FrancophonIA/ELRC3.0 huggingface dataset:
English: In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
Croatian: 364 [EARLY]) 185 bolesnika s PAH-om WHO funkcionalnog stupnja II (srednja početna vrijednost udaljenosti prijeđene šestominutnim hodanjem od 435 metara) dobivali su bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno (n = 93) ili placebo (n = 92)
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Croatian: Liječenje treba započeti i nadzirati jedino liječnik s iskustvom u liječenju plućne arterijske hipertenzije ili sistemske skleroze.
English: A reduction in symptoms of PAH was observed with bosentan treatment.
Croatian: Kod liječenja bosentanom primijećeno je smanjenje simptoma PAH-a.
English: Women of childbearing age
Croatian: Žene reproduktivne dobi
English: 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Croatian: Edem, retencija tekućine5 1 Podaci dobiveni iz razdoblja nakon stavljanja lijeka u promet, učestalosti se temelje na statističkom modeliranju podataka iz placebom kontroliranog kliničkog istraživanja.2
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Croatian: Stoga su koncentracije tvari koje metaboliziraju ti izoenzimi kod istodobne primjene STAYVEERA smanjene u plazmi.
English: STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Croatian: STAYVEER 62,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
English: Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations.
Croatian: Bolesnike kojima je potrebna kombinacija tih lijekova treba pažljivo nadzirati s obzirom na pojavu nuspojava vezanih za STAYVEER te s obzirom na koncentracije takrolimusa ili sirolimusa u plazmi.
English: > 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
Croatian: > 3 i ≤ 5 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđeno, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje
English: Package leaflet: Information for the user STAYVEER 125 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika STAYVEER 125 mg filmom obložene tablete bosentan
English: Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Croatian: Ciklosporin A: istodobna primjena STAYVEERA i ciklosporina A (inhibitor kalcineurina)
English: Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Croatian: Ako se kliničko stanje pogorša, treba razmotriti prijelaz na terapiju koja se preporučuje u teškoj fazi bolesti (npr.
English: Liver cirrhosis, liver failure1
Croatian: Ciroza jetre, zatajenje jetre1
English: Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Croatian: Zato, ako osjećate omaglicu ili primijetite zamagljen vid tijekom uzimanja STAYVEERA
English: There was evidence of a mild thyroid hormonal imbalance induced by bosentan in rats.
Croatian: Kod štakora je dokazan blagi hormonski poremećaj štitnjače induciran bosentanom.
English: Because STAYVEER may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Croatian: Budući da STAYVEER smanjuje učinkovitost hormonske kontracepcije (npr. tablete, u obliku injekcije, implantata ili kožnih flastera),
English: • jaundice (yellowing of your skin or the whites of your eyes)
Croatian: • žutica (žutilo kože ili bjeloočnica očiju) • tamno obojenu mokraću
English: - STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
Croatian: - STAYVEER 62,5 mg filmom obložene tablete: Djelatna tvar je bosentan u obliku bosentan hidrata.
English: The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Croatian: (min.: 0,1 godina; maks.: 3,3 godine), a bolesnici su praćeni tijekom 2,0 ± 0,6 godina.
English: STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Croatian: STAYVEER 125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata).
English: Uncommon (may affect up to one in 100 people):
Croatian: Manje česte (mogu se pojaviti u do 1 na 100 osoba):
English: STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Croatian: STAYVEER 62,5 mg filmom obložene tablete STAYVEER 125 mg filmom obložene tablete
English: STAYVEER 125 mg tablets bosentan
Croatian: STAYVEER 125 mg tablete bosentan
English: Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4.
Croatian: Bosentan inducira izoenzime citokroma P450 (CYP), CYP2C9 i CYP3A4.
English: Marketing authorisation holder:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet:
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Croatian: Iako je broj uključenih bolesnika bio ograničen i s visokom varijabilnošću, ovi podaci naznačuju značajno povećanje izloženosti bosentanu i njegovom primarnom metabolitu
English: STAYVEER 62.5 mg tablets bosentan
Croatian: STAYVEER 62,5 mg tablete bosentan
English: Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking STAYVEER.
Croatian: Metoda hormonske kontracepcije npr. uzeta kroz usta, u obliku injekcija, implantata ili flastera nije pouzdana u žena koje uzimaju lijek STAYVEER.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
Croatian: Kaplan-Meierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a)
English: Development of testicular tubular atrophy and impaired fertility has been linked with chronic administration of endothelin receptor antagonists in rodents.
Croatian: U glodavaca je kronična primjena antagonista endotelinskih receptora povezana s razvojem tubularne atrofije testisa i smanjenjem plodnosti.
English: No effect of bosentan on time to healing of digital ulcers was observed in either study.
Croatian: Ni u jednoj studiji nije zapažen učinak bosentana na vrijeme zacjeljivanja ulceracija prstiju.
English: Pulmonary arterial hypertension
Croatian: Plućna arterijska hipertenzija za koju je namijenjen
English: • flu-like syndrome (joint and muscle pain with fever)
Croatian: • bezvoljnost ili umor (neuobičajen osjećaj umora ili iscrpljenosti) • sindrom sličan gripi (bol u zglobovima i mišićima s vrućicom)
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Croatian: (FUTURE-4) ukupno je 13 novorođenčadi liječeno bosentanom u obliku tablete za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (8 bolesnika primalo je placebo).
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Croatian: n = 7), što je slično izloženosti zabilježenoj u odraslih bolesnika s PAH-om koji su primali 125 mg dvaput dnevno i uzimajući u obzir omjer distribucije u krvi i plazmi od 0,6.
English: If the aminotransferase levels return to pre-treatment values continuing or re-introducing STAYVEER according to the conditions described below should be considered.
Croatian: Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti nastavak ili ponovno liječenje
English: • a blood test to check for anaemia (low haemoglobin)
Croatian: • krvni nalazi za provjeru funkcije Vaše jetre • krvni nalazi za provjeru anemije (snižena koncentracija hemoglobina)
English: Therefore, concomitant use of STAYVEER and tacrolimus or sirolimus is not advisable.
Croatian: STAYVEERA i takrolimusa ili sirolimusa ne preporuča.
English: • Diarrhoea
Croatian: • Glavobolja
English: The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
Croatian: Najčešće nuspojave bile su glavobolja (11,5%), edem / zadržavanje tekućine (13,2%), promijenjeni nalazi jetrene funkcije
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Ro 48-5033 bio je 106 (58,4-192) ng⋅h/ml, tj. 12,4 puta viši nego kod bolesnika s normalnom funkcijom jetre (bosentan: srednji [95% CI] AUC: 76,1 [9,07-638] ng⋅h/ml; Ro 48 5033: srednji [95% CI] AUC 8,57 [1,28-57,2] ng⋅h/ml).
English: Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended.
Croatian: Kombinacija nevirapina i bosentana se ne preporučuje zbog izrazite hepatotoksičnosti nevirapina koja bi mogla pojačati hepatotoksičnost bosentana.
English: The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
Croatian: odnosno 2,3 puta (na 69. postpartalni dan) veća od terapijske izloženosti u ljudi.
English: Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Croatian: Najvjerojatniji je uzrok te interakcije inhibicija ritonavirom transportnog proteina kojim se bosentan unosi u hepatocite te CYP3A4, reducirajući pritom klirens bosentana.
English: STAYVEER 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Croatian: STAYVEER 125 mg filmom obložene tablete Narančasto-bijele, ovalne, bikonveksne filmom obložene tablete, s oznakom „125“ na jednoj strani.
English: No dose adjustment is required in patients with renal impairment.
Croatian: Prilagodba doze nije potrebna kod bolesnika s blagim oštećenjem funkcije jetre
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
Croatian: • Umjereno do teško oštećenje funkcije jetre, tj. Child-Pugh stadij B ili C (vidjeti dio 5.2)
English: Some improvements have also been shown in patients with class II PAH.
Croatian: Dokazana su neka poboljšanja i u bolesnika s II. stupnjem plućne arterijske hipertenzije.
English: Each tablet contains 62.5 mg of bosentan (as monohydrate).
Croatian: Jedna tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 125 mg film-coated tablets).
Croatian: Kutije sadrže 56 ili 112 filmom obloženih tableta (STAYVEER 125 mg filmom obloženih tableta).
English: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Croatian: Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata)
English: The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Croatian: Ro 48-5033 istraženo je u ispitivanju koje je uključivalo 5 bolesnika s plućnom hipertenzijom povezanom s portalnom hipertenzijom i jetrena oštećenja Child-Pugh stadija
English: Each film-coated tablet contains 125 mg bosentan (as monohydrate)
Croatian: Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata)
English: Headache3
Croatian: Glavobolja3
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Croatian: (AUCτ: 3577 ng•h/mL za 2 mg/kg dvaput dnevno i 3371 ng•h/mL za 4 mg/kg dvaput dnevno).
English: This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
Croatian: (medijan 71,8 tjedana) u usporedbi s odraslom populacijom (medijan 17,4 tjedna).
English: Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Croatian: Kutije sadrže 56 filmom obloženih tableta (STAYVEER 125 mg filmom obložene tablete).
English: After oral administration, the systemic exposure is proportional to dose up to 500 mg. At higher oral doses, Cmax and AUC increase less than proportionally to the dose.
Croatian: Nakon oralne primjene sistemska izloženost je proporcionalna sve do doze od 500 mg.
English: STAYVEER 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Croatian: STAYVEER 62,5 mg filmom obložene tablete Narančasto-bijele, okrugle, bikonveksne filmom obložene tablete, s oznakom „62,5“ na jednoj strani.
English: STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Croatian: STAYVEER 125 mg filmom obložene tablete su narančasto-bijele, ovalne filmom obložene tablete s oznakom „125“ na jednoj strani.
English: STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Croatian: STAYVEER 62,5 mg filmom obložene tablete su narančasto-bijele, okrugle filmom obložene tablete s oznakom „62,5“ na jednoj strani.
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
Croatian: Kutije sadrže 56 ili 112 filmom obloženih tableta (STAYVEER 62,5 mg filmom obloženih tableta).
English: Each tablet contains 125 mg of bosentan (as monohydrate).
Croatian: Jedna tableta sadrži 125 mg bosentana (u obliku bosentan hidrata).
English: Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Croatian: Plućna arterijska hipertenzija Liječenje smije započeti i nadzirati jedino liječnik s iskustvom u liječenju PAH-a.
English: STAYVEER 62.5 mg film-coated tablets bosentan
Croatian: STAYVEER 62,5 mg filmom obložene tablete bosentan
English: Monthly pregnancy tests are recommended while you are taking STAYVEER and are of childbearing age.
Croatian: Ako ste reproduktivne dobi, preporučuju se mjesečni testovi na trudnoću tijekom uzimanja STAYVEERA.
English: Based on these pharmacokinetic results, when used in children with PAH aged 1 year and older, the recommended starting and maintenance dose is 2 mg/kg morning and evening.
Croatian: Na temelju tih farmakokinetičkih rezultata, preporučena početna doza i doza održavanja u djece s
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Croatian: ukupno 2486 bolesnika dobivalo je bosentan u dnevnim dozama od 100 mg do 2000 mg,
English: • Nasal congestion
Croatian: • Začepljenost nosa
English: STAYVEER 125 mg film-coated tablets bosentan
Croatian: STAYVEER 125 mg filmom obložene tablete bosentan
English: Teл.
Croatian: ETB).
English: Treatment and monitoring recommendations
Croatian: Vrijednosti ALT/AST Preporuke za liječenje i praćenje bolesnika
English: The dose recommendation in children is only for PAH.
Croatian: Preporučena doza za djecu je samo za liječenje plućne arterijske hipertenzije.
English: Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Croatian: Kutije sadrže 56 filmom obloženih tableta (STAYVEER 62,5 mg filmom obložene tablete).
English: • The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24).
Croatian: CL 3,21; 12,21 dana) uz bosentan i 8,6 dana (95% CL 3,71; 9,66 dana) uz placebo (p = 0,24). • U jednog bolesnika iz skupine koja je primala bosentan došlo je do terapijskog neuspjeha
English: Baseline (BL); mean (SD)
Croatian: Početna vrijednost (BL);
English: There is limited clinical study experience with the use of STAYVEER in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Croatian: infekcijom koja je liječena antiretrovirusnim lijekovima ograničeno je (vidjeti dio 5.1).
English: • Hypersensitivity reactions (including skin inflammation, itching and rash)
Croatian: • Reakcije preosjetljivosti (uključujući upalu kože, svrbež i osip) • Gastroezofagealna refluksna bolest (vraćanje kiselog sadržaja iz želuca)
English: How to store STAYVEER
Croatian: Moguće nuspojave Kako čuvati STAYVEER
English: Ketoconazole: Co-administration for 6 days of bosentan 62.5 mg twice daily with ketoconazole, a potent CYP3A4 inhibitor, increased the plasma concentrations of bosentan approximately 2-fold.
Croatian: Ketokonazol: istodobna primjena bosentana 62,5 mg dvaput dnevno kroz 6 dana s ketokonazolom,
English: After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Croatian: Nakon 16 tjedana srednje povećanje 6-minutne udaljenosti prijeđene hodanjem bilo je 53 metra
English: These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking STAYVEER may get anaemia.
Croatian: S obzirom na to da bolesnici koji uzimaju STAYVEER mogu dobiti anemiju, ti nalazi provode se svakog mjeseca tijekom prva 4 mjeseca liječenja, a potom svaka 3 mjeseca.
English: Digoxin: Co-administration for 7 days of bosentan 500 mg twice daily with digoxin decreased the AUC, Cmax and Cmin of digoxin by 12%, 9% and 23%, respectively.
Croatian: AUC, Cmax i Cmin digoksina za 12%, 9%, odnosno 23%.
English: In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
Croatian: Eisenmengerovim sindromom povezanim s kongenitalnom srčanom bolesti dobivali su bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno tijekom daljnjih 12 tjedana (n = 37 od kojih je 31 imalo dvosmjerni unutarsrčani šant uglavnom s desne na lijevu stranu).
English: • Concomitant use of cyclosporine A (see section 4.5)
Croatian: Child-Pugh stadij A) (vidjeti dio 5.2).
English: Liver test abnormalities
Croatian: Abnormalne vrijednosti laboratorijskih nalaza Abnormalne vrijednosti testova jetrene funkcije
English: Please see also section 3.
Croatian: vidjeti dio 5.3).
English: Laboratory abnormalities
Croatian: Prijavljivanje nuspojava
English: In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
Croatian: Kod bolesnika s oštećenjem jetre Child-Pugh stadij B, srednja vrijednost (95% CI) AUC-a za bosentan u stanju dinamičke ravnoteže bila je 360 (212-613) ng⋅h/ml, tj.
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with STAYVEER.
Croatian: Prije početka liječenja i svaki mjesec tijekom liječenja STAYVEEROM treba izmjeriti vrijednosti jetrenih aminotransferaza.
English: Jul ______
Croatian: Vaše ime: __________________________________________________
English: Re-introduction of treatment
Croatian: UČINKOVITU PRIMJENU LIJEKA
English: Thrombocytopenia1
Croatian: Trombocitopenija1
English: It is given once every three weeks as an infusion lasting 10 minutes.
Croatian: Daje se jedanput svaka tri tjedna u obliku infuzije u trajanju od 10 minuta.
English: The recommended dose is calculated using the patient's height and weight.
Croatian: Preporučena doza izračunava se na osnovi visine i tjelesne težine bolesnika.
English: The full EPAR for Pemetrexed Fresenius Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR i sažetak plana upravljanja rizikom nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Pretvaranje pemetrekseda u njegov djelatni oblik odvija se brže u stanicama raka nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: The company provided data from the published literature on pemetrexed.
Croatian: Tvrtka je dostavila podatke o pemetreksedu iz objavljenje literature.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Croatian: Lijek se izdaje samo na liječnički recept i smije se davati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Croatian: Zbog toga se smanjuje dijeljenje stanica raka, dok je utjecaj na normalne stanice tek neznatan.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Croatian: Kao rezultat toga, djelatni oblik pemetrekseda usporava stvaranje DNK-a i RNK-a i sprečava dijeljenje i umnožavanje stanica.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: Pemetreksed se u tijelu pretvara u djelatni oblik koji onemogućuje djelovanje enzima koji su uključeni u proizvodnju „nukleotida” (temeljnih sastavnica DNK-a i RNK-a, odnosno genetskog materijala stanice).
English: This means that Pemetrexed Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da je lijek Pemetrexed Fresenius Kabi sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.