FrancophonIA/ELRC3.0 huggingface dataset:
English: Breakpoints apply to an oral dose of 500 mg x 1 to 500 mg x 2 and an intravenous dose of 500 mg x 1 to 500 mg x 2.
Danish: Grænseværdier gælder for en oral dosis på 500 mg dagligt til 500 mg 2 gange dagligt en intravenøs dosis på 500 mg dagligt til 500 mg 2 gange dagligt.
English: Acute bacterial exacerbations of chronic bronchitis
Danish: Akut bakteriel forværring af kronisk bronkitis
English: Bacteroides fragilis
Danish: Anaerobe bakterier Bacteroides fragilis
English: 500 mg once daily
Danish: 500 mg én gang dagligt
English: A score line allows adaptation of the dose in patients with impaired renal function.
Danish: En delekærv muliggør dosistilpasning til patienter med nedsat nyrefunktion.
English: Inherently Resistant Strains
Danish: Naturligt resistente stammer
English: The breakpoints for levofloxacin relate to high dose therapy.
Danish: Grænseværdier for levofloxacin relaterer til højdosisterapi.
English: • Temporary loss of vision
Danish: • Midlertidigt synstab
English: If you are not sure, talk to your doctor or pharmacist before taking Tavanic.
Danish: Er du i tvivl så spørg lægen eller på apoteket, hvis du er i tvivl, inden du tager Tavanic tabletter.
English: Tavanic tablets should be taken at least two hours before or after iron salts, zinc salts, magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents),and sucralfate administration, since reduction of absorption can occur (see section 4.5).
Danish: Tavanic tabletter skal indtages mindst to timer før eller efter administration af jernsalte, zinksalte, magnesium- eller aluminiumholdige antacida eller didanosin (kun didanosinpræparater med aluminium- eller magnesiumholdig buffer) og sucralfat, da absorptionen ellers kan nedsættes (se pkt.
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: - congenital long QT syndrome - concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia) - cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Danish: Der skal udvises forsigtighed ved anvendelse af fluoroquinoloner, inklusive levofloxacin, hos patienter med kendte risikofaktorer for forlænget QT-interval som f.eks.: - medfødt langt QT-syndrom - samtidig brug af lægemidler, der vides at forlænge QT-intervallet (f.eks. klasse IA og III antiarytmika, tricykliske antidepressiva, makrolider, antipsykotika) - ukorrigeret elektrolytforstyrrelse (f.eks. hypokaliæmi, hypomagnesiæmi) - hjertesygdom (f.eks. hjerteinsufficiens, myokardieinfarkt, bradykardi) Ældre patienter og kvinder er muligvis mere følsomme for lægemidler, der forlænger QTc.
English: Chlamydophila pneumoniae Chlamydophila psittaci Chlamydia trachomatis
Danish: Chlamydophila pneumoniae Chlamydophila psittaci Chlamydia trachomatis LEGIONELLA PNEUMOPHILA Mycoplasma pneumoniae Mycoplasma hominis Ureaplasma urealyticum
English: • Feeling sick (nausea, vomiting) and diarrhoea
Danish: • Kvalme, opkastning og diarré
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of Tavanic 250 mg contains 250 mg of levofloxacin as levofloxacin hemihydrate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken Tavanic 250 mg tablet indeholder 250 mg levofloxacin som levofloxacinhemihydrat.
English: Enterococcus faecium # Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Danish: # Methicillin-resistent S. aureus er højst sandsynligt co-resistent for fluoroquinoloner, inklusive levofloxacin.
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see section 4.8).
Danish: Der er rapporteret tilfælde af levernekrose og letal leverinsufficiens med levofloxacin, primært hos patienter med svære underliggende sygdomme, f.eks. sepsis (se pkt.
English: • Theophylline - used for breathing problems.
Danish: • Theophyllin - bruges mod vejrtrækningsproblemer (f.eks. astma).
English: • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease) • Persistent headache with or without blurred vision (benign intracranial hypertension)
Danish: • Porfyri anfald hos personer, der allerede har porfyri (en meget sjælden stofskiftesygdom)
English: Crospovidone Hypromellose Microcrystalline cellulose Sodium stearyl fumarate.
Danish: Hypromellose Mikrokrystallinsk cellulose Natriumstearylfumarat
English: • Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)
Danish: • Ændrer lugtesans, tab af lugte- eller smagssans
English: In patients treated with levofloxacin, determination of opiates in urine may give false-positive results.
Danish: Bestemmelse af opiater i urin kan give falsk-positive resultater hos patienter i behandling med levofloxacin.
English: • Loss of circulation (anaphylactic like shock)
Danish: • Kredsløbsshock (anafylaksi lignende shock)
English: • Lungs, in people with long-term breathing problems or pneumonia
Danish: • Lungerne hos personer med kronisk bronkitis eller lungebetændelse
English: • If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.
Danish: • Spørg lægen, hvis du tror, at virkningen af medicinen er for svag eller for stærk.
English: 50-20 ml/min then: 125 mg/24 h then: 250 mg/24 h then: 250 mg/12 h
Danish: 50-20 ml/min dernæst: 125 mg/24 t dernæst: 250 mg/24 t dernæst: 250 mg/12 t
English: • Joint pain or muscle pain
Danish: • Ledsmerter eller muskelsmerter
English: • in breast-feeding women.
Danish: • til ammende kvinder
English: 19-10 ml/min then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/12 h
Danish: 19-10 ml/min dernæst: 125 mg/48 t dernæst: 125 mg/24 t dernæst: 125 mg/12 t
English: (See sections 4.2 Elderly, 4.5, 4.8, and 4.9).
Danish: 4.3 og 4.8).
English: Jaundice and severe liver injury, including cases with fatal acute liver failure, primarily in patients with severe underlying diseases (see section 4.4) Hepatitis
Danish: Gulsot og svær leverskade, inklusiv letale tilfælde af akut leverinsufficiens, primært hos patienter med svære underliggende sygdomme (se pkt.
English: Food
Danish: Føde
English: You are more likely to have a fit (seizure) if taken with Tavanic
Danish: Du har større risiko for at få et krampeanfald, hvis det tages sammen med Tavanic
English: • Increase in the level of some liver enzymes in your blood
Danish: • Forhøjede leverenzymer i blodet
English: • Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation
Danish: • Ændringer i smagssans, appetittab, mavebesvær eller fordøjelsesbesvær , mavesmerter, oppustethed eller forstoppelse
English: Angioedema Hypersensitivity (see section 4.4)
Danish: Angioødem Overfølsomhed (se pkt.
English: Each tablet of Tavanic 250 mg tablets contains 250 mg of levofloxacin and each tablet of Tavanic 500 mg tablets contains 500 mg of levofloxacin.
Danish: Hver Tavanic 250 mg tablet indeholder 250 mg levofloxacin og hver Tavanic 500 mg tablet indeholder 500 mg levofloxacin.
English: Score line pale yellowish-white to reddish-white film-coated tablets.
Danish: Gullig-hvidlig til rødlig-hvide filmovertrukne tabletter med delekærv.
English: • Urinary tract, including your kidneys or bladder
Danish: • Urinvejene, inklusive nyrer og blære
English: Anaphylactic shocka Anaphylactoid shock a (see section 4.4)
Danish: Anafylaktisk shocka Anafylaktoidt shocka (se pkt.
English: What Tavanic tablets look like and contents of the pack Tavanic tablets are film-coated tablets for oral use.
Danish: Tavanic tabletter er filmovertrukne tabletter der tages gennem munden.
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000 personer)
English: Acute bacterial sinusitis
Danish: Akut bakteriel sinuitis
English: What Tavanic tablets are and what they are used for The name of your medicine is Tavanic tablets.
Danish: Navnet på din medicin er Tavanic tabletter.
English: If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Tavanic, consult an eye specialist immediately.
Danish: Du skal kontakte en øjenlæge omgående, hvis dit syn bliver forringet, eller hvis du får andre øjenproblemer, mens du tager Tavanic.
English: With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below:
Danish: Med faldende nyrefunktion falder renal elimination og clearance, og elimineringshalveringstiden stiger som vist i nedenstående tabel: Farmakokinetik ved nyreinsufficiens efter en enkelt oral 500 mg dosis
English: Bacillus anthracis
Danish: Aerobe grampositive bakterier Bacillus anthracis
English: • Or, 1/2 or one tablet of Tavanic 500 mg, each day
Danish: • Eller 1/2 eller én Tavanic 500 mg tablet hver dag
English: Each film-coated tablet of Tavanic 500 mg contains 500 mg of levofloxacin as levofloxacin hemihydrate.
Danish: Hver filmovertrukken Tavanic 500 mg tablet indeholder 500 mg levofloxacin som levofloxacinhemihydrat.
English: Psychotic reactions (with e.g. hallucination, paranoia)
Danish: Psykotiske reaktioner (med eksempelvis hallucinationer, paranoia) Depression Agitation Unormale drømme Mareridt
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Der skal tages passende forholdsregler, hvis superinfektion forekommer under behandlingen.
English: Other medicines and Tavanic
Danish: Brug af anden medicin sammen med Tavanic
English: Pneumonia
Danish: Lungebetændelse
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Danish: Som for andre quinoloner, bør levofloxacin anvendes med ekstrem forsigtighed til patienter, der er prædisponerede for krampeanfald eller ibehandling med aktive stoffer, der sænker den cerebrale krampetærskel, f.eks. theophyllin (se pkt.
English: Special populations Impaired renal function (creatinine clearance 50 ml/min)
Danish: Særlige populationer Nedsat nyrefunktion (kreatininclearance 50 ml/min) Dosisregime 250 mg/24 timer
English: • Severe skin rashes which may include blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals
Danish: • Alvorlige hududslæt, som kan inkludere blæredannelse eller afskalning af huden omkring læberne,
English: This is important for people that have diabetes.
Danish: Personer med sukkersyge (diabetes mellitus) skal være opmærksom herpå
English: • Joint redness and swelling (arthritis)
Danish: • Rødme og hævelse af leddene (artrit)
English: NAME OF THE MEDICINAL PRODUCT Tavanic 250 mg film-coated tablets Tavanic 500 mg film-coated tablets levofloxacin
Danish: LÆGEMIDLETS NAVN Tavanic 250 mg filmovertrukne tabletter Tavanic 500 mg filmovertrukne tabletter levofloxacin
English: Extrapyramidal disorder Ageusia
Danish: Ekstrapyramidale gener Ageusi
English: 500 mg once or twice daily
Danish: 500 mg én eller to gange dagligt 7-14 dage
English: Complicated skin and soft tissue infections
Danish: Komplicerede infektioner i hud- og bløddelsinfektioner
English: Each film-coated tablet contains 250 mg of levofloxacin as levofloxacin hemihydrate Each film-coated tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate
Danish: Hver filmovertrukken tablet indeholder 500 mg levofloxacin som levofloxacinhemihydrat Hver filmovertrukken tablet indeholder 250 mg levofloxacin som levofloxacinhemihydrat
English: Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT)
Danish: Lever og galdeveje Forhøjede leverenzymer (ALAT/ASAT, basisk fosfatase,
English: Common (≥1/100 to
Danish: Systemorganklasse Almindelig (≥1/100 til
English: • One or two tablets of Tavanic 250 mg, each day
Danish: • En eller to Tavanic 250 mg tabletter hver dag
English: Pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis
Danish: • Pyelonefritis og komplicerede urinvejsinfektioner (se pkt.
English: Photosensitisation has been reported with levofloxacin (see section 4.8).
Danish: Der er rapporteret fotosensibilisering med levofloxacin (se pkt.
English: Peripheral sensory neuropathy (see section 4.4) Peripheral sensory motor neuropathy (see section 4.4) Parosmia including anosmia Dyskinesia
Danish: 4.4) Perifer sensomotorisk neuropati (se pkt.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer)
English: For Tavanic 250 mg, the tablets are provided in pack sizes of 1, 3, 5, 7, 10, 50 and 200 tablets.
Danish: Tavanic 250 mg tabletterne markedsføres i pakningsstørrelser med 1, 3, 5, 7, 10, 50 og 200 tabletter.
English: How to take Tavanic tablets
Danish: SÅDAN SKAL DU TAGE TAVANIC TABLETTER
English: For Tavanic 500 mg, the tablets are provided in pack sizes of 1, 5, 7, 10, 50, 200 and 500 tablets.
Danish: Tavanic 500 mg tabletterne markedsføres i pakningsstørrelser med 1, 5, 7, 10, 50, 200 og 500 tabletter.
English: See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below.
Danish: Se ”Hvis du allerede tager jerntabletter, zinktilskud, antacider, didanosin eller sukralfat” nedenfor i afsnit 3 "Sådan skal du tage Tavanic tabletter".
English: Asthenia
Danish: Kvalme
English: If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: • Two tablets of Tavanic 250 mg, once each day
Danish: • To Tavanic 250 mg tabletter én gang dagligt
English: Impaired liver function
Danish: Nedsat leverfunktion
English: • Two tablets of Tavanic 250 mg, once or twice each day
Danish: • To Tavanic 250 mg tabletter én eller to gange dagligt
English: There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk.
Danish: Data for udskillelse af levofloxacin i human mælk er utilstrækkelige.
English: Hyperglycaemia Hypoglycaemic coma (see section 4.4)
Danish: Hyperglykæmi Hypoglykæmisk koma (se pkt.
English: • Or, one tablet of Tavanic 500 mg, once or twice each day
Danish: • Eller én Tavanic 500 mg tablet én eller to gange dagligt
English: Skin and subcutaneous tissue disorders b
Danish: Hud og subkutane vævb
English: Leukocytoclastic vasculitis Stomatitis
Danish: 4.4) Leukocytoklastisk vaskulitis
English: • Or, one tablet of Tavanic 500 mg, once each day
Danish: • Eller én Tavanic 500 mg tablet én gang dagligt
English: Tavanic tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used.
Danish: Tavanic tabletter kan også anvendes til at fuldføre et behandlingsforløb hos patienter, der har vist forbedring under den indledende behandling med intravenøs levofloxacin.
English: Diarrhoea Vomiting Nausea
Danish: Abdominalsmerter Dyspepsi Flatulens
English: • Headache, feeling dizzy
Danish: • Hovedpine, svimmelhed
English: • If you get any side effects, talk to your doctor or pharmacist.
Danish: • Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).
Danish: 4.4 'Tendinitis og seneruptur' og 'Forlænget QT-interval').
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: Pack sizes for 500 mg tablets: 1, 5, 7, 10, 50, 200 and 500 as commercially available.
Danish: Pakningsstørrelser for 500 mg tabletter: 1, 5, 7, 10, 50, 200 og 500.
English: Depression Agitation
Danish: • Besvimelse
English: • Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)
Danish: • Kløe og hududslæt, alvorlig kløe eller nældefeber, kraftig svedtendens
English: Toxic epidermal necrolysis Stevens-Johnson syndrome Erythema multiforme Photosensitivity reaction (see section 4.4)
Danish: Erythema multiforme Fotosensibiliseringsreakti on (se pkt.
English: Marketing Authorisation Holder [To be completed nationally]
Danish: Indehaver af markedsføringstilladelsen [Udfyldes nationalt]
English: Community-acquired pneumonia 500 mg once or twice daily
Danish: Pneumoni erhvervet uden for sygehus 500 mg én eller to gange dagligt 7-14 dage Pyelonefritis
English: Transient vision loss (see section 4.4)
Danish: Forbigående synstab (se pkt.
English: Nervousness
Danish: Obstipation
English: Pack sizes for 250 mg tablets: 1, 3, 5, 7, 10, 50 and 200 as commercially available.
Danish: Pakningsstørrelser for 250 mg tabletter: 1, 3, 5, 7, 10, 50 og 200.
English: (≥1/10,000 to estimated from available data)
Danish: (≥1/10.000 til
English: • Muscle weakness.
Danish: • Muskelsvækkelse.
English: DRIVING AND USING MACHINES
Danish: VIRKNING OG ANVENDELSE
English: Inhalation Anthrax
Danish: Inhalationsanthrax
English: Tavanic 250 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Tavanic 250 mg filmovertrukne tabletter Tavanic 500 mg filmovertrukne tabletter
English: Rhabdomyolysis Tendon rupture (e.g. Achilles tendon) (see sections 4.3 and
Danish: Rabdomyolyse Seneruptur (f.eks. akillessene) (se pkt.
English: CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis (see section 4.8).
Danish: Den sværeste form er pseudomembranøs colitis (se pkt.
English: 10 DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: Dysglycaemia
Danish: Hypo/hyperglykæmi
English: Vision disorders
Danish: Øjensygdomme
English: Tavanic”)
Danish: (vertigo)
English: Acute bacterial sinusitis Acute exacerbations of chronic bronchitis Community-acquired pneumonia Complicated skin and soft tissue infections
Danish: Akut bakterie-forårsaget forværring af kronisk bronkitis
English: If you take more Tavanic tablets than you should
Danish: Hvis du har taget for mange Tavanic tabletter
English: Talk to your doctor or pharmacist before taking your medicine if:
Danish: Kontakt en læge, skadestuen eller apoteket med det samme, hvis du ved et uheld har taget flere tabletter end foreskrevet.
English: Pharmacokinetics in renal insufficiency following single oral 500 mg dose Clcr [ml/min] <20
Danish: Clcr [ml/min] <20
English: Rare
Danish: Dyskinesi
English: • Sinuses
Danish: • Bihulerne
English: 24 March 2017 EMA/192276/2017 EMEA/H/C/004193
Danish: 24. marts 2017 EMA/192276/2017 EMEA/H/C/004193
English: It was to be available as capsules to be taken by mouth.
Danish: Det skulle havde været leveret som kapsler, der tages gennem munden.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden oprindeligt havde fremlagt, og udarbejdet en liste med spørgsmål.
English: The company presented data from a main study in 327 patients with myelofibrosis that looked at the number of patients whose spleen size reduced by at least 35% after 24 weeks of treatment.
Danish: Virksomheden fremlagde data fra en hovedundersøgelse hos 327 patienter med myelofibrose, hvor det blev registreret, hvor mange patienter der fik reduceret miltstørrelsen med mindst 35 % efter 24 ugers behandling.
English: Enpaxiq is a medicine that contains the active substance pacritinib.
Danish: Enpaxiq er et lægemiddel, der indeholder det aktive stof pacritinib.
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib) EMA/192276/2017
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Enpaxiq (pacritinib) EMA/192276/2017
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Enpaxiq (pacritinib)
English: The Committee had a number of concerns: the reduction in spleen size, the main measure of effectiveness in the study, appeared to be lower with Enpaxiq than with another medicine of its class, with no improvement in symptom scores; the incidence of low blood platelet levels (which can cause bleeding) was higher in patients treated with Enpaxiq; and a higher number of deaths occurred in patients taking Enpaxiq than in those receiving best available therapy, including deaths due to bleeding and effects on the heart.
Danish: Udvalget havde visse betænkeligheder: Reduktionen i miltens størrelse, der var det vigtigste mål for virkningen i undersøgelsen, syntes at være mindre med Enpaxiq end med et andet lægemiddel i samme klasse, uden at der var bedring i symptomscore; forekomsten af for lavt antal blodplader (som kan medføre blødning) var højere hos de patienter, der blev behandlet med Enpaxiq; der var også et større antal dødsfald blandt patienter, der fik Enpaxiq, end blandt dem, der fik bedste tilgængelige behandling, herunder dødsfald pga. blødning og virkninger på hjertet.
English: What was Enpaxiq expected to be used for?
Danish: Hvad forventedes Enpaxiq anvendt til?
English: Further information on its orphan designations can be found here.
Danish: Yderligere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her.
English: The company stated in its letter to the Agency that it was withdrawing the application because there was not enough time in the current application procedure to provide new data from a second main study with Enpaxiq.
Danish: I sit brev til agenturet anførte virksomheden, at den trak ansøgningen tilbage, fordi den aktuelle ansøgningsprocedure ikke gav tilstrækkelig tid til at tilvejebringe nye data fra endnu en hovedundersøgelse med Enpaxiq.
English: On 20 February 2017, CTI BioPharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Enpaxiq, for treating patients with an enlarged spleen or other symptoms of myelofibrosis.
Danish: Den 20. februar 2017 meddelte CTI BioPharma officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Enpaxiq til behandling af patienter med forstørret milt eller andre symptomer på myelofibrose.
English: Given these concerns, the Committee was of the opinion that the benefits of Enpaxiq had not been shown to outweigh its risks.
Danish: På baggrund af disse betænkeligheder var udvalget af den opfattelse, at det ikke var påvist, at fordelene ved Enpaxiq opvejer risiciene.
English: In myelofibrosis, patients have too much of these proteins, which cause the production of immature blood cells, some of which migrate to organs such as the spleen, causing them to become enlarged.
Danish: Ved myelofibrose har patienterne for meget af disse proteiner, hvilket medfører dannelse af umodne blodceller, hvoraf nogle vandrer til organer såsom milten, som derved bliver forstørret.
English: Furthermore, the CHMP noted that more information was needed about the starting materials used in the manufacture of Enpaxiq and how it acts on certain target proteins in the body.
Danish: Desuden bemærkede CHMP, at der behøvedes flere oplysninger om udgangsmaterialerne til fremstilling af Enpaxiq og om, hvordan Enpaxiq virker på visse målproteiner i kroppen