FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended period of use of this product is 21 days; however, according to the summary of product characteristics (SmPC) of the reference medicinal product, even though not the recommended regimen, the contraceptive efficacy of the reference product is maintained for up to 28 days.
Croatian: Međutim, prema sažetku opisa svojstava lijeka referentnog lijeka, iako se ne radi o preporučenom režimu, kontraceptivna djelotvornost referentnog lijeka održava se do 28 dana.
English: 48 tablets
Croatian: 48 tableta
English: Tell your doctor if you have one of the following conditions:
Croatian: Obavijestite svog liječnika ako imate jedno od sljedećih stanja:
English: It shall address the following key elements:
Croatian: Oni će sadržavati sljedeće ključne elemente:
English: Elderly patients (> 65 years of age)
Croatian: Stariji bolesnici (u dobi > 65 godina)
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Croatian: Važno je reći Vašem liječniku ako ste trudni, ako mislite da biste mogli biti trudni ili ako namjeravate zatrudnjeti.
English: • you have HIV.
Croatian: • ako imate HIV.
English: The tablets should be taken during or just after a meal.
Croatian: Tablete se moraju uzeti za vrijeme ili neposredno nakon jela.
English: However, if it is nearly time for the next dose, just skip the missed dose.
Croatian: Međutim, ako je već skoro vrijeme za sljedeću dozu, samo preskočite propuštenu dozu.
English: Short title: OTSUKA
Croatian: Kratki naslov: OTSUKA
English: If you forget a dose, take it as soon as you remember it.
Croatian: Ako ste zaboravili uzeti dozu, uzmite je čim se toga sjetite.
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je savjetovao liječnik.
English: Liver disorders is categorised as an important potential risk.
Croatian: Poremećaji jetre klasificirani su kao važan potencijalni rizik.
English: Swallow the tablets with water.
Croatian: Tablete progutajte s vodom.
English: Deltyba is not suitable for children under age 18.
Croatian: Deltyba nije prikladan za djecu mlađu od 18 godina.
English: 80636 München Germany
Croatian: 80636 München
English: You may be more at risk for dangerous changes of the heart rhythm.
Croatian: Možete biti izloženi povećanom riziku od opasnih promjena srčanog ritma.
English: • Increased need to urinate at night
Croatian: • pojačana potreba za mokrenjem noću
English: Aluminium/Aluminium blister: 48 tablets.
Croatian: Aluminij/aluminij blister: 48 tableta.
English: Elderly patients (≥ 65 years) No patients of ≥ 65 years of age were included in clinical trials.
Croatian: Stariji bolesnici (≥ 65 godina) Bolesnici ≥ 65 godina nisu bili uključeni u klinička ispitivanja.
English: DO NOT stop taking the tablets unless your doctor tells you to.
Croatian: NEMOJTE prestati uzimati tablete, osim ako Vam je liječnik rekao da tako učinite.
English: Deltyba may cause harm to an unborn baby.
Croatian: Deltyba može škoditi nerođenom djetetu.
English: Your doctor may also perform a blood test to check the concentration of some minerals and proteins which are important for the function of your heart.
Croatian: Vaš liječnik također može učiniti krvne pretrage za provjeru koncentracije nekih minerala i bjelančevina koji su važni za rad Vašeg srca.
English: This prolongation increases slowly over time in the first 6-10 weeks of treatment and remains stable therafter.
Croatian: Ovo se produljenje polagano povećava kroz vrijeme u prvih 6-10 tjedana liječenja i nakon toga ostaje stabilno.
English: No data are available in the elderly.
Croatian: Nema dostupnih podataka za starije.
English: It is not usually recommended for use during pregnancy.
Croatian: Obično se ne preporučuje primjena tijekom trudnoće.
English: Delamanid should be taken with food.
Croatian: Delamanid se mora uzimati s hranom.
English: If you experience side effects that might affect your ability to concentrate and react, do not drive or use machines.
Croatian: Ako osjetite nuspojave koje bi mogle utjecati na Vašu sposobnost koncentracije i reakcije, nemojte voziti niti upravljati strojevima.
English: - if you have very low levels of albumin, in the blood.
Croatian: − ako imate vrlo niske razine albumina u krvi.
English: • Hearing a persistent sound in your ear when no sound exists (tinnitus)
Croatian: • uporna zvonjava u ušima kad nema zvuka (tinitus)
English: Talk to your doctor, pharmacist or nurse before taking Deltyba.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Deltyba.
English: Non-clinical data reveal no specific hazard for humans based on conventional studies for genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne otkrivaju specifičan rizik za ljude na temelju konvencionalnih ispitivanja genotoksičnosti i kancerogenog potencijala.
English: The finding was shown to be partially reversible; the clinical relevance of this finding is unknown.
Croatian: Nalaz se pokazao djelomično reverzibilnim; klinički značaj ovog nalaza nije poznat.
English: Remember to take the pack with you so that it is clear what medicine you have taken.
Croatian: Ne zaboravite ponijeti vanjsku kutiju kako bi bilo jasno koji ste lijek uzeli.
English: What Deltyba is and what it is used for
Croatian: Što je Deltyba i za što se koristi
English: Dry eye* Photophobia
Croatian: suho oko* fotofobija
English: This leaflet was last revised in <{MM/YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u{MM/GGGG}.
English: All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis.
Croatian: Sve kulture koje su nedostajale do vremena konverzije kulture sputuma smatrale su se pozitivnim kulturama u primarnoj analizi.
English: These four patients were only receiving two other medicinal products in addition to delamanid.
Croatian: Ta četiri bolesnika primala su samo druga dva lijeka uz delamanid.
English: • Abnormal feeling in the mouth
Croatian: • nenormalan osjećaj u ustima
English: Do not take a double dose to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu tabletu.
English: Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks.
Croatian: Koncentracije identificiranih metabolita progresivno se povećavaju do stanja dinamičke ravnoteže nakon 6 do 10 tjedana.
English: • Decreased tolerability of the eyes for bright light
Croatian: • smanjena podnošljivost očiju za jarko svjetlo
English: The recommended dose is two 50 mg tablets taken twice a day (morning and evening) as advised by your doctor.
Croatian: Preporučena doza su dvije tablete od 50 mg dva puta dnevno (ujutro i navečer) kako Vam je savjetovao liječnik.
English: Contents of the pack and other information What Deltyba contains
Croatian: Sadržaj pakiranja i druge informacije Što Deltyba sadrži
English: Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%.
Croatian: Delamanid se izrazito veže za sve proteine plazme s vezanjem na ukupne proteine od ≥ 99,5%.
English: - if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6).
Croatian: − ako ste alergični na delamanid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6),
English: However, since the concentrations in the gut can potentially be much greater than these multiples of the Cmax, there is a potential for delamanid to have an effect on these transporters.
Croatian: Međutim, budući da koncentracije u crijevima potencijalno mogu biti puno veće od tih višekratnih Cmax, postoji mogućnost da delamanid ima učinak na te transportere.
English: The safety and efficacy of delamanid in children and adolescents below 18 years has not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost delamanida u djece i adolescenata mlađih od 18 godina još nije utvrđena.
English: Hereford, HR3 5PG United Kingdom
Croatian: Hereford, HR3 5PG Ujedinjeno Kraljevstvo
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: U obzir se moraju uzeti službene smjernice o odgovarajućoj primjeni antibakterijskih lijekova.
English: • Intense lack of energy
Croatian: • intenzivan manjak energije
English: Before you start taking Deltyba, and during the treatment, your doctor may check your heart's electrical activity using an ECG (electrocardiogram) machine (electrical recording of the heart).
Croatian: Prije nego počnete uzimati lijek Deltyba kao i tijekom liječenja, Vaš liječnik može provjeravati električnu aktivnost Vašeg srca uporabom uređaja za EKG snimanje (elektrokardiogram - snimanje električnih signala srca).
English: There are no data on treatment with delamanid for more than 24 consecutive weeks.
Croatian: Nema podataka o liječenju delamanidom u trajanju dužem od 24 uzastopna tjedna.
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material.
Croatian: Nositelj odobrenja će osigurati da svi zdravstveni djelatnici uključeni u propisivanje, izdavanje, rukovanje ili primjenu lijeka Deltyba dobiju edukacijske materijale.
English: Less than 5% of an oral dose of delamanid is recovered from urine.
Croatian: Manje od 5% oralne doze delamanida se izlučuje putem urina.
English: The Educational material for Healthcare Providers (HCPs) shall address the following key elements:
Croatian: Edukacijski materijali za zdravstvene djelatnike će sadržavati sljedeće ključne elemente:
English: If a QTcF >500 ms is observed either before the first dose of delamanid or during delamanid treatment, treatment with delamanid should either not be started or should be discontinued.
Croatian: Ako je opažen QTcF > 500 ms bilo prije prve doze delamanida ili tijekom liječenja delamanidom, liječenje delamanidom se ne smije započinjati ili se mora prekinuti.
English: The PRAC requests a cumulative review of this risk in next PSUR, using appropriate PT terms, in order to assess whether an update of the risk is needed.
Croatian: PRAC zahtijeva kumulativni pregled tog rizika u sljedećem PSUR-u, uz korištenje odgovarajućih preporučenih pojmova, kako bi se moglo procijeniti postoji li potreba za ažuriranjem tog rizika.
English: All QTcF prolongations above 60 ms were associated with concomitant fluoroquinolone use.
Croatian: Sva QTcF produljenja iznad 60 ms bila su povezana s istodobnom primjenom fluorokinolona.
English: Delamanid has a large apparent volume of distribution (Vz/F of 2,100 L).
Croatian: Delamanid ima veliki prividni volumen distribucije (Vz/F od 2100 L).
English: If you take more Deltyba than you should
Croatian: Ako uzmete više lijeka Deltyba nego što ste trebali
English: However, patients should be advised not to drive or use machines if they experience any adverse reaction with a potential impact on the ability to perform these activities (e.g. headache and tremor are very common).
Croatian: bolesnicima se mora savjetovati da ne upravljaju vozilima ili rade na strojevima ako osjete bilo koju nuspojavu koja bi mogla utjecati na sposobnost obavljanja tih radnji (npr. vrlo česte su glavobolja i tremor).
English: Elimination Delamanid disappears from plasma with a t1/2 of 30-38 hours.
Croatian: Delamanid nestaje iz plazme s poluvremenom od 30-38 sati.
English: Pharmacotherapeutic group: Antimycobacterials, antibiotics, ATC code: J04AK06.
Croatian: Farmakoterapijska skupina: antimikobakterijski lijekovi, antibiotici, ATK oznaka: J04AK06.
English: Delamanid does not show cross-resistance with any of the currently used anti-tuberculosis drugs.
Croatian: Delamanid ne pokazuje križnu rezistenciju s bilo kojim trenutno korištenim lijekovima protiv tuberkuloze.
English: Date of first authorisation: 28 April 2014 Date of latest renewal: 2 April 2019
Croatian: Datum posljednje obnove odobrenja: 2. travnja 2019.
English: Within each System Organ Class, adverse reactions are listed under frequency categories of 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 (cannot be estimated from the available data).
Croatian: Unutar svake klasifikacije organskih sustava nuspojave su navedene prema kategoriji učestalosti kao vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Delamanid plasma exposure increases less than proportionally with increasing dose.
Croatian: Izloženost delamanidu u plazmi povećava se manje od proporcionalnog s povećanjem doze.
English: What Deltyba looks like and contents of the pack
Croatian: Kako Deltyba izgleda i sadržaj pakiranja
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP:”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake "EXP:".
English: Treatment with delamanid should not be initiated in patients with the following risk factors unless the possible benefit of delamanid is considerd to outweigh the potential risks.
Croatian: Liječenje delamanidom se ne smije započeti u bolesnika sa sljedećim faktorima rizika osim ako se smatra da je moguća korist od delamanida veća od potencijalnih rizika.
English: Resistance to delamanid
Croatian: Rezistencija na delamanid
English: The frequency of the side effects listed below is defined using the following definitions: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Croatian: Učestalost nuspojava navedenih u nastavku definirana je prema sljedećim kriterijima: Vrlo često: mogu se javiti u više od 1 na 10 osoba
English: Deltyba is not expected to have an influence on your ability to drive and use machines.
Croatian: Ne očekuje se da će Deltyba imati utjecaj na Vašu sposobnost upravljanja vozilima i strojevima.
English: Deltyba contains lactose monohydrate.
Croatian: Deltyba sadrži laktozu monohidrat.
English: Delamanid and/or its metabolites have the potential to affect cardiac repolarisation via blockade of hERG potassium channels.
Croatian: Delamanid i/ili njegovi metaboliti imaju potencijal utjecanja na srčanu repolarizaciju blokadom kalijevih hERG kanala.
English: If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital.
Croatian: Ako ste uzeli više tableta nego što je propisana doza, javite se svom liječniku ili u lokalnu bolnicu.
English: Mutation in one of the 5 coenzyme F420 genes is suggested as the mechanism for resistance against delamanid in mycobacteria.
Croatian: Mutacija na jednom od 5 gena koenzima F420 predložena je kao mehanizam rezistencije mikobakterija na delamanid.
English: • Paranoia
Croatian: • paranoja
English: Mild renal impairment (50 mL/min < CrCLN < 80 mL/min) does not appear to affect delamanid exposure.
Croatian: Blago oštećenje bubrega (50 mL/min < CrCLN < 80 mL/min) ne čini se da utječe na izloženost delamanidu.
English: • A bone disease called osteochondrosis
Croatian: • bolest kostiju zvana osteohondroza
English: Deltyba had no effect on male or female fertility in animals (see section 5.3).
Croatian: Deltyba nije imala učinka na mušku ili žensku plodnost u životinja (vidjeti dio 5.3).
English: In-vitro studies showed that delamanid did not inhibit CYP450 isozymes.
Croatian: In-vitro ispitivanja su pokazala da delamanid nije inhibirao CYP450 izoenzime.
English: • Pain in the mouth or throat
Croatian: • bol u ustima ili grlu
English: • Sensations of irregular and/or forceful beating of the heart
Croatian: • osjećaj nepravilnog i/ili jakog lupanja srca
English: • you have been told that you have heart problems, for example a slow heart rhythm (bradycardia) or have a history of heart attack (myocardial infarction)
Croatian: • ako Vam je rečeno da imate srčanih problema, primjerice spori srčani ritam (bradikardija) ili ste imali srčani udar (infarkt miokarda)
English: Deltyba is not recommended in pregnant women or in women of childbearing potential unless they are using a reliable form of contraception.
Croatian: Ne preporučuje se primjena lijeka Deltyba u trudnica niti u žena reproduktivne dobi osim ako koriste pouzdani oblik kontracepcije.
English: Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.
Croatian: Deltyba se isporučuje u pakiranju od 48 filmom obloženih tableta u aluminij/aluminij blisterima.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR BLISTER PACKS
Croatian: PODACI NA KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJE ZA BLISTER PAKIRANJA
English: • Papules (small skin elevations)
Croatian: • papule (mala uzdignuća na koži)
English: The complete metabolic profile of delamanid has not yet been elucidated, and there is a potential for drug interactions with other co-administered medications, if significant unknown metabolites are discovered.
Croatian: Kompletni metabolički profil delamanida još nije razjašnjen, a postoji mogućnost nastanka interakcija s drugim istovremeno primijenjenim lijekovima, ako se otkriju značajni nepoznati metaboliti.
English: Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner.
Croatian: Ipak, neke su reakcije opažene s većom učestalošću, a brzina QT produljenja povećala se proporcionalno s dozom.
English: • you have reduced levels of albumin, potassium, magnesium or calcium in the blood
Croatian: • ako imate sniženu razinu albumina, kalija, magnezija ili kalcija u krvi
English: No studies have been performed in paediatric patients.
Croatian: Nisu provedena ispitivanja na pedijatrijskim bolesnicima.
English: Round, yellow, film-coated tablet.
Croatian: Okrugla, žuta, filmom obložena tableta.
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Croatian: - Poremećaji elektrolita, posebice hipokalemija, hipokalcemija ili hipomagnezemija.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, manjka Lapp laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Croatian: BROJ SERIJE<, OZNAKE DONACIJE I PROIZVODA>
English: If the QTc interval duration exceeds 450/470 ms for male/female patients during delamanid treatment, these patients should be administered more frequent ECG monitoring.
Croatian: Ako trajanje QTc intervala prelazi 450/470 ms za muške/ženske bolesnike tijekom liječenja delamanidom, u tih se bolesnika mora primjenjivati češće EKG praćenje.
English: Delamanid is primarily metabolised in plasma by albumin and to a lesser extent by CYP3A4.
Croatian: Biotransformacija Delamanid se primarno metabolizira albuminima iz plazme i u manjoj mjeri putem CYP3A4.
English: • Drug use during pregnancy
Croatian: • Upotreba lijeka tijekom trudnoće
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba whilst you are pregnant.
Croatian: Vaš će liječnik prosuditi o koristima za Vas nasuprot mogućim rizicima za Vaše dijete ako uzimate lijek Deltyba tijekom trudnoće.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for delamanid, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za delamanid, znanstveni zaključci CHMP-a su sljedeći:
English: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen Germany
Croatian: R-Pharm Germany GmbH Heinrich-Mack-Straße 35 89257 Illertissen
English: Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.
Croatian: Deltyba sadrži djelatnu tvar delamanid, antibiotik za liječenje plućne tuberkuloze uzrokovane bakterijama koje ne uništavaju antibiotici najčešće korišteni u liječenju tuberkuloze.
English: Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
Croatian: Liječenje s odgovarajućim kombiniranim režimom se mora nastaviti nakon završetka 24-tjednog perioda liječenja delamanidom, u skladu sa smjernicama SZO.
English: It is not known whether delamanid and metabolites will be significantly removed by haemodialysis or peritoneal dialysis.
Croatian: Nije poznato da li se delamanid i njegovi metaboliti značajno uklanjaju hemodijalizom ili peritonealnom dijalizom.
English: Data from clinical studies
Croatian: Podaci iz kliničkih ispitivanja
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1.
English: Trial 204 and 2 of 511 patients in Trial 213 (4 of 827 patients [0.48%]).
Croatian: 316 bolesnika u Ispitivanju 204 te u 2 od 511 bolesnika u Ispitivanju 213 (4 od 827 bolesnika [0,48 %]).
English: • Feeling of emotional and mental discomfort
Croatian: • osjećaj emocionalne i mentalne nelagode
English: In clinical trials resistance to delamanid has been defined as any growth in the presence of a delamanid concentration of 0.2 μg/mL that is greater than 1% of that on drug-free control cultures on Middlebrook 7H11 medium.
Croatian: U kliničkim ispitivanjima rezistencija na delamanid definirana je kao bilo koji rast u prisutnosti koncentracije delamanida od 0,2 μg/mL koji je veći za 1% od onog u kontrolnim kulturama bez lijeka na podlozi Middlebrook 7H11.
English: Stopping too early could allow the bacteria to recover and to become resistant to delamanid.
Croatian: Prerani prekid može omogućiti oporavak bakterija i one mogu postati otporne na delamanid.
English: The identified metabolites of delamanid do not show anti-mycobacterial activity.
Croatian: Identificirani metaboliti delamanida ne pokazuju antimikobakterijsku aktivnost.
English: Delamanid resistance emerged in 4 of 341 patients (1.2%) randomised to receive delamanid for 6 months in Trial 213.
Croatian: Rezistencija na delamanid pojavila se u 4 od 341 bolesnika (1,2 %) randomiziranog da prima delamanid tijekom 6 mjeseci u Ispitivanju 213.
English: • Itchy or red skin including around the hair roots.
Croatian: • svrbež ili crvenilo na koži uključujući oko korijena vlasi • retencija mokraće
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch.
Croatian: U svakoj državi članici nositelj odobrenja će se o sadržaju i obliku edukacijskih materijala dogovoriti s nacionalnim nadležnim tijelom i implementirati ih prije puštanja lijeka u promet.
English: • if you have a condition called congenital long QT syndrome or have a serious heart disease or problems with heart rhythm.
Croatian: • ako imate prirođeni sindrom produljenog QT intervala ili ozbiljnu srčanu bolest ili probleme sa srčanim ritmom.
English: • Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet
Croatian: • oštećenje živca koje uzrokuje utrnulost ili bol (žarenje) ili osjećaja trnaca u šakama i stopalima
English: Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required.
Croatian: Liječenje predoziranja mora uključivati trenutne mjere za uklanjanje delamanida iz gastrointestinalnog trakta i suportivnu skrb po potrebi.
English: It is recommended that delamanid is administered by directly observed therapy (DOT).
Croatian: Preporučuje se primjena delamanida izravno nadziranim liječenjem (DOT, engl. directly observed therapy).