natgillin/translations-raw huggingface dataset:
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.
When topotecan (0.75 mg/m2/day for five 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.
Pri dajanju topotekana (0,75 mg/m2/dan pet zaporednih dni) in cisplatina (60 mg/m2/dan na 1. dan) 13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (12 %, n = 9) in Cmax (23 %, n = 11).
Do not use Topotecan Eagle after the expiry date which is stated on the carton and vial after EXP.
Zdravila Topotekan Eagle ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- The other ingredients are: hydrochloric acid (E507) (for pH adjustment) and water for injections.
• Pomožne snovi so: klorovodikova kislina (E507) (za uravnanje pH) in voda za injekcije.
Skin and subcutaneous tissue disorders Very common: alopecia Common: pruritus
Bolezni kože in podkožja Zelo pogosti: alopecija.
1 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4)
1*Poročali so o pojavu nevtropeničnega kolitisa, vključno z usodnim nevtropeničnim kolitisom, kot zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4.4).
MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/744/001
The primary complications of overdose are anticipated to be bone marrow suppression and mucositis.
Kot pomembnejši posledici prevelikega odmerjanja lahko pričakujemo predvsem supresijo kostnega mozga in mukozitis.
Topotecan Eagle contains a higher dose concentration (3 mg/ml) than other topotecan products for intravenous infusion (usually 1 mg/ml).
Zdravilo Topotekan Eagle vsebuje večjo koncentracijo topotekana (3 mg/ml) kot druga zdravila s topotekanom za intravensko infundiranje (običajno 1 mg/ml).
The recommended monotherapy dose of topotecan in patients with small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnic z rakom jajčnika in bolnikov z drobnoceličnim pljučnim rakom, ki imajo očistek kreatinina med 20 in 39 ml/min je 0,75 mg/m2 na dan, pet zaporednih dni.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/744/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/744/002
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).
Če izberete zmanjšanje odmerka pri bolnikih s hudo nevtropenijo (število nevtrofilcev < 0,5 x 109/l), ki traja sedem ali več dni, ali s hudo nevtropenijo s povišano telesno temperaturo ali okužbo, ali pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, morate odmerek zmanjšati za 0,25 mg/m2/dan na 1,25 mg/m2/dan (ali ga po potrebi še dodatno zmanjšati do 1,0 mg/m2/dan).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 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).
Če izberete zmanjšanje odmerka pri bolnicah s hudo nevtropenijo (število nevtrofilcev manjše od 0,5 x 109/l), ki traja sedem ali več dni, ali s hudo nevtropenijo s povišano telesno temperaturo ali okužbo, ali pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, morate odmerek pri naslednjih ciklih zmanjšati za 20 % na 0,60 mg/m2/dan (ali po potrebi še dodatno zmanjšati na 0,45 mg/m2/dan).
Topotecan Eagle is supplied as a concentrate for solution for infusion.
Zdravilo Topotekan Eagle je v obliki koncentrata za raztopino za infundiranje.
Topotecan Eagle can make you feel tired or weak.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Topotekan Eagle lahko povzroči utrujenost ali šibkost.
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of
• Ob naključnem stiku zdravila s kožo ali z očmi morate le-to takoj sprati z velikimi količinami
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 22/12/2011
Each 5 ml multi dose vial contains 15 mg of topotecan.
5 ml večodmerna viala vsebuje 15 mg topotekana.
Topotecan Eagle concentrate is clear yellow to orange in colour and contains 3 mg/ml of topotecan, which is a higher concentration than found in other topotecan products for intravenous infusion.
Zdravilo Topotekan Eagle koncentrat je bistra, rumena do oranžna raztopina, ki vsebuje 3 mg/ml topotekana, kar je večja koncentracija kot pri drugih zdravilih s topotekanom za intravensko infundiranje.
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Predklinične raziskave so pokazale, da topotekan povzroča smrt in deformacije zarodka oziroma ploda (glejte poglavje 5.3).
- Pregnant staff should be excluded from working with this medicinal product.
• Nosečnice ne smejo rokovati z zdravilom.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
- Topotecan Eagle is supplied in cartons containing 1 vial.
• Zdravilo Topotekan Eagle je na voljo v škatlah z 1 vialo.
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).
Each vial contains 15 mg topotecan (as hydrochloride) in 5 ml concentrate.
Ena viala vsebuje 15 mg topotekana (v obliki klorida) v 5 ml koncentrata.
Each vial contains 3 mg topotecan (as hydrochloride) in 1 ml concentrate.
Ena viala vsebuje 3 mg topotekana (v obliki klorida) v 1 ml koncentrata.
Must be diluted before use.
Koncentrat je treba pred uporabo razredčiti.
− Personnel handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
- Osebje, ki pripravlja in daje zdravilo, mora med rekonstitucijo nositi zaščitna oblačila, masko,
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 infundiranju v odmerku 0,5 1,5 mg/m2 pet zaporednih dni pri času infuzije 30 minut visok, in sicer 62 l/h (SD 22), kar pomeni približno 2/3 pretoka krvi skozi jetra.
Small Cell Lung Carcinoma
Drobnocelični pljučni karcinom
QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml koncentrata za raztopino za infundiranje vsebuje 3 mg topotekana (v obliki klorida).
- severe infection (sepsis) - feeling unwell (malaise).
• huda okužba (sepsa);
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5 ml multidose vial
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 5 ml večodmerna viala
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 % skupnega topotekana in 1,7 % Ndesmetil topotekana.
N = total number of patients treated.
Razmerje tveganja (95 % IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0,5 x 109/l), ki je pri 20 % bolnikov trajala  sedem dni, pri 77 % pa ves čas (39 % ciklov zdravljenja).
Instructions for Preparation for Intravenous Administration for Cervical Cancer For recommended dose '0.75 mg/m
Navodilo za pripravo za intravensko dajanje pri raku materničnega vratu Za priporočeni odmerek „0,75 mg/m
Concentration must be noticed or life-threatening overdose may occur.
Upoštevajte koncentracijo, sicer lahko pride do življenjsko nevarnega prevelikega odmerjanja.
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 ciklom zdravljenja pri 16 % bolnikov opazili povišano telesno temperaturo ali različne okužbe, 23 % bolnikov pa je imelo takšne neželene učinke ves čas (6 % ciklov zdravljenja).
Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Pojavnost tako hude oblike utrujenosti kot astenije (3. ali 4. stopnje) je bila 3 %.
2 body surface area/day administered by intravenous The recommended dose of topotecan is 1.5 mg/m infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Začetni odmerek Priporočeni odmerek topotekana je 1,5 mg/m2 telesne površine na dan, z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklih po pet zaporednih dni in s tritedenskimi presledki med začetki vsakega cikla zdravljenja.
The second study included a dose range of 2.0 mg/m2 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 mg/m2 do 5,2 mg/m2.
1 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with blue polypropylene flip-off cap, and with yellow vial ring collar.
1 ml koncentrata v viali iz prozornega stekla (tip I), ki je opremljena s sivim zamaškom iz butilne gume, aluminijasto zaporko z modrim polipropilenskim pokrovčkom (flip-off) in rumenim obročkom na vratu viale.
Not known: severe bleeding (associated with thrombocytopenia) Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease (some cases have been fatal)
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: intersticijska bolezen pljuč (nekateri primeri s smrtnim izidom).
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
• Če kateri koli neželeni učinek postane resen, ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
5 ml concentrate in type 1 clear glass vial, together with grey butyl rubber stopper and aluminium seal with yellow polypropylene flip-off cap, and with yellow vial ring collar.
5 ml koncentrata v viali iz prozornega stekla (tip I), ki je opremljena s sivim zamaškom iz butilne gume, aluminijasto zaporko z rumenim propilenskim pokrovom (flip-off) in rumenim obročkom.
What Topotecan Eagle looks like and contents of the pack - Topotecan Eagle is a clear yellow to orange liquid in a colourless glass vial with a butyl rubber stopper, aluminium seal and blue snap-cap and with yellow vial ring collar.
• Zdravilo Topotekan Eagle je bistra, rumena do oranžna tekočina v viali iz prozornega stekla, ki je opremljena z zamaškom iz butilne gume, aluminijasto zaporko z modrim pokrovom in rumenim
Cervical cancer - The usual dose is 0.75 mg of the medicine for each square meter of your body.
• običajni odmerek je 0,75 mg zdravila na kvadratni meter telesne površine;
For reduced dose '0.60 mg/m
Za zmanjšani odmerek „0,60 mg/m
Patients with prior Cisplatin chemoradiotherapy
Bolnice s predhodno kemoterapijo s cisplatinom topotekan/cisplatin
For reduced dose '0.45 mg/m
Za zmanjšani odmerek „0,45 mg/m
• Lung inflammation (rare), with signs such as: - difficulty in breathing - cough - fever.
• Vnetje pljuč (redko) z znaki, kot so:
- Do not breast-feed while using Topotecan Eagle.
• Med zdravljenjem z zdravilom Topotekan Eagle ne smete dojiti.
Rare - 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) - sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema) - itchy rash (or hives).
• hude alergijske (anafilaktične), ki povzročijo otekanje ustnic, obraza ali vratu, kar vodi v oteženo dihanje, kožni izpuščaj ali koprivnica, anafilaktični šok (hud padec krvnega tlaka, bledost,
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 ciklom 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).
Mild abdominal pain was also reported amongst 4 % of patients.
4 % bolnikov je imelo blage bolečine v trebuhu.
- unusual bruising or bleeding, sometimes severe.
• neobičajne (lahko hujše) podplutbe ali krvavitve.
Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 109/l, the platelet count is more than or equal to 100 x 109/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary).
Bolnica topotekana ne sme prejeti, če število nevtrofilcev ni večje ali enako 1,5 x 109/l, število trombocitov večje ali enako 100 x 109/l in vrednost hemoglobina večja ali enaka 9 g/dl (po transfuziji, če je le-ta potrebna).
Topotecan Eagle 3 mg/1 ml is for single use only.
Zdravilo Topotekan Eagle 3 mg/1 ml je za enkratno uporabo.
ITT population Cisplatin 50mg/m d.1
cisplatin 50 mg/m2 1. dan +
Each 1 ml single dose vial contains 3 mg of topotecan.
Ena 1 ml enoodmerna viala vsebuje 3 mg topotekana.
Instructions for Preparation for Intravenous Administration for Small Cell Lung Cancer For recommended dose '1.5 mg/m2'
Navodilo za pripravo za intravensko dajanje pri drobnoceličnem pljučnem raku Za priporočeni odmerek „1,5 mg/m
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 ml vial
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA 1 ml viala
EXP Read the leaflet for the shelf life of the diluted product.
EXP Za rok uporabnosti razredčenega zdravila glejte priloženo navodilo.
Difference in response rate (95 % CI) Median time to progression (weeks)
Mediani čas do napredovanja (tedni) (95 % IZ)
- fever - sudden decline of your general health - sore throat or burning sensation when passing water - severe stomach pain, fever and possibly diarrhoea (rarely with blood in it) - these can be signs of bowel inflammation (neutropenic colitis).
‐ resno poslabšanje splošnega zdravstvenega stanja; ‐ vnetje žrela ali pekoč občutek med uriniranjem; ‐ huda bolečina v želodcu, povišana telesna temperatura in lahko tudi driska (redko krvava),
For reduced dose '1.25 mg/m2'
Za zmanjšani odmerek „1,25 mg/m
Very common: nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Zelo pogosti: navzeja, bruhanje in driska (vse lahko hudo), zaprtje, abdominalna bolečina1*, mukozitis.
- One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
• En ml koncentrata za raztopino za infundiranje vsebuje 3 mg topotekana (v obliki klorida).
The concentration of topotecan in the 5 ml vial is higher (3 mg/ml) than with other topotecan products.
Koncentracija topotekana v 5 ml viali je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
The concentration of topotecan is higher (3 mg/ml) than with other topotecan products.
Koncentracija topotekana je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
Median (95 % C.I) Hazard ratio (95 % C.I.)
Mediana vrednost (95 % interval zaupanja) Razmerje tveganja (95 % interval zaupanja) Log rank p-vrednost
Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali v naslednjih odstotkih: navzea 4 %, bruhanje 3 %, driska 2 %, mukozitis 1 %.
Cervical Carcinoma
Karcinom materničnega vratu
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Common: hypersensitivity reaction including rash Rare: anaphylactic reaction, angioedema, urticaria
Redki: anafilaktična reakcija, angioedem, urtikarija.
− 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.
- bolnicah, ki dojijo (glejte poglavje 4.6); - bolnikih, ki imajo hudo depresijo kostnega mozga že pred začetkom prvega cikla, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 109/l in/ali števila trombocitov
Hydrochloric acid (E507) (for pH adjustment) Water for injections
6.1 Seznam pomožnih snovi klorovodikova kislina (E507) (za uravnavanje pH) voda za injekcije
The concentration of topotecan in the 1 ml vial is higher (3 mg/ml) than with other topotecan products.
Koncentracija topotekana v 1 ml viali je večja (3 mg/ml) kot pri drugih zdravilih s topotekanom.
Common: malaise
Pogosti: pruritus.
To be diluted before use.
Pred uporabo razredčiti.
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil relaps ≥ 90 dni po koncu ene predhodne sheme kemoterapije, sta bili narejeni ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte preglednico 1).
Cisplatin 50mg/m d.1 + Topotecan 0.75mg/m2 dx3 q21
topotekan 2/dan x 3 0,75 mg/m na 21 dni
Hazard ratio (95 % CI) Response rate (%)
Delež odziva (%) (95 % IZ)
2 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4)
2 Pri bolnikih, ki so se zdravili s topotekanom, so poročali o smrti zaradi sepse (glejte poglavje
Very common: febrile neutropenia, neutropenia (see Gastrointestinal disorders),
Zelo pogosti: nevtropenija s sočasno povišano telesno temperaturo, nevtropenija (glejte Bolezni prebavil), trombocitopenija, anemija, levkopenija.
How Topotecan Eagle is given Topotecan Eagle is normally given by a doctor or nurse: - as a drip (infusion) for about 30 minutes - usually into your arm.
Kako se zdravilo Topotekan Eagle daje Zdravilo Topotekan Eagle običajno daje zdravnik ali medicinska sestra:
This medicine is not recommended if you have severe liver problems; - if you have lung problems, or if you have had lung problems before from using other medicines or radiation.
• če imate težave s pljuči ali če ste že imeli težave s pljuči zaradi drugih zdravil ali obsevanja.
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).
Pred naslednjo uporabo topotekana mora biti število nevtrofilcev  1 x 109/l, število trombocitov  100 x 109/l, vrednost hemoglobina pa  9 g/dl (po transfuziji, če je le-ta potrebna).
Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih v obeh teh študijah sta peroralni in intravenski topotekan pri bolnikih z relapsom občutljivega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
Topotecan/Cisplatin
Peroralni topotekan
A.
Ena
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Bolnica ga 1., 2. in 3. dan prejme v obliki 30minutne intravenske infuzije enkrat na dan. 1. dan po prejemu odmerka topotekana bolnica prejme še intravensko infuzijo cisplatina v odmerku 50 mg/m2/dan.
- if you are breast-feeding.
• če imate težave z jetri.
Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/min.
Samostojno zdravljenje (drobnocelični pljučni karcinom) Za zdravljenje bolnikov z očistkom kreatinina < 20 ml/min ne moremo priporočiti ustreznih odmerkov, saj imamo premalo izkušenj.
Small cell lung cancer - The usual dose is 1.5 mg of the medicine for each square meter of your body.
• običajni odmerek je 1,5 mg zdravila na kvadratni meter telesne površine;
NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion
IME ZDRAVILA Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje
− are breast feeding (see section 4.6)
(glejte poglavje 4.5).
Median survival (weeks)
Mediano preživetje (tedni) (95 % IZ)
Hydrochloric acid (E507) Water for injections
6.1 Seznam pomožnih snovi klorovodikova kislina (E507) (za uravnanje pH) voda za injekcije
NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion
IME ZDRAVILA Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje
For more information about cisplatin, please read its Package Leaflet.
Več informacij o cisplatinu najdete v njegovem navodilu za uporabo.
Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Topotekan Eagle 15 mg/5 ml koncentrat za raztopino za infundiranje topotekan
Tell your doctor immediately if you notice any of the following serious side effects.
Če opazite katerega od naslednjih resnih neželenih učinkov, nemudoma obvestite zdravnika.
For reduced dose '1.0 mg/m2'
Za zmanjšani odmerek „1,0 mg/m
Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion Topotecan
Topotekan Eagle 3 mg/1 ml koncentrat za raztopino za infundiranje topotekan
In another randomised phase III trial which compared intravenous topotecan to cyclophosphamide, Adriamycin (doxorubicin) and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
V drugi randomizirani raziskavi III. faze so primerjali intravenski topotekan s ciklofosfamidom, Adriamycinom (doksorubicin) in vinkristinom (CAV).
Cytotoxic Notice concentration or life-threatening overdose may occur.
Citotoksično zdravilo Upoštevajte koncentracijo, sicer lahko pride do življenjsko nevarnega prevelikega odmerjanja.