FrancophonIA/ELRC3.0 huggingface dataset:
English: CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, DOR = duration of response; IRC = independent review committee; nPR = nodular PR; NA = not available; NR = not reached; ORR = overall response rate; PFS = progression-free survival, PR = partial remission; TTR = time to first response.
Slovenian: IZ = interval zaupanja, CR = popolna remisija (complete remission), CRi = popolna remisija z nepopolnim okrevanjem kostnega mozga, DOR = trajanje odziva (duration of response), IRC = neodvisni odbor za pregled, NP = ni podatka, ND = ni doseženo, ORR = celokupni delež odziva (overall response rate), nPR = nodularna PR, PFS = čas preživetja brez napredovanja bolezni (progression-free survival), PR = delna remisija (partial remission),
English: Package leaflet: Information for the patient Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets venetoclax This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Venclyxto 10 mg filmsko obložene tablete Venclyxto 50 mg filmsko obložene tablete Venclyxto 100 mg filmsko obložene tablete venetoklaks Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: What Venclyxto is used for
Slovenian: Za kaj se uporablja zdravilo Venclyxto
English: • Take the tablets with a meal at around the same time each day
Slovenian: • tablete vzemite ob obroku vsak dan ob približno istem času • tablete pogoltnite cele s kozarcem vode
English: The median time on treatment for 158 patients was 17 months (range: 0 to 34 months).
Slovenian: Mediani čas zdravljenja pri 158 bolnikih je bil 17 mesecev
English: Tumour Lysis Syndrome
Slovenian: Sindrom tumorske lize
English: Anti-hyperuricaemic agents
Slovenian: Antihiperurikemiki
English: Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Slovenian: Venclyxto 50 mg filmsko obložena tableta je bež, podolgovata, dolga 14 mm, z oznako V na eni in 50 na drugi strani.
English: • fever or chills
Slovenian: • krči ali napadi krčev
English: Patients should be particularly instructed to drink 1.5 to 2.0 L of water daily, 2 days prior to and the days of dosing at initiation and each subsequent dose increase.
Slovenian: Bolnikom je treba posebej naročiti, naj popijejo 1,5 l do 2,0 l vode na dan,
English: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Slovenian: Bež, podolgovate, bikonveksne tablete, dolge 14 mm in široke 8 mm z oznako V na eni in 50 na drugi strani.
English: After a single oral administration of 200 mg radiolabeled [14C]-venetoclax to healthy subjects, >99.9% of the dose was recovered in faeces and <0.1% of the dose was excreted in urine within 9 days.
Slovenian: 9 dneh > 99,9 % odmerka izločilo v blatu in < 0,1 % v urinu.
English: • the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
Slovenian: • odmerek bo povečan na 50 mg (ena 50 mg tableta) enkrat na dan, 7dni
English: Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase (see sections 4.2 and 4.5).
Slovenian: Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka (glejte poglavji 4.2 in 4.5).
English: Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other.
Slovenian: Venclyxto 100 mg filmsko obložena tableta je svetlo rumena, podolgovata, dolga 17,2 mm, z oznako V na eni in 100 na drugi strani.
English: How to take Venclyxto
Slovenian: Kako jemati zdravilo Venclyxto
English: • 14 tablets (7 blisters each with 2 tablets)
Slovenian: • 14 tablet (7 pretisnih omotov s po 2 tabletama)
English: Ask your doctor for advice on sperm storage before starting treatment with Venclyxto.
Slovenian: Pred začetkom zdravljenja z zdravilom Venclyxto se z zdravnikom posvetujte o shranitvi semenske tekočine.
English: Venclyxto 100 mg film-coated tablets 3 years.
Slovenian: Venclyxto 100 mg filmsko obložene tablete 3 leta.
English: Venetoclax is highly bound to human plasma protein with unbound fraction in plasma <0.01 across a concentration range of 1-30 µM (0.87-26 µg/ml).
Slovenian: Venetoklaks je v veliki meri vezan na beljakovine v človeški plazmi; v razponu koncentracij od 1 do
English: Response rate ORR, % (95% CI)
Slovenian: Odzivnost ORR, % (95% IZ)
English: Median, months (95% CI)
Slovenian: Mediana (meseci) (95% IZ)
English: Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase (see sections 4.2 and 4.3).
Slovenian: Sočasna uporaba tega zdravila z močnimi ali zmernimi zaviralci CYP3A poveča izpostavljenost venetoklaksu in lahko poveča tveganje za TLS na začetku zdravljenja in med fazo titracije odmerka
English: The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhoea, and upper respiratory tract infection.
Slovenian: Najpogostejši neželeni učinki (≥ 20 %) katere koli stopnje pri bolnikih, ki so prejemali venetoklaks v kombinirani študiji z rituksimabom, so bili nevtropenija, driska in okužbe zgornjih dihal.V študijah z monoterapijo so bili najpogostejši neželeni učinki nevtropenija/zmanjšano število nevtrofilcev, driska, navzea, anemija, utrujenost in okužbe zgornjih dihal.
English: Film-coated tablet 7 film-coated tablets
Slovenian: filmsko obložena tableta 7 filmsko obloženih tablet
English: How Venclyxto works
Slovenian: Kako deluje zdravilo Venclyxto
English: Film-coated tablet 14 film-coated tablets
Slovenian: filmsko obložena tableta 14 filmsko obloženih tablet
English: • Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Slovenian: • Venclyxto 100 mg filmsko obložene tablete: rumeni železov oksid (E172), polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350 (E1521), smukec (E553b).
English: CR = complete remission; CRi = complete remission with incomplete marrow recovery; IRC = independent review committee; MRD = minimal residual disease; nPR = nodular partial remission; NA = not available; NR = not reached; ORR = overall response rate (CR + CRi + nPR + PR); PR = partial remission.
Slovenian: CR = popolna remisija (complete remission); CRi = popolna remisija z nepopolno obnovitvijo kostnega mozga (complete remission with incomplete marrow recovery); IRC = neodvisni odbor za pregled (independent review committee); MRD = minimalna rezidualna bolezen (minimal residual disease); nPR =
English: Venclyxto 50 mg film-coated tablets 2 years.
Slovenian: Venclyxto 50 mg filmsko obložene tablete 2 leti.
English: • higher level of potassium
Slovenian: • povečano vrednost kalija
English: If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
Slovenian: Če kaj od zgoraj navedenega velja za vas ali pa niste prepričani, se posvetujte z zdravnikom,
English: Patients followed a 4- to 5-week dose-titration schedule starting at 20 mg and increasing to 50 mg, 100 mg, 200 mg and finally 400 mg once daily.
Slovenian: do 5-tedensko shemo titracije odmerka, z začetnim odmerkom 20 mg, ki je bil nato povečan na 50 mg, 100 mg, 200 mg in nazadnje na 400 mg enkrat na dan. Bolniki so nato prejemali 400 mg venetoklaksa enkrat na dan do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Venetoclax binds directly to the BH3-binding groove of BCL-2, displacing BH3 motif-containing pro-apoptotic proteins like BIM, to initiate mitochondrial outer membrane permeabilization (MOMP), caspase activation, and programmed cell death.
Slovenian: tem sproži permeabilizacijo zunanje mitohondrijske membrane (MOMP - Mitochondrial Outer Membrane Permeabilization), aktivacijo kaspaze in programirano celično smrt.
English: In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose.
Slovenian: Pri kuncih je bil venetoklaks pri 0,1-kratni izpostavljenosti glede na izpostavljenost pri človeku (AUC) ob uporabi priporočenega odmerka toksičen za samice-matere, vendar ne za plod.
English: • 10 tablets (5 blisters each with 2 tablets)
Slovenian: • 10 tablet (5 pretisnih omotov s po 2 tabletama)
English: Film-coated tablet 10 film-coated tablets
Slovenian: filmsko obložena tableta 10 filmsko obloženih tablet
English: A randomised (1:1), multicenter, open-label phase 3 study evaluated the efficacy and safety of Venclyxto + rituximab versus BR in patients with previously treated CLL.
Slovenian: V randomizirani (1: 1), multicentrični, odprti študiji 3. faze so ocenili učinkovitost in varnost zdravila
English: Venclyxto 10 mg film-coated tablets 2 years.
Slovenian: Venclyxto 10 mg filmsko obložene tablete 2 leti.
English: Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO
Slovenian: Preglednica 4: Preživetje brez napredovanja bolezni ocenjeno s strani raziskovalca pri bolnikih s predhodno zdravljeno KLL v študiji MURANO venetoklaks + rituksimab N = 194
English: Low white blood cell count (neutropenia) (very common - may affect more than 1 in 10 people) Your doctor will check your blood count during treatment with Venclyxto.
Slovenian: Majhno število belih krvnih celic (nevtropenija) (zelo pogosti - pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: • the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
Slovenian: • odmerek bo povečan na 400 mg (štiri 100 mg tablete) enkrat na dan, 7 dni.
English: • the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
Slovenian: • odmerek bo povečan na 200 mg (dve 100 mg tableti) enkrat na dan, 7 dni
English: Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
Slovenian: polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b)
English: Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Slovenian: Venclyxto 10 mg filmsko obložena tableta je svetlo rumena, okrogla s premerom 6 mm, oznako V na eni in 10 na drugi strani.
English: Venclyxto 10 mg film-coated tablet Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other.
Slovenian: Venclyxto 10 mg filmsko obložene tablete Svetlo rumene, okrogle, bikonveksne tablete, premera 6 mm z oznako V na eni in 10 na drugi strani.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Venclyxto Vsebina pakiranja in dodatne informacije
English: You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto.
Slovenian: Na dan začetka zdravljenja z zdravilom Venclyxto nadaljujte s pitjem vsaj 1,5 do 2 litrov vode.
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171)
Slovenian: rdeči železov oksid (E172) črni železov oksid (E172)
English: Each film-coated tablet contains 50 mg venetoclax
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
English: Bile acid sequestrants
Slovenian: Izmenjevalci žolčnih kislin
English: Under low-fat meal conditions, venetoclax mean (± standard deviation) steady state Cmax was 2.1 ± 1.1 μg/ml and AUC24 was 32.8 ± 16.9 μg•h/ml at the 400 mg once daily dose.
Slovenian: ± 1,1 µg/ml in njegova AUC24 32,8 ± 16,9 µg•h/ml.
English: Film-coated tablet 5 film-coated tablets
Slovenian: filmsko obložena tableta 5 filmsko obloženih tablet
English: Each film-coated tablet contains 100 mg venetoclax
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
English: Venclyxto 100 mg tablets
Slovenian: Venclyxto 100 mg tablete
English: Your doctor may also give you medicines to help prevent the build up of uric acid in your body before you start treatment with Venclyxto.
Slovenian: Preden boste začeli zdravljenje z zdravilom Venclyxto, vam bo zdravnik morda predpisal zdravila za zmanjševanje vrednosti sečne kisline v telesu.
English: Venclyxto 50 mg tablets
Slovenian: Venclyxto 50 mg tablete
English: Each film-coated tablet contains 10 mg venetoclax
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
English: Venclyxto 10 mg tablets
Slovenian: Venclyxto 10 mg tablete
English: In the MURANO study, neutropenia was reported in 61% (all grades) of patients on the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia.
Slovenian: V študiji MURANO so poročali o nevtropeniji pri 61 % (vse stopnje) bolnikov zdravljenih z venetoklaksom in rituksimabom.
English: Colloidal anhydrous silica (E551) Polysorbate 80 (E433)
Slovenian: Jedro tablete kopovidon (K 28) brezvodni koloidni silicijev dioksid (E551) polisorbat 80 (E433) natrijev stearilfumarat brezvodni kalcijev hidrogenfosfat (E341 (ii))
English: • Venclyxto 50 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)
Slovenian: • Venclyxto 50 mg filmsko obložene tablete: rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172), polivinilalkohol (E1203), titanov dioksid (E171),
English: Hazard ratio (95% CI)
Slovenian: Razmerje tveganj (95% IZ)
English: Coadministration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased venetoclax Cmax by 2.4-fold and AUC by 7.9-fold.
Slovenian: in P-gp, v odmerku 50 mg enkrat na dan 14 dni je pri 6 zdravih osebah povečalo Cmax venetoklaksa za
English: The observed PFS benefit of venetoclax + rituximab compared with bendamustine + rituximab was consistently observed across all subgroups of patients evaluated, including age (< 65, ≥ 65 years and < 75, ≥ 75 years), prior lines of therapy (1, >1), bulky disease (< 5 cm, ≥ 5 cm), 17p deletion, 11q deletion, TP53 mutation, IgVH mutation, and refractory versus relapse to most recent therapy (Figure 3).
Slovenian: predhodne vrste zdravljenja (1, > 1 ), obsežnost bolezni (<5 cm, ≥ 5 cm), delecijo 17p, delecijo 11q, mutacijo TP53, mutacijo IgVH in neodzivnost v primerjavi z recidivom na zadnje predhodno zdravljenje (slika 3), so opazili PFS koristi kombinacije venetoklaks + rituksimab v primerjavi s kombinacijo bendamustin + rituksimab.
English: At initiation and during the dose-titration phase, concomitant use of venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided.
Slovenian: Sočasni uporabi venetoklaksa in zmernih zaviralcev CYP3A (npr. ciprofloksacina, diltiazema, eritromicina, flukonazola, verapamila) se je treba izogibati na začetku zdravljenja in med fazo titracije odmerka.
English: Agents that may alter venetoclax plasma concentrations
Slovenian: Učinkovine, ki lahko spremenijo plazemske koncentracije venetoklaksa Zaviralci CYP3A
English: Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased venetoclax Cmax by 2.3-fold and AUC∞ by 6.4-fold.
Slovenian: 7 dni, je pri 11 predhodno zdravljenih bolnikih z ne-Hodgkinovim limfomom (NHL) povečalo Cmax venetoklaksa za 2,3-krat in AUC∞ za 6,4-krat.
English: Tumour lysis syndrome (common - may affect up to 1 in 10 people) Stop taking Venclyxto and seek medical attention immediately if you notice any of the symptoms of TLS:
Slovenian: Takoj prenehajte z jemanjem zdravila Venclyxto in poiščite zdravniško pomoč, če opazite katerega od simptomov TLS: • zvišano telesno temperaturo ali mrzlico
English: Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax.
Slovenian: Venclyxto 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
English: - Women of childbearing age must use a highly effective method of contraception during treatment and for at least 30 days after receiving Venclyxto to avoid becoming pregnant.
Slovenian: Venclyxto uporabljati visoko učinkovito metodo kontracepcije, da bi se izognile nosečnosti.
English: Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax.
Slovenian: Venclyxto 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
English: • Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.
Slovenian: • Venclyxto 100 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
English: Venclyxto 50 mg tablets venetoclax
Slovenian: Venclyxto 50 mg tablete venetoklaks
English: • Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax.
Slovenian: • Venclyxto 50 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
English: These patients should be monitored more closely for signs of toxicity (see section 4.8).
Slovenian: Bolnike je treba skrbno spremljati glede znakov toksičnosti zaradi povečanega tveganja za TLS (glejte poglavje 4.4).
English: Venclyxto 50 mg film-coated tablets:
Slovenian: Venclyxto 50 mg filmsko obložene tablete:
English: Venclyxto 100 mg film-coated tablets:
Slovenian: Venclyxto 100 mg filmsko obložene tablete:
English: Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:
Slovenian: Pred začetkom jemanja zdravila Venclyxto se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
English: Venclyxto 10 mg film-coated tablets
Slovenian: Venclyxto 10 mg filmsko obložene tablete
English: LIST OF EXCIPIENTS
Slovenian: Ocena raziskovalca
English: • Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax.
Slovenian: • Venclyxto 10 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
English: Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax.
Slovenian: Venclyxto 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
English: Venclyxto 10 mg film-coated tablets:
Slovenian: Venclyxto 10 mg filmsko obložene tablete:
English: Venclyxto 50 mg film-coated tablets
Slovenian: Venclyxto 50 mg filmsko obložene tablete
English: Venclyxto 100 mg film-coated tablets
Slovenian: Venclyxto 100 mg filmsko obložene tablete
English: • the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
Slovenian: • omerek bo povečan na 100 mg (ena 100 mg tableta) enkrat na dan, 7 dni
English: Venclyxto 100 mg film-coated tablets venetoclax
Slovenian: Venclyxto 100 mg filmsko obložene tablete venetoklaks
English: Venclyxto 10 mg tablets venetoclax
Slovenian: Venclyxto 10 mg tablete venetoklaks
English: Venclyxto 100 mg tablets venetoclax
Slovenian: Venclyxto 100 mg tablete venetoklaks
English: Venclyxto 10 mg film-coated tablets venetoclax
Slovenian: Venclyxto 10 mg filmsko obložene tablete venetoklaks
English: Venclyxto 50 mg film-coated tablets venetoclax
Slovenian: Venclyxto 50 mg filmsko obložene tablete venetoklaks
English: Co administration with transporter substrates/inhibitors Venetoclax is a P-gp and BCRP substrate as well as a P-gp and BCRP inhibitor and a weak OATP1B1 inhibitor in vitro (see section 4.5).
Slovenian: Venetoklaks je substrat P-gp in BCRP, obenem pa je tudi zaviralec P-gp in BCRP in šibak zaviralec
English: What you need to know before you take Venclyxto 3.
Slovenian: Kaj je zdravilo Venclyxto in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Venclyxto Kako jemati zdravilo Venclyxto
English: Drink 1.5-2 litres of water a day.
Slovenian: Popijte 1,5 - 2 litra vode na dan. Pred uporabo preberite priloženo navodilo!
English: Urinary tract infection Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni zelo pogosti pljučnica okužbe zgornjih dihal pogosti sepsa okužbe sečil sepsa pljučnica okužbe sečil okužbe zgornjih dihal
English: 50 mg 100 mg 200 mg 400 mg
Slovenian: 200 mg
English: Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS (see section 4.4).
Slovenian: Venetoklaks se sme dajati bolnikom s hudo okvaro ledvic le, če koristi prevladajo nad tveganji.
English: Film-coated tablet (tablet).
Slovenian: filmsko obložena tableta
English: In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija anemija limfopenija nevtropenija anemija pogosti vročinska nevtropenija vročinska nevtropenija limfopenija
English: Busulfan Fresenius Kabi
Slovenian: Busulfan Fresenuis Kabi
English: 8 (8 x 1) vials
Slovenian: 8 (8 x 1) vial
English: Intravenous use vial (glass)
Slovenian: Viala (steklo)
English: Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone.
Slovenian: Nekateri bolniki imajo lahko korist od višjih dnevnih odmerkov do največ 60 mg/30 mg oksikodona.
English: Note: These amendments are to be incorporated to the valid summary of product characteristics, labelling and package leaflet which are the final versions achieved during the Coordination group procedure.
Slovenian: Opomba: Spremembe se implementirajo v veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, odobrene kot končne različice v postopku skupine za usklajevanje
English: The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride.
Slovenian: Povprečen dnevni odmerek v osrednji študiji je bil 20 mg/10 mg oksikodonijevega klorida/naloksonijevega klorida.
English: [The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required.
Slovenian: Če je potreben večji odmerek, se priporoča titriranje na tedenski osnovi.
English: Annex III Amendments to the summary of product characteristics
Slovenian: Spremembe povzetka glavnih značilnosti zdravila
English: • Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Slovenian: • Bioekvivalenca z referenčnim zdravilom, odobrenim v EU, je bila dokazana na podlagi primernih podatkov v skladu z zahtevami člena 10 Direktive 2001/83/ES (npr. primerjalne bioekvivalenčne študije z referenčnim zdravilom, odobrenim v EU).
English: For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holder(s)
Slovenian: Za preklic začasnega umika dovoljenj za promet z zdravilom, navedenih v Prilogi IB, morajo pristojni organi zagotoviti, da je/so imetnik(-i) dovoljenj(a) za promet z zdravilom izpolnil(-i) spodnje pogoje.
English: Annex III Conditions for lifting the suspension of the marketing authorisation(s)
Slovenian: Priloga III Pogoji za preklic začasnega umika dovoljenj(a) za promet z zdravilom
English: Date of first authorisation: 5 September 2017
Slovenian: Datum prve odobritve: 5. september 2017
English: Not known (frequency cannot be estimated from available data)
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: This medicine is for long-term use.
Slovenian: Zdravilo je namenjeno dolgotrajni uporabi.