natgillin/translations-raw huggingface dataset:
18.3, 31.6] compared to 13.9 weeks [95% C. I.
18, 3, 31, 6] v primerjavi s 13, 9 tedna (95% IZ:
11.1, 18.6] for patients receiving BSC alone.
11, 1, 18, 6) med bolniki, deležnimi samo NPO.
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy. (see Table 1) Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient self- reports on an unblinded symptom scale assessment in each of these two studies.
Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih v obeh teh študijah sta peroralni in intravenski topotekan pri bolnikih z relapsom občutljivega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
Intravenous Oral topotecan
Mediano preživetje (tedni)
(N = 52)
Peroralni topotekan (n = 52) 32, 3
(N = 54) (N
Intravenski topotekan (n = 54) 25, 1
= 153)
Peroralni topotekan (n = 153) 33, 0
Median survival (weeks)
Intravenski topotekan (n = 151) 35, 0
Hazard ratio (95% CI)
Razmerje tveganja (95% IZ)
CI = Confidence interval.
Pediatrični bolniki
32 Paediatrics Safety and effectiveness of oral topotecan in paediatric patients have not been established.
Varnost in učinkovitost peroralnega topotekana pri pediatričnih bolnikih nista ugotovljeni.
The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/ m2/ day and 4 mg/ m2/ day administered daily for 5 days.
Farmakokinetiko peroralnega topotekana so ocenili pri bolnikih z rakom po odmerkih od 1, 2 do 3, 1 mg/ m2/ dan in 4 mg/ m2/ dan, uporabljenih vsak dan 5 dni.
The bioavailability of oral topotecan (total and lactone) in humans is approximately 40%.
Biološka uporabnost peroralnega topotekana (celotnega in laktona) je pri človeku približno 40%.
Plasma concentrations of total topotecan (i. e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hour.
Celotna
Total exposure (AUC) increases approximately proportionally with dose.
32 izpostavljenost (AUC) se povečuje približno sorazmerno odmerku.
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Predklinične študije kažejo, da se topotekan le malo veže na beljakovine v plazmi (35%), porazdelitev med krvnimi celicami in plazmo pa je precej enakomerna.
Other than hydrolysis, topotecan is cleared predominantly renally, with a minor component metabolized to the N-desmethyl metabolite (SB-209780) identified in plasma, urine and faeces.
Poleg hidrolize se topotekan odstrani predvsem skozi ledvice, manjši del pa se ga presnovi v N- dezmetilni presnovek (SB- 209780), ki se pojavi v plazmi, urinu in blatu.
Overall recovery of topotecan-related material following five daily doses of topotecan was 41 to 76% (mean 57%) of the administered oral dose.
57%) uporabljenega peroralnega odmerka.
Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine.
V urinu se je izločilo približno 20% v obliki celotnega topotekana in 2% v obliki N- dezmetiltopotekana.
Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Z blatom se izloči 33% celotnega topotekana in 1, 7% N- dezmetiltopotekana.
Overall, the N-desmethyl metabolite contributed a mean of less than 6% (range 4-8%) of the total topotecan related material accounted for in the urine and faeces.
V celoti je predstavljal N- dezmetilni presnovek povprečno manj kot 6% (razpon: od 4 do 8%) vseh s topotekanom povezanih snovi v urinu in blatu.
O-glucuronides of both topotecan and N- desmethyl topotecan have been identified in the urine.
V urinu so odkrili O- glukuronida topotekana in N- dezmetiltopotekana.
The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Razmerje med AUC glavnega presnovka in matične snovi v plazmi je bilo manjše od 10% tako za celotni topotekan kot za topotekanov lakton.
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 ni zaviral delovanja encimov človeškega P450 (CYP1A2, CYP2A6, CYP2C8/ 9, CYP2C19, CYP2D6, CYP2E, CYP3A in CYP4A) in tudi ne človeških citosolskih encimov dihidropirimidin - ali ksantin- oksidaze.
Following coadministration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1,000 mg with oral topotecan, the AUC0- ∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Po sočasni uporabi elakridarja (GF120918) (zaviralca ABCB1 (P- gp) in ABCG2 (BCRP)) v odmerku 100 in 1. 000 mg skupaj s peroralnim topotekanom sta se AUC0– ∞ topotekanovega laktona in celotnega topotekana povečali približno 2, 5- krat (glejte poglavje 4. 5 za navodila).
Administration of oral cyclosporine A (15 mg/ kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0- and 2.5-fold, respectively (see section 4.5).
Peroralno uporabljeni ciklosporin A (15 mg/ kg), zaviralec transportnih beljakovin ABCB1 (P- gp) in ABCC1 (MRP- 1) ter presnovnega encima CYP3A4, je v 4 urah po peroralnem topotekanu povečal za odmerek normalizirano AUC0– 24h topotekanovega laktona za približno 2, 0- krat in celotnega topotekana za približno 2, 5- krat (glejte poglavje 4. 5).
The extent of exposure was similar following a high fat meal and fasted state while tmax was delayed from 1.5 to 3 hours (topotecan lactone) and from 3 to 4 hours (total topotecan).
Izpostavljenost je bila po mastnem obroku in na tešče podobna, tmax pa se je podaljšal z 1, 5 na 3 ure (topotekanov lakton) oz. s 3 na 4 ure (celotni topotekan).
The pharmacokinetics of oral topotecan has not been studied in patients with renal or hepatic impairment (see section 4.2 and 4.4).
Farmakokinetika peroralnega topotekana ni raziskana pri bolnikih z okvaro ledvic ali jeter (glejte poglavji 4. 2 in 4. 4).
There are insufficient data to determine an effect of race on pharmacokinetics of oral topotecan.
Za oceno vpliva rase na farmakokinetiko peroralnega topotekana ni dovolj podatkov.
Topotecan was also 33 shown to cause embryo-foetal lethality when given to rats and rabbits.
Pri podganah in kuncih je topotekan povzročil smrt zarodkov oz. plodov.
Hydrogenated vegetable oil Glyceryl monostearate
Vsebina kapsule: hidrogenirano rastlinsko olje glicerilmonostearat
Gelatin Titanium dioxide (E171)
Ovojnica kapsule: želatina titanov dioksid (E171)
Gelatin
Zaporni trak: želatina
Black ink comprising: black iron oxide (E172) shellac anhydrous ethanol – see leaflet for further information propylene glycol isopropyl alcohol butanol concentrated ammonia solution potassium hydroxide
Črno črnilo vsebuje: črni železov oksid (E172) šelak brezvodni etanol – za dodatne informacije glejte navodilo propilenglikol izopropilalkohol butanol koncentrirano raztopino amoniaka kalijev hidroksid
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Bel pretisni omot iz polivinilklorida/ poliklorotrifluoretilena z zaporno folijo iz aluminija/ polietiletereftalata (PET) / papirja.
34 Each blister card contains 10 capsules.
Vsak pretisni omot vsebuje 10 kapsul.
12/ 11/ 1996 Date of latest renewal:
12. november 1996 Datum zadnjega podaljšanja:
12/ 11/ 2006
12. november 2006
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 (EMEA): http: // www. emea. europa. eu /.
The capsules are opaque pink and imprinted with ‘ HYCAMTIN’ and ‘ 1 mg’.
Kapsule so opačne rožnate barve in označene s ‘ HYCAMTIN ’ in ‘ 1 mg ’.
Therapy with HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Le zdravnik, ki ima izkušnje z uporabo kemoterapevtikov, sme predpisati kapsule HYCAMTIN in nadzorovati zdravljenje.
Initial dose The recommended dose of HYCAMTIN capsules is 2.3 mg/ m2 body surface area/ day administered for 5 consecutive days with a 3 week interval between the start of each course.
Začetni odmerek Priporočeni odmerek kapsul HYCAMTIN je 2, 3 mg/ m2 telesne površine na dan 5 dni zapored in s 3- tedenskimi presledki med začetki vsakega ciklusa zdravljenja.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/ l, a platelet count of ≥ 100 x 109/ l and a haemoglobin level of ≥ 9 g/ dl (after transfusion if necessary)...
Pred prvim ciklusom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev ≥ 1, 5 x 109/ l, število trombocitov ≥ 100 x 109/ l in koncentracijo hemoglobina ≥ 9 g/ dl (po transfuziji, če je le- ta potrebna).
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/ l, the platelet count is ≥ 100 x 109/ l, and the haemoglobin level is ≥ 9 g/ dl.
Nadaljevalni odmerki Topotekana ne smete ponovno uporabiti, dokler ni število nevtrofilcev ≥ 1 x 109/ l, število trombocitov ≥ 100 x 109/ l in koncentracija hemoglobina ≥ 90 g/ l (po transfuziji, če je potrebna).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/ l) for 7 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/ m2/ day to 36 1.9 mg/ m2/ day (or subsequently down to 1.5 mg/ m2/ day if necessary).
Če izberete zmanjšanje odmerka pri bolnikih s hudo nevtropenijo (število nevtrofilcev < 0, 5 x 109/ l), ki traja 7 dni ali več, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo, in pri bolnikih, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, morate odmerek zmanjšati za 0, 4 mg/ m2/ dan na 1, 9 mg/ m2/ dan (ali ga po potrebi še dodatno zmanjšati do 1, 5 mg/ m2/ dan).
Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
36 Podobno morate zmanjšati odmerke, če število trombocitov pade pod 25 x 109/ l.
For patients who experience Grade 3 or 4 diarrhoea, the dose should be reduced by 0.4 mg/ m2/ day for subsequent courses (see section 4.4 Special warnings and precautions for use).
Pri bolnikih z drisko stopnje 3 ali 4 je potrebno odmerek zmanjšati za 0, 4 mg/ m2/ dan pri pri naslednjih ciklusih (glejte poglavje 4. 4).
HYCAMTIN is contraindicated in patients who − have a history of hypersensitivity to the active substance or to any of the excipients − are breast feeding (see section 4.6) − already have 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.
Zdravilo HYCAMTIN je kontraindicirano pri bolnikih oz. bolnicah − z anamnezo preobčutljivosti za zdravilno učinkovino ali katerokoli pomožno snov, − ki dojijo (glejte poglavje 4. 6), − ki imajo hudo depresijo kostnega mozga že pred začetkom prvega ciklusa, kar se kaže z izhodiščnim številom nevtrofilcev < 1. 5 x 109/ l in/ ali številom trombocitov < 100 x 109/ l.
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e. g.
Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na intersticijsko bolezen pljuč (npr. kašelj, zvišana telesna temperatura, dispneja in/ ali hipoksija); če je diagnoza intersticijske bolezni pljuč potrjena, je treba zdravljenje s topotekanom prekiniti.
37 cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
37 Uporabo samega topotekana in topotekana v kombinaciji s cisplatinom pogosto spremlja klinično pomembna trombocitopenija.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2-2.5-fold of control.
Hkrati s peroralnim topotekanom uporabljeni ciklosporin A (ki zavira ABCB1, ABCC1 [MRP- 1] in CYP3A4) je povečal AUC topotekana na približno 2 - 2, 5- kratno vrednost v primerjavi s kontrolno skupino.
38 In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Pri sočasni upoarbi topotekana z drugimi kemoterapevtiki bo morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
However, in combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Pri sočasni uporabi s platinovimi spojinami pride do izrazite interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega ali damo pripravek s
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, can not be excluded.
Ker pa je topotekan – tako kot druga citotoksična zdravila – genotoksičen, ni mogoče izključiti učinkov na plodnost, vključno s plodnostjo samcev.
39 4.8 Undesirable effects
4. 8 Neželeni učinki
The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/ possibly related to oral topotecan therapy.
V nadaljevanju navedene pogostnosti hematoloških in nehematoloških neželenih učinkov veljajo za učinke, ki so povezani ali so morda povezani s peroralno uporabo topotekana.
Adverse reactions are listed below, by system organ class and absolute frequency.
Spodaj so naveden neželeni učinki, razvrščeni po organskih sistemih in absolutni pogostnosti.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports and not known (cannot be estimated from the available data).
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri, ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Common: pancytopenia
39 Bolezni krvi in limfatičnega sistema Zelo pogosti: febrilna nevtropenija, nevtropenija (glejte Bolezni prebavil), trombocitopenija, anemija, levkopenija Pogosti: pancitopenija
40 Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
Ti podatki o varnosti predstavljajo celoten nabor podatkov o 682 bolnikih z relapsom pljučnega raka, ki so dobili 2536 ciklusov monoterapije s peroralnim topotekanom (275 bolnikov z relapsom drobnoceličnega pljučnega raka in 407 bolnikov z relapsom nedrobnoceličnega pljučnega raka).
In course 1 the incidence was 20%, by courses 4 the incidence was 8%.
V 1. ciklusu je bila incidenca 20%, do 4. ciklusa pa se je zmanjšala na 8%.
Pancytopenia has been reported.
Poročali so o pancitopeniji (glejte poglavje 4. 4).
Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 109/ l) occurred in 29% of patients in 14% of courses.
Zmerna trombocitopenija (3. stopnje – število trombocitov med 10, 0 in 50, 0 x 109/ l) se je pojavila pri 29%
Therapeutic interventions associated with non-haematological effects included anti emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Med terapevtskimi ukrepi zaradi nehematoloških učinkov so bili antiemetiki (dobilo jih je 47% bolnikov v 38% ciklusov) in antidiaroiki (dobilo jih je 15% bolnikov v 6% ciklusov).
A 5-HT3 antagonist was administered to 30% of patients in 24% of courses.
Antagonist 5- HT3 je dobilo 30% bolnikov v 24% ciklusov.
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.
Ta encim je tesno povezan s podvajanjem DNA in odpravlja torzijsko napetost, ki se pojavlja pred napredujočimi replikacijskimi vilicami.
Relapsed SCLC A phase III trial (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:
Relaps drobnoceličnega pljučnega raka V preskušanju III. faze (študija 478) so primerjali peroralni topotekan v kombinaciji z najboljšo podporno oskrbo [NPO] (n = 71) in NPO samo (n = 70) pri bolnikih z relapsom po terapiji prve izbire (mediani čas do napredovanja od terapije prve izbire:
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95% CI:
Nekorigirano razmerje tveganja za skupino s peroralnim topotekanom in NPO glede na skupino s samo NPO je bilo 0, 64 (95% IZ:
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
41 Neslepljeno ocenjene navedbe bolnikov samih o simptomih so pokazale dosleden trend k boljšemu simptomatskemu stanju v skupini, zdravljeni s peroralnim topotekanom in NPO.
(see Table 1).
Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil relaps ≥ 90 dni po koncu ene predhodne sheme kemoterapije, sta bili narejeni ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte tabelo 1).
Study 396
396
42 Paediatrics Safety and effectiveness of oral topotecan in paediatric patients have not been established.
Varnost in učinkovitost peroralnega topotekana pri pediatričnih bolnikih nista ugotovljeni.
Plasma concentrations of total topotecan (i. e. lactone and carboxylate forms) and topotecan lactone (active moiety) peak at approximately 2.0 hours and 1.5 hours, respectively, and decline bi-exponentially with mean terminal half-life of approximately 3.0 to 6.0 hour.
6, 0 ur (lakton).
Faecal elimination of total topotecan accounted for 33% while faecal elimination of N-desmethyl topotecan was 1.5%.
Z blatom se izloči 33% celotnega topotekana in 1, 5% N- dezmetiltopotekana.
Following coadministration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1,000 mg with oral topotecan, the AUC0- ∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance).
Po sočasni uporabi elakridarja (GF120918) (zaviralca ABCB1 (P- gp) in ABCG2 (BCRP)) v odmerku 100 in 1, 000 mg skupaj s peroralnim topotekanom sta se AUC0– ∞ topotekanovega laktona in celotnega topotekana povečali približno 2, 5- krat (glejte poglavje 4. 5 za navodila).
Administration of oral cyclosporine A (15 mg/ kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0- and 2.5-fold respectively (see section 4.5).
Peroralno uporabljeni ciklosporin A (15 mg/ kg), zaviralec transportnih beljakovin ABCB1 (P- gp) in ABCC1 (MRP- 1) ter presnovnega encima CYP3A4, je v 4 urah po peroralnem topotekanu povečal za odmerek normalizirano AUC0– 24h topotekanovega laktona za približno 2, 0- krat in celotnega topotekana za približno 2, 5- krat (glejte poglavje 4. 5).
43 Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Zaradi svojega mehanizma delovanja je topotekan genotoksičen za celice sesalcev (mišje limfomske celice in človeške limfocite) in vitro in celice mišjega kostnega mozga in vivo.
Hydrogenated vegetable oil, Glyceryl monostearate
Vsebina kapsule: hidrogenirano rastlinsko olje glicerilmonostearat
Gelatin, Titanium dioxide (E171), red iron oxide (E172)
Ovojnica kapsule: želatina titanov dioksid (E171) rdeči železov oksid (E172)
Gelatin
43 Zaporni trak: želatina
Black ink comprising: black iron oxide (E172) shellac anhydrous ethanol – see leaflet for further information, propylene glycol isopropyl alcohol butanol concentrated ammonia solution potassium hydroxide
Črno črnilo vsebuje: črni železov oksid (E172) šelak brezvodni etanol – za dodatne informacije glejte navodilo propilenglikol izopropilalkohol butanol koncentrirano raztopino amoniaka kalijev hidroksid.
44 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Beli pretisni omoti iz polivinilklorida/ poliklorotrifluoretilena z zaporno folijo iz aluminija/ polietiletereftalata (PET) / papirja.
12/ 11/ 1996 Date of latest renewal:
44 Datum zadnjega podaljšanja:
Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma Italy
Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma Italija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 05 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisano v različici 5 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, in ga vzdrževati ves čas trženja zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 01 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja tveganja Imetnik dovoljenja za promet z zdravilom mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 01 načrta upravljanja tveganja (RMP) v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta upravljanja tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Poleg tega je dopolnjen načrt za obvladovanje tveganja treba predložiti: • če se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja. • v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja). • na zahtevo Evropske agencije za zdravila (EMEA).
OUTER CARTON 1 x 1 mg vial 5x 1 mg vial
ZUNANJA OVOJNINA 1 x 1 mg viala 5 x 1 mg viala
Cytotoxic agents, special handling instructions (see Package Leaflet).
OPOZORILO: citotoksično zdravilo, posebna navodila za ravnanje (glejte Navodilo za uporabo).
EU/ 1/ 96/ 027/ 005 1 x 1 mg vial EU/ 1/ 96/ 027/ 004 5 x 1 mg vials
EU/ 1/ 96/ 027/ 005 1 x 1 mg viala EU/ 1/ 96/ 027/ 004 5 x 1 mg viala
HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan IV use
HYCAMTIN 1 mg prašek za koncentrat za raztopino za infundiranje topotekan i. v. uporaba