natgillin/translations-raw huggingface dataset:
independent assessment% (95% CI)
neodvisni oceni% (95% CI)
CI = confidence interval; NA = not applicable. a.
CI = interval zaupanja; NA = ne velja za ta primer. a.
Based on log-rank test stratified by prior nephrectomy and region. b.
Na podlagi testa log- rank, stratificiranega po predhodni nefrektomiji in regiji. b.
Based on Cox proportional hazard model stratified by prior nephrectomy and region (95% CI are descriptive, only). c.
Na podlagi Coxovega modela proporcionalnega tveganja, stratificiranega po predhodni nefrektomiji in regiji (95% CI so le opisni). c.
Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Na podlagi Cochran- Mantel- Haenszelovega testa, stratificiranega po predhodni nefrektomiji in regiji.
In Study 1, 31% of patients treated with TORISEL were 65 or older.
V študiji 1 je bilo 31% bolnikov, zdravljenih z zdravilom TORISEL, starih 65 ali več let.
In patients younger than 65, median overall survival was 12 months (95% CI 9.9, 14.2) with a hazard ratio of 0.67 (95% CI 0.52, 0.87) compared with those treated with IFN-α.
Pri bolnikih, mlajših od 65 let, je bilo mediano celotno preživetje v primerjavi s tistimi, ki so bili zdravljeni z IFN - α, 12 mesecev (95% CI 9, 9, 14, 2) z razmerjem tveganja 0, 67 (95% CI 0, 52, 0, 87).
In patients 65 or older, median overall survival was 8.6 months (95% CI 6.4, 11.5) with a hazard ratio of 1.15 (95% CI 0.78, 1.68) compared with those treated with IFN-α.
Pri bolnikih, starih 65 ali več let, je bilo mediano celotno preživetje 8, 6 meseca (95% CI 6, 4, 11, 5) z razmerjem tveganja 1, 15 (95% CI 0, 78, 1, 68) v primerjavi s tistimi, ki so bili zdravljeni z IFN- α.
Study 2 Study 2 was a randomised, double-blind, multi-centre, outpatient trial to evaluate the efficacy, safety, and pharmacokinetics of three dose levels of TORISEL when administered to previously treated patients with advanced RCC.
Študija 2 Študija 2 je bila randomizirana, dvojno slepa, multicentrična študija na ambulantnih bolnikih za ovrednotenje učinkovitosti, varnosti in farmakokinetike treh ravni odmerkov zdravila TORISEL, ki so ga dajali predhodno že zdravljenim bolnikom z napredovalim RCC.
The primary efficacy endpoint was ORR, and OS was also evaluated.
Primarni zaključek učinkovitosti je bila ORR, vrednotili pa so tudi OS.
One hundred eleven (111) patients were randomly assigned in a 1:1:1 ratio to receive 25 mg, 75 mg, or 250 mg temsirolimus intravenous weekly.
Sto enajst (111) bolnikov so v razmerju 1: 1: 1 po metodi naključne izbire razvrstili v tri skupine, ki so prejemale po 25 mg, 75 mg ali 250 mg temsirolimusa intravensko na teden.
In the 25 mg arm (n = 36), all patients had metastatic disease; 4 (11%) had no prior chemo- or immunotherapy; 17 (47%) had one prior treatment, and 15 (42%) had 2 or more prior treatments for RCC.
V kraku s 25 mg (n = 36) so imeli vsi bolniki metastatično bolezen; 4 (11%) 11 kemoterapije ali imunoterapije prej niso imeli; 17 (47%) jih je imelo po eno predhodno zdravljenje, 15 (42%) pa po 2 ali več predhodnih zdravljenj zaradi RCC.
Twenty-seven (27, 75%) had undergone a nephrectomy.
Sedemindvajset (27, 75%) jih je imelo nefrektomijo.
Twenty-four (24, 67%) were Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 1, and 12 (33%) were ECOG PS = 0.
Štiriindvajset (24, 67%) jih je imelo telesno zmogljivost (PS) po Eastern Cooperative Oncology Group (ECOG) = 1, 12 (33%) pa je imelo PS po ECOG = 0.
For patients treated weekly with 25 mg temsirolimus OS was 13.8 months (95% CI:
Pri bolnikih, ki so se zdravili s 25 mg temsirolimusa na teden, je bilo OS 13, 8 meseca (95% CI:
9.0, 18.7 months); ORR was 5.6% (95% CI:
9, 0, 18, 7 meseca); ORR je bila 5, 6% (95% CI:
Absorption Following administration of a single 25 mg intravenous dose of temsirolimus in patients with cancer, mean Cmax in whole blood was 585 ng/ ml (coefficient of variation, CV = 14%), and mean AUC in blood was 1627 ng• h/ ml (CV = 26%).
Absorpcija Potem ko so bolnikom z rakom dali en 25- miligramski intravenski odmerek temsirolimusa, je bila povprečna Cmax v polni krvi 585 ng/ ml (koeficient variacije, CV = 14%), povprečna AUC v krvi pa je bila 1627 ng• h/ ml (CV = 26%).
Distribution Temsirolimus exhibits a polyexponential decline in whole blood concentrations, and distribution is attributable to preferential binding to FKBP-12 in blood cells.
Porazdelitev Temsirolimus kaže polieksponencialno zniževanje koncentracije v polni krvi, porazdelitev pa lahko pripišemo preferenčni vezavi na FKBP- 12 v krvničkah.
The mean (standard deviation, SD) dissociation constant (Kd) of binding was 5.1 (3.0) ng/ ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Povprečna (standardna deviacija, SD) disociacijska konstanta (Kd) vezave je bila 5, 1 (3, 0) ng/ ml, kar pomeni koncentracijo, pri kateri je bilo zasedenih 50% vezavnih mest v krvničkah.
Following a single
Porazdelitev temsirolimusa je odvisna od odmerka s povprečno (10., 90. percentila) maksimalno specifično vezavo v krvničkah 1, 4 mg (0, 47 do 2, 5 mg).
12 25 mg temsirolimus intravenous dose, mean steady-state volume of distribution in whole blood of patients with cancer was 172 liters.
Po enem samem 25- miligramskem intravenskem odmerku temsirolimusa je bil povprečni porazdelitveni prostor v stanju dinamičnega ravnovesja v polni krvi pri bolnikih z rakom 172 litrov.
Metabolism Sirolimus, an equally potent metabolite to temsirolimus, was observed as the principal metabolite in humans following intravenous treatment.
Presnova Sirolimus, ki je enako močan presnovek kot temsirolimus, so pri ljudeh opazili kot glavni presnovek po intravenskem zdravljenju.
During in vitro temsirolimus metabolism studies, sirolimus, seco-temsirolimus and seco-sirolimus were observed; additional metabolic pathways were hydroxylation, reduction and demethylation.
Med raziskavami presnove temsirolimusa in vitro so našli sirolimus, seko- temsirolimus in seko- sirolimus; druge presnovne poti so bile hidroksilacija, redukcija in demetilacija.
Following a single 25 mg intravenous dose in patients with cancer, sirolimus AUC was 2.7-fold that of temsirolimus AUC, due principally to the longer half-life of sirolimus.
Potem ko so bolnikom z rakom dali en 25- miligramski intravenski odmerek, je bila AUC sirolimusa 2, 7- krat večja od AUC temsirolimusa, kar je bilo predvsem posledica daljše razpolovne dobe sirolimusa.
Elimination Following a single 25 mg intravenous dose of temsirolimus, temsirolimus mean ±SD systemic clearance was 11.4 ± 2.4 l/ h.
Izločanje Po enem 25- miligramskem intravenskem odmerku temsirolimusa je bil njegov povprečni ± SD sistemski očistek 11, 4 ± 2, 4 l/ h.
Mean half-lives of temsirolimus and sirolimus were 17.7 hr and 73.3 hr, respectively.
Povprečna razpolovna doba temsirolimusa je bila 17, 7 ure, sirolimusa pa 73, 3 ure.
Following administration of [14C] temsirolimus, excretion was predominantly via the faeces (78%), with renal elimination of active substance and metabolites accounting for 4.6% of the administered dose.
Po aplikaciji [14C] temsirolimusa se je le- ta izločal iz telesa pretežno z blatom (78%), 4, 6% danega odmerka zdravilne učinkovine in presnovkov pa se je izločilo preko ledvic.
Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Dokazali so, da sta temsirolimus in sirolimus substrata za P- gp in vitro.
Possible effects of inhibition of P-gp on elimination of temsirolimus and sirolimus in vivo have not been investigated.
Možnih učinkov inhibicije P- gp na izločanje temsirolimusa in sirolimusa in vivo niso raziskali.
Special Populations Hepatic impairment Temsirolimus and sirolimus pharmacokinetics have not been investigated in patients with hepatic impairment (see sections 4.2 and 4.4).
Posebne skupine bolnikov Okvara jeter Pri bolnikih z okvarami jeter farmakokinetike temsirolimusa in sirolimusa niso raziskovali (glejte poglavji 4. 2 in 4. 4).
Gender, weight, race, age Temsirolimus and sirolimus pharmacokinetics are not significantly affected by gender or body weight.
Spol, telesna teža, rasa, starost Spol ali telesna teža ne vpliva pomembno na farmakokinetiko temsirolimusa in sirolimusa.
Pharmacokinetic data on temsirolmus and sirolimus are available in patients up to age 79 years.
No voljo so podatki o farmakokinetiki temsirolimusa in sirolimusa pri bolnikih, starih do 79 let.
Paediatric population Temsirolimus and sirolimus pharmacokinetics in the paediatric population have not been investigated.
12 Otroci Pri otrocih farmakokinetike temsirolimusa in sirolimusa niso raziskovali.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to or even lower than clinical exposure levels and with possible relevance to clinical use, were as follows: pancreatic islet cell vacuolation (rat), testicular tubular degeneration (mouse, rat and monkey), lymphoid atrophy (mouse, rat and monkey), mixed cell inflammation of the colon/ caecum (monkey), and pulmonary phospholipidosis (rat).
Neželene reakcije, ki jih niso opazili v kliničnih študijah, pač pa pri živalih pri ravneh izpostavljenosti, ki so bile podobne ali celo manjše od ravni klinične izpostavljenosti in za katere je možno, da bi bile pomembne za klinično uporabo, so bile: vakuolizacija otočnih celic trebušne slinavke (podgana), tubulna degeneracija mod (miš, podgana in opica), limfoidna atrofija (miš, podgana in opica), vnetje kolona/ cekuma z mešanimi celicami (opica) in pljučna fosfolipidoza (podgana).
13 Diarrhoea with mixed cell inflammation of the caecum or colon was observed in monkeys and was associated with an inflammatory response, and may have been due to a disruption of the normal intestinal flora.
Pri opicah so opazili drisko z vnetjem cekuma ali kolona z mešanimi celicami, ki je bila povezana z vnetnim odzivom in bi lahko bila posledica uničenja normalne črevesne flore.
General inflammatory responses, as indicated by increased fibrinogen and neutrophils, and/ or changes in serum protein, were observed in mice, rats, and monkeys, although in some cases these clinical pathology changes were attributed to skin or intestinal inflammation as noted above.
Splošne vnetne odzive, na katere kažejo zvišan fibrinogen in nevtrofilci in/ ali spremembe serumskih beljakovin, so opazili pri miših, podganah in opicah, čeprav so v nekaterih primerih te klinično - patološke spremembe pripisali vnetju kože ali črevesa, kot je opisano zgoraj.
Temsirolimus was not genotoxic in a battery of in vitro (bacterial reverse mutation in Salmonella typhimurium and Escherichia coli, forward mutation in mouse lymphoma cells, and chromosome aberrations in Chinese hamster ovary cells) and in vivo (mouse micronucleus) assays.
Temsirolimus v bateriji testov in vitro (bakterijski test povratnih mutacij pri bakterijah Salmonella typhimurium in Escherichia coli, test naprednih mutacij v celicah limfoma pri miši in test kromosomskih aberacij v ovarijskih celicah kitajskega hrčka) in in vivo (mišji mikronukleusni test) ni bil genotoksičen.
The following effects were reported in mice and/ or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Pri miših in/ ali podganah so v opravljenih raziskavah kancerogenosti poročali o naslednjih učinkih: granulocitna levkemija, limfom, hepatocelularni adenom in karcinom ter testikularni adenom.
Reductions in testicular weights and/ or histological lesions (e. g., tubular atrophy and tubular giant cells) were observed in mice, rats, and monkeys.
Pri miših, podganah in opicah so opazili zmanjšanje teže mod in/ ali histološke lezije (npr. tubulno atrofijo in tubulne celice velikanke).
Anhydrous ethanol all-rac-α -Tocopherol (E 307) Propylene glycol Anhydrous citric acid (E 330)
Koncentrat: brezvodni etanol racemat ά- tokoferola (E 307) propilenglikol brezvodna citronska kislina (E 330)
Polysorbate 80 (E 433) Macrogol 400 Anhydrous ethanol
Vehikel: polisorbat 80 (E- 433) makrogol 400 brezvodni etanol
6.2 Incompatibilities
13 6. 2 Inkompatibilnosti
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Tega zdravila ni dovoljeno mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6. 6.
TORISEL 25 mg/ ml concentrate for solution for infusion must not be added directly to aqueous infusion solutions.
Zdravila TORISEL 25 mg/ ml koncentrat za raztopino za infundiranje ne smemo direktno dodati vodnim raztopinam za infundiranje.
Direct addition of TORISEL 25 mg/ ml concentrate to aqueous solutions will result in precipitation of medicinal product.
Direktno dodajanje zdravila TORISEL 25 mg/ ml koncentrat vodnim raztopinam povzroči obarjanje zdravila.
Always dilute TORISEL 25 mg/ ml concentrate for solution for infusion with the supplied diluent before adding to infusion solutions.
TORISEL 25 mg/ ml koncentrat za raztopino za infundiranje pred dodajanjem raztopinam za infundiranje vedno razredčimo s priloženim vehiklom.
14 solution for injection after the initial dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent.
Zdravilo TORISEL smemo uporabiti samo v raztopini natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje šele po začetnem razredčenju zdravila TORISEL 25 mg/ ml koncentrat z 1, 8 ml odvzetega priloženega vehikla.
TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate extraction (DEHP) from polyvinyl chloride (PVC).
Zdravilo TORISEL po razredčenju vsebuje polisorbat 80, za katerega je znano, da zveča hitrost ekstrakcije di - (2- etilheksil) ftalata (DEHP) iz polivinilklorida (PVC).
This incompatibility has to be considered during the preparation and administration of TORISEL.
To nekompatibilnost moramo upoštevati pri pripravi in uporabi zdravila TORISEL.
It is important that the recommendations in sections 4.2 and 6.6 be followed closely.
Pomembno je, da se natančno ravnamo po priporočilih v poglavjih 4. 2 in 6. 6.
After first dilution of TORISEL 25 mg/ ml concentrate with 1.8 ml of withdrawn diluent:
Po prvem razredčenju zdravila TORISEL 25 mg/ ml koncentrat z 1, 8 ml vehikla:
24 hours when stored below 25°C and protected from light.
24 ur pri temperaturi do 25 °C in zaščiteno pred svetlobo.
After further dilution of the concentrate-diluent mixture with sodium chloride 9 mg/ ml (0.9%) solution for injection:
Po nadaljnjem razredčenju zmesi koncentrata in vehikla z raztopino natrijevega klorida za injiciranje v koncentraciji 9 mg/ ml (0, 9%):
6 hours when stored below 25°C and protected from light.
6 ur pri temperaturi do 25 °C in zaščiteno pred svetlobo
TORISEL 25 mg/ ml concentrate:
TORISEL 25 mg/ ml koncentrat:
Clear glass vial (type 1 glass) with butyl rubber stopper and a plastic flip-top closure sealed with aluminum.
Viala iz prozornega stekla (steklo tipa 1) z zamaškom iz butilne gume in plastično zaporko, zavarjeno z aluminijem.
1 vial of 1.2 ml of TORISEL 25 mg/ ml concentrate and 1 vial of 2.2 ml of diluent.
1 viala z 1, 2 ml zdravila TORISEL 25 mg/ ml koncentrat in 1 viala z 2, 2 ml vehikla.
6.6 Special precautions for disposal and other handling
14 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
During handling and preparation of admixtures, TORISEL should be protected from excessive room light and sunlight.
Med ravnanjem z zdravilom in pripravo primesi je treba zdravilo TORISEL varovati pred močno sobno in sončno svetlobo.
TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Zdravilo TORISEL po razredčenju vsebuje polisorbat 80, za katerega je znano, da pospešuje ekstrakcijo di - (2- etilheksil) ftalata (DEHP) iz polivinilklorida (PVC).
15 Therefore, PVC bags and medical devices must not be used for the preparation, storage and administration of TORISEL solutions for infusions.
Zato se vrečke in medicinski pripomočki iz PVC ne smejo uporabljati za pripravo, shranjevanje in dajanje raztopin za infundiranje, ki vsebujejo TORISEL.
Bags/ containers that come in contact with TORISEL must be made of glass, polyolefin, or polyethylene.
Vrečke/ vsebniki, ki pridejo v stik z zdravilom TORISEL, morajo biti izdelani iz stekla, poliolefina ali polietilena.
Dilution TORISEL 25 mg/ ml concentrate must be diluted with the supplied diluent before administration in sodium chloride infusion.
Razredčenje Preden zdravilo TORISEL 25 mg/ ml koncentrat uporabimo v infuziji natrijevega klorida, ga moramo razredčiti s priloženim vehiklom.
In preparing the solution, the following two-step process must be carried out in an aseptic manner according to local standards for handling cytotoxic/ cytostatic drugs:
Pri pripravi raztopine morate na aseptičen način izvršiti naslednji dvostopenjski postopek v skladu z lokalnimi standardi za ravnanje s citotoksičnimi/ citostatičnimi zdravili:
DILUTION OF TORISEL 25 MG/ ML CONCENTRATE WITH THE SUPPLIED DILUENT • Withdraw 1.8 ml of the supplied diluent. • Inject the 1.8 ml of diluent into the vial of TORISEL 25 mg/ ml concentrate which contains 30 mg of temsirolimus (1.2 ml of concentrate). • Mix the diluent and the concentrate well by inversion of the vial.
RAZREDČENJE ZDRAVILA TORISEL 25 MG/ ML KONCENTRAT S PRILOŽENIM VEHIKLOM • Odvzemite 1, 8 ml priloženega vehikla. • Injicirajte teh 1, 8 ml vehikla v vialo z zdravilom TORISEL 25 mg/ ml koncentrat, ki vsebuje 30 mg temsirolimusa (1, 2 ml koncentrata). • Dobro zmešajte vehikel in koncentrat z obračanjem viale.
One vial of 1.2 ml of TORISEL 25 mg/ ml concentrate contains 30 mg of temsirolimus: when the 1.2 ml concentrate is combined with 1.8 ml of withdrawn diluent, a total volume of 3.0 ml is obtained, and the concentration of temsirolimus will be 10 mg/ ml.
Ena viala z 1, 2 ml zdravila TORISEL 25 mg/ ml koncentrat vsebuje 30 mg temsirolimusa; ko zmešate 1, 2 ml koncentrata z 1, 8 ml odvzetega priloženega vehikla, dobite skupni volumen 3, 0 ml, koncentracija temsirolimusa pa bo 10 mg/ ml.
The concentrate-diluent mixture is stable below 25°C for up to 24 hours.
Zmes koncentrata in vehikla je pri temperaturi 25 °C stabilna do 24 ur dolgo.
ADMINISTRATION OF CONCENTRATE-DILUENT MIXTURE IN SODIUM CHLORIDE INFUSION • Withdraw the required amount of concentrate-diluent mixture (containing temsirolimus 10 mg/ ml) from the vial; i. e., 2.5 ml for a temsirolimus dose of 25 mg. • Inject the withdrawn volume rapidly into 250 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to ensure adequate mixing.
DODAJANJE ZMESI KONCENTRATA IN VEHIKLA V INFUZIJO NATRIJEVEGA KLORIDA • Odvzemite potrebno količino zmesi koncentrata in vehikla (ki vsebuje 10 mg temsirolimusa na ml) iz viale; t. j., 2, 5 ml za 25- miligramski odmerek temsirolimusa. • Hitro injicirajte odvzeti volumen v 250 ml raztopine natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje, da zagotovite ustrezno mešanje.
The resulting solution should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Nastalo raztopino pred dajanjem preglejte, ali niso v njej vidni delci in ali ni spremenjena njena barva, če raztopina in vsebnik to omogočata.
The admixture of TORISEL in sodium chloride 9 mg/ ml (0.9%) solution for injection should be protected from excessive room light and sunlight.
Primes zdravila TORISEL v raztopini natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje morate zavarovati pred močno sobno in sončno svetlobo.
• Administration of the final diluted solution should be completed within six hours from the time that the TORISEL is first added to sodium chloride 9 mg/ ml (0.9%) solution for injection.
• Končna razredčena raztopina mora biti do konca porabljena v šestih urah od takrat, ko zdravilo TORISEL prvič dodate raztopini natrijevega klorida 9 mg/ ml (0, 9%) za injiciranje.
• TORISEL is infused over a 30- to 60-minute period once weekly.
• Zdravilo TORISEL infundiramo enkrat na teden, infuzija naj traja 30 do 60 minut.
• Appropriate administration materials must be composed of glass, polyolefin, or polyethylene to avoid excessive loss of medicinal product and to decrease the rate of DEHP extraction.
15 • Materiali, primerni za dajanje zdravila, morajo biti sestavljeni iz stekla, poliolefina ali polietilena, s čimer se izognemo večjim izgubam zdravila in zmanjšamo hitrost ekstrakcije DEHP.
If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i. e., an end-filter) before
Če infuzijski sistem, ki ga imate na voljo, nima zaporedno vključenega filtra, morate dodati filter na koncu infuzijskega sistema (t. j. končni filter), preden pripravljena raztopina doseže bolnikovo veno.
Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
Uporabljate lahko različne končne filtre, pri katerih sega velikost filtrirnih por od 0, 2 mikrona do 5 mikronov.
• TORISEL, when diluted, contains polysorbate 80, which is known to increase the rate of DEHP extraction from PVC.
• Zdravilo TORISEL po razredčenju vsebuje polisorbat 80, za katerega je znano, da zveča hitrost ekstrakcije DEHP iz PVC.
This should be considered during the preparation and administration of TORISEL following constitution.
To morate upoštevati pri pripravi in uporabi zdravila TORISEL.
It is important that the recommendations in section 4.2 be followed closely.
Pomembno je, da se natančno ravnate po priporočilih v poglavjih 4. 2.
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH United Kingdom
Wyeth Europa Ltd Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Velika Britanija
19 November 2007
19. november 2007.
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 tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 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 zagotoviti, da je sistem farmakovigilance, opisan v različici 1. 0, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.7 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 za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, ki so opisane v načrtu farmakovigilance, sprejetem v različici 1. 7 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in v vseh nadaljnjih posodobitvah RMP, s katerimi soglaša komisija za zdravila za uporabo v humani medicini (CHMP).
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Poleg tega je treba predložiti posodobljen RMP • ob prejemu novih podatkov, ki bi lahko vplivali na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja; • v 60 dneh po doseženem pomembnem mejniku (pri farmakovigilanci ali zmanjševanju tveganja); • na zahtevo Evropske agencije za zdravila (EMEA).
• At the request of the EMEA
OZNAČEVANJE IN NAVODILO ZA UPORABO
LABELLING
20 PODATKI NA ZUNANJI OVOJNINI
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
ŠKATLA
Each vial of 1.2 ml of TORISEL 25 mg/ ml concentrate contains 30 mg temsirolimus.
Ena viala z 1, 2 ml zdravila TORISEL 25 mg/ ml koncentrat vsebuje 30 mg temsirolimusa.