FrancophonIA/ELRC3.0 huggingface dataset:
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).
Estonian: Kui annust vähendatakse patsientidel, kellel esineb raske neutropeenia (neutrofiilide arv < 0,5 x 109/l), kestusega vähemalt seitse päeva või raske neutropeenia koos palaviku või infektsiooniga või kellel on ravi edasi lükatud neutropeenia tõttu, tuleb annust vähendada 0,25 mg/m2/ööpäevas võrra annuseni 1,25 mg/m2/ööpäevas (või järgnevalt vähendada vajadusel kuni annuseni 1,0 mg/m2/ööpäevas).
English: 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Estonian: 2 Teatatud on topotekaani kasutamise tagajärjel tekkinud neutropeenia tüsistusena tekkinud neutropeenilisest koliidist, sealhulgas surmlõppega neutropeeniline koliit (vt lõik 4.4).
English: Instructions for dilution
Estonian: Lahjendamise juhend
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.
Estonian: N-desmetüülmetaboliiti, millel oli rakkudel baseeruvas analüüsis sarnane või väiksem aktiivsus kui topotekaanil, leidus uriinis, plasmas ja roojas.
English: 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/day for five days every three weeks.
Estonian: Väikesele arvule maksakahjustusega patsientidele (seerumi bilirubiin 1,5…10 mg/dl) manustati intravenoosselt topotekaani 1,5 mg/m2/ööpäevas viie päeva jooksul iga kolme nädala järel.
English: 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.
Estonian: Ühes uuringus jäi refraktaarse soliidtuumoriga lastel (vanuses 2...12 aastat, n = 18), noorukitel (vanuses 12...16 aastat, n = 9) ja noortel täiskasvanutel (vanuses 16...21 aastat, n = 9) annus vahemikku 1,4...2,4 mg/m2.
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion EU/1/09/552/003- 1 vial
Estonian: Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat EU/1/09/552/003- 1 viaal
English: Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy.
Estonian: Topotekaani monoteraapia on näidustatud: metastaatilise munasarja kartsinoomi raviks, kui esimese rea ravi või sellele järgnev ravi ei ole andnud tulemusi.
English: Topotecan Teva helps to kill tumour cells.
Estonian: Topotecan Teva aitab tappa kasvajarakke.
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Estonian: Elulemuse, ravivastuse sageduse ja haiguse progresseerumiseni kulunud aja kokkuvõte väikerakk-kopsuvähiga patsientidel, keda raviti suukaudse või intravenoosse topotekaaniga
English: The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan.
Estonian: Kontsentraat on kahvatukollast värvi ja sisaldab 1 mg topotekaani ühe ml kohta.
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion EU/1/09/552/001- 1vial
Estonian: Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat EU/1/09/552/001- 1 viaal
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,
Estonian: Topotekaani ja paklitakseeli võrdlevas uuringus patsientidel, kes olid eelnevalt saanud munasarja kartsinoomi raviks plaatinal põhinevat kemoteraapiat (vastavalt n = 112 ja 114), oli ravile reageerinuid (95% CI) 20,5% (13%, 28%) versus 14% (8%, 20%) ja keskmine aeg progresseerumiseni 19 nädalat versus 15 nädalat (riski suhtarv 0,7 [0,6; 1,0]) vastavalt topotekaani ja paklitakseeli korral.
English: tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections.
Estonian: viinhape (E334), vesinikkloriidhape (E507) (pH kohandamiseks), naatriumhüdroksiid (E524) (pH kohandamiseks) ja süstevesi.
English: Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Estonian: - Tugev kõhuvalu, iiveldus, veriokse, must väljaheide või veri väljaheites (seedetrakti mulgustumise võimalikud nähud).
English: (95% CI) Hazard ratio (95% CI)
Estonian: (95% CI) Riskimäär (95% CI)
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Estonian: Emakakaelavähk Tavaline annus on 0,75 mg m2 kehapinna kohta üks kord ööpäevas 3 päeva jooksul.
English: Ovarian and small cell lung cancer The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days.
Estonian: Munasarja kartsinoom ja väikerakk-kopsuvähk Tavaline annus on 1,5 mg m2 kehapinna kohta üks kord ööpäevas 5 päeva jooksul.
English: Topotecan Teva contains sodium
Estonian: Topotecan Teva sisaldab naatriumi
English: Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation.
Estonian: - Iiveldus, oksendamine, kõhulahtisus, kõhuvalu, kõhukinnisus.
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]).
Estonian: - suuhaavandid, neelamisraskus, kõhuvalu, iiveldus, oksendamine, kõhulahtisus, veri väljaheites (suu-, mao- ja/või soolelimaskesta põletiku [limaskesta põletik] võimalikud nähud ja sümptomid).
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Estonian: Väsimuse ja asteenia raskete vormide (3. või 4. raskusaste) esinemissagedus oli mõlema korral 3%.
English: ovarian cancer or small cell lung cancer that has come back after chemotherapy advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Estonian: - kaugelearenenud emakakaelavähi raviks, kui kirurgiline või kiiritusravi ei ole võimalik.
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.
Estonian: Topotekaani manustamisel koos tsisplatiiniga emakakaela kartsinoomi kliinilistes uuringutes täheldati täiendavaid kõrvaltoimeid, kuid neid kõrvaltoimeid on täheldatud tsisplatiini monoteraapia puhul ning need ei ole tingitud topotekaanist.
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.
Estonian: On olemas piiratud kogemus topotekaani kasutamise kohta raske neerufunktsiooni kahjustusega (kreatiniini kliirens < 20 ml/min) või tsirroosist tingitud raske maksafunktsiooni kahjustusega (seerumi bilirubiin ≥ 10 mg/dl) patsientidel.
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Estonian: 1 Topotekaani kasutanud patsientidel on teatatud sepsisega seotud surmadest (vt lõik 4.4).
English: 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).
Estonian: Refraktaarse soliidtuumoriga lastel läbiviidud farmakokineetika uuringus määrati annust limiteeriva müelosupressiooni põhjal kindlaks maksimaalne talutav annus 2,0 mg/m2/ööpäevas koos G-CSF'iga ja 1,4 mg/m2/ööpäevas ilma G-CSF'ita kasutamisel (vt lõik 5.2).
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Estonian: Puudub piisav kogemus topotekaani kasutamisega tsirroosi tagajärjel tekkinud raske maksafunktsiooni kahjustuse (seerumi bilirubiin ≥ 10 mg/dl) korral.
English: 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.
Estonian: Topotekaani soovitatav annus on 1,5 mg/m2/ööpäevas, mida tuleb manustada intravenoosse infusioonina 30 minuti jooksul viiel järjestikusel päeval, kusjuures enne iga kuuri algust peetakse kolmenädalane paus.
English: Very rare (may affect up to 1 in 10,000 people)
Estonian: Väga harv (võib mõjutada kuni 1 inimest 10000st)
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).
Estonian: Suukaudse topotekaani pluss BSC patsientidel oli keskmine elulemus 25,9 nädalat (95% CI: 18,3; 31,6) võrreldes 13,9 nädalaga (95% CI: 11,1; 18,6) ainult BSC puhul (p = 0,0104).
English: if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section if you are breast-feeding; if your blood cells count is too low.
Estonian: - kui olete topotekaani või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline; - kui te toidate last rinnaga.
English: Use of topotecan in these patient groups is not recommended (see section 4.2).
Estonian: Nendes patsiendirühmades ei soovitata topotekaani kasutada (vt lõik 4.2).
English: - The active substance is topotecan hydrochloride.
Estonian: - Toimeaine on topotekaanvesinikkloriid.
English: If you have any further questions, ask your doctor or nurse.
Estonian: - Kui teil on lisaküsimusi, pidage nõu oma arsti või õega.
English: Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7 %.
Estonian: Roojaga eritus muutumatul kujul 18% ja N-desmetüültopotekaanina 1,7%.
English: 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.
Estonian: Teises uuringus jäi leukeemiaga lastel (n = 8), noorukitel (n = 3) ja noortel täiskasvanutel (n = 3) annus vahemikku 2,0...5,2 mg/m2.
English: Storage of the diluted solution
Estonian: Lahjendatud lahuse säilitamine
English: Concentrate for solution for infusion 1 vial of 1 ml (1 mg topotecan) 5 vials of 1 ml (1 mg topotecan)
Estonian: Infusioonilahuse kontsentraat 1 viaal 1 ml (1 mg topotekaani) 5 viaali 1 ml (1 mg topotekaani)
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient self reports on an unblinded symptom scale assessment in each of these two studies.
Estonian: Nendes kahes uuringus seostati suukaudset ja intravenoosset topotekaani sarnase sümptomite vähenemisega retsidiveerunud tundliku väikerakk-kopsuvähiga patsientidel nende poolt teatatud sümptomite alusel avatud hindamisskaalal.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Estonian: Topotekaani kliinilistes uuringutes on kirjeldatud neutropeenilisest koliidist tingitud surmajuhte.
English: When treating cervical cancer, Topotecan Teva is combined with another medicine called cisplatin.
Estonian: Emakakaelavähi ravis kombineeritakse Topotecan Teva't teise ravimiga, mida tuntakse tsisplatiini nime all.
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1.5 x 109/l, the platelet count is ≥100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Estonian: Topotekaani ei tohi uuesti manustada, kui neutrofiilide arv ei ole ≥ 1,5 x 109/l, trombotsüütide arv ei ole ≥ 100 x 109/l ja hemoglobiinisisaldus ei ole ≥ 9 g/dl (vajadusel pärast vereülekannet).
English: Package leaflet: Information for the user Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan
Estonian: Pakendi infoleht: teave kasutajale Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat
English: Women of childbearing potential / Contraception in males and females Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Estonian: Prekliinilistes uuringutes on topotekaan põhjustanud embrüo-loote surma ja väärarenguid (vt lõik 5.3).
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Estonian: Hävitamine Kasutamata ravimpreparaat või jäätmematerjal tuleb hävitada vastavalt kohalikele nõuetele.
English: 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.
Estonian: Sel juhul ütleb teile arst seda viimase vereanalüüsi vastuse põhjal.
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).
Estonian: Patsientide seas (n = 39), kellel tekkis retsidiiv 180 päeva jooksul pärast kemoradioteraapiat tsisplatiiniga, oli keskmine elulemus topotekaani pluss tsisplatiini grupis 4,6 kuud (95% usaldusvahemik: 2,6, 6,1) ja tsisplatiini grupis 4,5 kuud (95% usaldusvahemik: 2,9, 9,6); riskimäär 1,15 (0,59, 2,23).
English: Common (may affect up to 1 in 10 people)
Estonian: Sage (võib mõjutada kuni 1 inimest 10st)
English: Subsequent doses
Estonian: Järgnevad annused
English: Package leaflet: Information for the user Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan
Estonian: Pakendi infoleht: teave kasutajale Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat topotekaan (topotecanum)
English: Concentrate for solution for infusion 1 vial of 4 ml (4 mg topotecan) 5 vials of 4 ml (4 mg topotecan)
Estonian: 1 viaal 4 ml (4 mg topotekaani) 5 viaali 4 ml (4 mg topotekaani)
English: Decrease in the number of all blood cells (pancytopenia) Allergic or hypersensitivity reactions (including rash).
Estonian: - Allergilised või ülitundlikkusreaktsioonid (sealhulgas lööve).
English: Feeling unwell (malaise).
Estonian: - Halb enesetunne (haiguse tunne).
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion Topotecan Teva 4 mg/4 ml concentrate for solution for infusion
Estonian: Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat
English: Each vial contains 1 mg topotecan (as hydrochloride) in 1 ml concentrate.
Estonian: Iga viaal sisaldab 1 mg topotekaani (vesinikkloriidina) 1 ml kontsentraadis.
English: How to use Topotecan Teva
Estonian: Kuidas Topotecan Teva't kasutada
English: EU/1/09/552/001 - 1 vial EU/1/09/552/002 - 5 vials
Estonian: EU/1/09/552/001 - 1 viaal EU/1/09/552/002 - 5 viaali
English: EU/1/09/552/003 - 1 vial EU/1/09/552/004 - 5 vials
Estonian: EU/1/09/552/003 - 1 viaal EU/1/09/552/004 - 5 viaali
English: Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain2, mucositis
Estonian: Iiveldus, oksendamine ja kõhulahtisus (kõik võivad olla rasked), kõhukinnisus, kõhuvalu2, mukosiit
English: Each vial contains 4 mg topotecan (as hydrochloride) in 4 ml concentrate.
Estonian: Iga viaal sisaldab 4 mg topotekaani (vesinikkloriidina) 4 ml kontsentraadis.
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).
Estonian: Pärast 180 päeva tekkinud retsidiiviga patsientide seas (n = 102) oli keskmine elulemus topotekaani pluss tsisplatiini grupis 9,9 kuud (95% usaldusvahemik: 7, 12,6) ja tsisplatiini grupis 6,3 kuud (95% usaldusvahemik: 4,9, 9,5); riskimäär 0,75 (0,49, 1,16).
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of proteinassociated DNA single-strand breaks.
Estonian: Topotekaani poolt topoisomeraas-I pärssimise rakusiseseks tagajärjeks on valguliselt seotud DNA ühekeermeliste katkestuste teke.
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Estonian: Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat 1 ml infusioonilahuse kontsentraati sisaldab 1 mg topotekaani (vesinikkloriidina).
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 on days 1-3, every 21 days
Estonian: Tsisplatiin 50 mg/m2 1. päeval +
English: In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Estonian: Neutropeenilise koliidi võimalusega tuleb arvestada patsientide puhul, kellel esineb palavik, neutropeenia ja kaasuv kõhuvalu.
English: 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.
Estonian: Plasma kliirens langes maksakahjustusega patsientidel (seerumi bilirubiin 1,5…10 mg/dl) kontrollgrupiga võrreldes umbes 67%-ni. Topotekaani poolväärtusaeg oli umbes 30% võrra pikenenud, kuid jaotusruumala ilmset muutust ei täheldatud.
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan
Estonian: Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat topotecanum
English: Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).
Estonian: - Suu-, kõri-, keele- või igemepõletik (mukosiit) ja haavandid.
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Estonian: Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat 1 ml infusioonilahuse kontsentraati sisaldab 1 mg topotekaani (vesinikkloriidina).
English: Oral topotecan
Estonian: Topotecan
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Estonian: Üldise elulemuse mediaan oli topotekaani puhul 62 nädalat ja paklitakseeli puhul 53 nädalat (riski suhtarv
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan
Estonian: Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat topotecanum
English: EU/1/09/552/004- 5 vials
Estonian: EU/1/09/552/004- 5 viaali
English: Thrombocytopenia
Estonian: Topotekaan/ Tsisplatiin
English: EU/1/09/552/002- 5 vials
Estonian: EU/1/09/552/002- 5 viaali
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 30- minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Estonian: Avatud uuringus, kus osalesid retsidiveerunud või progresseeruva soliidtuumoriga lapsed (n = 108, vanusevahemik: väikelapsed kuni 16-aastased), manustati topotekaani algannuses 2,0 mg/m2
English: One vial of 4 ml of concentrate contains 4 mg topotecan (as hydrochloride).
Estonian: Üks 4 ml viaal kontsentraati sisaldab 4 mg topotekaani (vesinikkloriidina).
English: One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride).
Estonian: Üks 1 ml viaal kontsentraati sisaldab 1 mg topotekaani (vesinikkloriidina).
English: 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).
Estonian: ≥ 1,5 x 109/l, trombotsüütide arv ≥ 100 x 109/l ning hemoglobiini tase ≥ 9 g/dl (vajadusel pärast vereülekannet).
English: How Topotecan Teva is prepared
Estonian: Kuidas Topotecan Teva't ette valmistatakse
English: If you get any side effects, talk to your doctor or nurse.
Estonian: - Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või meditsiiniõega.
English: How to store Topotecan Teva
Estonian: Kuidas Topotecan Teva't säilitada
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
Estonian: Rakendada tuleb järgmisi vähivastaste ravimite nõuetele vastava käsitsemise ja hävitamise tavapäraseid protseduure: - Personali tuleb õpetada ravimit lahjendama.
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Estonian: Topotekaani kliirens toimub peamiselt laktoontsükli hüdrolüüsi kaudu, mille tulemusena moodustub avatud tsükliga karboksülaat.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Estonian: Rakendada tuleb järgmisi vähivastaste ravimite nõuetele vastava käsitsemise ja hävitamise tavapäraseid protseduure: - Personal tuleb õpetada ravimit lahjendama.
English: Rare (may affect up to 1 in 1,000 people)
Estonian: Harv (võib mõjutada kuni 1 inimest 1000st)
English: Each vial contains 1 ml of the concentrate for solution for infusion.
Estonian: Üks viaal sisaldab 1 ml infusioonilahuse kontsentraati.
English: 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).
Estonian: 1 ml infusioonilahuse kontsentraati sisaldab 1 mg topotekaani (vesinikkloriidina).
English: Clear pale yellow liquid.
Estonian: Selge kahvatukollane vedelik.
English: Each vial contains 4 ml of the concentrate for solution for infusion.
Estonian: Üks viaal sisaldab 4 ml infusioonilahuse kontsentraati.
English: One vial of 4 ml of concentrate for solution for infusion contains 4 mg topotecan (as hydrochloride).
Estonian: Üks 4 ml viaal infusioonilahuse kontsentraati sisaldab 4 mg topotekaani (vesinikkloriidina).
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Estonian: Topotekaaniga ravitud patsientidel on kirjeldatud sepsisega lõppenud müelosupressiooni ja sepsisest tingitud surmajuhte (vt lõik 4.8).
English: 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Estonian: Kui topotekaani ja tsisplatiini kombinatsioonravi ajal ületab seerumi kreatiniinisisaldus 1,5 mg/dl, soovitatakse järgida tsisplatiini ravimi omaduste kokkuvõttes toodud juhiseid annuse vähendamise/ravi katkestamise kohta.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Estonian: Eelnevat tsisplatiini kemoradioteraapiat mittesaanud patsiendid Tsisplatiin
English: Cervical carcinoma
Estonian: Emakakaela kartsinoom
English: How Topotecan Teva is given
Estonian: Kuidas Topotecan Teva't manustatakse
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).
Estonian: Topotekaani ei tohi taasmanustada, kui neutrofiilide arv ei ole ≥ 1 x 109/l ja trombotsüütide arv
English: Very common Pyrexia, asthenia, fatigue Common
Estonian: Püreksia, asteenia, väsimus
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Estonian: Eelnevat tsisplatiini kemoradioteraapiat saanud patsiendid Tsisplatiin
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Estonian: Tsisplatiiniga seotud kõrvaltoimete täieliku loetelu leiate tsisplatiini ravimi omaduste kokkuvõttest.