natgillin/translations-raw huggingface dataset:
In 34% of courses with severe neutropenia, the duration was >7 days.
V 34 % ciklusov s hudo nevtropenijo je ta trajala >7 dni.
The pharmacokinetics of oral topotecan have not been studied in patients with hepatic impairment (see section 4.2 and 4.4).
Farmakokinetika peroralnega topotekana ni raziskana pri bolnikih z okvaro jeter (glejte poglavji 4.2 in 4.4).
• Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
• rak jajčnika in drobnocelični pljučni rak: 1,5 mg na kvadratni meter telesne površine na dan.
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Neslepljeno ocenjene navedbe bolnikov samih o simptomih so pokazale dosleden trend k boljšemu simptomatskemu stanju v skupini, zdravljeni s peroralnim topotekanom in NPO.
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).
Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Driska zaradi peroralnega topotekana se lahko pojavi hkrati z nevtropenijo, povezano s tem zdravilom, in njenimi posledicami.
• Swelling caused by fluid build-up (angioedema).
• otekanje zaradi kopičenja tekočine (angioedem);
• 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);
The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Povprečno razmerje med AUC presnovka in matične snovi v plazmi je bilo manjše od 10 % tako za celotni topotekan kot za topotekanov lakton.
Median (95% CI) Hazard ratio (95% CI) Log rank p-value
Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) Log rank p-vrednost
Moderate to severe (Hb 8.0 g/dl) in 37% of patients (14% of courses).
Zmerna do huda oblika (Hb ≤8,0 g/dl) se je razvila pri 37 % bolnikov (v 14 % ciklusov zdravljenja).
The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
Kapsule morate pogoltniti cele in jih ne smete žvečiti, drobiti ali deliti.
Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Hematološka toksičnost je odvisna od odmerka, zato je treba bolnikom redno pregledovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4.2).
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Zmerna trombocitopenija (3. stopnje - število trombocitov med 10,0 in 50,0 x 10
Topotecan is contraindicated during breast-feeding (see section 4.3).
Topotekan je med dojenjem kontraindiciran (glejte poglavje 4.3).
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Okužbe so se pojavile pri 17 % bolnikov, sepsa pri 2 % in febrilna nevtropenija pri 4 %.
Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
Drisko zaradi zdravil proti raku spremlja velika obolevnost in je lahko smrtno nevarna.
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 %.
Side effects with frequency not known
Neželeni učinki z neznano pogostnostjo
Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
Topotekan je v kombinaciji s cisplatinom indiciran pri bolnicah s ponovitvijo karcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
Hard capsule.
trda kapsula
9/l) in 25% of patients (15% of courses).
9/l) pa pri 25 % bolnikov (v 15 % ciklusov zdravljenja).
When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Pri uporabi topotekana v kombinaciji s cisplatinom je treba upoštevati tudi navodila za predpisovanje cisplatina.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10
Pred prvim ciklusom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev 1,5 x 10
Those effects are described in the cisplatin patient leaflet.
Ti neželeni učinki so navedeni v navodilu za uporabo cisplatina.
Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Uporaba samega topotekana in topotekana v kombinaciji s cisplatinom je pogosto povezana s pojavljanjem klinično pomembne trombocitopenije.
VIAL
VIALA
Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Bolnice s predhodno kemoterapijo s cisplatinom cisplatin topotekan/cisplatin
Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Odlepite zadnjo plast: začnite na obarvanem vogalu ter jo dvignite in odlepite s celotnega žepa.
No in vivo human pharmacokinetic interaction studies have been performed.
Farmakokinetičnih študij medsebojnega delovanja in vivo pri ljudeh niso izvedli.
Frequently reported non-haematological effects were gastrointestinal, such as nausea (52%), vomiting (32%), diarrhoea (18%), constipation (9%) and mucositis (14%).
Pogostejši nehematološki učinki so bile gastrointestinalne težave, kot so navzea (52 %), bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m2/day and 4 mg/m2/day administered daily for 5 days.
Farmakokinetiko peroralnega topotekana so ocenili pri bolnikih z rakom po odmerkih od 1,2 do 3,1 mg/m2/dan in 4 mg/m2/dan, uporabljenih vsak dan pet dni.
• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
• bolnicah z rakom jajčnika z metastazami, če terapija prve linije in tudi naslednje terapije niso uspele,
If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).
Če je priprava potekala v strogo aseptičnih pogojih, lahko infundiranje zdravila Hycamtin končate v 12 urah, če raztopino hranite pri sobni temperaturi (ali v 24 urah, če jo hranite pri temperaturi od 2 do 8 °C).
One study included a dose range of 1.4 to 2.4 mg/m 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.
Interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common Nausea, vomiting and diarrhoea (all of which may be severe), which may lead to dehydration (see sections 4.2 and 4.4)
Bolezni prebavil zelo pogosti navzea, bruhanje in driska (vse lahko v hudi obliki), ki lahko povzročijo dehidracijo (glejte poglavji 4.2 in 4.4)
Since the vial contains a 10% overage, the clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Ker viala vsebuje 10 % prebitka, je pripravljena bistra raztopina rumene do rumeno-zelene barve in vsebuje 1 mg topotekana na mililiter.
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).
V populacijski študiji intravenske uporabe zdravila niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celotnega topotekana (aktivne in neaktivne oblike).
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
Protitumorsko delovanje topotekana vključuje zaviranje encima topoizomeraze I. Ta encim je tesno povezan s podvojevanjem DNA in odpravlja torzijsko napetost, ki se pojavlja pred napredujočimi replikacijskimi vilicami.
Relapsed ovarian cancer
Ponovitev raka jajčnikov
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Bel pretisni omot iz polivinilklorida/poliklorotrifluoretilena z zaporno folijo iz aluminija/polietilentereftalata (PET)/papirja.
The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections.
Vsebino viale z zdravilom HYCAMTIN 1 mg je treba rekonstituirati z 1,1 ml vode za injekcije.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Poročila o resnih zapletih, povezanih s trombocitopenijo, vključno s smrtnimi primeri zaradi tumorske krvavitve, so bila redka.
Titanium dioxide (E171) Red iron oxide (E172)
Ovojnica kapsule želatina titanov dioksid (E171) rdeči železov oksid (E172)
Keep the blister in the outer carton in order to protect from light.
Pretisni omot shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Loperamide was administered to 13% of patients in 5% of courses.
Loperamid je dobilo 13 % bolnikov v 5 % ciklusov.
Initial dose The recommended dose of HYCAMTIN capsules is 2.3 mg/m body surface area per day administered for five consecutive days with a three-week interval between the start of each course.
Priporočeni odmerek kapsul HYCAMTIN je 2,3 mg/m telesne površine na dan pet dni zapored in s tritedenskimi presledki med začetki posameznih ciklusov zdravljenja.
WARNING: Cytotoxic agent, special handling instructions (see Package Leaflet).
OPOZORILO: citotoksično zdravilo, posebna navodila za ravnanje (glejte Navodilo za uporabo).
Reconstitute before use.
za intravensko uporabo Pred uporabo rekonstituirajte.
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 koncentriranih eritrocitov, petdeset (46 %) bolnikov pa v 159 ciklusih (34,9 %) transfuzijo trombocitov.
topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects.
V kliničnih študijah so topotekan prenehali uporabljati, če je bil odmerek že zmanjšan na 1,0 mg/m 2/dan in bi ga bilo treba zaradi neželenih učinkov še dodatno zmanjšati.
• If you get any side effects, talk to your doctor.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
9/l) occurred in 6% of patients in 2% of courses.
9/l) se je pojavila pri 6 % bolnikov v 2 % ciklusov.
Titanium dioxide (E171)
Ovojnica kapsule želatina titanov dioksid (E171)
Overall, the N-desmethyl metabolite contributed a mean of less than 7% (range 4-9%) of the total topotecan-related material accounted for in the urine and faeces.
Presnovek N-desmetil predstavlja v povprečju manj kot 7 % (od 4 do 9 %) vseh s topotekanom povezanih snovi prisotnih v urinu in blatu.
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.
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.
In 46% of courses with moderate to severe anaemia, the duration was >7 days.
V 46 % ciklusov z zmerno do hudo anemijo je ta trajala >7 dni.
Overall, the Ndesmethyl metabolite contributed a mean of less than 6% (range 4-8%) of the total topotecan-related material accounted for in the urine and faeces.
V celoti je predstavljal N-desmetilni presnovek povprečno manj kot 6 % (od 4 do 8 %) vseh s topotekanom povezanih snovi v urinu in blatu.
The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections.
Vsebino viale z zdravilom HYCAMTIN 4 mg je treba rekonstituirati s 4 ml vode za injekcije.
Storage of the prepared solution
Shranjevanje pripravljene raztopine
Rarely, it can lead to more severe bleeding (haemorrhage).
V redkih primerih lahko pride tudi do hujših krvavitev.
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).
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).
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.
Manjšemu številu bolnikov z jetrno okvaro (z vrednostmi bilirubina v serumu med 1,5 in 10 mg/dl) so intravensko dajali odmerke topotekana 1,5 mg/m2/dan po pet dni na vsake tri tedne.
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).
Contact a doctor or pharmacist immediately for advice if you have taken too many capsules or if a child has accidentally taken the medicine.
Če ste vzeli večji odmerek zdravila Hycamtin, kot bi smeli Če ste vzeli preveč kapsul ali če je otrok po nesreči vzel vaše zdravilo, se nemudoma posvetujte z zdravnikom ali farmacevtom.
• Inflammation and ulcers of the mouth tongue or gums.
• vnetje in razjede na jeziku ali dlesnih;
Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose).
O prevelikem odmerjanju so poročali pri bolnikih, ki so prejemali topotekan v kapsulah (do 5-kratni priporočeni odmerek) in topotekan intravensko (do 10-kratni priporočeni odmerek).
Following co-administration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1000 mg with oral topotecan, the AUC0-∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Po sočasni uporabi elakridarja (GF120918) (zaviralca ABCB1 (P-gp) in ABCG2 (BCRP)) v odmerku 100 in 1.000 mg skupaj s peroralnim topotekanom sta se AUC0-∞ topotekanovega laktona in celotnega topotekana povečali približno 2,5-krat (glejte poglavje 4.5 za pojasnila).
• Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
• Občasne hude bolečine v želodcu, zvišana telesna temperatura, lahko tudi driska (redko krvava) so lahko znaki vnetja črevesja (kolitisa).
Signs include: difficulty breathing cough fever.
Med znaki so: težko dihanje, kašelj, zvišana telesna temperatura.
The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/possibly related to oral topotecan therapy.
V nadaljevanju navedene pogostnosti hematoloških in nehematoloških neželenih učinkov veljajo za učinke, ki so povezani ali so morda povezani s peroralno uporabo topotekana.
The recommended dose of topotecan is 1.5 mg/m 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/m 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.
9/l) during course 1 in 55% of patients, with duration  seven days in 20%, and overall in 77% of patients (39% of courses).
9/l), ki je pri 20 % bolnikov trajala najmanj sedem dni, med celotnim obdobjem zdravljenja pa se je huda nevtropenija pojavila pri 77 % bolnikov (v 39 % ciklusov zdravljenja).
What you need to know before you are given Hycamtin
Kaj morate vedeti, preden boste prejeli zdravilo Hycamtin
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
- Ob nehotenem stiku zdravila s kožo ali z očmi jih je treba takoj sprati z veliko količino vode.
9/l) occurred in 29% of patients in 14% of courses.
9/l) se je pojavila pri 29 % bolnikov v 14 % ciklusov.
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.
There are insufficient data available with HYCAMTIN capsules to make a dose recommendation for this patient group (see section 4.4).
Za kapsule HYCAMTIN ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v tej skupini bolnikov (glejte poglavje 4.4).
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).
O prevelikem odmerjanju so poročali pri bolnikih, ki so prejemali topotekan intravensko (do 10-kratni priporočeni odmerek) in topotekan v kapsulah (do 5-kratni priporočeni odmerek).
Geometric mean topotecan lactone dose-normalised AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively (see section 4.2 and 4.4).
Pri korejskih bolnikih so bile geometrične srednje vrednosti AUC(0-) za topotekan lakton, normalizirane glede na odmerek, 7,9, 12,9 oziroma 19,7 ng*h/ml pri posameznikih z očistkom kreatinina >80 ml/min, 50-80 ml/min oziroma 30-49 ml/min (glejte poglavji 4.2 in 4.4).
Pregnant staff should be excluded from working with this medicinal product.
- Pri rokovanju z zdravilom ne smejo sodelovati nosečnice.
The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Pripravljena bistra raztopina je rumene do rumeno-zelene barve in vsebuje 1 mg topotekana na mililiter.
The recommended monotherapy dose of topotecan in patients with ovarian or 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 s karcinomom jajčnika in bolnikov z drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/min, je 0,75 mg/m2/dan, pet zaporednih dni.
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 %.
The second study included a dose range of 2.0 to 5.2 mg/m 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.
The pharmacokinetics of topotecan were generally unchanged when co-administered with ranitidine.
Farmakokinetika topotekana se med sočasno uporabo z ranitidinom na splošno ni spremenila.
What Hycamtin is and what it is used for What you need to know before you are given Hycamtin How Hycamtin is used
Kaj je zdravilo Hycamtin in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Hycamtin Kako uporabljati zdravilo Hycamtin Možni neželeni učinki
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2-2.5-fold of control.
Hkrati s peroralnim topotekanom uporabljeni ciklosporin A (ki zavira ABCB1, ABCC1 [MRP-1] in CYP3A4) je povečal AUC topotekana na približno 2 - 2,5-kratno vrednost v primerjavi s kontrolno skupino.
Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Mediana časa do začetka hude nevtropenije je bila devet dni, mediana trajanja nevtropenije pa sedem dni.
Platelet transfusions were given to 10% of patients in 4% of courses.
Transfuzije trombocitov je dobilo 10 % bolnikov v 4 % ciklusov.
Hycamtin 1 mg capsules are pink and imprinted with “Hycamtin” and “1 mg”.
1-miligramske kapsule Hycamtin so rožnate barve in označene s ‘Hycamtin' in ‘1 mg'.
Geometric mean topotecan lactone dose-normalised AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively.
Geometrične srednje vrednosti AUC(0) za topotekan lakton, normalizirane glede na odmerek, so bile 9,4, 11,1 oziroma 12,0 ng*h/ml pri posameznikih z očistkom kreatinina >80 ml/min, 50 - 80 ml/min oziroma 30 - 49 ml/min.
Administration of oral cyclosporine A (15 mg/kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0and 2.5-fold, respectively (see section 4.5).
Peroralno uporabljeni ciklosporin A (15 mg/kg), zaviralec transportnih beljakovin ABCB1 (P-gp) in ABCC1 (MRP-1) ter presnovnega encima CYP3A4, je v 4 urah po peroralnem odmerjanju topotekana povečal za odmerek normalizirano AUC0-24h topotekanovega laktona za približno 2,0-krat in celotnega topotekana za približno 2,5-krat (glejte poglavje 4.5).
Haematological
Hematološki
Sealing band Gelatin
Zaporni trak želatina
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
V študijah vpliva na sposobnost razmnoževanja pri podganah niso ugotovili učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
What you need to know before you take Hycamtin
Kaj morate vedeti, preden boste vzeli zdravilo Hycamtin
Light yellow to greenish powder.
prašek za koncentrat za raztopino za infundiranje Svetlo rumen do zelenkast prašek.
Median (95% CI) Hazard ratio (95% CI)
Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ)
Erythropoietin was administered to 10% of patients in 8% of courses.
Eritropoetin je dobilo 10 % bolnikov v 8 % ciklusov.
Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Med uporabo topotekana so bili opisani primeri intersticijske bolezni pljuč (IBP), nekateri s smrtnim izidom (glejte poglavje 4.8).