FrancophonIA/ELRC3.0 huggingface dataset:
English: Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
Croatian: - ranice u ustima, otežano gutanje, bol u trbuhu, mučnina, povraćanje, proljev, krvave stolice (mogući znakovi i simptomi upale sluznice usta, želuca i/ili crijeva [upala sluznice]).
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Croatian: Potrebno je slijediti sljedeća pravila za ispravno rukovanje i zbrinjavanje lijekova za liječenje raka, tj.:
English: Initial dose The recommended dose of topotecan is 1.5 mg/m2 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/m2 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: (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Croatian: 5,2 mg/m2 u djece (n=8), adolescenata (n=3) i mlađih odraslih osoba (n=3) s leukemijom.
English: Potactasol may cause a decrease in the number of blood clotting cells (platelets).
Croatian: Potactasol može uzrokovati smanjenje broja krvnih stanica koje omogućavaju zgrušavanje krvi (trombociti).
English: pancytopenia
Croatian: pancitopenija
English: Other side effects with Potactasol include: Very common side effects (may affect more than 1 in 10 people)
Croatian: Ostale nuspojave lijeka Potactasol su: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake
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 zabilježeni su dodatni štetni događaj; međutim ti događaji bili su zabilježeni i u monoterapiji cisplatinom i nisu bili povezani s topotekanom.
English: Potactasol is not recommended in case of severe kidney impairment; - if you have liver problems.
Croatian: Potactasol se ne preporučuje u slučaju teškog oštećenja jetre.
English: Ovarian cancer and small cell lung cancer
Croatian: Rak jajnika i rak pluća malih stanica
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/m2 tjelesne površine/dan i to nakon doze topotekana.
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2).
Croatian: - Drugi sastojci su: manitol (E421), tartaratna kiselina (E334), kloridna kiselina (E507) i natrijev hidroksid (pogledajte dio 2).
English: Potactasol 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: - ako bolujete od upale pluća sa znakovima kao što su kašalj, vrućica i otežano disanje; pogledajte također dio 4 „Moguće nuspojave“.
English: In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Croatian: U komparativnom ispitivanju topotekana i paklitaksela u bolesnica s karcinomom jajnika prethodno liječenih kemoterapijom temeljenom na platini (n = 112 odnosno n = 114), stopa odgovora na lijek (95% CI) iznosila je 20,5% (13%, 28%) naspram 14% (8%, 20%), a medijan vremena do progresije iznosio je 19 tjedana naspram 15 tjedana (omjer hazarda 0,7 [0,6; 1,0]) za topotekan odnosno paklitaksel.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1.0 mg/m2/day if necessary).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila < 0,5 x 109/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti za 0,25 mg/m2/dan na 1,25 mg/m2/dan (ili ukoliko je potrebno, nadalje smanjiti dozu na 1,0 mg/m2/dan).
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: 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 funkcionalnog stanja (PS > 1, od engl. performance status) imaju manju stopu odgovora na liječenje i veću incidenciju komplikacija poput vrućice,
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Croatian: intersticijska bolest pluća (neki slučajevi su imali smrtni ishod) Poremećaji probavnog sustava
English: - Inflammation of the lining of the mouth and digestive tract.
Croatian: - upala sluznice usne šupljine i probavnog trakta.
English: - Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.
Croatian: - blaga bol i upala na mjestu injekcije zbog slučajne primjene lijeka u okolno tkivo
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions, and for 24 hours at 2°C to 8°C when protected from light.
Croatian: Kemijska i fizikalna stabilnost koncentrata je dokazana tijekom 24 sata na temperaturi od 25 ± 2°C pod normalnim svjetlosnim uvjetima te tijekom 24 sata na temperaturi od 2°C do 8°C kada je zaštićen od svjetlosti.
English: nausea, vomiting and diarrhoea (all of which may be severe) constipation abdominal pain2
Croatian: mučnina, povraćanje i proljev (svi mogu biti teški)
English: There were no signs of cumulative haematological or non-haematological toxicity.
Croatian: Toksičnost je bila predvidljiva i reverzibilna. nije bilo znakova koji bi upućivali na kumulativnu hematološku ili nehematološku toksičnost.
English: Potactasol is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Croatian: Potactasol je dostupan u bezbojnim bočicama od stakla tipa I, zatvorenim sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem.
English: Vials contain either 1 mg or 4 mg of topotecan.
Croatian: Bočice sadrže ili 1 mg ili 4 mg topotekana.
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: Thrombocytopenia: Severe (platelets < 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Croatian: Trombocitopenija: Teška trombocitopenija (broj trombocita < 25,0 x 109/l) zabilježena je u 25% bolesnika (8% ciklusa), a umjerena (broj trombocita između 25,0 i 50,0 x 109/l) u 25% bolesnika (15%
English: (95 % CI) Hazard ratio (95 % CI)
Croatian: (95% CI) Omjer hazarda (95% CI)
English: Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Croatian: Sadrži manitol (E421), tartaratnu kiselinu (E334), kloridnu kiselinu (E507) i natrijev hidroksid.
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Croatian: Uobičajena doza je 0,75 mg po m2 tjelesne površine jedanput na dan tijekom 3 dana.
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Croatian: Preporučena doza topotekana je 0,75 mg/m2 tjelesne površine/dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta prvog, drugog i trećeg dana ciklusa.
English: Precautions to be taken before handling or administering the medicinal product Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Croatian: Rekonstituciju i razrjeđivanje lijeka mora provoditi educirano osoblje.
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Croatian: Kemijska i fizikalna stabilnost otopine dobivene nakon razrjeđivanja koncentrata u otopini natrijevog klorida 9 mg/ml (0,9%) za injekciju ili u otopini glukoze 50 mg/ml (5%) za infuziju je dokazana za 4 sata na temperaturi od 25 ± 2°C, pod normalnim svjetlosnim uvjetima.
English: − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Croatian: - U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila < 0,5 x 109/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20%, na 0,60 mg/m2/dan (ili ukoliko je potrebno nadalje smanjiti dozu na 0,45 mg/m2/dan).
English: In an open-label study 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/m2 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 u obliku 30-minutne infuzije tijekom 5 dana ponavljano svaka 3 tjedna, u trajanju do godine dana, ovisno o terapijskom odgovoru.
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Croatian: Rijetko su prijavljene značajne posljedice povezane s trombocitopenijom, uključujući smrtne ishode zbog krvarenja povezanog s tumorom.
English: Median (95 % CI) Hazard ratio (95 % CI)
Croatian: Medijan (95% CI) Omjer hazarda (95% CI)
English: The physico-chemical stability of the medicinal product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25oC ± 2oC and then diluted.
Croatian: Kemijska i fizikalna stabilnost otopine lijeka dobivene nakon razrjeđivanja u otopinama za infuziju (natrijev klorid 0,9% i glukoza 5%) je dokazana za 4 sata na sobnoj temperaturi, pod normalnim svjetlosnim uvjetima na uzorcima koji su pripremljeni i pohranjeni tijekom 12 sati, odnosno 24 sata na temperaturi od 25°C ± 2°C, a potom razrijeđeni.
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Bočice lijeka Potactasol 1 mg moraju se rekonstituirati sa 1,1 ml vode za injekcije.
English: Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Croatian: Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Bezbojna bočica (8 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 4 mg topotekana.
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
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Croatian: U urinu, plazmi i fecesu pronađen je jedan N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od roditeljskog spoja u testu koji koristi stanice (engl. cell-based assay).
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Croatian: Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije ≥ 1 x 109/l, broj trombocita ≥ 100 x 109/l i razina hemoglobina ≥ 9 g/dl (nakon transfuzije, ukoliko je potrebna).
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Croatian: povraćanja (32%) i proljeva (18%), konstipacije (9%) i mukozitisa (14%).
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Croatian: U bolesnica (n = 39) s recidivom unutar 180 dana nakon kemoradioterapije cisplatinom, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 4,6 mjeseci (95% CI: 2,6; 6,1), naspram 4,5 mjeseca (95% CI: 2,9; 9,6) u skupini liječenoj cisplatinom, uz omjer hazarda od
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,
English: Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Bezbojna bočica (5 ml) od stakla tipa I, zatvorena sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem koja sadrži 1 mg topotekana.
English: Cisplatin 50 mg/m2 on day 1, + Topotecan 0,75 mg/m2 on days 1-3, every 21 days
Croatian: topotekan 0,75 mg/m2 1.-3.dana svakih 21 dan
English: ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
Croatian: cisplatin 50 mg/m2 1. dana, svakih 21 dan cisplatin 50 mg/m2 1. dana
English: - Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Croatian: - Teška depresija koštane srži prije započinjanja prvog ciklusa, na što ukazuje početni broj neutrofila < 1,5 x 109/l i/ili broj trombocita < 100 x 109/l.
English: − Pregnant staff should be excluded from working with this medicinal product.
Croatian: - Trudne djelatnice ne smiju rukovati ovim lijekom.
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n = 9) and Cmax (23 %, n = 11) was noted on day 5.
Croatian: Prilikom primjene topotekana (0,75 mg/m2/dan tijekom 5 uzastopnih dana) i cisplatina (60 mg/m2/dan 1. dana) u 13 bolesnica s rakom jajnika, 5. dan je zabilježen blagi porast vrijednosti AUC-a (12%,
English: mucositis
Croatian: mukozitis
English: - Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.
Croatian: Rizik da se u Vas razvije ovo teško stanje (intersticijska plućna bolest) je povećan ako već imate probleme s plućima ili ste liječeni zračenjem ili ako ste prije uzimali lijekove koji mogu oštetiti pluća;
English: Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Croatian: Neutropenija: Teška neutropenija (broj neutrofila < 0,5 x 109/l) tijekom prvog ciklusa u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju od sedam dana ili dulje.
English: - Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
Croatian: vrućice ozbiljnog pogoršanja Vašeg općeg stanja lokalnih simptoma kao što su grlobolja ili osjećaj pečenja pri mokrenju teške boli u trbuhu, vrućice i mogućeg proljeva (rijetko uz krv) što mogu biti znakovi upale crijeva (neutropenijski kolitis)
English: Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Croatian: - bolesnica s metastatskim karcinomom jajnika nakon neuspjeha prve i naknadnih linija liječenja - bolesnika s recidivom karcinoma pluća malih stanica (SCLC, od engl. small cell lung cancer)
English: Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Croatian: Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Bočice lijeka Potactasol 4 mg moraju se rekonstituirati sa 4 ml vode za injekcije.
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of packed red blood cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %), respectively.
Croatian: ciklusa primilo G-CSF; 65 bolesnika (60%) je tijekom 139 (30,5%) ciklusa primilo transfuziju eritrocita, a 50 njih (46%) tijekom 159 (34,9%) ciklusa transfuziju trombocita.
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Croatian: U skupini koja je primala oralni topotekan uz BSC bilo je statistički značajno poboljšanje u ukupnom preživljenju u odnosu na skupinu koja je liječena samo BSC-om
English: gastrointestinal perforation Hepatobiliary disorders Common:
Croatian: Nepoznato gastrointestinalna perforacija
English: - Weight loss and loss of appetite (anorexia); tiredness; weakness.
Croatian: - gubitak na težini i gubitak teka (anoreksija), umor, slabost. - mučnina, povraćanje, proljev, bolovi u trbuhu, zatvor.
English: A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
Croatian: [TTP; engl. time to progression] od prve linije liječenja iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za sam BSC) i u bolesnika koji nisu bili pogodni za ponovno liječenje intravenski primijenjenom kemoterapijom.
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 G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Croatian: U farmakokinetičkom ispitivanju kod pedijatrijskih bolesnika s refraktornim solidnim tumorima, ustanovljena maksimalna podnošljiva doza od 2,0 mg/m2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Croatian: teško krvarenje (povezano s trombocitopenijom)
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Croatian: Incidencija teških oblika (stupanj 3 ili 4) mučnine bila je 4%, povraćanja 3%, proljeva 2% i mukozitisa 1% bolesnika.
English: How to store Potactasol
Croatian: Kako primjenjivati Potactasol
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Croatian: Pripremljeni prozirni koncentrat je svijetložute boje i sadrži 1 mg topotekana po ml.
English: Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
English: Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows: - Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Potactasol 4 mg with 4 ml water for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
Croatian: - Potactasol 1 mg sa 1,1 ml vode za injekcije (jer sadrži 10% suviška u punjenju) - Potactasol 4 mg sa 4 ml vode za injekcije
English: Infections and infestations Very common:
Croatian: Infekcije i infestacije
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju Potactasol 4 mg prašak za koncentrat za otopinu za infuziju
English: Each vial contains 4 mg topotecan (as hydrochloride).
Croatian: Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).
English: Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Croatian: Potactasol 4 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).