FrancophonIA/ELRC3.0 huggingface dataset:
English: You must also use a barrier method of contraception such as condoms or the “coil” while taking Zydelig and for 1 month after your last treatment.
Slovenian: Med jemanjem zdravila Zydelig in še 1 mesec po zadnjem zdravljenju uporabljajte tudi pregradno metodo kontracepcije, kot so kondomi ali "špirala".
English: In general, the SmPC for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors (see section 4.4).
Slovenian: Na splošno je treba za priporočila glede sočasnega dajanja z zaviralci CYP3A4 upoštevati povzetek glavnih značilnosti drugega zdravila (glejte poglavje 4.4).
English: • colchicine, a medicine used to treat gout
Slovenian: • kolhicin, zdravilo, ki se uporablja za zdravljenje protina
English: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza hidroksipropilceluloza (E463) premreženi natrijev karmelozat natrijev karboksimetilškrob magnezijev stearat
English: Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.
Slovenian: V kliničnih študijah z idelalizibom so opazili povečanja ravni ALT in AST 3. in 4. stopnje (> 5 x ULN).
English: HMG CO-A REDUCTASE INHIBITORS
Slovenian: ZAVIRALCI REDUKTAZE HMG CO-A lovastatin, simvastatin atorvastatin
English: • redness and blistering of the skin • swelling and blistering of the lining of the mouth, genitals, and/or eyes
Slovenian: • otekla in mehurjasta ustna sluznica, spolovila in/ali oči.
English: Frequencies are defined as follows: very common
Slovenian: zelo pogosti zelo pogosti
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis.
Slovenian: Zdravljenje z zdravilom Zydelig je treba začasno ustaviti, če se pojavi driska/kolitis 3. ali 4. stopnje.
English: Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue.
Slovenian: Idelalizib je povzročil izginjanje limfoidov v vranici, priželjcu, bezgavkah in limfoidnem tkivu, povezanem s črevesjem.
English: A study of pharmacokinetics and safety of idelalisib was performed in healthy subjects and subjects with severe renal impairment (estimated CrCl 15 to 29 mL/min).
Slovenian: Pri zdravih osebah in osebah s hudo ledvično okvaro (ocenjeni CrCl 15 do 29 ml/min) so opravili študijo farmakokinetike in varnosti idelaliziba.
English: Inhaled/nasal corticosteroids: Budesonide, fluticasone
Slovenian: GLUKOKORTIKOIDI Inhalirani/nazalni kortikosteroidi: budezonid, flutikazon peroralni budezonid
English: If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Slovenian: Če se driska/kolitis ne ponovi, se lahko odmerek po presoji lečečega zdravnika ponovno poveča na 150 mg dvakrat na dan (glejte poglavje 4.8).
English: In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
Slovenian: Povišanje ravni ALT/AST se je ponovno pojavilo pri 26 % bolnikov, ki so ponovno začeli jemati idelalizib z nižjim odmerkom.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: PODATKI NA PRIMARNI OVOJNINI OZNAKA NA PLASTENKI
English: • itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections • boceprevir, telaprevir, medicines used to treat hepatitis C
Slovenian: • itrakonazol, ketokonazol, posakonazol, vorikonazol, zdravila, ki se uporabljajo za zdravljenje glivičnih okužb
English: CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Slovenian: IZ: interval zaupanja; O: ofatumumab; n: število odzivnih oseb; N: število oseb na skupino; ND: ni doseženo.
English: Each film-coated tablet contains 150 mg of idelalisib.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg idelaliziba.
English: However, idelalisib did not inhibit the normal host response to Staphylococcus aureus and did not exacerbate the myelosuppressive effect of cyclophosphamide.
Slovenian: odvisni od limfocitov T. Pri podganah lahko idelalizib povzroči zaviranje odzivov protiteles, odvisnih od limfocitov T. Vendar pa idelalizib ni zaviral normalnega odziva gostitelja na bakterijo Staphylococcus aureus in ni poslabšal mielosupresivnega učinka ciklofosfamida.
English: ↑ serum concentrations Idelalisib should not be co-administered with alfuzosin.
Slovenian: ↑ koncentracij v serumu Idelaliziba se ne sme dati sočasno z alfuzosinom.
English: PFS median (months) (95% CI)
Slovenian: PFS mediani čas (v mesecih) (95-odstotni IZ)
English: ↑ serum concentrations Idelalisib should not be co-administered with cisapride.
Slovenian: ↑ koncentracij v serumu Idelaliziba se ne sme dati sočasno s cisapridom.
English: If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Slovenian: Če se izpuščaj ne ponovi, se lahko odmerek po presoji lečečega zdravnika ponovno poveča na 150 mg dvakrat na dan (glejte poglavje 4.8).
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), sunset yellow FCF (E110) (see Section 2, What you need to know before you take Zydelig).
Slovenian: Filmska obloga: polivinilalkohol (E1203), makrogol 3350 (E1521), titanov dioksid (E171), smukec (E553B), sončno rumeno FCF (E110) (glejte poglavje 2, Kaj morate vedeti, preden boste vzeli zdravilo Zydelig).
English: ANTICONVULSANTS
Slovenian: ANTIKONVULZIVI
English: Talk to your doctor before taking Zydelig.
Slovenian: Pred začetkom jemanja zdravila Zydelig se posvetujte z zdravnikom.
English: Clinical efficacy in follicular lymphoma
Slovenian: Klinična učinkovitost pri folikularnem limfomu
English: General disorders and administration site conditions Pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija zelo pogosti pogosti
English: Ketoconazole, itraconazole, posaconazole, voriconazole
Slovenian: ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Antimikotiki ketokonazol, itrakonazol, posakonazol, vorikonazol
English: NR (NR, NR)
Slovenian: ND (ND; ND)
English: Hazard ratio (95% CI) ORR (95% CI)
Slovenian: Razmerje tveganja (95-odstotni IZ) ORR (95-odstotni IZ)
English: Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Slovenian: Ko je pnevmonitis minil in če je ponovno zdravljenje ustrezno, se lahko razmisli o nadaljevanju zdravljenja z odmerkom 100 mg dvakrat na dan. Zdravljenje z zdravilom Zydelig je treba trajno prekiniti v primeru zmernega ali hudega simptomatskega pnevmonitisa ali organizirajoče pljučnice (glejte poglavji 4.4 in 4.8).
English: You should not breast-feed while taking Zydelig.
Slovenian: Med uporabo zdravila Zydelig ne smete dojiti.
English: Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Slovenian: Ko se izpuščaj vrne na 1. ali nižjo stopnjo, se lahko zdravljenje nadaljuje z odmerkom 100 mg dvakrat na dan.
English: Bepridil, disopyramide, lidocaine
Slovenian: amiodaron, kinidin bepridil, dizopiramid, lidokain
English: Follicular lymphoma
Slovenian: Folikularni limfom
English: Idelalisib should not be co-administered with sildenafil.
Slovenian: Idelaliziba se ne sme dati sočasno s sildenafilom.
English: How to store Zydelig
Slovenian: Shranjevanje zdravila Zydelig
English: ↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
Slovenian: ↑ koncentracij v serumu Pri sočasnem dajanju in po prekinitvi zdravljenja z idelalizibom se priporoča spremljanje mednarodnega normaliziranega razmerja (INR
English: Ask your doctor if you have any questions about any of your medicines.
Slovenian: Če imate vprašanja o katerem koli od svojih zdravil, se posvetujte z zdravnikom.
English: No hepatic impairment or chronic transaminase elevations were observed in rats or dogs in studies of 13 weeks and longer duration.
Slovenian: V študijah pri podganah ali psih, ki so trajale 13 tednov in več, niso opazili okvar jeter ali kroničnega povečanja transaminaze.
English: CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Slovenian: IZ: interval zaupanja; R: rituksimab; N: število oseb na skupino, ND: ni doseženo
English: The analyses of PFS, overall response rate (ORR) and lymph node response rate (LNR) were based on evaluation by an independent review committee (IRC).
Slovenian: Analize PFS, celokupne stopnje odziva (ORR-overall response rate) in stopnje odziva bezgavk (LNR, lymph node response rate) so temeljile na oceni neodvisnega odbora za pregled (IRC-independent review committee) * Vrednost ORR je opredeljena kot delež oseb, ki so dosegle celoviti odziv (CR-complete response) ali delni odziv (PR-partial response) na podlagi kriterijev odziva po NCCN (National Comprehensive Cancer Network)
English: Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Slovenian: Ko se driska/kolitis vrne na 1. ali nižjo stopnjo, se lahko zdravljenje nadaljuje z odmerkom 100 mg dvakrat na dan.
English: Tell your doctor right away at the first sign of diarrhoea.
Slovenian: Ko opazite prve znake driske, takoj povejte zdravniku.
English: • dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer • oral or implanted hormonal contraceptives, used to prevent pregnancy
Slovenian: • dasatinib, nilotinib, paklitaksel, vinblastin, vinkristin, zdravila, ki se uporabljajo za zdravljenje raka
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Slovenian: Filmska obloga polivinilalkohol (E1203) makrogol 3350 (E1521) titanov dioksid (E171) smukec (E553B) sončno rumeno FCF (E110)
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Iron oxide red (E172)
Slovenian: Filmska obloga polivinilalkohol (E1203) makrogol 3350 (E1521) titanov dioksid (E171) smukec (E553B) rdeči železov oksid (E172)
English: 19.4 (12.3, NR)
Slovenian: 19,4 (12,3; ND)
English: Atorvastatin
Slovenian: Ofatumumab
English: Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS^ Median (months) (95% CI)
Slovenian: Razmerje tveganja (95-odstotni IZ) vrednost p ORR* n (%) (95-odstotni IZ) Razmerje verjetnosti (95-odstotni IZ) vrednost p LNR** n/N (%) (95-odstotni IZ) 102/106 (96,2 %) (90,6; 99,0) Razmerje verjetnosti (95-odstotni IZ) vrednost p OS^ Mediani čas (v mesecih) (95-odstotni IZ)
English: ↑ serum concentrations
Slovenian: ↑ koncentracij v serumu
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
Slovenian: Filmska obloga: polivinilalkohol (E1203), makrogol 3350 (E1521), titanov dioksid (E171), smukec (E553B), rdeči železov oksid (E172).
English: In follicular lymphoma, the B-lymphocytes multiply too quickly and live for too long, so there are too many of them in the lymph nodes.
Slovenian: Folikularni limfom (FL) je rak vrste belih krvnih celic, imenovanih limfociti B. Pri folikularnem limfomu se limfociti B prehitro razmnožujejo in predolgo živijo, zato jih je v bezgavkah preveč.
English: Table 6: Summary of PFS and response rates in pre-specified subgroups from study 312-0119 Idelalisib + O Ofatumumab
Slovenian: Preglednica 6: Povzetek PFS in stopnje odziva v vnaprej specificiranih podskupinah iz študije 312-0119
English: • increased blood levels of fats
Slovenian: • spremembe števila belih krvnih celic
English: [ULN]).
Slovenian: ORR*
English: ↑ serum concentrations Therapeutic monitoring is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se terapevtsko spremljanje.
English: Idelalisib should not be co-administered with lovastatin or simvastatin.
Slovenian: Idelaliziba se ne sme dati sočasno z lovastatinom ali simvastatinom.
English: In this disease, the lymphocytes multiply too quickly and live for too long, so that there are too many of them circulating in the blood.
Slovenian: Kronična limfocitna levkemija (KLL) je rak vrste belih krvnih celic, imenovane limfociti B. Pri tej bolezni se limfociti prehitro razmnožujejo in predolgo živijo, zato jih v krvi kroži preveč.
English: Blood and lymphatic system disorders Neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija zelo pogosti zelo pogosti limfocitoza**
English: Zydelig 100 mg film-coated tablets idelalisib
Slovenian: Zydelig 100 mg filmsko obložene tablete idelalizib
English: ↑ serum concentrations Concurrent administration of salmeterol and idelalisib is not recommended.
Slovenian: ↑ koncentracij v serumu Sočasno dajanje salmeterola in idelaliziba se ne priporoča.
English: Zydelig 150 mg film-coated tablets idelalisib
Slovenian: Zydelig 150 mg filmsko obložene tablete idelalizib
English: The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV).
Slovenian: Mediana starost je bila 71 let (razpon: 47 do 92), pri čemer je bilo 78,2 % oseb starih več kot 65 let; 65,5 % je bilo moških in 90,0 % jih je bilo belcev; 64,1 % je imelo stadij III ali IV po Raiju, 55,9 % pa jih je imelo stadij C po Binetu.
English: PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI)
Slovenian: PFS Mediani čas (v mesecih) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) vrednost p ORR* n (%) (95-odstotni IZ) Razmerje verjetnosti (95-odstotni IZ) vrednost p LNR** n/N (%) (95-odstotni IZ) 153/164 (93,3 %) (88,3; 96,6) Razmerje verjetnosti (95-odstotni IZ) vrednost p OS Mediani čas (v mesecih) (95-odstotni IZ)
English: Zydelig 150 mg film-coated tablets
Slovenian: IME ZDRAVILA Zydelig 150 mg filmsko obložene tablete
English: Zydelig 100 mg film-coated tablets
Slovenian: IME ZDRAVILA Zydelig 100 mg filmsko obložene tablete
English: Ofatumumab N = 87
Slovenian: N = 87
English: Contents of the pack and other information What Zydelig contains
Slovenian: Shranjevanje zdravila Zydelig Vsebina pakiranja in dodatne informacije
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) and maintained their response for at least 8 weeks.
Slovenian: Analize PFS, celokupne stopnje odziva (ORR-overall response rate) in stopnje odziva bezgavk (LNR-lymph node response rate) so temeljile na oceni neodvisnega odbora za pregled (IRC-independent review committee) * Vrednost ORR je opredeljena kot delež oseb, ki so dosegle celoviti odziv (CR-complete response) ali delni odziv (PR-partial response) in pri katerih se je odziv ohranil vsaj 8 tednov.
English: CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Slovenian: Razmerje tveganja (95-odstotni IZ) vrednost p IZ: interval zaupanja; R: rituksimab; n: število odzivnih oseb; N: število oseb na skupino; ND: ni doseženo.
English: Tablet core
Slovenian: OZNAKA NA ŠKATLI
English: Zydelig 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zydelig 150 mg
English: Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib
Slovenian: Navodilo za uporabo Zydelig 150 mg filmsko obložene tablete idelalizib
English: * ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012).
Slovenian: Analize PFS, celokupne stopnje odziva (ORR-overall response rate) in stopnje odziva bezgavk (LNR-lymph node response rate) so temeljile na oceni neodvisnega odbora za pregled (IRC-independent review committee) * Vrednost ORR je opredeljena kot delež oseb, ki so dosegle celoviti odziv (CR-complete response) ali delni odziv (PR-partial response) na podlagi kriterijev odziva po NCCN (National Comprehensive Cancer Network)
English: ↑ serum concentrations Clinical monitoring is recommended.
Slovenian: ↑ koncentracij v serumu Priporoča se klinično spremljanje.
English: Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib
Slovenian: Navodilo za uporabo Zydelig 100 mg filmsko obložene tablete idelalizib
English: Respiratory, thoracic and mediastinal disorders Pneumonitis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pnevmonitis pogosti pogosti organizirajoča pljučnica občasni občasni
English: ANTIDEPRESSANTS
Slovenian: ANTIARITMIKI
English: PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI)
Slovenian: PFS mediani čas (v mesecih) (95-odstotni IZ) 16,4 (13,4; 17,8) Razmerje tveganja (95-odstotni IZ) ORR (95-odstotni IZ)
English: Other medicines and Zydelig
Slovenian: Kaj vsebuje zdravilo Zydelig
English: Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib.
Slovenian: Pri sočasnem dajanju tadalafila z idelalizibom je potrebna previdnost, vključno z razmislekom o zmanjšanju odmerka.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: Idelalisib should not be co-administered with colchicine to patients with renal or hepatic impairment.
Slovenian: Bolnikom z ledvično ali jetrno okvaro se idelaliziba ne sme dati sočasno s kolhicinom.
English: 28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
Slovenian: 28 tablet (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
English: EU/1/13/836/023 Memantine ratiopharm 5 mg; 10 mg;
Slovenian: EU/1/13/836/023 Memantin ratiopharm 5 mg; 10 mg;
English: --1 - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria brunetti, strain 034 - 213-288 sporulated oocysts - Eimeria maxima, strain 013 - 196-265 sporulated oocysts - Eimeria necatrix, strain 033 - 340-460 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Slovenian: - Eimeria acervulina, sev 003 - 332 - 450 sporuliranih oocist - Eimeria brunetti, sev 034 - 213 - 288 sporuliranih oocist - Eimeria maxima, sev 013 - 196 - 265 sporuliranih oocist - Eimeria necatrix, sev 033 - 340 - 460 sporuliranih oocist - Eimeria tenella, sev 004 - 276 - 374 sporuliranih oocist
English: EU (MA) Number
Slovenian: EU (MA) številka
English: It was agreed that the following statement would be included:
Slovenian: Dogovorjeno je bilo, da se vključi naslednja izjava:
English: Very rare (less than 1 in 10.000 patients treated)
Slovenian: Zelo redki (pri manj kot 1 od 10.000 zdravljenih bolnikov)
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel}> <{faks}> <{e-pošta}>
English: Data from table 2.13 in Clinical Safety Report, dated 21 December 2001
Slovenian: Podatki iz tabele 2.13 poročila o klinični varnosti z dne 21. decembra 2001
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča pa je treba zdravilo porabiti nemudoma.
English: Overall discussion on OA
Slovenian: Splošna razprava o OA
English: These patients should commence treatment on the lowest dose available.
Slovenian: Ti bolniki morajo začeti zdravljenje z najmanjšim razpoložljivim odmerkom.
English: No differences were observed regarding the SPID parameter.
Slovenian: V zvezi s parametrom SPID ni bilo opaženih razlik.
English: No first-pass effect has been observed.
Slovenian: Učinka prvega prehoda niso opazili.
English: In case of premature termination, data of last observation were chosen.
Slovenian: V primeru prezgodnjega zaključka so bili izbrani nazadnje zabeleženi podatki.
English: Route of administration TOTPAR SPID IMP 1.
Slovenian: TOTPAR SPID IMP 1.
English: Increased toxicity may result.
Slovenian: Lahko pride do povečane toksičnosti.
English: Overall discussion on RA With respect to RA, the following can be summarised:
Slovenian: Splošna razprava o RA Z ozirom na RA je mogoče povzeti naslednje:
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); rare (≥1/10.000, <1/1.000); Very rare (<1/10.000).
Slovenian: 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).
English: Do not exceed the recommended dose of duration of treatment.
Slovenian: Ne prekoračite priporočenega odmerka ali trajanja zdravljenja.
English: Statistical analysis was therefore limited to a 4 week treatment phase which, based on international guidelines, is appropriate to assess therapeutic efficacy of NSAIDs in OA.
Slovenian: Statistična analiza je bila zato omejena na 4-tedensko fazo zdravljenja, ki je glede na mednarodne smernice ustrezna za oceno terapevtske učinkovitosti NSAID pri OA.
English: Reactions relating to other System organs (SOCs) occurred in less than 1% of the patients.
Slovenian: Reakcije, povezane z drugimi organskimi sistemi (OS), so se pojavile pri manj kot 1 % bolnikov.
English: The tablets should be taken before meals.
Slovenian: Tablete morate vzeti pred obrokom.
English: In elderly patients above age 65, the clearance is reduced with 30-40%.
Slovenian: Pri starostnikih nad 65 let je očistek manjši za 30-40 %.
English: Serious adverse event/deaths/other significant events
Slovenian: Resni neželeni učinki/smrti/drugi pomembni učinki
English: Number of Patients by Indication and Treatment
Slovenian: Število bolnikov glede na indikacijo in zdravljenje
English: This finding was supported by drug monitoring data from one year studies.
Slovenian: Ti rezultati se ujemajo s podatki o spremljanju zdravila v obdobju enega leta.
English: Opaque PVC/Aluminium.
Slovenian: Neprozoren PVC/aluminij.
English: 2610-016 Amadora, Portugal
Slovenian: 2610-016 Amadora, Portugalska
English: For this reason a new metaanalysis 3 with the p.o. data alone will not add much to the discussion.
Slovenian: Zato nova 3. metaanaliza samo s p.o. podatki ne bo veliko prispevala k razpravi.
English: Included in analysis
Slovenian: Vključenost v analizo
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Slovenian: 6.2 Inkompatibilnosti Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: Treatment of osteoarthritis has not been approved by 2/16 Member States (EE, IT).
Slovenian: Zdravljenja osteoartritisa nista odobrili 2 od 16 držav članic (EE, IT).
English: These symptoms have generally occurred in less than 10% of patients in available studies.
Slovenian: V razpoložljivih raziskavah so se ti simptomi na splošno pojavili pri manj kot 10 % bolnikov.
English: Additional information on special populations
Slovenian: Dodatni podatki o posebnih populacijah
English: Overall the Applicant has responded to the questions raised during the procedure in a satisfactory way, although minor deficits exist in the MAH's efficacy and safety database mainly related to small shortterm clinical studies conducted 15-20 years ago.
Slovenian: V splošnem je vlagatelj na vprašanja, ki so se pojavila med postopkom, odgovoril zadovoljivo, čeprav obstajajo manjše pomanjkljivosti v zbirki podatkov o učinkovitosti in varnosti imetnika dovoljenja za promet, ki so v glavnem povezane z manj obsežnimi kratkotrajnimi kliničnimi raziskavami, izvedenimi pred 15-20 leti.
English: Studies included in meta-analyses Parameters used
Slovenian: Raziskave, vključene v metaanalizo Uporabljeni parametri
English: The MAH's response is considered acceptable and no further data are requested.
Slovenian: Odgovor imetnika dovoljenja za promet je sprejemljiv, zato nadaljnji podatki niso zahtevani.