FrancophonIA/ELRC3.0 huggingface dataset:
English: These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.
Croatian: Ove komplikacije posljedica su raspada umirućih stanica raka i mogu uključivati sljedeće: promjene u biokemijskom sastavu krvi; povišeni kalij, fosfor i mokraćnu kiselinu te sniženi kalcij što posljedično vodi do promjena u funkciji bubrega, srčanom ritmu, do napadaja i ponekad smrti.
English: Most patients taking thalidomide can be expected to experience adverse reactions.
Croatian: Očekuje se da će većina bolesnika koja uzima talidomid iskusiti nuspojave.
English: Thalidomide is a powerful human teratogen, inducing a high frequency of severe and lifethreatening birth defects.
Croatian: Talidomid je snažan humani teratogen koji inducira visoku učestalost teških i po život opasnih urođenih anomalija.
English: • The collection of detailed data to understand demographics of target population, indication and number of women of child bearing potential in order to monitor closely the off-label use within national territory.
Croatian: • prikupljanje detaljnih podataka radi razumijevanja demografskih podataka ciljne populacije, indikacije i broja žena u reproduktivnoj dobi kako bi se pomno pratila primjena lijeka izvan odobrenih indikacija unutar teritorija pojedine države
English: Patients with severe organ impairment should be carefully monitored for adverse reactions.
Croatian: Bolesnike s teškim oštećenjem organa potrebno je pažljivo pratiti zbog mogućih nuspojava.
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the body which can lead to kidneys failure (this condition is called Tumour Lysis Syndrome) (see also section 4 “Possible side effects”).
Croatian: To može dovesti do stanja u kojem se tumori razgrađuju i uzrokuju nenormalne razine kemijskih tvari u tijelu što za posljedicu može imati zatajenje bubrega (to stanje zove se sindrom lize tumora) (vidjeti također dio 4 „Moguće nuspojave”).
English: • Levonorgestrel-releasing intrauterine system (IUS)
Croatian: • intrauterini sustav za otpuštanje levonorgestrela (intrauterini uložak)
English: If powder from thalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Croatian: Ako prašak talidomida dođe u kontakt s kožom, kožu treba odmah temeljito oprati vodom i sapunom.
English: If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide.
Croatian: Ako ne razumijete u potpunosti te upute, obratite se svom liječniku kako bi Vam ih ponovno rastumačio prije nego što uzmete talidomid.
English: • That he should not share the treatment with any other person
Croatian: • da ne smije davati svoj lijek drugim osobama
English: (see sections 4.2 and 4.8).
Croatian: (vidjeti dijelove 4.4 i 4.6).
English: Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors.
Croatian: Potrebno je primjenjivati tromboprofilaksu tijekom najmanje prvih 5 mjeseci liječenja, posebice u bolesnika s dodatnim čimbenicima rizika za razvoj tromboze.
English: Particularly, a haemoglobin concentration above 12g/dl should lead to discontinuation of erythropoietic agents.
Croatian: Točnije, pri koncentracijama hemoglobina iznad 12 g/dl potrebno je prekinuti liječenje lijekovima koji potiču eritropoezu.
English: These patients either exhibited no symptoms or exhibited symptoms of drowsiness, irritability, “sickness,” and/or headache.
Croatian: Ti bolesnici nisu imali simptome ili su imali simptome omamljenosti, razdražljivosti, mučnine i/ili glavobolje.
English: Some of the cases of herpes zoster reactivation resulted in disseminated herpes zoster, requiring a temporary hold of the treatment with thalidomide and adequate antiviral treatment.
Croatian: Neki od slučajeva reaktivacije herpes zostera rezultirali su širenjem herpes zostera, što je zahtijevalo privremeni prekid liječenja talidomidom i odgovarajuće antivirusno liječenje.
English: A study in rabbits demonstrated no effect on fertility indices in males or females although testicular degeneration was observed in males.
Croatian: Ispitivanje na kunićima nije pokazalo učinak na pokazatelje plodnosti u mužjaka ili ženki, iako je u mužjaka opažena degeneracija testisa.
English: The adverse reaction of the skin may appear as rashes with or without blisters.
Croatian: Nuspojave na koži mogu se pojaviti kao osip, s mjehurićima ili bez njih.
English: Patients should be monitored and dose reduction may be required.
Croatian: Bolesnike je potrebno nadzirati te može biti potrebno smanjenje doze.
English: In humans, thalidomide is a proven teratogen.
Croatian: Talidomid je u ljudi dokazano teratogen.
English: It is used in people who have recently been diagnosed and who have not been prescribed another medicine for their multiple myeloma before who are aged 65 years and over, or aged less than 65 years who cannot be treated with high dose chemotherapy, which can be very difficult for the body to handle.
Croatian: Primjenjuje se u osoba u dobi od 65 godina i starijih kojima je tek nedavno dijagnosticiran multipli mijelom i kojima prije nije bio propisan neki drugi lijek za liječenje multiplog mijeloma ili u osoba u dobi manjoj od 65 godina koji ne mogu primati kemoterapiju visokih doza kakve tijelo obično vrlo teško podnosi.
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Croatian: Bolesnici s rizikom od sindroma lize tumora jesu oni koji imaju veliko opterećenje tumorskom masom prije liječenja.
English: For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Croatian: Prije početka liječenja trebate se obratiti svom liječniku ako biste mogli zatrudnjeti, čak i ako mislite da to nije vjerojatno.
English: Criteria for women of non-childbearing potential
Croatian: Kriteriji za žene koje nisu u reproduktivnoj dobi
English: • Safety advice relevant to all patients o Description and management of ischaemic heart disease (including myocardial infarction) o Disposal of unwanted medicinal product o Not to donate blood during treatment (including during dose interruptions) and for at least 7 days following discontinuation of thalidomide
Croatian: • sigurnosne savjete koji vrijede za sve bolesnike o opis i zbrinjavanje ishemijske bolesti srca (uključujući infarkt miokarda) o zbrinjavanje neželjenog lijeka o zabrana darivanja krvi tijekom liječenja (uključujući tijekom pauza u uzimanju lijeka) i još najmanje 7 dana nakon završetka liječenja talidomidom
English: If the patient experiences peripheral neuropathy, follow the dose and schedule modification instruction provided in section 4.2.
Croatian: Ako se u bolesnika razvije periferna neuropatija, potrebno je pridržavati se uputa o promjenama doze i režima doziranja lijeka koje se nalaze u dijelu 4.2.
English: If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.
Croatian: Ako zatrudnite tijekom liječenja talidomidom, morate prekinuti liječenje i odmah obavijestiti svog liječnika.
English: Patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with thalidomide if they feel tired, dizzy, sleepy or have blurred vison.
Croatian: Bolesnike je potrebno upozoriti da ne upravljaju vozilima i strojevima ili da ne obavljaju opasne zadatke tijekom liječenja talidomidom ako osjećaju umor, omaglicu, pospanost ili imaju zamućen vid.
English: • Teratogenicity and the need to avoid foetal exposure
Croatian: • teratogenost i potrebu za izbjegavanjem fetalne izloženosti
English: A peri- and postnatal toxicity study performed in rabbits with thalidomide administered at doses up to 500 mg/kg/day resulted in abortions, increased stillbirths and decreased pup viability during lactation.
Croatian: Ispitivanja perinatalne i postnatalne toksičnosti provedena na kunićima uz primjenu talidomida u dozama do 500 mg/kg/dan rezultirala su pobačajima, povećanim brojem mrtvorođene mladunčadi i smanjenom sposobnošću preživljenja mladunčadi u razdoblju sisanja.
English: There is a linear relationship between body weight and estimated thalidomide clearance; in multiple myeloma patients with body weight from 47-133 kg, thalidomide clearance ranged from approximately 6-12 L/h, representing an increase in thalidomide clearance of 0.621 L/h per 10 kg body weight increase.
Croatian: Postoji linearni odnos između tjelesne težine i procijenjenog klirensa talidomida; u bolesnika s multiplim mijelomom s tjelesnom težinom od 47-133 kg, klirens talidomida bio je u rasponu od približno 6-12 l/h, prikazujući tako porast u klirensu od 0,621 l/h pri porastu tjelesne težine od 10 kg.
English: If you are pregnant, you must not take Thalidomide Celgene.
Croatian: Ako ste trudni, ne smijete uzimati Thalidomide Celgene.
English: This may be due to blood clots in the arteries leading to your lungs (called ‘pulmonary embolism'), which is a common side effect.
Croatian: To može biti zbog krvnih ugrušaka u arterijama koje dovode krv u Vaša pluća (stanje zvano „plućna embolija“), što je česta nuspojava.
English: • Women of childbearing potential unless all the conditions of the Pregnancy Prevention
Croatian: • Žene u reproduktivnoj dobi, osim ako ispunjavaju sve uvjete iz Programa prevencije trudnoće
English: Decreased platelet counts were noted in the mouse and rat studies.
Croatian: Pad broja trombocita zabilježen je u ispitivanjima na miševima i štakorima.
English: Acute myeloid leukaemia*
Croatian: Akutna mijeloična leukemija*,^
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti u više od 1 od 10 osoba)
English: There is no relevant use of Thalidomide Celgene in the paediatric population in the indication of multiple myeloma.
Croatian: Nema relevantne primjene Thalidomide Celgenea u pedijatrijskoj populaciji za liječenje multiplog mijeloma.
English: The results were similar with and without co-administration of thalidomide 200 mg/day to steady-state levels.
Croatian: Rezultati su bili slični sa ili bez istodobne primjene talidomida u dozi od 200 mg/dan do razina stanja dinamičke ravnoteže.
English: Caution should be used when thalidomide is given in combination with medicinal products that cause drowsiness.
Croatian: Potreban je oprez prilikom primjene talidomida u kombinaciji s lijekovima koji prouzročuju omamljenost.
English: Venous and arterial thromboembolic events
Croatian: Venski i arterijski tromboembolijski događaji
English: Very Common
Croatian: Vrlo često
English: Thalidomide Celgene is used with two other medicines called ‘melphalan' and ‘prednisone' to treat adults with a type of cancer called multiple myeloma.
Croatian: Thalidomide Celgene se primjenjuje s druga dva lijeka pod nazivom 'melfalan' i 'prednizon' za liječenje vrste raka koja se naziva multipli mijelom, u odraslih bolesnika.
English: Details of the PPP should be agreed wth the National Competent Authorities in each Member State and put in place prior to the launch of the medicinal product.
Croatian: Pojedinosti PPP-a treba dogovoriti s nadležnim državnim tijelima u svakoj državi članici i isti ustrojiti prije stavljanja lijeka u promet.
English: Non-enzymatic hydrolysis of thalidomide, being the primary clearance mechanism, suggests that the potential for drug-drug interactions with thalidomide is low.
Croatian: Neenzimatska hidroliza talidomida kao primarni mehanizam klirensa, upućuje na to da je potencijal za interakcije lijekova s talidomidom nizak.
English: At the end of your treatment you should return all unused capsules to the pharmacist or doctor.
Croatian: Po završetku liječenja morate sve neiskorištene kapsule vratiti ljekarniku ili liječniku.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI
English: • The patient complies with the conditions of the Pregnancy Prevention Programme including confirmation that she has an adequate level of understanding
Croatian: Programa prevencije trudnoće uključujući potvrdu da ima odgovarajući stupanj razumijevanja.
English: Measures of renal function (CrCl) and liver function (blood chemistry) indicate minimal effect of kidney and liver function on the pharmacokinetics of thalidomide.
Croatian: Mjere funkcije bubrega (CrCl) i funkcije jetre (biokemijske pretrage krvi) upućuju na minimalne učinke funkcije bubrega i jetre na farmakokinetiku talidomida.
English: • slow the heart rate (induce bradycardia, such as anticholinesterases and beta blockers).
Croatian: • usporavaju srčane otkucaje (izazivaju bradikardiju, poput inhibitora kolinesteraza i beta blokatora).
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
English: During the treatment with Thalidomide Celgene you have an increased risk of developing blood clots in the veins and arteries (see also section 4 “Possible side effects”).
Croatian: Tijekom liječenja lijekom Thalidomide Celgene imate povećani rizik od nastanka krvnog ugruška u venama i arterijama (vidjeti također dio 4 „Moguće nuspojave“).
English: In addition to thalidomide, hydrolytic products N-(o-carboxybenzoyl) glutarimide and phthaloyl isoglutamine formed via non-enzymatic processes are also present in plasma and in majority in urine.
Croatian: Pored talidomida, u plazmi su također prisutni i hidrolitički produkti N-(o-karboksibenzoil) glutarimid i ftaloil izoglutamin koji se stvaraju neenzimatskim procesima, a u mokraći su većinska komponenta.
English: In order to assist patients in avoiding foetal exposure to thalidomide, the Marketing Authorisation Holder will provide educational material to healthcare professionals to reinforce the warnings about the teratogenicity of thalidomide, to provide advice on contraception before treatment is started and provides guidance on the need for pregnancy testing.
Croatian: Kako bi se osiguralo sprječavanje izlaganja fetusa talidomidu, nositelj odobrenja će osigurati edukacijski materijal za zdravstvene djelatnike radi dodatnog naglašavanja upozorenja o teratogenosti talidomida, savjetovanja o kontracepciji prije početka liječenja i daje smjernice o potrebi za testiranjem na trudnoću.
English: Despite the small number of cases of DRESS, considering that this adverse reaction is a known risk listed in the EU SmPC of the structural analogues lenalidomide and pomalidomide and taking into consideration that other severe cutaneous adverse reactions (SCARs) are already listed in the thalidomide EU SmPC (SJS and TEN), the PRAC concluded that a causal relationship between thalidomide and DRESS cannot be excluded.
Croatian: Unatoč malom broju slučajeva DRESS-a, imajući u vidu da je ta nuspojava poznati rizik naveden u EU sažetku opisa svojstava lijeka za njegove strukturne analoge lenalidomid i pomalidomid, i uzimajući u obzir da su druge teške kožne reakcije (SCAR) već navedene u EU sažetku opisa svojstava lijeka (SJS i TEN) za talidomid, PRAC je zaključio da se uzročna povezanost talidomida i DRESS-a ne može isključiti.
English: For women of childbearing potential, thalidomide is contraindicated unless all of the following conditions are met:
Croatian: Za žene u reproduktivnoj dobi talidomid je kontraindiciran, osim ako bolesnica ispunjava sve sljedeće uvjete:
English: Your doctor will tell you how to take Thalidomide Celgene and for how long you will need to take it (see section 2, “What you need to know before you take Thalidomide Celgene”).
Croatian: Liječnik će Vam reći kako uzimati Thalidomide Celgene te koliko ćete ga dugo morati uzimati (vidjeti dio 2 „Što morate znati prije nego počnete uzimati Thalidomide Celgene“).
English: Thalidomide may cause fatigue (very common), dizziness (very common), somnolence (very common) and blurred vision (common) (see section 4.8).
Croatian: Talidomid može prouzročiti umor (vrlo često), omaglicu (vrlo često), somnolenciju (vrlo često) i zamućeni vid (često) (vidjeti dio 4.8).
English: To remove the capsule from the blister, press only one end of the capsule out to push it through the foil.
Croatian: Kada vadite kapsulu iz blistera, da biste je istisnuli kroz foliju pritisnite je samo na jednom kraju.
English: In 10 healthy women, the pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of a single dose containing 1.0 mg of norethindrone acetate and 0.75 mg of ethinyl estradiol were studied.
Croatian: U 10 zdravih žena proučavani su farmakokinetički profili noretindrona i etinilestradiola nakon primjene pojedinačne doze koja sadrži 1,0 mg noretindronacetata i 0,75 mg etinilestradiola.
English: for 4 days had no effect on the international normalized ratio (INR) in healthy volunteers.
Croatian: Primjena višekratne doze od 200 mg talidomida dnevno tijekom 4 dana nije imala učinka na međunarodni normalizirani omjer (INR) u zdravih dobrovoljaca.
English: If you take more Thalidomide Celgene than you should If you take more Thalidomide Celgene than you should, talk to a doctor or go to a hospital straightaway.
Croatian: Ako uzmete više lijeka Thalidomide Celgene nego što ste trebali, obratite se svom liječniku ili odmah otiđite u bolnicu.
English: Symptoms include paraesthesia, dysaesthesia, discomfort, abnormal co-ordination or weakness.
Croatian: Simptomi uključuju parestezije, dizesteziju, nelagodu, abnormalnu koordinaciju pokreta ili slabost.
English: The MAH should agree the final text of the Dear Healthcare Professional letter and the contents of the Educational Healthcare Professional's Kit with the National Competent Authority in each Member State prior to launch of the medicinal product and ensure that the materials contain the key elements as described below.
Croatian: Nositelj odobrenja će dogovoriti konačni tekst Pisma zdravstvenim djelatnicima i sadržaj edukacijskog materijala za zdravstvene djelatnike s nadležnim državnim tijelom u svakoj državi članici prije stavljanja lijeka u promet te će se pobrinuti da materijali sadrže ključne elemente, opisane u nastavku.
English: Table 1: Starting doses for thalidomide in combination with melphalan and prednisone Age (years)
Croatian: Tablica 1: Početne doze talidomida u kombinaciji s melfalanom i prednizonom Dob (godine)
English: • you have a fall in the number of platelets.
Croatian: • Ako imate pad broja krvnih pločica.
English: • A slow heart rate, heart failure.
Croatian: • usporeni rad srca, zatajenje srca
English: • She understands the need and accepts to undergo pregnancy testing every 4 weeks except in case of confirmed tubal sterilisation
Croatian: • Uviđa potrebu testiranja na trudnoću i pristaje podvrgnuti se testiranju svaka 4 tjedna, osim u slučaju potvrđenog podvezivanja jajovoda.
English: • you have high blood pressure in the arteries of the lungs (see also section 4 “Possible side effects”).
Croatian: • Ako imate visoki krvni tlak u plućnim arterijama (vidjeti također dio 4 „Moguće nuspojave”).
English: o The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.
Croatian: o Tinta za označivanje sastoji se od šelaka, crnog željezovog oksida (E172) i propilenglikola.
English: Capsule contents Starch, pregelatinised Magnesium stearate
Croatian: Sadržaj kapsule škrob, prethodno geliran magnezijev stearat
English: If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately.
Croatian: Ako Vaša partnerica zatrudni dok Vi uzimate talidomid, odmah obavijestite svog liječnika.
English: Pulmonary embolism*, Interstitial lung disease, Bronchopneumopathy, Dyspnea
Croatian: Plućna embolija*, intersticijska bolest pluća, bronhopneumopatija, dispneja
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the Pregnancy Prevention Programme are met (see section 4.3)
Croatian: Talidomid je kontraindiciran tijekom trudnoće te u žena u reproduktivnoj dobi, osim ako su ispunjeni svi uvjeti iz Programa prevencije trudnoće (vidjeti dio 4.3).
English: Medicinal products known to be associated with neuropathy should be used with caution in patients receiving thalidomide (see section 4.5).
Croatian: Lijekove za koje je poznato da su povezani s neuropatijom potrebno je primjenjivati s oprezom u bolesnika koji primaju talidomid (vidjeti dio 4.5).
English: • Pregnancy Prevention Programme information o Definition of women of childbearing potential and actions the prescriber should take if unsure o Information on what is effective contraception o Safety advice for women of childbearing potential
Croatian: • informacije o Programu prevencije trudnoće o definicija žena u reproduktivnoj dobi i mjera koje propisivač treba poduzeti ako nije siguran o informacije o učinkovitoj kontracepciji o sigurnosni savjet za žene u reproduktivnoj dobi
English: Allergic reactions (hypersensitivity, angioedema, urticaria)
Croatian: Alergijske reakcije (preosjetljivost, angioedem, urtikarija) †
English: Pulmonary hypertension
Croatian: Plućna hipertenzija
English: • by stopping blood vessels growing in the cancer
Croatian: • zaustavljanjem rasta krvnih žila u raku
English: Thalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Croatian: Privremeni prekid ili trajnu obustavu primjene talidomida treba razmotriti u slučaju kožnog osipa 2. do 3. stupnja.
English: • Increase in blood pressure within blood vessels that supply the lungs which can lead to shortness of breath, tiredness, dizziness, pain in the chest, a faster heartbeat, or swelling in the legs or ankles (pulmonary hypertension).
Croatian: • povišenje krvnog tlaka u krvnim žilama koje opskrbljuju pluća što može dovesti do nedostatka zraka, umora, omaglice, bola u prsnom košu, ubrzanih otkucaja srca ili oticanja nogu ili gležnjeva (plućna hipertenzija)
English: Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects - you may need urgent medical treatment:
Croatian: Sljedeće nuspojave mogu se pojaviti za vrijeme liječenja ovim lijekom: Prestanite uzimati Thalidomide Celgene i odmah posjetite liječnika ako primijetite sljedeće ozbiljne nuspojave - možda ćete trebati hitno medicinsko liječenje:
English: • Inflammation and swelling of the tubes in your lungs (bronchitis).
Croatian: • upala i oticanje cjevčica zvanih bronhi u plućima (bronhitis)
English: o The capsule shell contains gelatin and titanium dioxide (E171).
Croatian: o Ovojnica kapsule sadrži želatinu i titanijev dioksid (E171).
English: The maximum daily melphalan dose is 20 mg in patients > 75 years of age (see Table 1).
Croatian: Maksimalna dnevna doza melfalana je 20 mg u bolesnika starijih od 75 godina (vidjeti tablicu 1).
English: • A brain condition with symptoms including vision changes, headache, seizures, and confusion, with or without high blood pressure (Posterior Reversible Encephalopathy Syndrome or PRES).
Croatian: • Stanje mozga sa simptomima koji uključuju promjene vida, glavobolju, napadaje i smetenost, sa ili bez visokog krvnog tlaka (sindrom reverzibilne posteriorne encefalopatije, tj. PRES).
English: The test should ensure the patient is not pregnant when she starts treatment with thalidomide.
Croatian: Test treba potvrditi da bolesnica nije trudna u vrijeme početka liječenja talidomidom.
English: In the male dog, after one year of dosing, reversible bile plugs in canaliculi were observed at exposures greater than 1.9-fold the human exposure.
Croatian: U mužjaka pasa nakon godine dana doziranja primijećeni su reverzibilni čepovi žuči u kanalićima pri ekspozicijama više od 1,9 puta većim od ekspozicije u ljudi.