natgillin/translations-raw huggingface dataset:
The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Nekorigirano razmerje ogroženosti med skupino s peroralnim topotekanom in NPO ter skupino s samo NPO je bilo 0,64 (95-odstotni IZ: 0,45, 0,90).
Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Z urinom se izloči približno 51 % celotnega topotekana in 3 % N-desmetil topotekana.
Personnel should be trained to dilute the medicinal product.
- Osebje mora biti ustrezno izurjeno za redčenje zdravila.
Topotecan Teva is available in cartons containing 1 vial and 5 vials.
Topotekan Teva je na voljo v škatlah z 1 vialo ali 5 vialami.
The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
- Druge sestavine zdravila so: vinska kislina (E334), klorovodikova kislina (E507), natrijev hidroksid (E524) in voda za injekcije.
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Kombinirano zdravljenje (karcinom materničnega vratu) Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost kreatinina v serumu manjšo ali enako 1,5 mg/dl.
For cervical cancer it will be used together with another anticancer medicine containing cisplatin.
Pri zdravljenju raka materničnega vratu se uporablja skupaj z drugim zdravilom, ki vsebuje cisplatin.
Pregnant staff should be excluded from working with this medicinal product.
Pri rokovanju z zdravilom ne smejo sodelovati nosečnice.
Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Huda oblika (3. ali 4. stopnje) tako utrujenosti kot astenije se je pojavljala s pogostnostjo 3 %.
Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Vključene so bile naslednje vrste tumorjev: Ewingov sarkom/primitivni nevroektodermalni tumor, nevroblastom, osteoblastom in rabdomiosarkom.
Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Plazemski očistek pri bolnikih z jetrno okvaro (bilirubin v serumu med 1,5 in 10 mg/dl) se je v primerjavi s kontrolno skupino znižal na približno 67 %.
One study included a dose range of 1.4 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 do 2,4 mg/m2.
Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Pri bolnicah, ki so se predhodno zdravile s cisplatinom, mora preteči daljše obdobje brez zdravljenja, da bi bilo zdravljenje s kombinacijo smiselno (glejte poglavje 5.1).
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Madžarska V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca,
Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Mediana časa celokupnega preživetja je bila 62 tednov pri uporabi topotekana in 53 tednov pri zdravljenju s paklitakselom (razmerje ogroženosti 0,9 [0,6, 1,3]).
Ovarian and small cell lung carcinoma Initial dose
Drobnocelični pljučni karcinom in karcinom jajčnikov Začetni odmerek
Median time to onset of severe thrombocytopenia was day 15 and the median duration was five days.
Mediana časa do pojava hude trombocitopenije je bila 15. dan,
When treating cervical cancer, Topotecan Teva is combined with another medicine called cisplatin.
Pri zdravljenju raka materničnega vratu se zdravilo Topotekan Teva kombinira z zdravilom, imenovanim cisplatin.
Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).
- Vnetje in razjede v ustih, grlu, na jeziku ali dlesnih (vnetje ustne sluznice).
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.
Priporočeni odmerek topotekana je 1,5 mg/m2 telesne površine na dan z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklusih po pet zaporednih dni in s tritedenskimi presledki med začetki posameznih ciklusov zdravljenja.
Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Pri bolnikih, ki so prejemali topotekan, so v približno 25 % opazili utrujenost, v 16 % pa astenijo.
Your doctor will tell you whether this is the case, based on the results of your last blood test; →Tell your doctor if you think any of these could apply to you.
To vam bo povedal zdravnik na podlagi izvida vaše zadnje preiskave krvi.
Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Zdravila Tepotekan Teva ne smete uporabiti, če so v njem vidni delci ali če je raztopina motna.
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Uporaba topotekana naj vedno poteka pod nadzorom zdravnika z izkušnjami na področju kemoterapije (glejte poglavje 6.6).
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.
V tej študiji je šestinštirideset (43 %) bolnikov v 192 ciklusih (42,1 %) prejelo G-CSF, petinšestdeset (60 %) bolnikov je v 139 ciklusih (30,5 %) prejelo transfuzijo eritrocitov, petdeset (46 %) bolnikov pa v 159 ciklusih (34,9 %) transfuzijo trombocitov.
Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Običajni odmerek je 0,75 mg na m2 telesne površine enkrat na dan tri dni.
Staff handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
Osebje, ki pripravlja zdravilo, mora med redčenjem nositi zaščitna oblačila, masko, zaščitna očala in rokavice.
The use of Topotecan Teva is not recommended in patients with severe liver impairment; if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 4 ‘Possible side effects'); if you suffer from unusual bruising or bleeding (also see section 4 ‘Possible side effects'); if you are feeling very ill.
- če imate trenutno težave s pljuči ali ste se v preteklosti zdravili z obsevanjem ali pa ste prejeli zdravila, ki lahko vplivajo na delovanje pljuč (glejte poglavje 4 »Neželeni učinki«); - če imate nenavadne modrice ali krvavitve (glejte poglavje 4 »Neželeni učinki«); - če se počutite precej bolni;
Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation.
- Siljenje na bruhanje (slabost), bruhanje, driska, bolečine v trebuhu, zaprtje.
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.
Pri dajanju topotekana v kombinaciji s cisplatinom so opazili dodatne neželene učinke, vendar pa so te neželene učinke opažali tudi pri samostojnem zdravljenju s cisplatinom in jih ni mogoče pripisati topotekanu.
The second study included a dose range of 2.0 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
V drugi študiji so otroci (n = 8), mladostniki (n = 3) in mlajši odrasli (n = 3) z levkemijo prejemali odmerek od 2,0 do 5,2 mg/m2.
Combination therapy (cervical carcinoma)
Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom)
Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Ustrezen volumen koncentrata se redči z 9 mg/ml (0,9 %) injekcijsko raztopino natrijevega klorida ali 50 mg/ml (5 %) injekcijsko raztopino glukoze, da se doseže končno koncentracijo topotekana v raztopini za infundiranje med
Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
• hude bolečine v trebuhu, občutek slabosti, bruhanje krvi, črno ali krvavo blato (to so lahko simptomi gastrointestinalne perforacije ali predrtja stene prebavil),
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).
Pri odločitvi za zmanjšanje odmerka pri bolnicah s hudo nevtropenijo (število nevtrofilcev < 0,5 x 109/l), ki traja sedem ali več dni, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo ali pri bolnicah, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, je trebaodmerek pri naslednjih ciklusih zmanjšati za 20 % na 0,60 mg/m2/dan (ali ga po potrebi kasneje še dodatno zmanjšati na 0,45 mg/m2/dan).
Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
10-kratni priporočeni odmerek) in topotekan v kapsulah (do 5-kratni priporočeni odmerek).
The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid v urinu predstavljata manj kot
Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Ugotovili so, da je plazemski očistek topotekana po intravenskem odmerjanju s 30-minutno infuzijo v odmerku 0,5−1,5 mg/m2 5 zaporednih dni visok, in sicer 62 l/h (s standardno deviacijo 22), kar pomeni približno 2/3 pretoka krvi skozi jetra.
How to store Topotecan Teva Contents of the pack and other information
Shranjevanje zdravila Topotekan Teva Vsebina pakiranja in dodatne informacije
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).
Pri odločitvi za zmanjšanje odmerka pri bolnikih s hudo nevtropenijo (število nevtrofilcev < 0,5 x 109/l), ki traja sedem ali več dni, ali hudo nevtropenijo z zvišano telesno temperaturo ali okužbo ali tiste, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, izberemo zmanjšanje odmerka, je treba odmerek zmanjšati za 0,25 mg/m2/dan do 1,25 mg/ m2 na dan (ali ga kasneje po potrebi še dodatno zmanjšamo do 1,0 mg/m2 na dan).
Concentrate for solution for infusion 1 vial of 4 ml (4 mg topotecan) 5 vials of 4 ml (4 mg topotecan)
koncentrat za raztopino za infundiranje 1 viala s 4 ml (4 mg topotekana) 5 vial s 4 ml (4 mg topotekana)
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.
Nosečnost Če bolnica uporablja topotekan med nosečnostjo ali če zanosi med zdravljenjem s topotekanom,
Topotecan Teva 4 mg/4 ml concentrate for solution for infusion EU/1/09/552/003- 1 vial
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje EU/1/09/552/003 - 1 viala
You must not breast-feed while on treatment with Topotecan Teva.
Med zdravljenjem z zdravilom Topotekan Teva ne smete dojiti.
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).
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupini, ki je bila deležna le NPO (vrednost p za log-rang = 0,0104).
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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Običajno čas ne sme biti daljši od 12 ur pri temperaturi do 25 ºC ali 24 ur pri 2-8°C, razen če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.
Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7 %.
Ocenjeno je, da se z blatom izloči 18 % celotnega topotekana in 1,7 % N-desmetil topotekana.
Talk to your doctor or nurse before using Topotecan Teva: if you have any kidney problems.
Pred začetkom uporabe zdravila Topotekan Teva se posvetijte z zdravnikom ali medicinsko sestro: - če imate kakršne koli težave z ledvicami.
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion EU/1/09/552/001- 1vial
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje EU/1/09/552/001 - 1 viala
Feeling unwell (malaise).
- Slabo počutje (šibkost).
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).
Huda oblika (število trombocitov < 25 x 109/l) se je razvila pri 25 % bolnikov (v 8 % ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in 50,0 x 109/l) pa pri 25 % bolnikov (v
Concentrate for solution for infusion 1 vial of 1 ml (1 mg topotecan) 5 vials of 1 ml (1 mg topotecan)
koncentrat za raztopino za infundiranje 1 viala z 1 ml (1 mg topotekana) 5 vial po 1 ml (1 mg topotekana)
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Neporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of proteinassociated DNA single-strand breaks.
Celična posledica zaviranja topoizomeraze I s topotekanom je nastanek prekinitev na enojni verigi DNA, vezani na beljakovino.
tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections.
Vinska kislina (E334), klorovodikova kislina (E507) (za uravnavanje pH), natrijev hidroksid (E524) (za uravnavanje pH) in voda za injekcije.
Topotecan Teva is supplied as a concentrate for solution for infusion.
Zdravilo Topotekan Teva je v obliki koncentrata za pripravo raztopine za infundiranje.
Very rare (may affect up to 1 in 10,000 people)
Zelo redki (pojavijo se lahko pri največ 1 bolniku od 10.000 bolnikov)
1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
1 Pri bolnikih, ki so se zdravili s topotekanom, so poročali o smrti zaradi sepse (glejte poglavje 4.4).
- The active substance is topotecan hydrochloride.
- Učinkovina je topotekanijev klorid.
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).
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).
Topotecan Teva contains sodium
Zdravilo Topotecan vsebuje natrij
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.
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.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Imetnik dovoljenja za promet in izdelovalec
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- huda preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - dojenje (glejte poglavje 4.6)
Based on the doselimiting 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).
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 (glejte poglavje 5.2).
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 30- minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
V odprti študiji pri otrocih (n = 108, razpon starosti: od dojenčka do 16 let) z rekurentnim ali progresivnim solidnim tumorjem so otroci topotekan prejemali v začetnem odmerku 2,0 mg/m2
Mild abdominal pain was reported in 4 % of patients.
4 % bolnikov je imelo blage bolečine v trebuhu.
1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnega koli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
What Topotecan Teva looks like and contents of the pack
Izgled zdravila Topotekan Teva in vsebina pakiranja
CYTOTOXIC, special handling instructions (see package leaflet).
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO, posebna navodila za ravnanje (preberite priloženo navodilo).
In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Ob hudi nevtropeniji so med prvim ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužboe, 23 % bolnikovpa je imelo take neželene učinke ves čas (v 6 % ciklusov zdravljenja).
An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine.
V urinu so odkrili O-glukuronidacijski presnovek topotekana in N-desmetil topotekan.
Platelet transfusions were given in 4 % of courses.
V 4 % ciklusov zdravljenja so bolniki prejeli transfuzije trombocitov.
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy.
bolnikih z metastatskim karcinomom jajčnikov po neuspehu z zdravili prvega linije ali naslednjega izbora.
• Lung inflammation (rare (may affect up to 1 in 1,000 people)), with signs such as: difficulty breathing, cough fever.
• Vnetje pljuč (redko (pojavijo se lahko pri največ 1 od 1.000 bolnikov)) z znaki, kot so:
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).
Med prvim ciklusom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0,5 x 109/l), ki je pri 20 % bolnikov trajala najmanj sedem dni, pri 77 % pa ves čas (v 39 % ciklusov zdravljenja).
For more information about cisplatin, please refer to the corresponding Package Leaflet.
Za več podatkov o cisplatinu preberite ustrezno navodilo za uporabo.
Each vial contains 1 ml of the concentrate for solution for infusion.
Ena viala vsebuje 1 ml koncentrata za raztopino za infundiranje.
A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into your arm over about 30 minutes.
Zdravnik ali medicinska sestra vam bosta dala razredčeno raztopino Topotekana Teva v obliki kapljične infuzije.
In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celotnega topotekana (aktivne in neaktivne oblike).
Storage of the diluted solution
Shranjevanje razredčene raztopine
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]).
• razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic]).
Median (95% CI)
Mediana vrednost (95-odstotni IZ)
How to use Topotecan Teva
Kako uporabljati zdravilo Topotekan Teva
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
(35 %), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
Clinical efficacy and safety
Klinična učinkovitost in varnost Ponovitev raka jajčnikov
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).
Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoterapiji s cisplatinom je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95-odstotniIZ: 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).
(95% CI) Hazard ratio (95% CI)
(95-odstotni IZ) Razmerje tveganja (95-odstotni IZ)
There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Z uporabo topotekana pri bolnikih, ki imajo zaradi ciroze hudo okvaro jetrne funkcije (z vrednostmi bilirubina v serumu ≥ 10 mg/dl), ni na voljo dovolj izkušenj.
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.
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) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan.
Koncentrat je bledo rumena tekočina, ki vsebuje 1 mg/ml topotekana.
Serious side effects
Resni neželeni učinki:
Each vial contains 1 mg topotecan (as hydrochloride) in 1 ml concentrate.
Vsaka viala vsebuje 1 mg topotekana (v obliki topotekanijevega klorida) v 1 ml koncentrata.