FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with thalidomide in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja talidomida u svim podskupinama pedijatrijske populacije za multipli mijelom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Maximum duration of treatment prescribed o 4 weeks of treatment for women with childbearing potential o 12 weeks of treatment for men and women without childbearing potential
Croatian: • maksimalno trajanje liječenja po receptu o 4 tjedna liječenja za žene u reproduktivnoj dobi o 12 tjedana liječenja za muškarce i žene bez reproduktivnog potencijala
English: In addition, single dose administration of 0.5 mg digoxin had no apparent effect on thalidomide pharmacokinetics.
Croatian: Pored toga, primjena pojedinačne doze od 0,5 mg digoksina nije imala očitog učinka na farmakokinetiku talidomida.
English: This includes sedatives (such as anxiolytics, hypnotics, antipsychotics, H1 antihistamines, opiate derivatives and barbiturates).
Croatian: To uključuje sedative (kao što su anksiolitici, hipnotici, antipsihotici, H1 antihistaminici, opioidni derivati i barbiturati).
English: Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products that are inhibitors and/or inducers of this enzyme system are unlikely.
Croatian: Talidomid je slabi supstrat za izoenzime citokroma P450 pa stoga nisu vjerojatne klinički važne interakcije s lijekovima koji su inhibitori i/ili induktori ovog sustava enzima.
English: • Depression, confusion, mood changes, anxiety.
Croatian: • depresija, smetenost, promjene raspoloženja, tjeskoba
English: Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts:
Croatian: Pismo zdravstvenim radnicima Pismo zdravstvenim djelatnicima sastojat će se od dva dijela:
English: This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5 % confidence interval of 0.42-0.84 and p-value of < 0.001 (see Figure 1).
Croatian: Razlika od 18 mjeseci bila je statistički značajna uz omjer hazarda za smanjenje rizika od smrti u skupini MPT od 0,59, 97,5 % interval pouzdanosti od 0,42 do 0,84 i p-vrijednost od < 0,001 (vidjeti sliku 1).
English: Animal studies have demonstrated differences in species susceptibility to the teratogenic effects of thalidomide.
Croatian: Ispitivanja na životinjama pokazala su razlike u osjetljivosti vrsta na teratogene učinke talidomida.
English: • Hypersensitivity to thalidomide or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na talidomid ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The majority of the reactions occurred within the first 2 months of therapy and resolved spontaneously without treatment after thalidomide discontinuation.
Croatian: Većina nuspojava nastupila je unutar prva 2 mjeseca terapije i nestala je spontano, bez liječenja, nakon prekida terapije talidomidom.
English: The median overall survival (OS) was 51.6 ± 4.5 and 33.2 ± 3.2 months in the MPT and MP groups, respectively (97.5 % CI 0.42 to 0.84).
Croatian: Medijan ukupnog preživljenja iznosio je 51,6 ± 4,5 mjeseci odnosno 33,2 ± 3,2 u skupinama MPT i MP (97,5 %, CI 0,42 do 0,84).
English: • Women who are pregnant (see section 4.6).
Croatian: • Trudnice (vidjeti dio 4.6).
English: The recommended dose of thalidomide is 200 mg orally per day.
Croatian: Preporučena doza talidomida iznosi 200 mg peroralno na dan.
English: No fatalities have been reported and all overdose patients recovered without sequelae.
Croatian: Nisu prijavljeni smrtni slučajevi te su se svi predozirani bolesnici oporavili bez posljedica.
English: Do not use this medicine after the expiry date which is stated on the wallet card and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskom ovitku i blisteru iza oznake „EXP“.
English: Thromboprophylaxis and dosing/anticoagulation therapy recommendations are provided in section 4.2.
Croatian: Preporuke za tromboprofilaksu i doziranje/terapiju antikoagulansima nalaze se u dijelu 4.2.
English: Cardiac failure, Bradycardia
Croatian: Zatajenje srca, bradikardija
English: Previous history of thromboembolic events or concomitant administration of erythropoietic agents or other agents such as hormone replacement therapy, may also increase thromboembolic risk in these patients.
Croatian: Prethodna anamneza tromboembolijskih događaja ili istodobna primjena lijekova koji potiču eritropoezu ili drugih lijekova poput hormonske nadomjesne terapije, može također povećati tromboembolijski rizik u ovih bolesnika.
English: Extremely intense and serious skin reactions.
Croatian: • Vrlo jake i ozbiljne kožne reakcije.
English: There is no specific antidote for a thalidomide overdose.
Croatian: Nema specifičnog antidota za predoziranje talidomidom.
English: Patients must follow the Thalidomide Celgene Pregnancy Prevention Programme.
Croatian: Bolesnici se moraju pridržavati Programa prevencije trudnoće za Thalidomide Celgene.
English: Do not breastfeed when taking Thalidomide Celgene as it is not known if thalidomide is passed into human breast milk.
Croatian: Nemojte dojiti dok uzimate Thalidomide Celgene jer nije poznato prelazi li talidomid u majčino mlijeko.
English: Myocardial infarction (MI) has been reported in patients receiving thalidomide, particularly in those with known risk factors.
Croatian: Infarkt miokarda (IM) prijavljen je u bolesnika koji su primali talidomid, posebice u onih s poznatim čimbenicima rizika.
English: If not established on effective contraception, the patient must be referred preferably to an appropriately trained healthcare professional for contraceptive advice in order that contraception can be initiated.
Croatian: Ako za bolesnika nije utvrđena učinkovita kontracepcija, bolesnika se mora uputiti odgovarajuće osposobljenom zdravstvenom radniku po savjet o kontracepciji kako bi je bolesnik mogao početi upotrebljavati.
English: • you have experienced sleepiness.
Croatian: • Ako ste osjećali pospanost.
English: Prophylactic antithrombotic medicinal products, such as low molecular weight heparins or warfarin, should be recommended.
Croatian: Treba preporučiti primjenu profilaktičkih antitrombotika poput heparina niske molekularne mase ili varfarina.
English: This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier.
Croatian: Alkohol Vas može učiniti pospanima, a Thalidomide Celgene može tu pospanost pojačati.
English: • Pregnancy testing requirements ▪ Advice on suitable tests ▪ Frequency (before commencing, monthly during treatment and after finishing treatment)
Croatian: • zahtjevi za testove na trudnoću: savjeti o prikladnim testovima učestalost (prije početka liječenja, mjesečno tijekom liječenja i nakon završetka liječenja)
English: • by stopping the cancer cells developing
Croatian: • zaustavljanjem razvoja stanica raka
English: Amenorrhea during thalidomide therapy should be assumed to result from pregnancy, until it is medically confirmed that the patient is not pregnant.
Croatian: Treba pretpostaviti da je amenoreja tijekom liječenja talidomidom povezana s trudnoćom, sve dok se medicinski ne potvrdi da bolesnica nije trudna.
English: Thalidomide Celgene has not formally been studied in patients with impaired renal or hepatic function.
Croatian: Thalidomide Celgene nije službeno proučavan u bolesnika s oštećenom funkcijom bubrega ili jetre.
English: The majority of the reported cases had recognized risk factors for PRES/RPLS, including hypertension, renal impairment and concomitant use of high dose corticosteroids and/or chemotherapy.
Croatian: U većini prijavljenih slučajeva bili su prepoznati čimbenici rizika za PRES/RPLS uključujući hipertenziju, oštećenje funkcije bubrega i istodobnu primjenu visokih doza kortikosteroida i/ili kemoterapije.
English: No mutagenic or genotoxic effect has been revealed when thalidomide was assayed in a standard battery of genotoxicity tests.
Croatian: Nije otkriven mutagen ili genotoksičan učinak prilikom ispitivanja talidomida u seriji standardnih testova genotoksičnosti.
English: Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Croatian: Thalidomide Celgene se propisuje i izdaje u skladu s Programom prevencije trudnoće za Thalidomide Celgene (vidjeti dio 4.4).
English: Thalidomide is also a non-barbiturate centrally active hypnotic sedative.
Croatian: Talidomid je također i nebarbituratni hipnotički sedativ sa središnjim djelovanjem.
English: Medicinal products known to cause peripheral neuropathy Medicinal products known to be associated with peripheral neuropathy (e.g. vincristine and bortezomib) should be used with caution in patients receiving thalidomide.
Croatian: Lijekovi za koje je poznato da izazivaju perifernu neuropatiju Lijekove za koje je poznato da su povezani s perifernom neuropatijom (npr. vinkristin i bortezomib) potrebno je primjenjivati s oprezom u bolesnika koji primaju talidomid.
English: This decrease did not result in clinical signs.
Croatian: Pad broja trombocita nije se očitovao kliničkim znakovima.
English: It is recommended to press only on one end of the capsule to remove it from the blister, thereby reducing the risk of capsule deformation or breakage.
Croatian: Pri vađenju kapsule iz blistera preporučuje se pritisnuti samo jedan kraj kapsule, čime se smanjuje rizik od deformacije ili lomljenja kapsule.
English: Thalidomide Celgene is taken daily in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
Croatian: Thalidomide Celgene uzima se dnevno u ciklusima liječenja, svaki ciklus traje 6 tjedana, u kombinaciji s melfalanom i prednizonom koji se uzimaju od 1. do 4. dana svakog ciklusa od 6 tjedana.
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma (MM), combined oral contraceptive pills are not recommended (see section 4.5).
Croatian: Zbog povećanog rizika od venske tromboembolije u bolesnika s multiplim mijelomom (MM), ne preporučuju se kombinirane peroralne kontracepcijske tablete (vidjeti dio 4.5).
English: Peripheral neuropathy*, Tremor, Dizziness, Paraesthesia, Dysaesthesia, Somnolence
Croatian: Periferna neuropatija*, tremor, omaglica, parestezije, dizestezija, somnolencija
English: (For description of symptoms see section 4 “Possible side effects”).
Croatian: (Opis simptoma pogledajte u dijelu 4 „Moguće nuspojave“).
English: In documented case reports with hormone evaluation, the event of amenorrhoea was associated with decreased estradiol levels and elevated FSH/LH levels.
Croatian: U dokumentiranim slučajevima s procjenom hormonskog statusa, amenoreja je bila povezana sa smanjenom razinom estradiola i povišenim razinama FSH/LH.
English: • Previous bilateral salpingo-oophorectomy, or hysterectomy.
Croatian: • Prethodna obostrana salpingoovariektomija ili histerektomija.
English: The latter appears to be related to thalidomide and occurred at exposures greater than 2.4-fold the human exposure.
Croatian: Čini se da je potonji događaj povezan s talidomidom i javlja se pri ekspozicijama više od 2,4 puta većim od ekspozicija u ljudi.
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and/or dispensing controls, and the collecting of detailed data relating to the indication in order to monitor closely the off-label use within the national territory.
Croatian: Kontrolirani distribucijski sustav uključuje primjenu kartice za bolesnike i/ili odgovarajući alat za propisivanje i/ili kontrolu izdavanja, kao i za prikupljanje detaljnih podataka o indikaciji kako bi se pažljivo pratila primjena izvan odobrenih indikacija unutar teritorija pojedine države.
English: Platelet counts should be monitored on an ongoing basis, in accordance with oncology guidelines.
Croatian: Potrebno je redovito praćenje broja trombocita u skladu s onkološkim smjernicama.
English: The use of thalidomide could be associated with menstrual disorders including amenorrhea.
Croatian: Primjena talidomida može biti povezana s poremećajima menstrualnog ciklusa, uključujući amenoreju.
English: These may be symptoms of a heart attack/myocardial infarction (which may be due to blood clots in the arteries of your heart).
Croatian: To mogu biti simptomi srčanog udara/infarkta miokarda (što može biti zbog krvnih ugrušaka u arterijama srca).
English: When provided, antiovary antibodies were negative and prolactin level was within the normal range.
Croatian: U dostupnim nalazima protutijela na jajnike bila su negativna, a razina prolaktina bila je unutar normalnog raspona.
English: In 18 healthy male volunteers, multiple dose administration of 200 mg thalidomide had no apparent effect on the single dose pharmacokinetics of digoxin.
Croatian: U 18 zdravih muških dobrovoljaca, primjena višekratne doze od 200 mg talidomida nije imala očiti učinak na farmakokinetiku pojedinačne doze digoksina.
English: If you forget to take Thalidomide Celgene at your regular time and
Croatian: Ako ste zaboravili uzeti Thalidomide Celgene Ako ste zaboravili uzeti Thalidomide Celgene u svoje redovno vrijeme, a
English: It is recommended that clinical and neurological examinations are performed in patients prior to starting thalidomide therapy, and that routine monitoring is carried out regularly during treatment.
Croatian: Preporučuju se klinički i neurološki pregledi bolesnika prije početka liječenja talidomidom te redovito provođenje rutinskog nadzora tijekom liječenja.
English: • Treatment initiation forms and/or equivalent tool
Croatian: • obrasce za početak liječenja i/ili ekvivalentne materijale
English: Thalidomide Celgene as per the recommended posology has minor or moderate influence on the ability to drive and use machines.
Croatian: Thalidomide Celgene prema preporučenom doziranju malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Severe skin reactions
Croatian: Teške kožne reakcije
English: Educational Healthcare Professional's Kit The Educational Healthcare Professional's Kit shall contain the following elements:
Croatian: Edukacijski materijal za zdravstvene radnike Edukacijski materijal za zdravstvene radnike sadržavat će sljedeće elemente:
English: The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years.
Croatian: Preporučena doza je 200 mg (4 x 50 mg kapsule) na dan za odrasle u dobi od 75 godina ili manje te 100 mg (2 x 50 mg kapsule) na dan za osobe starije od 75 godina.
English: • Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Croatian: • Prije stavljanja lijeka na tržište svi liječnici i ljekarnici koji namjeravaju propisivati ili izdavati Thalidomide Celgene primiti Pismo zdravstvenim radnicima kako je to opisano u nastavku.
English: Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
Croatian: Nemojte voziti ili koristiti bilo kakve alate ili strojeve ako osjećate nuspojave poput omaglice, umora, pospanosti ili zamućenog vida.
English: • Decreased or abnormal sensation (dysaesthesia).
Croatian: • smanjeni ili neuobičajeni osjet (dizestezija)
English: Warfarin
Croatian: Varfarin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKI OVITAK
English: White blood cell count and differential should be monitored on an ongoing basis, in accordance with oncology guidelines, especially in patients who may be more prone to neutropenia.
Croatian: Potrebno je redovito praćenje broja leukocita i diferencijalne krve slike u skladu s onkološkim smjernicama, a osobito u bolesnika koji su možda skloniji neutropeniji.
English: Careful monitoring of patients for symptoms of neuropathy is recommended.
Croatian: Preporučuje se pažljivo praćenje bolesnika zbog moguće pojave simptoma neuropatije.
English: * WHO Criteria
Croatian: * kriteriji SZO
English: • Pain or swelling in your legs, especially in your lower leg or calves.
Croatian: • Bol ili oticanje u nogama, posebice u potkoljenicama ili listovima.
English: If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene.
Croatian: Ako niste sigurni, razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Thalidomide Celgene.
English: Patients should be monitored for syncope, bradycardia and atrioventricular block; dose reduction or discontinuation may be required.
Croatian: Bolesnike je potrebno nadzirati zbog moguće pojave sinkope, bradikardije i atrioventrikularnog bloka; možda će biti potrebno smanjenje doze ili prekid liječenja.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Croatian: Bolesnike je potrebno savjetovati da potraže liječničku pomoć ako razviju simptome poput nedostatka zraka, bolova u prsištu, oticanja ruke ili noge.
English: As thalidomide is found in semen, as a precaution all male patients taking thalidomide must meet the following conditions:
Croatian: S obzirom na činjenicu da se talidomid može naći u spermi, kao mjera opreza, svaki muški bolesnik koji uzima talidomid mora ispunjavati sljedeće uvjete:
English: Vomiting, Dry mouth
Croatian: Povraćanje, suhoća usta
English: Pups from mothers treated with thalidomide had increased abortions, reduced body weight gain, alterations in learning and memory, decreased fertility, and reduced pregnancy index.
Croatian: Mladunčad majki koje su primile talidomid imala je povećanu stopu pobačaja, smanjenu tjelesnu težinu, promjene u procesima učenja i pamćenja, smanjenu plodnost i smanjen indeks gravidnosti.
English: • XY genotype, Turner's syndrome, uterine agenesis.
Croatian: • XY genotip, Turnerov sindrom, ageneza maternice.
English: What Thalidomide Celgene looks like and contents of the pack Thalidomide Celgene are white hard capsules marked “Thalidomide Celgene 50 mg”.
Croatian: Kako Thalidomide Celgene izgleda i sadržaj pakiranja Thalidomide Celgene su bijele tvrde kapsule s oznakom „Thalidomide Celgene 50 mg“.
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology
Croatian: • knjižicu za zdravstvene radnike o povijest talidomida, temeljne podatke o Thalidomide Celgeneu i njegovim odobrenim indikacijama o doziranje
English: Signs and symptoms included visual disturbance, headache, seizures and altered mental status, with or without associated hypertension.
Croatian: Znakovi i simptomi uključivali su poremećaj vida, glavobolju, napadaje i promijenjen mentalni status, s pridruženom hipertenzijom ili bez nje.
English: The effect of thalidomide on thyroid function was assessed in both rats and dogs.
Croatian: Učinak talidomida na funkciju štitne žlijezde procijenjen je u štakora i pasa.
English: Due to thalidomide's potential to induce bradycardia, caution should be exercised with medicinal products having the same pharmacodynamic effect such as active substances known to induce torsade de pointes, beta blockers or anticholinesterase agents.
Croatian: Zbog potencijala talidomida da prouzroči bradikardiju potreban je oprez s lijekovima koji imaju isti farmakodinamički učinak, kao što su djelatne tvari za koje je poznato da induciraju aritmiju torsade de pointes, beta blokatori ili antikolinergici.
English: On the basis of the scientific conclusions for thalidomide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing thalidomide is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za talidomid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) talidomid nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The prescriber must inform male and female patients about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate educational brochure for patients, patient card and/or equivalent tool in accordance to the national implemented patient card system.
Croatian: Liječnik koji propisuje lijek mora obavijestiti pacijente i pacijentice o očekivanom teratogenom riziku i o strogim mjerama prevencije trudnoće koji su navedeni u Programu prevencije trudnoće te dati bolesnicima odgovarajuću edukacijsku brošuru za bolesnike, karticu za bolesnika i/ili odgovarajući alat u skladu s nacionalnim sustavom provedbe kartica za bolesnike.
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Croatian: Bolesnike je potrebno savjetovati da nikada ne daju svoj lijek drugoj osobi te da sve neiskorištene kapsule vrate svom ljekarniku po završetku liječenja.
English: For all other patients, prescriptions of thalidomide should be limited to a maximum of 12 weeks of treatment and continuation of treatment requires a new prescription.
Croatian: Za sve druge bolesnike, recepte za talidomid potrebno je ograničiti na najviše 12 tjedana liječenja, tako da nastavak liječenja zahtijeva novi recept.
English: However, due to the increased risk of thrombosis in cancer patients, and a potentially accelerated metabolism of warfarin with corticosteroids, close monitoring of INR values is advised during thalidomide-prednisone combination treatment as well as during the first weeks after ending these treatments.
Croatian: Međutim, zbog povećanog rizika od tromboze u bolesnika s karcinomom i potencijalno ubrzanog metabolizma varfarina u kombinaciji s kortikosteroidima, preporučuje se pomno praćenje vrijednosti INR-a tijekom liječenja kombinacijom talidomida i prednizona kao i tijekom prvih tjedana nakon završetka liječenja.
English: For patients > 75 years of age, the thalidomide recommended starting dose is 100 mg per day.
Croatian: Za bolesnike starije od 75 godina, preporučena početna doza talidomida je 100 mg na dan.
English: • He understands the teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential.
Croatian: • Razumije teratogeni rizik u slučaju spolnog odnosa s trudnicom ili ženom u reproduktivnoj dobi.
English: Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide Celgene (see also section 4 “Possible side effects”).
Croatian: Vaš liječnik treba procijeniti ako razvijete dodatne vrste hematoloških zloćudnih bolesti (nazvane akutna mijeloična leukemija i mijelodisplastični sindromi) tijekom primjene lijeka Thalidomide Celgene (vidjeti također dio 4 „Moguće nuspojave“).
English: No specific pattern was identified between hepatocellular and cholestatic abnormalities, with some cases having a mixed presentation.
Croatian: Između hepatocelularnih i kolestatskih abnormalnosti nije nađen specifični obrazac, a u nekim je slučajevima postojao njihov miješani oblik.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o Procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
Croatian: • specifičnih državnih zahtjeva dogovorenih s nadležnim državnim tijelom u svezi s: o distribucijom lijeka o postupcima za osiguravanje poduzimanja svih odgovarajućih mjera prije početka izdavanja talidomida.