FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose
Croatian: Uobičajena doza
English: This treatment schedule is repeated every 21 days for six courses or until progressive disease.
Croatian: Ovaj protokol ponavlja se tijekom šest ciklusa u intervalima od 21 dan ili do progresije bolesti.
English: As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
Croatian: Kao i kod svih citotoksičnih lijekova, bolesnicima koji su liječeni topotekanom nužno je savjetovati da oni i njihovi partneri moraju koristiti učinkovite metode kontracepcije.
English: Date of first authorisation: 12 November 1996 Date of latest renewal: 20 November 2006
Croatian: Datum posljednje obnove odobrenja: 20. studenog 2006.
English: Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Croatian: Bolesnici s klirensom kreatinina > 60 ml/min uključeni su u ispitivanja djelotvornosti/sigurnosti topotekana.
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Croatian: Topotekan ne inhibira ljudske P450 enzime (vidjeti dio 5.2).
English: You will have treatment once a day for 3 days.
Croatian: Liječenje ćete primati jednom dnevno tijekom 3 dana.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents: ATC code: L01XX17.
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici, ATK oznaka: L01XX17.
English: Clinical guidelines describing the aggressive management of CTID include specific recommendations on patient communication and awareness, recognition of early warning signs, use of anti-diarrhoeals and antibiotics, changes in fluid intake and diet, and need for hospitalisation (see sections 4.2 and 4.8).
Croatian: Kliničke smjernice koje propisuju agresivno zbrinjavanje CTID uključuju specifične preporuke o komunikaciji i osviještenosti bolesnika, prepoznavanju ranih znakova upozorenja, korištenju antidijaroika i antibiotika, promjenama u uzimanju tekućine i prehrani te o potrebi za hospitalizacijom (vidjeti dijelove 4.2 i 4.8).
English: Signs include: difficulty breathing cough fever.
Croatian: Znakovi uključuju: otežano disanje kašalj vrućicu.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Croatian: Važno je točno procijeniti opće stanje bolesnika prije početka terapije kako bi se moglo utvrditi da se ono nije pogoršalo na PS 3.
English: There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A. You will be monitored closely if you are taking both these medicines.
Croatian: Veća je vjerojatnost nuspojava ukoliko se liječite i ciklosporinom A. Pažljivo će Vas se pratiti ako uzimate ova dva lijeka.
English: If you forget to take Hycamtin
Croatian: Ako ste zaboravili uzeti Hycamtin
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje mora biti sukladno kliničkoj indikaciji ili preporukama nacionalnog centra za kontrolu otrovanja, ako on postoji.
English: Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolised to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Croatian: Osim hidrolizom, topotekan se uklanja uglavnom putem bubrega s manjom komponentom metaboliziranom u N-desmetil metabolit (SB-209780) koji je identificiran u plazmi, urinu i fecesu.
English: • Hair loss.
Croatian: • ispadanje kose
English: Area under the curve increased approximately in proportion to the increase in dose.
Croatian: Područje ispod krivulje koncentracije povećavalo se proporcionalno povećanju doze.
English: Diarrhoea, including severe diarrhoea requiring hospitalisation, has been reported during treatment with oral topotecan.
Croatian: Proljev, uključujući i teški proljev koji zahtjeva hospitalizaciju, prijavljen je tijekom liječenja oralnim topotekanom.
English: The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies.
Croatian: Farmakokinetika topotekana primijenjenog u obliku 30-minutne infuzije tijekom 5 dana procjenjivana je u dva ispitivanja.
English: • Allergic or hypersensitivity reactions (including rash).
Croatian: • alergijske reakcije ili reakcije preosjetljivosti (uključujući osip)
English: Combination therapy (cervical carcinoma):
Croatian: Kombinacijska terapija (karcinom vrata maternice):
English: Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in pharmacokinetics after multiple doses.
Croatian: Postoji malo ili ništa nakupljanja topotekana pri ponovljenom dnevnom doziranju i nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
English: These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Croatian: Ove podatke potrebno je promatrati u kontekstu cjelokupnog sigurnosnog profila lijeka, posebice s aspekta njegove značajne hematotoksičnosti (vidjeti dio 4.8).
English: • Yellow skin.
Croatian: • žutilo kože
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Croatian: Provedena je i dodatna retrospektivna analiza podataka dobivenih od 523 bolesnice s recidivom karcinoma jajnika.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11% (4% of courses) developed fever and 26% (9% of courses) developed infection.
Croatian: Među svim bolesnicima u kliničkim ispitivanjima (uključujući one s teškom neutropenijom i bez nje), 11% (4% ciklusa) je razvilo vrućicu, a 26% bolesnika (9% ciklusa) infekciju.
English: • Severe allergic or anaphylactic reactions.
Croatian: • teške alergijske ili anafilaktičke reakcije
English: • If you have any further questions, ask your doctor.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku.
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Croatian: • gubitak na težini i gubitak teka (anoreksija); umor; slabost
English: In course 1 the incidence was 20%, by course 4 the incidence was 8%.
Croatian: Tijekom prvog ciklusa incidencija je bila 20%, a do četvrtog ciklusa incidencija je bila 8%.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
Croatian: (mogući znakovi i simptomi upale sluznice usta, želuca i/ili crijeva [upala sluznice])
English: A cross-study analysis in 217 patients with advanced solid tumours indicated that gender did not affect the pharmacokinetics of HYCAMTIN capsules to a clinically relevant extent.
Croatian: Ukrižena analiza ispitivanja na 217 bolesnika s uznapredovalim solidnim tumorima ukazala je da spol ne utječe na farmakokinetiku HYCAMTIN kapsula u klinički značajnoj mjeri.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • Feeling generally weak and tired (temporary anaemia).
Croatian: • osjećaj opće slabosti i umora (privremena anemija).
English: • if you have any kidney or liver problems.
Croatian: • ako imate bilo kakvih problema s bubrezima ili s jetrom.
English: Age/weight
Croatian: Dob/tjelesna težina
English: Severe hypersensitivity to the active substance or to any of the excipients.
Croatian: Jaka preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari.
English: How Hycamtin is given A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
Croatian: Kako se primjenjuje Hycamtin Liječnik ili medicinska sestra će Vam dati Hycamtin u obliku infuzije u ruku u trajanju od 30 minuta.
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Croatian: In vitro topotekan ne inhibira ljudske P450 enzime CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ili CYP4A, niti inhibira citosolne enzime dihidropirimidin ili ksantin oksidazu.
English: Hycamtin is used to treat:
Croatian: Hycamtin se primjenjuje u liječenju:
English: Doses should be similarly reduced if the platelet count falls below 25 x 10
Croatian: Dozu je potrebno smanjiti na isti način ako broj trombocita padne ispod 25 x 10
English: Do not take Hycamtin:
Croatian: Nemojte uzimati Hycamtin:
English: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany
Croatian: Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nürnberg, Njemačka
English: Metabolism accounts for <10% of the elimination of topotecan.
Croatian: Metaboliziranjem se eliminira < 10% topotekana.
English: Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
Croatian: Proljev uzrokovan liječenjem karcinoma (CTID od engl. cancer treatment-induced diarrhoea) povezan je sa značajnim morbiditetom i može biti opasan po život.
English: Contact a doctor or pharmacist immediately for advice if you have taken too many capsules or if a child has accidentally taken the medicine.
Croatian: Ako uzmete više lijeka Hycamtin nego što ste trebali Odmah se obratite liječniku ili ljekarniku radi savjeta ukoliko ste uzeli previše kapsula ili ako je dijete slučajno uzelo lijek.
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Croatian: Ograničeni podaci upućuju na to da je potrebno smanjiti dozu u bolesnika s umjerenim oštećenjem bubrega.
English: • Mild pain and inflammation at the site of injection.
Croatian: • blaga bol i upala na mjestu primjene injekcije
English: In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Croatian: U populacijskim ispitivanjima, razni čimbenici uključujući dob, tjelesnu težinu i ascites, nisu imali značajan učinak na klirens ukupnog topotekana (aktivnog i neaktivnog oblika).
English: As would be expected, patients with poor performance status (PS >1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Croatian: Kao što se može očekivati, bolesnici slabijeg općeg stanja (PS > 1, od engl. performance status) imaju slabiji odgovor na liječenje i veću incidenciju komplikacija poput vrućice, infekcija i sepse (vidjeti dio 4.8).
English: Initial dose
Croatian: Početna doza
English: Pancytopenia has been reported.
Croatian: Prijavljena je pancitopenija.
English: 4.1 Therapeutic indications
Croatian: KLINIČKI PODACI 4.1 Terapijske indikacije
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzimajte Hycamtin točno onako kako Vam jer rekao liječnik.
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Croatian: Reakcije preosjetljivosti, koje uključuju osip, urtikariju, angioedem i anafilaktične reakcije su rijetko prijavljivane.
English: A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Croatian: Lijek će Vam primijeniti liječnik ili medicinska sestra u obliku intravenske infuzije u bolnici.
English: What Hycamtin contains
Croatian: Što Hycamtin sadrži
English: Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Croatian: Primjenu intravenskog topotekana treba razmotriti u sljedećim kliničkim situacijama: nekontrolirano povraćanje, poremećaji gutanja, nekontrolirani proljev, klinička stanja i liječenje koji mogu promijeniti gastrointestinalni motilitet i apsorpciju lijeka.
English: Separate one capsule: tear along the perforated lines to separate one capsule “pocket” from the strip.
Croatian: 1. Odvojite jednu kapsulu: otrgnite duž perforirane linije kako biste odvojili jedan „džepić“ s kapsulom od ostalih.
English: Paediatric population The safety and effectiveness of oral topotecan in paediatric patients have not been established.
Croatian: Pedijatrijska populacija Sigurnost i učinkovitost oralnog topotekana nisu ustanovljene u dječjoj populaciji.
English: 2, constipation, mucositis, dyspepsia
Croatian: 2, konstipacija, mukozitis, dispepsija
English: Limited data in Korean patients with creatinine clearance less than 50 ml/min suggest a further lowering of dose may be required (see section 5.2).
Croatian: Malobrojni podaci prikupljeni u bolesnika korejskog podrijetla s klirensom kreatinina manjim od 50 ml/min ukazuju na to da bi moglo biti potrebno daljnje smanjenje doze (vidjeti dio 5.2).
English: Topotecan is partly eliminated via renal excretion and renal impairment might lead to increased exposure to topotecan.
Croatian: Topotekan se djelomično eliminira renalnom ekskrecijom i oštećenje bubrega može dovesti do povećane izloženosti topotekanu.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Croatian: Pretklinička ispitivanja ukazuju na nisko vezanje topotekana na proteine plazme (35%) i prilično homogenu distribuciju između krvnih stanica i plazme.
English: As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Croatian: Kao i ostali citotoksični lijekovi, topotekan može uzrokovati fetalna oštećenja i stoga je ženama u generativnoj dobi potrebno savjetovati da izbjegavaju trudnoću tijekom liječenja topotekanom.
English: Patients should be carefully monitored for adverse reactions when oral topotecan is administered with a substance known to inhibit ABCB1 or ABCG2 (see section 5.2).
Croatian: Potrebno je pažljivo pratiti nuspojave u bolesnika u kojih se oralni topotekan primjenjuje istovremeno s tvari za koju se zna da inhibira ABCB1 ili ABCG2 (vidjeti dio 5.2).
English: The carcinogenic potential of topotecan has not been studied.
Croatian: Nisu provedena klinička ispitivanja karcinogenog potencijala topotekana.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI
English: Severe neutropenia lasted beyond seven days in 11% of courses overall.
Croatian: Teška neutropenija, koja traje dulje od sedam dana javila se u ukupno 11% ciklusa.
English: If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.
Croatian: Ukoliko se topotekan primjenjuje tijekom trudnoće ili ukoliko bolesnica zatrudni tijekom liječenja, bolesnicu se mora upozoriti na potencijalne rizike za fetus.
English: The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
Croatian: Bioraspoloživost peroralnog topotekana u ljudi (ukupni i lakton) je približno 40%.
English: Instructions on how to reconstitute, store and dispose of Hycamtin
Croatian: Upute za rekonstituciju, čuvanje i odlaganje lijeka Hycamtin
English: Topotecan was also shown to cause embryo-foetal lethality when given to rats and rabbits.
Croatian: Pokazalo se da je topotekan uzrokovao smrt embrija i fetusa kada se davao štakorima i kunićima.
English: • The active substance is topotecan.
Croatian: • Djelatna tvar je topotekan.
English: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Croatian: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
English: Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Croatian: Topotekan se smije primjenjivati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije (vidjeti dio 6.6).
English: The second study included a dose range of 2.0 to 5.2 mg/m in children (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Croatian: U drugom ispitivanju raspon doza bio je 2,0 do 5,2 mg/m u djece (n = 8), adolescenata (n = 3) i mlađih odraslih osoba (n = 3) s leukemijom.
English: Do not use this medicine after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: However in the two studies in which both oral and intravenous topotecan were administered, patients over 65 years old receiving oral topotecan experienced an increase in drugrelated diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
Croatian: Međutim, u dva ispitivanja u kojima je primjenjivan i oralni i intravenski topotekan, bolesnici stariji od 65 godina koji su dobivali oralni topotekan imali su više lijekom izazvanih proljeva u usporedbi s onima mlađima od 65 godina (vidjeti dijelove 4.4 i 4.8).
English: Elm Park, Merrion Road Dublin 4
Croatian: Elm Park, Merrion Road
English: You should use an effective method of contraception.
Croatian: Koristite učinkovite metode zaštite od trudnoće.
English: This can be serious.
Croatian: • Proljev: ovo može biti ozbiljno.
English: There is no known antidote for topotecan overdose.
Croatian: Nema poznatog protulijeka za predoziranje topotekanom.
English: The extent of exposure was similar following a high-fat meal and in the fasted state, while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
Croatian: Razina izloženosti bila je slična nakon obroka bogatog mastima i natašte, dok je tmax bio odgođen s 1,5 na 3 sata (topotekan lakton) i s 3 na 4 sata (ukupni topotekan).
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16%.
Croatian: Stopa odgovora na liječenje u skupini bolesnica s karcinomom jajnika (n = 392, koje su sve prethodno liječene cisplatinom ili cisplatinom i paklitakselom) bila je 16%.
English: Tell your doctor if any of these applies to you.
Croatian: Obavijestite liječnika ukoliko se nešto od gore navedenog odnosi na Vas.
English: Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2,536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Croatian: Podaci o sigurnosti primjene temelje se na integriranim podacima o 682 bolesnika s recidivirajućim karcinomom pluća u kojih je primijenjeno 2536 ciklusa monoterapije oralnim topotekanom (275 bolesnika s recidivirajućim SCLC-om i 407 bolesnika s recidivirajućim ne-SCLC-om).
English: If well tolerated, the dose may be increased to 2.3 mg/m 2/day in subsequent cycles (see section 5.2).
Croatian: Ako se ta doza dobro podnosi, može se u sljedećim ciklusima povećati na 2,3 mg/m2/dan (vidjeti dio 5.2).
English: Patients with Grade 2 diarrhoea may need to follow the same dose modification guidelines.
Croatian: Bolesnici s proljevom stupnja 2 također mogu zatrebati sličnu modifikaciju doze lijeka.
English: Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
Croatian: Vaš liječnik će u dogovoru s Vama odlučiti je li liječenje lijekom Hycamtin za Vas bolje od nastavka liječenja dosadašnjom terapijom.
English: Capsule contents Hydrogenated vegetable oil Glyceryl monostearate
Croatian: Sadržaj kapsule hidrogenirano biljno ulje glicerolmonostearat
English: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italy.
Croatian: GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italija.
English: • Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage.
Croatian: • Upala pluća (intersticijska bolest pluća): Pod povišenim ste rizikom ukoliko već imate bolest pluća, bili ste liječeni zračenjem pluća, ili ako ste prije uzimali lijekove koji mogu oštetiti pluća.
English: Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Croatian: Važna je komunikacija s bolesnicima vezana za ove nuspojave prije primjene lijeka kao i proaktivno zbrinjavanje ranih i svih znakova i simptoma proljeva.
English: It is available in packs containing either 1 or 5 glass vials; each vial contains 1 mg or 4 mg of topotecan.
Croatian: Dostupan je u kutiji s 1 ili 5 staklenih bočica; jedna bočica sadrži 1 mg ili 4 mg topotekana.
English: Skin and subcutaneous tissue disorders Very common Alopecia Common
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često alopecija
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Croatian: O-glukuronida topotekana i N-desmetil O-glukuronida topotekana u urinu bilo je manje od 2,0%.
English: Ask your doctor for advice.
Croatian: Posavjetujte se s liječnikom.
English: • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Croatian: • bolesnica s metastatskim karcinomom jajnika nakon neuspjeha prve i naknadnih linija liječenja
English: Signs include: fever serious deterioration of your general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).
Croatian: Znakovi uključuju: vrućicu ozbiljno pogoršanje općeg stanja lokalne simptome kao što su grlobolja ili problemi s mokrenjem (npr. osjećaj pečenja pri mokrenju, što može biti simptom infekcije mokraćnih putova).
English: This should be taken into account when prescribing HYCAMTIN, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Croatian: To treba uzeti u obzir kod uključivanja HYCAMTIN-a u terapiju, npr. u bolesnika s povećanim rizikom za krvarenje zbog tumora.
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30-minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Croatian: Nakon intravenske primjene topotekana u dozi od 0,5 do 1,5 mg/m u obliku 30-minutne infuzije dnevno tijekom 5 dana, topotekan je pokazao visoki klirens iz plazme u vrijednosti od 62 l/h (SD 22), koji odgovara približno 2/3 protoka krvi kroz jetru.
English: Oral topotecan
Croatian: Oralni topotekan
English: Hycamtin contains ethanol This medicine contains small amounts of ethanol (alcohol).
Croatian: Ovaj lijek sadrži malu količinu etanola (alkohola).
English: As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Croatian: Kao i kod ostalih citotoksičnih lijekova, topotekan može uzrokovati tešku mijelosupresiju.