FrancophonIA/ELRC3.0 huggingface dataset:
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 24 weeks
Croatian: * Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 48 tj. u odnosu na Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 24 tj.:
English: Haemoglobin - stable cardiac disease decrease ≥ 2 g/dl during any 4 weeks
Croatian: Hemoglobin - stabilna bolest srca smanjenje
English: Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
Croatian: U kliničkim ispitivanjima tumora bubrežnih stanica odnosno kronične mijeloične leukemije, bolesnici su primali tjedne doze od 540 odnosno 630 mikrograma lijeka Pegasys.
English: Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
Croatian: Prilikom primjene alfa interferona, uključujući i Pegasys, zabilježeni su poremećaji u funkciji štitnjače odnosno pogoršanja već postojećih poremećaja štitnjače.
English: Pegasys is intended for subcutaneous use (under the skin).
Croatian: Pegasys je namijenjen za potkožnu primjenu.
English: Skin disorders: Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Muscle and bone disorders: Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija, artralgija bol u leđima, artritis, slabost mišića, bolovi u kostima, bol u vratu, bol u mišićima i kostima, grčevi u mišićima miozitis rabdomioliza
English: Rash, pruritus, alopecia
Croatian: povraćanje, dispepsija, disfagija,
English: ● If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/003
English: Dyspnoea exertional, epistaxis, nasopharyngit is, sinus congestion, nasal congestion, rhinitis, sore throat
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, kašalj dispneja u naporu, epistaksa, nazofaringitis, kongestija sinusa, kongestija nosa,
English: Breathing disorders: Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
Croatian: rinitis, grlobolja piskanje intersticijski pneumonitis uključujući smrtni ishod, plućna embolija plućna arterijska hipertenzija§
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta bol u uhu
English: Keep the pre-filled pen in the outer carton in order to protect from light
Croatian: Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Croatian: Pegasys 180 mikrograma otopina za injekciju u napunjenoj štrcaljki peginterferon alfa-2a
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Croatian: Pegasys 180 mikrograma otopina za injekciju u napunjenoj brizgalici peginterferon alfa-2a
English: Pegasys dosing
Croatian: Pegasys.
English: cells/mm3
Croatian: ≥ 1000 stanica/mm
English: acetic acid and water for injections.
Croatian: bočica s Pegasys otopinom za injekciju
English: Substance overdose
Croatian: Velika količina virusa
English: Dyspnoea, cough
Croatian: disfagija,
English: Hepatic failure, cholangitis, fatty liver
Croatian: streptokokni faringitis, gripa,
English: Hold the pre-filled pen comfortably in your hand.
Croatian: 6) Postavite napunjenu brizgalicu na mjesto injekcije Napunjenu brizgalicu držite opušteno u ruci.
English: Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Croatian: U bolesnika liječenih kombinacijom lijeka Pegasys i ribavirina, prijavljeni su poremećaji zubi i desni koji mogu izazvati gubitak zuba.
English: Always wash hands after removing gloves.
Croatian: Uvijek operite ruke nakon skidanja rukavica.
English: CI = Confidence interval.
Croatian: CI = interval pouzdanosti.
English: This treatment cycle will normally be repeated every three weeks.
Croatian: Ovaj ciklus liječenja će se obično ponoviti svaka tri tjedna.
English: Reactions have been mild and have not generally required specific therapy
Croatian: Reakcije su bile blage i općenito nisu zahtijevale specifičnu terapiju.
English: If you are or think you might be pregnant, tell your doctor immediately.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, odmah o tome obavijestite svog liječnika.
English: Talk to your doctor for advice on how to minimize the risk of bleeding.
Croatian: Pitajte svog liječnika za savjet kako smanjiti rizik od krvarenja.
English: See section 6.6.
Croatian: Vidjeti dio 6.6.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Croatian: Srednja vrijednost poluvijeka se povećala s 1,9 sati na 4,9 sati.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Croatian: To može dovesti do teškog krvarenja nakon relativno malih ozljeda poput male posjekotine.
English: Extravasation has been reported very rarely.
Croatian: 3Vrlo rijetko je zabilježena ekstravazacija.
English: Table 2 Study results Study GOG-0179
Croatian: Rezultati ispitivanja studije GOG-0179
English: Yellow lyophilisate.
Croatian: Žuti liofilizat.
English: The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some ways feeling unwell.
Croatian: Liječnik će procijeniti Vaše opće zdravstveno stanje tijekom liječenja, stoga mu/joj recite ako imate vrućicu, infekciju ili se na neki način ne osjećate dobro.
English: You must tell your doctor immediately if you experience any of the following serious side effects.
Croatian: Morate odmah obavijestiti svog liječnika ako primijetite bilo koju od sljedećih ozbiljnih nuspojava.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Croatian: Nadalje, 5% svih liječenih bolesnika (1% ciklusa) je razvilo sepsu (vidjeti dio 4.4).
English: Other medicines and Topotecan Actavis Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Topotecan Actavis Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed.
Croatian: Poluvrijeme topotekana povećalo se oko 30% bez opaženih jasnih promjena u volumenu distribucije.
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57) and a relatively short half-life of 2-3 hours.
Croatian: Topotekan je također imao veliki volumen distribucije, oko 132 l (SD 57) te relativno kratki poluvijek od 2-3 sata.
English: However there are insufficient data available to make a dose recommendation for this patient group.
Croatian: Međutim, nema dovoljno dostupnih podataka za preporuku za doziranje u ovoj skupini bolesnika.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Croatian: Usporedba farmakokinetičkih parametara nije pokazivala promjene u farmakokinetici tijekom 5 dana doziranja.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Croatian: Topotekan je ispitivan i u pedijatrijskoj populaciji, međutim, dostupni su samo ograničeni podaci o njegovoj djelotvornosti i sigurnosti primjene.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000), uključujući izolirana izvješća i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Use in children and adolescents The experience in children and adolescents is limited and treatment is therefore not recommended.
Croatian: Primjena u djece i adolescenata Iskustvo u djece i adolescenata je ograničeno te se stoga ovaj lijek ne preporučuje za liječenje.
English: If severe it may cause breathing difficulties.
Croatian: U teškim stanjima mogu nastupiti poteškoće u disanju.
English: - If you have any further questions, ask your doctor or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku ili medicinskoj sestri.
English: Liquid waste may be flushed with large amounts of water.
Croatian: Tekući se otpad može isprati obilnim količinama vode.
English: 30 minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Croatian: u obliku 30-minutne infuzije tijekom 5 dana ponavljano svaka 3 tjedna, u trajanju do godine dana, ovisno o odgovoru na terapiju.
English: Among all patients treated in clinical trials (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 liječenim u kliničkim ispitivanjima (uključujući one s teškom neutropenijom i one koji nisu razvili tešku neutropeniju), 11% (4% ciklusa) je razvilo vrućicu, a 26% bolesnika (9% ciklusa) je razvilo infekciju.
English: If you experience this, do not drive or use machines.
Croatian: Ako se osjećate umornim ili slabim, nemojte upravljati vozilima ili raditi sa strojevima.
English: They may require hospitalisation and could even be life-threatening.
Croatian: Takve nuspojave može biti potrebno liječiti u bolnici, a mogu biti čak i opasne po život.
English: This concentrate (1 mg/ml) must be diluted prior to administration.
Croatian: Dobiveni koncentrat (1 mg/ml) mora se razrijediti prije primjene.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17.
Croatian: Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: L01XX17.
English: It must be reconstituted and further diluted before use (see section 6.6).
Croatian: Lijek se mora rekonstituirati i dodatno razrijediti prije primjene (vidjeti dio 6.6).
English: hypersensitivity reaction including rash
Croatian: reakcija preosjetljivosti uključujući osip
English: Antitumour activity was demonstrated primarily in patients with neuroblastoma.
Croatian: Antitumorsko djelovanje dokazano je prvenstveno u bolesnika s neuroblastomom.
English: Each vial is sheathed in a protective sleeve.
Croatian: Svaka bočica je omeđena zaštitnim omotom.
English: A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes.
Croatian: Liječnik ili medicinska sestra dat će Vam pripremljenu i razrijeđenu otopinu lijeka Topotecan Actavis u obliku infuzije (drip) koja se obično daje u ruku, u trajanju oko 30 minuta.
English: There were no signs of cumulative haematological or non-haematological toxicity.
Croatian: Nema znakova koji bi upućivali na kumulativnu hematološku ili nehematološku toksičnost.
English: The preparation should be performed in a designated area under aseptic conditions.
Croatian: Priprema se mora provesti u posebnom prostoru uz aseptičke uvjete rada.
English: Metabolism accounts for < 10 % of the elimination of topotecan.
Croatian: Metaboliziranjem se eliminira < 10% topotekana.
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 ljudske citosolne enzime dihidropirimidin ili ksantin oksidazu.
English: Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Croatian: Ostali teški događaji koji su se pojavili u bolesnika a koji su bili povezani ili se mogu povezati s liječenjem topotekanom bile su anoreksija (12%), malaksalost (3%) i hiperbilirubinemija (1%).
English: Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes.
Croatian: Moraju se poduzeti mjere opreza kako bi se izbjegao slučajni kontakt lijeka s očima.
English: Before infusion, Topotecan Actavis powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows:
Croatian: Prije infuzije, Topotecan Actavis prašak za koncentrat za otopinu za infuziju mora se rekonstituirati s odgovarajućim volumenom vode za injekcije, na sljedeći način:
English: Topotecan Actavis is available in cartons containing 1 vial and 5 vials.
Croatian: Topotecan Actavis je dostupan u kutijama koje sadrže 1 bočicu i 5 bočica.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3.
Croatian: Važno je točno procijeniti funkcionalno stanje bolesnika u vrijeme davanja terapije kako bi se moglo utvrditi da se ono nije pogoršalo na PS 3.
English: What Topotecan Actavis is and what it is used for What you need to know before you use Topotecan Actavis How to use Topotecan Actavis Possible side effects
Croatian: Što je Topotecan Actavis i za što se koristi Što morate znati prije nego počnete primjenjivati Topotecan Actavis Kako primjenjivati Topotecan Actavis Moguće nuspojave
English: 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Croatian: godina, n=18), adolescenata (u dobi od 12 do 16 godina, n=9) i mlađih odraslih osoba (u dobi od 16 do 21 godine, n=9) s refraktornim solidnim tumorima.
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: Topotecan Actavis is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Croatian: Topotecan Actavis se ne preporučuje u slučaju teškog oštećenja jetre. ako bolujete od upale pluća sa simptomima kao što su kašalj, vrućica i otežano disanje, pogledajte također dio 4 „Moguće nuspojave“.
English: Do not use Topotecan Actavis - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding.
Croatian: Nemojte primjenjivati Topotecan Actavis ako ste alergični na topotekan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); ako dojite.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, odgovornost o vremenu i uvjetima čuvanja prije primjene preuzima korisnik; odgoda u normalnim uvjetima ne bi smjela biti dulja od 24 sata na temperaturi od 2°C do 8°C, osim kad su rekonstitucija/razrjeđivanje izvedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Croatian: Ukoliko bolesnici dobro podnose topotekan, liječenje se može nastaviti sve do progresije bolesti (vidjeti dijelove 4.8 i 5.1).
English: anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Croatian: anoreksija (koja može biti teška) Poremećaji dišnog sustava, prsišta i sredoprsja Rijetko:
English: Talk to your doctor before using Topotecan Actavis: - if you have any kidney problems.
Croatian: Obratite se svom liječniku prije nego primijenite Topotecan Actavis: ako imate bilo kakvih problema s bubrezima.
English: Adequate protective disposable gloves, goggles, gown and mask should be worn.
Croatian: Moraju se nositi odgovarajuće zaštitne jednokratne rukavice, naočale, ogrtač i maske.
English: Your dose of Topotecan Actavis will depend on: - the disease being treated, - your body surface area (m - the results of blood tests carried out before and during treatment, - how well you tolerate treatment.
Croatian: Doza lijeka Topotecan Actavis će ovisiti o: bolesti koja se liječi, površini Vašeg tijela (m2), rezultatima krvnih pretraga koje se provode prije i tijekom liječenja, tome kako podnosite liječenje.
English: As 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: Prema očekivanjima, bolesnici slabijeg funkcionalnog stanja (PS > 1, engl. performance status) imaju slabiju stopu odgovora na liječenje i veću incidenciju komplikacija poput vrućice, infekcije i sepse (vidjeti dio 4.8).
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 pokazuju da je vezanje topotekana za proteine plazme nisko (35%), a distribucija između krvnih stanica i plazme jednakomjerna.
English: This should be taken into account, when prescribing topotecan e.g. in case patients at increased risk of tumour bleeds are considered for therapy.
Croatian: To treba uzeti u obzir kod propisivanja topotekana, npr. u slučaju kada se bolesnici s povećanim rizikom krvarenja zbog tumora razmatraju za terapiju.
English: What Topotecan Actavis is and what it is used for
Croatian: Što je Topotecan Actavis i za što se koristi
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: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Croatian: Podležeći rizični faktori uključuju anamnezu IBP-a, plućne fibroze, karcinoma pluća, izloženosti prsišta zračenju i uporabe pneumotoksičnih tvari i/ili čimbenika stimulacije kolonija.
English: As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.
Croatian: Kao i kod svih citotoksičnih kemoterapija, nužno je savjetovati primjenu učinkovitih metoda kontracepcije tijekom liječenja topotekanom bilo kojeg od partnera.
English: Topotecan Actavis INSTRUCTIONS ON USE
Croatian: Topotecan Actavis UPUTE ZA UPORABU
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 inaktivnog oblika).
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance <20 ml/min.
Croatian: Nema dovoljno podataka za preporuku doziranja u bolesnika s klirensom kreatinina <20 ml/min.
English: What you need to know before you use Topotecan Actavis
Croatian: Što morate znati prije nego počnete primjenjivati Topotecan Actavis
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Croatian: U rijetkim slučajevima može doći do teškog krvarenja (hemoragija).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic, special handling instructions (see package leaflet).
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksičan lijek, posebne upute za rukovanje (vidjeti Uputu o lijeku).
English: In an open-label trial involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m given as a
Croatian: U otvorenom ispitivanju u koje su bila uključena djeca (n=108, raspon dobi: od dojenačke dobi do 16 godina) s recidivirajućim ili progresivnim solidnim tumorima, topotekan se primjenjivao u početnoj dozi od 2,0 mg/m2
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Croatian: intersticijska bolest pluća (neki slučajevi su bili fatalni) Poremećaji probavnog sustava Vrlo često:
English: Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
Croatian: Topotekan u kombinaciji s cisplatinom indiciran je za bolesnice s recidivom karcinoma vrata maternice nakon provedene radioterapije i za bolesnice u IVB stadiju bolesti.
English: Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Croatian: Toksičnost topotekana u pedijatrijskih bolesnika s recidivirajućim i refraktornim solidnim tumorima slična je onoj već zabilježenoj u odraslih bolesnika.
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 bolesnica zatrudni tijekom liječenja topotekanom, bolesnica mora biti upozorena na potencijalne štetne učinke na fetus.
English: 1 x 1 mg vial; 5 x 1 mg vial 1 x 4 mg vial; 5 x 4 mg vial
Croatian: 1 bočica x 1 mg; 5 bočica x 1 mg 1 bočica x 4 mg; 5 bočica x 4 mg
English: Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Croatian: Ukupni povrat materijala povezanog s lijekom nakon pet dnevnih doza topotekana iznosio je 71 do 76% intravenski primijenjene doze.
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Croatian: S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bukurešt Rumunjska
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Croatian: U studijama reproduktivne toksičnosti u štakora nije zabilježen učinak na fertilitet u mužjaka i ženki, dok je u ženki primijećena superovulacija i malo povećani gubitak prije implantacije.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Croatian: Često zabilježene nehematološke nuspojave bile su gastrointestinalne poput mučnine (52%), povraćanja (32%) i proljeva (18%), konstipacije (9%) i mukozitisa (14%).
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Croatian: Anemija: umjerena do teška anemija (Hb ≤8,0 g/dl) javila se u 37% bolesnika (14% ciklusa).
English: Topotecan Actavis can make you feel tired or weak.
Croatian: Topotecan Actavis može izazivati osjećaj umora ili slabosti.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: DATUM REVIZIJE TEKSTA Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Doses should be similarly reduced if the platelet count falls below 25 x 10 9/l.
Croatian: Doze bi trebalo smanjiti na sličan način ako broj trombocita padne ispod 25 x 109/l.