FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the patients in the Vidaza group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Slovenian: Od bolnikov v skupini z zdravilom Vidaza, ki so bili v izhodišču odvisni od transfuzij trombocitov, jih je 40,6 % (95 % IZ = 30,9; 50,8) v obdobju zdravljenja postalo neodvisnih od transfuzij trombocitov, v primerjavi z 29,3 % (95 % IZ = 19,7; 40,4) bolnikov v skupinah s kombiniranimi CCR.
English: • Pain in your throat and voicebox.
Slovenian: • bolečine v žrelu in grlu
English: bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage (at injection site), malaise, chills, catheter site hemorrhage injection site necrosis (at injection site)
Slovenian: modrice, hematom, induracija, osip, srbenje, vnetje, razbarvanje, vozli in krvavitev (na mestu injiciranja), splošno slabo počutje, mrzlica, krvavitev na mestu kateteriziranja nekroza injekcijske ga mesta (na mestu injiciranja)
English: Hypersensitivity
Slovenian: Preobčutljivost
English: • Bleeding.
Slovenian: • Krvavitev.
English: Developmental abnormalities in the brain have been detected in mice given azacitidine on or before closure of the hard palate.
Slovenian: Pri miših, ki so dobivale azacitidin med ali pred zapiranjem trdega neba, so opazili razvojne abnormalnosti v možganih.
English: • Redness of your skin.
Slovenian: • pordelost kože
English: • Feeling generally unwell.
Slovenian: • splošno slabo počutje
English: General disorders and administration site conditions pyrexia*, fatigue, asthenia, chest pain, injection site erythema, injection site pain, injection site reaction (unspecified)
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija*, utrujenost, astenija, bolečine v prsih, eritem na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja (nedoločena)
English: Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle.
Slovenian: Pred začetkom zdravljenja in pred vsakim ciklom zdravljenja je treba izvesti teste delovanja jeter in določiti vrednost serumskega kreatinina in serumskega hidrogenkarbonata.
English: • Inflammation of the lining around the heart (pericarditis).
Slovenian: • vnetje osrčnika, mrene, ki obdaja srce (perikarditis)
English: APPROPRIATE
Slovenian: ocenjeno
English: • An infection of the blood caused by bacteria (sepsis).
Slovenian: • okužba krvi, ki jo povzroči bakterija (sepsa) - vzrok je lahko majhno število levkocitov v krvi
English: Patients should be premedicated with anti-emetics for nausea and vomiting.
Slovenian: Bolnikom je treba pred začetkom kemoterapije dati antiemetike proti navzei in bruhanju.
English: Of the patients in the Vidaza group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Slovenian: Od bolnikov v skupini z zdravilom Vidaza, ki so bili v izhodišču odvisni od transfuzij eritrocitov, jih je 38,5 % (95 % IZ = 31,1; 46,2) v obdobju zdravljenja postalo neodvisnih od transfuzij eritrocitov, v primerjavi s 27,6 % (95 % IZ = 20,9; 35,1) bolnikov v skupinah s kombiniranimi CCR.
English: These may be symptoms of liver failure and can be life-threatening.
Slovenian: To utegnejo biti simptomi odpovedi ledvic in so lahko smrtno nevarni.
English: When Vidaza is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Slovenian: Pri rekonstituciji zdravila Vidaza z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C), je rekonstituirano zdravilo kemijsko in fizikalno stabilno 22 ur pri 2 °C do 8 °C.
English: • Sore nose and throat.
Slovenian: • vnetje nosu in žrela
English: Necrotising fasciitis, including fatal cases, have been reported in patients treated with Vidaza.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Vidaza, so poročali o nekrotizantnem fasciitisu, vključno s smrtnimi primeri.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
English: Renal and urinary disorders renal failure*, haematuria, elevated serum creatinine renal tubular acidosis
Slovenian: Bolezni sečil odpoved ledvic*, hematurija, povečanje serumskega kreatinina ledvična tubularna acidoza
English: An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce CYP 1A2, 2C19, or 3A4 or 3A5.
Slovenian: do približno 30-krat višje kot klinično dosegljive koncentracije) azacitadin ne inducira CYP 1A2, 2C19, 3A4 ali 3A5.
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Gastrointestinal disorders diarrhoea, vomiting, constipation, nausea, abdominal pain (includes upper and abdominal discomfort)
Slovenian: Bolezni prebavil diareja, bruhanje, obstipacija, navzea, bolečine v trebuhu (vključuje bolečine v zgornjem delu trebuha in trebuhu)
English: Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
Slovenian: Po zdravljenju z zdravilom Vidaza naslednjega cikla ni treba prestaviti in prilagajati odmerka, če je zmanjšanje števila levkocitov ali ANC ali trombocitov ≤ 50 % od stanja pred zdravljenjem ali večje kot 50 % z izboljšanjem v diferenciaciji katerekoli celične linije.
English: If the elapsed time in the refrigerator is greater than 22 hours, the suspension should be discarded appropriately and a new dose prepared.
Slovenian: Če zdravilo shranjujete v hladilniku več kot 22 ur, morate suspenzijo zavreči in pripraviti nov odmerek.
English: Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Slovenian: število levkocitov < 3,0 x 109/l ali ANC < 1,5 x 109/l ali trombocitov < 75,0 x 109/l)
English: After reconstitution, each mL suspension contains 25 mg azacitidine.
Slovenian: Po rekonstituciji vsebuje vsak ml suspenzije 25 mg azacitidina.
English: Talk to your doctor, pharmacist or nurse before using Vidaza:
Slovenian: Pred začetkom uporabe zdravila Vidaza se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: • if you have decreased counts of platelets, red or white blood cells.
Slovenian: • če imate zmanjšano število trombocitov, eritrocitov ali levkocitov;
English: • higher-risk myelodysplastic syndromes (MDS).
Slovenian: • mielodisplastičnih sindromov (MDS) z večjim tveganjem;
English: The most commonly reported (≥ 10%) haematological adverse reactions associated with azacitidine treatment include anaemia, thrombocytopenia, neutropenia, febrile neutropenia and leukopenia, and were usually Grade 3 or 4.
Slovenian: Hematološki neželeni učinki, o katerih so najpogosteje (≥ 10 %) poročali v zvezi z zdravljenjem z azacitidinom, vključujejo anemijo, trombocitopenijo, nevtropenijo, febrilno nevtropenijo in levkopenijo.
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D bar code carrying the unique identifier 18.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: • Collection of fluid around the heart (pericardial effusion)..
Slovenian: • nabiranje tekočine okrog srca (perikardialni izliv)
English: Patients with hepatic impairment
Slovenian: Bolniki z okvaro jeter
English: Serious hypersensitivity reactions have been reported in patients receiving azacitidine.
Slovenian: Pri bolnikih, ki so se zdravili z azacitidinom, so poročali o resnih preobčutljivostnih reakcijah.
English: Reconstituted Vidaza should be injected subcutaneously into the upper arm, thigh or abdomen.
Slovenian: Rekonstituirano zdravilo Vidaza je treba injicirati pod kožo v nadlaket, stegno ali trebuh.
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: • Constipation, diarrhoea, nausea, vomiting.
Slovenian: • zapeka, driska, slabost, bruhanje
English: 1 vial - 100 mg METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za suspenzijo za injiciranje 1 viala - 100 mg POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Advanced malignant hepatic tumours (see section 4.4).
Slovenian: Napredovala oblika malignih jetrnih tumorjev (glejte poglavje 4.4).
English: Haematologic adverse reactions
Slovenian: Hematološki neželeni učinki
English: Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i.e. blood count at recovery ≥ nadir count + (0.5 x [baseline count - nadir count]).
Slovenian: Obnovitev je opredeljena kot porast celične linije/celičnih linij, pri katerih so opazili hematološko toksičnost, za vsaj polovico razlike med številom v najnižji točki in izhodiščnim številom plus število v najnižji točki (t.j.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: • Dizziness.
Slovenian: • izpuščaj
English: • Drowsiness, shaking, jaundice, abdominal bloating and easy bruising.
Slovenian: • Zaspanost, tresenje, zlatenica, napihnjen trebuh in nagnjenje k nastajanju modric.
English: gastrointestinal haemorrhage* (includes mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
Slovenian: krvavitev v prebavila* (vključuje krvavitve v ustih), hemoroidna krvavitev, stomatitis, krvavitev dlesni, dispepsija
English: Eye disorders eye haemorrhage, conjunctival haemorrhage
Slovenian: Očesne bolezni očesna krvavitev, krvavitev očesne veznice
English: Use an effective method of contraception during and up to 3 months after treatment.
Slovenian: Med zdravljenjem z zdravilom Vidaza in do 3 mesece po njem uporabljajte zanesljivo kontracepcijsko metodo.
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m2, almost 4 times the recommended starting dose.
Slovenian: Po enem intravenskem odmerku s približno 290 mg/m2, kar je skoraj 4-kratni priporočeni začetni odmerek, je bolnik dobil diarejo, občutil je navzeo ter je bruhal.
English: You should not breast-feed when using Vidaza.
Slovenian: Dojenje Če uporabljate zdravilo Vidaza, ne smete dojiti.
English: bleeding into your skin (haematoma), rash, itching and changes in the skin colour.
Slovenian: • spremembe kože na mestu injiciranja - to vključuje oteklost, zatrdelost, modrice, krvavitve v kožo (hematom), izpuščaj, srbenje in spremembe barve kože
English: • Chest pain, being short of breath.
Slovenian: • bolečine v prsih, kratka sapa
English: Soft tissue infections, including cellulitis and necrotising fasciitis in rare cases leading to death, have been reported with azacitidine in the post marketing setting.
Slovenian: Po prihodu zdravila na trg so v povezavi z azacitidinom poročali o okužbah mehkih tkiv, vključno s celulitisom in nekrotizantnim fasciitisom, kar se je v redkih primerih končalo s smrtjo.
English: Fatigue has been reported with the use of azacitidine.
Slovenian: Pri uporabi azacitidina so poročali o utrujenosti.
English: Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tubular acidosis, renal failure and death were reported in patients treated with azacitidine (see section 4.4).
Slovenian: Pri bolnikih, zdravljenih z azacitidinom, so poročali o ledvičnih nenormalnostih, ki so obsegale zvišan serumski kreatinin, hematurijo, ledvično tubularno acidozo, odpoved ledvic in smrt (glejte poglavje 4.4).
English: How Vidaza works
Slovenian: Kako zdravilo Vidaza deluje
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Talk to your doctor or nurse if you have any questions about how Vidaza works or why this medicine has been prescribed for you.
Slovenian: Če imate kakšna vprašanja o tem, kako zdravilo Vidaza deluje, ali o tem, zakaj so vam predpisali to zdravilo, se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: When reconstituting using refrigerated (2 °C to 8 °C) water for injections, the reconstituted suspension must be placed in a refrigerator (2 °C to 8 °C) immediately after reconstitution, and kept in a refrigerator for a maximum of 22 hours.
Slovenian: Pri rekonstituiranju z vodo za injekcije, ki je bila v hladilniku (2 °C do 8 °C), morate rekonstituirano suspenzijo takoj po rekonstituciji shraniti v hladilnik (2 °C do 8 °C) in jo v hladilniku shranjujte največ 22 ur.
English: If the Vidaza suspension is prepared using water for injections that has been stored in the refrigerator (2 °C - 8 °C), the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
Slovenian: Če suspenzijo zdravila Vidaza pripravite z vodo za injekcije, ki je bila v hladilniku (2 °C - 8 °C), morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 22 ur.
English: Vidaza treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Slovenian: Zdravljenje z zdravilom Vidaza je povzročilo manjšo potrebo po transfuzijah eritrocitov in trombocitov.
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: When reconstituting using water for injections that has not been refrigerated, the reconstituted suspension must be placed in a refrigerator (2 °C to 8 °C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours.
Slovenian: Pri rekonstituiranju z vodo za injekcije, ki ni bila v hladilniku, morate rekonstituirano suspenzijo takoj po rekonstituciji shraniti v hladilnik (2 °C do 8 °C) in jo v hladilniku shranjujte največ 8 ur.
English: • Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).
Slovenian: krvavitev v očesu, krvavitev pod ali v kožo (hematom)
English: • Fainting.
Slovenian: • omedlevica
English: • Tiredness (fatigue).
Slovenian: • oslabelost (astenija)
English: If the Vidaza suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
Slovenian: Če suspenzijo zdravila Vidaza pripravite z vodo za injekcije, ki ni bila v hladilniku, morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 8 ur.
English: HR = hazard ratio
Slovenian: Število ogroženih CCR azacitidin
English: Posology
Slovenian: Izdelovalec
English: What is in this leaflet:
Slovenian: Kaj vsebuje navodilo
English: What Vidaza is
Slovenian: Kaj je zdravilo Vidaza
English: OTHER
Slovenian: Občasni
English: Very common Common
Slovenian: Organski sistem Zelo pogosti
English: • Bruising.
Slovenian: • srbenje
English: One case of overdose with azacitidine was reported during clinical trials.
Slovenian: Med kliničnimi preskušanji so poročali o enem primeru prevelikega odmerjanja azacitidina.
English: • Being short of breath when you move.
Slovenian: • kratka sapa med gibanjem
English: • Shivering (chills).
Slovenian: • drgetanje (mrzlica)
English: How to store Vidaza
Slovenian: Zdravljenje azacitidin
English: • Weight loss.
Slovenian: • Zvišana telesna temperatura.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: • Rash.
Slovenian: • modrice
English: • Liver failure.
Slovenian: • odpoved jeter
English: • Muscle spasms.
Slovenian: • suh kašelj
English: In some cases these reactions can become severe.
Slovenian: V nekaterih primerih lahko te reakcije postanejo resne.
English: Further information can be found in the summary of the risk management plan.
Slovenian: Dodatne informacije so na voljo v povzetku načrta obvladovanja tveganj.
English: The injection is given into a vein over several minutes.
Slovenian: Injekcija se daje v veno nekaj minut.
English: Comparable results were seen in patients who continued to take the medicine after completion of the initial study.
Slovenian: Primerljive rezultate so opazili pri bolnikih, ki so po koncu začetne študije še naprej jemali zdravilo.
English: What measures are being taken to ensure the safe and effective use of Iblias?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Iblias?
English: Other information about Iblias
Slovenian: Druge informacije o zdravilu Iblias
English: Response to treatment was considered good or excellent in about 90% of cases.
Slovenian: Odziv na zdravljenje je bil v 90 % primerih ocenjen kot dober ali odličen.
English: The full EPAR and risk management plan summary for Iblias can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Iblias sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Slovenian: Pojasnjuje, kako je agencija ocenila to zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
English: Iblias octocog alfa
Slovenian: Iblias oktokog alfa
English: Regarding safety, the reported effects are in line with those expected for a factor VIII product.
Slovenian: Kar zadeva varnost, so učinki, o katerih so poročali, v skladu s pričakovanimi učinki pri zdravilu s faktorjem VIII.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Iblias's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Iblias večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Iblias.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iblias.
English: A risk management plan has been developed to ensure that Iblias is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Iblias je bil pripravljen načrt za obvladovanje tveganja.
English: Data from a supportive study also confirmed the benefits of preventative treatment with Iblias in reducing the number of bleeds.
Slovenian: Tudi podatki podporne študije so potrdili koristi preventivnega zdravljenja z zdravilom Iblias pri zmanjševanju števila krvavitev.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Slovenian: Če se pojavijo, lahko vključujejo angioedem (otekanje podkožnega tkiva), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, rdečico, srbeč izpuščaj po vsem telesu, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), letargijo, navzeo (slabost), nemir, tahikardijo (pospešen srčni utrip), tiščanje v prsnem košu, mravljinčenje, bruhanje in sopenje.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.
Slovenian: Nadomešča manjkajoči faktor VIII ter tako pripomore k strjevanju krvi in omogoči začasen nadzor nad krvavitvijo.
English: In 12 patients who required major surgery during the study, control of blood loss was also rated as good or excellent by the patients' doctors.
Slovenian: Tudi pri 12 bolnikih, ki so med študijo potrebovali večji kirurški poseg, so njihovi zdravniki ocenili, da je bil nadzor nad izgubo krvi dober ali odličen.
English: It contains the active substance octocog alfa, which is the same as human factor VIII.
Slovenian: Vsebuje zdravilno učinkovino oktokog alfa, ki je enaka humanemu faktorju VIII.
English: What is Iblias and what is it used for?
Slovenian: Kaj je zdravilo Iblias in za kaj se uporablja?
English: Why is Iblias approved?
Slovenian: Zakaj je bilo zdravilo Iblias odobreno?
English: It is not intended to provide practical advice on how to use Iblias.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Iblias has been shown to be effective in both preventing and treating bleeds, including managing blood loss during surgery, and can be used in all age groups.
Slovenian: Dokazali so, da je zdravilo Iblias učinkovito pri preprečevanju in zdravljenju krvavite, vključno z obvladovanjem izgube krvi med kirurškimi posegi, in se lahko uporablja pri vseh starostnih skupinah.
English: The dose and frequency of the injections depend on whether Iblias is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Iblias uporablja za zdravljenje ali preprečevanje krvavitve, resnosti bolnikovega pomanjkanja faktorja VIII, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
English: What benefits of Iblias have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Iblias izkazalo v študijah?
English: What are the risks associated with Iblias?
Slovenian: Kakšna so tveganja, povezana z zdravilom Iblias?
English: Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins.
Slovenian: Bolniki lahko tvorijo protitelesa proti beljakovinam hrčka ali miši; zdravilo se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) oktokog alfa ali beljakovine hrčka ali miši.
English: This compared with an average of 6.9 bleeds per year before Iblias treatment.
Slovenian: To povprečje je pred zdravljenjem z zdravilom Iblias znašalo 6,9 krvavitve na leto.