FrancophonIA/ELRC3.0 huggingface dataset:
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Imetnik dovoljenja za promet z zdravilom:
English: and Rubella Virus Vaccine Live) using separate sites and syringes for injectable vaccines.
Slovenian: Pertussis vaccine - cepivo proti davici, tetanusu in brezcelično cepivo proti oslovskemu kašlju), če se cepivo za injiciranje daje na drugo mesto in z drugo brizgo.
English: The addition of fenofibrate to simvastatin seems to reduce the incremental risk in this population and this has been reflected in the given indications for this product.
Slovenian: Zdi se, da dodajanje fenofibrata simvastatinu zmanjšuje naraščajoče tveganje v tej populaciji, kar odražajo tudi indikacije, podane za to zdravilo.
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil.
Slovenian: • CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil.
English: Regarding co-administration of fibrates with statins, there are insufficient data on the long term efficacy of such a therapy to allow any positive recommendations for most fibrates.
Slovenian: V zvezi s sočasno uporabo fibratov in statinov ni dovolj podatkov o dolgoročni učinkovitosti takšnega zdravljenja, ki bi omogočali kakršnakoli pozitivna priporočila za večino fibratov.
English: Fibrates have been shown to reduce plasma triglycerides (TG) by 30% to 50% and raise the level of high density lipoprotein cholesterol (HDL-C) by 2% to 20%.
Slovenian: Fibrati dokazano znižujejo trigliceride v plazmi (TG) za 30-50 % in zvišujejo raven holesterola v lipoproteinih visoke gostote (HDL-C) za 2-20 %.
English: Based on the above, the CHMP recommended the amendments of the marketing authorisations and concluded that the benefit risk profile of fibrates is still positive in the agreed indications.
Slovenian: Na osnovi zgoraj navedenega CHMP priporoča dopolnitev dovoljenj za promet in zaključuje, da je profil koristi in tveganja pri fibratih v okviru dogovorjenih indikacij še vedno ugoden.
English: • The CHMP considered the PhVWP recommendations on the review of the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases.
Slovenian: • CHMP je obravnaval priporočila delovne skupine za farmakovigilanco (PhVWP) glede pregleda koristi in tveganj fibratov pri zdravljenju kardiovaskularnih (umrljivost in obolevnost) in dislipidemičnih bolezni.
English: However in severe hypertriglyceridaemia and certain dyslipidaemias where a statin cannot be used patients can still benefit from treatment with fibrates.
Slovenian: Pri močni hipertrigliceridemiji in določenih dislipidemijah, pri katerih ni mogoče uporabiti statina, pa zdravljenje s fibrati lahko pacientom vseeno koristi.
English: No randomised, controlled trial data are available for ciprofibrate, but differences across the class in surrogate marker effects have not been shown.
Slovenian: Za ciprofibrat podatki randomiziranega in kontroliranega preskušanja niso na voljo, vendar v celotni skupini ni dokazanih razlik v nadomestnih kazalnikih učinka.
English: Their effect on low density lipoprotein cholesterol (LDL-C) is variable, ranging from no effect to a small decrease of the order of
Slovenian: Na holesterol v lipoproteinih nizke gostote (LDL-C) učinkujejo različno; lahko so brez učinka ali pa prispevajo k majhnemu znižanju v obsegu 10 %.
English: Fibrates (fenofibrate, bezafibrate, ciprofibrate and gemfibrozil) are a class of lipid-lowering drugs and exert their effects mainly by activating the peroxisome proliferator-activated receptor-alpha (PPARalpha), apart from bezafibrate which is an agonist for all three PPAR isoforms alpha, gamma, and delta.
Slovenian: Fibrati (fenofibrat, bezafibrat, ciprofibrat in gemfibrozil) so skupina zdravil, ki znižujejo lipide in v glavnem učinkujejo z aktiviranjem receptorja alfa, aktiviranega s peroksisomskim proliferatorjem (PPAR-alfa), razen bezafibrata, ki je agonist za vse tri izooblike PPAR, in sicer alfa, gama in delta.
English: Overall summary of the scientific evaluation of fenofibrate, bezafibrate, ciprofibrate and gemfibrozil containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil (glejte Dodatek I)
English: Furthermore fenofibrate showed benefit as add on treatment to statins as detailed above.
Slovenian: Kot je podrobneje opisano zgoraj, se je fenofibrat poleg tega izkazal za koristnega kot dodatek pri zdravljenju s statini.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: The fibrates share a common mechanism of action and exert qualitatively similar effects on serum lipid triglycerides (decrease) and HDL-cholesterol concentrations (increase).
Slovenian: Vsem fibratom je skupen enak mehanizem delovanja, imajo pa tudi kvalitativno podobne učinke na trigliceride v serumu (ki jih znižujejo) in koncentracije holesterola HDL (ki jih zvišujejo).
English: The long term efficacy and safety of the currently licensed fibrates has mainly been examined in six large randomised, placebo controlled trials: the Helsinki Heart Study (HHS) and Veterans Affairs HDL Intervention Trial (VA-HIT) with gemfibrozil, the Bezafibrate Infarction Prevention (BIP) Study and the Lower Extremity Arterial Disease Event Reduction (LEADER) Study with bezafibrate, the Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study and the Action to Control Cardiovascular Risk in Diabetes study (ACCORD) with fenofibrate.
Slovenian: Dolgoročna učinkovitost in varnost fibratov, za katere je trenutno izdano dovoljenje, sta bili v glavnem preučeni v šestih velikih randomiziranih in s placebom kontroliranih študijah: v študiji z nazivom Helsinško srce (Helsinki Heart, HHS) in intervencijskem preskušanju učinkov uravnavanja holesterola HDL, ki jo je sponzoriral ameriški urad za vojne veterane (Veterans Affairs HDL Intervention Trial, VA-HIT), so preučevali gemfibrozil, v študiji preprečevanja infarkcije s pomočjo bezafibrata (Bezafibrate Infarction Prevention, BIP) in študiji zmanjševanja dogodkov v zvezi z arterijskimi boleznimi spodnjih okončin (Lower Extremity Arterial Disease Event Reduction, LEADER) so preučevali bezafibrat, v intervencijski študiji zmanjševanja dogodkov pri sladkornih bolnikih s pomočjo fenofibrata (Fenofibrate Intervention in Event Lowering in Diabetes, FIELD) in študiji nadzorovanja kardiovaskularnega tveganja pri sladkornih bolnikih (Action to Control Cardiovascular Risk in Diabetes, ACCORD) pa so preučevali fenofibrat.
English: However, the effect of fibrates mainly on triglycerides but also a smaller but overall positive effect on HDL and LDL cholesterol suggest that there are subgroups of patients who may still benefit from this therapy.
Slovenian: Vendar pa učinki, ki jih imajo fibrati v glavnem na trigliceride (v manjši meri pa vplivajo tudi na holesterola HDL in LDL, vendar je ta vpliv na splošno pozitiven), kažejo, da obstajajo podskupine pacientov, ki bi jim tovrstno zdravljenje lahko vseeno koristilo.
English: Based on the above data, it was concluded that the product information for all fibrates should be updated to reflect the available evidence and current clinical practice, and define groups of patients that were more likely to derive benefit from fibrates such as patients with severe hypertriglyceridaemia with or without low HDL cholesterol or with mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Slovenian: Na osnovi zgoraj navedenih podatkov je bilo ugotovljeno, morajo biti podatki o zdravilu za vse fibrate posodobljeni, tako da bodo odražali razpoložljive dokaze in trenutno klinično prakso, in da je treba določiti skupine pacientov, ki jim bodo fibrati najverjetneje koristili, na primer paciente z močno hipertrigliceridemijo z nizko vrednostjo holesterola HDL ali brez njega ali paciente s kombinirano hiperlipidemijo, pri katerih je uporaba statina kontraindicirana ali pa ga ne prenašajo.
English: In this regard, the Pharmacovigilance Working Party (PhVWP) review of all available data on the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases, as initially endorsed by the CHMP, concluded that in most cases, the indications for fibrates had been granted mainly on the basis of their effects on these surrogate parameters and that little evidence was available on the effects of the different fibrates on cardiovascular morbidity and mortality.
Slovenian: Zato je bilo v pregledu vseh razpoložljivih podatkov v zvezi s koristmi in tveganji uporabe fibratov pri zdravljenju kardiovaskularnih (umrljivost in obolevnost) in dislipidemičnih bolezni, ki ga je opravila delovna skupina za farmakovigilanco (PhVWP) in ga je prvotno odobril CHMP, zaključeno, da so indikacije za fibrate odobrene večinoma na osnovi njihovega učinkovanja na te nadomestne parametre, dokazov glede učinkov različnih fibratov na umrljivost in obolevnost zaradi kardiovaskularnih bolezni pa je na voljo le malo.
English: Despite differences in methodology and study populations, the major fibrate trials have shown that treatment with fibrates may reduce coronary heart disease events but there is no clear evidence that they can reduce all cause mortality in the primary or secondary prevention of cardiovascular disease.
Slovenian: Kljub razlikam v metodologiji in študijskih populacijah so glavni preskusi s fibrati dokazali, da lahko zdravljenje z njimi zmanjša pogostost dogodkov v zvezi s koronarno boleznijo, ni pa jasnega dokaza, da lahko pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni znižajo umrljivost ne glede na vzrok smrti.
English: • The CHMP considered additional published data for the fibrates, including results of the ACCORD lipid trial which were supportive of the use of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) as add on therapy to a statin in patients with mixed hyperlipidaemia at high cardiovascular risk when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
Slovenian: • CHMP je upošteval dodatne objavljene podatke o fibratih, vključno z rezultati preskušanja v zvezi lipidi (ACCORD), ki potrjujejo koristi fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete), uporabljenega kot dodatek statinu pri zdravljenju pacientov s kombinirano hiperlipidemijo in visokim tveganjem za kardiovaskularne bolezni, kadar samo s statinom ni mogoče ustrezno nadzirati trigliceridov in holesterola HDL.
English: Since therapeutic efficacy cannot be obtained from the data provided the use of fibrates as first line treatment for these indications is no longer justified for all fibrates, with the exception of gemfibrozil which showed benefit on primary prevention of cardiovascular morbidity in males when a statin cannot be used.
Slovenian: Ker iz zbranih podatkov ni mogoče dokazati terapevtske učinkovitosti, uporaba fibratov kot zdravila prve izbire pri teh indikacijah za vse fibrate ni več upravičena, razen za gemfibrozil, pri katerem je dokazana korist pri primarnem preprečevanju umrljivosti moških zaradi kardiovaskularnih bolezni, če ni mogoče uporabiti statina.
English: Also recognizing that trials have provided evidence that gemfibrozil may differ from the rest of the class and may have a more favourable profile it was felt that a differentiation in the given indications for gemfibrozil was justified to also include treatment of primary hypercholesterolaemia and primary prevention of cardiovascular morbidity in males when a statin is contraindicated or not tolerated.
Slovenian: Poleg tega so upoštevani tudi s preskusi ugotovljeni dokazi, ki pričajo, da se gemfibrozil morda razlikuje od drugih fibratov v skupini in ima morda bolj ugoden profil; zato se šteje, da je diferenciacija pri danih indikacijah za gemfibrozil, ki naj vključuje še zdravljenje primarne hiperholesterolemije in primarno preprečevanje obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih je uporaba statina kontraindicirana ali pa ga ne prenašajo, upravičena.
English: • The CHMP concluded from the data provided that there is a lack of therapeutic efficacy in the primary or secondary prevention of cardiovascular disease for all fibrates, with the exception of gemfibrozil which showed benefit on primary prevention of cardiovascular morbidity in males when a statin cannot be used.
Slovenian: • Iz predloženih podatkov CHMP zaključuje, da pri primarnem ali sekundarnem preprečevanju kardiovaskularnih bolezni noben fibrat ni terapevtsko učinkovit, razen gemfibrozil, ki se je izkazal za koristnega pri primarnem preprečevanju obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih ni mogoče uporabljati statina.
English: Overall the available evidence suggested that despite the long presence of fibrates on the market, there is only limited evidence of a long term clinical benefit from their use in the primary or secondary prevention of cardiovascular disease.
Slovenian: Zbrani podatki, ki so na voljo, v splošnem kažejo, da je dokazov o dolgoročnih kliničnih koristih uporabe fibratov pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni le malo, čeprav so fibrati na trgu že dolgo.
English: However, for certain doses of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets), results from ACCORD lipid trial, taken together with previous outcome studies and fibrate trials meta-analyses support a benefit of add on therapy in the dyslipidaemic population, when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
Slovenian: Vendar pa rezultati preskušanja ACCORD, kjer so spremljali lipide, skupaj s prejšnjimi rezultati študij in meta analizami preskušanj v zvezi s fibrati za določene odmerke fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete) potrjujejo korist pri dodatnem zdravljenju pri populaciji z dislipidemijo, kadar trigliceridov in holesterola HDL ni mogoče ustrezno nadzirati le s statinom.
English: the CHMP has recommended the variation of the marketing authorisation for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil (see Annex I).
Slovenian: CHMP priporoča spremembo dovoljenj za promet za zdravila, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil (glejte Dodatek I) in katerih ustrezna poglavja povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedeni v Dodatku III.
English: Grounds for amendment of the summaries of product characteristics and package leaflets
Slovenian: Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo
English: IARs are described in section 4.8.
Slovenian: IARs so opisane v poglavju 4.8.
English: The results are shown in Table 4.
Slovenian: Rezultati so prikazani v tabeli 4.
English: Patient data will be anonymously collected in this Registry.
Slovenian: Podatki o bolniku bodo anonimno zbrani v tem registru.
English: It will be given to you once every 2 weeks.
Slovenian: Daje se enkrat na 2 tedna.
English: ATC code: A16AB07.
Slovenian: Oznaka ATC: A16AB07.
English: An infusionassociated reaction can sometimes be very severe.
Slovenian: Infuzijske reakcije so lahko včasih zelo hude.
English: No interactions studies have been performed.
Slovenian: Študij medsebojnega delovanja niso izvedli.
English: Patients improved following treatment interruption.
Slovenian: Stanje bolnikov se je izboljšalo po prekinitvi zdravljenja.
English: • Temporary suspension or sudden cessation of breathing
Slovenian: • začasen zastoj ali nenadna prekinitev dihanja
English: The t½ of approximately 2-3 hours was also similar in this group of patients.
Slovenian: Razpolovna doba (t½ ) približno 2-3 ure v tej skupini bolnikov je bila prav tako podobna.
English: However, motor and respiratory responses to treatment have been more variable.
Slovenian: Vendar pa so bili motorični in respiratorni odzivi na zdravljenje bolj spremenljivi.
English: Some reactions were severe (see section 4.8).
Slovenian: Nekatere reakcije so bile hude (glejte poglavje 4.8).
English: One additional patient died after study end and another one after withdrawal from the study.
Slovenian: En bolnik je umrl po zaključku študije in še eden po umiku iz študije.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate,ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The dose you receive is based on your body weight.
Slovenian: Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase.
English: Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease.
Slovenian: Odziv bolnika na zdravljenje je treba redno ocenjevati na osnovi vsestranskega ocenjevanja vseh kliničnih manifestacij bolezni.
English: The total time between reconstitution and completion of the infusion should not exceed 24 hours.
Slovenian: Skupni čas od rekonstitucije do zaključka infundiranja ne sme biti daljši od 24 ur.
English: The most common adverse reactions observed were IARs.
Slovenian: Najbolj pogosto opaženi neželeni učinki so bile IARs.
English: Reactions generally occurred shortly after initiation of the infusion.
Slovenian: Reakcije so se navadno pojavile kmalu po začetku infundiranja.
English: IgG antibody titres should be regularly monitored.
Slovenian: Titre protiteles IgG je treba redno nadzorovati.
English: Motor development is often completely arrested, or if motor milestones are achieved, they are subsequently lost.
Slovenian: Razvoj motorike pogosto povsem zastane ali če pa so dosežene popolne motorične sposobnosti, le-te kasneje izginejo.
English: Kaplan-Meier survival rates at 12, 24 and 36 months of age were 26%, 9% and 7%, respectively.
Slovenian: Stopnje preživetja po Kaplan-Meierju pri starosti 12, 24 in 36 mesecev so bile 26 %, 9 % oziroma 7 %.
English: In this group of patients a variable response has also been seen with respect to motor function.
Slovenian: V tej skupini bolnikov so bili opaženi tudi spremenljivi odzivi glede motoričnih funkcij.
English: • Protein loss in urine
Slovenian: • izguba beljakovin z urinom
English: ITI regimens may need to be tailored to individual patient needs (see section 5.1).
Slovenian: Sheme ITI je morda potrebno prilagoditi potrebam posameznega bolnika (glejte poglavje 5.1).
English: Due to the rarity of the condition and the limited experience to date, the effect of IgG antibody formation on safety and efficacy is currently not fully established.
Slovenian: Zaradi redkosti stanja in omejenih izkušenj učinek tvorbe protiteles IgG na varnost in učinkovitost trenutno ni povsem dokazan.
English: The majority of these reactions were non-serious, mild to moderate in intensity and resolved spontaneously.
Slovenian: Večina navedenih reakcij ni bila resna, njihova intenzivnost je bila blaga do zmerna in je spontano izginila.
English: Remove airspace within the infusion bag.
Slovenian: Odstranite zrak iz infuzijske vrečke.
English: The 9 remaining patients either died (5 patients) or became invasive-ventilator dependent (4 patients).
Slovenian: Preostalih 9 bolnikov je ali umrlo (5 bolnikov) ali pa so postali odvisni od invazivnega predihavanja (4 bolniki).
English: Manufacturer Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Slovenian: Proizvajalec Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska
English: Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Slovenian: Blagi in prehodni učinki morda ne bodo zahtevali zdravljenja ali prekinitve infuzije.
English: Two patients died and did not enter into the extension study.
Slovenian: Dva bolnika sta umrla in nista sodelovala v podaljšku študije.
English: Overall, the numbers of patients experiencing adverse reactions and serious adverse reactions were comparable between the two groups.
Slovenian: Na splošno je bilo število bolnikov, pri katerih so se pojavili neželeni učinki in resni neželeni učinki, primerljivo med obema skupinama.
English: The final infusion solution should be administered as close to preparation time as possible.
Slovenian: Končno infuzijsko raztopino je treba uporabiti v čim krajšem času od njene priprave.
English: Death typically occurs due to cardiac and/or respiratory failure before the age of one year.
Slovenian: Smrt običajno nastopi zaradi srčne in/ali dihalne odpovedi pred starostjo enega leta.
English: Using these medicines to suppress the immune system may further increase this risk.
Slovenian: Uporaba zdravil, ki zavirajo delovanje imunskega sistema, lahko to tveganje še dodatno poveča.
English: The pH of the reconstituted solution is approximately 6.2.
Slovenian: pH rekonstituirane raztopine je približno 6,2.
English: • polysorbate 80 (E433).
Slovenian: • polisorbat 80 (E433).
English: Each pack contains 1, 10 or 25 vials.
Slovenian: Eno pakiranje vsebuje 1, 10 ali 25 vial.
English: IOPD Immune Tolerance Induction
Slovenian: Indukcija imunske tolerance pri IOPD
English: However, high and sustained IgG antibody titres also occur in some CRIM-positive patients.
Slovenian: Vendar pa se visoki in vzdrževani titri protiteles IgG pojavljajo tudi pri nekaterih CRIM-pozitivnih bolnikih.
English: Cmax (µg/ml) AUC∞ (µg•h/ml) CL (ml/h/kg) Vss (ml/kg) Effective half-life (h)
Slovenian: AUC (g•h/ml) klirens CL (ml/h/kg) Vss (ml/kg) efektivna razpolovni čas (h)
English: It is recommended to start the administration of the diluted solution within three hours.
Slovenian: Priporočljivo je, da začnete z dajanjem razredčene raztopine v treh urah.
English: However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.
Slovenian: Vendar je bila dokazana kemična in fizikalna stabilnost za 24 ur pri 2 C do 8 C, če je zdravilo shranjeno v temnem prostoru.
English: Reconstitution and dilution should be performed in accordance with good practice rules, particularly for the respect of asepsis.
Slovenian: Rekonstitucijo in redčenje je treba izvesti v skladu s pravili dobre prakse, še posebej zaradi asepse.
English: • mannitol (E421),
Slovenian: • manitol (E421),
English: Linearity/non linearity Pharmacokinetics were dose proportional and did not change over time.
Slovenian: Linearnost/nelinearnost Farmakokinetika je bila sorazmerna z odmerkom in se ni spreminjala s časom.
English: 4 Additional adverse reactions from post-marketing, expanded access programs and non-controlled clinical trials.
Slovenian: 4 Dodatni neželeni učinki iz postmarketinških raziskav, programov razširjenega dostopa in nenadzorovanih kliničnih preskušanj.
English: 6-Minute Walk Test Distance (meters)
Slovenian: razdalja 6 minutnega testa hoje (v metrih)
English: The marketing authorisation holder (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 RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP