FrancophonIA/ELRC3.0 huggingface dataset:
English: Blurred vision Mydriasis Visual impairment
Croatian: Poremećaji oka zamućen vid midrijaza poremećaj vida glaukom
English: Diabetic peripheral neuropathic pain
Croatian: Bol kod dijabetičke periferne neuropatije
English: • coughing, wheezing and shortness of breath which may be accompanied by a high temperature inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
Croatian: • upala usta, svjetlocrvena krv u stolici, neugodan zadah, upala debelog crijeva (što dovodi do proljeva)
English: Duloxetine Lilly 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Croatian: Neprozirno tijelo bijele boje s otisnutom oznakom „30 mg“ i neprozirna plava kapica s otisnutom oznakom „9543“.
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Croatian: Za bolesnike s teškim oštećenjem bubrežne funkcije vidjeti dio 4.3. Vidjeti dio 4.2 za podatke o bolesnicima s blagim ili umjerenim poremećajem bubrežne funkcije.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Duloxetine Lilly in all subsets of the paediatric population in the treatment of major depressive disorder, diabetic neuropathic pain and generalised anxiety disorder.
Croatian: Lilly u svim podskupinama pedijatrijske populacije u liječenju velikog depresivnog poremećaja, boli kod dijabetičke neuropatije i generaliziranog anksioznog poremećaja.
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 30 ili 60 mg duloksetina (u obliku duloksetinklorida).
English: Rare side effects (may affect up to 1 in 1000 people)
Croatian: Rijetke nuspojave (mogu se javiti u najviše 1 do 1000 osoba)
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
Croatian: • "serotoninski sindrom" (rijetka reakcija koja može izazvati osjećaj velike sreće, omamljenost,
English: EXP
Croatian: Dob
English: Duloxetine Lilly 60 mg
Croatian: Duloksetin Lilly 60 mg
English: Duloxetine Lilly 30 mg
Croatian: Duloksetin Lilly 30 mg
English: • decreased thyroid gland activity which can cause tiredness or weight gain
Croatian: • smanjena aktivnost štitnjače koja može izazvati umor ili porast tjelesne težine
English: EU/1/14/972/008 (100 hard gastro-resistant capsules) (5 packs of 20) EU/1/14/972/009 (500 hard gastro-resistant capsules) (25 packs of 20)
Croatian: EU/1/14/972/009 (500 tvrdih želučanootpornih kapsula) (25 kutija s 20)
English: • weight gain
Croatian: • porast tjelesne težine
English: Feeling abnormal Feeling cold Thirst
Croatian: neuobičajeno osjećanje osjećaj hladnoće žeđ zimica malaksalost osjećaj vrućine smetnje hoda
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Croatian: Kod primjene selektivnih inhibitora ponovne pohrane serotonina (engl. selective serotonin reuptake inhibitors, SSRIs) i inhibitora ponovne pohrane serotonina i noradrenalina (engl. serotonin/noradrenaline reuptake inhibitors, SNRIs), uključujući duloksetin, bilo je izvješća o abnormalnim krvarenjima, poput ekhimoza, purpure i gastrointestinalnih krvarenja.
English: • blurred eyesight
Croatian: • zamućen vid
English: agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Croatian: glavobolja, mialgija, razdražljivost, proljev, hiperhidroza i vrtoglavica.
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
English: Duloxetine Lilly 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Croatian: Neprozirno tijelo zelene boje s otisnutom oznakom „60 mg“ i neprozirna plava kapica s otisnutom oznakom „9542“.
English: b. Tabulated list of adverse reactions
Croatian: Tablični popis nuspojava
English: 5.3 Preclinical safety data
Croatian: Sažetak sigurnosnog profila
English: The usually recommended dose of Duloxetine Lilly is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Croatian: Za depresiju i bol kod dijabetičke neuropatije: Uobičajena preporučena doza lijeka Duloksetin Lilly je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja Vama najbolje odgovara.
English: APPROPRIATE 11.
Croatian: PRILOG III.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u najviše 1 na 100 osoba):
English: Duloxetine Lilly contains sucrose.
Croatian: Duloksetin Lilly sadrži saharozu.
English: Ejaculation disorder
Croatian: Oštećenje jetrene funkcije
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Croatian: U kliničkim je ispitivanjima ocijenjena sigurnost primjene doza većih od 60 mg jednom dnevno, do najviše 120 mg na dan primijenjenih u ravnomjerno podijeljenim dozama.
English: • muscle pain, muscle spasm
Croatian: • mučnina, suha usta
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride)
Croatian: Duloksetin Lilly 30 mg tvrde želučanootporne kapsule Duloksetin Lilly 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
English: Orgasm abnormal Abnormal dreams
Croatian: Psihijatrijski poremećaji nesanica agitacija smanjen libido anksioznost abnormalni orgazam abnormalni snovi suicidalne misli5,7
English: Duloxetine Lilly contains sucrose
Croatian: Duloksetin Lilly sadrži saharozu
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Croatian: Duloksetin Lilly 30 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
English: Nervous system disorders Headache
Croatian: Oštećenje bubrežne funkcije
English: Trismus
Croatian: Midrijaza
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules
Croatian: Duloksetin Lilly 30 mg tvrde želučanootporne kapsule Duloksetin Lilly 60 mg tvrde želučanootporne kapsule
English: Povidone
Croatian: OBLIK
English: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min).
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koji su na hemodijalizi, povećana je koncentracija duloksetina u plazmi.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Croatian: Duloksetin Lilly 60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Croatian: Poremećaji probavnog sustava mučnina suha usta konstipacija proljev bol u abdomenu povraćanje dispepsija flatulencija gastrointestinalno krvarenje7 gastroenteritis podrigivanje gastritis disfagija stomatitis svježa krv u stolici neugodan zadah mikroskopski kolitis9
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Duloxetine Lilly and 23% of patients taking placebo.
Croatian: 45% bolesnika liječenih lijekom Duloksetin Lilly i u 23% bolesnika koji su uzimali placebo.
English: Cutaneous vasculitis
Croatian: kutani vaskulitis
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
English: Somnolence
Croatian: Krvarenje
English: Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine
Croatian: Duloksetin Lilly 60 mg tvrde želučanootporne kapsule duloksetin
English: Taking a MAOI together with many prescription medicines, including Duloxetine Lilly, can cause serious or even life-threatening side effects.
Croatian: uključujući Duloksetin Lilly, može izazvati ozbiljne, čak i po život opasne nuspojave.
English: PC:
Croatian: c.
English: Mechanism of action
Croatian: Način primjene
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - UNUTARNJA KUTIJA ZA 60 MG TVRDE
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules duloxetine
Croatian: Duloksetin Lilly 30 mg tvrde želučanootporne kapsule duloksetin
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Croatian: Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
English: Duloxetine Lilly may have a mild to moderate influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Duloksetin Lilly može imati blagi do umjereni utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Duloxetine Lilly is for oral use.
Croatian: Duloksetin Lilly se uzima kroz usta.
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja zijevanje stezanje u grlu epistaksa intersticijska plućna bolest10
English: Blood cholesterol increased
Croatian: Krvožilni poremećaji povišen krvni tlak3
English: Psychiatric disorders Insomnia
Croatian: psihomotorni nemir6
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Croatian: U kliničkim je ispitivanjima ocijenjena sigurnost primjene doza većih od 60 mg jednom dnevno, do najviše 120 mg na dan.
English: Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Croatian: Stope kliničkog odgovora među bolesnicima u kojih se javila somnolencija iznosile su 60%
English: Duloxetine Lilly contains the active substance duloxetine.
Croatian: Što je Duloksetin Lilly i za što se koristi Duloksetin Lilly sadrži djelatnu tvar duloksetin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK-OUTER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - VANJSKA KUTIJA ZA 60 MG TVRDE
English: Chest pain7
Croatian: Citokromi P450
English: Duloxetine Lilly demonstrated statistical superiority over placebo as measured by improvement in the 17-item Hamilton Depression Rating Scale (HAM-D) total score (including both the emotional and somatic symptoms of depression).
Croatian: Scale, HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
English: Duloxetine Lilly is a hard gastro-resistant capsule.
Croatian: Kako Duloksetin Lilly izgleda i sadržaj pakiranja Duloksetin Lilly je tvrda želučanootporna kapsula.
English: Increased tendency to bruise
Croatian: • pojačano zijevanje
English: Reproductive system and breast disorders Erectile dysfunction
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija poremećaj preosjetljivosti
English: Skin and subcutaneous tissue disorders Sweating increased
Croatian: Poremećaji kože i potkožnog tkiva pojačano znojenje osip noćno znojenje urtikarija kontaktni dermatitis hladan znoj reakcija fotoosjetljivosti povećana sklonost stvaranju modrica
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
Croatian: KUTIJE ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: Vascular disorders
Croatian: ŽELUČANOOTPORNE KAPSULE
English: Vertigo Ear pain
Croatian: Gospina trava
English: Fatigue
Croatian: Dojenje
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules
Croatian: KUTIJE ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
English: • fast and/or irregular heart beat
Croatian: • omaglica ili vrtoglavica, bol u uhu • brzi ili nepravilni otkucaji srca
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u najviše 1 na 10 osoba): • gubitak teka
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).
Croatian: Klirens duloksetina iz plazme nakon intravenski primijenjene doze kreće se u rasponu od 22 l/h do
English: Lilly Hungária Kft. Tel: + 36 1 328 5100
Croatian: Tel: + 36 1 328 5100
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • glavobolja, pospanost
English: Urine flow decreased
Croatian: Hamilton Depression Rating
English: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children.
Croatian: Ispitivanje provedeno u 6 bolesnica s laktacijom koje nisu dojile svoju djecu pokazalo je da se duloksetin u majčino mlijeko izlučuje u vrlo maloj mjeri.
English: Talk to your doctor before you take Duloxetine Lilly if you: - are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Lilly') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine Lilly')
Croatian: Lilly“) - ako uzimate biljni lijek gospinu travu (Hypericum perforatum) - ako imate bolest bubrega - ako ste imali napadaje (konvulzije) - ako ste imali maniju - ako patite od bipolarnog poremećaja
English: Obizur has been authorised under ‘exceptional circumstances'.
Croatian: Obizur je odobren u „iznimnim okolnostima”.
English: What is Obizur and what is it used for?
Croatian: Što je Obizur i za što se koristi?
English: Obizur susoctocog alfa
Croatian: Obizur susoktokog alfa
English: Factor VIII is one of the proteins needed for normal clotting of the blood.
Croatian: Faktor VIII jedan je od proteina potrebnih za normalno zgrušavanje krvi.
English: All 28 patients showed a positive response within 24 hours of starting treatment with Obizur; in 24 out of 28 patients, the bleeding stopped completely.
Croatian: Svih 28 bolesnika pokazalo je pozitivan odgovor unutar 24 sata od početka terapije lijekom Obizur; u 24 od 28 bolesnika krvarenje je u potpunosti zaustavljeno.
English: The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened.
Croatian: Odgovor na Obizur smatrao se pozitivnim ako je krvarenje zaustavljeno ili smanjeno, dok je negativan odgovor značio da se krvarenje nastavilo ili pogoršalo.
English: Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Croatian: Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
English: Why is Obizur approved?
Croatian: Zašto je lijek Obizur odobren?
English: Obizur was not compared with any other medicine.
Croatian: Obizur nije uspoređen niti s jednim drugim lijekom.
English: What are the risks associated with Obizur?
Croatian: Koji su rizici povezani s lijekom Obizur?
English: Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Croatian: Pri primjeni lijeka Obizur mogu nastupiti reakcije preosjetljivosti (alergije) koje mogu uključivati angioedem (oticanje tkiva ispod kože), osjećaj peckanja i žarenja na mjestu injekcije, drhtavicu, navalu vrućine, svrbljivi osip, glavobolju, urtikariju, hipotenziju (niski krvni tlak), osjećaj umora ili nemir, mučninu (osjećaj slabosti) ili povraćanje, tahikardiju (ubrzane otkucaje srca), zatezanje u prsima, zaduhu i osjećaje peckanja.
English: The full EPAR and risk management plan summary for Obizur can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Obizur nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease.
Croatian: Tome je razlog nemogućnost dobivanja potpunih informacija o lijeku Obizur zbog rijetkosti bolesti.
English: What measures are being taken to ensure the safe and effective use of Obizur?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Obizur?
English: This is a summary of the European public assessment report (EPAR) for Obizur.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Obizur.
English: Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.
Croatian: Budući da je Obizur odobren pod iznimnim okolnostima, tvrtka koja stavlja lijek u promet uspostavit će i održavati registar bolesnika kako bi prikupila i analizirala kratkoročne i dugoročne podatke o djelotvornosti i sigurnoj primjeni lijeka Obizur u bolesnika sa stečenom hemofilijom uzrokovanom protutijelima na faktor VIII.
English: In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
Croatian: U pojedinim slučajevima, reakcije postaju ozbiljne (anafilaksa) i mogu biti povezane s ozbiljnim naglim padom krvnog tlaka.
English: Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.
Croatian: Nadalje, tvrtka koja stavlja lijek Obizur dostavit će zdravstvenim djelatnicima za koje se očekuje da će primjenjivati Obizur edukacijske materijale koji će sadržavati informacije o načinu izračuna doze.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Obizur are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Obizur nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: As a result, it will not be as easily recognised by the antibodies and it can replace the human factor VIII that has been inactivated, thereby helping the blood to clot and controlling the bleeding.
Croatian: Kao posljedica toga, protutijela neće lako prepoznati ovaj lijek, pa on može zamijeniti ljudski faktor VIII koji je deaktiviran i tako pomoći pri zgrušavanju krvi i kontroli krvarenja.
English: susoctocog alfa, works in the body in the same way as human factor VIII, but has a slightly different shape.
Croatian: Djelatna tvar lijeka Obizur, susoktokog alfa, djeluje u tijelu na isti način kao ljudski faktor VIII, no ima malo drugačiji oblik.
English: The dose, and how often it is given, as well as the length of treatment, are adjusted depending on the patient's condition and requirements, and the degree of danger posed by the bleeding.
Croatian: Doza lijeka, kao i učestalost primjene te duljina terapije, prilagođavaju su ovisno o stanju i zahtjevima bolesnika te stupnju opasnosti koju predstavlja krvarenje.
English: Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Obizur je dostupan kao prašak i otapalo koji se miješaju kako bi se pripremila otopina za injekciju u venu.
English: Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein.
Croatian: Obizur se ne smije primjenjivati u bolesnika koji su imali ozbiljnu alergijsku reakciju na susoktokog alfa, bilo koji drugi sastojak lijeka ili protein hrčka.
English: With regard to safety, the Committee considered that the potential for allergic reactions and the development of antibodies against the medicine is expected, and is outweighed by the beneficial effects.
Croatian: S obzirom na sigurnost primjene, Odbor je zaključio da se mogu očekivati alergijske reakcije i razvoj protutijela na lijek, ali da ih koristi lijeka nadmašuju.
English: The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Croatian: Rezultati glavnog ispitivanja potvrdili su da je Obizur djelotvoran u liječenju ozbiljnih epizoda krvarenja u odraslih osoba s tim poremećajem.
English: Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Croatian: Bolesnici sa stečenom hemofilijom koju uzrokuju protutijela na faktor VIII imaju probleme sa zgrušavanjem krvi, poput krvarenja u zglobovima, mišićima i unutarnjim organima.
English: A risk management plan has been developed to ensure that Obizur is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Obizur.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Obizur nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII.
Croatian: CHMP je uočio manjak specifičnih terapija za stečenu hemofiliju uzrokovanu protutijelima na faktor VIII.
English: Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.
Croatian: Bolesnici sa stečenom hemofilijom uzrokovanom protutijelima na faktor VIII mogu razviti protutijela na susoktokog alfa.
English: For more information about treatment with Obizur, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Obizur pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Obizur.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Obizur.
English: Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode.
Croatian: Obizur je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 28 odraslih bolesnika sa stečenom hemofilijom uzrokovanom protutijelima na faktor VIII koji su imali ozbiljnu epizodu krvarenja.