FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP recommended that Vepesid should be used in combination with other cancer treatments to treat the following cancers in adults:
Croatian: CHMP je preporučio da se lijek Vepesid treba primjenjivati u kombinaciji s drugim terapijama za rak u liječenju sljedećih vrsta raka u odraslih:
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je dovelo do odstupanja među državama članicama u pogledu načina odobrene primjene lijeka, što je vidljivo u razlikama među sažetcima opisa svojstava lijeka (SmPC), u označivanju i uputama o lijeku u zemljama u kojima je lijek stavljen u promet.
English: The dose of Vepesid is based on the recommended dose for the intravenous etoposide medicines, with a 100 mg oral dose being comparable to a 75 mg intravenous one.
Croatian: Doza lijeka Vepesid temelji se na preporučenoj dozi za intravenske lijekove koji sadržavaju etopozid, pri čemu je oralna doza od 100 mg usporediva s intravenskom dozom od 75 mg.
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vepesid in the EU.
Croatian: Europska je komisija 14. listopada 2015. uputila predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Vepesid u EU-u.
English: In addition, the CHMP recommended Vepesid for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Croatian: Osim toga, CHMP je preporučio primjenu lijeka Vepesid za liječenje epitelijalnog raka jajnika koji je otporan na liječenje lijekovima koji sadržavaju platinu, bez navoda o tome da ga treba primjenjivati u kombinaciji s drugim lijekovima.
English: • Hodgkin's lymphoma as second-line treatment;
Croatian: • Hodgkinova limfoma (kao druga linija liječenja);
English: EMA/251790/2017 Rev. 1 EMEA/H/A-30/1425
Croatian: 1 EMEA/H/A-30/1425
English: Vepesid should not be taken at the same time as vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be taken by breast-feeding women.
Croatian: Vepesid se ne smije primjenjivati istodobno s cijepljenjem protiv žute groznice ili drugim živim cjepivima u bolesnika s oslabljenim imunosnim sustavom te u dojilja.
English: Vepesid contains the active substance etoposide and is available as capsules to be taken by mouth.
Croatian: Vepesid sadržava djelatnu tvar etopozid i dostupan je u obliku kapsula koje se uzimaju kroz usta.
English: It is also available in the EU under the trade name Vepesid K. The company that markets these medicines is Bristol-Myers Squibb.
Croatian: Te lijekove stavlja u promet tvrtka Bristol-Myers Squibb.
English: On 21 April 2017, the European Medicines Agency completed a review of Vepesid.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Vepesid 21. travnja 2017.
English: • acute myeloid leukaemia that is resistant to treatment or has come back;
Croatian: • akutne mijeloične leukemije koja je otporna na liječenje ili koja se vratila;
English: • testicular cancer that is resistant to treatment or has come back;
Croatian: • raka testisa koji je otporan na liječenje ili koji se vratio;
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, CHMP smatra da se sažetci opisa svojstava lijeka i upute za lijek moraju uskladiti na razini EU-a.
English: Vepesid capsules should be taken on an empty stomach.
Croatian: Kapsule Vepesid potrebno je uzimati natašte.
English: • non-Hodgkin's lymphoma that is resistant to treatment or has come back;
Croatian: • ne-Hodgkinova limfoma koji je otporan na liječenje ili koji se vratio;
English: Vepesid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) utvrdila je da je za lijeka Vepesid potrebno provesti usklađivanje.
English: 5 years
Croatian: 5 godina
English: This is called a ‘remission'.
Croatian: To se naziva 'remisija'.
English: It works in a number of different ways:
Croatian: Djeluje na više različitih načina:
English: Take your next capsules at the usual time the next day.
Croatian: Uzmite sljedeće kapsule u uobičajeno vrijeme sljedećeg dana.
English: The risk increased over time and was about 2 % after two years and about 4 % after three years.
Croatian: Rizik se povećavao s vremenom pa je nakon dvije godine iznosio oko 2 %, a nakon tri godine oko 4 %.
English: The risk appears to be greatest during the first 5 months of therapy.
Croatian: Čini se da je rizik najveći tijekom prvih 5 mjeseci terapije.
English: • Swallow the capsules whole with a full glass of water.
Croatian: • Progutajte kapsule cijele s punom čašom vode.
English: Key elements to be included
Croatian: Glavni elementi koje treba uključiti
English: However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Croatian: Međutim, znakovi i simptomi mogu se uvelike smanjiti ili nestati na neko vrijeme.
English: It has no antibacterial effects.
Croatian: Nema antibakterijskih učinaka.
English: It may become very severe, painful and disabling.
Croatian: To stanje može postati vrlo teško, bolno i onesposobljavajuće.
English: Date of first authorisation: 16 April 2008 Date of latest renewal: 08 February 2018
Croatian: Datum posljednje obnove odobrenja: 08. veljače 2018.
English: • Take the capsules as a single dose before going to bed.
Croatian: • Uzmite kapsule kao pojedinačnu dozu prije odlaska u krevet.
English: However, reports following relatively shortterm use also exist.
Croatian: No postoje i izvješća o pojavi nakon relativno kratkotrajne uporabe.
English: It may not go away, or may go away slowly.
Croatian: Možda se neće povući ili će se povlačiti sporo.
English: Other less frequent abnormalities have also been described.
Croatian: Opisane su također i druge manje učestale abnormalnosti.
English: Your doctor should check whether you have ever had hepatitis B infection.
Croatian: Liječnik mora provjeriti jeste li ikad imali infekciju hepatitisom B.
English: • Sexual dysfunction, for example impotence.
Croatian: • spolna disfunkcija, primjerice impotencija
English: This may mean that you are more likely to develop infections.
Croatian: To može značiti da ste skloniji razvoju infekcija.
English: Not known (frequency cannot be estimated from the available data) :
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: Keep the package intact.
Croatian: Čuvajte pakiranje neoštećeno.
English: Read it carefully and follow the related instructions.
Croatian: Pročitajte je pažljivo i pridržavajte se odgovarajućih uputa.
English: AND ≥ 100,000
Croatian: I ≥ 100 000
English: However your doctor will choose the dose for you, monitor your progress and may adjust your dose.
Croatian: No, liječnik će Vam odabrati dozu, nadzirati Vaš napredak te možda i prilagoditi dozu.
English: Even if you do not have a menstrual bleeding following cancer therapy, you may become pregnant.
Croatian: Čak i ako nemate menstrualno krvarenje nakon liječenja raka, možete zatrudnjeti.
English: This will make you less likely to feel sleepy at other times.
Croatian: To će Vam pomoći da smanjite vjerojatnost da budete pospani u neko drugo vrijeme.
English: It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Croatian: Ovo nije ugovor, i nikoga ne oslobođa vlastite odgovornosti u vezi sa sigurnom primjenom lijeka i prevencijom izlaganja fetusa.“
English: This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this.
Croatian: Ta se nuspojava obično događa nakon što ste uzimali ovaj lijek nekoliko mjeseci, ali može se dogoditi i prije.
English: Consider reducing dose if symptoms worsen.
Croatian: Razmotriti smanjenje doze ako se simptomi pogoršaju.
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Croatian: Kontrolirani distribucijski sustav na razini države proveden je u suradnji sa svakim nadležnim nacionalnim tijelom.
English: • are associated with neuropathy such as other treatments for cancer.
Croatian: • povezani su uz neuropatiju kao što su druge terapije za rak.
English: The prescriber must ensure that:
Croatian: Propisivač mora osigurati:
English: If possible, take the medicine pack and this leaflet with you.
Croatian: Ako je moguće, ponesite sa sobom pakiranje lijeka i ovu uputu.
English: PVC/PCTFE/aluminium blister containing 14 capsules.
Croatian: PVC/PCTFE/aluminij blister koji sadrži 14 kapsula.
English: Grade 1 (paraesthesia, weakness and/or loss of reflexes) with no loss of function
Croatian: Stupanj 1 (parestezije, slabost i/ili gubitak refleksa) bez gubitka funkcije
English: • Having difficulty in seeing or speaking, which is temporary.
Croatian: • Teškoće s vidom ili govorom, što je prolazno.
English: Educational materials
Croatian: Edukacijski materijali
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Croatian: Pogledajte također i dodatne informacije u ovom dijelu pod naslovom „Upozorenja i mjere opreza“ i „Trudnoća i dojenje“.
English: The maximum plasma concentrations are reached 1-5 hours after administration.
Croatian: Maksimalne plazmatske koncentracije postižu se 1-5 sati nakon primjene.
English: You will have been given an educational brochure for patient by your doctor.
Croatian: Dobit ćete edukacijsku brošuru za bolesnike od svog liječnika.
English: Figure 1: Overall survival according to treatment
Croatian: Slika 1: Ukupno preživljenje uz liječenje
English: • Take this medicine by mouth.
Croatian: • Uzmite ovaj lijek na usta.
English: • more than 12 hours have passed: do not take your capsules.
Croatian: • prošlo je više od 12 sati: nemojte uzimati kapsule.
English: Always take Thalidomide Celgene exactly as your doctor or pharmacist has told you to.
Croatian: Uvijek uzmite Thalidomide Celgene točno onako kako Vam je rekao liječnik ili ljekarnik.
English: If you are able to become pregnant:
Croatian: Ako biste mogli zatrudnjeti:
English: Total systemic exposure (AUC) is proportional to dose at single-dose conditions.
Croatian: Ukupna sistemska izloženost (AUC) proporcionalna je dozi prilikom uvjeta pojedinačnog doziranja.
English: Grade 4 (neuropathy which is disabling)
Croatian: Stupanj 4 (neuropatija koja onesposobljava)
English: Multiple myeloma generally cannot be cured.
Croatian: Multipli mijelom najčešće se ne može izliječiti.
English: Children and adolescents Thalidomide Celgene is not recommended for use in children and young people under 18 years.
Croatian: Djeca i adolescenti Thalidomide Celgene ne preporučuje se za primjenu u djece i osoba mlađih od 18 godina.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: You will be more prone to bleeding and bruising.
Croatian: Bit ćete skloniji krvarenju i zadobivanju modrica.
English: In plasma, unchanged thalidomide represents 80 % of the circulatory components.
Croatian: U plazmi, nepromijenjeni talidomid predstavlja 80 % cirkulirajućih komponenti.
English: This belongs to a group of medicines which affect how your immune system works.
Croatian: Tvar pripada skupini lijekova koji utječu na rad Vašeg imunološkog sustava.
English: This includes medicines obtained without a prescription, including herbal medicines.
Croatian: To uključuje lijekove koje ste nabavili bez recepta, uključujući i biljne lijekove.
English: • less than 12 hours have passed: take your capsules immediately.
Croatian: • prošlo je manje od 12 sati: odmah uzmite kapsule.
English: This can damage the bone and kidneys.
Croatian: To može oštetiti kosti i bubrege.
English: • She understands the teratogenic risk to the unborn child
Croatian: • Razumije teratogeni rizik za nerođeno dijete.
English: • Core text as agreed by the CHMP
Croatian: • osnovnog teksta kao što je dogovoreno s CHMP-om
English: No specific dose recommendations for these patient populations are available.
Croatian: Nisu dostupne specifične preporuke o doziranju za ove populacije bolesnika.
English: You must stop treatment and inform your doctor straight away if:
Croatian: Morate prekinuti liječenje i odmah obavijestiti svog liječnika ako:
English: Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow.
Croatian: Vaš liječnik može provjeriti imate li veliku količinu tumora u tijelu, uključujući i koštanu srž.
English: However, dose reduction is not necessarily followed by improvement of symptoms.
Croatian: Međutim, smanjenje doze ne mora nužno biti popraćeno smanjenjem simptoma.
English: Capsules should not be opened or crushed (see section 6.6).
Croatian: Kapsule se ne smiju otvarati ni drobiti (vidjeti dio 6.6).
English: Survival time median ± se (month)
Croatian: Vrijeme preživljenja Medijan ± se (mjeseci)
English: If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment.
Croatian: Ako iskusite takve simptome, odmah se obratite liječniku koji može smanjiti dozu ili prekinuti liječenje.
English: What is multiple myeloma
Croatian: Što je multipli mijelom
English: Eighteen cases of overdose have been reported in the literature concerning doses up to 14.4 grams.
Croatian: U literaturi je prijavljeno osamnaest slučajeva predoziranja koji su se odnosili na doze do 14,4 grama.
English: • you do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice.
Croatian: • Ako ne razumijete savjet o kontracepciji koji ste dobili od svog liječnika ili niste u stanju pridržavati se tog savjeta.
English: • Educational brochures for patients: o The educational brochures for patients should be of 3 types:
Croatian: • edukacijske brošure za bolesnike: o edukacijske brošure za bolesnike trebaju biti 3 vrste:
English: In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
Croatian: U ispitivanju faze 3, medijan vremena do prve pojave neuropatije iznosio je 42,3 tjedna.
English: Therefore, do not have unprotected intercourse, even if you had a vasectomy.
Croatian: Zato ne smijete stupati u spolne odnose bez zaštite, čak i ako ste imali vazektomiju.
English: • if you are allergic to thalidomide or any of the other ingredients of this medicine listed in section 6 “Contents of the pack and other information”.
Croatian: • ako ste alergični na talidomid ili neki drugi sastojak ovog lijeka naveden u dijelu 6 pod naslovom „Sadržaj pakiranja i druge informacije“.
English: • The need for effective contraception
Croatian: • potreba za učinkovitom kontracepcijom
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost se definira 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 (ne može se procijeniti iz dostupnih podataka).
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Croatian: • spolni odnos samo s partnerom koji je podvrgnut vazektomiji; vazektomiju treba potvrditi dvjema negativnim analizama sperme
English: Time from randomization ( month )
Croatian: Vrijeme od randomizacije (mjeseci)
English: The majority of the radioactive dose was excreted within 48 hour following dose administration.
Croatian: Većina radioaktivne doze izlučena je unutar 48 sati nakon primjene doze.
English: Pregnancy testing
Croatian: Testiranje na trudnoću
English: Confusional state, Depression
Croatian: Stanje konfuzije, depresija
English: • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
Croatian: • zahtjev za prevencijom trudnoće, definiciju i potrebu za odgovarajućim metodama kontracepcije
English: • Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment.
Croatian: • sindrom lize tumora - metaboličke komplikacije koje mogu nastati tijekom liječenja raka, a ponekad čak i bez liječenja.
English: However, patients with age > 75 years are potentially at risk for a higher frequency of serious adverse reactions.
Croatian: Međutim, u bolesnika starijih od 75 godina postoji potencijalni rizik za veću učestalost ozbiljnih nuspojava.
English: A maximum number of 12 cycles of 6 weeks (42 days) should be used.
Croatian: Potrebno je provesti maksimalan broj od 12 ciklusa liječenja u pojedinačnom trajanju od 6 tjedana (42 dana).
English: In one 2-year-old child who took 700 mg, there was an abnormal plantar response in addition to drowsiness and irritability.
Croatian: U dvogodišnjeg djeteta koje je primilo 700 mg, javio se abnormalni plantarni odgovor povrh omamljenosti i razdražljivosti.
English: Follow-up and end of treatment
Croatian: Praćenje i završetak liječenja
English: It is not known whether the effect will be different in multiple myeloma patients.
Croatian: Nije poznato hoće li učinak biti drugačiji u bolesnika s multiplim mijelomom.
English: Unchanged thalidomide was a minor component (< 3 % of the dose) in urine.
Croatian: Nepromijenjeni talidomid bio je manja komponenta (< 3 % doze) u mokraći.
English: If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Croatian: Ako je proteklo više od 12 sati od propuštanja doze u uobičajeno vrijeme, bolesnik ne smije uzeti dozu, nego sljedeću dozu treba uzeti u uobičajeno vrijeme sljedećeg dana.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107. c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: No effects were observed in dogs; however in rats, there was an apparent dose-dependent decrease in total and free T4 that was more consistent in the female.
Croatian: Nikakav učinak nije primijećen u pasa; međutim, u štakora je bilo prisutno vidljivo smanjenje ukupnog i slobodnog T4 ovisno o dozi, a koje je bilo dosljednije u ženki.
English: However, combined hormonal contraceptives are not recommended due to the increased risk of venous thromboembolic disease.
Croatian: Međutim, kombinirani hormonski kontraceptivi ne preporučuju se zbog povećanog rizika od venske tromboembolijske bolesti.
English: Peripheral neuropathy generally occurs following chronic use over a period of months.
Croatian: Periferna neuropatija se obično javlja nakon kronične uporabe lijeka tijekom nekoliko mjeseci.
English: • you have had a heart attack, have ever had a blood clot in the past, or if you smoke, have high blood pressure or high cholesterol levels.
Croatian: • Ako ste imali srčani udar, ako ste ikada u prošlosti imali krvni ugrušak ili ako pušite, imate povišeni krvni tlak ili visoke razine kolesterola.
English: The relevance to humans is unknown.
Croatian: Važnost tih nalaza za ljude nije poznata.
English: Thalidomide Celgene works by helping the body's immune system and directly attacking the cancer.
Croatian: Thalidomide Celgene djeluje tako da pomaže imunološkom sustavu tijela i izravno napada rak.
English: How much to take
Croatian: Koliko lijeka morate uzeti
English: Multiple myeloma is a type of cancer which affects a certain type of white blood cell, called the plasma cell.
Croatian: Multipli mijelom je vrsta raka koja pogađa određenu vrstu bijelih krvnih stanica pod nazivom plazma stanice.
English: • Swelling of hands and feet.
Croatian: • oticanje šaka i stopala
English: If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
Croatian: Ako je proteklo manje od 12 sati od propuštanja doze, bolesnik može uzeti dozu.
English: Grade 2 (interfering with function but not with activities of daily living)
Croatian: Stupanj 2 (utjecaj na funkcioniranje, ali ne i na svakodnevne aktivnosti)
English: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Croatian: • Vam je izostala menstruacija ili mislite da je izostala ili imate neuobičajena menstrualna krvarenja ili sumnjate da ste trudni.
English: Reduce dose or interrupt treatment and continue to monitor the patient with clinical and neurological examination.
Croatian: Smanjiti dozu ili prekinuti liječenje i nastaviti nadzirati bolesnika putem kliničkih i neuroloških pregleda.
English: • She is informed and understands the potential consequences of pregnancy and the need to rapidly consult her doctor if there is a risk of pregnancy
Croatian: • Informirana je i shvaća moguće posljedice trudnoće i potrebu za hitnim savjetovanjem sa svojim liječnikom u slučaju rizika od trudnoće.
English: The spectrum of activity of thalidomide is not fully characterised.
Croatian: Spektar aktivnosti talidomida nije potpuno okarakteriziran.
English: In this study the age range of patients was 65-75 years, with 41 % (183/447) of patients 70 years old or older.
Croatian: U ispitivanju je raspon dobi bolesnika iznosio 65-75 godina s 41 % (183/447) bolesnika u dobi od 70 godina i starijih.
English: Do not apply pressure on the centre of the capsule as this can cause it to break.
Croatian: Nemojte kapsulu pritiskati na sredini jer je tako možete razlomiti.
English: If a patient is currently using combined oral contraception, she should switch to one of the effective methods listed above.
Croatian: Ako bolesnica trenutno koristi kombiniranu oralnu kontracepciju, treba je zamijeniti nekom od prethodno navedenih učinkovitih metoda.
English: • Implant
Croatian: • implantat
English: The median dose of thalidomide was 217 mg and > 40 % of patients received 9 cycles.
Croatian: Medijan doze talidomida iznosio je 217 mg i > 40 % bolesnika primilo je 9 ciklusa.
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Croatian: Rizik od venske tromboembolije postoji narednih 4-6 tjedana nakon prekida uzimanja kombiniranih oralnih kontraceptiva.
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all male and female patients.
Croatian: Uvjete Programa prevencije trudnoće moraju ispuniti svi bolesnici i bolesnice.
English: Patients should be instructed to avoid situations where somnolence may be a problem and to seek medical advice before taking other medicinal products known to cause somnolence.
Croatian: Bolesnike je potrebno savjetovati da izbjegavaju situacije u kojima somnolencija može biti problem te da potraže liječnički savjet prije uzimanja drugih lijekova za koje je poznato da prouzročuju somnolenciju.
English: In thirteen of these cases, patients took thalidomide alone; amounts ranged from 350 mg to 4000 mg.
Croatian: U trinaest od navedenih slučajeva, bolesnici su uzimali samo talidomid; količine su varirale od 350 mg do 4000 mg.