FrancophonIA/ELRC3.0 huggingface dataset:
English: prolonged pancytopenia, aplastic anaemia Neoplasm benign, malignant and unspecified Very rare:
Danish: Erythema multiforme, erythroderma, urticaria, exantem Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma
Danish: Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom En behandlingsserie består af 28 dage.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/001
English: Temomedac 20 mg hard capsules shellac propylene glycol, titanium dioxide (E171) sunset yellow FCF (E110) aluminium lake
Danish: Temomedac 20 mg hårde kapsler: gelatin, titandioxid (E 171), shellac, propylenglycol, Sunset Yellow FCF (E 110).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/605/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/605/005
English: What Temomedac looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: condition aggravated, rigors, tongue discolouration, parosmia, thirst
Danish: Asteni, rødmen, hedestigninger, forværret tilstand, rigor, misfarvet
English: Binocrit received a marketing authorisation valid throughout the EU on 28 August 2007.
Danish: Binocrit fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2007.
English: Further information on Binocrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Binocrit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Binocrit must not be used in the following groups:
Danish: Binocrit må ikke anvendes til følgende grupper:
English: This means that Binocrit is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Binocrit i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: As for all medicines, data on the use of Binocrit are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Binocrit løbende overvåget.
English: The most common side effects with Binocrit (which may affect more than 1 in 10 people) are nausea (feeling sick),diarrhoea, vomiting, fever and headache.
Danish: De hyppigste bivirkninger ved Binocrit (der kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, diarré, opkastning, feber og hovedpine.
English: Other information about Binocrit
Danish: Andre oplysninger om Binocrit
English: When Binocrit is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Danish: Når Binocrit anvendes til autolog blodtransfusion, skal de begrænsninger, der normalt gælder for denne form for transfusion, overholdes.
English: An overview of Binocrit and why it is authorised in the EU
Danish: En oversigt over Binocrit, og hvorfor det er godkendt i EU
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
Danish: • patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt produktion af røde blodlegemer)
English: Side effects reported with Binocrit are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Binocrit vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: For more information about using Binocrit, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Binocrit, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Binocrit?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Binocrit?
English: For patients with kidney failure, myelodysplastic syndromes or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Danish: Hos patienter med nyresvigt eller myelodysplastisk syndrom og patienter i kemoterapi bør hæmoglobinniveauet holdes inden for det anbefalede interval (10-12 g/dl hos voksne og 9,5-11 g/dl hos børn).
English: The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Danish: Det primære mål for virkningen var ændringen i blodets indhold af hæmoglobin fra studiets start til vurderingsperioden, dvs. fra uge 25 til uge 29.
English: Binocrit is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Danish: Binocrit anvendes, når patienterne har lav eller mellemstor risiko for at udvikle akut myeloid leukæmi og har et lavt niveau af det naturlige hormon erytropoietin.
English: Binocrit is a medicine used for the following:
Danish: Binocrit er et lægemiddel, der anvendes til:
English: Why is Binocrit authorised in the EU?
Danish: Hvorfor blev Binocrit godkendt i EU?
English: Binocrit contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Danish: Binocrit indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel".
English: What is Binocrit and what is it used for?
Danish: Hvad er Binocrit, og hvad anvendes det til?
English: Binocrit, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Danish: Binocrit injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer.
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Danish: Hæmoglobin er et protein i de røde blodlegemer, som transporterer ilt rundt i kroppen.
English: All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Binocrit or remained on Eprex/Erypo.
Danish: Alle patienterne havde fået Eprex/Erypo som injektion i en blodåre i mindst 8 uger, inden de enten skiftede til Binocrit eller fortsatte med Eprex/Erypo.
English: Binocrit is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Danish: Binocrit fås i fyldte sprøjter med forskellig styrke og indgives som injektion i en blodåre eller som injektion under huden, alt efter hvilken sygdom patienten behandles for.
English: The reference medicine for Binocrit is Eprex/Erypo.
Danish: Referencelægemidlet for Binocrit er Eprex/Erypo.
English: Because Binocrit is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Binocrit.
Danish: Da Binocrit er et biosimilært lægemiddel, behøver de studier af epoetin alfas virkning og sikkerhed, der er udført for Eprex/Erypo, ikke at blive gentaget for Binocrit.
English: A further study showed that Binocrit was safe and effective when given under the skin in 416 patients with chronic kidney failure.
Danish: Et yderligere studie viste, at Binocrit var sikkert og effektivt, når det blev injiceret under huden, hos 416 patienter med kronisk nyresvigt.
English: What are the risks associated with Binocrit?
Danish: Hvilke risici er der forbundet med Binocrit?
English: Binocrit can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Binocrit is used for.
Danish: Binocrit udleveres kun efter recept, og behandlingen skal iværksættes under tilsyn af en læge, der har erfaring i behandling af patienter med de sygdomme, som lægemidlet er beregnet til.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Danish: • behandling af anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Danish: Binocrit anvendes til patienter med normalt jernindhold i blodet, hos hvem der vil kunne opstå komplikationer ved blodtransfusion, hvis de ikke inden operationen får tappet blod til eget brug, og som forventes at miste 9001 800 ml blod.
English: Patients switching to Binocrit maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Danish: Patienter, der skiftede til Binocrit, fastholdt niveauet af hæmoglobin i samme grad som dem, der fortsatte med Eprex/Erypo.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Binocrit has a highly similar structure, purity and biological activity to Eprex/Erypo 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 Binocrit har en struktur, renhed og biologisk aktivitet, der svarer til Eprex/Erypos, og at det fordeles i kroppen på samme måde.
English: The active substance in Binocrit, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Danish: Det aktive stof i Binocrit, epoetin alfa, er en kopi af det menneskelige hormon erytropoietin og har nøjagtigt samme stimulerende virkning på dannelsen af røde blodlegemer i rygmarven som det naturlige hormon.
English: For the full list of side effects of Binocrit, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Binocrit fremgår af indlægssedlen.
English: Another study showed that Binocrit injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Danish: Et andet studie viste, at Binocrit injiceret under huden var lige så effektivt som Eprex/Erypo til at fastholde hæmoglobinniveauet hos 114 kræftpatienter, der var i behandling med kemoterapi.
English: Laboratory studies comparing Binocrit with the reference medicine Eprex/Erypo have shown that the active substance in Binocrit is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Binocrit med referencelægemidlet Eprex/Erypo, har vist, at det aktive stof i Binocrit svarer til det aktive stof i Eprex/Erypo, hvad angår struktur, renhed og biologisk aktivitet.
English: How is Binocrit used?
Danish: Hvordan anvendes Binocrit?
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Binocrit outweighs the identified risk and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Binocrit opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes.
English: Studies have also shown that giving Binocrit produces similar levels of the active substance in the body to giving Eprex/Erypo.
Danish: Studier har også vist, at Binocrit giver samme niveau af det aktive stof i kroppen som Eprex/Erypo.
English: In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Danish: Desuden har studier vist, at lægemidlet er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer hos patienter, der har kronisk nyresvigt, eller som er i behandling med kemoterapi.
English: In addition, Binocrit was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Danish: Desuden er det i adskillige studier påvist, at Binocrit er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Binocrit 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 Binocrit.
English: How does Binocrit work?
Danish: Hvordan virker Binocrit?
English: What benefits of Binocrit have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Binocrit?
English: The dose, the frequency of injection and how long it is used for also depend on why Binocrit is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Danish: Injektionen under huden kan indgives af patienterne selv eller deres omsorgspersoner, hvis de har lært at gøre det. Dosen, injektionshyppigheden og behandlingsvarigheden beregnes ud fra, hvad Binocrit anvendes til og hvor meget patienten vejer, og skal desuden tilpasses patientens respons.
English: Let it dry completely before you use it again.
Danish: Lad den tørre helt, inden du bruger den igen.
English: These differences were observed in each different age group studied.
Danish: Disse forskelle blev set i hver undersøgt aldersgruppe.
English: Sucrose may be harmful to the teeth.
Danish: Saccharose kan være skadeligt for tænderne.
English: Take the syringe out of the bottle and wash it thoroughly in clean water.
Danish: Tag sprøjten op af flasken, og vask den grundigt i rent vand.
English: These may cause allergic reactions (possibly delayed).
Danish: Disse kan muligvis forårsage allergiske reaktioner (muligvis forsinket).
English: Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Danish: Gentag trin 3 til 7, indtil du har fået din samlede dosis.
English: The dose should therefore be adjusted (see tables).
Danish: Dosis bør derfor justeres (se tabellerne).
English: No specific signs or symptoms have been identified following such overdose.
Danish: Der er ikke iagttaget særlige tegn eller symptomer i forbindelse med overdosering.
English: Absorption differences have been observed between adult and paediatric populations (see Special populations).
Danish: Der er blevet observeret forskel i absorptionen mellem voksne og pædiatriske populationer (se Særlige populationer).
English: If you have taken Epivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Epivir under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Danish: Frekvenserne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Epivir helbreder ikke hiv-infektionen fuldstændigt, men nedsætter mængden af virus i kroppen og bevarer den på et lavt niveau.
English: • aches and pains (especially in the hip, knee or shoulder)
Danish: • ømhed og smerter (særligt i hofter, knæ eller skuldre)
English: 3 to 12 years (N=35)
Danish: 3 til 12 år (N=35)
English: Pancreatitis: Cases of pancreatitis have occurred rarely.
Danish: Pancreatitis: Der er i sjældne tilfælde set pancreatitis.
English: Epivir helps to control your condition.
Danish: Epivir hjælper til med at holde din sygdom under kontrol.
English: Date of first authorisation: 15 November 2001 Date of last renewal: 28 July 2006
Danish: Dato for første markedsføringstilladelse: 15. november 2001 Dato for fornyelse: 28. juli 2006
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-smitte spredes ved seksuel kontakt med en person, der har sygdommen, eller via smittet blod (f.eks. ved at dele injektionsnåle med andre).
English: Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in paediatric patients below 12 years of age.
Danish: Børn: Den absolutte biotilgængelighed af lamivudin (ca. 58-66 %) var reduceret hos pædiatriske patienter under 12 år.
English: If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Epivir.
Danish: Hvis du er gravid, bliver gravid eller planlægger at blive gravid, skal du tale med lægen om risici og fordele ved Epivir for dig og dit barn.
English: More than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect.
Danish: Udfaldet af flere end 1.000 eksponeringer under første trimester og flere end 1.000 eksponeringer under andet og tredje trimester hos gravide kvinder indikerede ingen misdannelser eller føtal/neonatal toksicitet.
English: There are limited pharmacokinetic data for patients less than three months of age.
Danish: Der er begrænsede farmakokinetiske data fra patienter under 3 måneder.
English: The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic potential relevant for humans.
Danish: Resultaterne fra langtidskarcinogenicitetsstudier hos rotter og mus viste intet karcinogent potentiale med relevans for mennesker.
English: Date of first authorisation: 8 August 1996 Date of last renewal: 28 July 2006
Danish: Dato for første markedsføringstilladelse: 8. august 1996 Dato for fornyelse: 28. juli 2006
English: mannitol, lactitol or maltitol), if taken regularly
Danish: xylitol, mannitol, lactitol eller maltitol), hvis de anvendes regelmæssigt
English: For example, if your dose is 15 ml, you need to take one and a half syringe-fulls of medicine.
Danish: Hvis din samlede dosis f.eks. er 15 ml, skal du tage en og en halv sprøjte fyldt med medicin.
English: It also increases the CD4 cell count in your blood.
Danish: Epivir øger også antallet af CD4-celler i dit blod.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler
English: Epivir can be taken with or without food.
Danish: Epivir kan indtages med eller uden mad.
English: Important information about some of the ingredients of Epivir
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Epivir
English: The true extent of penetration or relationship with any clinical efficacy is unknown.
Danish: Det sande omfang af penetrationen og sammenhængen med klinisk effekt er ukendt.
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany
Danish: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Tyskland
English: You need to know about important signs and symptoms to look out for while you are taking Epivir.
Danish: Du bør kende til vigtige tegn og symptomer, som du skal holde øje med, mens du tager Epivir.
English: • if their immune systems are very weak • if they are overweight.
Danish: • hvis dit immunsystem er meget svækket • hvis du er overvægtig.
English: Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations (see section 5.2).
Danish: Børn under 3 måneder: De begrænsede data, der foreligger, er utilstrækkelige til at foreslå specifikke doseringsanbefalinger (se pkt.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige sygdomme som fructoseintolerans, glucose-galactose malabsorption eller underskud af sucrase-isomaltase bør ikke tage dette lægemiddel.
English: Instructions for use are included in the pack.
Danish: Brugervejledning findes i pakningen.
English: Pull out syringe plunger until the syringe contains the first part of your full dose.
Danish: Træk i sprøjtens stempel, indtil sprøjten indeholder den første mængde af din samlede dosis.
English: Not everyone responds to treatment with Epivir in the same way.
Danish: Ikke alle reagerer ens på behandlingen med Epivir.
English: The therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør initieres af en læge med erfaring i behandling af hiv-infektion.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, der er hiv-positive, må ikke amme, da hiv-infektionen kan overføres til barnet gennem mælken.
English: • tingling or numbness of the arms, legs, hands or feet.
Danish: • prikken eller følelsesløshed i hænderne, armene, benene eller fødderne.
English: Do not push too hard and squirt the liquid into the back of your throat or you may choke.
Danish: Du må ikke trykke for hårdt eller sprøjte opløsningen ned i halsen, da du risikerer kvælning.
English: Treatment with Epivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Danish: Behandling med Epivir bør stoppes omgående, hvis kliniske tegn, symptomer eller unormale laboratoriefund tyder på udvikling af pancreatitis.
English: The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Danish: De bivirkninger, der anses for at kunne relateres til behandlingen, er nævnt nedenfor fordelt efter legemsdele, organklasser og absolut frekvens.
English: These results were obtained in an antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC stage A).
Danish: Disse resultater er opnået i en antiretroviral naive gruppe, primært bestående af asymptomatisk hiv-inficerede patienter (CDC trin A).
English: PVC/aluminium foil blister packs:
Danish: PVC/aluminium blisterpakning:
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii pneumoni (ofte omtalt som PCP).