FrancophonIA/ELRC3.0 huggingface dataset:
English: Score line pale yellowish-white to reddish-white film-coated tablets.
Slovenian: Bledo rumenkasto do rdečkasto bele filmsko obložene tablete z razdelilno zarezo.
English: • Urinary tract, including your kidneys or bladder
Slovenian: • Sečil, vključno z ledvicami ali mehurjem
English: Anaphylactic shocka Anaphylactoid shock a (see section 4.4)
Slovenian: Anafilaktični šok a Anafilaktoidni šok a (glejte poglavje 4.4)
English: No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study.
Slovenian: V klinični študiji niso ugotovili farmakokinetičnega medsebojnega delovanja med levofloksacinom in teofilinom.
English: If you are not sure, talk to your doctor or pharmacist before taking Tavanic.
Slovenian: Če ste negotovi, se pred jemanjem zdravila Tavanic posvetujte z zdravnikom ali s farmacevtom.
English: Tavanic tablets contain a medicine called levofloxacin.
Slovenian: Zdravilo Tavanic tablete vsebuje učinkovino levofloksacin.
English: However a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, or other agents which lower the seizure threshold.
Slovenian: Vendar se lahko med sočasno uporabo kinolonov ter teofilina, nesteroidnih protivnetnih zdravil in drugih zdravil, ki znižujejo cerebralni prag za konvulzivne napade, ta prag izrazito zniža.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega sistema
English: Elderly population
Slovenian: Starejši bolniki
English: Blood bilirubin increased
Slovenian: Zvišana vrednost bilirubina v krvi
English: • Feeling sick (nausea, vomiting) and diarrhoea
Slovenian: • Občutek slabosti (slabost, bruhanje) in driska
English: Phlebitis
Slovenian: Flebitis
English: • Loss of circulation (anaphylactic like shock)
Slovenian: • Prekinitev krvnega obtoka (kot anafilaktični šok)
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.
Slovenian: Ena tableta zdravila Tavanic 250 mg vsebuje 250 mg levofloksacina, ena tableta zdravila Tavanic 500 mg pa vsebuje 500 mg levofloksacina.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [izpolni država članica]
English: Daily dose regimen (according to severity)
Slovenian: indikacija dnevno odmerjanje (glede naresnost)
English: Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.
Slovenian: Pri bolnikih, ki so jemali kinolone, vključno z levofloksacinom so poročali o pojavu psihotičnih reakcij.
English: Dose regimen 250 mg/24 h
Slovenian: 250 mg/24 h
English: • Joint redness and swelling (arthritis)
Slovenian: • Rdečina in oteklina sklepa (artritis)
English: 250 mg once daily
Slovenian: 250 mg enkrat/dan
English: (≥1/10,000 to estimated from available data)
Slovenian: (ni mogoče oceniti iz razpoložljivih podatkov)
English: Other side effects include:
Slovenian: Drugi neželeni učinki:
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalneg a prostora
English: Impaired liver function
Slovenian: Okvarjeno delovanje jeter
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (prizadenejo lahko največ 1 od 1.000 oseb)
English: • Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen).
Slovenian: • Izguba teka, porumenelost kože in očesnih beločnic, temno obarvan urin, srbenje ali občutljiv trebuh.
English: Mechanism of action
Slovenian: Način delovanja
English: 50-20 ml/min then: 125 mg/24 h then: 250 mg/24 h then: 250 mg/12 h
Slovenian: 500 mg/12 h očistek kreatinina prvi odmerek: 250 mgprvi odmerek: 500 mgprvi odmerek: 500 mg 50-20 ml/min potem: 125 mg/24 ur potem: 250 mg/24 ur potem: 250 mg/12 ur 19-10 ml/min potem: 125 mg/48 ur potem: 125 mg/24 ur potem: 125 mg/12 ur < 10ml/min (vključno s hemodializo in
English: You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Po jemanju tega zdravila se lahko pojavijo neželeni učinki kot so omotica, zaspanost, vrtoglavica (vertigo) ali motnje vida.
English: • Headache, feeling dizzy
Slovenian: • Glavobol, omotica
English: • Shortness of breath (dyspnoea)
Slovenian: • Dihalna stiska (dispneja)
English: Enterococcus faecium # Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Slovenian: Pseudomonas aeruginosa Serratia marcescens anaerobne bakterije Bacteroides fragilis naravno odporni sevi aerobne po Gramu-pozitivne bakterije Enterococcus faecium # Proti meticilinu odporni S. aureus je zelo verjetno odporen tudi proti fluorokinolonom, vključno z levofloksacinom.
English: The breakpoints for levofloxacin relate to high dose therapy.
Slovenian: Mejne vrednosti levofloksacina se nanašajo na zdravljenje z visokimi odmerki.
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: What Tavanic tablets contain
Slovenian: Kaj vsebuje zdravilo Tavanic tablete
English: Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.
Slovenian: Levofloksacin se presnovi v zelo majhni meri; presnovka sta dezmetil-levofloksacin in levofloksacin N-oksid.
English: 6.5 Nature and Contents of Container PVC/ Aluminium blisters containing film-coated tablets.
Slovenian: PVC aluminijski pretisni omoti, ki vsebujejo filmsko obložene tablete:
English: Aerobic Gram-positive bacteria Enterococcus faecalis
Slovenian: Vrste, pri katerih je pridobljena odpornost lahko težava aerobne po Gramu-pozitivne bakterije Enterococcus faecalis
English: Angioedema Hypersensitivity (see section 4.4)
Slovenian: Angioedem Preobčutljivost (glejte poglavje 4.4)
English: Ventricular arrhythmia and torsade de pointes (reported predominantly in patients with risk factors of QT prolongation), electrocardiogram QT prolonged (see sections 4.4 and 4.9)
Slovenian: Ventrikularna aritmija in torsade de pointes (poročana predvsem pri bolnikih z nevarnostjo podaljšanja intervala QT),
English: For Tavanic 500 mg, the tablets are provided in pack sizes of 1, 5, 7, 10, 50, 200 and 500 tablets.
Slovenian: Zdravilo Tavanic 500 mg tablete je na voljo v pakiranjih po 1, 5, 7, 10, 50, 200 in 500 tablet.
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
Slovenian: Ena filmsko obložena tableta vsebuje 250 mg levofloksacina v obliki levofloksacin hemihidrata Ena filmsko obložena tableta vsebuje 500 mg levofloksacina v obliki levofloksacin hemihidrata
English: Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) are administered concomitantly with Tavanic tablets.
Slovenian: Sočasna uporaba zdravila Tavanic tablete s solmi železa, solmi cinka, antacidi, ki vsebujejo magnezij ali aluminij ali z didanozinom (samo oblike didanozina, ki kot pufer vsebujejo aluminij ali magnezij), zelo zmanjša absorpcijo levofloksacina.
English: For Tavanic 250 mg, the tablets are provided in pack sizes of 1, 3, 5, 7, 10, 50 and 200 tablets.
Slovenian: Zdravilo Tavanic 250 mg tablete je na voljo v pakiranjih po 1, 3, 5, 7, 10, 50 in 200 tablet.
English: Somnolence Tremor Dysgeusia
Slovenian: Zaspanost Tremor Motnje okusa
English: 500 mg once daily
Slovenian: 500 mg enkrat/dan
English: It is recommended that preparations containing divalent or trivalent cations such as iron salts, zinc salts or magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents) should not be taken 2 hours before or after Tavanic tablet administration (see section 4.2).
Slovenian: Priporočljivo je, da bolniki 2 uri pred zaužitjem zdravila Tavanic tablete in 2 uri po tem ne jemljejo pripravkov, ki vsebujejo dvoali trivalentne katione, npr. soli železa, soli cinka, antacidov z magnezijem ali aluminijem ali didanozina (samo oblike didanozina, ki kot pufer vsebujejo aluminij ali magnezij), (glejte poglavje 4.2).
English: Aerobic Gram-positive bacteria
Slovenian: (Običajno) občutljivi mikroorganizmi aerobne po Gramu-pozitivne bakterije Bacillus anthracis
English: Eikenella corrodens Haemophilus influenzae Haemophilus para-influenzae Klebsiella oxytoca Moraxella catarrhalis Pasteurella multocida Proteus vulgaris Providencia rettgeri
Slovenian: Moraxella catarrhalis Pasteurella multocida Proteus vulgaris
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM [izpolni država članica]
English: • Pancreatitis
Slovenian: Pankreatitis
English: However in the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women (see sections 4.3 and 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3) Ker pa ni podatkov pri človeku in ker je eksperimentalno ugotovljeno tveganje, da fluorokinoloni poškodujejo sklepni hrustanecrastočega organizma, nosečnice levofloksacina ne smejo uporabljati (glejte poglavji 4.3 in 5.3).
English: NAME OF THE MEDICINAL PRODUCT Tavanic 250 mg film-coated tablets Tavanic 500 mg film-coated tablets levofloxacin
Slovenian: Tavanic 250 mg filmsko obložene tablete Tavanic 500 mg filmsko obložene tablete levofloksacin
English: Dyspnoea
Slovenian: Diskinezija
English: Tavanic 250 mg film-coated tablets
Slovenian: Tavanic 250 mg filmsko obložene tablete Tavanic 500 mg filmsko obložene tablete
English: Pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis
Slovenian: • Pielonefritis in zapletene okužbe sečil (glejte poglavje 4.4)
English: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin).
Slovenian: Pri bolnikih, ki so dobivali levofloksacin v kombinaciji z antagonistom vitamina K (npr. varfarinom), so opisane zvišane vrednosti koagulacijskih testov (PČ/INR) in/ali krvavitve, ki so lahko hude.
English: CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience.
Slovenian: Med uporabo po prihodu zdravila na trg so ugotovili učinke na CŽS, vključno z zmedenostjo, konvulzijami, halucinacijami in tremorjem.
English: Headache Dizziness
Slovenian: Motnje vida
English: Pharmacokinetics in renal insufficiency following single oral 500 mg dose Clcr [ml/min] <20
Slovenian: Farmakokinetika pri ledvični odpovedi po enkratnem 500 mg odmerku
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (prizadenejo lahko največ 1 od 100 oseb)
English: LIST OF EXCIPIENTS
Slovenian: Providencia stuartii
English: Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Slovenian: V primeru, da se pojavijo znaki in simptomi nastanka jetrnega obolenja kot so anoreksija, zlatenica, temno obarvan urin, srbež ali boleč abdomen je treba bolniku svetovati, da prekine z zdravljenjem in o tem obvesti svojega zdravnika.
English: Common (may affect up to 1 in 10 people)
Slovenian: Pogosti (prizadenejo lahko največ 1 od 10 oseb)
English: Bacteroides fragilis
Slovenian: Patogeni mikroorganizmi občutljivi odporni
English: • You are breast-feeding or planning to breast-feed
Slovenian: • Dojite ali nameravate dojiti
English: Tavanic is contraindicated in breast-feeding women.
Slovenian: Zdravilo Tavanic je kontraindicirano med dojenjem.
English: Postmarketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
Slovenian: V obdobju po prihodu zdravila na trg je bila uporaba fluorokinolonov pri bolnikih z miastenijo gravis povezana z resnimi neželenimi učinki, vključno s smrtjo in potrebo po dihalni podpori.
English: PVC/ALUMINIUM FOIL / BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PVC/ ALUMINIJSKA FOLIJA/ PRETISNI OMOT
English: The pharmacokinetics of levofloxacin are affected by renal impairment.
Slovenian: Okvara ledvic vpliva na farmakokinetiko levofloksacina.
English: Pack sizes for 250 mg tablets: 1, 3, 5, 7, 10, 50 and 200 as commercially available.
Slovenian: Velikost pakiranja 250 mg tablet: 1, 3, 5, 7, 10, 50 in 200 tablet.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally]
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [izpolni država članica]
English: Tinnitus
Slovenian: Astenija
English: Rash
Slovenian: Lot
English: Pack sizes for 500 mg tablets: 1, 5, 7, 10, 50, 200 and 500 as commercially available.
Slovenian: Velikost pakiranja 500 mg tablet: 1, 5, 7, 10, 50, 200 in 500 tablet Na trgu morda ni vseh navedenih pakiranj.
English: Acinetobacter baumannii Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Serratia marcescens
Slovenian: Enterobacter aerogenes Enterobacter cloacae Escherichia coli
English: • Fits (convulsions)
Slovenian: • Pankreatitis (vnetje trebušne slinavke)
English: Method of administration
Slovenian: Postopek uporabe
English: What Tavanic tablets are and what they are used for The name of your medicine is Tavanic tablets.
Slovenian: Kaj je zdravilo Tavanic tablete in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tavanic tablete Kako jemati zdravilo Tavanic tablete Možni neželeni učinki
English: Asthenia
Slovenian: Dojenje
English: Sucralfate
Slovenian: Sukralfat
English: How to store Tavanic tablets
Slovenian: Shranjevanje zdravila Tavanic tablete
English: The active ingredient is levofloxacin.
Slovenian: Zdravilna učinkovina je levofloksacin.
English: Pneumonia
Slovenian: Bolezni živčevja
English: Skin and subcutaneous tissue disorders b
Slovenian: Bolezni kože in podkožjab
English: • This medicine has been prescribed for you only.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Annex III
Slovenian: CAPD)1
English: Tendon disorders (see sections 4.3 and 4.4) including tendinitis (e.g. Achilles tendon) Muscular weakness which may be of special importance in patients with myasthenia gravis (see section 4.4 )
Slovenian: Ahilove tetive), Mišična šibkost, ki je lahko posebno pomembna pri bolnikih z miastenijo gravis (glejte poglavje
English: Pyrexia
Slovenian: • Dojite
English: • Keep this leaflet.
Slovenian: • Ne sončite se
English: PACKAGE LEAFLET
Slovenian: odmerna shema
English: Package leaflet: Information for the user Tavanic 250 mg tablets
Slovenian: NAVODILO ZA UPORABO Tavanic 250 mg tablete
English: BATCH NUMBER Batch
Slovenian: ŠTEVILKA SERIJE Lot
English: Diarrhoea Vomiting Nausea
Slovenian: Toksična epidermalna nekroliza,
English: Ear and Labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta
English: Peripheral sensory neuropathy (see section 4.4) Peripheral sensory motor neuropathy (see section 4.4) Parosmia including anosmia Dyskinesia
Slovenian: Periferna senzoričnomotorična nevropatija (glejte poglavje 4.4)
English: Sinuses infection
Slovenian: Žilne bolezni
English: Insomnia Anxiety Confusional state
Slovenian: Nespečnost Ansioznost Zmedenost
English: The expiry date refers to the last day of the month.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Close monitoring of these patients is therefore necessary if they are prescribed levofloxacin.
Slovenian: Če takšni bolniki dobijo zdravilo Tavanic, jih je treba natančno nadzirati.
English: • General weakness
Slovenian: •Splošna šibkost
English: 24 March 2017 EMA/192276/2017 EMEA/H/C/004193
Slovenian: 24. marec 2017 EMA/192276/2017 EMEA/H/C/004193
English: Further information on its orphan designations can be found here.
Slovenian: Več informacij o zdravilih sirotah je na voljo tukaj.
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.
Slovenian: Družba je predložila podatke iz glavne študije, v kateri je sodelovalo 327 bolnikov z mielofibrozo, v njej pa so ugotavljali število bolnikov, pri katerih se je vranica po 24 tednih zdravljenja zmanjšala za vsaj 35 %.
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.
Slovenian: Nadalje je odbor CHMP poudaril, da je potrebnih več informacij o začetnih materialih, uporabljenih za izdelavo zdravila Enpaxiq, in o načinu njegovega delovanja na določene tarčne beljakovine v telesu.
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.
Slovenian: Odbor je imel številne pomisleke: zmanjšanje velikosti vranice, glavno merilo učinkovitosti v študiji je bilo pri zdravilu Enpaxiq manjše kot pri drugem zdravilu istega razreda, pri čemer se ocene simptomov niso izboljšale; pojavnost nizkih ravni trombocitov (kar lahko povzroči krvavitev) je bila pri bolnikih, zdravljenih z zdravilom Enpaxiq, večja; in večje število smrti pri bolnikih, zdravljenih z zdravilom Enpaxiq, kot pri bolnikih, ki so prejemali najboljše razpoložljivo zdravljenje, vključno s smrtmi zaradi krvavitve in učinkov na srce.
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib) EMA/192276/2017
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Enpaxiq (pakritinib) EMA/192276/2017
English: The study compared Enpaxiq with ‘best available therapy', which included treatments that do not act on JAK proteins such as hydroxyurea or supportive care.
Slovenian: V študiji so primerjali zdravilo Enpaxiq z „najboljšim razpoložljivim zdravljenjem“, ki je vključevalo zdravila, ki ne delujejo na beljakovine JAK, kot sta hidroksisečnina ali podporno zdravljenje.
English: The company said that it intends to integrate the new data from the study into its current dossier before approaching EMA to discuss a new application.
Slovenian: Družba je navedla, da bo nove podatke iz študije vključila v trenutno dokumentacijo, preden se bo z agencijo EMA dogovarjala o novi vlogi.
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.
Slovenian: Družba CTI BioPharma je 20. februarja 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Enpaxiq, namenjenim zdravljenju bolnikov s povečano vranico ali drugimi simptomi mielofibroze.
English: By blocking these proteins, Enpaxiq is expected to slow down the production of immature blood cells and thereby help reduce the symptoms of the disease.
Slovenian: Z zaviranjem teh beljakovin naj bi zdravilo Enpaxiq upočasnilo tvorbo nezrelih krvnih celic in tako zmanjšalo simptome bolezni.
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.
Slovenian: Pri mielofibrozi imajo bolniki teh beljakovin preveč, kar povzroči tvorbo nezrelih krvnih celic, od katerih nekatere potujejo v organe, kot je vranica, ki se zato povečajo.
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Enpaxiq (pakritinib)
English: Given these concerns, the Committee was of the opinion that the benefits of Enpaxiq had not been shown to outweigh its risks.
Slovenian: Glede na te pomisleke je Odbor menil, da koristi zdravila Enpaxiq ne odtehtajo z njim povezanih tveganj.
English: It was to be available as capsules to be taken by mouth.
Slovenian: Na voljo naj bi bilo v obliki kapsul, ki se jemljejo peroralno.
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.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da vlogo umika, ker v okviru trenutnega postopka za odobritev vloge za dovoljenje za promet z zdravilom ni dovolj časa, da bi lahko predložili nove podatke druge glavne študije, opravljene z zdravilom Enpaxiq.
English: Enpaxiq is a medicine that contains the active substance pacritinib.
Slovenian: Enpaxiq je zdravilo, ki vsebuje zdravilno učinkovino pakritinib.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Enpaxiq.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Enpaxiq.
English: Enpaxiq was expected to be used to treat patients with an enlarged spleen or other symptoms of myelofibrosis - a disorder in which scar tissue builds up in the bone marrow where blood cells are produced.
Slovenian: Zdravilo Enpaxiq naj bi se uporabljalo za zdravljenje bolnikov s povečano vranico ali drugimi simptomi mielofibroze, tj. motnje, pri kateri se v kostnem mozgu, kjer nastajajo krvne celice, kopiči brazgotinsko tkivo.
English: The active substance in Enpaxiq, pacritinib, blocks the action of JAK2 and FLT3, two proteins involved in the production and growth of blood cells.
Slovenian: Aktivna učinkovina zdravila Enpaxiq, pakritinib, zavira delovanje beljakovin JAK2 in FLT3, ki sta vključeni v tvorbo in rast krvnih celic.
English: Enpaxiq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 25 August 2010 for different types of myelofibrosis.
Slovenian: Zdravilo Enpaxiq je bilo 25. avgusta 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje različnih vrst mielofibroze.
English: What was Enpaxiq expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Enpaxiq uporabljalo?
English: What is Enpaxiq?
Slovenian: Kaj je zdravilo Enpaxiq?
English: At the time of the withdrawal of application, the CHMP was of the provisional opinion that Enpaxiq could not have been approved for myelofibrosis.
Slovenian: Odbor CHMP je ob umiku vloge začasno menil, da zdravila Enpaxiq ni mogoče odobriti za zdravljenje mielofibroze.
English: How does Enpaxiq work?
Slovenian: Kako zdravilo Enpaxiq deluje?
English: Further information on Mulpleo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mulpleo.
Slovenian: Nadaljnje informacije za zdravilo Mulpleo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/mulpleo.