FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung infiltration)
Danish: Det kan være tegn på problemer med milten (forstørret milt)  hvis De for nylig har haft en alvorlig lungebetændelse (pneumoni), væske i lungerne (lungeødem), inflammation (betændelseslignende reaktion) i lungerne (interstitiel lungesygdom) eller De har fået taget røntgenbilleder af brystet, der viste unormale forhold (lungeinfiltration)  hvis De er klar over, at De har ændrede blodtal (for eksempel en stigning i hvide blodlegemer eller blodmangel (anæmi)) eller fald i antallet af blodplader, hvilket reducerer blodets evne til at størkne (trombocytopeni).
English: Used syring barrel
Danish: Brugt kanyle
English: Each pre-filled syringe contains 6 mg of pegfilgrastim in
Danish: Hver fyldt injektionssprøjte indeholder 6 mg pegfilgrastim i 0,6 ml opløsning.
English: MA (EU) number (Invented) name
Danish: Pulver: hætteglas (glas); Solvens: hætteglas (glas)
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evotaz on 13 July 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Evotaz den 13. juli 2015.
English: Other information about Evotaz
Danish: Andre oplysninger om Evotaz
English: This is a summary of the European public assessment report (EPAR) for Evotaz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Evotaz.
English: The full EPAR and risk management plan summary for Evotaz 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 Evotaz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one tablet a day, taken with food.
Danish: Den anbefalede dosis af Evotaz er én tablet dagligt, der tages sammen med et måltid.
English: A risk management plan has been developed to ensure that Evotaz is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Evotaz anvendes så sikkert som muligt.
English: The medicine is for use only in patients whose infection is not expected to be resistant to atazanavir.
Danish: Lægemidlet må kun bruges til patienter, hvis infektion ikke forventes at være resistent over for atazanavir.
English: The virus needs protease to make more viruses.
Danish: Virussen har brug for protease til at danne flere vira.
English: It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke hiv-infektion, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Evotaz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Evotaz opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: When the enzyme is blocked, the virus cannot reproduce itself and its spread in the body slows down.
Danish: Når enzymet er blokeret, kan virussen ikke reproducere sig selv og spredes mindre hurtigt i kroppen.
English: Overall, 85% of patients (293 out of 344) treated with atazanavir and cobicistat achieved this reduction.
Danish: Samlet set opnåede 85 % af patienterne (293 ud af 344), som blev behandlet med atazanavir og cobicistat, dette fald.
English: The main measure of effectiveness was the proportion of patients in whom the HIV-1 count in the blood (known as viral load) was reduced to less than 50 copies/ml after 48 weeks of treatment.
Danish: Virkningen blev især målt ud fra andelen af patienter, hos hvem mængden af hiv-1 i blodet (kendt som virusbelastning) faldt til under 50 kopier/ml efter 48 ugers behandling.
English: This therefore boosts atazanavir's antiviral effect.
Danish: Dette øger derfor atazanavirs antivirale virkning.
English: It blocks an HIV enzyme called protease from working.
Danish: Det hindrer et hiv-enzym kaldet protease i at fungere.
English: This was comparable to a reduction in 87% of patients (304 of 348) treated with atazanavir and ritonavir.
Danish: Det kan sammenlignes med en nedgang på 87 % af de patienter (304 ud af 348), der blev behandlet med atazanavir og ritonavir.
English: In addition, the use of atazanavir with cobicistat has been evaluated in one main study in 698 HIV patients who had not been treated previously.
Danish: Dertil kommer, at brug af atazanavir i kombination med cobicistat blev vurderet i en hovedundersøgelse med 698 hiv-patienter, som ikke før havde været i behandling.
English: What is Evotaz and what is it used for?
Danish: Hvad er Evotaz, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Evotaz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Evotaz?
English: Why is Evotaz approved?
Danish: Hvorfor blev Evotaz godkendt?
English: It is not intended to provide practical advice on how to use Evotaz.
Danish: Det er ikke en praktisk vejledning i, hvordan Evotaz bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evotaz, 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 Evotaz, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It must also not be taken by patients taking certain medicines because of the possibility of interactions which could be harmful.
Danish: Lægemidlet må heller ikke gives til patienter, der indtager bestemte lægemidler, på grund af muligheden for skadelig kombinationseffekt.
English: Evotaz can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Evotaz udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i behandling af hiv-infektioner.
English: Evotaz, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Danish: Evotaz i kombination med andre hiv-lægemidler nedsætter mængden af hiv i blodet og holder virussen på et lavt niveau.
English: What are the risks associated with Evotaz?
Danish: Hvilke risici er der forbundet med Evotaz?
English: Combining atazanavir and cobicistat in a single tablet has the potential of simplifying the dosing regimen.
Danish: At kombinere atazanavir og cobicistat i en enkelt tablet kan potentielt forenkle doseringen.
English: Cobicistat increases the level of atazanavir in the blood by slowing its breakdown.
Danish: Cobicistat øger mængden af atazanavir i blodet ved at sænke nedbrydningshastigheden.
English: The most common side effects with Evotaz (which may affect more than 1 in 10 people) are jaundice, which may show as yellow discoloration of the eye, and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved brug af Evotaz (som kan ramme over 10 %) er gulsot, der kan vise sig ved en gulfarvning af øjnene, og kvalme (lyst til at kaste op).
English: Evotaz's adverse effects were similar to those that occur with the individual medicines.
Danish: Evotaz' skadelige virkninger svarer til de skadelige virkninger ved det enkelte lægemiddel.
English: For more information about treatment with Evotaz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Evotaz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because atazanavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Evotaz produced similar levels of atazanavir in the blood to the two active substances given separately, and to atazanavir given with a different booster medicine, ritonavir (an established combination).
Danish: Eftersom atazanavir og cobicistat begge tidligere har vist sig at være effektive og er godkendt til brug i behandlingen af hiv-infektion, har formålet med undersøgelserne primært været at påvise, at den mængde atazanavir i blodet, som Evotaz producerer, svarer til to aktive stoffer indgivet separat og til atazanavir indgivet med en anden booster, ritonavir (en etableret kombination).
English: Evotaz is an antiviral medicine used in combination with other medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Evotaz er et antiviralt lægemiddel, der anvendes sammen med andre lægemidler til behandling af voksne patienter smittet med hiv-1 (humant immundefektvirus type 1).
English: Atazanavir is a protease inhibitor.
Danish: Atazanavir er en proteasehæmmer.
English: Evotaz is available as tablets that contain 300 mg of atazanavir and 150 mg of cobicistat.
Danish: Evotaz findes som tabletter indeholdende 300 mg atazanavir og 150 mg cobicistat.
English: Both active substances have already been shown to be effective and Evotaz may be a useful substitute for atazanavir accompanied by ritonavir as a booster.
Danish: De to aktive stoffer har begge vist sig effektive, og Evotaz kan være en nyttig erstatning for atazanavir med ritonavir som booster.
English: The active substances in Evotaz are already available in the EU as individual medicines: atazanavir is available as Reyataz and cobicistat as Tybost.
Danish: De aktive stoffer i Evotaz er allerede tilgængelige i EU som individuelle lægemidler: atazanavir som Reyataz og cobicistat som Tybost.
English: Evotaz must not be taken by patients who have moderately or severely reduced liver function.
Danish: Evotaz må ikke gives til patienter med let til svært nedsat leverfunktion.
English: For the full list of all side effects reported with Evotaz, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Evotaz fremgår af indlægssedlen.
English: For practical information about using Evotaz, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Evotaz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Evotaz work?
Danish: Hvordan virker Evotaz?
English: What benefits of Evotaz have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Evotaz?
English: Evotaz contains the active substances atazanavir and cobicistat.
Danish: Evotaz indeholder de aktive stoffer atazanavir og cobicistat.
English: Evotaz contains two active substances: atazanavir and cobicistat.
Danish: Evotaz indeholder to aktive stoffer, atazanavir og cobicistat.
English: How is Evotaz used?
Danish: Hvordan anvendes Evotaz?
English: Atazanavir and cobicistat were compared with atazanavir and ritonavir; all patients also received the HIV medicines emtricitabine and tenofovir disoproxil.
Danish: Atazanavir og cobicistat blev sammenlignet med atazanavir og ritonavir.
English: 1 ml (150 mg/ml) 6 (3 x 2) pre-filled pens (multipack)
Danish: 1 ml (150 mg/ml) 6 (3 x 2) fyldte penne (multipakning)
English: 1 ml (150 mg/ml) 1 pre-filled pen
Danish: 1 ml (150 mg/ml) 1 fyldt pen
English: 1 ml (150 mg/ml) 2 pre-filled pens
Danish: 1 ml (150 mg/ml) 2 fyldte penne
English: 1 ml (150 mg/ml) 6 (3 x 2) pre-filled syringes (multipack)
Danish: Fyldt sprøjte (glas) 1 ml (150 mg/ml) 6 (3 x 2) fyldte injektionssprøjter (multipakning)
English: 1 ml (150 mg/ml) 2 pre-filled syringes
Danish: Fyldt sprøjte (glas) 1 ml (150 mg/ml) 2 fyldte injektionssprøjter
English: This is a summary of the European public assessment report (EPAR) for Kovaltry.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kovaltry.
English: Other information about Kovaltry
Danish: Andre oplysninger om Kovaltry
English: The full EPAR and risk management plan summary for Kovaltry 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 Kovaltry findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Kovaltry is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Kovaltry anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kovaltry's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Kovaltry opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Data from a supportive study also confirmed the benefits of preventative treatment with Kovaltry in reducing the number of bleeds.
Danish: Data fra en støttende undersøgelse bekræftede ligeledes fordelene ved forebyggende behandling med Kovaltry til at nedsætte antallet af blødninger.
English: Why is Kovaltry approved?
Danish: Hvorfor blev Kovaltry godkendt?
English: What measures are being taken to ensure the safe and effective use of Kovaltry?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kovaltry?
English: Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins.
Danish: Patienterne kan danne antistoffer mod proteiner fra hamstere eller mus; lægemidlet må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for octocog alfa eller hamster- eller museproteiner.
English: Kovaltry has been shown to be effective in both preventing and treating bleeds, including managing blood loss during surgery, and can be used in all age groups.
Danish: Kovaltry er påvist at være effektivt til både at forebygge og behandle blødninger, herunder at kontrollere blodtab under operationer, og det kan bruges hos alle aldersgrupper.
English: Hypersensitivity (allergic) reactions are uncommon with Kovaltry, affecting from 1 patient in 1,000 to less than 1 patient in 100.
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) er ikke almindelige med Kovaltry og optræder hos mellem 1 ud af 1 000 patienter og 1 ud af 100 patienter.
English: This compared with an average of 6.9 bleeds per year before Kovaltry treatment.
Danish: Dette skal sammenholdes med et gennemsnit på 6,9 blødninger per år før behandling med Kovaltry.
English: What is Kovaltry and what is it used for?
Danish: Hvad er Kovaltry, og hvad anvendes det til?
English: The dose and frequency of the injections depend on whether Kovaltry is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af, om Kovaltry skal anvendes til at behandle eller forebygge blødning, og desuden af, hvor alvorlig patientens mangel på faktor VIII er, blødningens omfang og beliggenhed samt patientens tilstand og legemsvægt.
English: The active substance in Kovaltry, octocog alfa, works in the body in the same way as human factor VIII.
Danish: Det aktive stof i Kovaltry, octocog alfa, virker på samme måde i kroppen som kroppens egen faktor VIII.
English: It is not intended to provide practical advice on how to use Kovaltry.
Danish: Det er ikke en praktisk vejledning i, hvordan Kovaltry bør anvendes.
English: What are the risks associated with Kovaltry?
Danish: Hvilke risici er der forbundet med Kovaltry?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kovaltry, 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 Kovaltry, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: A second study involved 51 children under 12 years of age previously treated with other factor VIII products, who also had 3.8 bleeds per year on average during treatment with Kovaltry (mostly related to injuries).
Danish: Endnu en undersøgelse omfattede 51 børn under 12 år, der tidligere var behandlet med et andet faktor VIII-produkt, og som ligeledes i gennemsnit fik 3,8 blødninger om året under behandlingen med Kovaltry (hovedsagelig som følge af skader).
English: Kovaltry can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Kovaltry udleveres kun efter recept, og behandlingen bør finde sted under opsyn af en læge med erfaring i behandling af hæmofili.
English: For the full list of all side effects and restrictions with Kovaltry, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Kovaltry fremgår af indlægssedlen.
English: The effectiveness of Kovaltry in preventing and treating bleeding has been shown in a main study involving 62 patients aged 12 years or older with severe haemophilia A who were previously treated with other factor VIII products.
Danish: Effektiviteten af Kovaltry til forebyggelse og behandling af blødning er påvist i en hovedundersøgelse med 62 patienter over 12 år med svær hæmofili A, som tidligere blev behandlet med andre faktor VIIIprodukter.
English: For more information about treatment with Kovaltry, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kovaltry, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In addition, the company that markets Kovaltry will complete studies to investigate the safety and efficacy of the medicine in patients who have not previously been treated with other factor VIII products, and to provide further evidence of the safety and efficacy of long-term treatment with Kovaltry in children.
Danish: Derudover skal den virksomhed, der markedsfører Kovaltry, udføre undersøgelser af sikkerheden og virkningen af lægemidlet hos patienter, som ikke tidligere er behandlet med et andet faktor VIIIprodukt, og skal indsende mere dokumentation for sikkerheden og virkningen ved langtidsbehandling med Kovaltry hos børn.
English: About 70% of the bleeding events that occurred were managed with a single injection of Kovaltry, and about another 15% responded to a second injection; the response was considered good or excellent in around 80% of cases.
Danish: Ca. 70 % af de blødningshændelser, der fandt sted, blev behandlet med en enkelt indsprøjtning af Kovaltry, og andre ca. 15 % reagerede positivt på endnu en indsprøjtning.
English: Kovaltry is available as a powder and solvent used to make a solution for injection.
Danish: Kovaltry fås som et pulver og en opløsningsvæske (et solvens), som bruges til at fremstille en opløsning, der gives som indsprøjtning.
English: What benefits of Kovaltry have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kovaltry?
English: For practical information about using Kovaltry, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kovaltry, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Kovaltry is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Danish: Kovaltry er et lægemiddel til behandling og forebyggelse af blødning ved den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på proteinet faktor VIII, som medvirker ved blodets størkning.
English: How is Kovaltry used?
Danish: Hvordan anvendes Kovaltry?
English: How does Kovaltry work?
Danish: Hvordan virker Kovaltry?
English: The number of bleeds that occurred during Kovaltry treatment was calculated as 3.8 bleeds per year on average (mostly into joints).
Danish: Ved behandling med Kovaltry forekom der gennemsnitligt 3,8 blødninger om året (hovedsagelig i led).
English: The studies also looked at how long the patients survived.
Danish: I studierne så man endvidere på, hvor længe patienterne overlevede.
English: This was switched to a full marketing authorisation on 17 February 2015.
Danish: Den blev ændret til en fuldgyldig markedsføringstilladelse den 17. februar 2015.
English: Tyverb is used in the following ways:
Danish: Tyverb anvendes på følgende måder:
English: All of the tablets must be taken together at the same time every day, at least 1 hour before or 1 hour after food.
Danish: Alle tabletterne skal tages samtidigt, og de skal tages samme tid hver dag mindst 1 time før eller efter et måltid.
English: Further information on Tyverb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Tyverb findes på agenturets websted under:ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tyverb received a conditional marketing authorisation valid throughout the EU on 10 June 2008.
Danish: Tyverb fik en betinget markedsføringstilladelse med gyldighed i hele EU den 10. juni 2008.
English: If patients start to take Tyverb again, they may need to use a lower dose.
Danish: Hvis patienterne begynder at tage Tyverb igen, kan det være nødvendigt at anvende en lavere dosis.
English: Other information about Tyverb
Danish: Andre oplysninger om Tyverb
English: As for all medicines, data on the use of Tyverb are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Tyverb løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Tyverb?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tyverb?
English: What is Tyverb and what is it used for?
Danish: Hvad er Tyverb, og hvad anvendes det til?
English: For more information about using Tyverb, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Tyverb, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.
Danish: Patienter, der holder op med at tage Tyverb efter at have fået alvorlige leverproblemer, bør ikke begynde at tage lægemidlet igen.
English: This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.
Danish: Denne kombination anvendes til kvinder, som for øjeblikket ikke har behov for standardkemoterapi til behandling af kræften.
English: In all the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse, which was assessed in scans.
Danish: I samtlige studier blev virkningen hovedsageligt målt på, hvor længe patienterne levede, uden at sygdommen forværredes, hvilket blev vurderet ved hjælp af scanninger.
English: Tyverb was originally given ‘conditional approval'.
Danish: Der blev oprindeligt udstedt en "betinget godkendelse" for Tyverb.
English: An overview of Tyverb and why it is authorised in the EU
Danish: En oversigt over Tyverb, og hvorfor det er godkendt i EU