FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52%), vomiting (32%), diarrhoea (18%), constipation (9%) and mucositis (14%).
Croatian: Često prijavljene nehematološke nuspojave bile su gastrointestinalne poput mučnine (52%), povraćanja (32%), proljeva (18%), konstipacije (9%) i mukozitisa (14%).
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Croatian: Bolesnice bez prethodne kemoradioterapije cisplatinom cisplatin topotekan/cisplatin
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group.
Croatian: U randomiziranom ispitivanju faze III u kojem se topotekan primijenjen intravenski (i.v.) uspoređivao s ciklofosfamidom, doksorubicinom i vinkristinom (CAV protokol) u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, ukupna stopa odgovora na topotekan iznosila je 24,3%, u usporedbi s 18,3% za skupinu koja je primala CAV protokol.
English: 5.2 Pharmacokinetic properties
Croatian: 5.2 Farmakokinetička svojstva Distribucija
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Croatian: • jaka bol u trbuhu, mučnina, povraćanje krvi, crne ili krvave stolice (mogući simptomi puknuća stijenke u probavnom traktu)
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95% CI: 0.78, 1.40).
Croatian: Omjer hazarda za preživljenje kod intravenski primijenjenog topotekana u odnosu na CAV protokol bio je 1,04 (95% CI: 0,78; 1,40).
English: • If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Korean patients with renal impairment had generally higher exposure than non-Asian patients with the same degree of renal impairment.
Croatian: U bolesnika korejskog podrijetla s oštećenjem bubrežne funkcije izloženost je u načelu bila viša nego u bolesnika koji nisu azijskog podrijetla, a imaju isti stupanj oštećenja bubrežne funkcije.
English: All cases were irrespective of associated causality.
Croatian: Nije bilo povezane uzročnosti u svim slučajevima.
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Croatian: Ako se tijekom liječenja kombinacijom topotekana i cisplatina vrijednost kreatinina poveća iznad 1,5 mg/dl, preporučuje se proučiti detaljne upute o lijeku za cisplatin radi informacije o smanjenju doze ili nastavku liječenja cisplatinom.
English: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Croatian: U slučaju prekida liječenja cisplatinom, nema dovoljno podataka o nastavku liječenja samim topotekanom u bolesnica s karcinomom vrata maternice.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima za citotoksične tvari.
English: 9/l and/or a platelet count of 100 x 10
Croatian: 9/l i/ili broj trombocita < 100 x 10
English: • if your blood cell counts are too low.
Croatian: • ako imate prenizak broj krvnih stanica.
English: Hyperbilirubinaemia
Croatian: Često hiperbilirubinemija
English: Red cell transfusions were given in 52% of patients (21% of courses).
Croatian: Transfuziju eritrocita primilo je 52% bolesnika (21% ciklusa).
English: Initial dose The recommended dose of HYCAMTIN capsules is 2.3 mg/m body surface area per day administered for five consecutive days with a three-week interval between the start of each course.
Croatian: Početna doza Preporučena doza HYCAMTIN kapsula je 2,3 mg/m tjelesne površine na dan, primijenjena tijekom pet uzastopnih dana, s intervalom od tri tjedna između početka svakog ciklusa.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Croatian: Nisu provedena ispitivanja farmakokinetičkih interakcija u ljudi in vivo.
English: Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Croatian: Umjerena do teška anemija (Stupanj 3 i 4 - Hb  8 g/dl) zabilježena je u 25% bolesnika (12% ciklusa).
English: ITT population Cisplatin 50 mg/m on day 1, every 21 days
Croatian: Uključene bolesnice (ITT populacija) cisplatin 50 mg/m 1. dana, svakih 21 dan cisplatin 50 mg/m
English: Therefore, use of the normal starting dose in patients with a mild decrease in renal function is considered established (see section 4.2).
Croatian: Stoga se smatra utemeljenim primijeniti uobičajenu početnu dozu u bolesnika s blagim smanjenjem bubrežne funkcije (vidjeti dio 4.2).
English: Plasma concentrations of total topotecan (i.e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hours.
Croatian: Vršne koncentracije ukupnog topotekana u plazmi (tj. laktonski i karboksilni oblici) postižu se približno nakon 2,0 sata, a topotekan laktona (aktivna tvar) nakon 1,5 sat i opadaju bieksponencijalno sa srednjim poluvijekom od približno 3,0 do 6,0 sati.
English: • Cervical cancer: 0.75 mg per square metre of body surface area per day.
Croatian: • Rak vrata maternice: 0,75 mg/m² tjelesne površine na dan.
English: In 46% of courses with moderate to severe anaemia, the duration was >7 days.
Croatian: U 46% ciklusa s umjerenom do teškom anemijom, trajanje je bilo > 7 dana.
English: Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Croatian: Hematotoksičnost topotekana je ovisna o dozi, te je stoga potrebno redovito određivanje kompletne krvne slike, uključujući broj trombocita (vidjeti dio 4.2).
English: When treating cervical cancer, Hycamtin is combined with another medicine called cisplatin.
Croatian: U liječenju raka vrata maternice Hycamtin se kombinira s drugim lijekom koji se zove cisplatin.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Croatian: Ukupni nalaz materijala povezanog s topotekanom nakon pet dnevnih doza topotekana iznosio je 71 do 76% intravenski primijenjene doze.
English: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
Croatian: • Ponekad jaka bol u trbuhu, vrućica i proljev (rijetko krvavi) mogu biti znakovi upale crijeva (kolitisa).
English: Hycamtin 1 mg capsules are pink and imprinted with “Hycamtin” and “1 mg”.
Croatian: Hycamtin 1 mg kapsule su ružičaste, s oznakom „Hycamtin“ i „1 mg“.
English: Moderate to severe (Hb 8.0 g/dl) in 37% of patients (14% of courses).
Croatian: Umjerena do teška anemija (Hb  8,0 g/dl) javila se u 37% bolesnika (14% ciklusa).
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95% CI: 0.45, 0.90).
Croatian: Neprilagođeni omjer hazarda za skupinu liječenu oralnim topotekanom uz BSC, u odnosu na skupinu koja je liječena samo BSC-om, iznosio je 0,64 (95% CI: 0,45; 0,90).
English: The dose of Hycamtin you are given will be worked out by your doctor, based on:
Croatian: Dozu lijeka Hycamtin će Vam propisati liječnik na temelju:
English: WARNING: Cytotoxic agents, special handling instructions (see Package Leaflet).
Croatian: UPOZORENJE: Citotoksičan lijek, posebne upute za rukovanje (vidjeti uputu o lijeku).
English: In 34% of courses with severe neutropenia, the duration was >7 days.
Croatian: U 34% ciklusa s teškom neutropenijom trajanje je bilo > 7 dana.
English: Keep the blister in the outer carton in order to protect from light.
Croatian: Blister čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Complete alopecia related/possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/possibly related to topotecan administration in 11% of patients.
Croatian: Potpuni gubitak kose povezan/vjerojatno povezan s primjenom topotekana zabilježen je u 9% bolesnika, a djelomičan gubitak kose povezan/vjerojatno povezan s primjenom topotekana u 11% bolesnika.
English: The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Croatian: Znakovi i simptomi primijećeni nakon predoziranja bili su u skladu s poznatim nuspojavama povezanima s primjenom topotekana (vidjeti dio 4.8).
English: Sealing band Gelatin
Croatian: Vrpca za pečaćenje želatina
English: Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1 x 10
Croatian: Daljnje doze Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije  1 x 10
English: Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Croatian: Proljev povezan s oralnim topotekanom može se pojaviti u isto vrijeme kad i uz terapiju povezana neutropenija i njene posljedice.
English: A major route of clearance of topotecan is by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Croatian: Glavni put klirensa topotekana je hidroliza laktonskog prstena koja stvara karboksilat otvorenog prstena.
English: The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor, based on:
Croatian: Dozu lijeka Hycamtin (broj kapsula) će Vam propisati liječnik na temelju:
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Croatian: Uključene su bile sljedeće vrste tumora: Ewingov sarkom/primitivni neuroektodermalni tumor, neuroblastom, osteoblastom i rabdomiosarkom.
English: Hard capsules
Croatian: tvrde kapsule
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Croatian: Primjena topotekana je kontraindicirana tijekom dojenja (vidjeti dio 4.3).
English: Your dose of Hycamtin may need to be adjusted.
Croatian: Možda će za Vam biti potrebna prilagodba doze lijeka Hycamtin.
English: 9/l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and
Croatian: 9/l) zabilježena je u 25% bolesnika (8% ciklusa), a umjerena (broj trombocita između 25,0 i 50,0 x 10
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34% of the value in control patients.
Croatian: U bolesnika s umjerenim oštećenjem bubrega klirens plazme za topotekan je smanjen na 34% vrijednosti kontrolne skupine.
English: Intravenous use.
Croatian: Za intravensku primjenu.
English: In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
Croatian: U randomiziranom komparativnom ispitivanju faze III Ginekološke onkološke grupe istraživača (ispitivanje GOG 0179), uspoređivana je kombinacija topotekana i cisplatina (n = 147) s monoterapijom cisplatinom (n = 146) u liječenju histološki potvrđenog perzistentnog recidivirajućeg karcinoma vrata maternice ili karcinoma vrata maternice stadija IVB koji nije bio pogodan za kurativno kirurško liječenje i/ili radioterapiju.
English: • Pregnant staff should be excluded from working with this medicinal product.
Croatian: • Trudne djelatnice ne smiju rukovati ovim lijekom.
English: No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
Croatian: U ispitivanjima reproduktivne toksičnosti u štakora nije zabilježen utjecaj na plodnost mužjaka ili ženki (vidjeti dio 5.3).
English: One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥90 days after completion of one prior regimen of chemotherapy (see Table 1).
Croatian: Jedno ispitivanje faze II (ispitivanje 065) i jedno faze III (ispitivanje 396) provedeno je radi procjene djelotvornosti peroralno i intravenski primijenjenog topotekana u bolesnika koji su imali recidiv nakon 90 ili više dana po završetku prethodnog kemoterapijskog protokola (vidjeti Tablicu 1).
English: The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Croatian: Antitumorska aktivnost topotekana uključuje inhibiciju topoizomeraze-I, enzima neposredno uključenog u replikaciju DNK koji opušta torzijsku napetost, što dovodi do razdvajanja DNK uzvojnice.
English: • Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
Croatian: • Rak jajnika i rak pluća malih stanica: 1,5 mg/m² tjelesne površine na dan.
English: Following co-administration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1000 mg with oral topotecan, the AUC0-∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Croatian: Nakon istodobne primjene inhibitora ABCB1 (P-gp) i ABCG2 (BCRP), elakridara (GF120918), u dozi od 100 do 1000 mg s oralnim topotekanom, AUC0-∞ topotekan laktona i ukupnog topotekana narasla je približno 2,5 puta (vidjeti dio 4.5).
English: Storage of the prepared solution
Croatian: Čuvanje pripremljene otopine
English: Proactive management of diarrhoea with anti-diarrhoeal agents is important.
Croatian: Važno je proaktivno zbrinjavati proljev antidijaroicima.
English: Loperamide was administered to 13% of patients in 5% of courses.
Croatian: Loperamid je primijenjen u 13% bolesnika, u 5% ciklusa.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Croatian: Bolesnice s prethodnom kemoradioterapijom cisplatinom cisplatin topotekan/cisplatin
English: What Hycamtin is and what it is used for What you need to know before you take Hycamtin How to take Hycamtin
Croatian: Što je Hycamtin i za što se koristi Što morate znati prije nego počnete uzimati Hycamtin Kako uzimati Hycamtin
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Croatian: Medijan vremena preživljenja bio je 62 tjedna za topotekan naspram 53 tjedna za paklitaksel (omjer hazarda 0,9 [0,6;
English: Median (95% CI) Hazard ratio (95% CI) Log rank p-value
Croatian: Medijan (95% CI) Omjer hazarda (95% CI) Log-rang p-vrijednost
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67% when compared with a control group of patients.
Croatian: Klirens plazme u bolesnika s oštećenjem jetre (vrijednosti bilirubina u serumu između 1,5 i 10 mg/dl) smanjen je na oko 67% u usporedbi s kontrolnom skupinom bolesnika.
English: However, there are insufficient data available to make a dose recommendation for this patient group.
Croatian: Međutim, nema dovoljno dostupnih podataka na temelju kojih bi se moglo preporučiti doziranje u ovoj skupini bolesnika.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Croatian: Primjena topotekana u monoterapiji i u kombinaciji s cisplatinom često je povezana s klinički značajnom trombocitopenijom.
English: The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Croatian: Iznad navedene nuspojave imaju veći potencijal pojavljivanja u bolesnika slabog općeg stanja (vidjeti dio 4.4).
English: Additional adverse events were seen when topotecan was given in combination with cisplatin; however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
Croatian: Prilikom primjene topotekana u kombinaciji s cisplatinom zabilježene su dodatne nuspojave; međutim one su bile zabilježene i u monoterapiji cisplatinom i nisu bile povezane s topotekanom.
English: The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
Croatian: Kapsule se moraju progutati cijele i ne smiju se žvakati, drobiti ili lomiti.
English: If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Hycamtin.
Croatian: Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka, cisplatina, koji primate zajedno s lijekom Hycamtin.
English: Those effects are described in the cisplatin patient leaflet.
Croatian: Te nuspojave opisane su u uputi o lijeku za cisplatin.
English: The recommended dose of topotecan is 1.5 mg/m body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Croatian: Preporučena doza topotekana je 1,5 mg/m tjelesne površine na dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno tijekom pet uzastopnih dana, s intervalom od tri tjedna između početka svakog ciklusa.
English: Currently there is only limited experience in combining oral topotecan with other chemotherapy agents.
Croatian: Trenutno iskustvo u primjeni oralnog topotekana s drugim kemoterapijskim lijekovima je ograničeno.
English: In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Croatian: U bolesnika s vrućicom, neutropenijom i pratećim bolovima u trbuhu, potrebno je posumnjati na neutropenijski kolitis.
English: In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose-limiting toxicity of topotecan monotherapy was found to be haematological.
Croatian: U ispitivanjima u kojima se utvrđuje doza lijeka, provedenima u 523 bolesnice s recidivom karcinoma jajnika i 631 bolesniku s recidivom karcinoma pluća malih stanica, hematotoksičnost se pokazala čimbenikom ograničenja doze u monoterapiji topotekanom.
English: Dosing recommendations for patients receiving oral topotecan with creatinine clearance less than 30 ml/min have not been established.
Croatian: Nisu ustanovljene preporučene doze za bolesnike koji uzimaju oralni topotekan s klirensom kreatinina manjim od 30 ml/min.
English: The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet).
Croatian: Ukupni sadržaj djelatne tvari u bočici iznosi 1 mg/ml djelatne tvari nakon pripreme kako je propisano (vidjeti uputu o lijeku).
English: Intravenous topotecan
Croatian: Intravenski topotekan
English: Titanium dioxide (E171)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171)
English: Administration of oral cyclosporine A (15 mg/kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0and 2.5-fold, respectively (see section 4.5).
Croatian: Primjena peroralnog ciklosporina A (15 mg/kg), inhibitora transportnih ABCB1 (P-gp) i ABCC1 (MRP-1), kao i metabolizirajućeg enzima CYP3A4, unutar 4 sata od oralnog topotekana povećala je dozu normalizirane AUC 0-24 h topotekan laktona približno 2,0 i ukupnog topotekana približno 2,5 puta (vidjeti dio 4.5).
English: Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Croatian: Ogulite vanjski ovoj: počevši od obojenog ugla, podignite i povucite ovoj.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10
Croatian: Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila  1,5 x 10
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Croatian: Cisplatin se primjenjuje prvog dana u obliku intravenske infuzije u dozi od 50 mg/m tjelesne površine/dan i to nakon doze topotekana.
English: Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Croatian: Kod bolesnica koje su prethodno liječene cisplatinom potrebna je dulja pauza kako bi se navedena kombinacija mogla primijeniti (vidjeti dio 5.1).
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Croatian: Standardizirani upitnici o simptomima koje su ispunjavali sami bolesnici , nakon otvorene (engl. unblinded) procjene pokazali su konzistentan trend u poboljšanju simptoma za oralni topotekan plus BSC.
English: topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects.
Croatian: U kliničkim se ispitivanjima primjena topotekana obustavljala ako je doza smanjena na 1,0 mg/m 2/dan i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole nuspojava lijeka.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Croatian: Peroralno i intravenski primijenjen topotekan pokazali su slično ublažavanje simptoma u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, standardiziranim upitnicima samih bolesnika na otvorenoj (engl. unblinded) skali procjene simptoma u svakoj od ove dvije studije.
English: The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Croatian: Medijan vremena do pojave proljeva stupnja 2 ili većeg bio je 9 dana.
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Croatian: Kad se topotekan koristi u kombinaciji s cisplatinom potrebno je slijediti upute za primjenu cisplatina.
English: The powder needs to be reconstituted and diluted before infusion.
Croatian: Prije primjene u obliku infuzije, prašak treba pripremiti i razrijediti.
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without GCSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Croatian: U farmakokinetičkom ispitivanju kod djece s refraktornim solidnim tumorima, ustanovljena maksimalna podnošljiva doza od 2,0 mg/m 2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF (vidjeti dio 5.2) na temelju toksičnosti ovisne o dozi u obliku mijelosupresije.
English: Titanium dioxide (E171) Red iron oxide (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, crveni (E172)
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Nuspojave unutar iste skupine učestalosti navedene su u padajućem nizu prema ozbiljnosti.
English: Erythropoietin was administered to 10% of patients in 8% of courses.
Croatian: Eritropoetin je bio primijenjen u 10% bolesnika u 8% ciklusa.
English: Since the vial contains a 10% overage, the clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Croatian: Kako bočica sadrži 10% suviška, rekonstituirana otopina je prozirna, žute do žuto-zelene boje i sadrži 1 mg topotekana u 1 ml otopine.