FrancophonIA/ELRC3.0 huggingface dataset:
English: How to use DuoTrav
Danish: Sådan skal du bruge DuoTrav
English: Skin: skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, peeling skin, abnormal hair texture, inflammation of the skin with itchy rash and redness, hair colour change, loss of eyelashes, itching, abnormal hair growth, skin redness.
Danish: Hud: Hvidligt, sølvfarvet (psoriasis-agtigt) udslæt eller forværring af psoriasis, afskalning af huden, unormal hårstruktur, betændelse i huden med kløende udslæt og rødme, ændring i hårfarve, tab af øjenvipper, kløe, unormal hårvækst, rødme i huden.
English: • if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough), or other types of breathing problems.
Danish: • hvis du har eller tidligere har haft åndedrætsproblemer såsom astma, alvorlig, kronisk,
English: Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see section 5.2).
Danish: Det er usandsynligt, at en dosisjustering af DuoTrav vil være nødvendig hos patienter med nedsat lever- eller nyrefunktion (pkt.
English: If you wear soft contact lenses do not use the drops with your lenses in. After using the drops wait 15 minutes before putting your lenses back in.
Danish: Hvis du bruger bløde kontaktlinser, må du ikke bruge dråberne med kontaktlinser i øjnene.
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops travoprost/timolol
Danish: DuoTrav 40 mikrog/ml + 5 mg/ml øjendråber travoprost/timolol
English: Thinning of the eye surface, inflammation of the eyelid glands, broken blood vessel in the eye, eyelid crusting, abnormally positioned eyelashes, abnormal growth of lashes.
Danish: Øjets overflade bliver tyndere, betændelse i øjenlågets kirtler, blodsprængninger i øjet, skorper på øjenlåget, usædvanligt placerede øjenvipper og unormal vækst af øjenvipper.
English: Rare side effects (may affect up to 1 in 1,000 people) Effects in the eye
Danish: Sjældne bivirkninger (kan forekomme hos 1 ud af 1.000 personer) Reaktioner i øjet
English: Uveitis, conjunctival follicles, eye discharge, periorbital oedema, eyelids pruritus, ectropion, cataract, iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, halo vision, hypoaesthesia eye, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, visual field defect
Danish: Uveitis, konjunktivale follikler, sekret fra øjet, periorbitalt ødem, kløende øjenlåg, ektropion, katarakt, iridocyclitis, herpes simplex i øjet, øjeninflammation, fotopsi, øjenlågseksem, halosyn, hypoæstesi i øjet, forkammerpigmentering, mydriasis, hyperpigmentering af øjenvipper, fortykkelse af øjenvipper, defekt i synsfeltet
English: In a 6-week controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of DuoTrav (polyquaternium-1-preserved) dosed once daily in the morning was 8 mmHg and equivalent to that of DuoTrav (benzalkonium chloride-preserved).
Danish: I et 6-ugers kontrolleret klinisk studie med patienter, der har åbenvinklet glaukom eller okulær hypertension og et gennemsnitligt intraokulært tryk på 24-26 mmHg ved baseline, var den gennemsnitlige intraokulære tryksænkning af DuoTrav (konserveret med polyquaternium-1) doseret 1 gang daligt om morgenen 8 mmHg og ækvivalent med effekten af DuoTrav (konserveret med benzalkoniumchlorid).
English: Inflammation of the eye surface, inflammation of the eyelid, swollen conjunctiva, increased growth of eyelashes, iris inflammation, eye inflammation, sensitivity to light, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, eyelid colour change, skin darkening (around the eye).
Danish: Betændelse på øjets overflade, betændelse på øjenlåget, hævet bindehinde (det hvide i øjet), øget vækst af øjenvipper, betændelse i den farvede del af øjet (iris), betændelse i øjet, lysfølsomme øjne, nedsat syn, trætte øjne, øjenallergi, hævelse af øjet, øget tåredannelse, røde øjenlåg, ændring af øjenlågets farve, mørkere hud (rundt om øjet/øjnene).
English: Oedema, congestive heart failure, atrioventricular block, cardiac arrest
Danish: Ødem, kongestiv hjerteinsufficiens, AV-blok, hjertestop
English: Choroidal detachment
Danish: Perifert ødem
English: • coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure.
Danish: • forkalkning af kranspulsåren (symptomer kan være brystsmerter eller trykken for brystet,
English: Rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation, palpitations, swelling in the lower limbs, bad taste.
Danish: Udslæt, hjertesvigt, brystsmerter, slagtilfælde, besvimelse, depression, astma, hurtigere hjerterytme (puls), følelsesløshed eller snurrende fornemmelse i huden, hjertebanken, hævede underben og underarme, dårlig smag i munden.
English: In two three-month controlled clinical studies in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 23 to 26 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 7 to 9 mmHg.
Danish: I to tre-måneders kontrollerede kliniske studier med patienter med åbenvinklet glaukom eller okulær hypertension og med gennemsnitligt IOP ved baseline på 23 til 26 mmHg var den gennemsnitlige IOP-sænkende virkning af DuoTrav doseret en gang dagligt om morgenen 7 til 9 mmHg.
English: Ophthalmic beta blockers may induce dryness of eyes.
Danish: Oftalmologiske betablokkere kan medføre øjentørhed.
English: Punctate keratitis, eye pain, visual disturbance, vision blurred, dry eye, eye pruritus, ocular discomfort, eye irritation
Danish: Punktat keratit, øjensmerter, synsforstyrrelser, sløret syn, tørre øjne, øjenkløe, okulært ubehag, øjenirritation
English: In a twelve-month controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 25 to 27 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 8 to 10 mmHg.
Danish: I et tolv-måneders kontrolleret klinisk studie, med patienter med åbenvinklet glaukom eller okulær hypertension og gennemsnitligt IOP ved baseline på 25 til 27 mmHg, var den gennemsnitlige IOP-sænkende virkning af DuoTrav doseret en gang dagligt om morgenen 8 til 10 mmHg.
English: Very common side effects (may affect more than 1 in 10 people) Effects in the eye
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end l ud af 10 personer) Reaktioner i øjet
English: Uncommon Keratitis, iritis, conjunctivitis, anterior chamber inflammation, blepharitis, photophobia, visual acuity reduced, asthenopia, eye swelling, lacrimation increased, erythema of eyelid, growth of eyelashes, eye allergy, conjunctival oedema, eyelid oedema
Danish: Keratitis, iritis, konjunktivitis, forkammerinflammation, blefaritis, fotofobi, nedsat skarpsyn, astenopi, hævelse i øjet, øget tåredannelse, øjenlågserytem, vækst af øjenvipper, øjenallergi, konjunktivalt ødem, øjenlågsødem
English: Eye surface inflammation with surface damage, eye pain, blurred vision, abnormal vision, dry eye, itchy eye, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).
Danish: Betændelse på øjet med overfladeskader, smerter i øjet, sløret syn, unormalt syn, tørre øjne, øjenkløe, ubehag i øjet, tegn og symptomer på øjenirritation (f.eks. brænden, svien).
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret DuoTrav til dig personligt.
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain, arthralgia Renal and urinary disorders
Danish: Muskuloskeletale smerter, artralgi
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution travoprost/timolol
Danish: DuoTrav 40 mikrogram/ml + 5 mg/ml øjendråber, opløsning travoprost/timolol
English: Common side effects (may affect up to 1 in 10 people) Effects in the eye
Danish: Almindelige bivirkninger (kan forekomme hos 1 ud af 10 personer) Reaktioner i øjet
English: If you use more DuoTrav than you should
Danish: Hvis du har brugt for meget DuoTrav
English: Travoprost, a prostaglandin F2α analogue, is a full agonist which is highly selective and has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.
Danish: Det er en meget selektiv fuld agonist, som har en høj affinitet for prostaglandin-FP-receptoren.
English: Like other topically applied ophthalmic agents, travoprost and timolol are absorbed systemically.
Danish: Travoprost og timolol absorberes lige som andre oftalmologiske midler systemisk.
English: What DuoTrav is and what it is used for What you need to know before you use DuoTrav How to use DuoTrav
Danish: Det skal du vide, før du begynder at bruge DuoTrav Sådan skal du bruge DuoTrav Bivirkninger
English: Uncommon side effects (may affect up to 1 in 100 people) Effects in the eye
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 100 personer) Reaktioner i øjet
English: DuoTrav 40 micrograms/mL + 5 mg/mL eye drops, solution
Danish: DuoTrav 40 mikrogram/ml + 5 mg/ml øjendråber, opløsning.
English: Arrhythmia, heart rate irregular Not known Cardiac failure, tachycardia, chest pain, palpitations
Danish: Hjerteinsufficiens, takykardi, brystsmerter, palpitationer
English: Dysphonia, bronchospasm, cough, throat irritation, oropharyngeal pain, nasal discomfort Not known Asthma
Danish: Dysfoni, bronkospasme, hoste, halsirritation, orofaryngeale smerter, ubehag i næsen
English: Gastrointestinal: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting and constipation.
Danish: Mave-tarm-kanalen: Forandringer i smag, kvalme, fordøjelsesbesvær, diarré, mundtørhed, mavesmerter, opkastning og forstoppelse.
English: 1 x 2.5 ml - PP bottle
Danish: 1 x 2,5 ml - PP-flaske
English: 1 x 2.5 ml - LDPE bottle
Danish: 1 x 2,5 ml - LDPE-flaske
English: 6 x 2.5 ml - PP bottle
Danish: 6 x 2,5 ml - PP-flaske
English: 6 x 2.5 ml - LDPE bottle
Danish: 6 x 2,5 ml - LDPE-flaske
English: 3 x 2.5 ml - PP bottle
Danish: 3 x 2,5 ml - PP-flaske
English: 3 x 2.5 ml - LDPE bottle
Danish: 3 x 2,5 ml - LDPE-flaske
English: Not known Macular oedema, eyelid ptosis, lid sulcus deepened, iris hyperpigmentation, corneal disorder
Danish: Makulaødem, øjenlågs-ptose, fordybning af øjenlågets sulcus, irishyperpigmentation, lidelse i cornea
English: Asthenia
Danish: Depression
English: Psoriasiform rash or exacerbation of psoriasis Musculoskeletal and connective tissue disorders Myalgia Reproductive system and breast disorders
Danish: Psoriasiformt udslæt eller forværring af psoriasis
English: Uncommon Dizziness, headache Not known Cerebrovascular accident, syncope, paraesthesia
Danish: Cerebrovaskulær hændelse, synkope, paræstesi
English: Frequency Adverse reactions
Danish: Systemorganklasse Hyppighed
English: Renal and urinary disorders Rare
Danish: Lever og galdeveje Sjælden
English: Uncommon Hypersensitivity
Danish: Hypertension, hypotension
English: OVERWRAP
Danish: Overfølsomhed
English: Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway.
Danish: Allergi: Øgede allergiske symptomer, generelle allergiske reaktioner, inkl.
English: This summary was last updated in 04-2016.
Danish: Denne oversigt blev sidst ajourført i 08-2018.
English: The full EPAR for Epoetin Alfa Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Epoetin Alfa Hexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Danish: Jernindholdet bør kontrolleres hos alle patienter for at sikre, at det ikke er for lavt, og der bør om nødvendigt gives jerntilskud.
English: For patients with kidney failure 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: Virkningen blev hovedsageligt målt på ændringen i blodets indhold af hæmoglobin fra studiets start til vurderingsperioden, dvs. fra uge 25 til 29.
English: When Epoetin Alfa Hexal is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Danish: Når Epoetin Alfa Hexal anvendes til autolog blodtransfusion, skal de begrænsninger, der normalt gælder for denne form for transfusion, overholdes.
English: The most common side effects with Epoetin Alfa Hexal (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache.
Danish: De hyppigste bivirkninger ved Epoetin Alfa Hexal (der kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, diarré, opkastning, feber og hovedpine.
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots.
Danish: • patienter, der gennemgår kirurgiske indgreb, og som ikke må få lægemidler til forebyggelse af blodpropper
English: The European Commission granted a marketing authorisation valid throughout the European Union for Epoetin Alfa Hexal on 28 August 2007.
Danish: Epoetin Alfa Hexal fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2007.
English: Epoetin Alfa Hexal must not be used in the following groups:
Danish: Epoetin Alfa Hexal må ikke anvendes til følgende grupper:
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Danish: Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturlige erytropoietin.
English: Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Danish: Epoetin Alfa Hexal injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer.
English: What measures are being taken to ensure the safe and effective use of Epoetin Alfa Hexal?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Epoetin Alfa Hexal?
English: All of the patients had been receiving Eprex/Erypo injected into a vein for at least eight weeks before they were either switched to Epoetin Alfa Hexal 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 Epoetin Alfa Hexal eller fortsatte med Eprex/Erypo.
English: The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo.
Danish: Referencelægemidlet for Epoetin Alfa Hexal er Eprex/Erypo.
English: It must not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Danish: • patienter, der skal have foretaget større ortopædkirurgiske indgreb, og som har alvorlige hjerte kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde.
English: It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Danish: Epoetin Alfa Hexal 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 900-1.800 ml blod.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om biosimilære lægemidler her.
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;
Danish: • patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt dannelse af røde blodlegemer)
English: The active substance in Epoetin Alfa Hexal, 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 from the bone marrow.
Danish: Det aktive stof i Epoetin Alfa Hexal, 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: This means that Epoetin Alfa Hexal is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union (EU), which is known as the ‘reference medicine'.
Danish: Det betyder, at Epoetin Alfa Hexal i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: Other information about Epoetin Alfa Hexal
Danish: Andre oplysninger om Epoetin Alfa Hexal
English: Epoetin Alfa Hexal 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: Epoetin Alfa Hexal 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: Treatment with Epoetin Alfa Hexal must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
Danish: Epoetin Alfa Hexal 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: For more information about treatment with Epoetin Alfa Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: For mere information om brug af Epoetin Alfa Hexal, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Epoetin Alfa Hexal was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.
Danish: Desuden er det i adskillige studier påvist, at Epoetin Alfa Hexal er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer.
English: What is the risk associated with Epoetin Alfa Hexal?
Danish: Hvilke risici er der forbundet med Epoetin Alfa Hexal?
English: The study in patients with chronic kidney failure showed that Epoetin Alfa Hexal was safe and effective when given under the skin.
Danish: Et yderligere studie 416 patienter med kronisk nyresvigt viste, at Epoetin Alfa Hexal var sikkert og effektivt, når det blev injiceret under huden.
English: Why has Epoetin Alfa Hexal been approved?
Danish: Hvorfor blev Epoetin Alfa Hexal godkendt i EU?
English: In these cases, epoetin alfa is used to replace the missing hormone or to increase red blood cell counts.
Danish: I disse tilfælde anvendes epoetin alfa til at øge antallet af røde blodlegemer.
English: For the full list of all side effects reported with Epoetin Alfa Hexal, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Epoetin Alfa Hexal fremgår af indlægssedlen.
English: The dose, the frequency of injection and how long it is used for also depend on why Epoetin Alfa Hexal is being used and on the patient's bodyweight, and are adjusted according to the patient's response.
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 Epoetin Alfa Hexal anvendes til og hvor meget patienten vejer, og skal desuden tilpasses patientens respons.
English: In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo.
Danish: Patienter, der skiftede til Epoetin Alfa Hexal, fastholdt niveauet af hæmoglobin i samme omfang som dem, der fortsatte med Eprex/Erypo.
English: The CHMP concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Epoetin Alfa Hexal har en struktur, renhed og biologisk aktivitet, der svarer til Eprex/Erypos, og at det fordeles i kroppen på samme måde.
English: Epoetin Alfa Hexal is a ‘biosimilar' medicine.
Danish: Epoetin Alfa Hexal indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel".
English: The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/Erypo when it was injected under the skin.
Danish: Et andet studie med 114 kræftpatienter, der var i kemoterapi, viste, at Epoetin Alfa Hexal injiceret under huden var lige så effektivt som Eprex/Erypo til at fastholde hæmoglobinniveauet.
English: Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Epoetin Alfa Hexal opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
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 Epoetin Alfa Hexal.
English: Epoetin Alfa Hexal is used for the following:
Danish: Epoetin Alfa Hexal er et lægemiddel, der anvendes til:
English: What is Epoetin Alfa Hexal used for?
Danish: Hvad er Epoetin Alfa Hexal, og hvad anvendes det til?
English: How is Epoetin Alfa Hexal used?
Danish: Hvordan anvendes Epoetin Alfa Hexal?
English: What benefit has Epoetin Alfa Hexal shown during the studies?
Danish: Hvilke fordele viser studierne, at der er ved Epoetin Alfa Hexal?
English: How does Epoetin Alfa Hexal work?
Danish: Hvordan virker Epoetin Alfa Hexal?
English: Epoetin Alfa Hexal was studied to show that it is comparable to the reference medicine, Eprex/Erypo.
Danish: Laboratoriestudier, der sammenligner Epoetin Alfa Hexal med referencelægemidlet Eprex/Erypo, har påvist, at det aktive stof i Epoetin Alfa Hexal svarer til det aktive stof i Eprex/Erypo, hvad angår struktur, renhed og biologisk aktivitet.
English: What is Protium?
Danish: Hvad er Protium?
English: Dr Enzmann (Germany)
Danish: Dr. Enzmann (Tyskland)
English: The amended information to doctors and patients is available here The European Commission issued a decision on 15 April 2010.
Danish: De ændrede informationer for læger og patienter findes her Europa-Kommissionen traf en afgørelse den 15. april 2010.
English: The main areas harmonised include:
Danish: De vigtigste harmoniserede områder omfatter:
English: Protium is authorised in the EU via national procedures.
Danish: Protium er godkendt i EU efter nationale procedurer.