natgillin/translations-raw huggingface dataset:
• at eculizumab kan være teratogent og behovet for sikker antikonception til kvinder i den fertile alder under behandlingen og i fem måneder efter behandlingen og at amning bør undlades under behandling og i fem måneder efter behandling
• That eculizumab may be teratogenic and the need for effective contraception in women of childbearing potential during and up to five months after treatment, and that breast-feeding should be discontinued during and up to five months after treatment.
• risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og behovet for klinisk post-infusion monitorering
• The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion
Behovet for sikker antikonception til kvinder i den fertile alder under behandlingen og i fem måneder efter behandlingen.
The need for effective contraception in women of childbearing potential during and up to five months after treatment.
• meddelelse om at patienten er i behandling med eculizumab
• Statement that the patient is receiving eculizumab
• kravet om at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab
• The requirement to vaccinate children against pneumococcus and haemophilus before eculizumab treatment
• behovet for at børn vaccineres mod pneumokokinfektioner og Haemophilus influenzae før behandling med eculizumab
• The need for children to be vaccinated against pneumococcus and haemophilus before eculizumab treatment
• risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati efter seponering og udsættelse af administration af eculizumab, tegn, symptomer, monitorering og håndtering (kun aHUS)
• Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only)
• Produktresumé
• Summary of product characteristics
• risikoen for svær hæmolyse efter seponering og udsættelse af administration af eculizumab, kriterier forbundet hermed, den påkrævede post-behandlings monitorering og den foreslåede håndtering heraf (kun PNH)
• Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only)
• risikoen for svær hæmolyse (i PNH) efter seponering/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før seponering/udsættelse af administration af eculizumab
• Risk of severe haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
• risikoen for alvorlige komplikationer som følge af trombotisk mikroangiopati (i aHUS) efter seponering/udsættelse af administration af eculizumab, tegn og symptomer forbundet hermed og anbefaling om at konsultere den ordinerende læge før seponering/udsættelse af administration af eculizumab
• Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Det skulle have været leveret som tabletter (15, 30 og 45 mg).
It was to be available as tablets (15, 30 and 45 mg).
Det skulle have været anvendt sammen med diæt og motion.
It was to be used in addition to diet and exercise.
Brevet om tilbagetrækningen findes her.
The withdrawal letter is available here.
Derved reduceres mængden af blodglukose, og dette medvirker til at regulere type 2-diabetes.
As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Det aktive stof i Pioglitazone ratiopharm, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
The active substance in Pioglitazone ratiopharm, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Det betyder, at Pioglitazone ratiopharm er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Actos.
This means that Pioglitazone ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
CHMP konkluderede, at det i overensstemmelse med EU's krav var blevet påvist, at Pioglitazone ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Actos.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm had been shown to have comparable quality and to be bioequivalent to Actos.
Pioglitazone ratiopharm skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige.
Pioglitazone ratiopharm was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Den 3. februar 2012 meddelte ratiopharm GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone ratiopharm til behandling af type 2-diabetes tilbage.
On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm, for the treatment of type 2 diabetes.
På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone ratiopharm til behandling af type 2-diabetes.
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm for the treatment of type 2 diabetes.
Pioglitazone ratiopharm blev udviklet som et ‘generisk lægemiddel'.
Pioglitazone ratiopharm was developed as a ‘generic medicine'.
Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke danner tilstrækkeligt insulin til at regulere blodets koncentration af glukose, eller hvor kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Pioglitazone ratiopharm er et lægemiddel, der indeholder det aktive stof pioglitazon.
Pioglitazone ratiopharm is a medicine that contains the active substance pioglitazone.
Da Pioglitazone ratiopharm er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
Because Pioglitazone ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Hvad er Pioglitazone ratiopharm?
What is Pioglitazone ratiopharm?
Pioglitazone ratiopharm skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
Pioglitazone ratiopharm was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Hvad forventedes Pioglitazone ratiopharm anvendt til?
What was Pioglitazone ratiopharm expected to be used for?
Pioglitazone ratiopharm skulle have været anvendt alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
Pioglitazone ratiopharm was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Pioglitazone ratiopharm skulle også have været anvendt i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), når metformin ikke er egnet (‘tostofsbehandling').
Pioglitazone ratiopharm was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Pioglitazone ratiopharm skulle desuden have været anvendt sammen med både metformin og et sulfonylurinstof til patienter, som ikke er tilfredsstillende reguleret trods tostofsbehandling med orale lægemidler (‘trestofsbehandling').
Pioglitazone ratiopharm was also to be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Hvordan forventedes Pioglitazone ratiopharm at virke?
How is Pioglitazone ratiopharm expected to work?
Undersøgelsen varede op til 18 måneder.
The study lasted for up to 18 months.
Resultaterne blev bekræftet i den anden undersøgelse, som omfattede børn i alderen mellem seks måneder og tre og et halvt år.
The results were confirmed in the other study, which involved children aged between six months and three and a half years.
I modsætning hertil var der kun en af de 42 patienter i den historiske sammenligningsgruppe, som var i live ved 18-månedersalderen.
In contrast, only one of the 42 patients in the historical comparison group was alive at 18 months of age.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Myozyme.
This is a summary of the European public assessment report (EPAR) for Myozyme.
Disse antistoffers effekt på Myozymes sikkerhed og virkning er endnu ikke klarlagt.
The effect of these antibodies on the safety and effectiveness of Myozyme is not yet clear.
Startinfusionen skal være langsom, derefter øges hastigheden gradvist, så længe der ikke er tegn på bivirkninger forårsaget af infusionen.
The infusion should start slowly and then be gradually sped up as long as there are no signs of side effects caused by the infusion.
Myozyme gives som en infusion i form af 20 mg pr. kg kropsvægt én gang hver anden uge.
Myozyme is given as an infusion of 20 mg per kilogram body weight given once every two weeks.
Sygdommen kan vise sig ved fødslen (med ”debut i spædbørnsalderen”), men kan også vise sig senere i livet (i en ”sent debuterende” form).
The disease can appear at birth (the ‘infantile-onset' form) but also later in life (the ‘late-onset' form).
Disse patienter blev sammenlignet med en ”historisk sammenligningsgruppe” af spædbørn og små børn med Pompes sygdom, som ikke havde modtaget behandling og ikke deltog i undersøgelserne.
These patients were compared with a ‘historical comparison group' of babies and young children with Pompe disease who had not received treatment and did not take part in the studies.
Det primære effektmål var forbedringen i den afstand, patienterne kunne gå på seks minutter, og forbedringen i deres ”forcerede vitalkapacitet” (et mål for, hvor godt deres lunger fungerede).
The main measures of effectiveness were the improvement in the distance the patients could walk in six minutes and in their ‘forced vital capacity' (a measure of how well their lungs were working).
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Myozyme.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myozyme.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Myozyme til Genzyme Europe B.V.
The European Commission granted a marketing authorisation valid throughout the European Union for Myozyme to Genzyme Europe B.V. on 29 March 2006.
I den første hovedundersøgelse, som omfattede spædbørn under seks måneder, var alle 18 patienter behandlet med Myozyme i live ved 18-månedersalderen, og 15 af disse havde ikke behov for en ventilator som hjælp til vejrtrækning.
In the first main study, which involved babies less than six months old, all 18 patients treated with Myozyme were alive at 18 months of age, and 15 of these did not need a ventilator to help them breathe.
Næsten alle bivirkningerne ved Myozyme optrådte under eller lige efter infusionen og var milde til moderate.
Almost all of the side effects seen with Myozyme occurred during or just after the infusion and were mild or moderate.
Hvis du ønsker yderligere oplysninger om behandling med Myozyme, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Myozyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det primære effektmål var antallet af patienter, som overlevede, og antallet, som ikke havde behov for en ventilator som hjælp til vejrtrækning.
The main measures of effectiveness were the number of patients who survived and the number who did not need a ventilator to help them breathe.
Da antallet af patienter med Pompes sygdom er lavt, anses sygdommen for at være ”sjælden”, og Myozyme blev udpeget som ”lægemiddel til sjældne sygdomme” den 14. februar 2001.
Because the number of patients with Pompe disease is low, the disease is considered ‘rare', and Myozyme was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 14 February
Det aktive stof i Myozyme, alglucosidase alfa, er en kopi af humant alpha-glucosidase, som fremstilles via en metode, der er kendt som ”rekombinant dna-teknologi”: Enzymet er fremstillet af en celle, som har modtaget et gen (dna), som sætter cellen i stand til at producere enzymet.
The active substance in Myozyme, alglucosidase alfa, is a copy of human alpha-glucosidase, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA) that makes it able to produce the enzyme.
CHMP besluttede, at fordelene ved Myozyme er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Myozyme.
The CHMP decided that Myozyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette enzym nedbryder normalt sukker, der er aflejret som glykogen, til glukose, der kan anvendes til energi af kroppens celler.
This enzyme normally breaks down sugar stored as glycogen into glucose that can be used for energy by the body's cells.
Det indeholder det aktive stof alglucosidase alfa.
It contains the active substance alglucosidase alfa.
Den fuldstændige EPAR for Myozyme findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Patienter, som får Myozyme, kan udvikle antistoffer (proteiner, der dannes som reaktion mod Myozyme).
Patients who receive Myozyme may develop antibodies (proteins that are produced in response to Myozyme).
Virksomheden, der fremstiller Myozyme, er ved at indføre en plan, som skal sikre, at Myozyme anvendes sikkert, navnlig ved at overvåge, hvordan patienter, som modtager Myozyme, kan udvikle antistoffer, og føre et register over alle patienter med Pompes sygdom og ved at påse, at læger har kendskab til de reaktioner, patienter kan få ved infusion.
The company that makes Myozyme is putting a plan in place to ensure that Myozyme is used safely, mainly by monitoring how patients who receive Myozyme develop antibodies, by setting up a register open to all patients with Pompe disease, and by ensuring that doctors know about the reactions that patients may have to the infusion.
Myozyme er en enzymsubstitutionsbehandling.
Myozyme is an enzyme replacement therapy.
Andre oplysninger om Myozyme:
Other information about Myozyme
Enzymsubstitutionsbehandling giver patienterne det enzym, de mangler, i dette tilfælde alpha-glucosidase.
Enzyme replacement therapy provides patients with the enzyme they are lacking; in this case, alpha-glucosidase.
Den progressive ophobning af glykogen giver en lang række symptomer, herunder forstørret hjerte, åndedrætsbesvær og muskelslaphed.
The progressive build-up of glycogen causes a wide range of symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
Myozyme blev undersøgt i to hovedundersøgelser af i alt 39 spædbørn og børn op til tre og et halvt år med Pompes sygdom med debut i spædbørnsalderen.
Myozyme has been studied in two main studies involving a total of 39 babies and children up to the age of three and a half years with infantile-onset Pompe disease.
Myozyme må ikke anvendes til personer, der har haft en livstruende anafylaktisk (svært allergisk) reaktion over for alglucosidase alfa eller andre af indholdsstofferne, som ikke kunne holdes under kontrol ved at give lægemidlet i en langsommere infusionsrate og nedsat dosis.
Myozyme must not be used in people who have had a life-threatening anaphylactic (severe allergic) reaction to alglucosidase alfa or any of the other ingredients, which could not be managed by giving the medicine at a slower infusion rate and reduced dose.
Hvis enzymet mangler, akkumuleres der glykogen i visse væv, navnlig musklerne, inklusive hjerte og diafragma (den vigtigste vejrtrækningsmuskel under lungerne).
If the enzyme is not present, glycogen builds up in certain tissues, particularly the muscles, including the heart and diaphragm (the main breathing muscle under the lungs).
I undersøgelsen af sen sygdomsdebut havde patienterne mange af de samme bivirkninger, men de forekom mindre hyppigt end i undersøgelserne af patienter med debut i spædbørnsalderen.
In the study of late-onset disease, patients had many of the same side effects, but they were seen less often than in studies of infantileonset disease.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Myozyme findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
The summary of the opinion of the Committee for Orphan Medicinal Products for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Myozyme blev også sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse, der omfattede 90 patienter med sent debuterende sygdom.
Myozyme has also been compared with placebo (a dummy treatment) in one main study involving 90 patients with late-onset disease.
Patienter med Pompes sygdom danner ikke tilstrækkeligt af et enzym kaldet alpha-glucosidase.
Patients with Pompe disease do not have enough of an enzyme called alpha-glucosidase.
Ved sent debuterende sygdom var Myozyme mere effektivt end placebo til forbedring af såvel distancen, patienterne kunne gå, som deres lungefunktion i løbet af undersøgelsen.
In late-onset disease, Myozyme was more effective than placebo at improving both the distance the patients could walk and their lung function over the course of the study.
I løbet af undersøgelserne var de hyppigste bivirkninger ved Myozyme, der blev iagttaget hos patienter med Pompes sygdom med debut i spædbørnsalderen (som optræder hos flere end 1 ud af 10 patienter), takykardi (hjertebanken), rødme, hoste, takypnø (hurtig vejrtrækning), opkastning, nældefeber, udslæt, pyreksi (feber) og faldende iltsaturation (lav iltmængde i blodet).
During the studies in patients with infantile-onset Pompe disease, the most common side effects with Myozyme (seen in more than 1 patient in 10) were tachycardia (rapid heartbeat), flushing (redness), cough, tachypnoea (rapid breathing), vomiting, urticaria (itchy rash), rash, pyrexia (fever) and decreased oxygen saturation (low oxygen levels in the blood).
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Myozyme?
What measures are being taken to ensure the safe use of Myozyme?
Behandling med Myozyme skal overvåges af en læge med erfaring i behandling af patienter med Pompes sygdom eller andre arvelige sygdomme af samme type.
Myozyme treatment should be supervised by a doctor who has experience in the management of patients with Pompe disease or other inherited diseases of the same type.
Substitutionsenzymet medvirker til at nedbryde glykogen og forhindrer derved abnorm ophobning i cellerne.
The replacement enzyme helps to break down glycogen and stops it building up abnormally in the cells.
Den fuldstændige liste over alle de indberettede bivirkninger ved Myozyme fremgår af indlægssedlen.
For the full list of all side effects reported with Myozyme, see the package leaflet.
Hvilke risici er der forbundet med Myozyme?
What is the risk associated with Myozyme?
Myozyme anvendes til behandling af patienter, som har Pompes sygdom, en sjælden arvelig lidelse.
Myozyme is used to treat patients who have Pompe disease, a rare inherited disorder.
Myozyme er et pulver, der blandes til en opløsning til infusion (drop i en vene).
Myozyme is a powder that is made up into a solution for infusion (drip into a vein).
Hvorfor blev Myozyme godkendt?
Why has Myozyme been approved?
Hvad er Myozyme?
What is Myozyme?
Hvad anvendes Myozyme til?
What is Myozyme used for?
Hvordan blev Myozyme undersøgt?
How has Myozyme been studied?
Hvilke fordele viser undersøgelserne, at der er ved Myozyme?
What benefit has Myozyme shown during the studies?
Hvordan anvendes Myozyme?
How is Myozyme used?
Hvordan virker Myozyme?
How does Myozyme work?
4 [Den nuværende tekst kan variere fra produkt til produkt]
Section 4 [Existing text may vary between products]
Sidstnævnte kan tilskrives paclitaxel uanset behandlingsregimet.
The latter ones may be attributed to paclitaxel regardless of the treatment regimen.
En frekvens på ”ikke kendt (kan ikke estimeres ud fra forhåndenværende data)” betragtes som passende.
A frequency of ‘not known (cannot be estimated from available data)' is considered appropriate.
Indlægssedlen bør opdateres tilsvarende.
The PL should be updated accordingly.
Bilag II Ændringer i produktinformationen for det/de nationalt godkendte lægemiddel/lægemidler
Annex II Amendments to the product information of the nationally authorised medicinal product(s)
Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for paclitaxel er CHMP nået frem til følgende videnskabelige konklusioner:
Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel, the scientific conclusions of the CHMP are as follows:
Data fra offentliggjort litteratur og administrative kravsdatabaser bekræftede persistens af neuropati med paclitaxel eksponering ud over 12 måneder.
Data from published literature and administrative claims databases confirmed the persistence of neuropathy with paclitaxel exposure beyond 12 months.
Fra tilfælde med palmar-plantar erytrodysæstesi-syndrom og symptomer modtaget af markedsføringstilladelsesindehaverene var der flere tilfælde med positiv dechallenge og med positiv rechallenge.
From the cases of palmarplantar erythrodysesthesia syndrome and symptoms received by the MAHs, there were several cases with a positive dechallenge and with a positive rechallenge.
På grundlag af de tilvejebragte data anbefales det at opdatere den aktuelle information om neuropati i produktresuméet ved at tilføje information vedrørende persistent neuropati efter seponering af paclitaxel.
Based on the data provided, it is recommended to update the current information on neuropathy in the SmPC, by adding information concerning persistent neuropathy after paclitaxel discontinuation.
På grundlag af en kumulativ gennemgang af data fra alle markedsføringstilladelser er paclitaxels kausale rolle i forbindelse med palmar-plantar erytrodysæstesisyndrom i det mindste en rimelig mulighed.
Based on a cumulative review of data from all the MAHs, the causal role of paclitaxel for palmarplantar erythrodysesthesia syndrome is at least a reasonable possibility.