FrancophonIA/ELRC3.0 huggingface dataset:
English: Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>)
Danish: Mælkeallergi [Følgende afklaring i parentes skal inkluderes i tilfælde af sammenlagt produktresume med styrke(r), der ikke er inkluderet i Bilag I] (følgende afsnit gælder kun for <Lægemidlets (sær)navn styrke(r)>)
English: [A warning should be included as follows.
Danish: [Følgende advarsel bør inkluderes.
English: 4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Følgende advarsel skal inkluderes]
English: OTHER SPECIAL WARNING(S), IF NECESSARY [A warning should be included as follows] Do not use in cow's milk allergy patients.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER [Følgende advarsel skal inkluderes] Må ikke bruges til patienter med mælkeallergi.
English: [A warning should be included as follows]
Danish: [Følgende advarsel skal inkluderes]
English: <Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4).
Danish: <Lægemidlets (sær)navn styrke(r)> er kontraindiceret til patienter med kendt eller formodet mælkeallergi (se punkt 4.4).
English: Patients with known or suspected allergy to cow's milk must not be administered <invented name and strength(s)> (see section 4.3).
Danish: Patienter med kendt eller formodet mælkeallergi må ikke få < Lægemidlets (sær)navn styrke(r))> (se punkt 4.3).
English: <invented name and strength(s)> contains cow's milk proteins If you are allergic or suspected to be allergic to cow's milk, you must not be given this medicine as it may contain trace amounts of cow's milk proteins.
Danish: Hvis du er allergisk eller har formodet allergi over for mælk, må du ikke få denne medicin, da den kan indeholde spor af mælkeproteiner.
English: VIAL
Danish: Produktresume
English: What you need to know before you are given <invented name> Do not use <invented name and strength(s)>:
Danish: Det skal <De> <du> vide, før <De> <du> begynder at <tage> <bruge> <Lægemidlets (sær)navn>
English: OTHER [A warning should be included as follows] Do not use in cow's milk allergy patients.
Danish: Må ikke bruges til patienter med mælkeallergi.
English: Immediate Packaging Pack size
Danish: Sildenafil Teva Sildenafil Teva Sildenafil Teva
English: This summary was last updated in 09-2014.
Danish: Dette sammendrag blev senest ajourført i 09-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Accofil den 18. september 2014.
English: Severe neutropenia lasted on average for 1.4 days.
Danish: Svær neutropeni varede i gennemsnit 1,4 dage.
English: This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim.
Danish: Dette er sammenligneligt med 1,6 dage og 1,8 dage, som angives i andre undersøgelser, der er beskrevet i litteraturen, hvor der er anvendt filgrastim.
English: This is a summary of the European public assessment report (EPAR) for Accofil.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Accofil.
English: The full EPAR and risk management plan summary for Accofil 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 Accofil 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 Accofil is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Accofil anvendes så sikkert som muligt.
English: Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil the next day and daily for up to 14 days.
Danish: Patienterne fik kemoterapien på dag ét i en 3-ugers cyklus og fik derefter én dosis af Accofil næste dag og dagligt i op til 14 dage.
English: Other information about Accofil
Danish: Andre oplysninger om Accofil
English: Accofil is a medicine that is used to stimulate the production of white blood cells in the following situations:
Danish: Accofil er et lægemiddel, der anvendes til at stimulere produktionen af hvide blodlegemer i følgende situationer:
English: The way Accofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Danish: Hvordan Accofil gives, og i hvilken dosis og hvor længe, afhænger af, hvorfor det bruges, patientens legemsvægt og behandlingens virkning.
English: This means that Accofil is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Accofil svarer til et biologisk lægemiddel (“referencelægemidlet”), som allerede er godkendt i EU.
English: What is Accofil and what is it used for?
Danish: Hvad er Accofil, og hvad anvendes det til?
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Neupogen, og anbefalede, at det godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Accofils og Neupogens kvalitet, sikkerhed og virkning svarer til hinanden.
English: Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia.
Danish: Accofil var genstand for én hovedundersøgelse med deltagelse af 120 voksne kvinder med brystkræft, der blev behandlet med kemoterapi, som vides at medføre neutropeni.
English: What measures are being taken to ensure the safe and effective use of Accofil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Accofil?
English: The reference medicine for Accofil is Neupogen.
Danish: Referencelægemidlet for Accofil er Neupogen.
English: The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Danish: Den hyppigste bivirkning med Accofil (som ses hos flere end 1 ud af 10 behandlede), er smerter i muskler og knogler (muskuloskeletale smerter).
English: The main measure of effectiveness was the duration of severe neutropenia.
Danish: Behandlingens virkning blev hovedsagelig bedømt på varigheden af svær neutropeni.
English: Why is Accofil approved?
Danish: Hvorfor er Accofil blevet godkendt?
English: It is not intended to provide practical advice on how to use Accofil.
Danish: Det er ikke en praktisk vejledning i, hvordan Accofil skal anvendes.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for.
Danish: Andre bivirkninger kan ses hos flere end 1 ud af hver 10 behandlede, afhængigt af, hvilken sygdom Accofil anvendes mod.
English: Accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine'.
Danish: Accofil, der indeholder det aktive stof filgrastim, er et “biosimilært lægemiddel”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Accofil, 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 Accofil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The filgrastim in Accofil is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.
Danish: Filgrastim i Accofil fremstilles ved “rekombinant DNA-teknologi”: Det produceres af bakterier, der har fået indsat et gen (DNA), som gør dem i stand til at producere filgrastim.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Danish: Offentliggjorte undersøgelser viser, at fordelene og sikkerheden med hen syn til filgrastim ikke adskiller sig mellem voksne og børn, der får kemoterapi.
English: Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Danish: Filgrastim virker ligesom naturligt dannet G-CSF ved at stimulere knoglemarven til at producere flere hvide blodlegemer.
English: What are the risks associated with Accofil?
Danish: Hvilke risici er der forbundet med Accofil?
English: The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Danish: Det aktive stof i Accofil er filgrastim, der meget ligner den humane protein granulocytkolonistimulerende faktor (G-CSF).
English: For more information about treatment with Accofil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Accofil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions reported with Accofil, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Accofil fremgår af indlægssedlen.
English: It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Danish: Lægemidlet fås kun på recept, og ordination og behandling skal ske i samarbejde med en kræftafdeling.
English: Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.
Danish: Der er udført undersøgelser, som viser, at Accofil frembringer samme mængde af det aktive stof i kroppen som Neupogen og øger antallet af neutrofile hvide blodlegemer lige så meget.
English: • to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Danish: • for at behandle varig neutropeni hos patienter med fremskreden infektion med hiv (humant immundefektvirus) med henblik på at nedsætte risikoen for bakterielle infektioner, når andre behandlinger ikke kan anvendes
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);
Danish: • for at mindske varigheden af for lavt indhold af hvide blodlegemer af typen neutrofile (neutropeni) og forekomsten af neutropeni med feber (febril neutropeni) hos patienter, som får celledræbende kræftmedicin (cytotoksisk kemoterapi)
English: More information can be found in the summary of product characteristics (also part of the EPAR).
Danish: Flere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: It is given by injection under the skin or infusion into a vein.
Danish: Accofil gives ved injektion under huden eller med drop i en vene.
English: Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes.
Danish: Accofil leveres som injektionsvæske eller som infusionsvæske (til drop) i fyldte sprøjter.
English: For practical information about using Accofil, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Accofil, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
Danish: • for at stimulere frigivelsen af celler fra knoglemarven hos donorer af stamceller til transplantation
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Danish: • for at øge indholdet af neutrofile og nedsætte risikoen for infektioner hos patienter med neutropeni, som tidligere har haft gentagne svære infektioner
English: What benefits of Accofil have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Accofil?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Danish: • for at nedsætte varigheden af neutropeni hos patienter, som er i behandling med henblik på at ødelægge cellerne i knoglemarven før en knoglemarvstransplantation (således visse patienter med leukæmi), hvis patienten har risiko for langvarig svær neutropeni
English: How is Accofil used?
Danish: Hvordan anvendes Accofil?
English: How does Accofil work?
Danish: Hvordan virker Accofil?
English: 10 (2 x 5) pre-filled pens (multipack)
Danish: 10 (2 x 5) fyldte penne (multipakning)
English: The medicine is used when initial treatment has not worked or the cancer has come back.
Danish: Lægemidlet anvendes, når den oprindelige behandling ikke har virket, eller kræften er vendt tilbage.
English: Carmustine Obvius is a ‘generic medicine'.
Danish: Carmustine Obvius er et "generisk lægemiddel".
English: Carmustine Obvius (carmustine) EMA/273425/2018
Danish: Carmustine Obvius (carmustin) EMA/273425/2018
English: • brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
Danish: • hjernetumorer (både dem, der udvikles direkte i hjernen, og dem, som har spredt sig fra andre dele af kroppen (metastaserende hjernetumorer))
English: • Hodgkin's lymphoma and non-Hodgkin's lymphomas, types of cancer that originate from white blood cells.
Danish: • Hodgkins lymfom og non-Hodgkins lymfom (kræfttyper, der opstår i de hvide blodlegemer).
English: Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:
Danish: Carmustine Obvius er et kræftlægemiddel, der anvendes alene eller sammen med andre kræftlægemidler og -behandlinger til behandling af følgende typer kræft:
English: It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription.
Danish: Det skal gives under overvågning af en læge med erfaring i anvendelsen af kræftlægemidler og udleveres kun efter recept.
English: For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Carmustine Obvius, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Further information on Carmustine Obvius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Carmustine Obvius findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Information om referencelægemidlet findes også på agenturets websted.
English: Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Carmustine Obvius er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Carmustine Obvius kan sammenlignes med Carmubris.
English: An overview of Carmustine Obvius and why it is authorised in the EU
Danish: Oversigt over Carmustine Obvius, og hvorfor det er godkendt i EU
English: Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Carmustine Obvius vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Other information about Carmustine Obvius
Danish: Andre oplysninger om Carmustine Obvius
English: Carmustine Obvius (carmustine)
Danish: Carmustine Obvius (carmustin)
English: By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading.
Danish: Carmustin virker ved at skade DNA'en i kræftcellerne, hvilket slår dem ihjel, og dermed forhindres kræften i at vokse og sprede sig.
English: It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply.
Danish: Det forstyrrer DNA's og RNA's normale funktion og reparationen af dem (DNA og RNA indeholder de genetiske oplysninger, som celler har brug for for at fungere og dele sig).
English: As for every medicine, the company provided studies on the quality of Carmustine Obvius.
Danish: Som for alle lægemidler har firmaet leveret studier vedrørende kvaliteten af Carmustine Obvius.
English: As for all medicines, data on the use of Carmustine Obvius are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Carmustine Obvius løbende overvåget.
English: There was no need for ‘bioequivalence' studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Carmustine Obvius optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
English: This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Carmubris.
Danish: Det betyder, at Carmustine Obvius indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Carmubris.
English: What is Carmustine Obvius and what is it used for?
Danish: Hvad er Carmustine Obvius, og hvad anvendes det til?
English: What are the benefits and risks of Carmustine Obvius?
Danish: Hvilke fordele og risici er der forbundet med Carmustine Obvius?
English: What measures are being taken to ensure the safe and effective use of Carmustine Obvius?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Carmustine Obvius?
English: Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.
Danish: Der er allerede foretaget studier over det aktive stof carmustins fordele og risici ved godkendt brug med referencelægemidlet, Carmubris, og de behøver ikke at blive gentaget for Carmustine Obvius.
English: This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Carmustine Obvius gives ved infusion i en blodåre, så det aktive stof ledes direkte ind i blodbanen.
English: Carmustine Obvius is given by infusion (drip) into a vein.
Danish: Carmustine Obvius gives som infusion (drop) i en blodåre.
English: Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent.
Danish: Carmustin, der er det aktive stof i dette lægemiddel, tilhører en gruppe kræftlægemidler, der kaldes "alkylerende stoffer".
English: Why is Carmustine Obvius authorised in the EU?
Danish: Hvorfor blev Carmustine Obvius godkendt i EU?
English: Therefore, the Agency's view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Carmustine Obvius opvejer de identificerede risici, som for Carmubris, og at det kan godkendes til anvendelse i EU.
English: A dose based on the patient's weight and height is given at intervals of at least 6 weeks, and should be adjusted according to the patient's blood cell counts.
Danish: Dosen afhænger af patientens vægt og højde og gives med mindst 6 ugers mellemrum.
English: Because cancer cells tend to grow and multiply more than normal
Danish: Eftersom kræftceller typisk vokser og deler sig hurtigere end normale celler, er de mere sårbare over for dette
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius 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 Carmustine Obvius.
English: How has Carmustine Obvius been studied?
Danish: Hvordan blev Carmustine Obvius undersøgt?
English: How is Carmustine Obvius used?
Danish: Hvordan anvendes Carmustine Obvius?
English: How does Carmustine Obvius work?
Danish: Hvordan virker Carmustine Obvius?
English: Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011
Danish: Dato for første markedsføringstilladelse: 26. juni 2006 Dato for sidste fornyelse af tilladelse: 26. juni 2011
English: Normalization of:f
Danish: Normalisering af: f
English: 2 years After opening, the solution can be used up to the expiry date on the bottle.
Danish: 2 år Efter åbning kan opløsningen anvendes indtil udløbsdatoen angivet på flasken.
English: If you forget to take Baraclude
Danish: Hvis du har glemt at tage Baraclude
English: Patients treated and monitored for resistanceb
Danish: Patienter behandlet og monitoreret for resistensb
English: Some people get very serious hepatitis symptoms when they stop taking Baraclude.
Danish: Nogle mennesker får meget alvorlige leversymptomer, når de holder op med at tage Baraclude.
English: Baraclude should be taken orally.
Danish: Baraclude skal tages oralt.
English: When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.
Danish: Hvis behandlingen med Baraclude skal stoppes, vil din læge følge dig og tage blodprøver igennem flere måneder.
English: Your doctor will monitor you regularly while you are receiving Baraclude.
Danish: Lægen vil jævnligt kontrollere dig, mens du tager Baraclude.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.