natgillin/translations-raw huggingface dataset:
Talk to your doctor before using Potactasol: - if you have any kidney problems.
Pred začetkom jemanja zdravila Potactasol se posvetujte z zdravnikom: - če imate kakršne težave z ledvicami.
The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Koncentrati, ki so bili testirani, so bili shranjenih pri temperaturi 25 ± 2 °C za 12 ur in 24 ur in potem razredčeni.
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).
The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days.
Običajen odmerek je 1,5 mg na m2 telesne površine enkrat na dan 5 dni.
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 karcinom 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.
Patients without prior cisplatin chemoradiotherapy Cisplatin
Bolniki brez predhodne cisplatinske kemoradioterapije cisplatin topotekan/cisplatin
In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m2 given as a
V odprti študiji pri otrocih (n = 108, razpon starosti: od dojenčka do 16 let) z rekurentnim ali progresivnim solidnim tumorjem so otroci topotekan prejemali v začetnem odmerku 2,0 mg/m2 v obliki 30-minutne infuzije 5 dni.
Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Z urinom se izloči približno 51 % celotnega topotekana in 3 % N-desmetil topotekana.
What Potactasol looks like and contents of the pack
Izgled zdravila Potactasol in vsebina pakiranja
Contents of the pack and other information
Shranjevanje zdravila Potactasol Vsebina pakiranja in dodatne informacije
Difference in response rate (95 % CI)
Razlika v deležu odziva (95-odstotni IZ)
Rarely, it can lead to more severe bleeding (haemorrhage).
Redko lahko to povzroči zelo hude krvavitve.
Other side effects with Potactasol include: Very common side effects (may affect more than 1 in 10 people)
Med drugimi neželenimi učinki zdravila Potactasol so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Ovarian cancer and small cell lung cancer
Rak jajčnika in drobnocelični pljučni rak
- Feeling unwell.
- Slabo počutje.
Vials contain either 1 mg or 4 mg of topotecan.
Viala vsebuje 1 mg ali 4 mg topotekana.
The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
ki so jih opažali po prevelikem odmerjanju, so bili v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
Monotherapy (ovarian and small cell lung carcinoma) There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom) Z uporabo topotekana pri bolnikih s hudo okvaro ledvične funkcije (z očistkom kreatinina < 20 ml/min) ni na voljo dovolj izkušenj.
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 arcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
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.
Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic]).
Patients with prior cisplatin chemoradiotherapy Cisplatin
Bolniki s predhodno cisplatinsko kemoradioterapijo cisplatin topotekan/cisplatin
(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.
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).
Pri odločitvi za zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev < 0,5 x 109/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo ali jim je bilo zdravljenje odloženo zaradi nevtropenije, je treba odmerek zmanjšati po 0,25 mg/m2/dan do 1,25 mg/m2/dan (ali kasneje nato do 1,0 mg/m2/dan, če je treba).
Thrombocytopenia: Severe (platelets < 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Trombocitopenija: Huda oblika (število trombocitov < 25 x 109/l) se je razvila pri 25 % bolnikov (v 8% ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in50,0 x 109/l) pa pri 25 % bolnikov
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 opisani primeri intersticijske bolezni pljuč (IBP), nekateri s smrtnim izidom (glejte poglavje 4.8).
Potactasol may cause a decrease in the number of blood clotting cells (platelets).
Zdravilo Potactasol lahko povzroči zmanjšanje števila krvnih ploščic (trombocitov), potrebnih za strjevanje krvi.
Initial dose The recommended dose of topotecan is 1.5 mg/m2 body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Priporočeni odmerek topotekana je 1,5 mg/m2 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.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Pri odločitvi za zmanjšanje odmerka pri bolnicah , ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev manj kot 0,5 x 109/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo ali pri bolnicah, ki jim je bilo zdravljenje odloženo zaradi nevtropenije, je treba odmerek za naslednje cikluse zmanjšati za 20 % na 0,60 mg/m2/dan (ali ga po potrebi kasneje še dodatno zmanjšati na 0,45 mg/m2/dan).
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar pomeni, da je praktično "brez-natrija".
Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Običajen odmerek je 0,75 mg na m2 telesne površine enkrat na dan 3 dni.
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
4.2 Odmerjanje in način uporabe Topotekan se sme uporabljati le v ustanovah, ki so specializirane za uporabo citotoksičnih kemoterapevtikov.
Median (95 % CI) Hazard ratio (95 % CI) Log rank p-value
Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) Log rank pvrednost
The physico-chemical stability of the medicinal product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25oC ± 2oC and then diluted.
Fizikalno-kemična stabilnost raztopine zdravila po redčenju v raztopinah za infundiranje (0,9 % NaCl in 5 % glukoza) je dokazana za 4 ure pri sobni temperaturi v normalnih svetlobnih pogojih, na vzorcih pripravljenih in shranjenih za 12 ur oz. 24 ur pri temperaturi 25 ± 2 °C in potem redčenih.
of patients (6 % of courses).
(v 15% ciklusov zdravljenja).
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% celotnega topotekana in 1,7 % N-desmetil topotekana.
- Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.
Tveganje za pojav te hude bolezni (intersticijske bolezni pljuč) je večje, če imate trenutno kakšne težave s pljuči, če ste bili predhodno obsevani ali ste dobivali kakšna zdravila, ki prizadenejo pljuča; glejte tudi poglavje 2, "Opozorila in previdnostni ukrepi''.
nausea, vomiting and diarrhoea (all of which may be severe) constipation abdominal pain2
navzea, bruhanje in driska (vsi so lahko hudi), zaprtje bolečine v trebuhu2
febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leucopenia
febrilna nevtropenija nevtropenija (glejte Bolezni prebavil, spodaj) trombocitopenija anemija levkopenija pancitopenija huda krvavitev (v povezavi s trombocitopenijo)
(95 % CI) Hazard ratio (95 % CI) N = total number of patients treated.
Razmerje ogroženosti (95-odstotni IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Bistri koncentrat je bledo rumene barve in vsebuje 1 mg topotekana na mililiter.
Potactasol is for intravenous infusion after reconstitution and dilution.
Zdravilo Potactasol je za intravensko infundiranje po rekonstituciji in redčenju.
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 je trajalo do 1 leta,
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.
(aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Pri tem je treba upoštevati običajne postopke za ustrezno ravnanje z zdravili proti raku in njihovo odstranjevanje, in sicer: - Osebje mora biti ustrezno izurjeno za rekonstitucijo in redčenje zdravila.
Neutropenia: Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklusom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0,5 x 109/l), ki je pri 20 % bolnikov trajala najmanj sedem dni, pri 77% pa ves čas (v39 % ciklusov zdravljenja).
- The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2).
− Druge sestavine so: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507) in natrijev hidroksid (glejte poglavje 2).
The volume of reconstituted concentrate corresponding to the calculated individual dose should be further diluted with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose, to give a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Količino pripravljenega koncentrata, ki ustreza izračunanemu individualnemu odmerku, je treba dodatno razredčiti bodisi z raztopino natrijevega klorida (9 mg/ml(0,9 %) ali 5-odstotno (m/v) glukozo, do končne koncentracije od 25 do 50 mikrogramov na ml raztopine za infundiranje, na primer:
Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Potactosol 4 mg prašek za koncentrat za raztopino za infundiranje Steklene viale (8 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 4 mg topotekana.
- Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - 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.
- huda depresija kostnega mozga že pred začetkom prvega ciklusa, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 109/l in/ali števila trombocitov < 100 x 109/l
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Potactosol 1 mg prašek za koncentrat za raztopino za infundiranje Zdravilo Potactasol 1 mg viale morate rekonstituirati z 1,1 ml vode za injekcije.
How to use Potactasol
Kako se uporablja zdravilo Potactasol
Cisplatin 50 mg/m2 on day 1, + Topotecan 0,75 mg/m2 on days 1-3, every 21 days
topotekan 0,75 mg/m2 na 1.-3. dan vsakih 21 dni
− Pregnant staff should be excluded from working with this medicinal product.
• Nosečnice ne smejo rokovati z zdravilom.
A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Potactasol v infuziji (kapalni), po navadi v roko; infuzija bo trajala približno 30 minut.
interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
intersticijska bolezen pljuč (nekateri primeri s smrtnim izidom)
Potactasol is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Zdravilo Potactasol je na voljo v vialah iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko.
In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95-odstotni IZ: 2,6, 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95-odstotni IZ: 2,9, 9,6), razmerje ogroženosti 1,15 (0,59, 2,23).
Potactasol is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
- če imate vnetje pljuč z znaki, kot so kašelj, zvišana telesna temperatura in težave z dihanjem; glejte tudi poglavje 4, "Možni neželeni učinki".
Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Potactosol 4 mg prašek za koncentrat za raztopino za infundiranje Vsebino viale z zdravilom Potactasol 4 mg je treba rekonstituirati s 4 ml vode za injekcije.
Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Potactosol 1 mg prašek za koncentrat za raztopino za infundiranje Steklene viale (5 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 1 mg topotekana.
− Personnel handling this medicinal product during reconstitution and dilution should wear protective clothing including mask, goggles and gloves.
- Osebje, ki pripravlja zdravilo, mora med rekonstitucijo in redčenjem nositi zaščitna oblačila,
If you get any side effects, talk to your doctor or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte s svojim zdravnikom ali farmacevtom.
Median (95 % CI) Hazard ratio (95 % CI)
Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ)
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.
Študija je bila opravljena pri bolnikih, pri katerih je po zdravljenju prve linije prišlo do ponovitve (mediana časa do napredovanja od zdravljenja prve linije: 84 dni za peroralni topotekan in NPO, 90 dni za samo NPO) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
2 O nevtropeničnem kolitisu, vključno z nevtropeničnim kolitisom s smrtnim izidom, so poročali kot o zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4.4).
Potactasol contains sodium
Zdravilo Potactasol vsebuje natrij
Rare side effects (may affect up to 1 in 1,000 people)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od1.000 bolnikov)
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions, and for 24 hours at 2°C to 8°C when protected from light.
Kemična in fizikalna stabilnost koncentrata sta dokazani za 24 ur pri temperaturi 25 ± 2 °C v normalnih svetlobnih pogojih in za 24 ur pri temperaturi od 2 do 8 °C, če je zaščiten pred svetlobo.
gastrointestinal perforation Hepatobiliary disorders Common:
Pogostnost neznana gastrointestinalna perforacija
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).
2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
- Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
zvišana telesna temperatura resno poslabšanje splošnega stanja lokalni simptomi, npr. vnetje žrela ali pekoč občutek pri uriniranju hude bolečine v trebuhu, zvišana telesna temperatura in driska (ki je v redkih primerih krvava) so lahko znaki vnetja črevesa (nevtropeničnega kolitisa)
ITT population Cisplatin 50 mg/m2 on day 1, every 21 days
cisplatin 50 mg/m2 na 1. dan vsakih 21 dni cisplatin 50 mg/m2 na 1. dan +
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Ustrezno količino tako pripravljene raztopine je treba še dodatno razredčiti bodisi z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml)ali s 5-odstotno (m/v) raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1 mg topotekana (v obliki klorida).
Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 4 mg topotekana (v obliki klorida).
Each vial contains 1 mg topotecan (as hydrochloride).
Ena viala vsebuje 1 mg topotekana (kot klorida).
In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 %
Ob hudi nevtropeniji so med prvim ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužbo, 23 % bolnikov pa je imelo takšne neželene učinke ves čas (v 6 % ciklusov zdravljenja).
Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Kemična in fizikalna stabilnost raztopine po redčenju koncentrata z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za infundiranje je dokazana za 4 ure pri temperaturi 25 ± 2 °C v normalnih svetlobnih razmerah.
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
Powder for concentrate for solution for infusion.
koncentrat za raztopino za infundiranje.
− Personnel should be trained to reconstitute and dilute the the medicinal product.
Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Each vial contains 4 mg topotecan (as hydrochloride).
Ena viala vsebuje 4 mg topotekana (kot klorida).
Hepatic impairment
splošno slabo počutje
Ovarian and small cell lung carcinoma
Karcinom jajčnika in drobnocelični pljučni karcinom Začetni odmerek
Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Potactasol 1 mg prašek za koncentrat za raztopino za infundiranje Potactasol 4 mg prašek za koncentrat za raztopino za infundiranje
pruritus
srbenje
Yellow lyophilisate.
Okvara ledvic
Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows: - Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Potactasol 4 mg with 4 ml water for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
- Potactasol 1 mg z 1,1 ml vode za injekcije (ker vsebuje 10 % prepolnjenja) - Potactasol 4 mg s 4 ml vode za injekcije
Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol (E421) vinska kislina (E334) natrijev hidroksid klorovodikova kislina (E507)
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali z naslednjimi pogostnostmi: navzea (4 %), bruhanje (3 %), driska (2 %) in vnetje ustne sluznice (1 %).