FrancophonIA/ELRC3.0 huggingface dataset:
English: • increase in creatine phosphokinase (an enzyme in muscles) seen in blood tests
Croatian: • porast razine kreatin fosfokinaze (enzim u mišićima) što se vidi iz krvnih pretraga
English: No dose adjustment of lurasidone is required in patients with mild hepatic impairment.
Croatian: Nije potrebna prilagodba doze lurasidona u bolesnika s blagim oštećenjem jetre.
English: Study D1050231 N=114 N=118 -
Croatian: Ispitivanje D1050231 N=114
English: • blood pressure dropping upon your standing up which may cause fainting.
Croatian: • ako Vam pri ustajanju pada krvani tlak, što može izazvati nesvjesticu.
English: • slow heart rate
Croatian: • spori otkucaji srca
English: Lurasidone is contraindicated with strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) (see section 4.3).
Croatian: Lurasidon je kontraindiciran s jakim inhibitorima CYP3A4 (npr. boceprevir, klaritromicin, kobicistat, indinavir, itrakonazol, ketokonazol, nefazodon, nelfinavir, posakonazol, ritonavir, sakvinavir, telaprevir, telitromicin, vorikonazol) (vidjeti dio 4.3).
English: The serum concentrations of lurasidone are increased in healthy subjects with Child-Pugh Class A, B and C hepatic impairment with an increased exposure of 1.5-, 1.7- and 3-fold respectively.
Croatian: Serumska koncentracija lurasidona bila je povećana u zdravih ispitanika s oštećenjem jetre po Child-Pugh ljestvici tipa A, B i C.
English: • an increase in your weight
Croatian: • povećanje tjelesne težine
English: Package leaflet: Information for the patient Latuda 18.5 mg film-coated tablets Latuda 37 mg film-coated tablets Latuda 74 mg film-coated tablets lurasidone
Croatian: Latuda 18,5 mg filmom obložene tablete Latuda 37 mg filmom obložene tablete Latuda 74 mg filmom obložene tablete lurasidon
English: Coadministration of lurasidone with the strong CYP3A4 inducer rifampicin resulted in a 6-fold decrease in exposure of lurasidone.
Croatian: Istovremena primjena lurasidona s jakim CYP3A4 induktorom rifampicinom rezultirala je 6 puta manjom izloženošću lurasidonu.
English: Lurasidone is an in vitro inhibitor of the efflux transporter BCRP and the clinical relevance of intestinal BCRP inhibition cannot be excluded.
Croatian: Lurasidon in vitro inhibira efluks transporter BCRP te se kliničko značenje inhibicije crijevnog BCRP ne može isključiti.
English: • muscle spasms and stiffness
Croatian: • grčenje i ukočenost mišića
English: The key secondary endpoint was Clinical Global Impression - Bipolar Version, Severity of Illness (CGI-BP-S) Depression Score.
Croatian: Clinical Global Impression - Bipolar Version, Severity of
English: How to take Latuda
Croatian: Kako uzimati lijek Latuda
English: (a) p-values for lurasidone vs. placebo were adjusted for multiple comparisons.
Croatian: N je broj ispitanika. (a) p-vrijednosti za lurasidone naspram placeba bile su prilagođene za višestruke usporedbe.
English: EU/1/14/913/015-021
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/913/015-021
English: Via Vecchia del Pinocchio, 22 60100
Croatian: Aziende Chimiche Riunite Angelini Francesco ACRAF SPA Via Vecchia del Pinocchio, 22 60100
English: Angelini S.p.A
Croatian: S.p.A
English: What you need to know before you take Latuda Do NOT take Latuda if you:
Croatian: Što morate znati prije nego počnete uzimati lijek Latuda
English: - Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) and strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort (Hypericum perforatum) (see section 4.5).
Croatian: - Istovremena primjena jakih CYP3A4 inhibitora (npr. boceprevira, klaritromicina, kobicistata, indinavira, itrakonazola, ketokonazola, nefazodona, nelfinavira, posakonazola, ritonavira, sakvinavira, telaprevira, telitromicina, vorikonazola) i jakih CYP3A4 induktora (npr. karbamazepina, fenobarbitala, fenitoina, rifampicina, gospine trave (Hypericum perforatum) (vidjeti dio 4.5).
English: • rufinamide (to treat seizures).
Croatian: • rufinamid (za liječenje napadaja).
English: Nightmare Catatonia
Croatian: • noćne more
English: White to off-white, film-coated round tablets of 8 mm debossed with ‘LB'
Croatian: Bijele do gotovo bijele, filmom obložene okrugle tablete promjera 8 mm s utisnutim „LB“
English: High serum prolactin levels in long-term repeat-dose studies in female rats were associated with effects on bones, adrenal glands, and reproductive tissues.
Croatian: U ispitivanjima dugotrajnih ponovljenih doza u ženki štakora, visoka razina serumskog prolaktina bila je povezana s djelovanjem na kosti, nadbubrežne žlijezde i reproduktivna tkiva.
English: • rigid posture
Croatian: • ukočeno držanje
English: How to store Latuda
Croatian: Kako čuvati lijek Latuda
English: Caution should be exercised when lurasidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, hypokalaemia, and in concomitant use with other medicinal products thought to prolong the QT interval.
Croatian: Kardiovaskularni poremećaji/produženje QT intervala Potreban je povećani oprez kad se lurasidon propisuje bolesnicima koji boluju od kardiovaskularnih bolesti ili s obiteljskom anamnezom produženog QT intervala, hipokalemijom i u istovremenoj primjeni s drugim lijekovima za koje se smatra da produžuju QT interval.
English: EU/1/14/913/002 28 x 1 film-coated tablets EU/1/14/913/003 30 x 1 film-coated tablets EU/1/14/913/004 56 x 1 film-coated tablets EU/1/14/913/005 60 x 1 film-coated tablets EU/1/14/913/006 90 x 1 film-coated tablets EU/1/14/913/007 98 x 1 film-coated tablets
Croatian: EU1/14/913/001 14 x 1 filmom obloženih tableta EU1/14/913/002 28 x 1 filmom obloženih tableta EU/1/14/913/003 30 x 1 filmom obloženih tableta EU/1/14/913/004 56 x 1 filmom obloženih tableta EU/1/14/913/005 60 x 1 filmom obloženih tableta EU/1/14/913/006 90 x 1 filmom obloženih tableta EU/1/14/913/007 98 x 1 filmom obloženih tableta
English: 1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300
Croatian: Angelini Farmacêutica, Lda Rua João Chagas, 53, Piso 3 1499-040 Cruz Quebrada- Dafundo Tel: + 351 21 414 8300 apoio.utente@angelini.pt
English: Each 18.5 mg tablet contains lurasidone hydrochloride equivalent to 18.6 mg lurasidone.
Croatian: Jedna 18,5 mg tableta sadrži lurasidonklorid što odgovara 18,6 mg lurasidona.
English: Angelini Pharma Österreich GmbH
Croatian: Austria/ Österreich Angelini Pharma Österreich GmbH Brigittenauer Lände 50-54
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur lurasidone.
Croatian: Uz lurasidon, zabilježen je nastanak neuroleptičkog malignog sindroma, karakteriziran hipertermijom, rigidnošću mišića, autonomnom nestabilnošću, promijenjenom sviješću i povišenim razinama serumske kreatin fosfokinaze.
English: Lurasidone is an in vitro inhibitor of the efflux transporter P-gp and the clinical relevance of intestinal P-gp inhibition cannot be excluded.
Croatian: Lurasidon in vitro inhibira efluks transporter P-gp te se kliničko značanje inhibicije crijevnog P-gp ne može isključiti.
English: • newborn babies may show the following: agitation, increase or decreases in muscle tone, tremor,
Croatian: • u novorođenčadi se može javiti sljedeće: uznemirenost, povećanje ili smanjenje mišićnog tonusa, nevoljno drhtanje, pospanost, poteškoće s disanjem ili hranjenjem
English: White to off-white, film-coated round tablets of 6 mm debossed with ‘LA'
Croatian: Bijele do gotovo bijele, filmom obložene okrugle tablete promjera 6 mm s utisnutim „LA“
English: Baseline Mean (SD)
Croatian: Srednja početna vrijednost (SD)
English: Breast enlargement**** Breast pain**** Galactorrhoea**** Erectile dysfunction**** Amenorrhoea**** Dysmenorrhoea****
Croatian: Nepoznata učestalost erektilna disfunkcija**** amenoreja**** dismenoreja****
English: The most common adverse drug reactions (ADRs) (≥ 10%) were akathisia and somnolence, which were dose-related up to
Croatian: Najčešće nuspojave lijeka (≥ 10%) bile su akatizija i pospanost, koje su ovisile o dozi do 111 mg dnevno.
English: Tel: + 36 1 336 1614
Croatian: Tel: + 36 1 336 1614 office@angelini.hu
English: Tel: + 421 2 59 207 320
Croatian: Tel: + 421 2 59 207 320 office@angelini.sk
English: • slurred speech
Croatian: • nerazgovijetan govor
English: • deliberate injury to oneself
Croatian: • namjerno samoranjavanje
English: Lurasidone was not teratogenic in rats or rabbits at an exposure similar to or below the maximum recommended human dose (148 mg lurasidone ).
Croatian: Lurasidon nije bio teratogen u štakora ili kunića prilikom izloženosti dozi sličnoj ili onoj ispod maksimalne preporučene doze za ljude
English: Uncommon Rare
Croatian: Nepoznata učestalost
English: • dizziness
Croatian: • pospanost.
English: EU/1/14/913/016 28 x 1 film-coated tablets EU/1/14/913/017 30 x 1 film-coated tablets EU/1/14/913/018 56 x 1 film-coated tablets EU/1/14/913/019 60 x 1 film-coated tablets EU/1/14/913/020 90 x 1 film-coated tablets EU/1/14/913/021 98 x 1 film-coated tablets
Croatian: EU1/14/913/015 14 x 1 filmom obloženih tableta EU1/14/913/016 28 x 1 filmom obloženih tableta EU1/14/913/017 30 x 1 filmom obloženih tableta EU1/14/913/018 56 x 1 filmom obloženih tableta EU1/14/913/019 60 x 1 filmom obloženih tableta EU1/14/913/020 90 x 1 filmom obloženih tableta EU1/14/913/021 98 x 1 filmom obloženih tableta
English: Suicidal behaviour**** Panic attack**** Sleep disorder****
Croatian: Psihijatrijski poremećaji nesanica agitacija anksioznost nemir noćne more katatonija suicidalno ponašanje**** napad panike**** poremećaji spavanja****
English: EU/1/14/913/001-007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/913/001-007
English: • diabetes or are prone to diabetes
Croatian: • ako bolujete od dijabetesa ili ste skloni dijabetesu
English: Additionally, lurasidone was superior to placebo on the predefined secondary endpoint Clinical Global Impression - Severity (CGI-S) scale.
Croatian: Nadalje, lurasidon je bio superioran u odnosu na placebo na predefiniranoj drugoj mjeri ishoda ljestvice
English: Tel: + 420 546 123 111
Croatian: Tel: + 420 546 123 111 info@angelini.cz
English: 0.1 mg/kg/day lurasidone hydrochloride, respectively, or on early embryonic development at an oral dose of 15 mg/kg/day lurasidone hydrochloride.
Croatian: U štakora, lurasidon nije imao učinak na mušku ni na žensku reprodukciju u oralnoj dozi od 150, odnosno 0,1 mg/kg/dan lurasidonklorida, ili na rani embrionalni razvoj u oralnoj dozi od 15 mg/kg/dan lurasidonklorida.
English: magnesium stearate (E470b), titanium dioxide (E171), macrogol, yellow iron oxide (E172)
Croatian: Ovojnica tablete hipromeloza 2910 (E 464) titanijev dioksid (E 171) makrogol 8000 željezni oksid, žuti (E 172) indigotin (E 132) karnauba vosak (E 903)
English: EU/1/14/913/008-014
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/913/008-014
English: Each 37 mg tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Croatian: Jedna 37 mg tableta sadrži lurasidonklorid što odgovara 37,2 mg lurasidona.
English: Following administration of 37 mg of lurasidone, the mean approximate apparent volume of distribution was 6000 L. Lurasidone is highly bound (~99%) to serum proteins.
Croatian: Nakon primjene 37 mg lurasidona, približna srednja vrijednost prividnog volumena distribucije bila je 6000 L.
English: Contact your doctor if you have questions on this medicine.
Croatian: Ako imate pitanja o ovom lijeku, obratite se Vašem liječniku.
English: Vomiting Dyspepsia Salivary hypersecretion Dry mouth Upper abdominal pain Stomach discomfort
Croatian: Poremećaji probavnog sustava mučnina povraćanje dispepsija povećano lučenje sline suha usta bol u gornjem dijelu trbuha želučana nelagoda flatulencija dijareja**** disfagija**** gastritis****
English: p-value (a) Olanzapine 15 mg in Study D1050231, quetiapine extended-release (XR) 600 mg in Study
Croatian: Srednja početna vrijednost (SD) LS srednja vrijednost promjene (SE) Razlika Liječeni naspram placebo Procjena (SE) p-vrijednost (a) Olanzapin 15 mg u Ispitivanju D1050231, kvetiapin s produljenim oslobađanjem (XR) 600 mg u ispitivanju D1050233.
English: Each 74 mg tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Croatian: Jedna 74 mg tableta sadrži lurasidonklorid što odgovara 74,5 mg lurasidona.
English: Latuda 18.5 mg film-coated tablets
Croatian: NAZIV LIJEKA Latuda 18,5 mg filmom obložene tablete
English: Weight gain has been observed with atypical antipsychotic use.
Croatian: Kod korištenja atipičnih antipsihotika zabilježeno je povećanje tjelesne težine.
English: Common (may affect up to 1 in 10 people):
Croatian: Često (može zahvatiti do 1 na 10 osoba):
English: Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.
Croatian: Kod bolesnika osjetljivih na hipotenziju potrebno je praćenje vitalnih ortostatskih znakova.
English: Close supervision of high-risk patients should accompany antipsychotic therapy.
Croatian: Uz liječenje antipsihoticima, visokorizične bolesnike treba pažljivo nadgledati.
English: • prednisone (to treat inflammatory disease)
Croatian: • prednizon (za liječenje upalnih bolesti)
English: Decreased appetite Blood glucose increased Hyponatraemia
Croatian: Poremećaji metabolizma i prehrane povećanje tjelesne težine smanjenje teka povećanje glukoze u krvi hiponatremija
English: Tel: + 43 5 9606 0
Croatian: Tel: + 43 5 9606 0 office@angelini.at
English: Latuda 74 mg tablets lurasidone
Croatian: NAZIV LIJEKA Latuda 74 mg tablete lurasidon
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava akatizija pospanost*
English: You can also report side effects directly via the following website: www.mhra.gov.uk/yellowcard.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava obavijesti o nuspojavama putem sljedeće web-stranice: www.halmed.hr.
English: The pharmacokinetics of lurasidone is dose-proportional within a total daily dose range of 18.5 mg to 148 mg. Steady-state concentrations of lurasidone are reached within 7 days of starting lurasidone.
Croatian: Farmakokinetika lurasidona proporcionalna je dozi u ukupnom dnevnom rasponu doza od 18,5 mg do 148 mg.
English: Latuda 18.5 mg film-coated tablets lurasidone
Croatian: Latuda 18,5 mg filmom obložene tablete lurasidon
English: • irritation to lining of stomach
Croatian: • nadraženost sluznice želuca
English: Latuda 37 mg tablets lurasidone
Croatian: NAZIV LIJEKA Latuda 37 mg tablete lurasidon
English: Latuda 74 mg film-coated tablets lurasidone
Croatian: Latuda 74 mg filmom obložene tablete lurasidon
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava eozinofilija leukopenija**** neutropenija**** anemija****
English: -0.44 (0.112; -0.66 to -0.22)
Croatian: do -0,22)
English: Eosinophilia Leukopenia**** Neutropenia****
Croatian: Porast serumskog kreatinina dizurija zatajenje bubrega****
English: Latuda 74 mg film-coated tablets
Croatian: NAZIV LIJEKA Latuda 74 mg filmom obložene tablete
English: • rash and itching
Croatian: • osip i svrbež
English: • decreased kidney function
Croatian: • ako Vam je oslabljena funkcija bubrega
English: (IC50>5.9 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2B6, CYP2C8, CYP2C9,
Croatian: In vitro, lurasidon nije pokazao izravnu, ili slabu inhibiciju (izravnu ili ovisnu o vremenu) (IC50>5,9 μM) citokrom P450 enzima (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 i CYP3A4.
English: Latuda 37 mg film-coated tablets lurasidone
Croatian: Latuda 37 mg filmom obložene tablete lurasidon
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje često (može zahvatiti do 1 na 100 osoba):
English: Latuda 37 mg film-coated tablets
Croatian: NAZIV LIJEKA Latuda 37 mg filmom obložene tablete
English: Sudden death attributable to underlying cardiovascular disease observed during the clinical development programme**** *Somnolence includes adverse reaction terms: hypersomnia, hypersomnolence, sedation, and somnolence **Parkinsonism includes adverse reaction terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor ***Dystonia includes adverse reaction terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus.
Croatian: **Parkinsonizam obuhvaća nuspojave pod sljedećim nazivima: bradikinezija, „zupčasta ukočenost“, slinjenje, ekstrapiramidni poremećaji, hipokinezija, mišićna ukočenost, parkinsonizam, psihomotorna retardacija i tremor.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.
Croatian: TVARI Jedna filmom obložena tableta sadrži lurasidonklorid, što odgovara 18,6 mg lurasidona.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Croatian: TVARI Jedna filmom obložena tableta sadrži lurasidonklorid što odgovara 37,2 mg lurasidona.
English: Rare cases of glucose related adverse reactions, e.g. increase in blood glucose, have been reported in clinical trials with lurasidone.
Croatian: U kliničkim istraživanjima s lurasidonom prijavljeni su rijetki slučajevi nuspojava povezani s glukozom, npr. povećanje glukoze u krvi.
English: • joint pains
Croatian: Mixed Model
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Croatian: TVARI Jedna filmom obložena tableta sadrži lurasidonklorid što odgovara 74,5 mg lurasidona.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta vrtoglavica****
English: RO-București 050451 Tel: + 40 21 331 6767
Croatian: Tel: + 40 21 331 6767 office@angelini.ro
English: Tardive dyskinesia
Croatian: Istovremena primjena
English: • weight gain
Croatian: • ako dobijete na težini
English: Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,
Croatian: Latuda filmom obložene tablete dostupne su u pakiranjima veličine 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1 ili 98 x 1 filmom obloženih tableta u aluminij/aluminij perforiranim blisterima s jediničnim dozama.
English: Angelini Pharmaceuticals România SRL Str. Carol Davila, Nr. 9, Sector 5
Croatian: Romania/ România Angelini Pharmaceuticals România SRL Str.
English: • back pain
Croatian: • bolovi u leđima
English: Parameters
Croatian: Intent-to-Treat) Parametri
English: • problems walking
Croatian: • poteškoće u hodu
English: Lurasidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Croatian: U bolesnika s anamnezom epileptičkih napadaja ili drugih stanja koja mogu potencijalno smanjiti konvulzivni prag, lurasidon treba koristiti oprezno.
English: Schizophrenia Studies: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6- MMRM for Studies D1050229, D1050231, and D1050233: Intent-to-Treat Analysis Set
Croatian: Mixed Model Repeated Measures) za Ispitivanja D1050229, D1050231 i D1050233: prema Intent-to-Treat analizi
English: Study D1050229 N=124 N=121 N=118 N=123 -Baseline Mean (SD)
Croatian: Ispitivanje D1050229 N=124
English: Hypersensitivity
Croatian: Hiperprolaktinemija
English: Viale Amelia 70
Croatian: Italy/ Italia Angelini S.p.A Viale Amelia 70
English: Treatment Difference vs. placebo Estimate (SE)
Croatian: Razlika Liječeni naspram placebo
English: Treatment Difference vs. placebo Estimate (SE) p-value
Croatian: Razlika Liječeni naspram placebo Procjena (SE) p-vrijednost Ispitivanje D1050233
English: Weight gain
Croatian: Rok valjanosti
English: • seizure (fits)
Croatian: • epileptički napadaji (konvulzije)
English: Drug withdrawal syndrome neonatal (see 4.6)
Croatian: Stanja vezana uz trudnoću, babinje i perinatalno razdoblje apstinencijski sindrom kod novorođenčeta (vidjeti 4.6)
English: Primary Endpoint:
Croatian: Ključna sekundarna mjera ishoda:
English: 1 x 1 tablet (unit dose)
Croatian: 1 x 1 tablet (jedinična doza)
English: MA (EU) Number Invented name Strength Pharmaceutical form Route of administration Immediate Packaging Package size
Croatian: Doza Farmaceutski oblik Put primjene
English: Annex V
Croatian: Dodatak V
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Croatian: Provedba sporazuma u državama članicama (dostavljanje izmjene nositelja odobrenja za stavljanje lijeka u promet):
English: 20 February 2014
Croatian: 20. veljače 2015.
English: Most of them received only one infusion.
Croatian: Većina njih primila je samo jednu infuziju.
English: The majority of patients were female.
Croatian: Većina bolesnika bile su žene.
English: Published literature was also provided.
Croatian: Također je priložena i objavljena literatura.
English: In about 80% of the cases, the outcome of pregnancy was unknown.
Croatian: U otprilike 80% slučajeva, ishod trudnoće bio je nepoznat.
English: Risk minimisation measures and other pharmacovigilance activities
Croatian: Mjere minimizacije rizika i druge farmakovigilancijske aktivnosti
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for intravenous iron containing medicinal products.
Croatian: • Povjerenstvo je razmatralo postupak pod člankom 31 Direktive 2001/83/EZ za intravenske lijekove koji sadrže željezo.
English: The majority of studies were retrospective.
Croatian: Većina ispitivanja bila je retrospektivna.
English: A fatal case was also reported.
Croatian: Prijavljen je također i jedan smrtni slučaj.
English: Test dose
Croatian: Probna doza
English: A total of 33 publications reporting on the safety of LMWID were identified.
Croatian: Ukupno je identificirano 33 publikacije o sigurnosti LMWID.
English: Thirty-two of 88 patients experienced a reaction at injection site.
Croatian: Trideset i dva od 88 bolesnika iskusilo je reakciju na mjestu injekcije.
English: The majority of cases were reported as serious (366/587; 62%).
Croatian: Većina slučajeva prijavljena je kao ozbiljni slučajevi (366/587; 62%).
English: Anti-allergic treatment was reported for 94/168 cases.
Croatian: Anti alergijsko liječenje prijavljeno je za 94 od 168 slučaja.
English: These reactions may be damaging, uncomfortable, or occasionally fatal.
Croatian: Te reakcije mogu uzrokovati oštećenje, nelagodu, a ponekad i smrt.
English: This recommendation was also advised by the PRAC during the consultation requested by the CHMP.
Croatian: Ovu preporuku podržao je i PRAC tijekom konzultacija koje je zatražio CHMP.
English: Overall conclusion
Croatian: Ukupni zaključak
English: For one patient, the event of hypersensitivity occurred after the first and the second injection.
Croatian: Kod jednog bolesnika događaj preosjetljivosti pojavio se nakon prve i druge injekcije.
English: Different regimens were employed from 100 mg maintenance doses in HD to high accelerated total dose infusions (TDIs).
Croatian: Bili su uključeni različiti režimi od doze održavanja od 100 mg u HD do visoko ubrzanih ukupnih doza u infuziji (TDIs).
English: The following analyses were performed on spontaneous or solicited cases, medically confirmed or not, recorded until 15 December 2011.
Croatian: Provedene su sljedeće analize o spontanim islučajevima ili onim prikupljenim kroz ispitivanja, bez obzira jesu li medicinski potvrđeni ili ne, a koji su zabilježeni do 15. prosinca 2011.
English: Among all studies provided, only one life-threatening reaction was reported (Michael, et al 2002).
Croatian: U svim priloženim ispitivanjima zabilježena je samo jedna po život opasna reakcija (Michael, et al 2002).
English: Therefore, no conclusions on safety can be drawn from these studies alone.
Croatian: Stoga se ne mogu povući zaključci o sigurnosti iz samih ispitivanja.