natgillin/translations-raw huggingface dataset:
In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Kombinirano zdravljenje (karcinom materničnega vratu) Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost serumskega kreatinina manjšo ali enako 1,5 mg/dl.
In case of skin contact, thoroughly wash the affected area with large amount of water.
Če zdravilo pride v stik s kožo, je treba prizadeti predel sprati z veliko količino vode.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar pomeni, da je praktično "brez natrija".
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.
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.
9/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
9/l), ki je pri 20% bolnikov trajala ≥ sedem dni, pri 77% pa ves čas (39% ciklov zdravljenja).
A reduction in topotecan clearance was observed.
Pri tem so opazili manjši očistek topotekana.
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, tesno povezanega s podvojevanjem DNA, saj sprošča torzijsko napetost, ki nastopa pred napredujočimi replikacijskimi vilicami.
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 (ILD - interstitial lung disease), nekateri s smrtnim izidom (glejte poglavje 4.8).
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/m 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/m v obliki 30-minutne infuzije 5 dni.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Če ste dobili preveč zdravila Topotekan Actavis Ker vam bo to zdravilo dal vaš zdravnik ali medicinska sestra je malo verjetno, da boste dobili prevelik odmerek.
What Topotecan Actavis is and what it is used for What you need to know before you use Topotecan Actavis How to use Topotecan Actavis Possible side effects
Kaj je zdravilo Topotekan Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Topotekan Actavis
Initial dose The recommended dose of topotecan is 1.5 mg/m body surface area/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 ciklih po pet zaporednih dni in s tritedenskimi presledki med začetki vsakega cikla zdravljenja.
What Topotecan Actavis looks like and contents of the pack Topotecan Actavis is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Izgled zdravila Topotekan Actavis in vsebina pakiranja Zdravilo Topotekan Actavis je na voljo v vialah iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko.
Topotecan Actavis 4 mg vials must be reconstituted with 4 ml water for injections.
Topotekan Actavis 4 mg viale morate rekonstituirati s 4 ml vode za injekcije.
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Topotekan zavira delovanje topoizomeraze I, tako da stabilizira kovalentni kompleks tega encima in ene verige DNA, ki je vmesni produkt katalitičnega mehanizma.
Platelet transfusions were given in 4 % of courses.
V 4% ciklov zdravljenja so bile uporabljene transfuzije trombocitov.
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 v kombinaciji s cisplatinom je indiciran pri bolnicah s ponovitvijo karcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
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 pojavom klinično pomembne trombocitopenije.
Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml
4 ml raztopine topotekana 1 mg/ml Dodajte 156 ml, da boste dobili 160 ml
When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Pri uporabi zdravila v kombinaciji s cisplatinom je treba upoštevati tudi navodila za predpisovanje cisplatina.
The recommended monotherapy dose of topotecan in patients with small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnikov z drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/min je 0,75 mg/m na dan, pet zaporednih dni.
Doses should be similarly reduced if the platelet count falls below 25 x 10 9/l.
Odmerke je treba podobno zmanjšati, če število trombocitov pade pod 25 x 10
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, 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°C do 8°C, če je zaščiten pred svetlobo.
Marketing Authorisation Holder Actavis Group PTC ehf.
Imetnik dovoljenja za promet z zdravilom: Actavis Group PTC ehf.
Thrombocytopenia: Severe (platelets less than 25 x 10
Trombocitopenija: Huda oblika (število trombocitov manjše od 25 x 10
Each vial contains 0.52 mg (0.0225 mmol) sodium.
Pomožna snov z znanim učinkom: Ena viala vsebuje 0,52 mg (0,0225 mmol) natrija.
In the event of contact with the eyes, irrigate with large amounts of water.
Če zdravilo pride v oči, jih je treba sprati z veliko količino vode.
moderate (platelets between 25.0 and 50.0 x 10
ciklov zdravljenja); zmerna (število trombocitov med 25,0 in 50,0 x 10
Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.
Pri dajanju topotekana v kombinaciji s cisplatinom so opazili dodatne neželene učinke, vendar pa so bili ti neželeni učinki opaženi tudi pri samostojnem zdravljenju s cisplatinom in jih niso pripisali topotekanu.
Reconstitution and dilution prior to administration
Priprava in razredčenje pred uporabo
Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Median (95 % C.I.)
Mediana vrednost (95 %
1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
1 ml raztopine topotekana 1 mg/ml Dodajte 39 ml, da boste
Talk to your doctor before using Topotecan Actavis: - if you have any kidney problems.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Topotekan Actavis se posvetujte z zdravnikom: - če imate kakšne težave z ledvicami.
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Uporaba zdravila naj vedno poteka pod nadzorom zdravnika z izkušnjami na področju kemoterapije (glejte poglavje 6.6).
In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Poleg tega so poročali o zvišanih vrednostih jetrnih encimov v primeru prevelikega odmerjanja z intravensko danim topotekanom.
The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to 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%) za injiciranje ali raztopino 50 mg/ml (5%) glukoze za infundiranje, do končne koncentracije od 25 do 50 mikrogramov na ml raztopine za infundiranje, na primer:
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Predklinične študije so pokazale, da topotekan povzroča smrt in malformacije zarodka oziroma ploda (glejte poglavje 5.3).
Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Steklene viale (8 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 4 mg topotekana.
You must not breast-feed while on treatment with Topotecan Actavis.
Med zdravljenjem z zdravilom Topotekan Actavis ne smete dojiti.
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/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
9/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo, ali jim je bilo zdravljenje odloženo zaradi nevtropenije, morate odmerek za naslednje cikluse zmanjšati za 20% na 0,60 mg/m2/dan (ali nato na 0,45 mg/m2/dan,
Precautions to be taken before handling or administering the medicinal product Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Previdnostni ukrepi pred ravnanjem z zdravilom in njegovo uporabo Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Topotecan is supplied as a powder for concentrate for solution for infusion.
Topotekan je na voljo kot prašek za koncentrat za raztopino za infundiranje.
- Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Topotecan Actavis 4 mg with 4 ml water for injections
Pred infundiranjem je treba Topotekan Actavis prašek za koncentrat za raztopino za infundiranje pripraviti z ustrezno količino vode za injekcije, in sicer takole: - Topotekan Actavis 1 mg z 1,1 ml vode za injekcije (ker vsebuje 10% prepolnjenja) - Topotekan Actavis 4 mg s 4 ml vode za injekcije
Common side effects (may affect up to 1 in 10 people) - Allergic (hypersensitivity) reactions (including rash).
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - Alergijske (preobčutljivostne) reakcije (vključno z izpuščajem).
Each vial contains 2.07 mg (0.09 mmol) sodium.
Pomožna snov z znanim učinkom: Ena viala vsebuje 2,07 mg (0,09 mmol) natrija.
Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Pri otrocih z rekurentnimi in neodzivnimi solidnimi tumorji je bila toksičnost topotekana podobna toksičnosti, ki je že bila opažena pri odraslih bolnikih.
hypersensitivity reaction including rash
preobčutljivostna reakcija, vključno z izpuščajem
In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Ob hudi nevtropeniji so med prvim ciklom zdravljenja pri 16% bolnikov opazili zvišano telesno temperaturo ali različne okužbe, 23% bolnikov pa je imelo takšne neželene učinke ves čas (6% ciklov zdravljenja).
Topotecan Actavis is for intravenous infusion after reconstitution and dilution.
Zdravilo Topotekan Actavis je za intravensko infundiranje po rekonstituciji in redčenju.
Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Steklene viale (5 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 1 mg topotekana.
The usual dose is 0.75 mg per m of body surface area once daily for 3 days.
Rak materničnega vratu Običajen odmerek je 0,75 mg na m telesne površine enkrat na dan 3 dni.
Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Pri vmesni analizi je imela kombinacija topotekana in cisplatina statistično pomembno korist na skupno preživetje v primerjavi z zdravljenjem s samim cisplatinom (log-rank p = 0,033).
Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Ocenjeno je, da se z blatom izloči 18% skupnega topotekana in 1,7% N-desmetil topotekana.
Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Zdravilo vsebuje: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507) in natrijev hidroksid.
interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
intersticijska bolezen pljuč (nekateri primeri s smrtnim
Each vial contains 1 mg or 4 mg topotecan (as hydrochloride).
Ena viala vsebuje 1 mg ali 4 mg topotekana (v obliki klorida).
Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively.
Pojavnost tako hude oblike utrujenosti kot astenije (3. ali 4. stopnje) je bila 3%.
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).
Pri bolnikih z relapsom drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve izbire ni primerno (glejte poglavje 5.1).
Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507)
6.1 Seznam pomožnih snovi manitol (E421) vinska kislina (E334) natrijev hidroksid klorovodikova kislina (E507)
The physico-chemical stability of the drug 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 25
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.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
C. DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN UPORABE
Topotecan Actavis 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".
CI = Confidence interval.
n = celotno število zdravljenih bolnikov IZ = interval zaupanja
- Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty in 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”.This condition can be fatal.
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".
Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
5 zaporednih dni pri času infuzije 30 minut visok, in sicer 62 l/h (SD 22), kar pomeni približno 2/3 pretoka krvi skozi jetra.
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 mg/m do 5,2 mg/m2.
Small Cell Lung Carcinoma
Drobnocelični pljučni karcinom Začetni odmerek
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic, special handling instructions (see package leaflet).
Citotoksično, posebna navodila za ravnanje (glejte navodilo za uporabo)
An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
V urinu so odkrili O-glukuronidacijski presnovek topotekana in N-desmetil topotekan.
9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
≥ 100 x 10 9/l, vrednost hemoglobina pa ≥ 9 g/dl (po transfuziji, če je le-ta potrebna).
For more information about cisplatin, please refer to the corresponding package leaflet.
Za več informacij o cisplatinu glejte navodilo za uporabo cisplatina.
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Ustrezno količino tako pripravljene raztopine morate še dodatno razredčiti z 9 mg/ml (0,9%) intravensko infuzijsko raztopino natrijevega klorida ali s 50 mg/ml ( 5%) infuzijsko raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Hude oblike (3. ali 4. stopnje) navzea (4%), bruhanje (3%), driska (2%) in mukozitis (1%).
Mild abdominal pain was also reported amongst 4 % of patients.
4% bolnikov je imelo blage bolečine v trebuhu.
After reconstitution 1 ml concentrate contains 1 mg topotecan.
Po pripravi 1 ml koncentrata vsebuje 1 mg topotekana.
If you get any side effects, talk to your doctor or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
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 0.25 mg/m 2/day to 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
9/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo, ali jim je bilo zdravljenje odloženo zaradi nevtropenije, morate odmerek zmanjšati po 0,25 mg/m2/dan, če je treba).
The integrated safety data for topotecan monotherapy are presented below.
V nadaljevanju navajamo povzetek podatkov o varnosti topotekana kot samostojnega zdravila.
9/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary).
9/l, število trombocitov večje ali enako 100 x 10 9/l in vrednost hemoglobina večja ali enaka 9 g/dl (po transfuziji,če je le-ta potrebna).
Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3
Topotekan 0,75 mg/m2/dan x 3 na 21 dni
- The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
− Pomožne snovi so: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507)
Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
S pripravo nastane koncentrat, ki vsebuje 1 mg topotekana na ml.
5 x 4 mg vial
5 x 4 mg viala
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 razredčenju 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.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 10
Če izberete zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev manj kot 0,5 x 10
5 x 1 mg vial
5 x 1 mg viala
OTHER CONDITIONS AND REQUIREMENTS OF THE
DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN
9/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
≥ 9 g/dl (po transfuziji, če je potrebna).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF i
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Če utrujenost in astenija ne mineta, je pri vožnji ali upravljanju s stroji potrebna previdnost.
Topotecan Actavis can make you feel tired or weak.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Topotekan Actavis lahko povzroči utrujenost in šibkost.
Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Topotekan Actavis 1 mg prašek za koncentrat za raztopino za infundiranje Topotekan Actavis 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products.
Pri odstranjevanju predmetov (brizg, igel itn.), uporabljenih za pripravo in/ali razredčenje citotoksičnih zdravil, sta potrebna ustrezna skrb in upoštevanje previdnostnih ukrepov.
No in vivo human pharmacokinetic interaction studies have been performed.
Farmakokinetične študije medsebojnega delovanja zdravila z drugimi zdravili in vivo pri ljudeh niso bile izvedene.
- If you get any side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Po pripravi vsebuje 1 ml koncentrata 1 mg topotekana.
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104).
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za lograng = 0,0104).