FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht , Nizozemska
English: Over the entire 36-week course of the study, 6 out of 333 patients initially randomized to duloxetine and 3 out of 225 patients initially randomized to fluoxetine experienced suicidal behaviour (exposure adjusted incidence 0.039 events per patient year for duloxetine and 0.026 for fluoxetine).
Croatian: Tijekom cjelokupnog trajanja ispitivanja (36 tjedana), suicidalno ponašanje pojavilo se u 6 od 333 bolesnika prvotno randomizirana za primanje duloksetina te u 3 od 225 bolesnika prvotno randomizirana za liječenje fluoksetinom (incidencija prilagođena za izloženost iznosila je 0,039
English: 28 hard gastro-resistant capsules 84 hard gastro-resistant capsules 98 hard gastro-resistant capsules 56 hard gastro-resistant capsules
Croatian: 28 tvrdih želučanootpornih kapsula 84 tvrde želučanootporne kapsule 98 tvrdih želučanootpornih kapsula 56 tvrdih želučanootpornih kapsula
English: Xeristar 30 mg Xeristar 30 mg is available in packs of 7 and 28 hard gastro-resistant capsules.
Croatian: Xeristar 30 mg Xeristar 30 mg dostupan je u pakiranjima koja sadrže 7 i 28 tvrdih želučanootpornih kapsula.
English: Response and remission rates were also higher with Xeristar compared to placebo.
Croatian: Stopa odgovora na liječenje i stopa remisije bile su također više kod primjene lijeka Xeristar u usporedbi s placebom.
English: Consequently, caution is advised when Xeristar 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).
Croatian: Stoga se preporučuje oprez kada se Xeristar primjenjuje u kombinaciji s drugim lijekovima i tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike,
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Xeristar to patients with increased intraocular pressure, or those at risk of acute narrowangle glaucoma.
Croatian: Prijavljeni su slučajevi midrijaze pri uzimanju duloksetina te se stoga Xeristar mora s oprezom propisivati bolesnicima s povišenim očnim tlakom i onima s rizikom za pojavu akutnog glaukoma uskog kuta.
English: How to store Xeristar
Croatian: Kako čuvati Xeristar
English: The use of Xeristar while breastfeeding is not recommended.
Croatian: Ne preporučuje se uzimanje lijeka Xeristar za vrijeme dojenja.
English: The efficacy of Xeristar at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Croatian: Djelotvornost lijeka Xeristar pri preporučenoj dozi od 60 mg jednom dnevno pokazana je u tri od tri randomizirana, dvostruko slijepa, placebom kontrolirana kratkoročna ispitivanja fiksnih doza u odraslih ambulantno liječenih bolesnika s velikim depresivnim poremećajem.
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take Xeristar.
Croatian: Nakon što ste prestali uzimati inhibitor MAO, morate pričekati najmanje 14 dana prije nego počnete uzimati Xeristar.
English: Xeristar hard gastro-resistant capsules contain sucrose.
Croatian: Xeristar tvrde želučanootporne kapsule sadrže saharozu.
English: Xeristar contains sucrose
Croatian: Xeristar sadrži saharozu
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 UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA TVRDIH ŽELUČANOOTPORNIH KAPSULA OD 60 MG (bez plavog okvira)
English: Response and remission rates were also statistically significantly higher with Xeristar compared with placebo.
Croatian: Stope odgovora na liječenje i remisije bile su također statistički značajno veće pri uzimanju lijeka Xeristar nego pri uzimanju placeba.
English: The corresponding figures for at least 50% pain reduction were 50% and 26% respectively.
Croatian: Smanjenje boli od najmanje 50%
English: Major Depressive Disorder: Xeristar was studied in a clinical programme involving 3,158 patients (1,285 patient-years of exposure) meeting DSM-IV criteria for major depression.
Croatian: 3158 bolesnika (1285 bolesnik-godina izloženosti) koji su zadovoljavali DSM-IV kriterije za veliki depresivni poremećaj.
English: Xeristar may be associated with sedation and dizziness.
Croatian: Uzimanje lijeka Xeristar može biti povezano s pojavom sedacije i omaglice.
English: The risk of withdrawal symptoms seen with SSRI's and SNRI's may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Croatian: Rizik od pojave simptoma ustezanja uočenih kod primjene SSRI-ja i SNRI-ja može ovisiti o nekoliko čimbenika,
English: EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20)
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/297/007 (500 tvrdih želučanootpornih kapsula) (25 pakiranja od 20) EU/1/04/297/008 (100 tvrdih želučanootpornih kapsula) (5 pakiranja od 20)
English: Overall, Xeristar's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Croatian: Sveukupno je djelotvornost lijeka Xeristar u dnevnim dozama od 60 do 120 mg pokazana u ukupno pet od sedam randomiziranih, dvostruko slijepih, placebom kontroliranih kratkoročnih ispitivanja fiksnih doza u odraslih ambulantno liječenih bolesnika s velikim depresivnim poremećajem.
English: Caution is advisable if Xeristar is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Croatian: Xeristar primjenjuje istodobno sa serotoninergičkim lijekovima poput SSRI-ja, SNRI-ja, tricikličkih antidepresiva poput klomipramina ili amitriptilina, inhibitora MAO poput moklobemida ili linezolida, gospine trave (Hypericum perforatum) ili triptana, tramadola, petidina i triptofana (vidjeti dio 4.4).
English: Talk to your doctor before you take Xeristar if you: - are taking other medicines to treat depression (see ‘Other medicines and Xeristar') - 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), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - 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 Xeristar')
Croatian: - ako patite od bipolarnog poremećaja - ako imate tegobe s očima poput određenih vrsta glaukoma (povišen očni tlak) - ako u povijesti bolesti imate poremećaje krvarenja (sklonost pojavi modrica), osobito ako ste trudni (pogledajte dio „Trudnoća i dojenje“) - imate rizik od pojave niske razine natrija (primjerice, ako uzimate diuretike, osobito ako ste starija osoba)
English: España
Croatian: Španjolska
English: EU/1/04/297/002 (28 hard gastro-resistant capsules) EU/1/04/297/003 (84 hard gastro-resistant capsules) EU/1/04/297/004 (98 hard gastro-resistant capsules) EU/1/04/297/005 (56 hard gastro-resistant capsules)
Croatian: EU/1/04/297/002 (28 tvrdih želučanootpornih kapsula) EU/1/04/297/003 (84 tvrde želučanootporne kapsule) EU/1/04/297/004 (98 tvrdih želučanootpornih kapsula) EU/1/04/297/005 (56 tvrdih želučanootpornih kapsula)
English: Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
Croatian: crvenilo uz osjećaj vrućine sinkopa2 hipertenzija3,7 ortostatska hipotenzija2
English: Data on the use of Xeristar 120 mg in elderly patients with major depressive disorder and generalised anxiety disorder are limited.
Croatian: Starije osobe Postoje samo ograničeni podaci o primjeni lijeka Xeristar u dozi od 120 mg u starijih osoba s velikim depresivnim poremećajem i generaliziranim anksioznim poremećajem.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Xeristar 60 mg once daily were randomised to either Xeristar 60 mg once daily or placebo for a further 6-months.
Croatian: U ispitivanju prevencije relapsa, bolesnici koji su reagirali na otvoreno akutno liječenje lijekom Xeristar u dozi od 60 mg jednom dnevno u trajanju od 12 tjedana randomizirani su ili u skupinu koja je sljedećih 6 mjeseci uzimala lijek Xeristar u dozi od 60 mg jednom dnevno ili u skupinu koja je uzimala placebo.
English: What you need to know before you take Xeristar DO NOT take Xeristar if you:
Croatian: Što morate znati prije nego počnete uzimati Xeristar
English: Xeristar contains sucrose.
Croatian: Xeristar sadrži saharozu.
English: Capsule shell
Croatian: KAPSULA
English: Rare side effects (may affect up to 1 in 1000 people)
Croatian: Rijetke nuspojave (mogu se javiti u najviše 1 na 1000 osoba)
English: Concomitant use of Xeristar with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena lijeka Xeristar s neselektivnim, ireverzibilnim inhibitorima monoaminooksidaze (MAOI) (vidjeti dio 4.5).
English: 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: 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: Τηλ: +357 22 715000
Croatian: Phadisco Ltd Tηλ: +357 22 715000
English: There was no statistically significant difference in discontinuation due to adverse events between duloxetine and placebo groups during the 10 week acute treatment phase.
Croatian: 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.
English: Adverse reactions may be more common during concomitant use of Xeristar and herbal preparations containing St John's wort (Hypericum perforatum).
Croatian: Pri istodobnom uzimanju lijeka Xeristar i biljnih pripravaka koji sadrže gospinu travu (Hypericum perforatum) nuspojave mogu biti češće.
English: Orgasm abnormal Abnormal dreams ideation5,7
Croatian: Psihijatrijski poremećaji nesanica agitacija smanjen libido anksioznost abnormalni orgazam abnormalni snovi suicidalne misli5,7
English: The concomitant use of Xeristar with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Xeristar sa selektivnim reverzibilnim inhibitorima MAO, poput moklobemida (vidjeti dio 4.4).
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Croatian: Najčešće prijavljene reakcije su omaglica, senzorni poremećaji (uključujući paresteziju ili osjete nalik elektrošoku, osobito u glavi), poremećaji spavanja (uključujući nesanicu i intenzivne snove), umor, somnolencija, agitacija ili anksioznost, mučnina i/ili povraćanje, tremor,
English: Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules
Croatian: Xeristar 30 mg tvrde želučanootporne kapsule Xeristar 60 mg tvrde želučanootporne kapsule
English: • dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
Croatian: • omaglica, trnci ili osjeti nalik strujnom udaru (osobito u glavi), smetnje spavanja (živopisni snovi, noćne more, nemogućnost spavanja), umor, pospanost, nemir ili uznemirenost, tjeskoba,
English: • suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
Croatian: • samoubilačko ponašanje, manija (prekomjerna aktivnost, brze misli i smanjena potreba za spavanjem), halucinacije, agresivnost i bijes • "serotoninski sindrom" (rijetka reakcija koja može izazvati osjećaj velike sreće, omamljenost,
English: Gynaecological haemorrhage Menstrual disorder Sexual dysfunction Testicular pain
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija poremećaj ejakulacije odgođena ejakulacija ginekološko krvarenje menstrualni poremećaj seksualna disfunkcija bol u testisima simptomi menopauze galaktoreja hiperprolaktinemija poslijeporođajno krvarenje6
English: Xeristar contains the active substance duloxetine.
Croatian: Što je Xeristar i za što se koristi Xeristar sadrži djelatnu tvar duloksetin.
English: Xeristar is for oral use.
Croatian: Xeristar se uzima kroz usta.
English: 28 hard gastro-resistant capsules 7 hard gastro-resistant capsules
Croatian: 7 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Xeristar and 23% of patients taking placebo.
Croatian: 45% bolesnika liječenih lijekom Xeristar i u 23% bolesnika koji su uzimali placebo.
English: Xeristar 60 mg hard gastro-resistant capsules Duloxetine
Croatian: Xeristar 60 mg tvrde želučanootporne kapsule duloksetin
English: Xeristar 30 mg hard gastro-resistant capsules Duloxetine
Croatian: Xeristar 30 mg tvrde želučanootporne kapsule duloksetin
English: These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly,
Croatian: Ovi simptomi mogu uključivati mlohave mišiće, drhtanje, nervozne pokrete, poteškoće s hranjenjem, poteškoće s disanjem i napadaje.
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: 22 l/h do 46 l/h (srednja vrijednost 36 l/h).
English: Xeristar 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: HAM-D) zasnovanom na 17 pokazatelja (uključujući emocionalne i somatske simptome depresije).
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Croatian: Xeristar 60 mg: želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) željezov oksid, žuti (E172) bijela tinta, jestiva
English: The usual dose of Xeristar 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 doza lijeka Xeristar je 60 mg jednom na dan, no liječnik će Vam propisati dozu koja Vama najbolje odgovara.
English: − are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar') Talk to your doctor if you have high blood pressure or heart disease.
Croatian: − ako uzimate druge lijekove koji sadrže duloksetin (pogledajte „Drugi lijekovi i Xeristar“)
English: EU/1/04/297/001 (28 hard gastro-resistant capsules) EU/1/04/297/006 (7 hard gastro-resistant capsules)
Croatian: EU/1/04/297/006 (7 tvrdih želučanootpornih kapsula)
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Edible green ink
Croatian: Ovojnica kapsule Xeristar 30 mg želatina natrijev laurilsulfat titanijev dioksid (E171) indigo karmin (E132) zelena tinta, jestiva
English: Dry mouth
Croatian: Kroz usta.
English: Mydriasis
Croatian: Xeristar.
English: Xeristar should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Croatian: (tj. potentnim inhibitorima CYP1A2) jer se pri toj kombinaciji povećava koncentracija duloksetina u plazmi (vidjeti dio 4.5).
English: Xeristar is a hard gastro-resistant capsule.
Croatian: Kako Xeristar izgleda i sadržaj pakiranja Xeristar je tvrda želučanootporna kapsula.
English: Gastrointestinal disorders Nausea
Croatian: Tablični prikaz nuspojava
English: Ejaculation disorder
Croatian: Prijavljivanje nuspojava
English: The incidence of relapse during the 6months double-blind follow-up period was 14% for Xeristar and 42% for placebo.
Croatian: 6-mjesečnog razdoblja dvostruko slijepog praćenja iznosila je 14% u bolesnika koji su uzimali
English: Xeristar 60 mg hard gastro-resistant capsules.
Croatian: 60 mg tvrde želučanootporne kapsule
English: How to store Xeristar Keep this medicine out of the sight and reach of children.
Croatian: Lijek čuvajte izvan pogleda i dohvata djece.
English: Xeristar 30 mg hard gastro-resistant capsules.
Croatian: 30 mg tvrde želučanootporne kapsule
English: Malaise
Croatian: Trudnoća
English: Postpartum haemorrhage6
Croatian: akutno oštećenje jetre zatajenje jetre6 žutica6
English: Nervousness Disturbance in attention
Croatian: Incidencija relapsa tijekom
English: Very rare side effects (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u najviše 1 na 10 000 osoba) • upala krvnih žila u koži (kutani vaskulitis)
English: The effect of Xeristar 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Croatian: posebno je ispitivan u ispitivanju koje je pokazalo statistički značajnu razliku u smanjenju broja bodova na HAMD17 ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
English: Urinary retention Urinary hesitation Nocturia
Croatian: Inhibitore monoaminooksidaze (MAOI):
English: Contents of the pack and other information What Xeristar contains
Croatian: Što Xeristar sadrži
English: The safety profile was similar for all the diseases and was considered acceptable.
Croatian: Sigurnosni profil bio je sličan za sve bolesti i smatrao se prihvatljivim.
English: Soliris is given weekly initially and then every two or three weeks.
Croatian: U početku se Soliris daje jednom tjedno, a zatim jednom svaka dva do tri tjedna.
English: Soliris (eculizumab)
Croatian: Soliris (ekulizumab)
English: Myasthenia gravis
Croatian: Mijastenija gravis
English: Further information on Soliris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Soliris.
Croatian: Više informacija o lijeku Soliris dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Soliris.
English: In case of any infusion-related reactions, the doctor may slow down or stop the infusion.
Croatian: U slučaju bilo kakvih reakcija na infuziju, liječnik je može usporiti ili prekinuti.
English: This overview was last updated in 09-2019.
Croatian: Pregled informacija posljednji je put ažuriran u 9. 2019.
English: Further information on the orphan designations can be found on the European Medicines Agency's website (PNH: 17 October 2003; aHUS: 24 July 2009; myasthenia gravis: 29 July 2014; NMOSD: 24 April 2019).
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se na internetskim stranicama Europske agencije za lijekove:(PNH: 17. listopada 2003.; aHUS: 24. srpnja 2009.; mijastenija gravis: 29. srpnja 2014.; NMOSD: 24. travnja
English: A reduction in the score by 2 points indicates a clinically significant improvement of the patient's condition.
Croatian: Smanjenje rezultata za dva boda ukazuje na klinički značajno poboljšanje bolesnikova stanja.
English: Soliris received a marketing authorisation valid throughout the EU on 20 June 2007.
Croatian: Lijek Soliris dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. lipnja 2007.
English: Soliris was shown to benefit patients with these rare diseases.
Croatian: Pokazalo se da Soliris koristi bolesnicima s tim rijetkim bolestima.
English: The most common side effect with Soliris (which may affect more than 1 in 10 people) is headache.
Croatian: Najčešća nuspojava lijeka Soliris (koja se može javiti u više od 1 na 10 osoba) jest glavobolja.
English: The main measure of effectiveness was the time it took until a certain number of patients experienced a relapse.
Croatian: Mjerilo učinkovitosti bilo je vrijeme koje je proteklo dok se određenom dijelu bolesnika bolest nije vratila.
English: Other information about Soliris
Croatian: Ostale informacije o lijeku Soliris
English: What measures are being taken to ensure the safe and effective use of Soliris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Soliris?
English: The most serious side effect, which may affect up to 1 in 100 people, is meningococcal sepsis (when bacteria and their toxins circulate in the blood and damage the organs).
Croatian: Najozbiljnija nuspojava koja se može javiti u do 1 na 100 osoba jest meningokokna sepsa (kada bakterije i njihovi otrovi kruže krvlju i oštećuju organe).
English: Why is Soliris authorised in the EU?
Croatian: Zašto je Soliris odobren u EU-u?
English: What is Soliris and what is it used for?
Croatian: Što je Soliris i za što se koristi?
English: Treatment with Soliris improved patients' symptoms and their ability to undertake daily activities based on a standard scoring system.
Croatian: Terapija lijekom Soliris poboljšala je simptome bolesnika i njihovu sposobnost obavljanja dnevnih aktivnosti na temelju standardnog sustava ocjenjivanja.
English: Patients will also be given a special card that explains the symptoms of certain types of infection, instructing patients to seek medical care immediately if they experience them.
Croatian: Bolesnici će također dobiti posebnu karticu koja sadrži pojašnjenja simptoma određenih tipova infekcija te ih upućuje da odmah potraže liječničku pomoć ako uoče znakove tih infekcija.
English: The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with kidney disorders and disorders affecting the nervous system or the blood.
Croatian: Lijek se izdaje samo na liječnički recept te se mora primjenjivati pod nadzorom liječnika s iskustvom u liječenju bolesnika s bubrežnim poremećajima i poremećajima živčanog sustava ili krvi.
English: It is used in patients who have an antibody called AQP4 and whose disease is relapsing (where the patient has attacks [relapses] between periods with no symptoms).
Croatian: Primjenjuje se u bolesnika s protutijelom naziva AQP4 čija se bolest vratila (kad bolesnik iskusi napadaje [relapse] između razdoblja bez simptoma bolesti).
English: The main measures of effectiveness were the effect of Soliris on blood levels of haemoglobin and the need for transfusions.
Croatian: Glavno mjerilo učinkovitosti bio je učinak lijeka Soliris na razine hemoglobina u krvi i na potrebu za transfuzijama.