FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before taking Nexavar.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Nexavar se posvetujte z zdravnikom ali farmacevtom.
English: There were no cases of CTCAE Grade 4 hypophosphataemia (< 1 mg/dl) reported in either sorafenib or placebo patients in study 1, and 1 case in the placebo group in study 3.
Slovenian: V študiji 1 se v nobeni skupini bolnikov ni pojavila hipofosfatemija 4. stopnje po CTCAE (< 1 mg/dl), v študiji 3 pa se je pojavila pri enem bolniku v skupini bolnikov, ki so prejemali placebo.
English: In study 5 (see section 5.1), increases in TSH levels above 0.5mU/L were observed in sorafenib treated patients.
Slovenian: Supresija TSH pri diferenciranem karcinomu ščitnice V študiji 5 (glejte poglavje 5.1) so pri bolnikih, ki so se zdravili s sorafenibom, opazili vrednosti TSH, večje od 0,5 mE/l.
English: You will usually be taken off Nexavar if you are having an operation.
Slovenian: Običajno je treba zdravilo Nexavar prenehati jemati pred kirurškim posegom.
English: The median OS was not reached in the sorafenib arm and was 36.5 months in the placebo arm. One hundred fifty seven (75%) patients randomised to placebo and 61 (30%) patients randomised to sorafenib received open-label sorafenib.
Slovenian: 157 (75 %) bolnikov je bilo randomiziranih v skupino bolnikov, ki so prejemali placebo in 61 (30 %) bolnikov v skupino, ki je prejemala sorafenib.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05 Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and antiangiogenic properties in vitro and in vivo.
Slovenian: Farmakoterapevtska skupina: druge učinkovine z delovanjem na novotvorbe, zaviralci proteinskih kinaz, oznaka ATC: L01XE05
English: No single cause of death dominated, but higher incidence of respiratory failure, hemorrhages and infectious adverse events were observed in patients treated with sorafenib as add-on to platinum-based chemotherapies.
Slovenian: Noben od posameznih vzrokov smrti ni izstopal, vendar pa so pri bolnikih, ki so bili zdravljeni s sorafenibom v kombinaciji s spojinami platine, opazili večjo pogostnost neželenih učinkov kot so odpoved dihanja, krvavitve in okužbe.
English: Bayer d. o. o. Tel.: +386 (0)1 58 14 400
Slovenian: Tel: +386 (0)1 58 14 400
English: ** Hand foot skin reaction corresponds to palmar plantar erythrodysaesthesia syndrome in
Slovenian: ** Kožne reakcije na dlaneh in podplatih ustrezajo sindromu palmarno-plantarne eritrodisestezije po klasifikaciji MedDRA. ° O primerih so poročali v obdobju trženja zdravila.
English: Sorafenib inhibits tumour growth of a broad spectrum of human tumour xenografts in athymic mice accompanied by a reduction of tumour angiogenesis.
Slovenian: Zavira rast širokega spektra humanih tumorskih presadkov pri atimičnih miših, hkrati pa zmanjšuje tumorsko angiogenezo.
English: An increased incidence of arterial hypertension was observed in sorafenib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili s sorafenibom, so opazili zvečano incidenco arterijske hipertenzije.
English: Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischaemia and/or infarction (see section 4.8).
Slovenian: Pri bolnikih, pri katerih se pojavi srčna ishemija in/ali infarkt, je treba razmisliti o začasnem ali trajnem prenehanju zdravljenja s sorafenibom (glejte poglavje 4.8).
English: The HR of progression free survival was 0.39 (95% CI: 0.21 - 0.72) for patients with symptoms at baseline and 0.60 (95% CI: 0.45 - 0.81) for patients without symptoms at baseline.
Slovenian: 0,21 - 0,72) pri bolnikih s simptomi na začetku zdravljenja in 0,60 (95-% IZ: 0,45 - 0,81) pri bolnikih brez simptomov na začetku zdravljenja.
English: 112 film-coated tablets (4 x 28) in transparent (PP/Aluminium) blister packs.
Slovenian: 112 filmsko obloženih tablet (4 x 28) v prozornih (PP/Alu) pretisnih omotih 6.6 Posebni varnostni ukrepi za odstranjevanje To zdravilo je lahko nevarno za okolje.
English: No studies have been conducted to investigate the pharmacokinetics of sorafenib in paediatric patients.
Slovenian: Farmakokinetičnih študij sorafeniba pri otrocih niso izvedli.
English: Efficacy Parameter
Slovenian: UČINKOVITO UPORABO ZDRAVILA
English: Blood and lymphatic system disorders Anemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija trombocitopenija nevtropenija limfopenija
English: Luxembourg / Luxemburg
Slovenian: Luxembourg/Luxemburg Bayer SA-NV
English: When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended.
Slovenian: Hipokalciemija pri diferenciranem karcinomu ščitnice Pri uporabi sorafeniba pri bolnikih z diferenciranim karcinomom ščitnice se priporoča skrbno spremljanje vrednosti kalcija v krvi.
English: Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on sorafenib therapy.
Slovenian: Med zdravljenjem s sorafenibom so pri nekaterih bolnikih, ki so jemali varfarin, poročali o posameznih primerih krvavitev ali zvečanju mednarodnega umerjenega razmerja (INR - International Normalized Ratio).
English: Hypophosphatemia**
Slovenian: Presnovne in prehranske motnje hipokaliemija hipofosfatemija**
English: Mean Cmax and AUC increased less than proportionally beyond doses of 400 mg administered twice daily.
Slovenian: Pri odmerkih več kot 400 mg dvakrat na dan, se povprečna Cmax in AUC nista zvečali sorazmerno z odmerki.
English: Sorafenib inhibited CYP2B6, CYP2C8 and CYP2C9 in vitro with similar potency.
Slovenian: Sorafenib je in vitro približno enako močno zaviral CYP2B6, CYP2C8 in CYP2C9.
English: Nexavar 200 mg film-coated tablets sorafenib
Slovenian: Nexavar 200 mg filmsko obložene tablete sorafenib
English: Common:
Slovenian: Pogosti
English: Dermatological toxicities
Slovenian: Toksičnost za kožo
English: Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patients compared to 12 % and 11 % of placebo patients in study 1 and study 3, respectively.
Slovenian: Laboratorijsko so zelo pogosto ugotovili hipofosfatemijo: v študiji 1 se je pojavila pri 45 % bolnikov, ki so se zdravili s sorafenibom, in 12 % bolnikov, ki so prejemali placebo, v študiji 3 pa pri 35 % bolnikov, ki so se zdravili s sorafenibom, in 11 % bolnikov, ki so prejemali placebo.
English: If you could become pregnant use adequate contraception during treatment.
Slovenian: Če menite, da bi med zdravljenjem z zdravilom Nexavar lahko zanosili, uporabljajte zanesljivo kontracepcijo.
English: may affect up to 1 in 10 people - flu-like illness - indigestion (dyspepsia) - difficulty swallowing (dysphagia) - inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation) - low calcium levels in the blood (hypocalcaemia) - low potassium levels in the blood (hypokalaemia) - low blood sugar level (hypoglycaemia) - muscle pain (myalgia) - disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy) - depression - erection problems (impotence) - altered voice (dysphonia) - acne - inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation) - heart failure - heart attack (myocardial infarction) or chest pain - tinnitus (ringing sound in the ear) - kidney failure - abnormally high levels of protein in the urine (proteinuria) - general weakness or loss of strength (asthenia) - decrease in the number of white blood cells (leucopenia and neutropenia) - decrease in the number of red blood cells (anaemia) - low number of platelets in the blood (thrombocytopenia) - inflammation of hair follicles (folliculitis) - underactive thyroid gland (hypothyroidism) - low sodium levels in the blood (hyponatraemia) - distortion of the sense of taste (dysgeusia) - red in the face and often other areas of the skin (flushing) - runny nose (rhinorrhoea) - heartburn (gastro oesophageal reflux disease) - skin cancer (keratoacanthomas/squamous cell cancer of the skin) - a thickening of the outer layer of the skin (hyperkeratosis) - a sudden, involuntary contraction of a muscle (muscle spasms)
Slovenian: - nenormalno visoke vrednosti beljakovin v seču (proteinurija) - splošna oslabelost ali izguba moči (astenija) - zmanjšanje števila belih krvnih celic (levkopenija ali nevtropenija) - zmanjšanje števila rdečih krvnih celic (anemija) - zmanjšanje števila krvnih ploščic v krvi (trombocitopenija) - vnetje lasnih foliklov (folikulitis) - zmanjšano delovanje ščitnice (hipotiroidizem) - zmanjšane vrednosti natrija v krvi (hiponatremija) - motnje okušanja (disgevzija) - pordelost obraza in pogosto tudi drugih delov kože - izcejanje iz nosu (rinoreja) - zgaga (gastroezofagealni refluks) - kožni rak (keratoakantom/ploščatocelični karcinom kože) - zadebelitev zunanje plasti kože (hiperkeratoza) - nenadno, nenamerno krčenje mišice (mišični spazmi)
English: The steady-state concentrations of sorafenib administered at 400 mg twice daily were evaluated in DTC, RCC and HCC patients.
Slovenian: Koncentracije sorafeniba v stanju dinamičnega ravnovesja po dajanju odmerkov 400 mg dvakrat na dan so ocenili pri bolnikih z diferenciranim karcinomom ščitnice, karcinomom ledvičnih celic in karcinomom jetrnih celic.
English: encephalopathy°
Slovenian: KLINIČNI PODATKI
English: Bayer Austria Ges.
Slovenian: Bayer Austria Ges.m.b.H.
English: (drug induced hepatitis) - a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis) - serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis) - abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis) - damage of the kidney causing them to leak large amounts of protein (nephrotic syndrome) - inflammation of the vessels in the skin which may result in rash (leucocytoclastic vasculitis)
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov - alergijske reakcije z otekanjem (npr. obraza, jezika), ki lahko povzročijo težave pri dihanju in požiranju (angioedem) - nenormalni srčni ritem (podaljšanje intervala QT) - vnetje jeter, ki lahko privede do navzee (občutek siljenja na bruhanje), bruhanja, bolečin v trebuhu in zlatenice (hepatitis zaradi zdravil) - izpuščaj podoben sončnim opeklinam, ki se lahko pojavi na koži, ki je bila predhodno izpostavljena obsevanju; pojavi se lahko v hudi obliki (dermatitis zaradi obsevanja) - hude kožne spremembe in/ali spremembe sluznice, tudi boleče mehurjaste kožne spremembe in zvišana telesna temperatura, vključno z obsežnim odstopanjem kože (Stevens-Johnsonov sindrom in toksična epidermalna nekroliza) - nenormalni razpad mišic, ki lahko povzroči okvaro ledvic (rabdomioliza) - okvara ledvic, zaradi katere žile v ledvicah prepuščajo velike količine beljakovin (nefrotski sindrom) - vnetje krvnih žil v koži, ki se lahko izraža kot izpuščaj (levkocitoklastični vaskulitis)
English: Lymphopenia
Slovenian: Docetaksel
English: CTCAE grade 3 hypocalcaemia (6.0 - 7.0 mg /dL) occurred in 1.1% and 1.8% of sorafenib treated patients and 0.2% and 1.1% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia (< 6.0 mg/dL) occurred in 1.1% and 0.4% of sorafenib treated patients and 0.5% and 0% of patients in the placebo group in study 1 and 3, respectively.
Slovenian: Hipokalciemija 3. stopnje po CTCAE (6,0 - 7,0 mg/dl) se je v študiji 1 pojavila pri 1,1 % bolnikov, ki so se zdravili s sorafenibom, in pri 0,2 % bolnikov, ki so prejemali placebo, v študiji 3 pa se je pojavila pri 1,8 % bolnikov, ki so se zdravili s sorafenibom, in 1,1 % bolnikov, ki so prejemali placebo.
English: An increased risk of bleeding may occur following sorafenib administration.
Slovenian: Med zdravljenjem s sorafenibom se lahko zveča tveganje za krvavitve.
English: CTCAE Grade 3 or 4 lipase elevations occurred in 11 % and 9 % of patients in the sorafenib group in study 1 (RCC) and study 3 (HCC), respectively, compared to 7 % and 9 % of patients in the placebo group.
Slovenian: V študiji 1 (karcinom ledvičnih celic) so se vrednosti lipaz zvečale na 3. ali 4. stopnjo po CTCAE pri 11 % bolnikov, ki so se zdravili s sorafenibom, in 7 % bolnikov, ki so prejemali placebo, v študiji 3 (karcinom jetrnih celic) pa pri 9 % bolnikov, ki so se zdravili s sorafenibom, in 9 % bolnikov, ki so prejemali placebo.
English: Docetaxel
Slovenian: placebo
English: Package Leaflet: Information for the user Nexavar 200 mg film-coated tablets sorafenib
Slovenian: Navodilo za uporabo Nexavar 200 mg filmsko obložene tablete sorafenib
English: Nexavar 200 mg film-coated tablets
Slovenian: IME ZDRAVILA Nexavar 200 mg filmsko obložene tablete
English: may affect up to 1 in 100 people - inflamed stomach lining (gastritis) - pain in the tummy (abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts - yellow skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia) - allergic like reactions (including skin reactions and hives) - dehydration - enlarged breasts (gynaecomastia) - breathing difficulty (lung disease) - eczema - overactive thyroid gland (hyperthyroidism) - multiple skin eruptions (erythema multiforme) - abnormally high blood pressure - holes in the gut wall (gastrointestinal perforation) - reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy) - a sudden, severe allergic reaction (anaphylactic reaction)
Slovenian: - čezmerno delovanje ščitnice (hipertiroidizem) - kožni izpuščaji različnih oblik (multiformni eritem) - nenormalno visok krvni tlak - predrtje želodčne/črevesne stene (gastrointestinalna perforacija) - reverzibilna oteklina v zadnjem delu možganov, ki je lahko povezana z glavoboli, motnjami zavesti, krči in motnjami vida vključno z izgubo vida (reverzibilna posteriorna levkoencefalopatija)
English: Pregnancy and breast-feeding Avoid becoming pregnant while being treated with Nexavar.
Slovenian: Pazite, da med zdravljenjem z zdravilom Nexavar ne zanosite.
English: Investigations weight decreased increased amylase increased lipase transient increase in transaminases transient increase in blood alkaline phosphatase
Slovenian: Preiskave zmanjšanje telesne mase zvečanje vrednosti amilaz v krvi zvečanje vrednosti lipaz prehodno zvečanje vrednosti transaminaz prehodno zvečanje vrednosti alkalne fosfataze v krvi nenormalna vrednost INR nenormalna vrednost protrombina * Neželeni učinki lahko ogrozijo življenje ali povzročijo smrt.
English: Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.4).
Slovenian: Pri sočasni uporabi sorafeniba in docetaksela je potrebna previdnost (glejte poglavje 4.4).
English: CTCAE Grade 3 or 4 amylase elevations were reported in 1 % and 2 % of patients in the sorafenib group in study 1 and study 3, respectively, compared to 3 % of patients in each placebo group.
Slovenian: Vrednosti amilaz so se v študiji 1 zvečale na 3. ali 4. stopnjo po CTCAE pri 1 % bolnikov, ki so se zdravili s sorafenibom, in pri 3 % bolnikov, ki so prejemali placebo, v študiji 3 pa pri 2 % bolnikov, ki so se zdravili s sorafenibom, in 3 % bolnikov, ki so prejemali placebo.
English: Rare: may affect up to 1 in 1,000 people - allergic reaction with swelling of the skin (e. g. face, tongue) that may cause difficulty in breathing or swallowing (angioedema) - abnormal heart rhythm (QT prolongation) - inflammation of the liver, which may lead to nausea, vomiting, abdominal pain, and jaundice
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov - vneta želodčna sluznica (gastritis) - bolečine v trebuhu (abdomnu) zaradi vnetja trebušne slinavke, žolčnika in/ali žolčnih vodov - porumenela koža ali oči (zlatenica) zaradi zvečanih vrednosti žolčnih barvil
English: anaphylactic reaction angioedema
Slovenian: - nenadna, huda alergijska reakcija (anafilaktična reakcija)
English: Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib.
Slovenian: Najpogostejši neželeni učinki zdravljenja s sorafenibom so kožne reakcije na dlaneh in podplatih (palmarno-plantarna eritrodisestezija) in izpuščaji.
English: Temporary interruption of sorafenib therapy is recommended for precautionary reasons in patients undergoing major surgical procedures.
Slovenian: Pri bolnikih, pri katerih je načrtovan velik kirurški poseg se kot previdnostni ukrep priporoča začasno prenehanje zdravljenja s sorafenibom.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer (Logo)
English: Each tablet contains 200 mg of sorafenib (as tosylate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 200 mg sorafeniba (v obliki sorafenibijevega tosilata).
English: Treatment with
Slovenian: PROMET Z ZDRAVILOM
English: Contents of the pack and other information What Nexavar contains
Slovenian: Shranjevanje zdravila Nexavar Vsebina pakiranja in dodatne informacije
English: If not, your doctor may interrupt treatment or stop it altogether.
Slovenian: V nasprotnem primeru, bo zdravnik zdravljenje z zdravilom Nexavar začasno ali trajno prenehal.
English: Combination with other anti-neoplastic agents
Slovenian: Sočasno jemanje z drugimi učinkovinami z delovanjem na novotvorbe
English: Your doctor may decide to interrupt treatment or stop it altogether.
Slovenian: Zdravnik se bo morda odločil za začasno ali trajno prenehanje zdravljenja z zdravilom Nexavar.
English: Study 2 was a Phase II, discontinuation study in patients with metastatic malignancies, including RCC.
Slovenian: faze, v katero so bili vključeni bolniki z različnimi vrstami rakavih bolezni z metastazami, tudi s karcinomom ledvičnih celic.
English: Vascular disorders haemorrhage (inc. gastrointestinal*, respiratory tract* and cerebral haemorrhage*)
Slovenian: Žilne bolezni krvavitev (vključno s krvavitvami v prebavilih* in dihalih* ter možganske krvavitve*) hipertenzija pordevanje hipertenzivne krize*
English: Take special care with Nexavar
Slovenian: Shranjevanje zdravila Nexavar
English: It is available in strengths from 2,000 IU/ml to 20,000 IU/ml.
Slovenian: Na voljo je v jakostih od 2.000 i.e./ml do 20.000 i.e./ml.
English: Doses are adjusted depending on the response.
Slovenian: Odmerke je potrebno prilagoditi glede na odziv
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dynepo to Shire Pharmaceutical Contracts Ltd on 18 March 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dynepo, veljavno po vsej Evropski uniji, odobrila družbi Shire Pharmaceutical Contracts Ltd dne 18. marca 2002.
English: The starting doses are 50 IU/kg three times a week if given intravenously, and twice a week if given subcutaneously.
Slovenian: Začetni odmerki so 50 i.e./kg trikrat tedensko, če se zdravilo daje intravensko, oziroma dvakrat tedensko, če se daje subkutano.
English: Epoetin delta, the active ingredient of Dynepo, is a copy of the human hormone, produced by a method known as ‘genetic engineering': the enzyme is made by a cell in which the gene (the code) for the enzyme is activated so that the cell makes more of the enzyme and it can then be extracted and used in Dynepo.
Slovenian: Zdravilna učinkovina zdravila Dynepo, epoetin delta, ki je kopija človeškega encima, je izdelana po metodi ‘‘genskega inženiringa'': encim izdela celica, v kateri se aktivira gen (koda) za encim, zaradi česar celica tvori več encima, ki se nato izloči iz nje in uporabi pri izdelavi zdravila Dynepo.
English: In the other study, three different dosing schedules of subcutaneous Dynepo were compared.
Slovenian: V drugi študiji pa so primerjali tri različne sheme odmerjanja zdravila Dynepo, ki so ga dajali subkutano.
English: What is the risk associated with Dynepo?
Slovenian: Kakšna tveganja so povezana z zdravilom Dynepo?
English: What benefit has Dynepo shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dynepo izkazalo med raziskavami?
English: In patients with long-term kidney failure, a cause of their anaemia can be a lack of erythropoietin.
Slovenian: Pri bolnikih z dolgotrajno odpovedjo ledvic je lahko vzrok za slabokrvnost pomanjkanje eritropoetina.
English: Dynepo can be given intravenously (injection into a vein) or subcutaneously (injection under the skin).
Slovenian: Dynepo se lahko daje intravensko (z injiciranjem v žilo) ali subkutano (z injiciranjem pod kožo).
English: Allergic reactions have occasionally been seen, so it is recommended that the first dose of Dynepo be given under medical supervision.
Slovenian: Ker je bil v redkih primerih opažen pojav alergijskih reakcij, je priporočeno, da se prvi odmerek daje pod zdravniškim nadzorom.
English: The effectiveness of Dynepo to treat anaemia has been studied in a total of 1308 patients with chronic renal failure, including two main clinical studies.
Slovenian: Učinkovitost zdravila Dynepo pri zdravljenju slabokrvnosti je bila raziskana pri 1.308 bolnikih s kronično odpovedjo ledvic, med drugim v dveh večjih kliničnih študijah.
English: The most common side effects are hypertension (raised blood pressure), headache, and, for patients on dialysis, problems with the dialysis tubes.
Slovenian: Najbolj pogosti neželeni učinki so hipertenzija (povišan krvni tlak), glavobol, pri bolnikih, ki so na dializi, pa težave z dializnimi cevkami.
English: Dynepo should not be used in people who may be hypersensitive (allergic) to epoetin delta or any of the other ingredients, and in patients who have uncontrolled high blood pressure.
Slovenian: Zdravila Dynepo ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) epoetin delta ali na katero koli drugo sestavino, ter bolniki s slabo nadzorovanim visokim krvnim tlakom.
English: Dynepo is used to treat anaemia (fewer than normal red blood cells in the blood) in adult patients with chronic renal failure (long-term kidney disease).
Slovenian: Dynepo se uporablja za zdravljenje slabokrvnosti (pri kateri je število rdečih krvnih celic v krvi nižje od normalnega) pri odraslih bolnikih s kronično odpovedjo ledvic (dolgotrajno ledvično obolenje).
English: The main measure of effectiveness in the clinical studies was whether Dynepo increased haemoglobin levels (the protein found in red blood cells that carries oxygen around the body).
Slovenian: V kliničnih študijah je bil glavni pokazatelj učinkovitosti zdravila Dynepo dvig ravni hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik po telesu).
English: Dynepo is a solution for injection in pre-filled syringe.
Slovenian: Zdravilo Dynepo je raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: The effectiveness was the same if it was administered intravenously or subcutaneously.
Slovenian: Učinkovitost zdravila je bila enaka pri intravenskem in subkutanem dajanju.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DYNEPO EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) DYNEPO
English: In one of these, Dynepo given intravenously was compared with epoetin alfa (a similar type of drug).
Slovenian: V eni izmed njih so primerjali učinek zdravila Dynepo, ki so ga dajali intravensko, z učinkom epoetina alfa (podobna vrsta zdravila).
English: Dynepo works by stimulating production of red blood cells in the same way as erythropoietin.
Slovenian: Zdravilo Dynepo učinkuje tako, da spodbuja tvorbo rdečih krvnih celic na enak način kot eritropoetin.
English: Dynepo contains the active ingredient epoetin delta.
Slovenian: Dynepo vsebuje zdravilno učinkovino epoetin delta.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Dynepo's benefits are greater than its risks for the treatment of anaemia in patients with chronic renal failure.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Dynepo pri zdravljenju slabokrvnosti pri bolnikih s kronično odpovedjo ledvic večje od z njim povezanih tveganj.