FrancophonIA/ELRC3.0 huggingface dataset:
English: In open wound surgery - for spray application of Quixil, a pressure regulator device that delivers a maximum pressure of no more than 2.5 bar and uses carbon dioxide gas only should be used.
Slovenian: Pri odprtem kirurškem posegu - za nanos zdravila Quixil s pršenjem se lahko uporablja samo regulator tlaka, ki dovaja najvišji tlak 2,5 bar in uporablja plinski ogljikov dioksid.
English: Should be replaced with the following text, in bold and underlined format:
Slovenian: je treba zamenjati z naslednjim besedilom, v krepkem tisku in podčrtano:
English: Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Slovenian: Priključite kratko cevko na aplikatorju na moški priključek luer-lock dolge plinske cevke.
English: Spray devices and the accessory tip provide instructions for use with recommendations for pressure ranges and to the spraying distance from the tissue surface.
Slovenian: Pršilnikom in nastavkom so priložena navodila za uporabo, kjer so navedena priporočila za razpon tlakov in razdaljo pršenja od tkivne površine.
English: Quixil spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer - do not spray closer than the recommended distance.
Slovenian: Zdravilo Quixil se s pršenjem lahko nanaša le, kadar je mogoče natančno presoditi razdaljo od pršilnika, kot priporoča izdelovalec - ne pršite bližje kot s priporočene razdalje.
English: “Quixil should only be used by experienced surgeons.
Slovenian: »Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi.
English: Recommended spray pressure
Slovenian: Priporočeni tlak pršenja
English: 4.2 Posology and method of administration The following text should be added to this section: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.“ 4.2.2 Method and Route of Administration
Slovenian: Besedilo tega poglavja se mora glasiti: »Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila QUIXIL.« 4.2.2 Postopek in pot uporabe zdravila
English: Should be replaced with the following text, in bold and underlined format where indicated
Slovenian: je treba zamenjati z naslednjim besedilom, v krepkem tisku in podčrtano, kjer je tako označeno:
English: In the absence of a specific recommendation the pressure should not exceed 2.0-2.5 bars.
Slovenian: Če ni posebnega priporočila, tlak ne sme presegati 2,0 bara-2,5 bara.
English: Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision.
Slovenian: Opomba: Te spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo so veljavne ob izdaji odločbe Komisije Pristojni nacionalni organi bodo po odločbi Komisije posodobili informacije o zdravilu v skladu z zahtevami.
English: The text should read as follows: “Store at  -18C.
Slovenian: »Shranjujte pri temperaturi  -18C.
English: Quixil Applicator Device
Slovenian: Aplikator Quixil
English: • “Spray application of Quixil should not be used in endoscopic procedures.”
Slovenian: • »Zdravila Quixil s pršenjem ne smete uporabiti pri endoskopskih posegih.«
English: HOW QUIXIL IS USED
Slovenian: KAKO UPORABLJAMO ZDRAVILO QUIXIL
English: When special care should be taken with Quixil:
Slovenian: Kdaj je treba biti pri zdravilu Quixil posebno pozoren:
English: Do not spray at a distance closer than the recommended by the spray device manufacturer.
Slovenian: Ne pršite s krajše razdalje, kot jo priporoča izdelovalec pršilnika.
English: To avoid the risk of potentially life threatening air embolism your surgeon is recommended to spray Quixil using pressurised CO2 only.
Slovenian: Da bi se izognili tveganju za potencialno življenjsko nevarno zračno embolijo, vašemu kirurgu priporočamo, da prši zdravilo Quixil samo s plinom CO2 pod tlakom.
English: • Handling
Slovenian: • Ravnanje z zdravilom
English: 4.8 Undesirable effects The following text should be added at the end of the section, before the last sentence, as shown below:
Slovenian: Na konec poglavja, pred zadnjim stavkom, je treba dodati naslednje besedilo, kot je prikazano spodaj:
English: In the absence of a specific recommendation avoid using pressure above 2.0-2.5 bars.
Slovenian: Če ni posebnega priporočila, se izogibajte uporabi tlaka nad 2,0 bara-2,5 bara.
English: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.
Slovenian: »Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila QUIXIL.«
English: Quixil forms a clear film over the area of application.
Slovenian: Zdravilo Quixil na področju nanosa napravi prozoren film.
English: In the absence of a specific recommendation Quixil should not be sprayed closer than 10-15 cm from the tissue surface.
Slovenian: Če ni posebnega priporočila, zdravila Quixil ne pršite bližje kot 10 cm-15 cm od površine tkiva.
English: In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the tissue surface.
Slovenian: Če ni posebnega priporočila, se izogibajte pršenju bližje kot 10 cm-15 cm od površine tkiva.
English: • „Quixil should not be used in endoscopic surgery or for keyhole surgery.“
Slovenian: • »Zdravila Quixil ne smete uporabljati pri endoskopskih ali laparoskopskih kirurških posegih.«
English: Connect the female luer lock of the gas tube (with the bacteriostatic filter) to a pressure regulator The pressure regulator should be used in accordance with the manufacturer's instructions.
Slovenian: Ženski priključek luer lock na cevi za plin (z bakteriostatskim filtrom) priključite na regulator tlaka.
English: This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Slovenian: Zdi se, da je ta pojav povezan z uporabo pršilnika s tlaki, ki so višji od priporočenih, in/ali z uporabo v neposredni bližini tkivne površine.
English: Pressure regulator to be used
Slovenian: Uporabljeni regulator tlaka
English: Surgery
Slovenian: Kirurški poseg
English: When using an accessory tip with this product, be sure to follow carefully the instructions for use.”
Slovenian: Če uporabljate dodaten nastavek, se prepričajte, da natančno upoštevate navodila za uporabo.«
English: The following changes should be made to the SmPC of Quixil:
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA (SmPC) V SmPC zdravila Quixil je treba narediti naslednje spremembe:
English: When using accessory tips with this product, be sure to follow carefully the instructions for use.”
Slovenian: Če uporabljate dodatne nastavke, se prepričajte, da natančno upoštevate navodila za uporabo.«
English: To avoid the risk of potentially life threatening air embolism Quixil should be sprayed using pressurised CO2 gas only.
Slovenian: Da bi se izognili tveganju za potencialno življenjsko nevarno zračno embolijo, pršite zdravilo Quixil samo s plinom CO2 pod tlakom.
English: When applying Quixil using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer (see table in Section 6.6 for pressures and distance).
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak v tlačnem razponu, ki ga priporoča izdelovalec pršilnika (za tlake in razdaljo glejte tabelo v poglavju 6.6) .
English: Quixil should not be sprayed at a distance closer than the recommended by the spray device manufacturer.
Slovenian: Zdravila Quixil ne smete pršiti s krajše razdalje, kot jo priporoča izdelovalec pršilnika.
English: The following changes should be made to the package leaflet of Quixil:
Slovenian: V navodilu za uporabo zdravila Quixil je treba narediti naslednje spremembe:
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue.”
Slovenian: Za posebna priporočila v zvezi s potrebnim tlakom in razdaljo od tkiva pri nanosu s pršenjem glejte poglavji 4.4 in 6.6.«
English: Open surgery
Slovenian: Odprt kirurški poseg
English: • “Life threatening air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Slovenian: • »Opisani so pojavi življenjsko nevarne zračne ali plinske embolije (zrak, ki pride v krvni obtok, kar je lahko resno ali življenjsko nevarno) ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
English: When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer (see section 4.4)
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki ju priporoča izdelovalec (glejte poglavje 4.4).
English: When using accessory tips with this product, the instructions for use of the tips should be followed.”
Slovenian: Če uporabljate dodatne nastavke, upoštevajte navodila za njihovo uporabo.«
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (See sections 4.2 and 4.4).
Slovenian: Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije (glejte poglavji 4.2 in 4.4).
English: When applying Quixil using a spray device, the pressure should be within the range recommended by the spray device manufacturer.
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom mora biti tlak v razponu, ki ga priporoča izdelovalec pršilnika.
English: When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki ju priporoča izdelovalec, kot sledi:
English: When applying Quixil using a spray device, be sure to use only the pressure within the range recommended by the spray device manufacturer.
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate le tlak v razponu, ki ga priporoča izdelovalec pršilnika.
English: Spray Application
Slovenian: NAVODILO ZA UPORABO
English: This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.” For safety with respect to transmissible agents, see 4.4.
Slovenian: Zdi se, da je ta pojav povezan z uporabo pršilnika s tlaki, ki so višji od priporočenih, in/ali z uporabo v neposredni bližini tkivne površine.«
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (also see section 4.2).
Slovenian: Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije (glejte tudi poglavje 4.2).«
English: • “Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Slovenian: • »Opisani so pojavi zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
English: When applying Quixil using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer.
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak v tlačnem razponu, ki ga priporoča izdelovalec pršilnika.
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.”
Slovenian: Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.«
English: When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the range recommended by the manufacturer as follows:.
Slovenian: Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponu, ki ga priporoča izdelovalec, kot sledi: Kirurški poseg
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 will be monitored because of the possibility of occurrence of air or gas embolism.
Slovenian: Med pršenjem zdravila Quixil se bodo spremljale spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.
English: Applicator tips to be used
Slovenian: Uporabljeni nastavki aplikatorja
English: “Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Slovenian: »Opisani so pojavi življenjsko nevarne zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
English: When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Slovenian: Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.
English: • “Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil.
Slovenian: • »Opisani so pojavi življenjsko nevarne zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
English: PACKAGE LEAFLET
Slovenian: Nanašanje s pršenjem
English: Two types of profiles were seen.
Slovenian: Opazili so dve vrsti profila.
English: Grounds for positive opinion
Slovenian: Razlogi za pozitivno mnenje
English: Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za pozitivno mnenje, ki jih je predstavila Evropska agencija za zdravila
English: Whereas
Slovenian: e i
English: The Netherlands and Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Slovenian: Nizozemska in Nemčija sta menili, da odobritev dovoljenja za promet z zdravilom predstavlja morebitno resno tveganje za javno zdravje;
English: The 90% CI for these measures were within the acceptance interval of 80%-125%.
Slovenian: Devetdesetodstotni IZ za ta merila je bil znotraj sprejemljivega intervala od 80 do 125 %.
English: • all strengths have the same qualitative composition
Slovenian: • vse jakosti imajo enako kakovostno sestavo;
English: The major concern raised by Germany and the Netherlands could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP.
Slovenian: Glavnega pomisleka, ki sta ga izpostavili Nemčija in Nizozemska, med napotitvenim postopkom skupine CMD(h) ni bilo mogoče odpraviti, zato je bila zadeva posredovana odboru CHMP.
English: in FeSSIF and FeSSGF
Slovenian: 6,8 ter v FeSSIF in FeSSGF;
English: • The Committed considered the notification of the referral triggered by Denmark under Article 29(4) of Directive 2001/83/EC.
Slovenian: • odbor je obravnaval uradno obvestilo o napotitvenem postopku, ki ga je v skladu s členom 29(4) Direktive 2001/83/ES sprožila Danska.
English: Pharmacokinetic data
Slovenian: Farmakokinetični podatki
English: These ratios are considered as key element responsible for the controlled release of the drug from the tablet core.
Slovenian: Ta razmerja so ključni elementi, odgovorni za nadzorovano sproščanje zdravila iz jedra tablete.
English: Overall summary of the scientific evaluation of Methylphenidate Sandoz and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Methylphenidate Sandoz in povezanih imen (glejte Prilogo I)
English: Pharmaceutical data
Slovenian: Farmacevtski podatki
English: • all strengths are manufactured by the same manufacturer and process
Slovenian: • vse jakosti izdeluje isti izdelovalec po istem postopku;
English: The use of partial metrics under fed condition was considered necessary as the reference product can also be taken with food.
Slovenian: Uporaba delne metrike pri pogojih na poln želodec je nujna, saj se lahko referenčno zdravilo jemlje skupaj s hrano.
English: The waiver of studies under fed conditions for the lower strengths are considered justified for the following reasons:
Slovenian: Opustitev študij pri pogojih na poln želodec za manjši jakosti je upravičena zaradi naslednjih razlogov:
English: • all strengths shows comparable dissolution profiles in various media in the pH range 1 to 6.8,
Slovenian: • vse jakosti so pokazale primerljive profile raztopitve v različnih medijih z razponom pH od 1 do
English: • The outer drug coat is proportional in composition among all strengths and the ratio between the amount of the semipermeable membrane and the surface area are comparable amongst all strengths for the applied product.
Slovenian: • sestava zunanje obloge zdravila je sorazmerna pri vseh jakostih, razmerje med količino polprepustne membrane in površino pa je primerljivo pri vseh jakostih uporabljenega zdravila.
English: The repeat-use MRP was closed on day 210, with most of the CMS agreeing with the conclusions of the RMS's assessment report except Germany and the Netherlands which raised a potential serious risk to public health (PSRPH).
Slovenian: Postopek z medsebojnim priznavanjem za večkratno uporabo se je končal 210. dan, pri čemer se je večina zadevnih držav članic strinjala z zaključki poročila o oceni referenčne države članice, z izjemo Nemčije in Nizozemske, ki sta izpostavili morebitno resno tveganje za javno zdravje.
English: The first pharmacokinetic studies were performed by the applicant/MAH in 2009-2010 and submitted in the first DCP starting in January 2011.
Slovenian: Prve farmakokinetične študije je predlagatelj/imetnik dovoljenja za promet z zdravilom izvedel med letoma 2009 in 2010 ter jih predložil za namene prvega decentraliziranega postopka, ki se je začel januarja 2011.
English: The applicant/MAH further provided a re-evaluation of the data from the fed study based on the different types of plasma profiles observed in this study.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je dodatno predložil ponovno vrednotenje podatkov iz študije pri pogojih na poln želodec, ki je temeljilo na različnih vrstah profilov v plazmi, opaženih v tej študiji.
English: The application for Methylphenidate Sandoz is therefore based on bioequivalence studies between the applied and the reference product.
Slovenian: Uporaba zdravila Methylphenidate Sandoz temelji na študijah biološke enakovrednosti med uporabljenim in referenčnim zdravilom.
English: • methylphenidate exhibits linear kinetics among all strengths
Slovenian: • metilfenidat kaže linearno kinetiko pri vseh jakostih;
English: If no significantly different pharmacokinetic profile between fasting and fed state is expected then the cut-off time point should be identical.
Slovenian: Če se ne pričakuje pomembna razlika v farmakokinetičnem profilu pri pogojih na poln želodec in na tešče, potem morata biti razmejitveni časovni točki enaki.
English: The studies demonstrated bioequivalence between test and reference product according to the guideline requirements for a modified release dosage form (Guideline on the investigation of bioequivalence, 2010 CPMP/EWP/QWP/1401/98 Rev. 1 and Note for Guidance on Modified Release Oral and Transdermal Dosage Forms, 1999 EMA/CPMP/EWP/280/96 Corr*) in force at time of study conduct (2009 - 2010).
Slovenian: Študij so pokazale biološko enakovrednost med preiskovanim in referenčnim zdravilom v skladu z zahtevam smernic za obliko odmerjanja s prilagojenim sproščanjem (Guideline on the investigation of bioequivalence, 2010 CPMP/EWP/QWP/1401/98 Rev. 1 in Note for Guidance on Modified Release Oral and Transdermal Dosage Forms, 1999 EMA/CPMP/EWP/280/96 Corr*), ki so veljale v času izvajanja študije (2009-2010).
English: This is also due to the fact that the intra-individual variability decreased (19% instead of 110% for AUC, and 12% instead of 67% for Cmax) by taking into account only those subjects who exhibit a distinct peak for the initial phase under high fat fed conditions.
Slovenian: To je tudi posledica zmanjšane variabilnosti med posamezniki (19-% namesto 110-% za AUC in 12-% namesto 67-% za Cmax), pri čemer so se upoštevali samo preskušanci z jasno največjo koncentracijo pri začetni fazi in pogojih na poln želodec z veliko vsebnostjo maščobe.
English: The current repeat use procedure started in April 2012, two months after the EMA Question & Answer Position Paper (EMA/618604/2008 Rev. 4) concerning biphasic formulations was published.
Slovenian: Trenutni postopek za večkratno uporabo se je začel aprila 2012, dva meseca po objavi dokumenta s stališčem Evropske agencije za zdravila v obliki vprašanj in odgovorov (EMA/618604/2008 Rev. 4) glede dvofaznih formulacij.
English: Based on the discussion above, it is considered reasonable to look at the immediate release phase separately, and fasting conditions is considered more sensitive in relation to detect difference between test and reference for a highly soluble immediate release formulation in order to provide proof of bioequivalence.
Slovenian: Na podlagi zgornje razprave je smiselno, da se faza s takojšnjim sproščanjem obravnava ločeno, saj so pogoji na tešče občutljivejši za zaznavanje razlike med preiskovanim in referenčnim zdravilom z zelo lahko topno formulacijo s takojšnjim sproščanjem, da bi se lahko podali dokazi za biološko enakovrednost.
English: The results showed that by identifying true biphasic profiles for the early absorption phase, bioequivalence for both the AUC and Cmax during the initial phase between both investigational products is proven.
Slovenian: Rezultati so pokazali, da je z določitvijo dejanskih dvofaznih profilov za zgodnjo fazo absorpcije biološka enakovrednost med obema preiskovanima zdraviloma za AUC in Cmax med začetno fazo dokazana.
English: • The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phase and under fed conditions for the prolonged release phase.
Slovenian: • odbor meni, da je bila biološka enakovrednost pri pogojih na tešče dokazana za fazi s takojšnjim in podaljšanim sproščanjem ter pri pogojih na poln želodec za fazo s podaljšanim sproščanjem;
English: • For the second phase, the assessment of equivalence should be based on the AUC from the cut-off time until the end of observation period, and on Cmax during the second phase.
Slovenian: • pri drugi fazi mora ocena enakovrednosti temeljiti na AUC od razmejitvene časovne točke do konca opazovalnega obdobja in na Cmax med drugo fazo.
English: The applicant/MAH claimed that this is primarily attributed to the high intra-subject variability (66.5% for Cmax(0-2h), 110.1% for AUC (0-2h)) observed in this early phase as the point estimators Cmax(0-2h) and AUC (0-2h) are very close to 100% indicating that with an adequate sample size bioequivalence could have been shown also for these two parameters.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je izjavil, da je to predvsem posledica velike variabilnosti med preskušanci (66,5 % za Cmax(0-2h), 110,1 % za AUC (0-2h)), ki so jo opazili v tej zgodnji fazi, saj sta bili ocenjeni vrednosti Cmax(0-2h) in AUC (0-2h) zelo blizu 100 %, kar kaže, da bi lahko z ustrezno velikostjo vzorca biološko enakovrednost pokazali tudi za ta parametra.