FrancophonIA/ELRC3.0 huggingface dataset:
English: This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis with secondary hyperparathyroidism or after renal transplantation.
Croatian: Taj se rizik povećava istovremenom primjenom fluorokinolona i u bolesnika koji primaju dijalizu sa sekundarnim hiperparatiroidizmom ili nakon transplantacije bubrega.
English: If such patients have been in contact with people with chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate.
Croatian: Ako su takve osobe došle u kontakt s osobama oboljelima od vodenih kozica ili ospica, potrebno je započeti primjereno preventivno liječenje intravenoznim normalnim imunoglobulinom ili pasivnu imunizaciju varicela zoster imunoglobulinom (VZIG).
English: Children do not develop multiple myeloma.
Croatian: Multipli mijelom ne razvija se u djece.
English: • With non-steroidal anti-inflammatory drugs (NSAIDs), due to an increased risk of gastrointestinal ulceration.
Croatian: • s nesteroidnim protuupalnim lijekovima (NSAID-ima), zbog povišenog rizika od gastrointestinalne ulceracije.
English: Very common: Fatigue, asthenia, oedema (including peripheral and facial oedema);
Croatian: Vrlo često: umor, astenija, edem (uključujući periferni i facijalni edem);
English: Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives.
Croatian: Posebna se pozornost treba obratiti prilikom razmatranja primjene sistemskih kortikosteroida u bolesnika s postojećim ozbiljnim afektivnim poremećajima ili anamnezom istih u njih samih ili rodbine prvog reda.
English: Dexamethasone has no clinically significant pharmacokinetic interaction with thalidomide, lenalidomide, pomalidomide, bortezomib, vincristine or doxorubicin.
Croatian: Deksametazon nema klinički značajnu farmakokinetičku interakciju s talidomidom, lenalidomidom, pomalidomidom, bortezomibom, vinkristinom ili doksorubicinom.
English: In particular, pneumonia occurs commonly.
Croatian: Posebice je česta upala pluća.
English: In addition, amphotericin B carries a risk of cardiac enlargement and cardiac failure with concurrent use.
Croatian: Nadalje, amfotericin B nosi sa sobom rizik od povećanja srca i zatajenja srca u slučaju istodobne primjene.
English: Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected tendon.
Croatian: Kortikosteroidi mogu potaknuti razvoj tendinitisa i, u iznimnim slučajevima, rupturu zahvaćene tetive.
English: If you take more Neofordex than you should If you take too much Neofordex contact your doctor or hospital immediately.
Croatian: Ako uzmete previše lijeka Neofordex, odmah kontaktirajte svog liječnika ili bolnicu.
English: − Tiredness, weakness, swelling of the body and face.
Croatian: − Umor, slabost, oticanje tijela i lica.
English: Post-natal development assessment of animals treated prenatally presented decreased glucose tolerance and insulin sensitivity, behavioural alterations and decrease in brain and body weight.
Croatian: Ocjena postnatalnog razvoja životinja koje su liječene prenatalno dokazala je smanjenu podnošljivost glukoze i osjetljivost na inzulin, promjene u ponašanju i smanjenje mase mozga i tjelesne težine.
English: Parasite eradication must be successfully terminated before dexamethasone use (see section 4.4).
Croatian: Eradikacija parazita mora se uspješno završiti prije primjene deksametazona (vidjeti dio 4.4).
English: Paediatric population There is no relevant use of Neofordex in the paediatric population in the indication multiple myeloma.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka Neofordex u pedijatrijskoj populaciji u indikaciji multiplog mijeloma.
English: − Stroke, difficulties in coordination or movement, fainting;
Croatian: Moždani udar, poteškoće u koordinaciji ili pokretu, nesvjestica;
English: Studies in animals have shown reductions in female fertility (see Section 5.3).
Croatian: Ispitivanja provedena u životinja pokazala su smanjenje u plodnosti ženki (vidjeti dio 5.3).
English: − Fast or irregular heart rhythm, too high or too low blood pressure, formation of blood clots that may clog blood vessels (for example in legs or lungs), swelling of arms or legs, reddening of the skin of the face or body;
Croatian: Brz ili nepravilan srčani ritam, previsok ili prenizak krvni tlak, formiranje krvnih ugrušaka koji mogu začepiti krvne žile (primjerice u nogama ili plućima), oticanje ruku ili nogu, crvenilo kože lica ili tijela;
English: At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop.
Croatian: Po završetku liječenja deksametazonom, doza se treba postepeno smanjivati sve do potpunog završetka terapije.
English: Tablets may be broken in two equal halves using the score line to provide the 20 mg dose.
Croatian: Tablets se mogu razlomiti na dvije jednake polovice pomoću razdjelnog ureza kako bi se dobila doza od 20 mg.
English: Very common: Hyperglycaemia;
Croatian: Vrlo često: hiperglikemija;
English: Dexamethasone can suppress skin reaction to allergy testing.
Croatian: Deksametazon može smanjiti reakciju kože na alergološkom testiranju.
English: Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies.
Croatian: Neofordex se primjenjuje za liječenje odraslih bolesnika oboljelih od multiplog mijeloma, raka krvi koji pogađa bijele krvne stanice koje proizvode protutijela.
English: The efficacy of oral contraceptives may be reduced during dexamethasone treatment (see section 4.5).
Croatian: Djelotvornost oralnih kontraceptiva može se smanjiti tijekom liječenja deksametazonom (vidjeti dio 4.5).
English: After oral administration of Neofordex, dexamethasone peak plasma levels are reached at a median of three hours.
Croatian: Nakon peroralne primjene lijeka Neofordex, vršne razine deksametazona u plazmi postignute su u medijanu od tri sata.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisetru iza oznake „EXP“ (Rok valjanosti).
English: Neofordex should not be used with live attenuated vaccines (see section 4.5).
Croatian: Neofordex se ne smije primjenjivati sa živim atenuiranim cjepivima (vidjeti dio 4.5).
English: Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the treatment with dexamethasone and thalidomide or its analogues may be restarted at the original dose dependent upon a benefit risk assessment.
Croatian: Nakon što se bolesnik stabilizira antikoagulacijskim liječenjem te je uspostavljana kontrola nad svim komplikacijama tromboembolijskog događaja, može se ponovno započeti liječenje deksametazonom i talidomidom ili njegovim analozima u izvornoj dozi ovisno o ocjeni omjera koristi i rizika.
English: Keep tablets in the blister packaging until you take them.
Croatian: Čuvajte tablete u blister pakiranju do uzimanja.
English: Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity.
Croatian: Deksametazon je sintetski glukokortikoid; kombinira snažan protuupalni učinak sa blagim mineralokortikoidnim djelovanjem.
English: Dexamethasone also down-regulated anti apoptotic genes and increased IκB-α protein levels.
Croatian: Deksametazon također snižava razinu protuapoptotskih gena i povećava razine IκB-α proteina.
English: Dexamethasone may cause congenital malformations (see section 5.3).
Croatian: Deksametazon može uzrokovati kongenitalne malformacije (vidjeti dio 5.3).
English: Concomitant administration of erythropoietic medicinal products may also increase thrombotic risk in these patients.
Croatian: Istovremena primjena eritropoetskih lijekova može također povećati rizik od tromboembolije u ovih bolesnika.
English: Patients receiving Neofordex in combination with products containing thalidomide, lenalidomide or pomalidomide should adhere to the pregnancy prevention programmes of those products.
Croatian: Bolesnice koje primaju Neofordex u kombinaciji s lijekovima koji sadrže talidomid, lenalidomid ili pomalidomid trebaju se pridržavati programa za prevenciju trudnoće tih lijekova.
English: In Pom + LD-Dex treated patients neutropenia was infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients.
Croatian: U bolesnika liječenih kombinacijom Pom+LDDex neutropenija je rijetko bila ozbiljna (2,0 % bolesnika), nije dovela do prekida liječenja i bila je povezana s prekidima u liječenju u 21,0 % bolesnika te smanjenjem doze u 7,7 % bolesnika.
English: No data are available on the biotransformation of dexamethasone in hepatically impaired patients.
Croatian: Nema dostupnih podataka o biotransformaciji deksametazona u bolesnika s oštećenom funkcijom jetre.
English: • Clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, nelfinavir, ritonavir: Increased dexamethasone plasma concentration due to reduction of its hepatic metabolism by these enzyme inhibitors.
Croatian: • klaritromicin, eritromicin, telitromicin, itrakonazol, ketokonazol, posakonazol, vorikonazol, nelfinavir, ritonavir: povišena koncentracija deksametazona u plazmi zbog smanjenja njegovog hepatičkog metabolizma ovim inhibitorima enzima.
English: Adverse reactions to Neofordex correspond to the predictable safety profile of glucocorticoids.
Croatian: Nuspojave lijeka Neofordex odgovaraju predvidljivom sigurnosnom profilu glukokortikoida.
English: Concomitant use of dexamethasone and ciclosporine should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu deksametazona i ciklosporina.
English: • Oral anticoagulants, due to a possible impact of corticosteroids on the metabolism of the oral anticoagulant and on coagulation factors, as well as the haemorrhagic risk (mucosa of the digestive tract, vascular fragility) of dexamethasone therapy itself at high doses or treatment periods above 10 days.
Croatian: • oralnih antikoagulansa, zbog mogućeg djelovanja kortikosteroida na metabolizam oralnih antikoagulansa i na koagulacijske faktore, kao i na hemoragijski rizik (sluznica probavnog trakta, vaskularna osjetljivost) same terapije deksametazonom u velikim dozama ili razdoblja liječenja dulja od 10 dana.
English: Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products.
Croatian: Neofordex je indiciran u odraslih osoba za liječenje simptomatskog multiplog mijeloma u kombinaciji s drugim lijekovima.
English: The combination of dexamethasone with lenalidomide or pomalidomide may cause a decrease in normal white blood cells (blood cells that help fight infection) and/or blood platelets (which help prevent bleeding).
Croatian: Kombinacija deksametazona s lenalidomidom ili pomalidomidom može uzrokovati smanjenje broja normalnih bijelih krvnih stanica (krvne stanice koje pomažu u borbi protiv infekcije) i/ili trombocita (koji pomažu pri sprječavanju krvarenja).
English: In case of neutropenia, the physician should consider the use of growth factors in patient management.
Croatian: U slučaju neutropenije, liječnik treba razmotriti primjenu faktora rasta kao mjere zbrinjavanja bolesnika.
English: − Thinning of the bones with increased risk of fracture, bone disease, ruptured tendon.
Croatian: Stanjivanja kostiju s povećanim rizikom od frakture, bolesti kosti, puknuta tetiva.
English: − Increased pressure in the eye including glaucoma, choroid and retinal disorders (chorioretinopathy);
Croatian: Povišeni tlak u oku uključujući glaukom, poremećaji koroida i mrežnice (korioretinopatija);
English: Treatment with this medicine may cause tendon inflammation.
Croatian: Liječenje ovim lijekom može prouzročiti upalu tetive.
English: A minor part of administered dexamethasone is excreted unchanged by the kidney.
Croatian: Manji dio primijenjenog deksametazona izlučuje se nepromijenjen putem bubrega.
English: Women should avoid pregnancy during Neofordex treatment.
Croatian: Žene trebaju izbjegavati trudnoću tijekom liječenja lijekom Neofordex.
English: The incidence of predictable adverse reactions, including adrenal atrophy, correlates with dose, timing of administration and the duration of treatment (see section 4.4).
Croatian: Incidencija predvidivih nuspojava, uključujući adrenalnu atrofiju, korelira s dozom, određivanjem trenutka primjene i trajanja liječenja (vidjeti dio 4.4).
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Not known: Mania, psychosis, behavioural disturbance.
Croatian: Nepoznato: manija, psihoza, bihevijoralan poremećaj.
English: Common: Weight decreased, weight increased.
Croatian: Često: smanjenje tjelesne težine, povećanje tjelesne težine.
English: You should tell your doctor if you have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath
Croatian: Obavijestite svog liječnika ukoliko imate simptome sindroma lize tumora, kao što su: grčevi mišića, slabost mišića, smetenost, gubitak ili poremećaji vida i nedostatak zraka.
English: When Neofordex is used in combination with known teratogens (e.g. thalidomide, lenalidomide, pomalidomide, plerixafor), particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Croatian: Ako se Neofordex koristi u kombinaciji s poznatim teratogenima (primjerice talidomid, lenalidomid, pomalidomid, pleriksafor), posebna se pozornost mora obratiti na test na trudnoću te je potrebno pridržavanje zahtjeva za prevenciju (vidjeti dio 4.6).
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Croatian: Bolesnike je potrebno nadzirati zbog hematoloških nuspojava, posebno neutropenije.
English: If you notice any of these symptoms talk to a doctor straight away.
Croatian: Ako uočite bilo koji od ovih simptoma odmah se obratite svojem liječniku.
English: Contact your doctor if you notice painful, stiff or swollen joints or tendons.
Croatian: Kontaktirajte liječnika ako uočite bol, krute ili nateknute zglobove ili tetive.
English: The patient should continue anticoagulation therapy during the course of treatment with dexamethasone and thalidomide or its analogues.
Croatian: Bolesnik mora nastaviti antikoagulacijsku terapiju tijekom cijelog tijeka liječenja deksametazonom i talidomidom ili njegovim analozima.
English: Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred or distorted vision.
Croatian: Liječenje ovim lijekom može prouzročiti centralnu seroznu korioretinopatiju, bolest oka koja rezultira zamućenim ili iskrivljenim vidom.
English: This may include headache, problems with your vision (including pain or swelling in the eye), feeling or being sick, fever, pain in your muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and conjunctivitis.
Croatian: To može uključivati glavobolju, probleme s vidom (uključujući bol ili oticanje u oku), osjećaj mučnine ili mučninu, vrućicu, bol u mišićima i zglobovima, oticanje unutar nosa, gubitak tjelesne težine, svrbljenje kože i konjunktivitis.
English: • With erythropoietic medicinal products or other medicinal products that may increase the risk of thrombosis, such as hormone replacement therapy, in patients receiving thalidomide or its analogues with Neofordex (see sections 4.4 and 4.8).
Croatian: • s eritropoetskim lijekovima ili drugim lijekovima koji mogu povećati rizik od tromboze, poput hormonske zamjenske terapije, u bolesnika koji primaju talidomid ili njegove analoge zajedno s lijekom Neofordex (vidjeti dijelove 4.4 i 4.8).
English: Methotrexate is also used to treat rheumatism or psoriasis; - Erythropoietin (EPO, to treat anaemia) - Ciclosporin (for the treatment of psoriasis, atopic dermatitis, rheumatoid arthritis or nephrotic syndrome, and to suppress immune reactions after an organ or bone marrow transplantation) - Ephedrine (to treat asthma attacks or relieve nasal congestion).
Croatian: Metotreksat se također koristi za liječenje reumatizma ili psorijaze; - eritropoietin (EPO, za liječenje anemije) - ciklosporin (za liječenje psorijaze, atopijskog dermatitisa, reumatoidnog artritisa ili nefrotičkog sindroma, i za smanjivanje imunoloških reakcija nakon presađivanja organa ili koštane srži) - efedrin (za liječenje napadaja astme ili ublažavanje začepljenja nosa).
English: − Development of diabetes, loss or increase of appetite, weight gain or weight loss, water retention;
Croatian: Razvoj dijabetesa, gubitak ili povećanje apetita, povećanje ili gubitak tjelesne težine, zadržavanje vode;
English: Note: It is important that while you are taking Neofordex you avoid contact with anyone who is suffering from chickenpox, measles or shingles.
Croatian: Napomena: Izuzetno je važno da tijekom terapije lijekom Neofordex izbjegavate kontakt s osobama koje boluju od vodenih kozica, ospica ili herpesa zoster.
English: High-dose (40 mg or 20 mg) oral dexamethasone has been studied in the therapy of multiple myeloma in combination with chemotherapy in the VAD regimen (vincristine, adriamycin/doxorubicin and dexamethasone) or in association with novel agents, including thalidomide and its analogues as well as proteasome inhibitors.
Croatian: Ispitan je deksametazon za oralnu primjenu u velikoj dozi (40 mg ili 20 mg) u terapiji multiplog mijeloma u kombinaciji s kemoterapijom u VAD režimu (vinkristin, adriamicin/doksorubicin i deksametazon) ili povezan s novim agensima, uključujući talidomid i njegove analoge kao i inhibitore proteazoma.
English: Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Croatian: Sistemsko liječenje glukokortikoidima može izazvati korioretinopatiju koja može rezultirati oštećenim vidom, uključujući gubitak vida.
English: 10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.
Croatian: 10 x 1 tableta u perforiranom OPA/aluminij/PVC-aluminij blisteru djeljivom na jedinične doze.
English: Uncommon: Myocardial ischaemia, bradycardia; Not known: Congestive heart failure.
Croatian: Manje često: ishemija miokarda, bradikardija; Nepoznato: kongestivno zatajenje srca.
English: − Reduction in the number of red or white blood cells and/or platelets, or increased number of white blood cells, decreased levels of potassium or of albumin (a protein) in the blood, increased levels of uric acid in the blood, changes in liver function tests;
Croatian: − Smanjenje u broju crvenih ili bijelih krvnih stanica i/ili trombocita, ili povećani broj bijelih krvnih stanica, smanjene razine kalija ili albumina (vrste proteina) u krvi, povišene razine uratne (mokraćne)
English: Data are derived from historical experience and clinical studies in multiple myeloma patients in which dexamethasone was used as monotherapy or in combination with placebo.
Croatian: Podaci su prikupljeni iz povijesnog iskustva i kliničkih ispitivanja provedenih u bolesnika oboljelih od multiplog mijeloma u kojih se deksametazon primjenjivao kao monoterapija ili u kombinaciji s placebom.
English: Neofordex will be given with other medicines for multiple myeloma.
Croatian: Neofordex će se primjenjivati s drugim lijekovima za multipli mijelom.
English: Consequently, patients with known risk factors for thromboembolism (including prior thrombosis) should be closely monitored.
Croatian: Slijedom navedenog, treba pažljivo pratiti bolesnike s poznatim faktorima rizika od tromboembolije (uključujući raniju trombozu).
English: Talk to your doctor before taking Neofordex - if you have liver or kidney disease, - if you have heart disease or you have recently had a heart attack, - if you have high blood pressure, high cholesterol or you are a smoker, - if you have diabetes or if there is a history of diabetes in your family, - if you have osteoporosis, especially if you are a woman who has been through the menopause, - if you have glaucoma (increased eye pressure) or if there is a history of glaucoma in your family, - if you have myasthenia gravis (a disease affecting the muscles), - if you have a peptic ulcer (ulcer in your stomach or duodenum), or a history of peptic ulcers, stomach bleeding or perforation, - if you have inflammation of the colon, diverticulitis, or have recently had surgery on the intestine, - if you have inflammation of a tendon.
Croatian: Razgovarajte sa svojim liječnikom prije uzimanja lijeka Neofordex - ako bolujete od bolesti jetre ili bubrega, - ako bolujete od srčane bolesti ili ste nedavno imali srčani udar, - ako imate visoki krvni tlak, visoki kolesterol ili ako ste pušač, - ako bolujete od dijabetesa ili ako je u Vašoj obitelji netko bolovao od dijabetesa, - ako bolujete od osteoporoze, posebno ako ste žena koja je prošla kroz menopauzu, - ako imate glaukom (povišeni očni tlak) ili ako je u Vašoj obitelji netko bolovao od glaukoma, - ako bolujete od mijastenije gravis (bolesti koja zahvaća mišiće), - ako imate peptički ulkus (čir na želucu ili dvanaesniku) ili imate peptički ulkus u povijesti bolesti,
English: What you need to know before you take Neofordex
Croatian: Što morate znati prije nego počnete uzimati Neofordex
English: Dexamethasone apoptotic activity is enhanced by the combination with thalidomide or its analogues and with proteasome inhibitor (e.g. bortezomib).
Croatian: Apoptotska aktivnost deksametazona pojačava se kombinacijom s talidomidom ili njegovim analozima i s inhibitorom proteazoma (primjerice bortezomibom).
English: Lactose monohydrate Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Croatian: Mikrokristalična celuloza Magnezijev stearat Koloidni bezvodni silicijev dioksid
English: During treatment, patients should be closely monitored for the appearance of infections.
Croatian: Bolesnici se trebaju pažljivo pratiti tijekom liječenja kako bi se uočilo javljanje infekcija.
English: Exposed patients should be advised to seek medical attention without delay.
Croatian: Bolesnicima izloženima virusu potrebno je savjetovati da odmah potraže liječničku pomoć.
English: Low-grade peripheral neuropathic reactions, predominantly grade 1 paraesthesia, may be observed with dexamethasone alone in up to 34% of newly diagnosed multiple myeloma patients.
Croatian: Periferne neuropatijske reakcije niskog stupnja, predominatno parestezija stupnja 1, mogu se uočiti u slučaju monoterapije deksametazonom u do 34% novodijagnosticiranih bolesnika oboljelih od multiplog mijeloma.
English: Immunocompromised patients who have not previously had chickenpox or measles are particularly at risk.
Croatian: Riziku su posebno izloženi imunokompromitirani bolesnici koji prethodno nisu imali vodene kozice ili ospice.
English: In one study, 10.7% of patients treated with thalidomide and dexamethasone experienced grade 3/4 neuropathic reactions, compared to 0.9% of patients treated with dexamethasone alone.
Croatian: U jednom ispitivanju, 10,7% bolesnika liječenih talidomidom i deksametazonom doživjelo je neuropatske reakcije stupnja 3/4, u usporedbi s 0,9% bolesnika liječenih samo deksametazonom.
English: • With methotrexate, due to an increased risk of haematological toxicity.
Croatian: • s metotreksatom, zbog povećanog rizika od hematološke toksičnosti.
English: • With hypoglycaemic medicinal products, as dexamethasone can raise glycaemic levels and diminish glucose tolerance, with a possibility of ketoacidosis.
Croatian: • s hipoglikemijskim lijekovima, budući da deksametazon može povisiti glikemijske razine i umanjiti toleranciju glukoze s mogućnošću ketoacidoze.