natgillin/translations-raw huggingface dataset:
It is important that you tell your doctor, pharmacist, or nurse about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 
Pomembno je, da zdravniku, farmacevtu ali medicinski sestri poveste o vseh zdravilih, ki jih jemljete,
All events were laboratory TLS 
Vsi bolniki so imeli CrCL
If a moderate CYP3A inhibitor must be used, the initiation dose of venetoclax and the doses for the titration phase (see section 4.2) should be reduced by at least 50%. 
nujna, je treba začetni odmerek venetoklaksa in odmerke v fazi titracije (glejte poglavje 4.2) zmanjšati za vsaj 50 %.
There were no overall differences in safety or efficacy observed between older and younger patients in the combination study with venetoclax + rituximab and the monotherapy studies. 
Med starejšimi in mlajšimi bolniki v študiji s kombinacijo venetoklaks + rituksimab in v študijah z monoterapijo v celoti niso ugotovili razlik glede varnosti in učinkovitosti.
ORR, % (95% CI) 
ORR, % (95 % IZ)
PFS, months, median (95% CI) 
PFS, meseci, mediana (95% IZ)
Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets 
Venclyxto 10 mg filmsko obložene tablete Venclyxto 50 mg filmsko obložene tablete Venclyxto 100 mg filmsko obložene tablete
Table 7: Efficacy results as assessed by investigator in patients who have failed a B-cell receptor pathway inhibitor (study M14-032) 
Preglednica 7: Rezultati učinkovitosti po oceni raziskovalca pri bolnikih, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno (študija M14-032) Skupina A (neuspeh z ibrutinibom) (N = 91)
Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment. 
Ženske se morajo izogniti zanositvi med jemanjem zdravila Venclyxto in še vsaj 30 dni po končanem zdravljenju.
Co-administration of venetoclax with other strong CYP3A4 inhibitors is predicted to increase venetoclax AUC by on average 5.8- to 7.8-fold. 
predvideno AUC venetoklaksa poveča v povprečju za 5,8- do 7,8-krat.
The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see sections 4.4 and 4.5). 
Odmerek venetoklaksa, ki se je uporabljal pred začetkom sočasnega zdravljenja z zaviralcem CYP3A, je treba znova uvesti 2 do 3 dni po prekinitvi zdravljenja z zaviralcem (glejte poglavji 4.4 in 4.5).
• 7 tablets (7 blisters each with 1 tablet) 
• 7 tablet (7 pretisnih omotov s po 1 tableto)
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. 
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),
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. 
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.
What Venclyxto is used for 
Za kaj se uporablja zdravilo Venclyxto
• Take the tablets with a meal at around the same time each day 
• tablete vzemite ob obroku vsak dan ob približno istem času • tablete pogoltnite cele s kozarcem vode
The median time on treatment for 158 patients was 17 months (range: 0 to 34 months). 
Mediani čas zdravljenja pri 158 bolnikih je bil 17 mesecev
Tumour Lysis Syndrome 
Sindrom tumorske lize
Anti-hyperuricaemic agents 
Antihiperurikemiki
Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other. 
Venclyxto 50 mg filmsko obložena tableta je bež, podolgovata, dolga 14 mm, z oznako V na eni in 50 na drugi strani.
• fever or chills 
• krči ali napadi krčev
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. 
Bolnikom je treba posebej naročiti, naj popijejo 1,5 l do 2,0 l vode na dan,
Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other. 
Bež, podolgovate, bikonveksne tablete, dolge 14 mm in široke 8 mm z oznako V na eni in 50 na drugi strani.
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. 
9 dneh > 99,9 % odmerka izločilo v blatu in < 0,1 % v urinu.
• the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days. 
• odmerek bo povečan na 50 mg (ena 50 mg tableta) enkrat na dan, 7dni
Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase (see sections 4.2 and 4.5). 
Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka (glejte poglavji 4.2 in 4.5).
Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other. 
Venclyxto 100 mg filmsko obložena tableta je svetlo rumena, podolgovata, dolga 17,2 mm, z oznako V na eni in 100 na drugi strani.
How to take Venclyxto 
Kako jemati zdravilo Venclyxto
• 14 tablets (7 blisters each with 2 tablets) 
• 14 tablet (7 pretisnih omotov s po 2 tabletama)
Ask your doctor for advice on sperm storage before starting treatment with Venclyxto. 
Pred začetkom zdravljenja z zdravilom Venclyxto se z zdravnikom posvetujte o shranitvi semenske tekočine.
Venclyxto 100 mg film-coated tablets 3 years. 
Venclyxto 100 mg filmsko obložene tablete 3 leta.
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). 
Venetoklaks je v veliki meri vezan na beljakovine v človeški plazmi; v razponu koncentracij od 1 do
Response rate ORR, % (95% CI) 
Odzivnost ORR, % (95% IZ)
Median, months (95% CI) 
Mediana (meseci) (95% IZ)
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). 
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
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. 
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.
Film-coated tablet 7 film-coated tablets 
filmsko obložena tableta 7 filmsko obloženih tablet
How Venclyxto works 
Kako deluje zdravilo Venclyxto
Film-coated tablet 14 film-coated tablets 
filmsko obložena tableta 14 filmsko obloženih tablet
• Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b). 
• Venclyxto 100 mg filmsko obložene tablete: rumeni železov oksid (E172), polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350 (E1521), smukec (E553b).
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. 
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 =
Venclyxto 50 mg film-coated tablets 2 years. 
Venclyxto 50 mg filmsko obložene tablete 2 leti.
• higher level of potassium 
• povečano vrednost kalija
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine. 
Če kaj od zgoraj navedenega velja za vas ali pa niste prepričani, se posvetujte z zdravnikom,
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. 
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.
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. 
tem sproži permeabilizacijo zunanje mitohondrijske membrane (MOMP - Mitochondrial Outer Membrane Permeabilization), aktivacijo kaspaze in programirano celično smrt.
In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose. 
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.
• 10 tablets (5 blisters each with 2 tablets) 
• 10 tablet (5 pretisnih omotov s po 2 tabletama)
Film-coated tablet 10 film-coated tablets 
filmsko obložena tableta 10 filmsko obloženih tablet
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. 
V randomizirani (1: 1), multicentrični, odprti študiji 3. faze so ocenili učinkovitost in varnost zdravila
Venclyxto 10 mg film-coated tablets 2 years. 
Venclyxto 10 mg filmsko obložene tablete 2 leti.
Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO 
Preglednica 4: Preživetje brez napredovanja bolezni ocenjeno s strani raziskovalca pri bolnikih s predhodno zdravljeno KLL v študiji MURANO venetoklaks + rituksimab N = 194
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. 
Majhno število belih krvnih celic (nevtropenija) (zelo pogosti - pojavijo se lahko pri več kot 1 od 10 bolnikov)
• the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days. 
• odmerek bo povečan na 400 mg (štiri 100 mg tablete) enkrat na dan, 7 dni.
• the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days. 
• odmerek bo povečan na 200 mg (dve 100 mg tableti) enkrat na dan, 7 dni
Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) 
polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b)
Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other. 
Venclyxto 10 mg filmsko obložena tableta je svetlo rumena, okrogla s premerom 6 mm, oznako V na eni in 10 na drugi strani.
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. 
Venclyxto 10 mg filmsko obložene tablete Svetlo rumene, okrogle, bikonveksne tablete, premera 6 mm z oznako V na eni in 10 na drugi strani.
Contents of the pack and other information 
Shranjevanje zdravila Venclyxto Vsebina pakiranja in dodatne informacije
You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto. 
Na dan začetka zdravljenja z zdravilom Venclyxto nadaljujte s pitjem vsaj 1,5 do 2 litrov vode.
Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) 
rdeči železov oksid (E172) črni železov oksid (E172)
Each film-coated tablet contains 50 mg venetoclax 
Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
Bile acid sequestrants 
Izmenjevalci žolčnih kislin
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. 
± 1,1 µg/ml in njegova AUC24 32,8 ± 16,9 µg•h/ml.
Film-coated tablet 5 film-coated tablets 
filmsko obložena tableta 5 filmsko obloženih tablet
Each film-coated tablet contains 100 mg venetoclax 
Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
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. 
Preden boste začeli zdravljenje z zdravilom Venclyxto, vam bo zdravnik morda predpisal zdravila za zmanjševanje vrednosti sečne kisline v telesu.
Venclyxto 50 mg tablets 
Venclyxto 50 mg tablete
Each film-coated tablet contains 10 mg venetoclax 
Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
Venclyxto 10 mg tablets 
Venclyxto 10 mg tablete
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. 
V študiji MURANO so poročali o nevtropeniji pri 61 % (vse stopnje) bolnikov zdravljenih z venetoklaksom in rituksimabom.
Colloidal anhydrous silica (E551) Polysorbate 80 (E433) 
Jedro tablete kopovidon (K 28) brezvodni koloidni silicijev dioksid (E551) polisorbat 80 (E433) natrijev stearilfumarat brezvodni kalcijev hidrogenfosfat (E341 (ii))
• 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) 
• Venclyxto 50 mg filmsko obložene tablete: rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172), polivinilalkohol (E1203), titanov dioksid (E171),
Hazard ratio (95% CI) 
Razmerje tveganj (95% IZ)
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. 
in P-gp, v odmerku 50 mg enkrat na dan 14 dni je pri 6 zdravih osebah povečalo Cmax venetoklaksa za
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). 
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.
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. 
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.
Agents that may alter venetoclax plasma concentrations 
Učinkovine, ki lahko spremenijo plazemske koncentracije venetoklaksa Zaviralci CYP3A
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. 
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.
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: 
Takoj prenehajte z jemanjem zdravila Venclyxto in poiščite zdravniško pomoč, če opazite katerega od simptomov TLS: • zvišano telesno temperaturo ali mrzlico
Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax. 
Venclyxto 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
- 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. 
Venclyxto uporabljati visoko učinkovito metodo kontracepcije, da bi se izognile nosečnosti.
Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax. 
Venclyxto 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
• Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax. 
• Venclyxto 100 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 100 mg venetoklaksa.
• Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax. 
• Venclyxto 50 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 50 mg venetoklaksa.
These patients should be monitored more closely for signs of toxicity (see section 4.8). 
Bolnike je treba skrbno spremljati glede znakov toksičnosti zaradi povečanega tveganja za TLS (glejte poglavje 4.4).
Venclyxto 50 mg film-coated tablets: 
Venclyxto 50 mg filmsko obložene tablete:
Venclyxto 100 mg film-coated tablets: 
Venclyxto 100 mg filmsko obložene tablete:
Talk to your doctor, pharmacist, or nurse before taking Venclyxto if: 
Pred začetkom jemanja zdravila Venclyxto se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
Venclyxto 10 mg film-coated tablets 
Venclyxto 10 mg filmsko obložene tablete
LIST OF EXCIPIENTS 
Ocena raziskovalca
• Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax. 
• Venclyxto 10 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax. 
Venclyxto 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg venetoklaksa.
Venclyxto 10 mg film-coated tablets: 
Venclyxto 10 mg filmsko obložene tablete:
Venclyxto 50 mg film-coated tablets 
Venclyxto 50 mg filmsko obložene tablete
Venclyxto 100 mg film-coated tablets 
Venclyxto 100 mg filmsko obložene tablete
• the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days. 
• omerek bo povečan na 100 mg (ena 100 mg tableta) enkrat na dan, 7 dni
Venclyxto 100 mg film-coated tablets venetoclax 
Venclyxto 100 mg filmsko obložene tablete venetoklaks
Venclyxto 10 mg film-coated tablets venetoclax 
Venclyxto 10 mg filmsko obložene tablete venetoklaks
Venclyxto 50 mg film-coated tablets venetoclax 
Venclyxto 50 mg filmsko obložene tablete venetoklaks
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). 
Venetoklaks je substrat P-gp in BCRP, obenem pa je tudi zaviralec P-gp in BCRP in šibak zaviralec
What you need to know before you take Venclyxto 3. 
Kaj je zdravilo Venclyxto in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Venclyxto Kako jemati zdravilo Venclyxto
Drink 1.5-2 litres of water a day. 
Popijte 1,5 - 2 litra vode na dan. Pred uporabo preberite priloženo navodilo!
Urinary tract infection Upper respiratory tract infection 
Infekcijske in parazitske bolezni zelo pogosti pljučnica okužbe zgornjih dihal pogosti sepsa okužbe sečil sepsa pljučnica okužbe sečil okužbe zgornjih dihal
50 mg 100 mg 200 mg 400 mg 
200 mg
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). 
Venetoklaks se sme dajati bolnikom s hudo okvaro ledvic le, če koristi prevladajo nad tveganji.
Film-coated tablet (tablet). 
filmsko obložena tableta
In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. 
Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija anemija limfopenija nevtropenija anemija pogosti vročinska nevtropenija vročinska nevtropenija limfopenija
Busulfan Fresenius Kabi 
Busulfan Fresenuis Kabi
8 (8 x 1) vials 
8 (8 x 1) vial
Intravenous use vial (glass) 
Viala (steklo)
Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone. 
Nekateri bolniki imajo lahko korist od višjih dnevnih odmerkov do največ 60 mg/30 mg oksikodona.
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. 
Opomba: Spremembe se implementirajo v veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, odobrene kot končne različice v postopku skupine za usklajevanje
The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride. 
Povprečen dnevni odmerek v osrednji študiji je bil 20 mg/10 mg oksikodonijevega klorida/naloksonijevega klorida.
[The below wording should replace the previous wording] Titration on a weekly basis is recommended in case higher doses are required. 
Če je potreben večji odmerek, se priporoča titriranje na tedenski osnovi.
Annex III Amendments to the summary of product characteristics 
Spremembe povzetka glavnih značilnosti zdravila
• 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). 
• 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).
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) 
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.
Annex III Conditions for lifting the suspension of the marketing authorisation(s) 
Priloga III Pogoji za preklic začasnega umika dovoljenj(a) za promet z zdravilom
Date of first authorisation: 5 September 2017 
Datum prve odobritve: 5. september 2017
Not known (frequency cannot be estimated from available data) 
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
This medicine is for long-term use. 
Zdravilo je namenjeno dolgotrajni uporabi.