FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Slovenian: Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na IBP (npr. kašelj, zvišana telesna temperatura, dispneja in/ali hipoksija).
English: If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2ºC - 8ºC after the first puncture of the vial.
Slovenian: Če priprava in redčenje potekata v strogo aseptičnih pogojih, na primer v napravi z laminarnim tokom zraka (LAF), je treba zdravilo porabiti (dokončati infuzijo) v 24 urah, če ga takoj po prvem odprtju viale hranimo pri temperaturi od 2 °C do 8 °C.
English: Red blood cell transfusions were given in 30% of patients (13% of courses).
Slovenian: Transfuzije eritrocitov je dobilo 30 % bolnikov (v 13 % ciklusov).
English: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Slovenian: Če se pri bolnicah z rakom materničnega vratu zdravljenje s cisplatinom ukine, za nadaljevanje zdravljenja samo s topotekanom ni zadostnih podatkov.
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: Reconstitution
Slovenian: Rekonstitucija
English: Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Slovenian: Bolezni prebavil zelo pogosti navzea, bruhanje in driska (vse lahko v hudi obliki), zaprtje, bolečine v trebuhu
English: What Hycamtin is and what it is used for What you need to know before you take Hycamtin How to take Hycamtin
Slovenian: Kaj je zdravilo Hycamtin in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Hycamtin Kako jemati zdravilo Hycamtin Možni neželeni učinki
English: The primary complications of overdose are bone marrow suppression and mucositis.
Slovenian: Primarna zapleta prevelikega odmerjanja sta supresija kostnega mozga in vnetje ustne sluznice.
English: A major route of clearance of topotecan is by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Slovenian: Glavna pot razgradnje topotekana je hidroliza laktonskega obroča, s katero nastane karboksilat z odprtim obročem.
English: Median survival in patients treated with oral topotecan plus BSC was 25.9 weeks (95% CI: 18.3, 31.6) compared to 13.9 weeks (95% CI: 11.1, 18.6) for patients receiving BSC alone (p = 0.0104).
Slovenian: Mediana časa preživetja bolnikov, ki so bili zdravljeni s peroralnim topotekanom v kombinaciji z NPO, je bila 25,9 tedna (95-odstotni IZ: 18,3, 31,6), pri bolnikih, ki so bili zdravljeni z NPO samo, pa 13,9 tedna (95-odstotni IZ: 11,1, 18,6) (p = 0,0104).
English: HYCAMTIN 4 mg is available in packs containing 1 vial and 5 vials.
Slovenian: Zdravilo HYCAMTIN 4 mg je na voljo v pakiranjih z 1 vialo ali 5 vialami.
English: Also contains: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
Slovenian: Vsebuje tudi: vinsko kislino (E334), manitol (E421), klorovodikovo kislino (E507) in natrijev hidroksid.
English: However, there are insufficient data available to make a dose recommendation for this patient group.
Slovenian: Pri tem so opažali zmanjšan očistek topotekana, vendar ni na voljo dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje za to skupino bolnikov.
English: Hycamtin capsules must not be opened or crushed.
Slovenian: Kapsul HYCAMTIN se ne sme odpirati ali drobiti.
English: Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Slovenian: Po prilagajanju na vmesno analizo je kombinacija topotekana in cisplatina dosegla statistično značilno boljše celokupno preživetje v primerjavi z zdravljenjem s samim cisplatinom (log-rank p = 0,033).
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).
Slovenian: Pri sočasni uporabi peroralnega topotekana s katero od učinkovin, ki zavira ABCB1 ali ABCG2, je treba bolnike natančno spremljati glede neželenih učinkov (glejte poglavje 5.2).
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9%) or 5% w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Slovenian: Ustrezno količino tako pripravljene raztopine je treba še dodatno razredčiti bodisi z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) ali s 5-odstotno (m/v) raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
English: Median time to onset of severe thrombocytopenia was day 15 and the median duration was five days.
Slovenian: Mediana časa do pojava hude trombocitopenije je bila 15. dan, mediana trajanja trombocitopenije pa pet dni.
English: The appropriate volume of the reconstituted solution should be diluted with either 0.9 % w/v sodium chloride intravenous infusion or 5 % w/v glucose intravenous infusion, to a final concentration of between 25 and 50 microgram per ml.
Slovenian: Ustrezni volumen rekonstituirane raztopine morate razredčiti še bodisi z 0,9-odstotno (m/v) raztopino natrijevega klorida za intravensko uporabo bodisi s 5-odstotno (m/v) raztopino glukoze za intravensko uporabo, da dobite končno raztopino s koncentracijo med 25 in 50 mikrogrami/ml.
English: Non-haematological
Slovenian: Nehematološki
English: • Hair loss.
Slovenian: • izpadanje las.
English: When treating cervical cancer, Hycamtin is combined with another medicine called cisplatin.
Slovenian: Pri zdravljenju raka materničnega vratu se zdravilo Hycamtin uporablja skupaj z drugim zdravilom, ki vsebuje cisplatin.
English: HYCAMTIN 1 mg is available in packs containing 1 vial and 5 vials.
Slovenian: Zdravilo HYCAMTIN 1 mg je na voljo v pakiranjih z 1 vialo ali 5 vialami.
English: 9/l, and the haemoglobin level is 9 g/dl (after transfusion if necessary).
Slovenian: 9/l, vrednost hemoglobina pa 9 g/dl (po prejemu transfuzije, če je ta potrebna).
English: Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
Slovenian: Z urinom se izloči približno 20 % celotnega topotekana in 2 % N-desmetil topotekana.
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).
Slovenian: Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95-odstotni IZ: 2,6, 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95--odstotni IZ: 2,9, 9,6), razmerje ogroženosti 1,15 (0,59, 2,23).
English: • Diarrhoea.
Slovenian: • srbenje.
English: Tartaric acid (E334) Mannitol (E421) Hydrochloric acid (E507) Sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi vinska kislina (E334) manitol (E421) klorovodikova kislina (E507) natrijev hidroksid
English: Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).
Slovenian: Ena viala vsebuje 1 mg ali 4 mg topotekana (v obliki klorida).
English: Currently there is only limited experience in combining oral topotecan with other chemotherapy agents.
Slovenian: Izkušnje z uporabo peroralnega topotekana v kombinaciji z drugimi kemoterapevtiki so trenutno nezadostne.
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).
Slovenian: Celotna količina učinkovine v viali zagotavlja koncentracijo 1 mg učinkovine na 1 ml, če zdravilo rekonstituiramo v skladu s priporočili (glejte Navodilo za uporabo).
English: [n = 9]) (see section 4.5).
Slovenian: (glejte poglavje 4.5).
English: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Slovenian: Pri kombiniranem zdravljenju raka materničnega vratu s cisplatinom v kliničnih študijah je bil varnostni profil topotekana podoben kot pri samostojnem zdravljenju s topotekanom.
English: See section “Pregnancy and breast-feeding”
Slovenian: Glejte poglavje "Nosečnost in dojenje" v nadaljevanju,
English: Median time to onset of severe thrombocytopenia was day 15 with a median duration of 2.5 days.
Slovenian: Mediani čas do pojava hude trombocitopenije je bil 15 dni, trajala pa je mediano 2,5 dni.
English: HYCAMTIN 1 mg hard capsules
Slovenian: HYCAMTIN 1 mg trde kapsule
English: Approximately 51% was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Slovenian: Z urinom se izloči približno 51 % celotnega topotekana in 3 % N-desmetil topotekana.
English: 9/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
Slovenian: 9/l in vrednost hemoglobina 9 g/dl (po prejemu transfuzije, če je le-ta potrebna).
English: Topotecan 0.75 mg/m on days 1-3, every 21 days
Slovenian: 1. dan vsakih 21 dni cisplatin 50 mg/m na 1. dan + topotekan 0,75 mg/m na 1.-3. dan vsakih 21 dni
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Mild abdominal pain was reported in 4% of patients.
Slovenian: 4 % bolnikov je imelo blage bolečine v trebuhu.
English: The blisters are sealed with a peel-push child resistant opening feature.
Slovenian: Pretisni omoti so zaprti z za otroke varnim sistemom, ki za odpiranje zahteva odstranitev zaporne folije in iztiskanje kapsule (peel-push sistem).
English: What Hycamtin looks like and contents of the pack Hycamtin 0.25 mg capsules are white to yellowish white and imprinted with “Hycamtin” and “0.25 mg”.
Slovenian: 0,25-miligramske kapsule Hycamtin so bele do rumenkasto bele in označene s ‘Hycamtin' in ‘0.25 mg'.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
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.
Slovenian: Plazemska koncentracija celotnega topotekana (tj. laktona in karboksilata) doseže vrh po približno 2,0 urah, topotekanovega laktona (aktivne skupine) pa po približno 1,5 ure.
English: Use of topotecan in this group of patients is not recommended (see section 4.4).
Slovenian: Uporaba topotekana pri tej skupini bolnikov ni priporočena (glejte poglavje 4.4).
English: The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
Slovenian: Celotna količina učinkovine v viali zagotavlja koncentracijo 1 mg učinkovine na 1 ml po rekonstituciji v skladu s priporočili.
English: Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Slovenian: Mediani čas do pojava zmerne do hude anemije je bil 12 dni, trajala pa je mediano sedem dni.
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min) or severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis.
Slovenian: Z uporabo topotekana za zdravljenje bolnikov s hudo okvaro ledvične funkcije (očistek kreatinina <20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (bilirubin v serumu ≥10 mg/dl), ni na voljo dovolj izkušenj.
English: This rare side effect may affect up to 1 in 1,000 people treated with Hycamtin:
Slovenian: Ti redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Hycamtin:
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Slovenian: V kliničnih študijah s topotekanom so poročali o smrtnih izidih zaradi nevtropeničnega kolitisa.
English: Thrombocytopenia Severe (platelets <25 x 10
Slovenian: Trombocitopenija Huda oblika (število trombocitov <25 x 10
English: Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Slovenian: Z blatom se izloči 33 % celotnega topotekana in 1,5 % N-desmetil topotekana.
English: • if you are breast-feeding.
Slovenian: • če nameravate zaploditi otroka.
English: 4 mg vial
Slovenian: 4 mg viala
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Slovenian: HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1 mg topotekana (v obliki klorida).
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: In those patients (n = 102) with recurrence after 180 days, median survival in the topotecan plus cisplatin arm was 9.9 months (95% CI: 7, 12.6) versus 6.3 months (95% CI: 4.9, 9.5) for the cisplatin arm, with a hazard ratio of 0.75 (0.49, 1.16).
Slovenian: Pri bolnicah (n = 102) s ponovitvijo po 180 dneh je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 9,9 meseca (95-odstotni IZ: 7, 12,6) v skupini, ki je prejemala cisplatin, pa 6,3 meseca (95-odstotni IZ: 4,9, 9,5), razmerje ogroženosti 0,75 (0,49, 1,16).
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Slovenian: Če utrujenost in astenija ne mineta, je pri vožnji ali upravljanju strojev potrebna previdnost.
English: 9/l, the platelet count is 100 x 10
Slovenian: 9/l, število trombocitov 100 x 10
English: Use of topotecan in these patients is not recommended (see section 4.2).
Slovenian: Uporaba topotekana pri teh bolnikih ni priporočena (glejte poglavje 4.2).
English: Insufficient data are available to make a recommendation for patients with a creatinine clearance <30 ml/min.
Slovenian: Za bolnike z očistkom kreatinina <30 ml/min zaradi pomanjkanja podatkov ni mogoče dati priporočil.
English: Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1.5 x 10
Slovenian: Naslednji odmerki Pred naslednjo uporabo topotekana mora biti število nevtrofilcev 1,5 x 10
English: 1 mg vial
Slovenian: 1 mg viala
English: If reconstitution and dilution is performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored at 2-8
Slovenian: Če priprava in redčenje potekata v strogo aseptičnih pogojih, na primer v napravi z laminarnim tokom zraka (LAF), je treba zdravilo porabiti (končati infuzijo) v 12 urah, v kolikor ga hranimo pri sobni temperaturi, oziroma v 24 urah, če ga takoj po prvem odprtju shranimo pri 2 do 8 °C.
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).
Slovenian: Pri pediatričnih bolnikih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti (mielosupresije) določen največji odmerek, ki so ga bolniki še prenašali, 2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF
English: HYCAMTIN 1 mg hard capsules topotecan
Slovenian: HYCAMTIN 1 mg trde kapsule topotekan
English: Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1 x 10
Slovenian: Naslednji odmerki Pred naslednjo uporabo topotekana mora biti število nevtrofilcev 1 x 10
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Slovenian: V urinu so odkrili O-glukuronida topotekana in N-desmetil topotekana.
English: Each capsule contains 1 mg of topotecan (as hydrochloride).
Slovenian: Ena kapsula vsebuje 1 mg topotekana (v obliki klorida).
English: • Feeling unwell.
Slovenian: • slabo počutje;
English: What Hycamtin looks like and contents of the pack Hycamtin comes as a powder for concentrate for solution for intravenous infusion.
Slovenian: Zdravilo Hycamtin je v obliki praška za koncentrat za raztopino za intravensko infundiranje.
English: • if you plan to father a child. See section “Pregnancy and breast-feeding” below.
Slovenian: Glejte poglavje "Nosečnost in dojenje" v nadaljevanju.
English: How to take Hycamtin
Slovenian: Kako jemati zdravilo Hycamtin
English: The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days.
Slovenian: Pri zdravljenju bolnikov z drobnoceličnim pljučnim karcinomom in očistkom kreatinina med 30 in 49 ml/min s peroralnim topotekanom v monoterapiji je priporočeni odmerek zdravila 1,9 mg/m telesne površine na dan pet zaporednih dni.
English: Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
Slovenian: Ena kapsula vsebuje 0,25 mg oz. 1 mg topotekana (v obliki klorida).
English: Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7%.
Slovenian: Ocenjeno je, da se z blatom izloči 18 % celotnega topotekana in 1,7 % Ndesmetil topotekana.
English: Cervical carcinoma
Slovenian: Karcinom materničnega vratu
English: HYCAMTIN 0.25 mg hard capsules
Slovenian: HYCAMTIN 0,25 mg trde kapsule
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.
Slovenian: Študija je bila opravljena pri bolnikih, pri katerih je po zdravljenju prve linije prišlo do ponovitve (mediana časa do napredovanja od zdravljenja prve linije: 84 dni za peroralni topotekan in NPO, 90 dni za samo NPO), pri katerih ponovno zdravljenje z intravensko kemoterapijo ni bilo primerno.
English: The powder in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
Slovenian: Prašek v viali zagotavlja koncentracijo 1 mg učinkovine na 1 ml, če se zdravilo rekonstituira v skladu s priporočili.
English: HYCAMTIN 0.25 mg hard capsules HYCAMTIN 1 mg hard capsules
Slovenian: HYCAMTIN 0,25 mg trde kapsule HYCAMTIN 1 mg trde kapsule
English: Use of topotecan in these patient groups is not recommended (see section 4.2).
Slovenian: Uporaba topotekana pri teh skupinah bolnikov ni priporočena (glejte poglavje 4.2).
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Slovenian: HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 4 mg topotekana (v obliki klorida).
English: 1 x 1 mg 5 x 1 mg
Slovenian: 5 x 1 mg
English: Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti febrilna nevtropenija, nevtropenija (glejte "Bolezni prebavil"), trombocitopenija, anemija, levkopenija pogosti pancitopenija pogostnost neznana huda krvavitev (v povezavi s trombocitopenijo) Bolezni imunskega sistema pogosti preobčutljivostna reakcija, vključno z izpuščajem redki anafilaktična reakcija, angioedem, urtikarija Presnovne in prehranske motnje zelo pogosti anoreksija (ki je lahko huda)
English: OUTER CARTON
Slovenian: ZUNANJA OVOJNINA
English: Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan.
Slovenian: HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje Viala iz kristalnega stekla (tipa I) s sivim zamaškom iz butilne gume in aluminijasto zaporko s plastičnim pokrovom (flip-off) vsebuje 1 mg topotekana.
English: 1 x 4 mg 5 x 4 mg
Slovenian: 5 x 4 mg
English: There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl).
Slovenian: Z uporabo topotekana pri bolnikih s hudo okvarjenim delovanjem jeter (bilirubin v serumu 10 mg/dl) ni dovolj izkušenj.
English: HYCAMTIN 0.25 mg hard capsules topotecan
Slovenian: HYCAMTIN 0,25 mg trde kapsule topotekan
English: Each capsule contains 0.25 mg of topotecan (as hydrochloride).
Slovenian: Ena kapsula vsebuje 0,25 mg topotekana (v obliki klorida).
English: Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan.
Slovenian: HYCAMTIN 4 mg prašek za koncentrat za raztopino za infundiranje Viala iz kristalnega stekla (tipa I) s sivim zamaškom iz butilne gume in aluminijasto zaporko s plastičnim pokrovom (flip-off) vsebuje 4 mg topotekana.
English: 5 x 4 mg vials
Slovenian: 5 x 4 mg viale
English: There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Slovenian: Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom): Z uporabo topotekana pri bolnikih s hudo okvaro ledvične funkcije (z očistkom kreatinina <20 ml/min) ni na voljo dovolj izkušenj.
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).
Slovenian: Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, pri katerih je prišlo do ponovitve ≥90 dni po koncu ene predhodne sheme kemoterapije, so izvedli eno študijo faze II (Študija 065) in eno študijo faze III (Študija 396) (glejte preglednico 1).
English: Median time to onset of severe neutropenia was day 12 with a median duration of 7 days.
Slovenian: Mediani čas do pojava hude nevtropenije je bil 12 dni, trajala pa je mediano sedem dni.
English: 9/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/m 2/day to
Slovenian: 9/l), ki traja sedem ali več dni, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo ali pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, je treba odmerek zmanjšati za 0,25 mg/m 2/dan na 1,25 mg/m 2/dan (ali ga kasneje po potrebi še dodatno zmanjšati do
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso, in o primerih smrti zaradi sepse (glejte poglavje 4.8).
English: Topotecan is partly eliminated via renal excretion and renal impairment might lead to increased exposure to topotecan.
Slovenian: Okvara ledvic zato lahko poveča izpostavljenost topotekanu.
English: 1 x 1 mg vial
Slovenian: 1 x 1 mg viala
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Slovenian: Za celoten seznam neželenih učinkov, povezanih s cisplatinom, glejte podatke za predpisovanje cisplatina.
English: • The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.
Slovenian: • Druge sestavine zdravila so: vinska kislina (E334), manitol (E421), klorovodikova kislina
English: Pruritus
Slovenian: Dojenje
English: How to store Hycamtin
Slovenian: Kako dajati zdravilo Hycamtin