FrancophonIA/ELRC3.0 huggingface dataset:
English: Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
Danish: I en anden undersøgelse, der omfattede ca. 800 piger og kvinder, blev virkningen af to doser Gardasil hos piger i alderen 9-13 år sammenlignet med virkningen af tre doser hos piger og unge kvinder i alderen 16-24 år.
English: Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Danish: Tre undersøgelser af Gardasil givet som tre doser omhandlede Gardasils evne til at forebygge infektion med HPV-type 6, 11, 16 og 18 samt kønsvorter forårsaget af disse HPV-typer hos knap 4 000 kvinder i alderen 24-45 år samt dannelsen af antistoffer mod disse HPV-typer hos ca. 1 700 piger og drenge i alderen 9-15 år.
English: In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Danish: I de tre undersøgelser vedrørende kønsvorter udviklede to kvinder ud af næsten 8 000 i Gardasilgruppen kønsvorter, og der var ingen tilfælde af præcancerøse læsioner i de ydre kønsdele og i vagina.
English: In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women.
Danish: Undersøgelserne bekræftede endvidere Gardasils evne til at beskytte mod læsioner og HPV-forårsagede infektioner hos kvinder i alderen 24-45 år.
English: What is Gardasil?
Danish: Hvad er Gardasil?
English: The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Danish: Undersøgelserne viste desuden, at Gardasil ydede en vis beskyttelse mod læsioner i livmoderhalsen, som skyldes to andre HPV-typer, herunder type 31.
English: For the full list of all side effects reported with Gardasil, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Gardasil fremgår af indlægssedlen.
English: Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Danish: Endelig blev vaccinen sammenlignet med placebo i en hovedundersøgelse, der omfattede ca. 4 000 drenge og mænd i alderen 16 og derover, med henblik på at undersøge vaccinens virkning i forbindelse med forebyggelse af kønsvorter, præcancerøse anallæsioner og analkræft.
English: Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Danish: Gardasil indeholder oprensede L1-proteiner fra HPV-type 6, 11, 16 og 18, som er fremstillet ved hjælp af en metode, der kaldes »rekombinant DNA-teknologi«.
English: What is Gardasil used for?
Danish: Hvad anvendes Gardasil til?
English: The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Danish: Undersøgelsen af Gardasil givet som to doser hos piger i alderen 9-13 år viste, at de to doser givet med seks måneders mellemrum ikke var mindre effektive end tredosisvaccinationen.
English: What benefit has Gardasil shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der ved Gardasil?
English: How has Gardasil been studied?
Danish: Hvordan blev Gardasil undersøgt?
English: How is Gardasil used?
Danish: Hvordan anvendes Gardasil?
English: It is available in vials or prefilled syringes.
Danish: Det fås i hætteglas eller fyldte injektionssprøjter.
English: How does Gardasil work?
Danish: Hvordan virker Gardasil?
English: Patients can inject themselves if they have been trained appropriately.
Danish: Patienterne kan give sig selv indsprøjtningerne, hvis de er blevet oplært i det.
English: Filgrastim has been available in other medicines in the EU for a number of years.
Danish: Filgrastim har været markedsført i andre lægemidler i EU i en årrække.
English: Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
Danish: Yderligere information vedrørende Pegfilgrastim Mundipharma findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
English: The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Pegfilgrastim Mundipharma (som kan forekomme hos mere end 1 ud af 10 personer) er knoglesmerter.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).
Danish: Det gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber på grund af en infektion.
English: This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Pegfilgrastim Mundipharma i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: Pegfilgrastim Mundipharma can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Pegfilgrastim Mundipharma fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
English: Pegfilgrastim Mundipharma is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy.
Danish: Pegfilgrastim Mundipharma gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi.
English: Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Pegfilgrastim Mundipharma vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Pegfilgrastim Mundipharma løbende overvåget.
English: For more information about using Pegfilgrastim Mundipharma, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Pegfilgrastim Mundipharma, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The safety of Pegfilgrastim Mundipharma has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Danish: Sikkerheden ved Pegfilgrastim Mundipharma er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet Neulasta.
English: Because Pegfilgrastim Mundipharma is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pegfilgrastim Mundipharma.
Danish: Da Pegfilgrastim Mundipharma er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke alle at blive gentaget for Pegfilgrastim Mundipharma.
English: An overview of Pegfilgrastim Mundipharma and why it is authorised in the EU
Danish: En oversigt over Pegfilgrastim Mundipharma, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pegfilgrastim Mundipharma?
English: Pegfilgrastim Mundipharma is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Danish: Pegfilgrastim Mundipharma er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastiske syndromer (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: What is Pegfilgrastim Mundipharma and what is it used for?
Danish: Hvad er Pegfilgrastim Mundipharma, og hvad anvendes det til?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pegfilgrastim Mundipharma has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Pegfilgrastim Mundipharma har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Pegfilgrastim Mundipharma outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Pegfilgrastim Mundipharma opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: The active substance in Pegfilgrastim Mundipharma, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Pegfilgrastim Mundipharma, pegfilgrastim, er en form for filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: All these data were considered sufficient to conclude that Pegfilgrastim Mundipharma will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Pegfilgrastim Mundipharma vil have de samme egenskaber som Neulasta hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: The reference medicine for Pegfilgrastim Mundipharma is Neulasta.
Danish: Referencelægemidlet for Pegfilgrastim Mundipharma er Neulasta.
English: Other information about Pegfilgrastim Mundipharma
Danish: Andre oplysninger om Pegfilgrastim Mundipharma
English: Why is Pegfilgrastim Mundipharma authorised in the EU?
Danish: Hvorfor er Pegfilgrastim Mundipharma godkendt i EU?
English: Laboratory studies comparing Pegfilgrastim Mundipharma with Neulasta have shown that the active substance in Pegfilgrastim Mundipharma is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Pegfilgrastim Mundipharma med Neulasta, har vist, at det aktive stof i Pegfilgrastim Mundipharma svarer til det aktive stof i Neulasta hvad angår struktur, renhed og biologisk aktivitet.
English: Studies have also shown that giving Pegfilgrastim Mundipharma produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at Pegfilgrastim Mundipharma giver samme niveau af det aktive stof i kroppen som Neulasta.
English: Pegfilgrastim Mundipharma contains the active substance pegfilgrastim.
Danish: Pegfilgrastim Mundipharma indeholder det aktive stof pegfilgrastim.
English: For the full list of side effects and restrictions with Pegfilgrastim Mundipharma, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pegfilgrastim Mundipharma fremgår af indlægssedlen.
English: What are the risks associated with Pegfilgrastim Mundipharma?
Danish: Hvilke risici er der forbundet med Pegfilgrastim Mundipharma?
English: Pegfilgrastim Mundipharma is a ‘biosimilar medicine'.
Danish: Pegfilgrastim Mundipharma er et "biosimilært" lægemiddel.
English: Mundipharma, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Pegfilgrastim Mundipharma er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pegfilgrastim Mundipharma have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pegfilgrastim Mundipharma.
English: How is Pegfilgrastim Mundipharma used?
Danish: Hvordan anvendes Pegfilgrastim Mundipharma?
English: Pegfilgrastim Mundipharma is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
Danish: Pegfilgrastim Mundipharma er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Pegfilgrastim Mundipharma fås som en fyldt sprøjte med injektionsvæske til indsprøjtning under huden.
English: How does Pegfilgrastim Mundipharma work?
Danish: Hvordan virker Pegfilgrastim Mundipharma?
English: What benefits of Pegfilgrastim Mundipharma have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pegfilgrastim Mundipharma?
English: • the possible development of tolerance,
Danish: • mulig udvikling af tolerans
English: 0.8 (sublingual)
Danish: 0,8 (sublingualt)
English: Non-epileptic (myo)clonic reactions can occur.
Danish: Ikke-epileptiske (myo)klone reaktioner kan forekomme.
English: {Name and Address} {tel} {fax} {e-mail}
Danish: {Navn og adresse} {tlf} {fax} {email}
English: The tendency to develop tolerance varies considerably between individuals.
Danish: Tendensen til udvikling af tolerance kan variere betydeligt hos forskellige personer.
English: painful flatulence, ileus.
Danish: Smertefuld flatulens, ileus.
English: Austria ratiopharm
Danish: Østrig ratiopharm
English: However, this is rarely seen during treatment of pain due to cancer.
Danish: Det ses dog sjældent under behandling af smerter, der skyldes kræft.
English: The experience in children under 12 years of age is limited.
Danish: Erfaring med behandling af børn under 12 år er begrænset.
English: - Apply a new patch as described above but on another part of the skin.
Danish: - Anbring et nyt plaster på samme måde som beskrevet ovenfor, men på et andet område af huden.
English: Usually the patch does not come off by itself.
Danish: Sædvanligvis går plasteret ikke løs af sig selv.
English: Madrid, Spain transdérmicos EFG
Danish: Madrid, Spanien transdérmicos EFG
English: Switching from other opioids
Danish: Ved skift fra andre opioider
English: Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin.
Danish: Brug ikke sæbe, olie, lotion, alkohol eller andre rensemidler, der kunne irritere huden.
English: This is also the case with used transdermal patches.
Danish: Dette gælder også for brugte depotplastre.
English: This may help you remember when to change your patch.
Danish: Det kan være en hjælp til at huske, hvornår plasteret skal skiftes.
English: WARNING:
Danish: ADVARSEL:
English: Symptoms are that the person breathes abnormally slowly or weakly.
Danish: Symptomerne viser sig ved, at personen trækker vejret unormalt langsomt eller dårligt.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Danish: Disse handlinger kan efterfølges af administration af en specifik opioidantagonist såsom naloxon.
English: Not known (cannot be estimated from the available data): Long-term use of fentanyl can lead to development of tolerance and physical and psychological dependence.
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data): Under langtidsanvendelse af fentanyl kan der udvikles tolerance og fysisk og psykologisk afhængighed.
English: The first of these are transient and their cause should be investigated if symptoms persist.
Danish: De første er forbigående og bør undersøges nærmere, hvis symptomerne varer ved.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 °C.
English: • the current general condition, the medical status of the patient, and
Danish: • patientens aktuelle almentilstand og medicinske status
English: If analgesia is insufficient at the end of the initial application period, the dose may be increased after 3 days, until the desired effect is obtained for each patient.
Danish: I tilfælde af utilstrækkelig analgesi efter den initiale applikationsperiode kan dosis øges efter 3 dage, indtil den ønskede virkning opnås for den enkelte patient.
English: Long-term carcinogenicity studies have not been performed.
Danish: Der er ikke udført langtidskarcinogenicitetsforsøg.
English: Spain ratiopharm España, S.A.
Danish: Spanien ratiopharm España, S.A.
English: In most cases this is after 72 hours (3 days), in some patients after 48 hours (2 days).
Danish: I de fleste tilfælde skal der gå 72 timer (3 døgn), men hos nogle patienter 48 timer (2 døgn).
English: If progressive dose increases are made, the active surface area required may reach a point where no further increase is possible.
Danish: I tilfælde af stigende dosisøgninger kan det aktive overfladeområde nå til et punkt, hvor yderligere stigning ikke kan finde sted.
English: Therefore, patients should consult their physician as to whether driving or use of machines is permitted.
Danish: Patienter bør derfor spørge deres læge, om de må køre eller betjene maskiner.
English: Distribution The plasma protein binding for fentanyl is 84 %.
Danish: Fordeling Bindingen til plasmaproteiner er 84 %.
English: This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers.
Danish: Dette gælder især i begyndelsen af behandlingen, ved hver dosisændring samt i forbindelse med alkohol eller sedativa.
English: If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Danish: Hvis der er behov for højere doser end 500 mg morphinækvivalent, anbefales det at revurdere opioidbehandlingen.
English: Patients with myasthenia gravis
Danish: Patienter med myasthenia gravis
English: Albert-SchweitzerGasse 3, 1140 WIEN, Austria
Danish: Albert-SchweitzerGasse 3, 1140 WIEN, Østrig
English: As a general rule in EU, if such a study would have to be conducted, the 50 µg/h strength would be recommended.
Danish: Hvis en sådan undersøgelse skulle udføres i EU, ville styrken 50 µg/time sædvanligvis blive anbefalet.
English: - The patch must be stuck on immediately after opening the package.
Danish: - Plasteret skal sættes på umiddelbart efter, at pakningen åbnes.
English: The skin must be completely dry before applying the patch.
Danish: Huden skal være helt tør, før plasteret anbringes.
English: skin reactions on the application site.
Danish: Hudreaktioner ved applikationsstedet.
English: You should change your patch at the same time of day every three days (every 72 hours), unless directed otherwise by your doctor.
Danish: Plasteret skal skiftes på samme tid af dagen hver tredje dag (efter 72 timer), med mindre lægen har givet andre anvisninger.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge medicinen.
English: It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Danish: Udendørs ophold i solen er tilladt, men Deres påklædning skal holde plasteret tildækket på varme sommerdage.
English: Intramuscular administration will give a more prolonged effect than intravenous administration.
Danish: Intramuskulær administration giver en længere virkning end intravenøs administration.
English: The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration.
Danish: Doseringen af fentanyl tilpasses individuelt og bør vurderes løbende efter hver administration.
English: Patients stabilized on a specific dosage will not necessarily be restricted.
Danish: Patienter, der er stabiliseret med en specifik dosering, vil ikke nødvendigvis opleve sådanne begrænsninger.
English: The product should be used only as part of an integrated treatment of pain in cases where the patient is adequately assessed medically, socially and psychologically.
Danish: Præparatet bør udelukkende anvendes som led i en integreret smertebehandling i tilfælde, hvor der foreligger en fuldstændig vurdering af patienten såvel medicinsk som socialt og psykologisk.
English: In such cases increased care and observation of the patient should be undertaken.
Danish: I så fald anbefales ekstra pleje og observation af patienten.
English: Therefore, due to ethical and safety reasons, it would be questionable to conduct studies with the highest strength when all necessary information could be derived from studies with lower patch strengths.
Danish: Undersøgelser med den højeste styrke vil derfor etisk og sikkerhedsmæssigt være problematiske, når al nødvendig information kan fås ved undersøgelser med depotplastre af lavere styrke.
English: - Acute or postoperative pain, since dosage titration is not possible during short-term use.
Danish: - Akutte eller postoperative smerter, da dosistitrering ikke kan udføres under kortvarig brug.
English: The body part must not have been irradiated in connection with radiation therapy.
Danish: Området må ikke være bestrålet i forbindelse med strålebehandling.
English: Increased intracranial pressure
Danish: Øget intrakranielt tryk
English: - if your central nervous system is severely impaired, for instance by brain injury.
Danish: - hvis Deres centralnervesystem er alvorligt svækket, for eksempel på grund af en hjerneskade.
English: - Severe impairment of the central nervous system.
Danish: - Alvorlig svækkelse af centralnervesystemet.
English: Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/hour.
Danish: Yderligere eller alternative metoder til analgesi eller alternativ administration af opioider bør overvejes, når doseringen af Fentanyl-ratiopharm overstiger 300 mikrogram/time.
English: Tolerance and physical and psychological dependence may develop upon repeated administration of opioids, but is rare in treatment of cancer related pain.
Danish: Tolerance og fysisk og psykologisk afhængighed kan opstå efter gentagen administration af opioider, men forekommer sjældent under behandling af cancersmerter.
English: An exception can be made if the doctor has expressly prescribed Fentanyl-ratiopharm.
Danish: Der kan dog gøres en undtagelse, hvis lægen udtrykkeligt har ordineret Fentanylratiopharm.
English: Constipation, on the other hand, does not stop if treatment continues.
Danish: Derimod holder obstipation ikke op, hvis behandlingen fortsættes.