natgillin/translations-raw huggingface dataset:
• Nødvendigheden af at sundhedspersonale udfører en årlig klinisk evaluering af patienter med hensyn til en potentiel øget risiko for udvikling af maligniteter;
• The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
• Den korrekte patientbehandling med hensyn til interaktion ved vaccination;
• The proper patient management as regards the interaction with vaccination;
• Nødvendigheden af at instruere patienterne i den korrekte teknik til selv-administration, når patienten er villig til og har mulighed for at gøre dette, samt vejledning til sundhedspersonale i rapportering af administrationsfejl;
• The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
• Risikoen for alvorlige infektioner, herunder opportunistiske bakterie-, virus- og svampeinfektioner hos patienter, som behandles med Ilaris;
• The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Ilaris;
• Patientkortets formål og anvendelse.
• The role and use of patient alert card.
• Nødvendigheden af at måle neutrofiltal før initiering af behandlingen, efter 1 til 2 måneder og periodisk herefter, så længe patienten er i behandling med Ilaris, da behandling med Ilaris ikke må initieres hos patienter med neutropeni;
• The need to measure neutrophil counts prior to initiating treatment, after 1 to 2 months and periodically thereafter while receiving Ilaris as treatment with Ilaris should not be initiated in patients with neutropenia;
• Nødvendigheden af at monitorere ændringer i patientens lipidprofiler;
• The need to monitor patients for changes in their lipid profiles;
• Den ukendte sikkerhed af Ilaris hos gravide og ammende kvinder, og nødvendigheden af, at lægen diskuterer risici med patienter, der bliver gravide eller planlægger at blive gravide;
• The unknown safety of Ilaris in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Medlemslandende skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor er implementeret:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
• Informationsmateriale
• Educational material
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Medlemsstaterne skal sikre, at alle betingelser med hensyn til en sikker og effektiv anvendelse af de beskrevne lægemidler bliver implementeret:
The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
Indehaveren af markedsføringstilladelsen skal aftale indholdet i et informationsprogram med de relevante nationale myndigheder og skal derefter implementere programmet nationalt for at sikre, at læger, før de ordinerer lægemidlet, modtager en informationspakke, der er målrettet mod sundhedspersonale, og som har følgende indhold:
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Tilvejebringelse af en doseringsberegner, der kan gøre beregningen af den korrekte dosis simplere og hjælpe til at sikre korrekt rekonstitution og administration.
Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Henstilling om, hvornår yderligere undersøgelser samt knoglemarvsbiopsi kan blive nødvendige.
Advice on when further investigations and a bone marrow biopsy might be appropriate.
• Produktresumé (SPC) samt indlægsseddel og etikettering.
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Hvis brug af romiplostim skønnes nødvendig, skal trombocyttallet overvåges nøje for at minimere risikoen for tromboemboliske komplikationer.
If use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
Data fra kliniske undersøgelser om MDS vedrørende incidensen af blastcelle-stigninger og progression til AML.
Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Baggrundsinformation om retikulin i knoglemarven.
Background information on reticulin in the bone marrow.
Romiplostim må ikke anvendes til patienter med moderat til svært nedsat leverfunktion medmindre den forventede fordel opvejer den påviste risiko for portal venetrombose.
Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
• Sundhedspersonalets pligter i forbindelse med ordination af romiplostim og nødvendigheden af grundig patientvejledning angående forholdet mellem risici og fordele.
• Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients.
Henstilling om at følge retningslinjerne for dosisjustering for at undgå trombocyttal over normalområdet.
Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Information om, at antistof-testning er tilgængelig på lægens begæring, og kontaktinformation til sådan antistof-testning.
Antibody testing available upon request of physician, contact details for this antibody testing.
Muligheden for tromboemboliske hændelser hos patienter med kronisk ITP og de kendte risikofaktorer for tromboemboliske hændelser (f.eks., Faktor V Leiden, ATIII-deficiens, antiphospholipid syndrom).
The potential for thromboembolic events in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Incidensen af medicineringsfejl i kliniske undersøgelser.
The incidence of medication errors in clinical trials.
Vejledning angående behandling af patienterne efter seponering af romiplostim.
Advice on management of patients upon cessation of romiplostim.
Baggrundsniveauer for retikulin i knoglemarven hos ITP-patienter samt den observerede incidens af og mulige virkningsmekanisme for retikulinaflejring som følge af behandling med romiplostim.
Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Tydeliggørelse af, at forholdet mellem risikoen og fordelene ved pædiatrisk ITP-behandling ikke er afklaret.
Clarification that risk-benefit for the treatment of paediatric ITP has not been established.
Implikationerne af romiplostim-neutraliserende antistoffers krydsreaktion med endogent trombopoietin (TPO).
The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO).
• Dosering.
• Posology
Risikoen og fordelene ved behandling af trombocytopeni hos ikke-ITPpatientpopulationer er ikke afklaret.
Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Romiplostim kan inducere progressionen af eksisterende hæmatologiske maligniteter og myelodysplastisk syndrom (MDS), og det bør følgelig kun anvendes som angivet i kliniske undersøgelser.
Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Incidensen af romiplostim-neutraliserende antistoffer i kliniske undersøgelser.
The incidence of neutralising antibodies to romiplostim in clinical trials.
Incidensen af trombotiske/tromboemboliske komplikationer i kliniske undersøgelser.
The incidence in clinical trials of thrombotic/thromboembolic complications.
Advarsel om, at retikulinaflejring som følge af behandling med romiplostim muligvis kan føre til knoglemarvsfibrose, da der ikke er datagrundlag, som udelukker dette.
Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Incidensen af trombocytopeni i kliniske undersøgelser samt sandsynligheden for recidiv af trombocytopeni ved seponering af behandlingen.
• The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
Storbritannien Alkem Pharma GmbH
United Kingdom Alkem Pharma GmbH
Indehaver af markedsføri ngstilladelse
Marketing Authorisatio n Holder
Aktivt stof Styrke Lægemiddelform Indgivelsesvej
Active Substance
Ricefan 250 mg Cefuroxime 250 mg Filmovertrukken tablet
Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet
Ricefan 500 mg Cefuroxime 500 mg Filmovertrukken tablet
Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet
14. oktober 2016 EMA/659373/2016 EMEA/H/C/004306
14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Derved forhindres kræftcellerne i at vokse og dele sig, mens de normale celler kun påvirkes i begrænset omfang.
This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Omdannelsen til den aktive form sker hurtigere i kræftceller end i normale celler.
active form happens more readily in cancer cells than in normal cells.
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen er sket på grund af en ændring i deres handelsstrategi.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden oprindeligt havde fremlagt, og udarbejdet en liste med spørgsmål.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen bad CHMP virksomheden om at gøre nærmere rede for nogle aspekter med hensyn til fremstilling og opbevaring samt planer for overvågning af lægemidlets sikkerhed og virkning efter godkendelse.
Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Det aktive stof i de to lægemidler, pemetrexed, omsættes i kroppen til en aktiv form, der blokerer de enzymer, som skal bruges til at danne genetisk materiale (dna og rna).
The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Den 22. september 2016 meddelte Hospira UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Pemetrexed Hospira (som ditromethamin) til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft.
On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Det betyder, at det var hensigten, at Pemetrexed Hospira (som ditromethamin) skulle være identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Alimta.
This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Da Pemetrexed Hospira (som ditromethamin) blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser for at påvise lægemidlets kvalitet.
Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Der er ikke gennemført yderligere undersøgelser, da Pemetrexed Hospira (som ditromethamin), der gives ved infusion i en blodåre, er et generisk lægemiddel, som indeholder det samme aktive stof som referencelægemidlet Alimta.
No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
CHMP mente, at virksomheden kunne have afhjulpet disse betænkeligheder, og var af den foreløbige opfattelse, at Pemetrexed Hospira (som ditromethamin) kunne være blevet godkendt til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft.
The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Pemetrexed Hospira (som ditromethamin) skulle anvendes til behandling af to typer lungekræft: kræft i lungehinderne (malignt pleuramesoteliom), som typisk skyldes eksponering for asbest, og fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekræft.
Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Pemetrexed Hospira (som ditromethamin) er et kræftlægemiddel, der indeholder det aktive stof pemetrexed.
Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Det skulle markedsføres som et pulver, der fortyndes til en opløsning, som gives som infusion (drop) i en blodåre.
It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Pemetrexed Hospira (som ditromethamin) blev udviklet som et "generisk lægemiddel".
Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Pemetrexed Hospira (som ditromethamin) forventes at virke på samme måde som referencelægemidlet Alimta.
Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Pemetrexed Hospira (som ditromethamin) med særlig udleveringstilladelse.
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Hvad er Pemetrexed Hospira (som ditromethamin)?
What is Pemetrexed (as ditromethamine) Hospira?
Hvad forventedes Pemetrexed Hospira (som ditromethamin) anvendt til?
What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Hvordan virker Pemetrexed Hospira (som ditromethamin)?
How does Pemetrexed (as ditromethamine) Hospira work?
Yderligere information vedrørende Enurev Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Agenturet bemærkede endvidere, at det, at lægemidlet tages en gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen.
The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Enurev Breezhaler fik markedsføringstilladelse med gyldighed i hele EU den 28. september 2012.
Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
undersøgelser blev virkningen hovedsageligt målt på forbedringen af patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund).
the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Efter 12 måneders behandling havde Enurev Breezhaler øget FEV1 med 97 ml mere end placebo i den første undersøgelse, og med 108 ml mere i den anden undersøgelse.
After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Patienterne bør højst anvende en kapsel dagligt.
Patients should not use more than one capsule in a day.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler?
What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?
Enurev Breezhaler (glycopyrroniumbromid) EMA/326865/2018
Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
De hyppigste bivirkninger ved Enurev Breezhaler (som optræder hos mere end 1 ud af 100 patienter) er tørhed i munden, nasopharyngitis (betændelse i næse og hals), søvnløshed, muskel- og knoglesmerter og gastroenteritis (diarré og opkast).
The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Hvis du ønsker mere information om brugen af Enurev Breezhaler, kan du læse indlægssedlen eller kontakte lægen eller apoteket.
For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Som for alle lægemidler bliver data vedrørende brugen af Enurev Breezhaler løbende overvåget.
As for all medicines, data on the use of Enurev Breezhaler are continuously monitored.
Det betyder, at det udvider luftvejene ved at blokere de muskarine receptorer (mål) i muskelceller og lungerne.
This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Desuden var der ingen væsentlige sikkerhedsproblemer forbundet med Enurev Breezhaler, hvis bivirkninger svarer til dem, der er forbundet med andre muskarine receptorantagonistlægemidler.
In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Enurev Breezhaler-kapsler, som indeholder et pulver til inhalation, anvendes udelukkende med Enurev Breezhaler-inhalatoren og må ikke sluges.
Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed.
Agenturet afgjorde, at fordelene ved Enurev Breezhaler opvejer risiciene, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency decided that Enurev Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
De bivirkninger, der er indberettet for Enurev Breezhaler, vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Dosis tages ved, at patienten anbringer en kapsel i inhalatoren og indånder pulveret fra kapslen gennem munden.
To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Agenturet bemærkede, at Enurev Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL.
The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Hvad er Enurev Breezhaler, og hvad anvendes det til?
What is Enurev Breezhaler and what is it used for?
Enurev Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
Enurev Breezhaler is used for maintenance (regular) treatment.
Enurev Breezhaler er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
Enurev Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Hvorfor er Enurev Breezhaler godkendt i EU?
Why is Enurev Breezhaler authorised in the EU?
Oversigt over Enurev Breezhaler, og hvorfor det er godkendt i EU
An overview of Enurev Breezhaler and why it is authorised in the EU
Enurev Breezhaler (glycopyrroniumbromid)
Enurev Breezhaler (glycopyrronium bromide)
Hvilke risici er der forbundet med Enurev Breezhaler?
What are the risks associated with Enurev Breezhaler?
Det aktive stof i Enurev Breezhaler, glycopyrroniumbromid, er en muskarin receptorantagonist.
The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Enurev Breezhaler udleveres kun på recept.
Enurev Breezhaler can only be obtained with a prescription.
Den fuldstændige liste over bivirkninger og begrænsninger ved Enurev Breezhaler fremgår af indlægssedlen.
For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.
Andre oplysninger om Enurev Breezhaler
Other information about Enurev Breezhaler
Enurev Breezhaler indeholder det aktive stof glycopyrroniumbromid.
Enurev Breezhaler contains the active substance glycopyrronium bromide.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet.
Hvordan anvendes Enurev Breezhaler?
How is Enurev Breezhaler used?
Hvilke fordele viser studierne, at der er ved Enurev Breezhaler?
What benefits of Enurev Breezhaler have been shown in studies?
Det blev i to hovedundersøgelser med i alt 1 888 patienter med KOL påvist, at Enurev Breezhaler er mere effektivt end placebo (en uvirksom behandling) til at lindre symptomerne på KOL.
Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Hvordan virker Enurev Breezhaler?
How does Enurev Breezhaler work?
Indhold (Koncentrati on)
Content (concentration)
1 cylinderampul
Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
For alle indikationer
For all indications
Det er ingen grund til, at du skynder dig med injektionen - 5 minutter giver dig rigeligt tid.
There is no need to rush your injection - 5 minutes gives you enough time.
• Vask dine hænder grundigt.
• Wash your hands thoroughly.
Den tilbageværende tid vises på skærmen.
The time left is shown on screen.
Lægen kan rådgive dig.
Your doctor can provide advice.
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data):
Not known (frequency cannot be estimated from the available data):
Disse data er i rimelig overensstemmelse med observerede data.
These data are reasonably in agreement with observed data.
Del af multipakning, kan ikke sælges separat
Component of a multipack, cannot be sold separately
- Visse vaccinationer kan medføre infektion.
- Certain vaccinations may cause infections.