natgillin/translations-raw huggingface dataset:
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.
U kliničkim se ispitivanjima primjena topotekana obustavljala ako je doza smanjena na 1,0 mg/m 2/dan i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole nuspojava lijeka.
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.
Peroralno i intravenski primijenjen topotekan pokazali su slično ublažavanje simptoma u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, standardiziranim upitnicima samih bolesnika na otvorenoj (engl. unblinded) skali procjene simptoma u svakoj od ove dvije studije.
The median time to onset of Grade 2 or worse diarrhoea was 9 days.
Medijan vremena do pojave proljeva stupnja 2 ili većeg bio je 9 dana.
When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Kad se topotekan koristi u kombinaciji s cisplatinom potrebno je slijediti upute za primjenu cisplatina.
The powder needs to be reconstituted and diluted before infusion.
Prije primjene u obliku infuzije, prašak treba pripremiti i razrijediti.
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 GCSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
U farmakokinetičkom ispitivanju kod djece s refraktornim solidnim tumorima, ustanovljena maksimalna podnošljiva doza od 2,0 mg/m 2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF (vidjeti dio 5.2) na temelju toksičnosti ovisne o dozi u obliku mijelosupresije.
Titanium dioxide (E171) Red iron oxide (E172)
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, crveni (E172)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Nuspojave unutar iste skupine učestalosti navedene su u padajućem nizu prema ozbiljnosti.
Erythropoietin was administered to 10% of patients in 8% of courses.
Eritropoetin je bio primijenjen u 10% bolesnika u 8% ciklusa.
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.
Kako bočica sadrži 10% suviška, rekonstituirana otopina je prozirna, žute do žuto-zelene boje i sadrži 1 mg topotekana u 1 ml otopine.
Powder for concentrate for solution for infusion.
Prašak za koncentrat za otopinu za infuziju.
Neutropenia Severe neutropenia (Grade 4 - neutrophil count <0.5 x 10
Neutropenija Teška neutropenija (Stupanj 4 - broj neutrofila < 0,5 x 10
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
• U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
What Hycamtin is and what it is used for What you need to know before you are given Hycamtin How Hycamtin is used
Što je Hycamtin i za što se koristi Što morate znati prije nego počnete primati Hycamtin Kako se primjenjuje Hycamtin Moguće nuspojave
A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first-line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
U ispitivanju faze III (ispitivanje 478), uspoređivana je kombinacija topotekana primijenjenog peroralno i najboljeg potpornog liječenja (BSC; engl. best supportive care) (n = 71), sa samim BSC-om (n = 70) u bolesnika s recidivom karcinoma nakon prve linije liječenja (medijan vremena do progresije od prve linije liječenja [TTP] iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za sam BSC) i u bolesnika koji nisu bili pogodni za ponovno liječenje intravenski primijenjenom kemoterapijom.
The mean metabolite:parent AUC ratio was <10% for both total topotecan and topotecan lactone.
Prosječan omjer AUC metabolita i roditeljskog spoja bio je < 10% i za topotekan i za topotekan lakton.
What you need to know before you take Hycamtin
Što morate znati prije nego počnete uzimati Hycamtin
Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan.
Bočica od kremenog stakla tipa I, zatvorena sivim čepom od butilne gume i aluminijskim pokrovom te pokrivena plastičnom flip off kapicom, koja sadrži 4 mg topotekana.
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.
Ciklosporin A (inhibitor ABCB1, ABCC1 [MRP-1] i CYP3A4), primijenjen istovremeno s oralnim topotekanom povećava AUC topotekana prosječno 2 - 2,5 puta u usporedbi s kontrolnom skupinom.
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).
Predoziranja su prijavljena u bolesnika liječenih intravenskom formulacijom topotekana (dozama do 10 puta većima od preporučene) i kapsulama topotekana (dozama do 5 puta većima od preporučene).
The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”.
Kapsule su neprozirne, bijele do žućkasto bijele boje s otisnutim „HYCAMTIN“ i „0,25 mg“.
The integrated safety data for topotecan monotherapy are presented below.
U daljnjem tekstu su navedeni cjelokupni podaci o sigurnosti primjene topotekana u monoterapiji.
Very rare
Rijetke nuspojave
See section “Pregnancy and breast-feeding”
Pogledajte dio „Trudnoća i dojenje“.
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
Ukupni sadržaj djelatne tvari u bočici daje 1 mg/ml djelatne tvari nakon pripreme kako je propisano.
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Uobičajena onkološka metoda sprečavanja neutropenije je primjena topotekana s drugim lijekovima (npr. G-CSF) ili smanjenje doze s ciljem održanja primjerenog broja neutrofila.
Growth factors were administered to 19% of patients in 8% of courses.
Čimbenici rasta primijenjeni su u 19% bolesnika, u 8% ciklusa liječenja.
Relapsed ovarian cancer
Recidiv karcinoma jajnika
In clinical studies involving patients with relapsed small cell lung cancer, the dose-limiting toxicity of oral topotecan monotherapy was found to be haematological.
U kliničkim ispitivanjima koja su uključivala bolesnike s recidivom karcinoma pluća malih stanica, hematotoksičnost se pokazala čimbenikom ograničenja doze u monoterapiji oralnim topotekanom.
After opening, the product should be used immediately.
Lijek treba primijeniti odmah nakon otvaranja.
Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
Oko 20% bilo je izlučeno urinom kao ukupni topotekan, a 2% kao N-desmetiltopotekan.
The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy.
Učestalost dolje opisanih hematoloških i nehematoloških nuspojava dobivena je iz prijava nuspojava koje su ocijenjene kao povezane/moguće povezane s terapijom topotekanom.
Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7%.
Fecesom se eliminiralo 18% ukupnog topotekana i 1,7% N-desmetiltopotekana.
The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”.
Kapsule su neprozirne, ružičaste boje s otisnutim „HYCAMTIN“ i „1 mg“.
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Posljedica inhibicije topoizomeraze-I topotekanom na staničnoj razini je indukcija cijepanja jednog lanca DNK povezanih s proteinom.
• Itchy rash (or hives).
• urtikarija (ili koprivnjača)
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).
Geometrijska srednja vrijednost AUC(0-) topotekan laktona normalizirana prema dozi u bolesnika korejskog podrijetla iznosila je 7,9 ng*h/ml u ispitanika s klirensom kreatinina većim od 80 ml/min, 12,9 ng*h/ml u ispitanika s klirensom kreatinina od 50-80 ml/min i 19,7 ng*h/ml u ispitanika s klirensom kreatinina od 30-49 ml/min (vidjeti dijelove 4.2 i 4.4).
Pregnant staff should be excluded from working with this medicinal product.
Trudne djelatnice ne smiju rukovati ovim lijekom.
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).
Predoziranja su prijavljena u bolesnika liječenih kapsulama topotekana (dozama do 5 puta većima od preporučene) i intravenskom formulacijom topotekana (dozama do 10 puta većima od preporučene).
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.
U ovom je ispitivanju 46 bolesnika (43%) nakon 192 (42,1%) ciklusa primilo filgrastim (G-CSF); 65 bolesnika (60%) je nakon 139 (30,5%) ciklusa primilo transfuziju eritrocita, a 50 njih (46%) nakon 159 (34,9%) ciklusa transfuziju trombocita.
Platelet transfusions were given to 10% of patients in 4% of courses.
Transfuzije trombocita primijenjene su u 10% bolesnika u 4% ciklusa.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
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.
Farmakokinetika topotekana ispitivana je u bolesnika s karcinomom nakon peroralne primjene topotekana u dozi od 1,2 do 3,1 mg/m2/dan i 4 mg/m2/dan tijekom 5 dana.
Approximately 51% was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Oko 51% bilo je izlučeno urinom kao ukupni topotekan, a 3% kao N-desmetiltopotekan.
The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days.
Preporučena doza kod monoterapije oralnim topotekanom u bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 30 i 49 ml/min iznosi 1,9 mg/m2/dan tijekom pet uzastopnih dana.
Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan.
Bočica od kremenog stakla tipa I, zatvorena sivim čepom od butilne gume i aluminijskim pokrovom te pokrivena plastičnom flip off kapicom, koja sadrži 1 mg topotekana.
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/m given as a
U otvorenom ispitivanju u koje su bila uključena djeca (n = 108, raspon dobi: od dojenačke dobi do 16 godina) s recidivirajućim ili progresivnim solidnim tumorima, topotekan se primjenjivao u početnoj dozi od 2,0 mg/m u obliku 30-minutne infuzije tijekom 5 dana ponavljano svaka 3 tjedna, u trajanju do godine dana, ovisno o terapijskom odgovoru.
The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml.
Rekonstituirana otopina je prozirna, žute do žuto-zelene boje i sadrži 1 mg topotekana u 1 ml otopine.
How to take Hycamtin
Kako uzimati Hycamtin
Red blood cell transfusions were given in 30% of patients (13% of courses).
Transfuziju eritrocita primilo je 30% bolesnika (13% ciklusa).
9/l, and the haemoglobin level is 9 g/dl (after transfusion if necessary).
9/l i razina hemoglobina  9 g/dl (nakon transfuzije, ukoliko je potrebna).
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.
Preporučena doza topotekana u monoterapiji bolesnica s karcinomom jajnika i bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 20 i 39 ml/min iznosi 0,75 mg/m2/dan tijekom pet uzastopnih dana.
The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
U bolesnica liječenih kombinacijom topotekana i cisplatina ukupna hematološka toksičnost je manja nego kod monoterapije topotekanom, ali veća nego pri monoterapiji cisplatinom.
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, respectively.
U komparativnom ispitivanju topotekana i paklitaksela u bolesnica s karcinomom jajnika prethodno liječenih platinom (n = 112 i n = 114 po istom redoslijedu), stopa odgovora na lijek (95% CI) iznosila je 20,5% (13%, 28%) naspram 14% (8%, 20%), a medijan vremena do progresije iznosio je 19 tjedana naspram 15 tjedana (omjer hazarda 0,7 [0,6; 1,0]) za topotekan i paklitaksel.
Each capsule contains topotecan hydrochloride equivalent to 1 mg of topotecan.
Jedna kapsula sadržava topotekanklorid u količini koja odgovara 1 mg topotekana.
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.
Navedene su učestalosti hematoloških i nehematoloških nuspojava za koje se smatra da su povezane/vjerojatno povezane s liječenjem oralnim topotekanom.
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Infekcija se razvila u 17% bolesnika, sepsa u 2% bolesnika, a neutropenija s vrućicom javila se u 4% bolesnika.
9/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 0.4 mg/m 2/day to
9/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti za 0,4 mg/m 2/dan na
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients.
Potpuni ili izraziti gubitak kose zabilježen je u 30%, a djelomičan u 15% bolesnika.
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.
12 godina, n = 18), adolescenata (u dobi od 12-16 godina, n = 9) i mlađih odraslih osoba (u dobi od 16-21 godine, n = 9) s refraktornim solidnim tumorima.
The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Prosječan AUC omjer metabolita i roditeljskog spoja bio je manji od 10% i za topotekan i za topotekan lakton.
The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Preporučena doza topotekana je 0,75 mg/m tjelesne površine/dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta prvog, drugog i trećeg dana ciklusa.
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Pretklinička ispitivanja su pokazala da topotekan uzrokuje smrt i malformacije embrija i fetusa (vidjeti dio 5.3).
9/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/m 2/day for subsequent courses (or subsequently down to 0.45 mg/m 2/day if necessary).
9/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20%, na 0,60 mg/m 2/dan (ukoliko je potrebno nadalje smanjiti dozu na 0,45 mg/m 2/dan).
Hycamtin capsules must not be opened or crushed.
Hycamtin kapsule se ne smiju otvarati ili drobiti.
Platelet transfusions were given in 4% of courses.
Transfuzije trombocita davane su u 4% ciklusa.
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Topotekan je potrebno primjenjivati samo na odjelima specijaliziranim za primjenu citotoksičnih lijekova.
In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Osim toga, pri predoziranju intravenskom formulacijom topotekana prijavljene su povišene vrijednosti jetrenih enzima.
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.
Mali broj bolesnika s oštećenjem jetrene funkcije (vrijednost bilirubina u serumu između 1,5 i 10 mg/dl) primio je topotekan intravenski u dozi od 1,5 mg/m²/dan tijekom pet dana svaka tri tjedna.
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.
Sveukupno, doprinos N-desmetil metabolita ukupnom materijalu povezanom s topotekanom u urinu i fecesu je bio prosječno manji od 7% (u rasponu od 4 - 9%).
Each capsule contains topotecan hydrochloride equivalent to 0.25 mg of topotecan.
Jedna kapsula sadržava topotekanklorid u količini koja odgovara 0,25 mg topotekana.
If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2ºC - 8ºC after the first puncture of the vial.
Ako su rekonstitucija i razrjeđivanje provedeni pod strogim aseptičkim uvjetima (npr. klupa s laminarnim strujanjem zraka), lijek treba upotrijebiti (završiti s infuzijom) unutar 24 sata ukoliko se, nakon prvog otvaranja bočice, čuva pri temperaturi od 2°C - 8°C.
Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Medijan vremena do pojave teške neutropenije iznosio je devet dana, s medijanom vremena trajanja od sedam dana.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA
Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Fecesom se eliminiralo 33% ukupnog topotekana i 1,5% N-desmetiltopotekana.
HYCAMTIN 4 mg is available in packs containing 1 vial and 5 vials.
HYCAMTIN 4 mg je dostupan u pakiranjima od 1 bočice i 5 bočica.
Median time to onset of severe thrombocytopenia was day 15 and the median duration was five days.
Medijan vremena do pojave teške trombocitopenije bio je 15. dan liječenja, a medijan vremena trajanja iznosio je pet dana.
HYCAMTIN capsules should not be broken or crushed.
HYCAMTIN kapsule se ne smiju lomiti ili drobiti.
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.
Sveukupno, doprinos N-desmetil metabolita ukupnom materijalu povezanom s topotekanom u urinu i fecesu je bio prosječno manji od 6% (u rasponu od 4-8%).
• Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
• mučnina, povraćanje; proljev; bolovi u trbuhu; zatvor (konstipacija)
The contents of HYCAMTIN 4 mg vials must be reconstituted with 4 ml water for injections.
Sadržaj bočice lijeka HYCAMTIN 4 mg mora se rekonstituirati s 4 ml vode za injekcije.
Anaphylactic reaction, angioedema, urticaria Metabolism and nutrition disorders Very common Anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare
Rijetko anafilaktička reakcija, angioedem, urtikarija Poremećaji metabolizma i prehrane Vrlo često anoreksija (koja može biti teška)
Reconstitution
Rekonstitucija
However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.4).
Međutim, nema dovoljno dostupnih podataka koji su potrebni za preporuku o doziranju u toj skupini bolesnika (vidjeti dio 4.4).
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Umjerena trombocitopenija (Stupanj 3 - trombociti između 10 i 50 x 10
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is 1.5 x 10
Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije  1,5 x 10
• Inflammation and ulcers of the mouth tongue or gums.
• upala sluznice i stvaranje rana (ulceracija) usne šupljine, jezika ili desni
The contents of HYCAMTIN 1 mg vials must be reconstituted with 1.1 ml water for injections.
Sadržaj bočice lijeka HYCAMTIN 1 mg mora se rekonstituirati s 1,1 ml vode za injekcije.
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)
Rijetko anafilaktička reakcija, angioedem, urtikarija Poremećaji metabolizma i prehrane Vrlo često anoreksija (koja može biti teška) Poremećaji dišnog sustava, prsišta i sredoprsja Rijetko intersticijska bolest pluća (neki slučajevi su bili fatalni) Poremećaji probavnog sustava Vrlo često mučnina, povraćanje i proljev (svi mogu biti teški) koji mogu dovesti do dehidracije (vidjeti dijelove 4.2 i 4.4)
The capsule(s) must be swallowed whole, and must not be chewed crushed or divided.
Kapsule se moraju progutati cijele i ne smiju se žvakati niti lomiti.
HYCAMTIN 1 mg is available in packs containing 1 vial and 5 vials.
HYCAMTIN 1 mg je dostupan u pakiranjima od 1 bočice i 5 bočica.
HYCAMTIN 1 mg hard capsules
HYCAMTIN 1 mg tvrde kapsule
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).
Medijan vremena preživljenja bolesnika liječenih oralnim topotekanom plus BSC-om iznosio je 25,9 tjedana (95% CI: 18,3; 31,6) u usporedbi s 13,9 tjedana (95% CI :11,1;18,6), za bolesnike liječene samo BSC-om (p = 0,0104).
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Rijetko su prijavljene značajne posljedice povezane s trombocitopenijom, uključujući smrtne slučajeve zbog krvarenja povezanog s tumorom.
This rare side effect may affect up to 1 in 1,000 people treated with Hycamtin:
Ova rijetka nuspojava može se javiti u do 1 na 1000 osoba liječenih lijekom Hycamtin:
Median time to onset of severe neutropenia was day 12 with a median duration of 7 days.
Medijan vremena do pojave teške neutropenije je 12. dan s medijanom vremena trajanja od 7 dana.
A reduction in topotecan clearance was observed.
Uočeno je smanjenje klirensa kreatinina.
Median time to onset of severe thrombocytopenia was day 15 with a median duration of 2.5 days.
Medijan vremena do pojave teške trombocitopenije bio je 15. dan liječenja, s medijanom vremena trajanja od 2,5 dana.
Asthenia, pyrexia, malaise
Često astenija, pireksija, opća slabost