FrancophonIA/ELRC3.0 huggingface dataset:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Gdje je to potrebno, podaci o lijeku mogu naknadno biti ažurirani od strane nadležnih tijela zemlje članice, u suradnji s referentnom zemljom članicom, i u skladu s postupcima opisanim u Poglavlju 4, Glave III, Direktive 2001/83/EZ.
English: Treatment with hydroxyzine should be stopped.
Croatian: Liječenje hidroksizinom treba prekinuti.
English: Section 4 “Possible side effects”
Croatian: Dio 4 „Moguće nuspojave”
English: Check with your <doctor> <or> <pharmacist> if you are not sure.>
Croatian: . Provjerite sa svojim <liječnikom> <ili> <ljekarnikom> ako niste sigurni.>
English: If you <take> <use> more X than you should
Croatian: Ako <uzmete> <primijenite> više X nego što ste trebali
English: Therefore, tell your doctor if you have any heart problems or are taking any other medicines, including medicines obtained without prescription.
Croatian: Stoga, obavijestite svog liječnika ako imate bilo kakve probleme sa srcem, odnosno ako uzimate bilo koje druge lijekove, uključujući one koji se nabavljaju bez recepta.
English: Patients should be advised to promptly report any cardiac symptoms.
Croatian: Bolesnike treba savjetovati da bez odgađanja prijave bilo kakve kardiološke simptome.
English: X may be associated with an increased risk of heart rhythm disorder which may be life threatening.
Croatian: Primjena X može biti povezana s povećanim rizikom od poremećaja srčanog ritma, što može biti opasno po život.
English: Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.
Croatian: Liječenje hidroksizinom treba prekinuti ako se pojave znakovi ili simptomi koji mogu biti povezani sa srčanom aritmijom, a bolesnik odmah treba potražiti liječničku pomoć.
English: Section 2 “What you need to know before you <take> <use> X”
Croatian: Dio 2 „Što morate znati prije nego počnete <uzimati> <primjenjivati> X”
English: Associations contraindicated
Croatian: Kontraindicirane kombinacije
English: Hydroxyzine is not recommended in elderly patients because of a decrease of hydroxyzine elimination in this population as compared to adults and the greater risk of adverse reactions (e.g. anticholinergic effects) (see sections 4.2 and 4.8).
Croatian: Hidroksizin se ne preporučuje starijim bolesnicima zbog smanjene mogućnosti eliminacije hidroksizina kod ove populacije u odnosu na populaciju odraslih te zbog većeg rizika od nuspojava (npr. antikolinergički učinci) (vidjeti dijelove 4.2 i 4.8).
English: Hydroxyzine is metabolized by alcohol dehydrogenase and CYP3A4/5 and an increase in hydroxyzine blood concentrations may be expected when hydroxyzine is co-administered with drugs known to be potent inhibitors of these enzymes.
Croatian: Hidroksizin se metabolizira putem alkohol dehidrogenaze i CYP3A4/5 te se može očekivati povećanje koncentracije hidroksizina u krvi kada se hidroksizin uzima istodobno s lijekovima koji su poznati kao jaki inhibitori ovih enzima.
English: In the elderly, the maximum daily dose is 50 mg per day (see section 4.4).
Croatian: U starijih osoba, maksimalna dnevna doza iznosi 50 mg na dan (vidjeti dio 4.4).
English: • depression (e.g. citalopram, escitalopram)
Croatian: • depresije (npr. citalopram, escitalopram)
English: While taking X, seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness.
Croatian: Tijekom uzimanja X, odmah potražite medicinsku pomoć ako osjetite probleme sa srcem poput lupanja srca, poteškoća s disanjem, gubitka svijesti.
English: • psychoses (e.g. haloperidol)
Croatian: • psihoze (npr. haloperidol)
English: Do not <take> <use> X
Croatian: Nemojte <uzimati> <primjenjivati> X<:>
English: Co-administration of hydroxyzine with drugs known to prolong the QT interval and/or induce Torsade de Pointes e.g. class IA (e.g. quinidine, disopyramide) and III antiarrhythmics (e.g. amiodarone, sotalol), some antihistamines, some antipsychotics (e.g. haloperidol), some antidepressants (e.g. citalopram, escitalopram), some antimalarial drugs (e.g. mefloquine), some antibiotics (e.g. erythromycin, levofloxacin, moxifloxacin), some antifungal agents (e.g. pentamidine), some gastro-intestinal medicines (e.g. prucalopride), some medicines used in cancer (e.g., toremifene, vandetanib), methadone, increase the risk of cardiac arrhythmia.
Croatian: Istodobna primjena hidroksizina s lijekovima za koje je poznato da izazivaju prolongaciju QTintervala i/ili Torsades de pointes npr. skupinom IA (npr. kinidin, dizopiramid) i III antiaritmika (npr. amiodaron, sotalol), nekim antihistaminicima, nekim antipsihoticima (npr. haloperidol), nekim antidepresivima (npr. citalopram, escitalopram), nekim lijekovima protiv malarije (npr. meflokin), nekim antibioticima (npr. eritromicin, levofloksacin, moksifloksacin), nekim lijekovima protiv gljivica (npr. pentamidin), nekim gastrointestinalnim lijekovima (npr. prukaloprid), nekim lijekovima koji se koriste u liječenju raka (npr. toremifen, vandetanib) i metadonom, povećava rizik od srčane aritmije.
English: Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have been contributory (see section 4.8).
Croatian: Većina tih bolesnika imala je druge faktore rizika, poremećaje elektrolita i istovremeno liječenje koje je tome moglo pridonijeti (vidjeti dio
English: - if your ECG (electrocardiogram) shows a heart rhythm problem called “QT interval prolongation” - if you have or had a cardiovascular disease or if your heart rate is very low - if you have low salt levels in your body (e.g. low level of potassium or of magnesium) - if you are taking certain medicines for heart rhythm problems or medicines that may affect the heart rhythm (see “Other medicines and X”) - if anyone in your close family has died suddenly of heart problems
Croatian: „prolongacija QT-intervala” - ako imate ili ste imali kardiovaskularnu bolest ili vrlo nizak broj otkucaja srca - ako imate nisku razinu soli u organizmu (npr. nisku razinu kalija ili magnezija) - ako uzimate određene lijekove za probleme sa srčanim ritmom ili lijekove koji mogu utjecati na srčani ritam (pogledajte odjeljak „Drugi lijekovi i X”) - ako je bilo tko u vašoj užoj obitelji iznenadno umro od problema sa srcem
English: • bacterial infections (e.g. the antibiotics erythromycin, moxifloxacin, levofloxacin)
Croatian: • bakterijskih infekcija (npr. antibiotike eritromicin, moksifloksacin, levofloksacin)
English: • heart problems or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol)
Croatian: • problema sa srcem ili visokim krvnim tlakom (npr. amiodaron, kinidin, dizopiramid, sotalol)
English: Patients with a known acquired or congenital QT interval prolongation.
Croatian: Bolesnici s poznatom stečenom ili kongenitalnom prolongacijom QT-intervala.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i uputa o lijeku rezultat su arbitražnog postupka.
English: Patients with a known risk factor to QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, concomitant use with drugs known to prolong the QT interval and/or induce Torsade de Pointes (see sections 4.4 and 4.5).
Croatian: Bolesnici s poznatim faktorom rizika za prolongaciju QT-intervala uključujući i poznatu kardiovaskularnu bolest, značajnu neuravnoteženost elektrolita (hipokalijemija, hipomagnezemija), iznenadnu srčanu smrt u obiteljskoj anamnezi, značajnu bradikardiju, istovremeno korištenje lijekova za koje se zna da izazivaju prolongaciju QT-intervala i/ili Torsades de pointes (vidjeti dio 4.4 ili 4.5).
English: Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram.
Croatian: Hidroksizin je povezan s prolongacijom QT-intervala utvrđenom elektrokardiogramom.
English: <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.> This includes any medicines obtained without prescription.
Croatian: <primjenjujete> ili ste nedavno <uzeli> <primijenili> ili biste mogli <uzeti> <primijeniti> bilo koje druge lijekove.
English: The following wording should be present in this section:
Croatian: U ovom dijelu se mora nalaziti sljedeći tekst:
English: Caution with bradycardia and hypokalaemia-inducing drugs.
Croatian: Potreban je oprez s lijekovima koji izazivaju bradikardiju i hipokalijemiju.
English: Hydroxyzine should be used at the lowest effective dose and for the shortest possible duration.
Croatian: Potrebno je primijeniti najnižu učinkovitu dozu hidroksizina tijekom najkraćeg mogućeg vremenskog perioda.
English: X should be used at the lowest effective dose and the treatment period should be as short as possible.
Croatian: Potrebno je primijeniti najnižu učinkovitu dozu X tijekom najkraćeg mogućeg perioda liječenja.
English: An ECG monitoring could be undertaken, because of the possibility of a heart rhythm problem such as QT interval prolongation or Torsade de Pointes.
Croatian: Može se napraviti EKG zbog mogućih problema sa srčanim ritmom poput prolongacije QT-intervala ili Torsades de pointes.
English: • gastro-intestinal disorders (e.g. prucalopride)
Croatian: • gastrointestinalnih poremećaja (npr. prukaloprid)
English: • malaria (e.g. mefloquine)
Croatian: • malarije (npr. meflokin)
English: X can affect or be affected by other medicinal products.
Croatian: X može utjecati na druge lijekove u primjeni i obratno.
English: In the elderly, the maximum daily dose is 50 mg per day.
Croatian: U starijih osoba, maksimalna dnevna doza iznosi 50 mg na dan.
English: • fungal infections (e.g. pentamidine)
Croatian: • gljivičnih infekcija (npr. pentamidin)
English: The following wording should be included in the specified sections:
Croatian: U određene dijelove potrebno je dodati sljedeći tekst:
English: Section 4.4 Special warnings and precautions for use The following wording should be added to this section:
Croatian: Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: During post-marketing surveillance, there have been cases of QT interval prolongation and torsade de pointes in patients taking hydroxyzine.
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet, u bolesnika koji su uzimali hidroksizin bilo je slučajeva s prolongacijom QT-intervala i Torsades de pointes.
English: Not known (frequency cannot be estimated from the available data) Stop taking the medicine and seek immediate medical attention if you experience any problems with the heart rhythm such as palpitations, trouble breathing or loss of consciousness.
Croatian: Prekinite uzimati lijek i odmah potražite medicinsku pomoć ako osjetite bilo kakve probleme sa srčanim ritmom poput lupanja srca, poteškoća s disanjem ili gubitka svijesti.
English: In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day.
Croatian: U djece do 40 kg težine, maksimalna dnevna doza iznosi 2 mg/kg/dan.
English: <Always <take> <use> this medicine exactly as your doctor <or pharmacist> has told you.
Croatian: Dio 3 „Kako <uzimati><primjenjivati> X” <Uvijek <uzmite> <primijenite> ovaj lijek točno onako kako <su> Vam <je> rekao(li) Vaš liječnik <ili> <ljekarnik>
English: Section 4.8 Undesirable effects The following wording should be added to this section: Not known: ventricular arrhythmias (e.g. Torsade de Pointes), QT interval prolongation (see section 4.4).
Croatian: Nepoznato: ventrikularne aritmije (npr. Torsades de pointes), prolongacija QT-intervala (vidjeti dio
English: In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day.
Croatian: U odraslih i djece teže od 40 kg, maksimalna dnevna doza iznosi 100 mg na dan.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i uputa o lijeku
English: In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day in all indications.
Croatian: U odraslih i djece teže od 40 kg, maksimalna dnevna doza iznosi 100 mg na dan bez obzira na indikacije.
English: • cancer (e.g. toremifene, vandetanib)
Croatian: • raka (npr. toremifen, vandetanib) • ovisnosti o drogama ili teške boli (metadon)
English: The marketing authorisation holders shall provide evidence in support of proportionate, feasible and effective measures to prevent the risk of overdose and minimise the risk of hepatic injury following intentional or accidental overdoses with modified release paracetamol containing products.
Croatian: Nositelji odobrenja za stavljanje lijeka u promet moraju pružiti dokaze o razmjernim, izvedivim i učinkovitim mjerama za sprječavanje rizika od predoziranja i smanjenje rizika od oštećenja jetre na najmanju moguću mjeru nakon namjernog ili slučajnog predoziranja lijekovima s prilagođenim oslobađanjem koji sadrže paracetamol.
English: Conditions for lifting the suspension of the marketing authorisations
Croatian: Uvjeti za ukidanje obustave odobrenja za stavljanje lijeka u promet
English: For the suspension of products containing paracetamol, modified and prolonged to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holders.
Croatian: Kako bi se ukinula obustava lijekova s prilagođenim i produljenim oslobađanjem koji sadrže paracetamol, nadležna tijela osiguravaju da nositelji odobrenja za stavljanje lijeka u promet ispunjavaju sljedeće uvjete:
English: Recommended dose for adults:
Croatian: Preporučena doza za odrasle:
English: Do not give this medicine to children and adolescents under 18 years of age.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Croatian: Imajte bočicu s tabletama sa sobom, tako da možete lako opisati što ste uzeli.
English: • One tablet each day by mouth, with food.
Croatian: • Jedna tableta svaki dan kroz usta, s hranom.
English: You must keep in regular contact with your doctor.
Croatian: Morate biti u redovitom kontaktu sa svojim liječnikom.
English: Always take the tablet with food.
Croatian: Tabletu uvijek uzmite s hranom.
English: Contact your doctor or nearest emergency department immediately for advice.
Croatian: Odmah se javite liječniku ili u najbližu hitnu službu zbog savjeta.
English: You may still develop infections or other illnesses associated with HIV infection.
Croatian: I dalje možete razviti infekcije i druge bolesti povezane s infekcijom HIV-om.
English: Wait and take the next dose, with food, at your usual time.
Croatian: Pričekajte i uzmite sljedeću dozu s hranom u uobičajeno vrijeme.
English: Alternative forms of contraception should be considered.
Croatian: Potrebno je razmotriti druge oblike kontracepcije.
English: This medicine does not directly treat your HIV infection.
Croatian: Ovaj lijek ne liječi izravno Vašu infekciju HIV-om.
English: Always take the dose recommended by your doctor.
Croatian: Uvijek uzimajte onu dozu koju Vam je preporučio Vaš liječnik.
English: The other ingredients are
Croatian: Drugi sastojci su
English: In the ritonavir group, genotypic data was available for all 19 virologic failures.
Croatian: U skupini s ritonavirom, genotipski podaci bili su dostupni za svih 19 viroloških neuspjeha.
English: As a result, the amounts of Tybost or other medicines in your blood may be affected.
Croatian: Kao rezultat, količine lijeka Tybost ili drugih lijekova u Vašoj krvi mogu biti promijenjene.
English: This is to make sure that your medicine is fully effective.
Croatian: To je iz razloga da budete sigurni da je lijek koji uzimate potpuno djelotvoran.
English: • increased appetite, disturbed sense of taste, dry mouth
Croatian: • povećan apetit, poremećen osjet okusa, suha usta
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Croatian: Sa svojim liječnikom razgovarajte o mjerama opreza koje trebate poduzeti kako ne biste zarazili druge osobe.
English: • feeling depressed
Croatian: • osjećaj depresije
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Croatian: Amlodipin Diltiazem Felodipin Nikardipin Nifedipin Verapamil
English: NC = not calculated
Croatian: NI = nije izračunato
English: Do not chew, crush or split the tablet.
Croatian: Nemojte žvakati, drobiti ili lomiti tabletu.
English: • Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: • Odmah obavijestite svog liječnika ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: Your doctor will carefully consider whether to treat you with Tybost.
Croatian: Vaš će liječnik pažljivo razmotriti o tome hoće li Vas liječiti lijekom Tybost.
English: ND = not determined
Croatian: NO = nije određeno
English: What Tybost is and what it is used for
Croatian: Što je Tybost i za što se koristi
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Tybost or by other medicines that you are taking at the same time, or by the HIV disease itself.
Croatian: Kad se liječi HIV-infekcija, nije uvijek moguće odrediti jesu li neki od neželjenih učinaka prouzrokovani lijekom Tybost ili drugim lijekovima koje istodobno uzimate, ili samom HIV-bolešću.
English: The safety and efficacy of cobicistat in children aged 0 to less than 18 years have not been established (see section 5.1).
Croatian: Sigurnost i djelotvornost kobicistata u djece u dobi od 0 do manje od 18 godina nisu ustanovljene (vidjeti dio 5.1).
English: The use of Tybost in children and adolescents has not yet been studied.
Croatian: Primjena lijeka Tybost u djece i adolescenata još nije ispitana.
English: EU/1/13/872/001 EU/1/13/872/002
Croatian: EU/1/13/872/002
English: A food effect study was not conducted for Tybost.
Croatian: Ispitivanje učinka hrane nije provedeno za Tybost.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: I dalje možete prenijeti HIV drugima dok uzimate ovaj lijek, iako je rizik umanjen djelotvornom antiretrovirusnom terapijom.
English: Date of first authorisation: 19 September 2013 Date of latest renewal: 26 July 2018
Croatian: Datum posljednje obnove odobrenja: 26 srpanj 2018
English: In some cases, your doctor may need to adjust your dose or check the levels of medicine in your blood.
Croatian: U nekim će Vam slučajevima liječnik trebati prilagoditi dozu ili provjeriti razine lijeka u krvi.
English: • If you are allergic to cobicistat or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: • ako ste alergični na kobicistat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 ove upute).
English: What Tybost looks like and contents of the pack
Croatian: Kako Tybost izgleda i sadržaj pakiranja
English: If you do miss a dose and notice:
Croatian: Ako ipak propustite dozu i primjetite to:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (frequency cannot be estimated from the available data).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: What Tybost is and what it is used for What you need to know before you take Tybost How to take Tybost
Croatian: Što je Tybost i za što se koristi Što morate znati prije nego počnete uzimati Tybost Kako uzimati Tybost
English: Talk to your doctor if you are taking
Croatian: Recite svom liječniku ako uzimate
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, genotoksičnosti te reproduktivne i razvojne toksičnosti.
English: If you take more Tybost than you should
Croatian: Ako uzmete više lijeka Tybost nego što ste trebali
English: • yellowing of the skin and/or eyes (jaundice)
Croatian: • žutilo kože i/ili očiju (žutica).
English: A long term carcinogenicity study in mice did not show any carcinogenic potential.
Croatian: Dugoročno ispitivanje kancerogenosti u miševa nije pokazalo nikakav kancerogeni potencijal.
English: It should be kept in mind that a twice weekly dose of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifabutin resistance and a treatment failure.
Croatian: Mora se imati na umu da doza od 150 mg dvaput tjedno možda neće omogućiti optimalnu izloženost rifabutinu te stoga može dovesti do rizika rezistencije na rifabutin i neuspjeh liječenja.
English: Tybost must be taken orally, once daily with food.
Croatian: Tybost se mora primijeniti peroralno, jednom dnevno s hranom.
English: • alpha 1-adrenoreceptor antagonists: alfuzosin
Croatian: • antagonisti alfa 1-adrenoreceptora: alfuzozin
English: Pharmacokinetics of cobicistat have not been fully evaluated in the elderly (65 years of age and older).
Croatian: Farmakokinetika kobicistata nije u potpunosti ispitana u starijih osoba (u starosti od 65 i više godina).
English: These are mentioned above under the heading “Do not take Tybost-If you are taking medicines containing any one of the following”.
Croatian: Ti su lijekovi navedeni pod naslovom „Nemojte uzimati Tybost - ako uzimate lijekove koji sadrže nešto od navedenog“.
English: Tybost does not directly treat your HIV, but boosts the levels of atazanavir and darunavir in the blood.
Croatian: Tybost ne liječi izravno Vaš HIV, ali pojačava razine atazanavira i darunavira u krvi.
English: The film-coated tablet should not be chewed or crushed.
Croatian: Filmom obložena tableta ne smije se žvakati niti drobiti.
English: Tybost has no or negligible influence on the ability to drive and use machines.
Croatian: Tybost ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Tybost should be taken orally, once daily with food (see section 5.2).
Croatian: Tybost se mora uzimati peroralno, jedanput na dan, s hranom (vidjeti dio 5.2).
English: Cobicistat has not been studied in patients receiving dialysis, and, therefore, no recommendation can be made for these patients.
Croatian: Kobicistat nije proučavan u bolesnika koji su na dijalizi i stoga se ne mogu dati preporuke za te bolesnike.
English: Dose reductions of colchicine may be required.
Croatian: Mogu biti potrebna smanjenja doze kolhicina.
English: It is recommended that Tybost be administered with food.
Croatian: Preporučuje se da se Tybost primjenjuje s hranom.
English: Treatment of overdose with cobicistat consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Croatian: Liječenje predoziranja kobicistatom sastoji se od općih suportivnih mjera uključujući praćenje vitalnih znakova kao i promatranje kliničkog statusa bolesnika.
English: This increase is not considered to be clinically relevant and does not necessitate dose adjustment of tenofovir disoproxil.
Croatian: To se povećanje ne smatra klinički značajnim i ne zahtijeva potrebu prilagodbe doze tenofovirdizoproksila.
English: Pregnant women should not take Tybost with darunavir.
Croatian: Trudnice ne smiju uzimati Tybost s darunavirom.