FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional measures may be requested subsequently for these sites, but pending conclusion of the ongoing article 31 these cannot be identified.
Slovenian: Naknadno se lahko za te proizvodne obrate zahtevajo tudi dodatni ukrepi, vendar le teh ni mogoče določiti pred zaključkom postopka v skladu s členom 31.
English: The available data to support inclusion of sites from which products are currently being imported (Canada, Turkey and USA) into the existing PD solutions marketing authorisations were submitted.
Slovenian: Predloženi so bili razpoložljivi podatki v podporo vključitvi obratov, v katerih se proizvajajo zdravila, ki se trenutno uvažajo (Kanada, Turčija in ZDA), v obstoječa dovoljenja za promet z raztopinami za PD.
English: The CHMP considers of extreme importance to retain coordination of the review of the conditions presently identified for the site in the USA.
Slovenian: CHMP meni, da je vzdrževanje koordinacije pregleda stanja, trenutno ugotovljenega na proizvodnem obratu v ZDA, zelo pomembno.
English: The introduction of a more sensitive kinetic turbidimetric limulus amebocyte lysate (LAL) method for endotoxin testing and the re-submission of the full description of the manufacturing processes for all sites together with its critical review should thus be undertaken.
Slovenian: Zato je treba vključiti bolj občutljive kinetične turbidimetrične metode LAL (testi na osnovi lizata, pridobljenega iz krvi podkvastih rakov) za preverjanje endotoksinov in ponovno predložiti celoten opis proizvodnega procesa za vse proizvodne obrate, skupaj s kritičnim pregledom.
English: Considering the likelihood of prolonged use of large quantities of unlicensed (imported) PD solutions on the EU market, and in order to ensure continued supply of licensed medicinal products to the EU, the necessary data packages to support the inclusion of additional manufacturing sites were expedited within the ongoing article 31 referral procedure.
Slovenian: Ob upoštevanju verjetnosti podaljšane uporabe večjih količin raztopin za PD brez licence (uvoženih) na trgu EU in za zagotovitev nemotene dobave zdravil z licenco v EU so bili v podporo vključitvi dodatnega proizvodnega obrata pospešeno vključeni potrebni podatkovni paketi v potekajoči napotitveni postopek v skladu s členom 31.
English: - All drug substances should be supported by active substance master files or appropriate data and comply with Ph Eur requirements.
Slovenian: - Vse zdravilne učinkovine morajo biti ustrezno podprte z glavno dokumentacijo ali ustreznimi podatki ter v skladu z zahtevami Evropske farmakopeje.
English: A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Slovenian: Usklajen evropski pristop do oskrbe je vzpostavljen od ugotovitve, da obstajajo težave glede obrata v Castlebaru, postopek po členu 31 pa bo potekal, dokler odprta vprašanja ne bodo rešena.
English: In particular, the peritoneal dialysis (PD) Dianeal, Extraneal and Nutrineal were affected by this procedure.
Slovenian: Ta postopek zadeva predvsem zdravila Dianeal, Extraneal in Nutrineal, namenjena za peritonealno dializo (PD).
English: • The review of the issues identified at Castlebar is ongoing, and peritoneal dialysis solutions are not being released from this manufacturing plant which is the main marketing authorisation holder's supplier in Europe.
Slovenian: • Pregled težav, ugotovljenih v Castlebaru, še poteka, raztopine za peritonealno dializo pa se iz tega proizvodnega obrata, ki je glavni dobavitelj imetnika dovoljenja za promet z zdravilom za Evropo, ne dobavljajo.
English: At this stage of the article 31 procedure, sufficient data is available to recommend the variation to the marketing authorisations consisting in the inclusion of the site located in the USA as additional manufacturing site, as no major quality issues were identified.
Slovenian: V tej fazi postopka v skladu s členom 31 je na voljo dovolj podatkov, da se priporoči sprememba dovoljenj za promet z zdravilom, in sicer vključitev proizvodnega obrata v ZDA kot dodatnega proizvodnega obrata, saj v njem niso ugotovili nobenih večjih težav s kakovostjo.
English: Overall summary of the scientific evaluation on the inclusion of an additional site into the existing licenses of dialysis solutions (Dianeal PD4 and Extraneal) from Baxter group of companies and associated companies (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja vključitve dodatnega proizvodnega obrata v obstoječe licence za dializne raztopine (Dianeal PD4 in Extraneal) skupine družb Baxter in povezanih družb (glejte Prilogo I)
English: Taking into account the crucial nature of these medicinal products, unaffected batches of PD solutions had to be made available to patients across the EU in the shortest possible timeframe, and thus alternatives were sought.
Slovenian: Ob upoštevanju pomena teh zdravil so morale biti enake serije raztopin za PD v najkrajšem možnem času na voljo bolnikom po vsej EU, zaradi česar so se iskala nadomestna zdravila.
English: In view of severe supply limitations for Dianeal, Extraneal and Nutrineal and the risk of switching patients to alternative PD solutions or therapies, the CHMP considered that the use of comparable products produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) should be prioritised.
Slovenian: Zaradi velikih omejitev dobave zdravil Dianeal, Extraneal in Nutrineal ter tveganja pri bolnikih zaradi zamenjave zdravila z nadomestnimi raztopinami ali terapijami za PD je CHMP menil, da je uporaba primerljivih zdravil, ki jih proizvaja družba Baxter v drugih proizvodnih obratih izven EGP (Evropski gospodarski prostor), prednostna.
English: • The CHMP considers that sufficient quality data is available to recommend the inclusion of the manufacturing site located in the USA into the existing marketing authorisations for the peritoneal dialysis solutions, as applicable.
Slovenian: • CHMP meni, da so na voljo zadostni podatki o kakovosti, da lahko priporoči vključitev proizvodnega obrata v ZDA v obstoječa dovoljenja za promet z zdravilom za raztopine za peritonealno dializo, če je to smiselno.
English: The opinion on the Castlebar site cannot be finalised at this stage as issues remain for resolution by the marketing authorisation holder.
Slovenian: Mnenje glede proizvodnega obrata v Castlebaru ne more biti dokončno, saj so v tej fazi še vedno odprta nekatera vprašanja, ki jih mora rešiti imetnik dovoljenja za promet z zdravilom.
English: In April 2011, the Committee considered that sufficient information was available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations.
Slovenian: Odbor je aprila 2011 menil, da je na voljo dovolj informacij za izdajo prvega mnenja o postopku v skladu s členom 31, ki priporoča, da se v obstoječa dovoljenja za promet z raztopinami za PD dodajo proizvodni obrati v Kanadi, na Poljskem in v Turčiji.
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
Slovenian: • CHMP je proučil napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za raztopine za dializo skupine družb Baxter in povezanih družb, proizvedene v Castlebaru.
English: In light of the current uncertainty over the root cause and the future re-instatement of supply from Castlebar, the addition of manufacturing sites to the marketing authorisations aimed at mitigating future supply problems arising for PD solutions in Europe, ensuring that sufficient PD solutions are available.
Slovenian: Zaradi trenutne negotovosti glede glavnega vzroka in ponovne vzpostavitve dobave iz Castlebara v prihodnje je dodajanje proizvodnih obratov v dovoljenja za promet z zdravilom namenjeno reševanju prihodnjih težav z dobavo raztopin za PD v Evropi ter zagotavljanju razpoložljivosti zadostnih raztopin za PD.
English: - Water for injections, and other excipients, should fully comply with Ph Eur monograph requirements, where applicable.
Slovenian: - Voda za injekcije in druge pomožne snovi morajo biti popolnoma v skladu z zahtevami Evropske farmakopeje, kjer je primerno.
English: Pending conclusion of the ongoing Article 31, it is expected that the MAH implements in all its sites the outcome of lessons learned from the findings at Castlebar, to ensure a safe product supply.
Slovenian: Glede na zaključek postopka po členu 31 se pričakuje, da bo imetnik dovoljenja za promet z zdravilom v vseh proizvodnih obratih upošteval pridobljene izkušnje in ugotovitve iz obrata v Castlebaru in tako zagotovil oskrbo z varnim zdravilom.
English: Standard QP release should apply for all products released under the terms of EU marketing authorisations; in particular the QPs must be satisfied that the active substances are manufactured in accordance with EU GMP requirements.
Slovenian: Standardna usposobljenost za proizvodnjo (QP) se mora uporabljati za vsa zdravila, ki se izdajajo v skladu s pogoji dovoljenj za promet z zdravili v EU; izpolnjeni morajo biti zlasti standardi usposobljenosti za proizvodnjo glede proizvajanja zdravilnih učinkovin v skladu z zahtevami dobre proizvodne prakse (GMP) v EU.
English: • Unaffected batches of peritoneal dialysis solutions needed to be made available to patients across the EU in the shortest possible timeframe, thus alternative PD solutions produced by Baxter at alternative manufacturing sites outside the EEA (European Economic Area) were prioritised.
Slovenian: • Za bolnike po vsej EU je bilo treba v najkrajšem možnem času zagotoviti enake raztopine za peritonealno dializo, zaradi česar so bile nadomestne raztopine za PD, proizvedene v drugih obratih družbe Baxter izven EGP (Evropski gospodarski prostor), prednostne.
English: An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions from Baxter group of companies and associated companies produced at Castlebar.
Slovenian: Napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, je sprožila Evropska komisija po poročanju o rezultatih izven specifikacijskih meja za endotoksine v dializnih raztopinah skupine družb in povezanih družb Baxter, proizvedenih v Castlebaru.
English: Whilst all data to finalise the ongoing article 31 is not available, a stepwise approach is followed for the assessment, resulting in subsequent opinions being adopted by the CHMP.
Slovenian: Dokler ne bodo na voljo vsi podatki za dokončanje postopka po členu 31, bo vrednotenje in posledično izdajanje mnenj CHMP potekalo postopoma.
English: Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a second opinion for this Article 31 procedure recommending the addition of the USA manufacturing site to the relevant PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Slovenian: Zato CHMP ne glede na potekajoči postopek v skladu s členom 31 meni, da je na voljo dovolj podatkov za izdajo drugega mnenja o tem postopku iz člena 31, ki priporoča dodajanje proizvodnega obrata v ZDA v zadevna dovoljenja za promet z raztopinami za PD v skladu s pogoji, navedenimi v Prilogi IV. Na splošno je treba upoštevati naslednje:
English: the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of the manufacturing site in the USA and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I).
Slovenian: CHMP priporoča spremembo pogojev za dovoljenja za promet z zdravilom v zvezi z dodajanjem proizvodnega obrata v ZDA, katerih ustrezna dopolnila poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo raztopin za peritonealno dializo skupine družb Baxter in povezanih družb, proizvedenih v Castlebaru (glejte Prilogo I), so navedena v Prilogi III.
English: The review of the issues identified at Castlebar, with the interruption of supply from this site, led to the need to authorise additional manufacturing sites to ensure supply of PD solutions in Europe.
Slovenian: Pregled težav, odkritih v proizvodnem obratu Castlebar, in motnje z dobavo s tega proizvodnega obrata so vodili do potrebe po odobritvi dodatnega proizvodnega obrata, ki bi zagotovil oskrbo z raztopinami za PD po Evropi.
English: Scientific conclusions and grounds for the addition of a manufacturing site to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za dodajanje novega proizvodnega obrata v dovoljenja za promet z zdravilom in dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: Terminal sterilisation has to be expressed as a minimum exposure time to a minimum temperature as per Ph. Eur.
Slovenian: Končna sterilizacija mora bi izražena kot najkrajši čas izpostavljenosti najnižji temperaturi v skladu z Evropsko farmakopejo in usklajena v vseh proizvodnih obratih.
English: - All starting materials (including excipients) should be subject to satisfactory routine control of microbial contamination and, unless justified, endotoxin testing.
Slovenian: - Opraviti je treba ustrezno rutinsko kontrolo mikrobne kontaminacije in, razen če ni utemeljeno, testiranje za endotoksine vsega izhodiščnega materiala (vključno s pomožnimi snovmi).
English: Grounds for the addition of an additional manufacturing site to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets
Slovenian: Podlaga za dodajanje treh proizvodnih obratov v dovoljenja za promet z zdravilom ter dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo
English: This summary was last updated in 08-2007.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2007.
English: The marketing authorisation was renewed on 3 April 2006.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano 3. aprila 2006.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Starlix to Novartis Europharm Limited on 3 April 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Starlix, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 3. aprila 2001.
English: Starlix is given within one to 30 minutes before breakfast, lunch and dinner and the dose is adjusted to give the best control.
Slovenian: Zdravilo Starlix se zaužije minuto do 30 minut pred zajtrkom, kosilom in večerjo, pri čemer se odmerek prilagodi tako, da omogoča najboljši nadzor.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) STARLIX EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) STARLIX Povzetek EPAR za javnost
English: Other information about Starlix:
Slovenian: Druge informacije o zdravilu Starlix:
English: The Committee recommended that Starlix be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Starlix odobri dovoljenje za promet.
English: Starlix may in some cases cause hypoglycaemia (low blood glucose).
Slovenian: Starlix lahko v nekaterih primerih povzroči hipoglikemijo (nizko koncentracijo glukoze v krvi).
English: A total of 2,122 patients received Starlix in all trials combined.
Slovenian: V vseh preizkušanjih skupaj je zdravilo Starlix prejemalo 2122 bolnikov.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Starlix's benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Starlix večje od z njim povezanih tveganj pri zdravljenju sladkorne bolezni tipa 2 v kombinaciji z metforminom pri bolnikih, pri katerih ni bil dosežen zadosten nadzor bolezni kljub prejemanju največjega dnevnega odmerka metformina.
English: In combination with metformin, which mainly affected fasting plasma glucose (the amount of glucose in the blood when the person has not eaten anything), the effect of Starlix on HbA1c was better than either medicine alone.
Slovenian: V kombinaciji z metforminom, ki v glavnem vpliva na koncentracijo glukoze v plazmi na tešče (količino glukoze v krvi, ko še ni bila zaužita nobena hrana), je bil učinek zdravila Starlix na HbA1c boljši od učinka katerega koli drugega zdravila, uporabljenega samostojno.
English: Nateglinide, the active ingredient in Starlix, stimulates the pancreas to produce insulin more quickly.
Slovenian: Nateglinid, zdravilna učinkovina v zdravilu Starlix, spodbuja trebušno slinavko k hitrejši tvorbi insulina.
English: Other studies also looked at ‘switching' from an antidiabetes medicine to Starlix, and ‘adding' Starlix to other antidiabetes medicines.
Slovenian: V drugih študijah so preučevali tudi „prehod“ z zdravila za sladkorno bolezen na zdravilo Starlix ter „dodajanje“ zdravila Starlix drugemu zdravilu za sladkorno bolezen.
English: Starlix should not be used in people who may be hypersensitive (allergic) to nateglinide or any of the other ingredients, who have type 1 diabetes or a severe liver problem, or who have diabetic ketoacidosis (a serious complication of diabetes).
Slovenian: Zdravila Starlix se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) nateglinid ali katerokoli drugo sestavino zdravila ali imajo sladkorno bolezen tipa 1 ali hude težave z jetri ali diabetično ketoacidozo (resen zaplet, povezan s sladkorno boleznijo).
English: Starlix is used in patients who have non insulin-dependent diabetes (type 2 diabetes).
Slovenian: Starlix se uporablja pri bolnikih s sladkorno boleznijo, ki ni odvisna od insulina (sladkorna bolezen tipa 2).
English: On its own, Starlix was shown to be more effective than placebo, but less effective than some antidiabetes medicines such as metformin.
Slovenian: Izkazalo se je, da je zdravilo Starlix kot samostojno zdravilo bolj učinkovito kot placebo, vendar manj učinkovito kot nekatera druga zdravila za sladkorno bolezen, kot je metformin.
English: What benefit has Starlix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Starlix izkazalo med raziskavami?
English: Starlix doses might also need to be adjusted when given with some medicines used in heart conditions, to treat pain, to treat asthma, and other conditions.
Slovenian: Odmerke zdravila Starlix bo morda treba prilagoditi, če se uporabljajo istočasno z zdravili za zdravljenje bolezni srca, bolečin, astme in drugih bolezni.
English: Starlix is used together with metformin (another antidiabetes medicine) to lower blood glucose (sugar) in patients whose diabetes cannot be controlled by metformin alone.
Slovenian: Zdravilo Starlix se uporablja skupaj z metforminom (drugim zdravilom za sladkorno bolezen) za zniževanje koncentracije glukoze (sladkorja) v krvi pri bolnikih s sladkorno boleznijo, katerih sladkorno bolezen ni mogoče nadzorovati samo z metforminom.
English: For the full list of all side effects reported with Starlix, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Starlix, glejte Navodilo za uporabo.
English: The main studies compared Starlix to placebo (a dummy treatment), or to other medicines used in type 2 diabetes (metformin, glibenclamide or troglitazone).
Slovenian: V glavnih študijah so primerjali zdravilo Starlix s placebom (zdravilom brez zdravilne učinkovine) ali z drugimi zdravili za sladkorno bolezen tipa 2 (metforminom, gliklazidom ali troglitazonom).
English: This helps to keep the blood glucose controlled after meals and is used to control type 2 diabetes.
Slovenian: S tem se uravnavajo koncentracije glukoze v krvi po obrokih in nadzira sladkorna bolezen tipa 2.
English: Starlix is a medicine containing the active substance nateglinide.
Slovenian: Zdravilo Starlix vsebuje zdravilno učinkovino nateglinid.
English: What is the risk associated with Starlix?
Slovenian: Kakšna tveganja so povezana z zdravilom Starlix?
English: The full EPAR for Starlix is available here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Starlix je na voljo tukaj.
English: Why has Starlix been approved?
Slovenian: Zakaj je bilo zdravilo Starlix odobreno?
English: What is Starlix?
Slovenian: Kaj je zdravilo Starlix?
English: How has Starlix been studied?
Slovenian: Kako je bilo zdravilo Starlix raziskano?
English: What is Starlix used for?
Slovenian: Za kaj se zdravilo Starlix uporablja?
English: How does Starlix work?
Slovenian: Kako zdravilo Starlix deluje?
English: How is Starlix used?
Slovenian: Kako se zdravilo Starlix uporablja?
English: Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
Slovenian: Datum prve odobritve: 29. avgust 2008 Datum zadnjega podaljšanja: 31. julij 2013
English: Alfred-Nobel Strasse 10
Slovenian: Alfred-Nobel Str. 10
English: This pack (treatment initiation pack) is used when you start your treatment with Vimpat.
Slovenian: To pakiranje (paket za začetek zdravljenja) se uporablja, ko začnete zdravljenje z zdravilom Vimpat.
English: You should continue to take Vimpat until your doctor tells you to stop.
Slovenian: Zdravilo Vimpat morate jemati, dokler vam zdravnik ne naroči, da prenehate.
English: Not known: frequency cannot be estimated from available data
Slovenian: Neznana: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: Vimpat is used as a long term treatment.
Slovenian: Zdravilo Vimpat se uporablja za dolgotrajno zdravljenje.
English: Vimpat may be used on its own or with other antiepileptic medicines.
Slovenian: • Zdravilo Vimpat se lahko uporablja samostojno ali z drugimi antiepileptiki.
English: Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.
Slovenian: Vsako pakiranje vsebuje drugo jakost zdravila Vimpat, tako da boste odmerek povečevali postopno.
English: This dose is called a maintenance dose and will depend on how you respond to Vimpat.
Slovenian: Odmerek se imenuje vzdrževalni odmerek in bo odvisen od vašega odziva na zdravilo Vimpat.
English: If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Slovenian: Če vam je zdravnik povedal, da vi (ali vaš otrok) ne prenašate nekaterih sladkorjev ali če so pri vas ugotovili dedno intoleranco za fruktozo, redko genetsko bolezen, pri kateri ne morete razgraditi fruktoze, se posvetujte z zdravnikom, preden vi (ali vaš otrok) vzamete ali dobite to zdravilo.
English: The bottle containing Vimpat syrup should be shaken well before use.
Slovenian: Steklenico z zdravilom Vimpat sirup je treba pred uporabo dobro pretresti.
English: When you take Vimpat with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Slovenian: Ko boste vzeli zdravilo Vimpat skupaj z drugimi antiepileptiki - Začetek zdravljenja (prvi 4 tedni)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.