FrancophonIA/ELRC3.0 huggingface dataset:
English: d Includes patients who discontinued due to adverse event (AE) or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Croatian: d Obuhvaća bolesnike koji su prekinuli zbog nuspojava ili smrti u bilo kojem trenutku od 1. dana do vremenskog okvira ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni e Obuhvaća ispitanike s prekidom iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja.
English: • etravirine
Croatian: • etravirin
English: Therefore, therapy with cobicistat and darunavir should not be initiated during pregnancy, and women who become pregnant during therapy with cobicistat and darunavir should be switched to an alternative regimen (see sections 4.4 and 4.6).
Croatian: Stoga se terapija kobicistatom i darunavirom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije kobicistatom i darunavirom treba prebaciti na drugi režim (vidjeti dijelove 4.4 i 4.6).
English: alfuzosin, used to treat an enlarged prostate gland amiodarone, quinidine, used to correct irregular heartbeats dabigatran, used to prevent and treat blood clots carbamazepine, phenobarbital, phenytoin, used to prevent seizures rifampicin, used to prevent and treat tuberculosis and other infections dihydroergotamine, ergometrine, ergotamine, used to treat migraine headache
Croatian: • ako uzimate lijekove koji sadrže nešto od navedenog: alfuzozin, primjenjuje se za liječenje povećane prostate amiodaron, kinidin, primjenjuju se za ispravljanje nepravilnih otkucaja srca dabigatran, primjenjuje se za sprječavanje i liječenje krvnih ugrušaka karbamazepin, fenobarbital, fenitoin, primjenjuju se za sprječavanje napadaja rifampicin, primjenjuje se za sprječavanje i liječenje tuberkuloze i drugih infekcija dihidroergotamin, ergometrin, ergotamin, primjenjuju se za liječenje migrene gospina trava (Hypericum perforatum), biljni lijek koji se primjenjuje za depresiju i tjeskobu lovastatin, simvastatin, primjenjuju se za snižavanje kolesterola u krvi pimozid, lurasidon, primjenjuje se za liječenje abnormalnih misli i osjećaja sildenafil, primjenjuje se za liječenje plućne arterijske hipertenzije - bolest pluća koja otežava disanje midazolam primijenjen peroralno, triazolam, pomaže Vam da zaspete i/ili za ublažavanje tjeskobe
English: Estazolam
Croatian: Nuspojava
English: Therapeutic monitoring is recommended upon co-administration with Tybost.
Croatian: Terapijski nadzor se preporučuje prilikom istodobne primjene s lijekom Tybost.
English: The safety of Tybost in 73 HIV-1 infected treatment-experienced patients with mild to moderate renal impairment (eGFR by Cockcroft-Gault method 50-89 ml/min) who switched pharmacokinetic enhancer from ritonavir to cobicistat was evaluated in an open-label clinical Study (GS-US-236-0118) of cobicistat-boosted atazanavir or darunavir plus two NRTIs.
Croatian: U otvorenom kliničkom ispitivanju (GS-US-236-0118) kobicistatom pojačanog atazanavira ili darunavira zajedno s dva NRTI-ja, procjenjivana je sigurnost primjene lijeka Tybost u 73 već liječena HIV-1 zaražena bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (eGFR izračunat metodom Cockcroft-Gault 50-89 ml/min) kojima je farmakokinetički pojačivač ritonavir zamijenjen kobicistatom.
English: Therefore, therapy with cobicistat and darunavir should not be initiated during pregnancy, and women who become pregnant during therapy with cobicistat and darunavir should be switched to an alternative regimen (see sections 4.2 and 4.6).
Croatian: Stoga terapija kobicistatom i darunavirom ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije kobicistatom i darunavirom treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.6).
English: myalgia
Croatian: mialgija
English: Tybost [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Tybost [samo vanjsko pakiranje]
English: AUC: ↑ 290% Cmax: ↑ 319%
Croatian: Atorvastatin: AUC: ↑ 290% Cmax: ↑ 319% Cmin: NI
English: The peak concentration of digoxin is increased when co-administered with Tybost.
Croatian: Vršna koncentracija digoksina može se povećati kod istodobne primjene s lijekom Tybost.
English: Clinical monitoring is recommended upon co-administration with Tybost.
Croatian: Klinički nadzor se preporuča prilikom istodobne primjene lijeka Tybost.
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Croatian: Ako se drospirenon/etinilestradiol primjenjuje istodobno s atazanavirom/kobicistatom, preporučuje se kliničko praćenje zbog moguće pojave hiperkalijemije.
English: Cmax (µg/ml)
Croatian: AUCtau (µg•h/ml) Cmax (µg/ml) C0h (µg/ml) Antivirusno djelovanje in vitro
English: > 100,000 copies/ml
Croatian: Postotak ispitanika s virusnim opterećenjem > 100 000 kopija/ml
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Karbamazepin (200 mg dva puta dnevno)/elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: Caution is warranted and clinical monitoring is recommended during co-administration.
Croatian: U slučaju istodobne primjene preporučuju se primjena mjera opreza i klinički nadzor.
English: Nevirapine plasma concentrations may be increased when co-administered with cobicistat.
Croatian: Koncentracije nevirapina u plazmi mogu se povećati kad se nevirapin istodobno primjenjuje s kobicistatom.
English: Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Drospirenon/etinilestradiol (jedna doza od 3 mg/0,02 mg)/atazanavir (300 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: Atorvastatin:
Croatian: Kobicistat:
English: Caution should be exercised when co-administering cobicistat with pitavastatin.
Croatian: Istodobnu primjenu kobicistata i pitavastatina mora se provoditi s oprezom.
English: Tybost contains sunset yellow FCF aluminium lake (E110) Tell your doctor if you have an allergy to sunset yellow FCF aluminium lake (E110).
Croatian: Obavijestite svog liječnika ako ste alergični na bojilo sunset yellow FCF aluminium lake (E110).
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat or darunavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Croatian: Ako se drospirenon/etinilestradiol primjenjuje istodobno s atazanavirom/kobicistatom ili darunavirom/kobicistatom, preporučuje se kliničko praćenje zbog moguće pojave hiperkalijemije.
English: ANTICOAGULANTS Dabigatran
Croatian: ORALNI ANTIDIJABETICI
English: INHALED BETA AGONISTS Salmeterol
Croatian: INHALIRANI BETA-AGONISTI
English: If drospirenone/ethinyloestradiol is co-administered with darunavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Croatian: Ako se drospirenon/etinilestradiol primjenjuje istodobno s darunavirom/kobicistatom, preporučuje se kliničko praćenje zbog moguće pojave hiperkalijemije.
English: f Plus background regimen of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed-dose combination
Croatian: f Plus pozadinski režim kombinacije fiksne doze emtricitabina 200 mg i tenofovirdizoproksilfumarata 300 mg
English: Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1888
Croatian: Gilead Sciences Ireland UC Тел.: + 353 (0) 1 686 1888
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (600 mg single dose) Co-administration of efavirenz and cobicistat is expected to decrease cobicistat plasma concentrations.
Croatian: Inhibitori nenukleozidne reverzne transkriptaze (NNRTI) Efavirenz (600 mg jedna doza)
English: Co-administration of nevirapine and cobicistat is expected to decrease cobicistat plasma concentrations.
Croatian: Očekuje se da će istodobna primjena nevirapina i kobicistata smanjiti koncentracije kobicistata u plazmi.
English: Baseline characteristics and treatment outcomes at weeks 48 and 144 for Study GS-US-216-0114 are presented in Tables 6 and 7, respectively.
Croatian: Početne značajke i ishodi liječenja u ispitivanju GS-US-216-0114 u 48. i 144. tjednu prikazani su u Tablici 6, odnosno Tablici 7.
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyloestradiol (3 mg/0.02 mg single dose)/ Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Drospirenon/etinilestradiol (jedna doza od 3 mg/0,02 mg)/darunavir (800 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: ANTI-HYPERTENSIVES Metoprolol
Croatian: ANTIHIPERTENZIVI
English: Polyvinyl alcohol (partially hydrolysed) (E1203) Talc (E553B)
Croatian: makrogol 3350 (E1521) poli(vinilni alkohol) (djelomično hidroliziran) (E1203) talk (E553B) titanijev dioksid (E171) željezov oksid, žuti (E172)
English: Concentrations of norgestimate may be affected on co-administration with cobicistat.
Croatian: Istodobna primjena s kobicistatom može utjecati na koncentracije norgestimata.
English: Median baseline plasma HIV-1 RNA (range)
Croatian: Medijan početne vrijednosti HIV-1 RNK (raspon) log10 kopija/ml u plazmi
English: Plasma concentrations of digoxin may be increased when co-administered with cobicistat.
Croatian: Koncentracije digoksina u plazmi mogu se povećati kod istodobne primjene digoksina s kobicistatom.
English: Table 6: Demographic and baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in Study GS-US-216-0114
Croatian: Tablica 6: Demografske značajke i početne značajke bolesti u odraslih HIV-1 zaraženih ispitanika koji prije nisu bili liječeni antiretrovirusnim lijekovima, u ispitivanju
English: NEUROLEPTICS Perphenazine Risperidone Thioridazine
Croatian: Perfenazin Risperidon Tioridazin
English: Caution should be exercised, including consideration of dose reduction, when co-administering Tybost with tadalafil for the treatment of pulmonary arterial hypertension.
Croatian: Istodobnu primjenu lijeka Tybost i tadalafila za liječenje plućne arterijske hipertenzije mora se provoditi s oprezom, uključujući i razmatranje snižavanja doze.
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration with Tybost.
Croatian: U slučaju istodobne primjene lijeka Tybost preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
English: • dasatinib, nilotinib, vinblastine and vincristine, medicines used to treat cancer • corticosteroids including betamethasone, budesonide, fluticasone, mometasone,
Croatian: • dasatinib, nilotinib, vinblastin i vinkristin, lijekovi koji se primjenjuju za liječenje raka
English: Concentrations of these medicinal products may be increased when co-administered with cobicistat.
Croatian: Koncentracije ovih lijekova mogu se povećati kod istodobne primjene s kobicistatom.
English: Co-administration of bosentan with cobicistat may lead to decreased cobicistat plasma concentrations.
Croatian: Istodobna primjena bosentana s kobicistatom može uzrokovati smanjenje koncentracija kobicistata u plazmi.
English: Atorvastatin (10 mg single dose)/Darunavir (800 mg)/Cobicistat (150 mg once daily)
Croatian: Atorvastatin (jedna doza od 10 mg)/darunavir (800 mg)/kobicistat (150 mg jedanput na dan)
English: Package leaflet: Information for the patient Tybost 150 mg film-coated tablets cobicistat
Croatian: NAZIV LIJEKA Tybost 150 mg filmom obložene tablete
English: Rosuvastatin (10 mg single dose)/Darunavir (800 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Rosuvastatin (jedna doza od 10 mg)/darunavir (800 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: Concentrations of clarithromycin may be increased upon co-administration with cobicistat.
Croatian: Koncentracije klaritromicina mogu se povećati kad se klaritromicin istodobno primjenjuje s kobicistatom.
English: Plasma concentrations of rosuvastatin are increased when co-administered with atazanavir/cobicistat.
Croatian: Koncentracije rosuvastatina u plazmi povećane su kod istodobne primjene s atazanavirom/kobicistatom.
English: Silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Croatian: Jezgra tablete silicijev dioksid karmelozanatrij, umrežena magnezijev stearat celuloza, mikrokristalična Film ovojnica bojilo sunset yellow FCF aluminium lake (E110)
English: Plasma concentrations of drospirenone are increased following administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat or with darunavir/cobicistat.
Croatian: Koncentracije drospirenona u plazmi povećane su nakon primjene drospirenona/etinilestradiola s atazanavirom/kobicistatom ili darunavirom/kobicistatom.
English: Atorvastatin (10 mg single dose)/Atazanavir (300 mg)/Cobicistat (150 mg once daily)
Croatian: Atorvastatin (jedna doza od 10 mg)/atazanavir (300 mg)/kobicistat (150 mg jedanput na dan)
English: Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat.
Croatian: Koncentracije drospirenona u plazmi povećane su nakon istodobne primjene drospirenona/etinilestradiola s atazanavirom/kobicistatom.
English: Plasma concentrations of rosuvastatin are increased when co-administered with darunavir/cobicistat.
Croatian: Koncentracije rosuvastatina u plazmi povećane su kod istodobne primjene s darunavirom/kobicistatom.
English: Rosuvastatin (10 mg single dose)/Atazanavir (300 mg once daily)/Cobicistat (150 mg once daily)
Croatian: Rosuvastatin (jedna doza od 10 mg)/atazanavir (300 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)
English: Plasma concentrations of trazodone may be increased when co-administered with cobicistat.
Croatian: Koncentracije trazodona u plazmi mogu se povećati kod istodobne primjene s kobicistatom.
English: Co-administration of etravirine and cobicistat is expected to decrease cobicistat plasma concentrations.
Croatian: Očekuje se da će istodobna primjena etravirina i kobicistata smanjiti koncentracije kobicistata u plazmi.
English: AUC: ↑ 130% Cmax: ↔
Croatian: Drospirenon: AUC: ↑ 130% Cmax: ↔ Cmin: NI
English: Concentrations of warfarin may be affected upon co-administration with cobicistat.
Croatian: Istodobna primjena kobicistata može utjecati na koncentracije varfarina.
English: Apixaban Rivaroxaban Edoxaban
Croatian: Česte nuspojave
English: AUC: ↑ 58% Cmax: ↔
Croatian: Drospirenon: AUC: ↑ 58% Cmax: ↔ Cmin: NI
English: Effects on drug levels Mean percent change in AUC,
Croatian: Učinci na razinu lijekova Srednja vrijednost postotka promjene AUC, Cmax, Cmin
English: Plasma concentrations of atorvastatin are increased when co-administered with atazanavir/cobicistat.
Croatian: Koncentracije atorvastatina u plazmi povećane su kod istodobne primjene s atazanavirom/kobicistatom.
English: Caution is warranted and clinical monitoring is recommended upon co-administration of these antiarrhythmic medicinal products with Tybost.
Croatian: U slučaju istodobne primjene lijeka Tybost i ovih lijekova preporučuje se klinički nadzor terapijskih učinaka i nuspojava.
English: Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are co-administered with darunavir/cobicistat.
Croatian: Kada se kontraceptivi koji sadrže estrogen primjenjuju istodobno s darunavirom/kobicistatom, preporučuje se primjena drugih ili dodatnih mjera kontracepcije.
English: Cmax: ↑ 277% Cmin: NC
Croatian: Rosuvastatin: AUC: ↑ 93% Cmax: ↑ 277% Cmin: NI
English: Baseline disease characteristics
Croatian: Početne značajke bolesti
English: Plasma concentrations of atorvastatin are increased when co-administered with darunavir/cobicistat.
Croatian: Koncentracije atorvastatina u plazmi povećane su kod istodobne primjene s darunavirom/kobicistatom.
English: Plasma concentrations of ethinyloestradiol are decreased following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat.
Croatian: Koncentracije etinilestradiola u plazmi smanjene su nakon istodobne primjene drospirenona/etinilestradiola s darunavirom/kobicistatom.
English: Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with darunavir/cobicistat.
Croatian: Koncentracije drospirenona u plazmi povećane su nakon istodobne primjene drospirenona/etinilestradiola s darunavirom/kobicistatom.
English: get more from your doctor or pharmacist.
Croatian: Kad Vam se smanji zaliha lijeka Tybost, nabavite još lijeka od liječnika ili ljekarnika.
English: jaundice
Croatian: Učestalost
English: ANTI-NEOPLASTICS Dasatinib
Croatian: ANTINEOPLASTICI
English: Table 8: Changes in CD4+ cell counts through weeks 48 and 144 in Study GS-US-216-0114 Week 48
Croatian: Promjene broja CD4+ stanica kroz 48 tjedana odnosno 144 tjedna ispitivanja
English: Sunset yellow FCF aluminium lake (E110) Macrogol 3350 (E1521)
Croatian: Tybost sadrži bojilo sunset yellow FCF aluminium lake (E110)
English: Pravastatin
Croatian: Doziranje
English: Clorazepate
Croatian: Kolhicin
English: Atazanavir + ritonavirf (n = 348)
Croatian: Atazanavir + ritonavirf
English: Colchicine plasma concentrations may be increased when co-administered with cobicistat.
Croatian: Koncentracije kolhicina u plazmi mogu se povećati kod istodobne primjene s kobicistatom.
English: Cobicistat should not be co-administered with colchicine to patients with renal or hepatic impairment.
Croatian: Bolesnicima s oštećenjem funkcije bubrega ili jetre kobicistat se ne smije istodobno primjeniti s kolhicinom.
English: Antiviral activity in vitro
Croatian: Bez viroloških podataka u okviru
English: Female
Croatian: • kobicistat
English: GLUCOCORTICOIDS
Croatian: GLUKOKORTIKOIDI
English: nausea
Croatian: mučnina
English: • maraviroc
Croatian: • ritonavir
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders: Common:
Croatian: Poremećaji kože i potkožnog tkiva: Često:
English: Medicines used in treating HIV infection:
Croatian: Uputa o lijeku: Informacije za bolesnika
English: Cmax: ↑ 958% Cmin: NC
Croatian: Rosuvastatin: AUC: ↑ 242% Cmax: ↑ 958% Cmin: NI
English: AUC: ↑ 242%
Croatian: Cmin: ↓ 41%
English: Cmin: NC Ethinyloestradiol: AUC: ↓ 30%
Croatian: Etinilestradiol: AUC: ↓ 30% Cmax: ↔ Cmin: NI
English: Sirolimus
Croatian: žutica
English: Talk to your doctor before taking Tybost: • If you are taking another protease inhibitor.
Croatian: Obratite se svom liječniku prije nego uzmete Tybost:
English: Annex II Scientific conclusions
Croatian: Znanstveni zaključci
English: - Treatment of acute alcohol intoxication
Croatian: - Liječenje akutne intoksikacije alkoholom
English: - Treatment of schizophrenia in paediatric population
Croatian: - Liječenje shizofrenije u pedijatrijskoj populaciji
English: - Agitation, aggression and psychotic symptoms associated with dementia
Croatian: - Agitacija, agresija i psihotični simptomi povezani s demencijom
English: It was agreed that the maximum dose in elderly patients should be 5 mg/day, while higher doses should only be considered in patients who have tolerated higher doses and after reassessment of the patient's individual benefit-risk profile.
Croatian: Dogovoreno je da bi najveća doza za starije bolesnike trebala iznositi 5 mg dnevno, dok bi se veće doze trebale uzeti u obzir samo u bolesnika koji su prethodno liječeni većim dozama i nakon ponovne procjene profila koristi i rizika za pojedinačnog bolesnika.
English: Also patients with severe renal impairment may require a lower initial dose, with subsequent adjustments.
Croatian: U bolesnika s teškim oštećenjem bubrega može biti potrebna manja početna doza, uz naknadne prilagodbe.
English: It is advised that measurement of haloperidol concentrations may be considered in individual cases.
Croatian: Preporučuje se uzimanje u obzir mjerenja koncentracija haloperidola u pojedinim slučajevima.
English: Furthermore, observational studies have consistently reported an increased mortality in elderly haloperidol users - the highest mortality risk with haloperidol was in the first 30 days and persists for at least 6 months.
Croatian: Nadalje, u opservacijskim je ispitivanjima dosljedno uočena povećana smrtnost starijih korisnika haloperidola, a najveći rizik od smrtnosti prilikom njegove uporabe zabilježen je u prvih 30 dana te traje barem šest mjeseci.
English: - Tic disorders including Tourette's syndrome
Croatian: - Tikovi, uključujući Touretteov sindrom
English: Haldol has been approved nationally in the European Union (EU) with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Croatian: Haldol je u Europskoj uniji (EU) odobren na nacionalnoj razini uz mnogo razlika u tekstu sažetka opisa svojstava lijeka u različitim državama članicama.
English: Paediatric indications were agreed only for the oral formulations for the treatment of:
Croatian: Pedijatrijske indikacije usuglašene su samo za oralne formulacije namijenjene liječenju:
English: Section 4.3 was also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Croatian: Odjeljak 4.3 izmijenjen je i kako bi se uključio tekst u vezi s kontraindikacijom rizika od kardiotoksičnosti haloperidola.
English: In section 4.4; Special warnings and precautions for use, the following changes have been included: the risk of a rapid switch to depression in patient populations with bipolar disorder was added under a separate subheading, also advising close supervision of patients and in particular those at high risk.
Croatian: U odjeljak 4.4 (Posebna upozorenja i mjere opreza pri uporabi) uključene su sljedeće izmjene: rizik od brzog prijelaza na depresiju u populacijama bolesnika s bipolarnim poremećajem dodan je pod posebnim podnaslovom, pri čemu se savjetuje i strogi nadzor bolesnika, osobito onih izloženih većem riziku.
English: It is a potent central dopamine type 2 receptor antagonist, and at recommended dosages, has no antihistaminergic or anticholinergic activity and minimal alpha 1 adrenergic activity.
Croatian: Potentan je antagonist centralnih dopaminskih receptora D2, a pri preporučenim dozama ne pokazuje antihistaminergičko ili antikolinergičko djelovanje, uz minimalno alfa-1 adrenergičko djelovanje.
English: Grounds for the CHMP opinion Whereas
Croatian: Razlozi za mišljenje CHMP-a Budući da:
English: The information under the subheading extrapyramidal symptoms was further elaborated to include the symptoms and time to onset of acute dystonia and akathisia.
Croatian: Informacije navedene pod podnaslovom ekstrapiramidalni simptomi dodatno su razrađene kako bi se uključili simptomi i vrijeme javljanja akutne distonije i akatizije.
English: The Committee as a consequence, recommends the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Haldol and associated names (see Annex I).
Croatian: Odbor posljedično preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za koje su informacije o lijeku utvrđene u Prilogu III. za Haldol i povezane nazive (vidi Prilog I.).
English: Scientific conclusions Haldol, which contains the active substance haloperidol, is an antipsychotic belonging to the butyrophenone group.
Croatian: Haldol, koji sadrži djelatnu tvar haloperidol, antipsihotik je iz skupine butirofenona.
English: The SAG Psychiatry was consulted on the clinical value of the following adult and paediatric indications (section 4.1) and also on dosing recommendations in clinical practice (section 4.2):
Croatian: Od SAG-a za psihijatriju zatraženo je mišljenje o kliničkoj vrijednosti sljedećih indikacija u odraslih i pedijatrijskih bolesnika (odjeljak 4.1) i također o preporukama o doziranju u kliničkoj praksi (odjeljak 4.2):
English: - Symptoms of persistent aggression in children with autism or pervasive developmental disorders
Croatian: - Simptomi dugotrajne agresije u djece s autizmom ili pervazivnim razvojnim poremećajima