natgillin/translations-raw huggingface dataset:
Chemical and physical in-use stability has been demonstrated for 14 days at 20°C - 25°C when stored in the outer carton to protect from light.
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 14 dni pri 20 °C do 25 °C, če je zdravilo shranjeno v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Med osnovnimi dejavniki tveganja so anamneza IBP, pljučna fibroza, rak pljuč, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih zdravil in/ali kolonijo stimulirajočih faktorjev.
As expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Kot je bilo pričakovati, se bolniki v slabšem telesnem stanju (PS > 1) slabše odzivajo na zdravilo in pri njih tudi pogosteje opažamo zaplete, kot so povišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.
Med kliničnimi preskušanji so topotekan prenehali uporabljati, če je bil odmerek že zmanjšan na 1,0 mg/m2 in bi ga bilo treba zaradi neželenih učinkov še dodatno zmanjšati.
Metabolism and nutrition disorders Very common: anorexia (which may be severe)
Presnovne in prehranske motnje Zelo pogosti: anoreksija (ki je lahko huda).
In this case, it is used with another medicine called cisplatin.
V tem primeru ga uporabljamo skupaj z drugim zdravilom, imenovanim cisplatin.
Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3.
Pomembno je, da se bolnikovo telesno stanje ob začetku zdravljenja natančno oceni in zagotovi, da se ne poslabša na 3.
This is because you are more likely to get severe lung problems (interstitial lung disease) when using Topotecan Eagle;
To pomeni, da je verjetnost za pojav hudih težav s pljuči (intersticijska bolezen pljuč) večja, če uporabljate zdravilo Topotekan Eagle;
For storage conditions of once-opened and diluted medicinal product, see section 6.3.
Za pogoje shranjevanja po prvem odprtju in redčenju zdravila glejte poglavje 6.3.
As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.
Kot velja za vsako citotoksično kemoterapijo, morate svetovati uporabo učinkovite kontracepcijske zaščite, če se kateri od partnerjev zdravi s topotekanom.
- Liquid waste may be flushed with large amounts of water.
• Odpadno tekočino lahko sperete z veliko količino vode.
Your dose of Topotecan Eagle may need to be adjusted.
Odmerek zdravila Topotekan Eagle bo morda treba prilagoditi.
Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom Tel: +1 (201) 326-5324 Fax: +1 (201) 391-2430
Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT Združeno kraljestvo tel.: +1 (201) 326-5324 fax: +1 (201) 391-2430
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Ker pa je topotekan - tako kot druga citotoksična zdravilagenotoksičen, ni mogoče izključiti učinkov na plodnost, vključno s plodnostjo samcev.
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and 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 mukozitis (14 %).
Contraception in males and females
Kontracepcijska zaščita moških in žensk
You should not receive Topotecan Eagle: - if you are allergic (hypersensitive) to topotecan or to any of the other ingredients of this
Zdravila Topotekan Eagle ne smete prejeti: • če ste alergični (preobčutljivi) na topotekan ali katero koli drugo sestavino tega zdravila,
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Čeprav ni znano, če se topotekan izloča v materino mleko, morajo matere ob začetku zdravljenja s topotekanom prenehati dojiti.
Like all medicines, Topotecan Eagle can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Topotekan Eagle neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Summary of survival, response rate and time to progression in SCLC patients treated with oral or intravenous topotecan
Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim oz. intravenskim topotekanom
If you are not sure, talk to your doctor or nurse before using this medicine.
Če ste negotovi, se pred uporabo tega zdravila posvetujte z zdravnikom ali medicinsko sestro.
Do not use Topotecan Eagle if you notice any visible particles or if the solution is unclear.
Ne uporabljajte zdravila Topotekan Eagle, če opazite vidne delce ali če je raztopina motna.
• The anticipated effects of overdose (e.g. bone marrow suppression).
• pričakovane učinke prevelikega odmerjanja (npr. supresija kostnega mozga);
Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Drugi hujši učinki, ki so se pojavili pri bolnikih in so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12 %), občutek slabosti (3 %) in hiperbilirubinemija
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Topotecan Eagle.
Če kar koli od navedenega velja za vas (oz. ste negotovi), se pred uporabo zdravila Topotekan Eagle posvetujte z zdravnikom ali medicinsko sestro.
Dilution should be performed under strict aseptic conditions (e.g. an LAF bench).
Redčenje mora potekati v strogo aseptičnih pogojih (na primer na pultu z laminarnim pretokom zraka (LAF)).
Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Anemija: Zmerna do huda (Hb ≤ 8,0 g/dl) pri 37 % bolnikov (14 % ciklov zdravljenja).
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 Eagle.
Če se zdravite zaradi raka materničnega vratu, se lahko pojavijo neželeni učinki zaradi drugega zdravila (cisplatina), ki ga boste prejeli skupaj z zdravilom Topotekan Eagle.
If, during topotecan/cisplatin combination therapy serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost serumskega kreatinina preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnega koli zmanjšanja odmerka cisplatina ali nadaljevanju zdravljenja.
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na IBP (npr. kašelj, povišana telesna temperatura, dispneja in/ali hipoksija); če je diagnoza IBP potrjena, je treba zdravljenje s topotekanom prekiniti.
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A, or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Topotekan in vitro pri človeku ni zaviral delovanja encimov P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A).
Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients.
Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
Reactions have been mild and have not generally required specific therapy.
Reakcije so bile blage, specifično zdravljenje pa
Body surface area (m
Telesna površina (m2)
Doses should be similarly reduced if the platelet count falls below 25 x 109/l.
Podobno je odmerke potrebno zmanjšati, če se število trombocitov zmanjša pod 25 x 109/l.
How Topotecan Eagle is prepared
Kako se zdravilo Topotekan Eagle pripravi
− Personnel should be trained to dilute the medicinal product.
• Osebje mora biti ustrezno izurjeno za rekonstitucijo zdravila.
Also some other medicines can affect the way Topotecan Eagle works.
Tudi druga zdravila lahko vplivajo na delovanje zdravila Topotekan Eagle.
Among all patients treated in clinical trials (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
11 % vseh bolnikov (4 % ciklov zdravljenja), ki so se zdravili v kliničnih raziskavah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se nevtropenija ni pojavila), je imelo povišano telesno temperaturo, pri 26 % (9 % ciklov zdravljenja) pa so se pojavile okužbe.
In an intravenous population study, 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 po intravenski aplikaciji niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celokupnega topotekana (aktivne in neaktivne oblike).
The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Odstotek odziva na topotekan pri kombiniranem režimu zdravljenja drobnoceličnega pljučnega raka (n = 480) pri bolnikih z relapsom bolezni, dovzetne na zdravljenje s terapijo prve izbire je bil 20,2 %.
Topotecan Eagle requires appropriate dilution before use.
Zdravilo Topotekan Eagle je treba pred uporabo ustrezno razredčiti.
Pregnancy and breast-feeding - Topotecan Eagle should not be used during pregnancy, unless clearly necessary.
• Zdravila Topotekan Eagle ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
It is important that Topotecan Eagle is further diluted before use (see section 6.6).
Pomembno je, da zdravilo Topotekan Eagle pred uporabo dodatno razredčite (glejte poglavje 6.6).
From a microbiological point of view, once opened, the product may be stored for a maximum of 14 days at 20°C - 25°C.
Z mikrobiološkega vidika se lahko odprto zdravilo shranjuje največ 14 dni pri 20 °C do 25 °C.
VIAL 5 ml
VIALA 5 ml
VIAL 1 ml
VIALA 1 ml
Multidose vial: once opened, store for a maximum of 14 days at 20°C-25°C.
Večodmerna viala: po odprtju shranjujte največ 14 dni pri 20 °C do 25 °C.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
In dose-finding trials involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose limiting toxicity of topotecan monotherapy was found to be haematological.
Med preskušanji za določitev ustreznega odmerka, v katere je bilo vključenih 523 bolnic z relapsom raka na jajčniku in 631 bolnikov z relapsom drobnoceličnega pljučnega raka, so ugotovili, da pri zdravljenju s topotekanom kot samostojnim zdravilom odmerek omejuje hematološka toksičnost.
Red cell transfusions were given in 52 % of patients (21 % of courses).
52 % bolnikov je prejelo transfuzijo eritrocitov (21 % ciklov zdravljenja).
Topotecan Eagle must be diluted to a final concentration between 25 µg/ml and 50 µg/ml (see section 6.6 for dilution instructions).
Zdravilo Topotekan Eagle morate razredčiti do končne koncentracije med 25 µg/ml in 50 µg/ml (glejte navodila za redčenje v poglavju 6.6).
30-minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Zdravljenje se je ponavljalo vsake 3 tedne in trajalo do 1 leta, odvisno od odziva na zdravljenje.
You are more likely to get severe lung problems (interstitial lung disease) if you already have lung problems or have had lung problems before from using other medicines or radiation.
Verjetnost za pojav hudih težav s pljuči (intersticijska bolezen pljuč) je večja, če že imate težave s pljuči ali če ste že imeli težave s pljuči zaradi drugih zdravil ali obsevanja.
The concentration of topotecan in Topotecan Eagle differs from other topotecan products (see section 6.6 for further instructions on dilution).
Koncentracija topotekana v zdravilu Topotekan Eagle je drugačna kot pri drugih zdravilih s topotekanom (glejte dodatna navodila za redčenje v poglavju 6.6).
Instructions on how to dilute, store and dispose of Topotecan Eagle
Navodila za redčenje, shranjevanje in odstranjevanje zdravila Topotekan Eagle
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 for five days every three weeks.
Le manjše število bolnikov z jetrno okvaro (vrednost serumskega bilirubina med 1,5 in 10 mg/dl) je prejelo intravensko odmerek topotekana 1,5 mg/m2 po pet dni na vsake tri tedne.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Tako kot druga citotoksična zdravila lahko tudi topotekan škoduje plodu, zato je ženskam v rodni dobi potrebno svetovati, da med zdravljenjem s topotekanom ne smejo zanositi.
The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Razmerje tveganja za preživetje z intravenskim topotekanom relativno glede na kombinacijo CAV je bilo 1,04 (95 % interval zaupanja: 0,78 - 1,40).
- It is given once each day for 5 days.
• zdravilo se daje 5 dni po enkrat na dan;
The concentration of topotecan in Topotecan Eagle differs from other topotecan products and care should be taken to ensure appropriate dilution occurs to achieve the intended dose, which should be checked prior to administration to the patient.
Koncentracija topotekana v zdravilu Topotekan Eagle je drugačna kot pri drugih zdravilih s topotekanom, zato je pri pripravi zdravila potrebna previdnost za zagotovitev ustreznega redčenja zdravila, da se pripravi želeni odmerek, ki ga je treba pred dajanjem bolniku preveriti.
There is no known antidote for topotecan overdose.
Za preveliko odmerjanje topotekana ne poznamo antidota.
- Men having Topotecan Eagle who wish to father a child should ask their doctor for family
• Moški, ki uporabljajo zdravilo Topotekan Eagle in želijo zaploditi otroka, se morajo z zdravnikom posvetovati glede načrtovanja družine.
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Nekorigirano razmerje tveganja med skupino s peroralnim topotekanom in NPO ter skupino s samo NPO je bilo 0,64 (95 % IZ: 0,45, 0,90).
Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Samostojno zdravljenje s topotekanom je indicirano pri bolnikih z relapsom drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve izbire ni primerno (glejte poglavje 5.1).
In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %.
V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (obliko, ki se ne odziva na zdravljenje s terapijo prve izbire) je bil odziv na topotekan 4,0-odstoten.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Za nadaljnje informacije o uporabi tega zdravilu se obrnite na svojega zdravnika ali medicinsko sestro.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali medicinsko sestro.
The incidence of adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Pojavnost zgoraj navedenih neželenih dogodkov je lahko pogostejša pri bolnikih s slabšim telesnim stanjem (glejte poglavje 4.4).
In an open-label trial 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
Med odprtim preskušanjem pri otrocih (n = 108, razpon starosti: dojenčki do 16 let) z rekurentnim ali progresivnim solidnim tumorjem so otroci topotekan prejemali v začetnem odmerku 2,0 mg/m2 v obliki
Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Huda nevtropenija je pri 11 % vseh ciklov zdravljenja trajala več kot sedem dni.
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 po 192 (42,1 %) ciklih prejelo G-CSF, petinšestdeset (60 %) bolnikov je po 139 (30,5 %) ciklih prejelo transfuzijo eritrocitov, petdeset (46 %) bolnikov pa po 159 (34,9 %) ciklih transfuzijo trombocitov.
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 (serumski bilirubin med 1.5 in 10 mg/dl) se je v primerjavi s kontrolno skupino znižal na približno 67 %.
Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan.
Med zdravljenjem s topotekanom so pri približno 25 % bolnikov opazili utrujenost, pri 16 % pa astenijo.
Volume of solution required (ml)
Potrebna prostornina raztopine (ml)
This is caused by a drop in the number of blood
So posledica zmanjšanja števila trombocitov v krvi;
- if you have unusual bruising or bleeding; - if you are feeling very ill.
• če imate nenavadne podplutbe ali krvavitve;
What Topotecan Eagle is and what it is used for
KAJ JE ZDRAVILO TOPOTEKAN EAGLE IN ZA KAJ GA UPORABLJAMO
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
Neslepljeno ocenjene navedbe bolnikov samih o simptomih so pokazale dosleden trend k boljšemu simptomatskemu stanju v skupini, zdravljeni s peroralnim topotekanom in NPO.
Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom
Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT Združeno kraljestvo
- All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
- Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
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).
Pri dajanju v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dne) je bil 5. dan očistek topotekana v primerjavi s 1. dnem manjši (19,1 l/uro/m2 v primerjavi s 21,3 l/uro/m2 [n = 9])
Very rare - Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.
• blaga bolečina in vnetje na mestu injiciranja zdravila zaradi nenamernega dajanja zdravila v okoliško tkivo (ekstravazacija), npr. zaradi uhajanja.
Topotecan is contra-indicated during breast-feeding (see section 4.3).
Topotekan je med dojenjem kontraindiciran (glejte poglavje 4.3).
- It is given once each day for 3 days.
• zdravilo se daje 3 dni po enkrat na dan;
− Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
• Ob naključnem stiku zdravila s kožo ali z očmi morate le-to takoj sprati z velikimi količinami vode.
How likely these side effects may happen, is as follows: - very common affects more than 1 user in 10 - common - uncommon affects 1 to 10 users in 1,000 - rare - very rare - not known frequency cannot be estimated from the available data.
• zelo redki pojavijo se pri manj kot 1 bolniku od 10 000 • neznana pogostnost pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
General disorders and administration site conditions Very common: pyrexia, asthenia, fatigue
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: pireksija, astenija, utrujenost.
In addition, an updated RMP should be submitted
Poleg tega je posodobljen načrt za obvladovanje tveganja treba predložiti:
Patients without prior Cisplatin chemoradiotherapy Cisplatin
Bolnice brez predhodne kemoterapije s cisplatinom topotekan/cisplatin
Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Z urinom se izloči približno 51 % skupnega topotekana in 3 % N-desmetil topotekana.
Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Med primerjavo farmakokinetičnih parametrov nismo ugotavljali razlik med farmakokinetičnimi podatki v petih dneh uporabe topotekana.
SPECIAL STORAGE CONDITIONS Do not store above 25ºC.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 C.
Further dilution of Topotecan Eagle is required with either sodium chloride 9 mg/ml (0.9 % w/v) solution for injection or glucose 50 mg/ml (5 % w/v) solution for injection in order to reach a final topotecan concentration of between 25 µg/ml and 50 µg/ml in the solution for infusion to the patient.
Potrebno je nadaljnje redčenje zdravila Topotekan Eagle z raztopino natrijevega klorida 9 mg/ml (0,9 % m/v) za injiciranje ali raztopino glukoze 50 mg/ml (5 % m/v) za injiciranje, da se doseže končna koncentracija topotekana med 25 µg/ml in 50 µg/ml v raztopini za infundiranje za bolnika.
Platelet transfusions were given in 4 % of courses.
V 4 % ciklov zdravljenja so bile uporabljene transfuzije trombocitov.
For cervical cancer Topotecan Eagle will be used with another medicine called cisplatin.
Pri zdravljenju raka materničnega vratu se zdravilo Topotekan Eagle uporablja skupaj z drugim zdravilom, imenovanim cisplatin.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
- Women who could get pregnant should use contraception to stop them getting pregnant during
• Ženske v rodni dobi morajo uporabljati kontracepcijo za preprečevanje zanositve med
Thrombocytopenia: Severe (platelets less than 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).
Trombocitopenija: Huda oblika (število trombocitov manjše od 25 x 109/l) pri 25 % bolnikov (8 % ciklov zdravljenja); zmerna (število trombocitov med 25,0 in 50,0 x 109/l) pa pri 25 % bolnikov (15 % ciklov zdravljenja).
Take special care with Topotecan Eagle Check with your doctor or nurse before using your medicine: - if you have any kidney problems.
Bodite posebno pozorni pri uporabi zdravila Topotekan Eagle Pred uporabo tega zdravila se posvetujte z zdravnikom ali medicinsko sestro: