huggingface dataset:
English: If a vaccine against hepatitis B has not been given at birth, Tritanrix HepB can be given as early as eight weeks of age.
Danish: Hvis der ikke er givet nogen vaccine mod hepatitis B ved fødslen, kan Tritanrix HepB gives allerede ved otte-ugers-alderen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB's benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tritanrix HepB er større end risiciene ved Tritanrix HepB ved aktiv immunisering mod difteri, stivkrampe, kighoste og hepatitis B hos spædbørn fra seks uger og opefter.
English: Tritanrix HepB contains small amounts of:
Danish: Tritanrix HepB indeholder små mængder
English: Tritanrix HepB should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Danish: Tritanrix HepB bør ikke anvendes til spædbørn, der kan være overfølsomme over for et eller flere af de aktive stoffer eller et eller flere af indholdsstofferne.
English: Tritanrix HepB is given by deep injection into a muscle, preferably the thigh.
Danish: Tritanrix HepB gives som en dyb injektion i en muskel, fortrinsvis i låret.
English: The full EPAR for Tritanrix HepB can be found here.
Danish: Den fuldstændige EPAR for Tritanrix HepB findes her.
English: Tritanrix HepB is a vaccine, which is available as a suspension for injection.
Danish: Tritanrix HepB er en vaccine, der fås som en suspension til injektion.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRITANRIX HEPB EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TRITANRIX HEPB
English: How has Tritanrix HepB been studied?
Danish: Hvordan blev Tritanrix HepB undersøgt?
English: What is the risk associated with Tritanrix HepB?
Danish: Hvilken risiko er der forbundet med Tritanrix HepB?
English: In areas where hepatitis B is common, vaccination against hepatitis B at birth should be continued as normal, with Tritanrix HepB started at six weeks of age.
Danish: I områder, hvor hepatitis B er almindeligt forekommende, bør der fortsat vaccineres mod hepatitis B ved fødslen, og vaccination med Tritanrix HepB kan
English: For the full list of all side effects reported with Tritanrix HepB, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Tritanrix HepB fremgår af indlægssedlen.
English: A booster dose is recommended before the end of the second year of life.
Danish: Det anbefales at give en boosterdosis (revaccination), inden barnet fylder to år.
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses contained in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når et spædbarn bliver vaccineret, opfatter immunsystemet delene fra bakterierne og viraene i vaccinen som fremmede og danner antistoffer mod dem. Immunsystemet vil efterfølgende være i stand til at danne antistoffer langt hurtigere, når personen på naturlig vis eksponeres for bakterierne eller viraene.
English: As for all vaccines, if Tritanrix HepB is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Danish: Ligesom for andre vacciner gælder det for Tritanrix HepB, at der er en risiko for apnø, dvs. korte pauser i vejrtrækningen, hvis vaccinen gives til spædbørn, der er født meget for tidligt.
English: Tritanrix HepB should be postponed in infants with a severe sudden fever, and it should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination
Danish: Den bør heller ikke anvendes til spædbørn, der har haft en overfølsomhedsreaktion, efter de har fået en vaccine mod difteri, stivkrampe, kighoste eller hepatitis B. Vaccination med Tritanrix HepB skal udskydes hos spædbørn med pludseligt opstået, alvorlig feber, og den bør ikke gives, hvis barnet har haft hjernelidelsen encefalopati af ukendte årsager inden for syv dage efter en tidligere vaccination med en vaccine, der indeholder en
English: Tritanrix HepB is used to vaccinate infants from six weeks of age against diphtheria, tetanus, pertussis The medicine can only be obtained with a prescription.
Danish: Tritanrix HepB anvendes til at vaccinere spædbørn fra seks-ugers-alderen mod difteri, stivkrampe,
English: What benefit has Tritanrix HepB shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tritanrix HepB?
English: The full EPAR and risk management plan summary for Imlygic 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 Imlygic findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Imlygic.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imlygic.
English: The second dose is given three weeks after the first dose and treatment is continued every two weeks for at least six months, unless the doctor considers that the patient is not benefiting from the medicine.
Danish: Den anden dosis gives tre uger efter den første dosis, og behandlingen fortsættes hver anden uge i mindst seks måneder, medmindre lægen finder, at patienten ikke har gavn af lægemidlet.
English: Response to treatment was defined as reduction by at least 50% in the signs of melanoma.
Danish: Virkning af behandlingen blev defineret som mindst 50 % reduktion i tegnene på melanom.
English: Imlygic talimogene laherparepvec
Danish: Imlygic talimogen laherparepvec
English: The company has put in place a controlled distribution programme to qualified centres to ensure that the cold storage and handling requirements are observed and to control the distribution to the patients.
Danish: Virksomheden har iværksat et program for kontrolleret distribution til kvalificerede centre for at sikre overholdelse af kravene til kold opbevaring og håndtering og til kontrol af fordelingen til patienterne.
English: Treatment with Imlygic should be started and given under the supervision of a doctor with expertise in the treatment of cancer.
Danish: Behandling med Imlygic bør påbegyndes og gives under opsyn af en læge med ekspertise i behandling af kræft.
English: Other information about Imlygic
Danish: Andre oplysninger om Imlygic
English: A risk management plan has been developed to ensure that Imlygic is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Imlygic anvendes så sikkert som muligt.
English: Most of these side effects were mild or moderate in severity.
Danish: Størstedelen af disse bivirkninger var lette eller moderate.
English: This is a type of medicine that works by delivering genes into the cells of the body.
Danish: Denne type lægemiddel virker ved at tilføre gener til kroppens celler.
English: Regarding safety, Imlygic was relatively well tolerated and most side effects were mild or moderate in severity.
Danish: Hvad sikkerheden angår, var Imlygic forholdsvis veltolereret, og de fleste bivirkninger var lette eller moderate.
English: It is derived from a weakened herpes simplex virus 1 (the cold sore virus).
Danish: Det er afledt af svækkede herpes simplex virus 1 (forkølelsessår-virus).
English: The first dose is given using the lower strength of Imlygic, but subsequent doses use the higher strength.
Danish: Den første dosis gives med den lave styrke af Imlygic, men til de efterfølgende doser anvendes den høje styrke.
English: It contains the active substance talimogene laherparepvec.
Danish: Det indeholder det aktive stof talimogen laherparepvec.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and for whom the response lasted for at least six months before the patients' health declined or they required another therapy.
Danish: Det vigtigste mål for virkningen var den andel af patienterne, der havde virkning af behandlingen, og hos hvem virkningen varede mindst seks måneder, før patienternes helbred blev forringet, eller de behøvede anden behandling.
English: When looking at the subset of patients in the study (249 patients) whose disease had not spread to the lung or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a sustained response to treatment, compared with around 1% (1 out of 86) of patients treated with GM-CSF.
Danish: For den undergruppe af patienterne i undersøgelsen (249 patienter), hvis sygdom ikke havde bredt sig til lungerne eller andre indre organer, havde 25 % (41 ud af 163) af de patienter, der blev behandlet med Imlygic, vedholdende virkning af behandlingen, sammenholdt med omkring 1 % (1 out of 86) af dem, der blev behandlet GM-CSF.
English: Thus, CHMP decided that Imlygic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP afgjorde derfor, at fordelene ved Imlygic overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin).
Danish: Den hyppigste alvorlige bivirkning (der omfatter omkring 2 ud af 100 personer) var infektion i de øvre hudlag (cellulitis).
English: This protein stimulates the patient's immune system (the body's natural defences) to recognise and destroy melanoma cells.
Danish: Dette protein stimulerer patientens naturlige forsvar (immunsystemet), så det genkender og ødelægger melanomcellerne.
English: What measures are being taken to ensure the safe and effective use of Imlygic?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imlygic?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) bemærkede, at Imlygic er et lægemiddel med en ny virkningsmekanisme, som kan være et værdifuldt supplement til eksisterende behandlinger for fremskredent inoperabelt melanom, som frembyder et uopfyldt medicinsk behov.
English: Because Imlygic contains a herpes virus, it may reactivate at a later time causing herpes infections such as cold sores.
Danish: Da Imlygic indeholder et herpesvirus, kan det genaktiveres på et senere tidspunkt og forårsage herpesinfektioner såsom forkølelsessår.
English: What is Imlygic and what is it used for?
Danish: Hvad er Imlygic, og hvad anvendes det til?
English: The company will also carry out three studies to further characterise the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.
Danish: Virksomheden skal desuden udføre tre undersøgelser til yderligere karakterisering af fordelene og risiciene ved Imlygic, herunder en undersøgelse af Imlygic hos patienter med fremskredent melanom, som kan fjernes ved operation.
English: The study, which lasted 24 months, compared Imlygic with GM-CSF injected under the skin.
Danish: I denne undersøgelse, der varede 24 måneder, blev Imlygic sammenlignet med GM-CSF indsprøjtet under huden.
English: As part of this programme, the medicine will only be supplied to doctors who have received appropriate educational materials on the risk of herpes infection, particularly in patients with an impaired immune system, on the risk of transmission of the virus to healthcare professionals or other close contacts of the patient (accidental exposure), and on the necessary precautions to be taken when administering and disposing of the product.
Danish: Som led i dette program vil lægemidlet kun blive udleveret til læger, som har modtaget passende oplysningsmateriale om risikoen for herpesinfektion, navnlig hos patienter med nedsat immunforsvar, og risikoen for overførsel af virusset til sundhedspersoner eller andre med tæt kontakt til patienten (accidentel eksponering), og om de forholdsregler, der skal træffes ved indgift og bortskaffelse af produktet.
English: In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF.
Danish: Imlygic bevirker desuden, at de inficerede melanomcellerne producerer proteinet GM-CSF.
English: It is not intended to provide practical advice on how to use Imlygic.
Danish: Det er ikke en praktisk vejledning i, hvordan Imlygic bør anvendes.
English: Why is Imlygic approved?
Danish: Hvorfor er Imlygic blevet godkendt?
English: The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called ‘oncolytic virus'.
Danish: Det aktive stof i Imlygic, talimogen laherparepvec, er genterapi af typen "onkolytisk virus".
English: Imlygic is a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Imlygic er et lægemiddel til avanceret terapi, som kaldes et "genterapiprodukt".
English: This virus has been modified so it can infect and multiply inside melanoma cells.
Danish: Virusset er ændret, så det kan inficere og formere sig i melanomceller.
English: What are the risks associated with Imlygic?
Danish: Hvilke risici er der forbundet med Imlygic?
English: Patients will also be provided with educational materials and a patient alert card informing on the risks with the medicine and how to avoid accidental exposure to Imlygic.
Danish: Patienterne vil desuden få udleveret oplysningsmateriale og et patientkort, der informerer om risiciene ved lægemidlet, og om, hvordan de skal undgå utilsigtet udsættelse for Imlygic.
English: Imlygic must not be used in patients with a severely impaired immune system because if the virus gets reactivated, the herpes infection could spread to other parts of the body.
Danish: Imlygic må ikke anvendes hos patienter med stærkt svækket immunsystem, da reaktivering af virus kan medføre, at herpesinfektionen breder sig til andre dele af kroppen.
English: For more information about treatment with Imlygic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imlygic, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea (feeling sick), flu-like illness and pain at the injection site.
Danish: De hyppigste bivirkninger ved Imlygic (som kan forekomme hos over til 1 ud af 4 behandlede) er træthed, kulderystelser, feber, kvalme, influenzalignende sygdom og smerter på injektionsstedet.
English: Patients with inoperable melanoma which had spread to other parts of the body (but not to bone, brain or lung) showed a prolonged reduction in their melanoma tumours when treated with Imlygic, although it is still not known whether this will translate into longer survival.
Danish: Patienter med melanom, der havde bredt sig til andre dele af kroppen (man ikke til knoglerne, hjernen eller lungerne) udviste langvarig reduktion i deres melanomsvulster ved behandling med Imlygic, skønt det endnu ikke vides, om dette vil medføre længere overlevelse.
English: Imlygic is available as a solution for injection in two different strengths.
Danish: Imlygic fås som injektionsvæske i to forskellige styrker.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imlygic, 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 Imlygic, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: In patients whose immune system is weak (e.g. patients with HIV), Imlygic may cause more widespread disease.
Danish: Hos patienter med svækket immunsystem (fx patienter med hiv) kan Imlygic medføre mere udbredt sygdom.
English: Imlygic has been studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (but not to bone and brain).
Danish: Imlygic er undersøgt i én hovedundersøgelse med 436 patienter med melanom, der ikke kunne opereres og havde bredt sig til andre dele af kroppen (men ikke til knoglerne eller hjernen).
English: It is given as an injection into melanoma tumours.
Danish: Det gives ved indsprøjtning i melanomsvulster.
English: For the full list of all side effects and restrictions reported with Imlygic, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Imlygic fremgår af indlægssedlen.
English: For practical information about using Imlygic, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Imlygic, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Imlygic used?
Danish: Hvordan anvendes Imlygic?
English: Imlygic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that cannot be surgically removed and that has spread to other parts of the body (but not to bone, lung, brain and other internal organs).
Danish: Imlygic er et lægemiddel til behandling af voksne med hudkræft af typen melanom, der har bredt sig til andre dele af kroppen (men ikke til knogler, lunger, hjerne eller andre indre organer) og ikke kan fjernes ved operation.
English: The volume to be injected depends on the size of the tumour and the number of tumours to be injected.
Danish: Det volumen, der skal indsprøjtes, afhænger af svulstens størrelse, og hvor mange svulster, der skal indsprøjtes i. Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: Imlygic uses the melanoma cells' own machinery to multiply, eventually overwhelming melanoma cells and killing them.
Danish: Imlygic anvender melanomcellernes eget system til at formere sig, så det til sidst overvinder melanomcellerne og dræber dem. Imlygic kan indtræde i raske celler, men er ikke beregnet til at formere sig i dem.
English: What benefits of Imlygic have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Imlygic?
English: How does Imlygic work?
Danish: Hvordan virker Imlygic?
English: This information is presented below.
Danish: Disse oplysninger vises nedenfor.
English: 06 May 2019
Danish: 06. maj 2019
English: Ελλάδα Teva Ελλάς Α.Ε.
Danish: Teva Ελλάς Α.Ε.
English: This means that other chemicals that can cause side effects that can be life threatening are not needed.
Danish: Dette betyder, at andre kemikalier, der kan forårsage bivirkninger, som kan være livstruende, ikke er nødvendige.
English: There were no differences in terminal half-lives.
Danish: Der var ingen forskelle i terminal halveringstid.
English: Based on findings in animals, male and female fertility may be compromised.
Danish: Baseret på resultater fra dyr kan fertiliteten hos mænd og kvinder blive kompromitteret.
English: The dose you receive is based on your body surface area and blood test results.
Danish: Den dosis, du får, er baseret på din legemsoverflade og resultaterne af blodprøverne.
English: Neither freezing nor refrigeration adversely affects the stability of the product.
Danish: Hverken frost eller nedkøling påvirker præparatets stabilitet negativt.
English: How often will you receive Pazenir?
Danish: Hvor tit skal jeg have Pazenir?
English: Some people may feel tired or dizzy after being given Pazenir.
Danish: Nogle personer kan føle sig trætte eller svimle, efter de har fået Pazenir.
English: Post-marketing experience
Danish: Postmarketing-erfaringer
English: In the event of an overdose, the patient should be closely monitored.
Danish: I tilfælde af en overdosering skal patienten overvåges nøje.
English: a P-value is based on a chi-square test.
Danish: a P-værdien er baseret på en chi2-test.
English: 2 Year
Danish: 2 år
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis præparatet ikke bruges med det samme, er opbevaringstider og opbevaringsforhold er på brugerens ansvar.
English: Over 99% of patients had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Danish: Over 99% af patienterne havde en ECOG- (Eastern Cooperative Oncology Group) performancestatus på 0 eller 1.
English: Gemcitabine (N=430)
Danish: Gemcitabin (N=430)
English: Ask your doctor for advice before taking this medicine.
Danish: Spørg din læge til råds, før du bruger dette lægemiddel.
English: Reconstitution of 100 mg:
Danish: Rekonstitution af 100 mg:
English: Patients should be advised not to drive and use machines if they feel tired or dizzy.
Danish: Patienter bør frarådes at føre eller betjene maskiner, hvis de føler sig trætte eller svimle.
English: The powder is white to yellow.
Danish: Pulveret er hvidt til gult.
English: Patients were treated without steroid pre-treatment or planned G-CSF support.
Danish: Patienterne blev behandlet uden præmedicinering med steroider eller planlagt G-CSF støtte.
English: Treat with same dose
Danish: Behandl med same dosis
English: 1The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
Danish: 1 Hyppigheden af overfølsomhedsreaktioner er udregnet ud fra ét sikkert relateret tilfælde i en population på 789 patienter.
English: • if you have heart problems.
Danish: • hvis du har problemer med hjertet.
English: Your doctor or pharmacist is responsible for disposing of any unused Pazenir correctly.
Danish: Din læge eller apotekspersonalet har ansvaret for at bortskaffe al ubrugt Pazenirpå korrekt vis.
English: The reconstituted dispersion should be milky and homogenous without visible precipitates.
Danish: Den rekonstituerede dispersion skal være mælkeagtig og homogen uden synligt bundfald.
English: Alternative light-protection may be used in the clean room.
Danish: Der kan anvendes alternativ lysbeskyttelse i renrummet.
English: When it happens, hair loss is pronounced (over 50%) in the majority of patients)
Danish: Når hårtab forekommer, er det omfattende (over 50%) hos de fleste patienter)
English: Febrile Neutropenia:
Danish: Febril neutropeni:
English: CNS metastases are generally not well controlled by systemic chemotherapy.
Danish: CNS-metastaser er generelt ikke velkontrollerede med systemisk kemoterapi.
English: If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.
Danish: Hvis du får andre lægemidler som en del af din behandling, skal du spørge din læge til råds vedrørende kørsel og betjening af maskiner.
English: Pazenir is used to treat the following types of cancer:
Danish: Pazenir anvendes til behandling af de følgende kræfttyper:
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).
Danish: Hyppighederne er defineret som: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), sjældne (≥ 1/10.000 til < 1/1.000), meget sjældne (< 1/10.000).
English: Randomised comparative study
Danish: Randomiseret, sammenligningsstudie
English: 1 Year
Danish: 1 år
English: Treat with same doses as patients with normal hepatic function.
Danish: De behandles med samme doser som patienter med normal leverfunktion.
English: Death or progression, n (%)
Danish: Død eller progression, n (%)
English: • Breast cancer which has spread to other parts of the body (this is called “metastatic” breast cancer).
Danish: • Brystkræft, som har spredt sig til andre dele af kroppen (dette kaldes ”metastatisk” brystkræft).