natgillin/translations-raw huggingface dataset:
One study included a dose range of 1.4 mg/ m2 to 2.4 mg/ m2 in children (aged 2 up to 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.
V eni študiji so otroci (stari od 2 do 12 let, n = 18), mladostniki (stari od 12 do 16 let, n = 9) in mlajši odrasli (stari od 16 do 21 let, n = 9) z neodzivnim solidnim tumorjem prejemali odmerek od 1, 4 mg/ m2 do 2, 4 mg/ m2.
HYCAMTIN 4 mg is supplied in 17 ml type I flint glass vials, together with 20 mm grey butyl rubber stoppers and 20 mm aluminium seals with plastic flip-off caps.
HYCAMTIN 4 mg je na voljo v 17- ml vialah iz kristalnega stekla (tip I), ki so opremljene s 20- mm sivimi zamaški iz butilne gume, zapečatene s 20- mm aluminijasto zaporko s plastičnim pokrovom (flip- off).
24 HYCAMTIN 4 mg is available in cartons containing 1 vial and 5 vials.
HYCAMTIN 4 mg je na voljo v škatlah z 1 vialo in 5 vialami.
Not all pack sizes may be marketed.
24 Na trgu ni vseh navedenih pakiranj.
The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg per ml of topotecan.
Pripravljena raztopina je bistra, rumene do rumene- zelene barve in vsebuje 1 mg topotekana na ml.
4 mg vials:
4 mg viale:
HYCAMTIN 0.25 mg hard capsules
HYCAMTIN 0, 25 mg trde kapsule
Each capsule contains topotecan hydrochloride equivalent to 0.25 mg of topotecan.
Ena kapsula vsebuje topotekanijev klorid, ki ustreza 0, 25 mg topotekana.
The capsules are opaque white to yellowish white and imprinted with ‘ HYCAMTIN’ and ‘ 0.25 mg’.
Kapsule so motne bele do rumenkasto bele barve in označene s ‘ HYCAMTIN ’ in ‘ 0. 25 mg ’.
HYCAMTIN capsules are indicated as monotherapy for the treatment of adult 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).
Kapsule HYCAMTIN so indicirane kot monoterapija za zdravljenje odraslih bolnikov z relapsom drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve izbire ni primerno (glejte poglavje 5. 1).
Initial dose The recommended dose of HYCAMTIN capsules is 2.3 mg/ m2 body surface area/ day administered for 5 consecutive days with a 3 week interval between the start of each course.
Začetni odmerek Priporočeni odmerek kapsul HYCAMTIN je 2, 3 mg/ m2 telesne površine na dan 5 dni zapored in s 3- tedenskimi presledki med začetki vsakega cikla zdravljenja.
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Če bolniki zdravilo dobro prenašajo, se zdravljenje lahko nadaljuje, dokler bolezen ne napreduje (glejte poglavji 4. 8 in 5. 1).
Hycamtin capsules may be taken with or without food (see section 5.2).
Kapsule zdravila Hycamtin lahko vzame s hrano ali brez nje (glejte poglavje 5. 2).
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/ l, a platelet count of ≥ 100 x 109/ l and a haemoglobin level of ≥ 9 g/ dl (after transfusion if necessary)..
Pred prvim ciklusom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev ≥ 1, 5 x 109/ l, število trombocitov ≥ 100 x 109/ l in koncentracijo hemoglobina ≥ 9 g/ dl (po transfuziji, če je le- ta potrebna).
Subsequent doses 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).
Nadaljevalni odmerki Topotekana ne smete ponovno uporabiti, dokler ni število nevtrofilcev ≥ 1 x 109/ l, število trombocitov ≥ 100 x 109/ l in koncentracija hemoglobina ≥ 90 g/ l (po transfuziji, če je potrebna).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/ l) for 7 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 0.4 mg/ m2/ day to 1.9 mg/ m2/ day (or subsequently down to 1.5 mg/ m2/ day if necessary).
Če izberete zmanjšanje odmerka pri bolnikih s hudo nevtropenijo (število nevtrofilcev < 0, 5 x 109/ l), ki traja 7 dni ali več, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo, in pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, morate odmerek zmanjšati za 0, 4 mg/ m2/ dan na 1, 9 mg/ m2/ dan (ali ga po potrebi še dodatno zmanjšati do 1, 5 mg/ m2/ dan).
26 Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
26 Podobno morate zmanjšati odmerke, če število trombocitov pade pod 25 x 109/ l.
In clinical trials, topotecan was discontinued if the dose needed to be reduced below 1.5 mg/ m2.
Med kliničnimi preskušanji so topotekan nehali uporabljati, če je bilo treba odmerek zmanjšati pod 1, 5 mg/ m2.
For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/ m2/ day for subsequent courses (see section 4.4).
Pri bolnikih z drisko stopnje 3 ali 4 je potrebno odmerek zmanjšati za 0, 4 mg/ m2/ dan pri naslednjih ciklusih (glejte poglavje 4. 4).
Dosage in renally impaired patients Patients with small cell lung carcinoma who participated in oral topotecan clinical trials had a serum creatinine less than or equal to 1.5 mg/ dl (133 µmol/ l) or a creatinine clearance of greater than or equal to 60 ml/ min.
Odmerjanje pri bolnikih z okvaro ledvic Bolniki z drobnoceličnim pljučnim karcinomom, ki so sodelovali v kliničnih preskušanjih peroralnega topotekana, so imeli kreatinin v serumu 1, 5 mg/ dl (133 µmol/ l) ali manj oz. očistek kreatinina 60 ml/ min ali več.
Dosing recommendations for patients receiving oral topotecan with Clcr less than 60 ml/ min have not been established (see section 4.4).
Priporočila za odmerjanje peroralnega topotekana pri bolnikih z očistkom kreatinina pod 60 ml/ min niso določena (glejte poglavje 4. 4).
Dosage in hepatically impaired patients Pharmacokinetics of HYCAMTIN capsules have not been specifically studied in patients with impaired hepatic function.
Odmerjanje pri bolnikih z okvaro jeter Farmakokinetike kapsul HYCAMTIN niso posebej raziskali pri bolnikih z okvarjenim delovanjem jeter.
There are insufficient data available with HYCAMTIN capsules to make a dose recommendation for this patient group (see section 4.4).
Za kapsule HYCAMTIN ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v tej skupini bolnikov (glejte poglavje 4. 4).
Paediatrics The experience in children is limited, therefore no recommendation for treatment of paediatric patients with HYCAMTIN can be given (see section 5.1).
Pediatrični bolniki Izkušnje pri otrocih so nezadostne, zato ni mogoče dati priporočil za zdravljenje pediatričnih bolnikov s kapsulami HYCAMTIN (glejte poglavje 5. 1).
Elderly No overall differences in effectiveness were observed between patients over 65 years and younger adult patients.
Starejši V celoti niso ugotovili razlik v učinkovitosti med bolniki, starejšimi od 65 let, in mlajšimi odraslimi bolniki.
However in the two studies administering both oral and intravenous topotecan, patients older than 65 years old receiving oral topotecan experienced an increase in drug related diarrhoea compared to those younger than 65 years of age (see section 4.4 and 4.8).
A v dveh študijah, v katerih so uporabljali peroralni in intravenski topotekan, so med starejšimi od 65 let, ki so dobivali peroralni topotekan, zabeležili več z zdravilom povezane driske kot med mlajšimi od 65 let (glejte poglavji 4. 4 in 4. 8).
HYCAMTIN is contraindicated in patients who − have a history of hypersensitivity to the active substance or to any of the excipients − are breast feeding (see section 4.6) − already have 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.
Zdravilo HYCAMTIN je kontraindicirano pri bolnikih oz. bolnicah − z anamnezo preobčutljivosti za zdravilno učinkovino ali katerokoli pomožno snov, − ki dojijo (glejte poglavje 4. 6), − ki imajo hudo depresijo kostnega mozga že pred začetkom prvega ciklusa, kar se kaže z izhodiščnim številom nevtrofilcev < 1, 5 x 109/ l in/ ali številom trombocitov < 100 x 109/ l.
Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
Hematotoksičnost je odvisna od odmerka, zato morate bolnikom redno nadzorovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4. 2).
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Pri bolnikih, zdravljenih s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso in smrti zaradi sepse (glejte poglavje 4. 8).
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e. g. cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of 27 ILD is confirmed.
Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na intersticijsko bolezen pljuč (npr. kašelj, zvišana telesna temperatura, dispneja in/ ali hipoksija); če je diagnoza intersticijske bolezni pljuč potrjena, je treba zdravljenje s topotekanom prekiniti.
Topotecan and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
27 Uporabo samega topotekana in topotekana v kombinaciji s cisplatinom pogosto spremlja klinično pomembna trombocitopenija.
This should be taken into account, e. g. in case patients at increased risk of tumour bleeds are considered for therapy.
To morate upoštevati, če npr. razmišljate o zdravljenju bolnikov, ki imajo večje tveganje za tumorske krvavitve.
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).
Po pričakovanju je med bolniki s slabim stanjem zmogljivosti (stanje zmogljivosti > 1) delež odziva manjši; hkrati imajo večjo incidenco zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4. 8).
Dosing recommendations for patients receiving oral topotecan with Clcr less than 60 ml/ min have not been established.
Priporočila za odmerjanje peroralnega topotekana pri bolnikih z očistkom kreatinina pod 60 ml/ min niso določena (glejte poglavje 4. 4).
There is insufficient experience of the use of oral or intravenous topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/ min).
Pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina < 20 ml/ min) z uporabo peroralnega ali intravenskega topotekana ni dovolj izkušenj.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/ dl) were given intravenous topotecan at 1.5 mg/ m2 for five days every three weeks.
Majhno število bolnikov z okvaro jeter (koncentracija bilirubina v serumu med 1, 5 in 10 mg/ dl) je dobivalo intravenski topotekan v odmerku 1, 5 mg/ m2 pet dni vsake tri tedne.
A reduction in topotecan clearance was observed however there are insufficient data available to make a dose recommendation for this patient group.
Očistek je bil zmanjšan, vendar ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v tej skupini bolnikov.
There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/ dl).
Z uporabo topotekana ni dovolj izkušenj pri bolnikih s hudo okvarjenim delovanjem jeter (bilirubin v serumu ≥ 10 mg/ dl).
Diarrhoea, including severe diarrhoea requiring hospitalization, has been reported during treatment with oral topotecan.
Med zdravljenjem s peroralnim topotekanom so poročali o driski, vključno s hudo drisko, ki je zahtevala sprejem v bolnišnico.
Clinical guidelines describing the aggressive management of CTID includes 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 hospitalization.
Klinične smernice za odločno obvladovanje driske zaradi zdravil proti raku vključujejo specifična priporočila za informiranje in ozaveščanje bolnika, prepoznavanje zgodnjih opozorilnih znakov, uporabo antidiaroikov in antibiotikov, spremembe v uživanju tekočin in prehrani ter sprejem v bolnišnico.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2 - 2.5-fold of control.
Hkrati s peroralnim topotekanom uporabljeni ciklosporin A (ki zavira ABCB1, ABCC1 [MRP- 1] in CYP3A4) je povečal AUC topotekana na približno 2 - 2, 5- kratno vrednost v primerjavi s kontrolno skupino.
Patients should be carefully monitored for adverse reactions when oral topotecan is administered with a drug known to inhibit ABCB1 or ABCG2 (see section 5.2).
Če peroralni topotekan uporabljate s kakšnim zdravilom, ki zavira ABCB1 ali ABCG2, morate bolnike natančno spremljati glede neželenih reakcij (glejte poglavje 5. 2).
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal 28 product may be required to improve tolerability.
Pri sočasni upoarbi topotekana z drugimi kemoterapevtiki bo morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Če dajemo cisplatin ali karboplatin na 1. dan dajanja topotekana, je potrebno zaradi boljšega prenašanja zmanjšati odmerek teh zdravil v primerjavi z
Currently there is only limited experience in combining oral topotecan with other chemotherapy agents.
28 odmerki, ki jih lahko dajemo, kadar damo platinove spojine na 5. dan uporabe topotekana.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of child bearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Tako kot druga citotoksična zdravila lahko tudi topotekan škoduje plodu, zato morate ženskam v rodni dobi povedati, da med zdravljenjem s topotekanom ne smejo zanositi.
29 The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/ possibly related to oral topotecan therapy.
V nadaljevanju navedene pogostnosti hematoloških in nehematoloških neželenih učinkov veljajo za učinke, ki so povezani ali so morda povezani s peroralno uporabo topotekana.
Adverse reactions are listed below, by system organ class and absolute frequency.
29 Spodaj so naveden neželeni učinki, razvrščeni po organskih sistemih in absolutni pogostnosti.
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).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri, in ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Common: pancytopenia
Bolezni krvi in limfatičnega sistema Zelo pogosti: nevtropenija s sočasno povišano telesno temperaturo, nevtropenija (glejte Bolezni prebavil), trombocitopenija, anemija, levkopenija Pogosti: pancitopenija
Nausea, vomiting and diarrhoea (all of which may be severe), Common: abdominal pain*, constipation, stomatitis, dyspepsia *Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Bolezni prebavil Zelo pogosti: navzea, bruhanje in driska (vse lahko hudo) Pogosti: abdominalna bolečina *, zaprtje, stomatitis, dispepsija * Poročali so o pojavu nevtropeničnega kolitisa, vključno z usodnim nevtropeničnim kolitisom, kot zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4. 4).
Common: pruritis
Bolezni kože in podkožja Zelo pogosti: alopecija Pogosti: pruritus
Common: asthenia, pyrexia, malaise.
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: utrujenost Pogosti: astenija, pireksija, splošno slabo počutje
Immune system disorders Common: hypersensitivity reaction including rash Not known: anaphylactic reaction, angioedema, urticaria.
Bolezni imunskega sistema Pogosti: preobčutljivostna reakcija, vključno z izpuščajem Ni znano: anafilaktična reakcija, angioedem, urtikarija
Hepato-biliary disorders Uncommon: hyperbilirubinaemia.
Bolezni jeter, žolčnika in žolčevodov Občasni: hiperbilirubinemija
The incidence of adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Incidenca navedenih neželenih učinkov je lahko večja med bolniki s slabim stanjem zmogljivosti (glejte poglavje 4. 4).
30 Haematological Neutropenia:
Hematološki Nevtropenija:
Severe neutropenia (Grade 4 - neutrophil count < 0.5 x 109/ l) occurred in 32% of patients in 13% of courses.
Huda nevtropenija (4. stopnje – število nevtrofilcev < 0, 5 x 109/ l) se je pojavila pri 32% bolnikov v 13% ciklusov.
Median time to onset of severe neutropenia was Day 12 with a median duration of 7 days.
Mediani čas do pojava hude nevtropenije je bil 12 dni, trajala pa je mediano 7 dni.
In 34% of courses with severe neutropenia, the duration was > 7 days.
V 34% ciklusov s hudo nevtropenijo je ta trajala > 7 dni.
In course 1 the incidence was 20%, by courses 4 the incidence was 8%.
V 1. ciklusu je bila incidenca 20%,
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Okužbe so se pojavile pri 17% bolnikov, sepsa pri 2% in febrilna nevtropenija pri 4%.
Death due to sepsis occurred in 1% of patients.
Smrt zaradi sepse je doletela 1% bolnikov.
Growth factors were administered to 19% of patients in 8% of courses.
Rastne dejavnike so uporabili pri 19% bolnikov v 8% ciklusov.
Severe thrombocytopenia (Grade 4 - platelets less than 10 x 109/ l) occurred in 6% of patients in 2% of courses.
Huda trombocitopenija (4. stopnje – število trombocitov manj kot 10 x 109/ l) se je pojavila pri 6% bolnikov v 2% ciklusov.
Median time to onset of severe thrombocytopenia was Day 15 with a median duration of 2.5 days.
Mediani čas do pojava hude trombocitopenije je bil 15 dni, trajala pa je mediano 2, 5 dni.
In 18% of courses with severe thrombocytopenia the duration was > 7 days.
V 18% ciklusov s hudo trombocitopenijo je ta trajala > 7 dni.
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 109/ l) occurred in 29% of patients in 14% of courses.
Zmerna trombocitopenija (3. stopnje – število trombocitov med 10, 0 in 50, 0 x 109/ l) se je pojavila pri 29% bolnikov v 14% ciklusov.
Platelet transfusions were given to 10% of patients in 4% of courses.
Transfuzije trombocitov je dobilo 10% bolnikov v 4% ciklusov.
Moderate to severe anaemia (Grade 3 and 4 – Hb ≤ 8.0 g/ dl) occurred in 25% of patients (12% of courses).
Zmerna do huda anemija (3. in 4. stopnje – Hb ≤ 80 g/ l) se je pojavila pri 25% bolnikov (12% ciklusov).
Median time to onset of moderate to severe anaemia was Day 12 with a median duration of 7 days.
Mediani čas do pojava zmerne do hude anemije je bil 12 dni, trajala pa je mediano 7 dni.
In 46% of courses with moderate to severe anaemia, the duration was > 7 days.
V 46% ciklusov z zmerno do hudo anemijo je ta trajala > 7 dni.
Red blood cell transfusions were given in 30% of patients (13% of courses).
Transfuzije eritrocitov je dobilo 30% bolnikov (13% ciklusov).
Erythropoietin was administered to 10% of patients in 8% of courses.
Eritropoetin je dobilo 10% bolnikov v 8% ciklusov.
Non-haematological The most frequently reported non-haematological effects were nausea (37%), diarrhoea (29%), fatigue (26%), vomiting (24%), alopecia (21%) and anorexia (18%).
Nehematološki Najpogosteje opisani nehematološki učinki so bili: navzea (37%), driska (29%), utrujenost (26%), bruhanje (24%), alopecija (21%) in anoreksija (18%).
For severe cases (CTC grade 3/ 4) reported as related / possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
Incidenca hudih primerov (3. in 4. stopnja po CTC), ki so bili opisani kot povezani ali morda povezani z uporabo topotekana, je bila: driska 5% (glejte poglavje 4. 4), utrujenost 4%, bruhanje 3%, navzea 3% in anoreksija 2%.
The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Skupna incidenca z zdravilom povezane driske je bila 22%, vključno s 4% 3. stopnje in 0, 4% 4. stopnje.
Drug-related diarrhoea was more frequent in patients ≥ 65 years of age (28%) compared to those less than 65 years of age (19%).
Z zdravilom povezana driska je bila pogostejša med bolniki, starimi ≥ 65 let (28%), kot med bolniki, mlajšimi od 65 let (19%).
Complete alopecia related/ possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/ possibly related to topotecan administration in 11% of patients.
Popolno alopecijo, povezano ali morda povezano z uporabo topotekana, so zabeležili pri 9% bolnikov, delno takšno alopecijo pa pri 11%.
Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Med terapevtskimi ukrepi zaradi nehematoloških učinkov so bili antiemetiki (dobilo jih je 47% bolnikov v 38% ciklusov) in antidiaroiki (dobilo jih je 15% bolnikov v 6% ciklusov).
A 5-HT3 antagonist was administered to 30% of patients in 24% of courses.
Antagonist 5- HT3 je dobila 30% bolnikov v 24% ciklusov.
Loperamide was administered to 13% of patients in 5% of courses.
Loperamid je dobilo 13% bolnikov v 5% ciklusov.
There is no known antidote for topotecan overdose.
Za preveliko odmerjanje topotekana ni znanega antidota.
The primary complications of overdose are anticipated to be bone marrow suppression and mucositis.
Najpomembnejši pričakovani posledici prevelikega odmerjanja sta supresija kostnega mozga in mukozitis.
Other antineoplastic agents:
Druga zdravila z delovanjem na novotvorbe (citostatiki).
31 The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Ta encim je tesno povezan s podvajanjem DNA in odpravlja torzijsko napetost, ki se pojavlja pred napredujočimi replikacijskimi vilicami.
Relapsed SCLC A phase III trial (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:
31 Relaps drobnoceličnega pljučnega raka V preskušanju III. faze (študija 478) so primerjali peroralni topotekan v kombinaciji z najboljšo podporno oskrbo [NPO] (n = 71) in NPO samo (n = 70) pri bolnikih z relapsom po terapiji prve izbire (mediani čas do napredovanja od terapije prve izbire:
84 days for oral topotecan + BSC, 90 days for BSC] and for whom retreatment with intravenous chemotherapy was not considered appropriate.
84 dni za peroralni topotekan in NPO, 90 dni za NPO), pri katerih ponovno zdravljenje z intravensko kemoterapijo ni bilo primerno.
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p=0.0104).
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za log- rang = 0, 0104).
The median survival for patients treated with topotecan + BSC was 25.9 weeks [95% C. I.
Mediano preživetje bolnikov, zdravljenih s topotekanom in NPO, je bilo 25, 9 tedna [95% IZ: