FrancophonIA/ELRC3.0 huggingface dataset:
English: Weight loss and loss of appetite (anorexia), tiredness, weakness.
Danish: • Vægttab og tab af appetit (anoreksi), træthed, slaphed.
English: When treating cervical cancer, Topotecan Teva is combined with another medicine called cisplatin.
Danish: Ved behandling af livmoderhalskræft gives Topotecan Teva sammen med et andet lægemiddelstof, der kaldes cisplatin.
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.
Danish: Plasmaclearance hos patienter med nedsat leverfunktion (serumbilirubin mellem 1,5 og 10 mg/dl) faldt til ca. 67 % sammenlignet med en kontrolgruppe af patienter.
English: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m2 compared to 21.3 l/h/m2 [n = 9]) (see section 4.5).
Danish: Ved administration i kombination med cisplatin (cisplatin dag 1, topotecan dag 1 til 5) blev topotecanclearance reduceret på dag 5 sammenlignet med dag 1 (19,1 l/time/m2 legemsoverflade sammenlignet med 21,3 l/time/m2 legemsoverflade [n = 9]) (se pkt.
English: Topotecan Teva is supplied as a concentrate for solution for infusion.
Danish: Topotecan Teva leveres som et koncentrat til infusionsvæske, opløsning.
English: Hair loss.
Danish: • Hårtab.
English: However there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Danish: Der er dog ikke en tilstrækkelig mængde data tilgængelig til at kunne give en anbefaling vedrørende dosering til denne patientgruppe (se pkt.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglassene efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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.
Danish: Der er utilstrækkelig erfaring med brugen af topotecan hos patienter med alvorlig nedsat leverfunktion (serumbilirubin ≥ 10 mg/dl) på grund af cirrose.
English: 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).
Danish: Alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) under serie 1 hos 55 % af patienterne med en varighed ≥ syv dage hos 20 % og totalt set hos 77 % af patienterne (39 % af serierne).
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n = 9) and Cmax (23%, n = 11) was noted on day 5.
Danish: Ved administration af topotecan (0,75 mg/m2 legemsoverflade/dag i 5 sammenhængende dage) og cisplatin (60 mg/m2 legemsoverflade/dag på dag 1) til 13 patienter med ovariecancer, blev en svag stigning set i AUC (12 %, n = 9) og Cmax (23 %, n = 11) på dag 5.
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Danish: Hyppigheden af alvorlig (grad 3 eller 4) træthed og asteni var i begge tilfælde 3 %.
English: Anaphylactic reaction, angioedema, urticaria
Danish: Anafylaktisk reaktion, angioødem, urticaria
English: Your dose of Topotecan Teva may need to be adjusted.
Danish: Der kan være behov for at justere din dosis af Topotecan Teva.
English: 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).
Danish: Topotecan bør kun administreres under overvågning af en læge, der har erfaring i brugen af kemoterapi (se pkt.
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.
Danish: Din læge vil give dig besked, hvis dette er tilfældet på baggrund af resultaterne fra din seneste blodprøve.
English: 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.
Danish: - Alvorlig knoglemarvssuppression allerede inden første serie indledes, defineret som et neutrofiltal på < 1,5 x 109/l og/eller et trombocyttal på < 100 x 109/l ved baseline.
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of proteinassociated DNA single-strand breaks.
Danish: Den cellulære følge af topotecans hæmning af topoisomerase-I skyldes proteinassocierede enkelstrengsbrud på DNA.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksisk materiale.
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).
Danish: Medianoverlevelsen hos patienter behandlet med oral topotecan plus BSC var 25,9 uger (95 % CI: 18,3; 31,6) sammenlignet med 13,9 uger (95 % CI: 11,1; 18,6) for patienter, der fik BSC alene (p = 0,0104).
English: • Lung inflammation (rare (may affect up to 1 in 1,000 people)), with signs such as: difficulty breathing, cough fever.
Danish: • Tegn på lungebetændelse (sjælden (kan forekomme hos op til 1 ud af 1.000 patienter)): - vejrtrækningsproblemer - hoste - feber.
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,
Danish: I et sammenlignende studie med topotecan og paclitaxel hos patienter tidligere behandlet for ovariecancer med platinbaseret kemoterapi (henholdsvis n = 112 og n = 114), var responsraten (95 % CI) 20,5 % (13 %, 28 %) versus 14 % (8 %, 20 %) og mediantiden til progression var 19 uger versus 15 uger (hazard ratio 0,7 [0,6; 1,0] for henholdsvis topotecan og paclitaxel.
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.
Danish: Den anbefalede dosis af topotecan er 1,5 mg/m2 legemsoverflade pr. dag administreret som intravenøs infusion over 30 minutter hver dag fem dage i træk, med et interval på tre uger mellem begyndelsen af hver serie.
English: The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
Danish: - Øvrige indholdsstoffer: vinsyre (E334), saltsyre (E507), natriumhydroxid (E524) og vand til injektion.
English: 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).
Danish: Alvorlig trombocytopeni (trombocyttal < 25 x 109/l) hos 25 % af patienterne (8 % af serierne), moderat (trombocyttal mellem 25,0 og 50,0 x 109/l) hos 25 % af patienterne (15 % af serierne).
English: METHOD OF ADMINISTRATION EXPIRY DATE
Danish: ANVENDELSESMÅDE UDLØBSDATO
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).
Danish: Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 0,25 mg/m2/dag til 1,25 mg/m2/dag (eller derefter om nødvendigt ned til 1,0 mg/m2 /dag).
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.
Danish: I et ikke blindet studie af børn (n = 108; aldersgruppe: børn op til 16 år) med recidiverende eller progredierende solide tumorer, blev topotecan administreret med en startdosis på 2,0 mg/m2 som intravenøs infusion over 30 minutter i 5 dage.
English: Contents of the pack and other information What Topotecan Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Topotecan Teva indeholder:
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Water for injections
Danish: Saltsyre (E507) (til pH-justering) Natriumhydroxid (E524) (til pH-justering) Vand til injektionsvæsker
English: The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Danish: Første dosis Den anbefalede dosis af topotecan er 0,75 mg/m2 legemsoverflade/dag administreret som en intravenøs infusion over 30 minutter på dag 1, 2 og 3.
English: The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan.
Danish: Koncentratet har en lysegul farve og indeholder 1 mg pr. ml topotecan.
English: Teva B.V.
Danish: Teva Pharm B.V.
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]).
Danish: • Mundsår, synkebesvær, mavesmerter, kvalme, opkastning, diarré, blodig afføring (mulige tegn og symptomer på betændelse i mundslimhinden, maven og/eller tarmene [slimhindeinflammation]).
English: Severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness).
Danish: • Alvorlige allergiske (anafylaktiske) reaktioner som giver hævede læber, ansigt og hals, som kan føre til alvorlig vejrtrækningsbesvær, hududslæt og nældefeber, anafylaktisk chok (et alvorligt fald i blodtrykket, bleghed, ophidselse, lav puls, lav bevidsthed).
English: Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Danish: • Alvorlige mavesmerter, kvalme, opkastning af blod, sort eller blodig afføring (mulige symptomer på perforering af mave-tarmkanalen).
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Danish: Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 20 % til 0,60 mg/m2/dag i de efterfølgende serier (eller derefter om nødvendigt ned til 0,45 mg/m2/dag).
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.
Danish: Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med svært nedsat nyrefunktion (kreatinin-clearance < 20 ml/min) eller svært nedsat leverfunktion (serumbilirubin ≥ 10 mg/dl) på grund af cirrose.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Other medicines and Topotecan Teva
Danish: Brug af anden medicin sammen med Topotecan Teva
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).
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Prækliniske studier har vist, at topotecan medfører embryo/fosterdødelighed og misdannelser (se pkt.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Danish: De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes, dvs.: - Personale skal oplæres i fortynding af medikamentet.
English: 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.
Danish: Yderligere fortynding af det passende volumen af koncentratet med enten natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller glucose 50 mg/ml (5 %) injektionsvæske, opløsning, er nødvendig for en endelig topotecankoncentration mellem 25 og 50 mikrogram/ml i infusionsvæsken, opløsningen.
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Danish: Den sædvanlige dosis er 0,75 mg/m2 af kroppens overfladeareal 1 gang dagligt i 3 dage.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Danish: Patienter uden forudgående cisplatin-kemo/stråleterapi Cisplatin
English: Topotecan Teva is supplied in cartons containing 1 vial or 5 vials.
Danish: Topotecan Teva leveres i æsker indeholdende 1 hætteglas eller 5 hætteglas.
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.
Danish: Topotecan Teva bruges til at behandle: - ovariekræft eller småcellet lungekræft, som er kommet igen efter kemoterapi - fremskreden livmoderhalskræft, hvor behandling med kirurgi eller stråleterapi ikke er mulig.
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).
Danish: Før administration af den første serie med topotecan skal patienten have et neutrofiltal på ≥ 1,5 x 109/l, et trombocyttal på ≥ 100 x 109/l og et hæmoglobinniveau på ≥ 9 g/dl (om nødvendigt efter transfusion) ved baseline.
English: Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Danish: • Følelse af almen slaphed og træthed, som kan være symptomer på blodmangel (anæmi).
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter)
English: Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).
Danish: • Betændelse og sår i mund, hals, på tunge eller gummer.
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Danish: Signifikante følger af trombocytopeni herunder letal tumorblødning er sjældent rapporteret.
English: Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Danish: • Usædvanlige blå mærker eller blødninger, der er forårsaget af en nedsættelse i antallet af de celler, som får blodet til at størkne.
English: Yellow skin (jaundice) caused by abnormal liver function.
Danish: • Gulfarvning af huden forårsaget af nedsat leverfunktion.
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of packed red blood cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %), respectively.
Danish: 65 patienter (60 %) fik transfusion af pakket blod og 50 patienter (46 %) fik transfusion af trombocytter henholdsvis over 139 og 159 serier (henholdsvis 30,5 % og 34,9 %).
English: • Infections (very common (may affect more than 1 in 10 people)), with signs such as:
Danish: • Tegn på infektion (meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter)): - feber.
English: Topotecan Teva can make you feel tired or weak.
Danish: Topotecan Teva kan medføre træthed.
English: 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Danish: Hvis serumkreatinin under kombinationsbehandling overstiger 1,5 mg/dl anbefales det at konsultere cisplatins produktinformation vedrørende dosisreduktion/fortsat behandling.
English: Tell a doctor if any of these becomes troublesome.
Danish: Kontakt lægen, hvis bivirkningerne bliver generende.
English: Sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema).
Danish: • Hurtigt indsættende hævelse af hud og slimhinder (f.eks. hals og tunge), der er forårsaget af væskeophobninger (angioødemer).
English: If you experience this, do not drive or use machines.
Danish: Kør ikke bil og brug ikke værktøj eller maskiner, hvis du føler dig træt eller svag.
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion EU/1/09/552/001- 1vial
Danish: Topotecan Teva 1 mg/1 ml koncentrat til infusionsvæske, opløsning EU/1/09/552/001- 1 hætteglas
English: Severe infection (sepsis).
Danish: • Alvorlig infektion.
English: Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation.
Danish: • Utilpashed (kvalme), sygdomsfølelse (opkastning), diarré, mavesmerter, forstoppelse.
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 on days 1-3, every 21 days
Danish: topotecan 0,75 mg/m2 på dag 1-3,
English: tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections.
Danish: Vinsyre (E334), saltsyre (E507) (til pH-justering), natriumhydroxid (E524) (til pH-justering) og vand til injektionsvæsker.
English: How Topotecan Teva is given
Danish: Sådan bliver Topotecan Teva givet
English: Each vial contains 4 mg topotecan (as hydrochloride) in 4 ml concentrate.
Danish: Hvert hætteglas indeholder 4 mg topotecan (som hydrochlorid) i 4 ml koncentrat.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Danish: Patienter med forudgående cisplatin-kemo/stråleterapi Cisplatin
English: Each vial contains 1 mg topotecan (as hydrochloride) in 1 ml concentrate.
Danish: Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid) i 1 ml koncentrat.
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion EU/1/09/552/003- 1 vial
Danish: Topotecan Teva 4 mg/4 ml koncentrat til infusionsvæske, opløsning EU/1/09/552/003- 1 hætteglas
English: Difference in response rate (95% CI)
Danish: Forskel i responsrate (95 % CI)
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).
Danish: Efterfølgende doser af topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1 x 109/l, trombocyttallet er ≥ 100 x 109/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
English: Concentrate for solution for infusion 1 vial of 4 ml (4 mg topotecan) 5 vials of 4 ml (4 mg topotecan)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas med 4 ml (4 mg topotecan) 5 hætteglas med ml (4 mg topotecan)
English: Concentrate for solution for infusion 1 vial of 1 ml (1 mg topotecan) 5 vials of 1 ml (1 mg topotecan)
Danish: Koncentrat til infusionsvæske, opløsning 1 hætteglas med 1 ml (1 mg topotecan) 5 hætteglas med 1 ml (1 mg topotecan)
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.
Danish: I patienternes egne rapporteringer vha. en ublindet vurdering på en symptomskala i begge studier var oral og intravenøs topotecan forbundet med samme symptomlindring hos patienter med recidiverende, sensitiv SCLC.
English: Package leaflet: Information for the user Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan
Danish: Indlægsseddel: information til brugeren Topotecan Teva 1 mg/1 ml koncentrat til infusionsvæske, opløsning topotecan
English: 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.
Danish: En læge eller en sygeplejerske vil give dig den fortyndede Topotecan Teva som infusion (intravenøst drop).
English: Package leaflet: Information for the user Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan
Danish: Indlægsseddel: information til brugeren Topotecan Teva 4 mg/4 ml koncentrat til infusionsvæske, opløsning topotecan
English: Ovarian and small cell lung carcinoma Initial dose
Danish: Ovariecancer og småcellet lungecancer
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter)
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevar Topotecan Teva i køleskab (2-8 °C).
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion Topotecan Teva 4 mg/4 ml concentrate for solution for infusion
Danish: Topotecan Teva 1 mg/1 ml koncentrat til infusionsvæske, opløsning Topotecan Teva 4 mg/4 ml koncentrat til infusionsvæske, opløsning
English: 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.
Danish: - hvis du har problemer med lungerne, eller du tidligere har fået strålebehandling eller har fået lægemidler, som påvirker dine lunger (se også punkt 4 ”bivirkninger”).
English: If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan Teva.
Danish: Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin
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.
Danish: (n = 8), unge (n = 3) og yngre voksne (n = 3) med leukæmi.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Clear pale yellow liquid.
Danish: Klar lysegul væske.
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).
Danish: Topotecan Teva 4 mg/4 ml koncentrat til infusionsvæske, opløsning 1 ml koncentrat til infusionsvæske, opløsning, indeholder 1 mg topotecan (som hydrochlorid).
English: Use of topotecan in these patient groups is not recommended (see section 4.2).
Danish: Anvendelse af topotecan til disse patienter anbefales ikke (se pkt.
English: Each vial contains 4 ml of the concentrate for solution for infusion.
Danish: Hvert hætteglas indeholder 4 ml koncentrat til infusionsvæske, opløsning.