natgillin/translations-raw huggingface dataset:
Very rare side effects (may affect up to 1 in 10,000 people) 
Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba)
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Duloxetine Lilly before starting an MAOI (see section 
mora proći najmanje 5 dana nakon prestanka uzimanja lijeka Duloksetin Lilly prije započinjanja liječenja inhibitorom MAO (vidjeti dio 4.3).
Edible green ink contains: Black iron oxide - synthetic (E172) Yellow iron oxide - synthetic (E172) Propylene glycol 
Jestiva zelena tinta sadrži: željezov oksid, crni - sintetski (E172) željezov oksid, žuti - sintetski (E172) propilenglikol šelak
Also, you need to wait at least 5 days after you stop taking Duloxetine Lilly before you take a MAOI. 
Također, nakon što ste prestali uzimati Duloksetin Lilly, morate pričekati najmanje 5 dana prije nego počnete uzimati inhibitor MAO.
Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac. 
Jestiva zelena tinta: sintetski crni željezov oksid (E172), sintetski žuti željezov oksid (E172), propilenglikol, šelak.
Duloxetine Lilly hard gastro-resistant capsules contain sucrose. 
Duloksetin Lilly tvrde želučanootporne kapsule sadrže saharozu.
Major Depressive Disorder: Duloxetine Lilly was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression. 
3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow 
• otežano mokrenje ili nemogućnost mokrenja, otežan početak mokrenja, potreba za mokrenjem tijekom noći, pojačana potreba za mokrenjem, smanjen protok mokraće
No malformations were observed in another study testing a higher dose of a different salt of duloxetine. 
U drugom ispitivanju u kojem se ispitivala veća doza druge soli duloksetina nisu uočene malformacije.
The concomitant use of Duloxetine Lilly with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4). 
Ne preporučuje se istodobna primjena lijeka Duloksetin Lilly sa selektivnim reverzibilnim inhibitorima MAO, poput moklobemida (vidjeti dio 4.4).
A total of 509 paediatric patients aged 7 to 17 years with major depressive disorder and 241 paediatric patients aged 7 to 17 years with generalised anxiety disorder were treated with duloxetine in clinical trials. 
17 godina s velikim depresivnim poremećajem i 241 pedijatrijski bolesnik u dobi od 7 do 17 godina s generaliziranim anksioznim poremećajem.
Duloxetine is well absorbed after oral administration with a Cmax occurring 6 hours post dose. 
Duloksetin se nakon peroralne primjene dobro apsorbira, pri čemu se Cmax postiže
Consequently, caution is advised when Duloxetine Lilly is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines). 
Stoga se preporučuje oprez kada se Duloksetin Lilly primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine,
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind 
• zatvor, proljev, bol u želucu, povraćanje, žgaravica ili loša probava, vjetrovi
There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase. 
Tijekom 10-tjedne akutne faze liječenja nije bilo statistički značajne razlike između skupina koje su primale duloksetin odnosno placebo s obzirom na prekid liječenja zbog nuspojava.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). 
Simptomi serotoninskog sindroma mogu uključivati promjene mentalnog statusa (npr. agitaciju, halucinacije, komu), nestabilnost autonomnog živčanog sustava (npr. tahikardiju, nestabilan krvni tlak,
Protein binding is not affected by renal or hepatic impairment. 
Oštećenje bubrežne ili jetrene funkcije ne utječe na vezanje za proteine.
For patients who experience a sustained increase in blood pressure while receiving duloxetine either dose reduction or gradual discontinuation should be considered (see section 4.8). 
U bolesnika koji imaju kontinuirano povišenje krvnog tlaka za vrijeme uzimanja duloksetina mora se razmotriti ili smanjivanje doze ili postupan prekid uzimanja lijeka
EU/1/14/972/001 (7 hard gastro-resistant capsules) EU/1/14/972/002 (28 hard gastro-resistant capsules) EU/1/14/972/003 (98 hard gastro-resistant capsules) 
EU/1/14/972/001 (7 tvrdih želučanootpornih kapsula) EU/1/14/972/002 (28 tvrdih želučanootpornih kapsula) EU/1/14/972/003 (98 tvrdih želučanootpornih kapsula)
The use of Duloxetine Lilly while breastfeeding is not recommended. 
Ne preporučuje se uzimanje lijeka Duloksetin Lilly za vrijeme dojenja.
Aggression and anger4 
manija halucinacije agresija i bijes4
duloxetine 
Stoga se Duloksetin
7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules 
7 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula
EU/1/14/972/004 (28 hard gastro-resistant capsules) EU/1/14/972/005 (56 hard gastro-resistant capsules) EU/1/14/972/006 (84 hard gastro-resistant capsules) EU/1/14/972/007 (98 hard gastro-resistant capsules) 
EU/1/14/972/004 (28 tvrdih želučanootpornih kapsula) EU/1/14/972/005 (56 tvrdih želučanootpornih kapsula) EU/1/14/972/006 (84 tvrde želučanootporne kapsule) EU/1/14/972/007 (98 tvrdih želučanootpornih kapsula)
Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia. 
Znakovi i simptomi predoziranja (samim duloksetinom ili u kombinaciji s drugim lijekovima) uključivali su somnolenciju, komu, serotoninski sindrom, napadaje, povraćanje i tahikardiju.
Edible white ink contains: Titanium dioxide (E171) Propylene glycol Shellac 
Jestiva bijela tinta sadrži: titanijev dioksid (E171) propilenglikol šelak povidon
Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment. 
Podaci o farmakokinetici duloksetina u bolesnika s blagim ili umjerenim oštećenjem bubrežne funkcije su ograničeni.
In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. 
U bolesnika koji su reagirali na duloksetin, a u anamnezi imaju ponavljajuće epizode velike depresije, može se razmotriti daljnje dugotrajno liječenje dozom od
The incidence of relapse during the 6-months double-blind follow-up period was 17% and 29% for duloxetine and placebo, respectively. 
6-mjesečnog razdoblja dvostruko slijepog praćenja iznosila je 17% u bolesnika koji su uzimali duloksetin i 29% u onih koji su uzimali placebo.
Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain 
Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija poremećaj ejakulacije odgođena ejakulacija ginekološko krvarenje menstrualni poremećaj seksualna disfunkcija bol u testisima simptomi menopauze galaktoreja hiperprolaktinemija
Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial. 
hemoperfuzija i izmjena perfuzijom vjerojatno ne bi koristile.
What you need to know before you take Duloxetine Lilly DO NOT take Duloxetine Lilly if you: 
Što morate znati prije nego počnete uzimati Duloksetin Lilly
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid). 
Lijekovi koji povećavaju razinu serotonina: Triptani, tramadol, triptofan, selektivni inhibitori ponovne pohrane serotonina (poput paroksetina i fluoksetina), inhibitori ponovne pohrane serotonina i noradrenalina (poput venlafaksina), triciklički antidepresivi (poput klomipramina, amitriptilina),
A free airway should be established. 
Mora se osigurati prohodnost dišnih putova.
• increased blood pressure, flushing 
• povišen krvni tlak, crvenilo uz osjećaj vrućine
Blurred vision Mydriasis Visual impairment 
Poremećaji oka zamućen vid midrijaza poremećaj vida glaukom
Diabetic peripheral neuropathic pain 
Bol kod dijabetičke periferne neuropatije
• 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) 
• upala usta, svjetlocrvena krv u stolici, neugodan zadah, upala debelog crijeva (što dovodi do proljeva)
Duloxetine Lilly 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'. 
Neprozirno tijelo bijele boje s otisnutom oznakom „30 mg“ i neprozirna plava kapica s otisnutom oznakom „9543“.
See section 4.2 for information on patients with mild or moderate renal dysfunction. 
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.
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. 
Lilly u svim podskupinama pedijatrijske populacije u liječenju velikog depresivnog poremećaja, boli kod dijabetičke neuropatije i generaliziranog anksioznog poremećaja.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride). 
Jedna kapsula sadrži 30 ili 60 mg duloksetina (u obliku duloksetinklorida).
Rare side effects (may affect up to 1 in 1000 people) 
Rijetke nuspojave (mogu se javiti u najviše 1 do 1000 osoba)
• “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 
• "serotoninski sindrom" (rijetka reakcija koja može izazvati osjećaj velike sreće, omamljenost,
EXP 
Dob
Duloxetine Lilly 60 mg 
Duloksetin Lilly 60 mg
Duloxetine Lilly 30 mg 
Duloksetin Lilly 30 mg
• decreased thyroid gland activity which can cause tiredness or weight gain 
• smanjena aktivnost štitnjače koja može izazvati umor ili porast tjelesne težine
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) 
EU/1/14/972/009 (500 tvrdih želučanootpornih kapsula) (25 kutija s 20)
• weight gain 
• porast tjelesne težine
Feeling abnormal Feeling cold Thirst 
neuobičajeno osjećanje osjećaj hladnoće žeđ zimica malaksalost osjećaj vrućine smetnje hoda
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. 
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.
• blurred eyesight 
• zamućen vid
agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions. 
glavobolja, mialgija, razdražljivost, proljev, hiperhidroza i vrtoglavica.
Duloxetine Lilly 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'. 
Neprozirno tijelo zelene boje s otisnutom oznakom „60 mg“ i neprozirna plava kapica s otisnutom oznakom „9542“.
b. Tabulated list of adverse reactions 
Tablični popis nuspojava
5.3 Preclinical safety data 
Sažetak sigurnosnog profila
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. 
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.
APPROPRIATE 11. 
PRILOG III.
Uncommon side effects (may affect up to 1 in 100 people) 
Manje česte nuspojave (mogu se javiti u najviše 1 na 100 osoba):
Duloxetine Lilly contains sucrose. 
Duloksetin Lilly sadrži saharozu.
Ejaculation disorder 
Oštećenje jetrene funkcije
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. 
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.
• muscle pain, muscle spasm 
• mučnina, suha usta
Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine (as hydrochloride) 
Duloksetin Lilly 30 mg tvrde želučanootporne kapsule Duloksetin Lilly 60 mg tvrde želučanootporne kapsule duloksetin (u obliku duloksetinklorida)
Orgasm abnormal Abnormal dreams 
Psihijatrijski poremećaji nesanica agitacija smanjen libido anksioznost abnormalni orgazam abnormalni snovi suicidalne misli5,7
Duloxetine Lilly contains sucrose 
Duloksetin Lilly sadrži saharozu
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink 
Duloksetin Lilly 30 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
Nervous system disorders Headache 
Oštećenje bubrežne funkcije
Trismus 
Midrijaza
Duloxetine Lilly 30 mg hard gastro-resistant capsules Duloxetine Lilly 60 mg hard gastro-resistant capsules 
Duloksetin Lilly 30 mg tvrde želučanootporne kapsule Duloksetin Lilly 60 mg tvrde želučanootporne kapsule
Povidone 
OBLIK
Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30 ml/min). 
U bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) koji su na hemodijalizi, povećana je koncentracija duloksetina u plazmi.
Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink 
Duloksetin Lilly 60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia 
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
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. 
45% bolesnika liječenih lijekom Duloksetin Lilly i u 23% bolesnika koji su uzimali placebo.
Cutaneous vasculitis 
kutani vaskulitis
Each capsule contains 60 mg of duloxetine (as hydrochloride). 
Jedna kapsula sadrži 60 mg duloksetina (u obliku duloksetinklorida).
Somnolence 
Krvarenje
Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine 
Duloksetin Lilly 60 mg tvrde želučanootporne kapsule duloksetin
Taking a MAOI together with many prescription medicines, including Duloxetine Lilly, can cause serious or even life-threatening side effects. 
uključujući Duloksetin Lilly, može izazvati ozbiljne, čak i po život opasne nuspojave.
Mechanism of action 
Način primjene
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - UNUTARNJA KUTIJA ZA 60 MG TVRDE
Duloxetine Lilly 30 mg hard gastro-resistant capsules duloxetine 
Duloksetin Lilly 30 mg tvrde želučanootporne kapsule duloksetin
Each capsule contains 30 mg of duloxetine (as hydrochloride). 
Jedna kapsula sadrži 30 mg duloksetina (u obliku duloksetinklorida).
Duloxetine Lilly may have a mild to moderate influence on the ability to drive and use machines. 
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.
Duloxetine Lilly is for oral use. 
Duloksetin Lilly se uzima kroz usta.
Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence 
Poremećaji dišnog sustava, prsišta i sredoprsja zijevanje stezanje u grlu epistaksa intersticijska plućna bolest10
Blood cholesterol increased 
Krvožilni poremećaji povišen krvni tlak3
Psychiatric disorders Insomnia 
psihomotorni nemir6
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. 
U kliničkim je ispitivanjima ocijenjena sigurnost primjene doza većih od 60 mg jednom dnevno, do najviše 120 mg na dan.
Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo. 
Stope kliničkog odgovora među bolesnicima u kojih se javila somnolencija iznosile su 60%
Duloxetine Lilly contains the active substance duloxetine. 
Što je Duloksetin Lilly i za što se koristi Duloksetin Lilly sadrži djelatnu tvar duloksetin.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK-OUTER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - VANJSKA KUTIJA ZA 60 MG TVRDE
Chest pain7 
Citokromi P450
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). 
Scale, HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
Duloxetine Lilly is a hard gastro-resistant capsule. 
Kako Duloksetin Lilly izgleda i sadržaj pakiranja Duloksetin Lilly je tvrda želučanootporna kapsula.
Increased tendency to bruise 
• pojačano zijevanje
Reproductive system and breast disorders Erectile dysfunction 
Poremećaji imunološkog sustava anafilaktička reakcija poremećaj preosjetljivosti
Skin and subcutaneous tissue disorders Sweating increased 
Poremećaji kože i potkožnog tkiva pojačano znojenje osip noćno znojenje urtikarija kontaktni dermatitis hladan znoj reakcija fotoosjetljivosti povećana sklonost stvaranju modrica
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules 
KUTIJE ZA 60 MG TVRDE ŽELUČANOOTPORNE KAPSULE
Vascular disorders 
ŽELUČANOOTPORNE KAPSULE
Vertigo Ear pain 
Gospina trava
Fatigue 
Dojenje
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 30 mg hard gastro-resistant capsules 
KUTIJE ZA 30 MG TVRDE ŽELUČANOOTPORNE KAPSULE
• fast and/or irregular heart beat 
• omaglica ili vrtoglavica, bol u uhu • brzi ili nepravilni otkucaji srca
Common side effects (may affect up to 1 in 10 people) 
Česte nuspojave (mogu se javiti u najviše 1 na 10 osoba): • gubitak teka
After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr). 
Klirens duloksetina iz plazme nakon intravenski primijenjene doze kreće se u rasponu od 22 l/h do
Very common side effects (may affect more than 1 in 10 people) 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • glavobolja, pospanost
Urine flow decreased 
Hamilton Depression Rating
Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients, who did not breast feed their children. 
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.
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') 
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
Obizur has been authorised under ‘exceptional circumstances'. 
Obizur je odobren u „iznimnim okolnostima”.
What is Obizur and what is it used for? 
Što je Obizur i za što se koristi?
Obizur susoctocog alfa 
Obizur susoktokog alfa
Factor VIII is one of the proteins needed for normal clotting of the blood. 
Faktor VIII jedan je od proteina potrebnih za normalno zgrušavanje krvi.
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. 
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.
The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened. 
Odgovor na Obizur smatrao se pozitivnim ako je krvarenje zaustavljeno ili smanjeno, dok je negativan odgovor značio da se krvarenje nastavilo ili pogoršalo.
Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary. 
Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
Why is Obizur approved? 
Zašto je lijek Obizur odobren?
Obizur was not compared with any other medicine. 
Obizur nije uspoređen niti s jednim drugim lijekom.
What are the risks associated with Obizur? 
Koji su rizici povezani s lijekom Obizur?
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. 
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.