FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for methadone medicinal products for oral use containing povidone.
Slovenian: • odbor PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravila za peroralno uporabo, ki vsebujejo metadon in povidon;
English: Pathological fractures were observed in two of the five patients, with deposits of povidone also in the bone tissue.
Slovenian: Pri dveh od petih bolnikov so opazili patološke zlome, pri čemer se je povidon nalagal tudi v kostnem tkivu.
English: Therefore, the PRAC considered that additional risk minimisation measures could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90).
Slovenian: Odbor PRAC je zato menil, da dodatni ukrepi za zmanjšanje tveganja ne bi mogli zmanjšati znanega tveganja za napačno uporabo pri predvideni ciljni populaciji in za povezane morebitne resne okvare zaradi injiciranja povidona z veliko relativno molekulsko maso (K90).
English: However, the causality of povidone deposits and bone marrow failure and skeletal fracture has been reasonably demonstrated, and the mechanism of pathophysiology appears to be related to the spatial competition of deposits and bone marrow (Kepes et al 1993; Kuo et al 1997; Dunn et al 1998; Huang et al 2012).
Slovenian: Po drugi strani pa je vzročna zveza med kopičenjem povidona in okvaro kostnega mozga ter zlomi kosti dovolj dobro dokazana in zdi se, da je mehanizem patofiziologije povezan s tem, da nakopičeni povidon tekmuje za prostor s kostnim mozgom (Kepes in sod., 1993; Kuo in sod., 1997; Dunn in sod., 1998; Huang in sod., 2012).
English: The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Slovenian: Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi teh zdravil ugodno pod pogojem, da se v informacije o zdravilu vključijo spremembe, tako da se bo uskladilo in okrepilo opozorilo, da so tablete namenjene samo za peroralno uporabo in se ne smejo injicirati.
English: • The PRAC noted that the risk of misuse by injection of methadone products for oral use is wellknown in the target population, evidence of which is available from the literature;
Slovenian: • odbor PRAC je izpostavil, da je napačna uporaba zdravil za peroralno uporabo, ki vsebujejo metadon, z injiciranjem dobro znano tveganje pri ciljni populaciji, ki je dokumentirano v literaturi;
English: • The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Slovenian: • Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi teh zdravil ugodno pod pogojem, da se v informacije o zdravilu vključijo spremembe, tako da se bo uskladilo in okrepilo opozorilo, da so tablete namenjene samo za peroralno uporabo in se ne smejo injicirati.
English: • The PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml, which contains povidone K90 with an average molecular weight of 1,100,000.
Slovenian: • odbor PRAC je upošteval, da je povidon z veliko relativno molekulsko maso prisoten samo v eni peroralni raztopini, ki vsebuje metadon v odmerku 2 mg/ml in povidon K90 s povprečno relativno molekulsko maso 1.100.000.
English: • The PRAC considered that the proposed risk minimisation measures to update the product information could not mitigate the known risk of misuse by the intended target population and the associated potential serious harm caused by the injection of high molecular weight povidone (K90);
Slovenian: • odbor PRAC je menil, da predlagani ukrepi za zmanjšanje tveganja, ki zajemajo posodobitev informacij o zdravilu, ne bi mogli zmanjšati znanega tveganja za napačno uporabo pri predvideni ciljni populaciji in za povezane morebitne resne okvare zaradi injiciranja povidona z veliko relativno molekulsko maso (K90);
English: The CMDh, having considered the PRAC recommendation dated 23 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Slovenian: Skupina CMDh je po obravnavi priporočila odbora PRAC z dne 23. julija 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES dosegla sporazum glede začasnega umika dovoljenj za promet s peroralno raztopino, ki vsebuje metadon in povidon z veliko relativno molekulsko maso (K90).
English: • The PRAC considered that the potential for harm was likely to be associated with the misuse of methadone oral solutions containing high molecular weight povidone K90;
Slovenian: • odbor PRAC je menil, da je potencial za povzročanje okvar verjetno povezan z napačno uporabo peroralnih raztopin, ki vsebujejo metadon in povidon z veliko relativno molekulsko maso K90;
English: In the context of the review of methadone products containing povidone, the PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml (containing high molecular weight povidone, K90).
Slovenian: V okviru pregleda zdravil, ki vsebujejo metadon in povidon, je odbor PRAC upošteval, da je povidon z veliko relativno molekulsko maso prisoten samo v eni peroralni raztopini, ki vsebuje metadon v odmerku 2 mg/ml (in 11,7 mg/ml povidona z veliko relativno molekulsko maso, K90).
English: As a consequence, following the provisions under Article 107j(3) of Directive 2001/83/EC, the PRAC recommends the variation of marketing authorisations for methadone tablets containing low molecular weight povidone (K25 or K30).
Slovenian: Posledično je odbor PRAC v skladu z določbami člena 107j(3) Direktive 2001/83/ES priporočil spremembo dovoljenj za promet s tabletami metadona, ki vsebujejo povidon z majhno relativno molekulsko maso (K25 ali K30).
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Slovenian: Za preklic začasnega umika morajo pristojni nacionalni organi držav članic preveriti, ali imetnik dovoljenja za promet z zdravilom izpolnjuje naslednje pogoje: Imetniki dovoljenja za promet morajo ustrezno reformulirati zdravilo ob upoštevanju možnosti za napačno uporabo.
English: Methadone oral solution containing high molecular weight povidone (K90)
Slovenian: Peroralna raztopina, ki vsebuje metadon in povidon z veliko relativno molekulsko maso (K90)
English: It followed the decision of NOMA to suspend the only methadonecontaining oral solution that contains povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Slovenian: Pregled se je začel, potem ko se je agencija NOMA odločila, da bo zaradi poročil o resnih neželenih dogodkih, opaženih pri nekdanjih ali trenutnih uporabnikih drog na Norveškem, začasno umaknila edino peroralno raztopino na nacionalnem trgu, ki vsebuje metadon in povidon.
English: High molecular weight povidone therefore accumulates if injected intravenously and povidone deposition in organs and tissues (in particular bone marrow and bone tissue) have been reported in the literature after substantial intravenous administration leading to ‘povidone storage disease' (Kepes et al. 1993; Kuo et al. 1997; Dunn et al. 1998; Huang et al. 2012).
Slovenian: Povidon z veliko relativno molekulsko maso se tako v primeru intravenskega injiciranja nakopiči, poleg tega pa so v literaturi poročila o tem, da se je povidon po pogosti intravenski uporabi nalagal v organih in tkivih (zlasti v kostnem mozgu in kostnem tkivu), kar je privedlo do „bolezni kopičenja povidona“ (Kepes in sod., 1993; Kuo in sod., 1997; Dunn in sod., 1998; Huang in sod.
English: As a consequence, following the provisions under Article 107j (3) of Directive 2001/83/EC, the PRAC recommends the suspension of the marketing authorisations for methadone oral solution containing high molecular weight povidone (K90).
Slovenian: Posledično je odbor PRAC v skladu z določbami člena 107j (3) Direktive 2001/83/ES priporočil začasen umik dovoljenj za promet s peroralno raztopino, ki vsebuje metadon in povidon z veliko relativno molekulsko maso (K90).
English: in addition to the acknowledged difficulty of adequately mitigate the well-known risk of misuse in the target population, the PRAC concluded that the benefits no longer outweigh the risks for methadone oral solution containing povidone K90.
Slovenian: Odbor PRAC je ob upoštevanju prijavljenih resnih neželenih učinkov, ki vključujejo okvaro kostnega mozga (npr. anemijo) in patološke zlome, ter možnosti za kopičenje povidona z veliko Mr v primeru injiciranja in ob že znanem dejstvu, da je težko zadovoljivo zmanjšati dobro znano tveganje za napačno uporabo pri ciljni populaciji, zaključil, da koristi peroralne raztopine, ki vsebuje metadon in povidon K90, ne odtehtajo več z njo povezanih tveganj.
English: 2001/83/EC the benefit risk balance of methadone oral solutions containing povidone K90 is not favourable;
Slovenian: • na podlagi razpoložljivih podatkov je odbor PRAC zaključil, da v skladu s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi peroralnih raztopin, ki vsebujejo metadon in povidon K90, ni ugodno;
English: These products are therefore not associated with the potential for harm of oral solutions containing high Mw.
Slovenian: Ta zdravila torej v nasprotju s peroralnimi raztopinami, ki vsebujejo povidon z veliko Mr, niso povezana s potencialom za povzročanje okvar.
English: K30) were to be injected, it is expected to be readily excreted and not to accumulate and therefore was not associated with the potential for harm of oral solutions containing high Mw.
Slovenian: • Odbor PRAC je menil, da se povidon z majhno relativno molekulsko maso, ki ga vsebujejo tablete metadona (K25 ali K30), v primeru injiciranja verjetno zlahka izloči in se ne kopiči, kar pomeni, da v nasprotju s peroralnimi raztopinami, ki vsebujejo povidon z veliko Mr, ni povezan s potencialom za povzročanje okvar.
English: • 18 months.
Slovenian: • 18 mesecev.
English: PC: {number} SN: {number} NN: {number]
Slovenian: PC: {številka} SN: {številka} NN: {številka}
English: Magyarország Teva Gyógyszergyár Zrt.
Slovenian: Teva Gyógyszergyár Zrt.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravilo se ne sme mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: • change or absence of menstrual period
Slovenian: • spremembe ali izostanek menstruacije;
English: Each carton contains:
Slovenian: Vsaka kartonska škatla vsebuje:
English: Tumour size <2 cm >2 cm
Slovenian: <2 cm >2 cm
English: TTP=time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Slovenian: ČDN = čas do napredovanja; »NO« pomeni, da ga ni bilo mogoče oceniti ali še ni dosežen.
English: Quality of life parameters
Slovenian: Parametri kakovosti življenja
English: Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Slovenian: Swensweg 5, Postbus 522, 2003 RN Haarlem Nizozemska
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Cases of electrolyte imbalance have been reported.
Slovenian: Poročali so o primerih neravnovesja eletrolitov.
English: No statistical differences were observed between treatment groups for Global Quality of Life.
Slovenian: Med skupinami zdravljenja niso opazili statističnih razlik po oceni globalnega vprašalnika o kakovosti življenja (»Global Quality of Life«).
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: FORMULATION
Slovenian: FORMULACIJA
English: In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Slovenian: V obeh krakih je bila kakovost življenja, ocenjena z vprašalnikom EORTC, med zdravljenjem in poznejšim spremljanjem primerljiva in stabilna.
English: • bleeding from the nose
Slovenian: • krvavitev iz nosu;
English: 2 Estimated median survival
Slovenian: 2 ocenjeno povprečno preživetje
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za nadaljnje informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
English: The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
Slovenian: Populacija študije je obsegala bolnike s tehnično neresektabilno boleznijo, bolnike z majhno verjetnostjo kirurške ozdravitve in bolnike, ki so stremeli k ohranitvi organov.
English: Overall response rate (%):
Slovenian: celotni delež odziva (%):
English: Clinical benefit parameters
Slovenian: Parametri klinične koristi
English: 2003 RN Haarlem The Netherlands
Slovenian: 2003 RN Haarlem, Nizozemska
English: (26.8-ne)
Slovenian: (26,8-NO)
English: A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Slovenian: Za pospešene režime so priporočili celotni odmerek 70 Gy, za hiperfrakcionirne režime pa
English: Between infusions of Docetaxel Teva the following may occur, and the frequency may vary with the combinations of medicines that are received:
Slovenian: Med infuzijami zdravila Docetaksel Teva se lahko pojavi naslednje in pogostost se lahko razlikuje glede na kombinacijo uporabljenih zdravil:
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Teva.
Slovenian: Zdravnik bo morda spremenil odmerek in pogostost odmerjanja glede na izvide vaših preiskav krvi, vaše splošno stanje in vaš odziv na zdravilo Docetaksel Teva.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne: Drugi viri informacij
English: • injection site reactions at the site of a previous reaction
Slovenian: • reakcije na mestu injiciranja na mestu predhodne reakcije;
English: For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Slovenian: Pri kombinaciji s trastuzumabom so predstavljeni neželeni učinki (vseh stopenj), o katerih so poročali pri ≥ 10 %.
English: In some cases (frequency not known) permanent hair loss has been observed
Slovenian: V nekaterih primerih (pogostnost neznana) so opazili trajno izgubo las.
English: Efficacy results are summarized in the following table:
Slovenian: Rezultati o učinkovitosti so povzeti v naslednji razpredelnici.
English: The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Slovenian: Lestvica stanja zmogljivosti s podlestvicama za glavo in vrat (PSS-HN), namenjenima merjenju razumljivosti govora, sposobnosti uživanja hrane na javnem mestu in normalnosti prehrane je pokazala pomembno korist TPF v primerjavi s PF.
English: Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Slovenian: Glede na to, da je tedensko odmerjanje docetaksela pokazalo nekoliko boljši varnostni profil kot odmerjanje docetaksela vsake tri tedne, je možno, da bi nekaterim bolnikom koristilo tedensko odmerjanje docetaksela.
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Slovenian: Farmakoterapevtska skupina: taksani; oznaka ATC: L01CD02 Mehanizem delovanja
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki kategoriji pogostosti so neželeni učinki navedeni po padajoči resnosti.
English: • raised liver enzymes (hence the need for regular blood tests).
Slovenian: • krvavitev; • povišanje ravni jetrnih encimov (zato so potrebne redne preiskave krvi).
English: Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Slovenian: Profilaktični G-CSF se lahko uporabi, da se ublaži tveganje za hematološko toksičnost.
English: A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Slovenian: Manjši delež bolnic so testirali z uporabo fluorescenčne hibridizacije in situ (FISH).
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Slovenian: • okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužb) in trombocitov;
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Slovenian: Tudi to je bilo statistično značilno: RO 0,71, 95-% IZ 0,56-0,90, test log-rank p = 0,004.
English: Docetaxel1 n=94
Slovenian: docetaksel1 n = 94
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 January 2010
Slovenian: Datum prve odobritve: 26. januar 2010 Datum zadnjega podaljšanja: 14. julij 2014
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Slovenian: Upoštevajte, da je to verjetno podcenjen delež, kajti znano je, da sam docetaksel v odmerku 100 mg/m2 povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
English: • One vial of concentrate and,
Slovenian: • eno vialo koncentrata in
English: Docetaxel Teva will be given by infusion into one of your veins (intravenous use).
Slovenian: Zdravilo Docetaksel Teva boste dobili v infuziji v eno od ven (intravenska uporaba).
English: The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Slovenian: Pri ocenljivih bolnikih je bil celotni delež odziva 6,8 %, srednje trajanje odziva pa 26,1 tednov.
English: If this happens, you must tell your doctor immediately
Slovenian: Če se to zgodi, morate nemudoma obvestiti zdravnika;
English: The safety and efficacy of Docetaxel Teva in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Docetaksel Teva za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
English: The incidence of serious adverse events was higher in older people compared to younger patients.
Slovenian: Incidenca resnih neželenih učinkov je bila pri starejših osebah večja kot pri mlajših.
English: What Docetaxel Teva is and what it is used for
Slovenian: Kaj je zdravilo Docetaksel Teva in za kaj ga uporabljamo
English: to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana ( ni mogoče oceniti iz razpoložljivih podatkov).
English: Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Slovenian: Z modelom dobljeni farmakokinetični parametri so bili zelo blizu parametrom, ocenjenim v študijah I.
English: Treatment is repeated every three weeks.
Slovenian: Zdravljenje se ponavlja na 3 tedne.
English: Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Slovenian: Najmanjše število nevtrofilcev se je pojavilo po mediani 7 dni, vendar je ta čas lahko krajši pri bolnikih, ki so se že intenzivno zdravili.
English: Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Slovenian: Podatki o preživetju, srednji čas do napredovanja bolezni in delež odziva v dveh krakih te raziskave so prikazani v naslednji razpredelnici:
English: • decrease of the sodium, potassium, magnesium, and/or calcium in your blood (electrolyte balance disorders)
Slovenian: • znižanje natrija, kalija, magnezija in/ali kalcija v krvi (motnje ravnotežja elektrolitov)
English: 1-year Survival (%)
Slovenian: enoletno preživetje (%)
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Slovenian: Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih pomembnih prognostičnih dejavnikih:
English: Other medicines and Docetaxel Teva
Slovenian: Druga zdravila in zdravilo Docetaksel Teva
English: Before each treatment with Docetaxel Teva, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Teva.
Slovenian: Pred vsako uporabo zdravila Docetaksel Teva boste opravili preiskave krvi, da bo zdravnik preveril, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo Docetaksel Teva.
English: This is because Docetaxel Teva or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Slovenian: Zdravilo Docetaksel Teva ali drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
English: PF).
Slovenian: (PF/KRT).
English: 2-year Survival (%)
Slovenian: dveletno preživetje (%)
English: All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Slovenian: Vsi bolniki v kraku z docetakselom študij TAX 323 in TAX 324 so dobivali antibiotično profilakso.
English: • swelling caused by faulty lymphatic drainage
Slovenian: • otekanje zaradi nepravilne limfne drenaže;
English: This medicine should not be used after the expiry date which is stated on the carton and vials after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli in vialah poleg oznake »EXP«.
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Slovenian: Med zdravljenjem morajo tako moški kot ženske, moški pa še vsaj šest mesecev po njegovem koncu uporabljati kontracepcijsko zaščito (glejte poglavje 4.6).
English: 95% CI
Slovenian: 95% ZI
English: In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Slovenian: V ključnem preskušanju so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Slovenian: Ta režim so uporabljali 4 cikle vsake 3 tedne, če so po 2 ciklih opazili vsaj majhen odziv (≥ 25 %
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Slovenian: febrilna nevtropenija (vključuje nevtropenijo, povezano s povišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
English: Median survival (months)
Slovenian: srednji čas preživetja (meseci)
English: and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Slovenian: IHK 3+, 95 % vključenih bolnic pa je imelo bolezen, ki je bila IHK 3+ in/ali FISH-pozitivna.