FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of cholesterol (a type of fat) in the blood.
Slovenian: Najpogostejša neželena učinka pri jemanju zdravila Telzir pri odraslih (opažena pri več kot 1 bolniku od 10) sta driska in povišana raven holesterola (vrste maščob) v krvi.
English: Two of the studies in previously untreated patients showed that Telzir in combination with other antiviral medicines was as effective as comparator medicines.
Slovenian: Dve študiji s predhodno nezdravljenimi bolniki sta pokazali, da je zdravilo Telzir v kombinaciji z drugimi protivirusnimi zdravili enako učinkovito kot primerjalna zdravila.
English: Telzir is used in combination with ritonavir and other HIV medicines.
Slovenian: Zdravilo Telzir se uporablja v kombinaciji z ritonavirjem in drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: Similar results were seen in the other study comparing ritonavir-boosted Telzir with ritonavir-boosted lopinavir, with around three-quarters of both groups of previously untreated patients having viral loads below 400 copies/ml.
Slovenian: Podobne rezultate so opazili tudi v drugi študiji, v kateri so z ritonavirjem ojačano zdravilo Telzir primerjali z lopinavirjem, ojačanim prav tako z ritonavirjem, pri čemer so imele približno tri četrtine predhodno nezdravljenih bolnikov v obeh skupinah virusno breme pod 400 kopij/ml.
English: It slows down the rate at which amprenavir is broken down, helping to increase levels of amprenavir in the blood.
Slovenian: Ker upočasni hitrost razgradnje amprenavirja, s tem zviša njegove ravni v krvi.
English: Adults with liver problems should take a reduced dose of Telzir and be closely monitored for side effects and their response to treatment.
Slovenian: Odrasli z jetrnimi obolenji naj jemljejo manjši odmerek zdravila Telzir, med jemanjem pa jih je treba skrbno spremljati zaradi neželenih učinkov in odziva na zdravljenje.
English: Patients in these three adult studies also took two reverse-transcriptase inhibitors (another type of antiviral medicine) in addition to Telzir or the medicine Telzir was being compared with.
Slovenian: V teh treh študijah pri odraslih so bolniki poleg zdravila Telzir jemali tudi dva zaviralca reverzne transkriptaze (drugo vrsto protivirusnega zdravila) ali pa so zdravilo Telzir primerjali z njima.
English: For the full list of side effects of Telzir, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Telzir glejte navodilo za uporabo.
English: There is no recommended dose for patients below 18 years who weigh less than 25 kg.
Slovenian: Za bolnike, mlajše od 18 let, ki tehtajo manj kot 25 kg, ni priporočenega odmerka.
English: Ritonavir, another protease inhibitor, is used with Telzir as a ‘booster'.
Slovenian: Ritonavir, drugi zaviralec proteaze, se v kombinaciji z zdravilom Telzir uporablja kot „spodbujevalec“.
English: How does Telzir work?
Slovenian: Kako zdravilo Telzir deluje?
English: How is Telzir used?
Slovenian: Kako se zdravilo Telzir uporablja?
English: blocks an enzyme that is involved in the reproduction of HIV.
Slovenian: Amprenavir, ki je bil na voljo v EU že prej, zavira encim, ki sodeluje pri razmnoževanju virusa HIV.
English: Packaging Content Package size
Slovenian: Pot uporabe Pakiranje Vsebina Velikost pakiranj a
English: EU (MA) number Invented name
Slovenian: Številka (EU) dovoljenja za promet
English: EU/1/03/249/016 Vivanza 10 mg Orodispersible tablet blister (alu/alu) 4 x 1 tablets (unit dose)
Slovenian: 10 mg orodisperzibilna tableta peroralna uporaba pretisni omot (alu/alu) 4 x 1 tableta (enkratni odmerek)
English: Strength Pharmaceutical form Route of administration
Slovenian: Jakost Farmacevtska oblika
English: MA (EU) Number Invented name
Slovenian: Številka (EU) dovoljenja za promet
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Pot uporabe Stična ovojnina
English: London, June 2008 EMEA/532267/2007- Rev.1
Slovenian: London, junij 2008 EMEA/532267/2007- Wer.
English: The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
Slovenian: CVMP je zaključil, da na podlagi vseh razpoložljivih podatkov ni zadržkov glede varnosti in učinkovitosti zdravila.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) started the referral procedure on 19 July 2006.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je začel napotitveni postopek dne 19. julija 2006.
English: France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Parvo/E.
Slovenian: Francija je dne 11. julija 2006 obvestila EMEA o napotitvi v skladu s členom 40 Direktive Sveta 2001/82/ES, kakor je bila spremenjena, v zvezi z zdravilom Suvaxyn Parvo/E.
English: However, it was important to ensure that the pass limits of the potency test do not drift from the original.
Slovenian: Kljub temu pa je bilo pomembno zagotoviti, da se meje sprejemljivosti pri preskusu učinkovitosti ne oddaljijo od prvotnih meja.
English: The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 17 April 2007.
Slovenian: Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto 17. januarja 2007, s tem povezana odločba Komisije pa 17. aprila 2007.
English: In addition, a more robust test for potency should be applied to the product in the future.
Slovenian: Poleg tega bi bilo treba v prihodnje za učinkovitost uporabljati odpornejšo obliko preskusa.
English: The CVMP, therefore, recommended that the Marketing Authorisation should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Slovenian: CVMP je zato priporočil, da bi dovoljenje za promet morali spremeniti tako, da bi se odstopanja pri preskusu serološke učinkovitosti pri miših zmanjšala z ustreznimi ukrepi, kot je zamenjava uporabe referenčnega cepiva v preskusih serološke učinkovitosti pri miših z uporabo referenčnega seruma.
English: Suvaxyn Parvo/E is indicated for the active immunisation of pigs (gilts and sows) to prevent reproductive disorders caused by porcine parvovirus and to reduce clinical signs caused by Erysipelothrix rhusiopathiae infections, serotype 2 and serotype 1.
Slovenian: Zdravilo Suvaxyn Parvo/E je indicirano za aktivno imunizacijo prašičev (mladic ali svinj) za preprečevanje motenj pri reprodukciji, ki jih povzroča prašičji parvovirus, in zmanjševanje kliničnih znakov, ki jih povzročajo okužbe z Erysipelothrix rhusiopathiae, serotipa 1 in serotipa 2.
English: OPINION FOLLOWING AN ARTICLE 40 REFERRAL FOR SUVAXYN PARVO/E
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 40 ZA ZDRAVILO SUVAXYN PARVO/E
English: The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
Slovenian: Napotitveni postopek obravnava vprašanje enakovrednosti, ki po mnenju Francije med referenčno serijo cepiva za preskus učinkovitosti serije proti erizipelu, ki je bila potrjena v prvotni dokumentaciji, in med novimi referenčnimi serijami cepiva ni bila izkazana za ti dve seriji, zato je posledično CVMP moral razmisliti o spremembi, umiku ali preklicu dovoljenja za promet z zdravilom.
English: Invented Name
Slovenian: Izmišljeno ime Ime
English: Member State EU/EEA Applicant
Slovenian: Država članica EU/EGP
English: Three definitions of Cmin were discussed:
Slovenian: Obravnavane so bile tri opredelitve vrednosti Cmin:
English: In addition, tmax was in the same range for both products.
Slovenian: Poleg tega je bila vrednost tmax v istem razponu za obe zdravili.
English: Scientific conclusions and grounds for refusal
Slovenian: Znanstveni zaključki in podlaga za zavrnitev
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, predlagateljev v državah članicah
English: • The risk-benefit balance is therefore not positive.
Slovenian: • razmerje med koristmi in tveganji je zato negativno;
English: • Bioequivalence issues
Slovenian: • Zadržki glede biološke enakovrednosti
English: However none of the 90%CI for this parameter fit into the standard bioequivalence limits.
Slovenian: Vendar nobeden od 90-odstotnih intervalov zaupanja za ta parameter ne ustreza standardnim mejam biološke enakovrednosti.
English: Overall summary of the scientific evaluation of Galantamine STADA and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Galantamine STADA in povezanih imen (glejte Dodatek I)
English: The active substance galantamine, a tertiary alkaloid, is a selective, competitive and reversible inhibitor of acetylcholinesterase (AChE).
Slovenian: Zdravilna učinkovina galantamin, terciarni alkaloid, je selektivni, kompetitivni in reverzibilni zaviralec acetilholinesteraze (AChE).
English: • Bioequivalence in the multiple dose study has not been sufficiently demonstrated.
Slovenian: • biološka enakovrednost v študiji z več odmerki ni bila zadostno dokazana,
English: It is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
Slovenian: Indicirana je za simptomatsko zdravljenje blage do zmerno hude demence Alzheimerjevega tipa.
English: This procedure concerns a hybrid application (submitted under Art 10(3) of Directive 2001/83/EC as amended) of galantamine containing prolonged release tablets.
Slovenian: Ta postopek zadeva hibridno vlogo (predloženo v skladu s členom 10(3) Direktive 2001/83/ES, kakor je bila spremenjena) za tablete s podaljšanim sproščanjem, ki vsebujejo galantamin.
English: Grounds for refusal
Slovenian: Podlaga za zavrnitev
English: In addition the CHMP agreed that the method of analysis should have been clearly indicated in the protocol, and that post-hoc calculations of Cpd and Ctrough were therefore not acceptable.
Slovenian: Poleg tega se je CHMP strinjal, da bi morala biti metoda analize jasno določena v protokolu, zato post hoc izračuni vrednosti Cpd in Ctrough niso sprejemljivi.
English: This is a product, which is intended to present prolonged release characteristics and therefore the maintenance of sufficient plasma levels is among the main parameters connected to the claimed pharmaceutical form.
Slovenian: To je zdravilo, ki je namenjeno izražanju značilnosti podaljšanega sproščanja, zato je ohranjanje zadostnih ravni plazme eden od glavnih parametrov, povezanih s predlagano farmacevtsko obliko.
English: It was also noted that the IS-CV was not as high for the 8mg and 16mg strengths (18% and 25%).
Slovenian: Ugotovljeno je bilo tudi, da vrednost IS-CV ni bila tako velika za jakosti 8 mg in 16 mg (18 in 25 odstotkov).
English: the CHMP has recommended the refusal of the granting of the marketing authorisation for Galantamine and associated names (see Annex I).
Slovenian: je CHMP priporočil zavrnitev odobritve dovoljenja za promet z zdravilom Galantamine in povezanimi imeni (glejte Dodatek I).
English: In the case of prolonged release formulations, Cmin is usually lower than Ctrough.
Slovenian: V primeru formulacij s podaljšanim sproščanjem je vrednost Cmin običajno nižja od vrednosti Ctrough.
English: The Applicant also argued that %PTF is in fact a better parameter for the assessment of prolonged release products.
Slovenian: Predlagatelj je utemeljeval, da je vrednost % PTF dejansko boljši parameter za ocenjevanje zdravil s podaljšanim sproščanjem.
English: The intra-subject coefficient of variation (IS-CV) of Cminss was found to be markedly higher in comparison to Cmaxss (37.2 % vs. 11.1% for the 24mg strength).
Slovenian: Koeficient variacije znotraj preiskovancev (IS-CV) vrednosti Cminss je bil bistveno večji v primerjavi s Cmaxss (37,2 odstotka v primerjavi z 11,1 odstotka za jakost 24 mg).
English: Taking into account all the arguments presented, the CHMP agreed that the originally prespecified Cminss values most adequately described the release characteristics of the product in this situation.
Slovenian: Ob upoštevanju vseh predstavljenih argumentov se je CHMP strinjal, da prvotno predhodno določene vrednosti Cminss najbolje opisujejo značilnosti sproščanja zdravila v teh okoliščinah.
English: A single dose study with galantamine 24 mg was not considered ethically acceptable as such a dose is not given as a first dose to patients.
Slovenian: Študija z enim 24-miligramskim odmerkom galantamina se je štela za etično nesprejemljivo, ker se tak odmerek bolnikom ne daje kot prvi odmerek.
English: It was also noted by the CHMP that descriptive Cmin data had already been reported initially.
Slovenian: CHMP je ugotovil tudi, da so o opisnih podatkih za vrednost Cmin že prvotno poročali.
English: The high CV may therefore just reflect a sufficiently large difference between the performance of the compared products.
Slovenian: Velik koeficient variacije tako morda odraža dovolj veliko razliko med zmogljivostjo primerjanih zdravil.
English: The reference product is Reminyl 8mg/16mg and 24mg in the form of prolonged release capsules.
Slovenian: Referenčno zdravilo je Reminyl 8 mg/16 mg in 24 mg v obliki kapsul s podaljšanim sproščanjem.
English: A single dose study with 24 mg was considered to be acceptable due to the poor tolerability of galantamine in patients and in healthy volunteers, provided that the following multiple dose study was performed, which included the 24 mg dose:
Slovenian: Študija z enim 24-miligramskim odmerkom se je štela za sprejemljivo zaradi slabega prenašanja galantamina pri bolnikih in zdravih prostovoljcih, če je bila izvedena naslednja študija z več odmerki, v katero je bil vključen 24-miligramski odmerek:
English: The two other ways of calculations (Cpd and Ctrough) were conducted post hoc after it became apparent that prespecified Cminss data did not result in acceptable 90%CI.
Slovenian: Druga načina izračuna (Cpd in Ctrough) sta bila opravljena post hoc potem, ko je postalo jasno, da predhodno določeni podatki za vrednost Cminss ne dajo sprejemljivega 90odstotnega intervala zaupanja.
English: In addition the CHMP was also of the view that for cholinesterase inhibitors like galantamine, the relationship between administered dose and therapeutic effect is not entirely clear, and for this reason the results from the bioequivalence studies are considered to be of primary importance in this application.
Slovenian: CHMP je tudi menil, da za zaviralce holinesteraze, kot je galantamin, zveza med uporabljenim odmerkom in terapevtskim učinkom ni povsem jasna, zato se šteje, da so rezultati študije biološke enakovrednosti v tej vlogi primarnega pomena.
English: Furthermore as mentioned previously the Cpd and Ctrough definitions are indeed considered post-hoc, introducing an unacceptable level of bias.
Slovenian: Poleg tega sta omenjeni opredelitvi vrednosti Cpd in Ctrough dejansko obravnavani post hoc, kar uvede nesprejemljivo raven napake.
English: The three single dose studies were carried out using the 8 and 16mg strengths:
Slovenian: Tri študije z enim odmerkom so bile izvedene z jakostma 8 in 16 mg:
English: All bioequivalence criteria were fulfilled in this study, except for Cmin, which the Applicant originally calculated as the minimum value recorded during 24 hours at steady-state.
Slovenian: V tej študiji so bila izpolnjena vsa merila biološke enakovrednosti, razen za vrednost Cmin, ki jo je predlagatelj prvotno izračunal kot najmanjšo vrednost, zabeleženo v 24 urah dinamičnega ravnovesja.
English: A single dose study with the 16 mg dose after a high fat meal Single dose studies with the 8 mg and 16 mg formulations demonstrated bioequivalence with the reference product Reminyl (once daily), not only in the conventional bioequivalence range of 80-125%, but in an even tighter range of 90-111% for both AUCt and Cmax.
Slovenian: Študije z enim odmerkom s formulacijama 8 in 16 mg so dokazale biološko enakovrednost z referenčnim zdravilom Reminyl (enkrat dnevno), vendar ne samo v običajnem razponu biološke enakovrednosti 80-125 odstotkov, ampak celo v ožjem razponu 90-111 odstotkov za vrednost AUCt in Cmax.
English: Additionally the Applicant also presented as supportive data the peak-trough-fluctuation (%PTF) values for all three strengths and an analysis using repeated measurements of Cmin pd at days 10, 11 and 12 (i.e. at the 24 mg dose) of the multiple dose study.
Slovenian: Poleg tega je predlagatelj kot podporne podatke predložil tudi nihanje med najmanjšo in najvišjo koncentracijo (% PTF) za vse tri jakosti ter analizo s ponovitvami meritev vrednosti Cmin pd 10., 11. in 12. dan (tj. za 24-miligramski odmerek) študije z več odmerki.
English: As apparent from the protocol, Cmin (defined as minimum drug concentration in the dosing interval) was pre-specified as secondary parameter (descriptive statistics) and descriptive Cmin data had already been reported in the initial submission.
Slovenian: Kot je razvidno iz protokola, je bila vrednost Cmin (opredeljena kot najmanjša koncentracija zdravila v odmernem intervalu) predhodno določena kot sekundarni parameter (opisna statistika), o opisnih podatkih vrednosti Cmin pa so že poročali v prvotni vlogi.
English: If the Cmin values of the test product tend to decrease more than in a reference product, one could also expect lower clinical efficacy of the test product.
Slovenian: Če so vrednosti Cmin za preskušano zdravilo nagnjene k zmanjševanju v večji meri kot za referenčno zdravilo, lahko pričakujemo manjšo klinično učinkovitost preskušanega zdravila.
English: The CHMP agreed that although there is no explicit recommendation for computing of Cmin for prolonged release products at the present time, recommendations connected to immediate release products cannot be extrapolated to prolonged release products, which differ from immediate release products with respect to the shape of the pharmacokinetic profile.
Slovenian: CHMP se je strinjal, da kljub trenutni odsotnosti izrecnega priporočila za izračun vrednosti Cmin za zdravila s podaljšanim sproščanjem priporočil za zdravila s takojšnim sproščanjem ni možno ekstrapolirati na zdravila s podaljšanim sproščanjem, ki se razlikujejo od zdravil s takojšnim sproščanjem glede oblike farmakokinetičnega profila.
English: The CHMP was therefore of the view that the risk benefit ratio of Galantamine STADA is negative and that a marketing authorization should not be granted.
Slovenian: CHMP je zato menil, da je razmerje med koristmi in tveganji za zdravilo Galantamine STADA negativno, zato se dovoljenje za promet z zdravilom ne sme odobriti.
English: The CHMP was of the view that Cmin is considered to be an important rate parameter especially in multiple dose bioequivalence studies, and that demonstration of bioequivalence is of paramount importance.
Slovenian: CHMP je menil, da se vrednost Cmin šteje za pomemben parameter hitrosti, zlasti v študijah biološke enakovrednosti z več odmerki, in da je dokaz biološke enakovrednosti ključnega pomena.
English: It was clear, that the way for computing Cmin as Cminss was preferred initially, and descriptive statistics for this parameter were submitted in the final study report.
Slovenian: Jasno je bilo, da je bil način izračuna vrednosti Cmin v obliki Cminss prvotno prednostni, v končnem poročilu študije pa je bila predložena opisna statistika za ta parameter.
English: The Applicant was requested by the CHMP to provide justification for the choice of the method for Cmin calculation in the steady state study and also to discuss which definition of Cmin would best reflect the prolonged release characteristics of the product and allow detection of possible differences between test and reference product.
Slovenian: CHMP je predlagatelja zaprosil, da predloži utemeljitev izbire metode za izračun vrednosti Cmin v dinamičnem ravnovesju ter razpravlja o tem, katera opredelitev vrednosti Cmin bi najbolje odražala značilnost podaljšanega sproščanja zdravila ter omogočila odkrivanje možnih razlik med preskušanim in referenčnim zdravilom.
English: A study at steady state with the highest strength (24 mg) after gradual dose increase (8 mg and
Slovenian: študija v dinamičnem ravnovesju z največjo jakostjo (24 mg) po postopnem zviševanju odmerka
English: 1) Cminss defined as the lowest concentration on a concentration-time curve at steady-state within one dosing interval including the pre-dose concentration value.
Slovenian: 1) Vrednost Cminss opredeljena kot najnižja koncentracija na krivulji koncentracije v odvisnosti od časa v dinamičnem ravnovesju v enem odmernem intervalu, vključno z vrednostjo koncentracije pred odmerkom.
English: The CHMP concluded that bioequivalence had not been shown and that the pharmacokinetic characteristics suggest inferior performance of Galantamine STADA prolonged release capsules in comparison with the reference product.
Slovenian: Zaključek CHMP je, da biološka enakovrednost ni bila dokazana in da farmakokinetične značilnosti nakazujejo inferiorno zmogljivost zdravila Galantamine STADA kapsule s podaljšanim sproščanjem v primerjavi z referenčnim zdravilom.
English: 3) Cminss defined as the concentration 24 h after the 4th dose immediately before the next dose would be administered (Ctrough)
Slovenian: 3) Vrednost Cminss opredeljena kot koncentracija 24 ur po četrtem odmerku tik pred dajanjem naslednjega odmerka (Ctrough).
English: 2) Cminss defined as the concentration immediately before the 4th dose (Cpd)
Slovenian: 2) Vrednost Cminss opredeljena kot koncentracija tik pred četrtim odmerkom (Cpd).
English: The presented results of the single multiple dose steady state study demonstrated that Cmin values after the test product are likely to be substantially lower in comparison to the reference product.
Slovenian: Predstavljeni rezultati študije z več odmerki v dinamičnem ravnovesju so pokazali, da so vrednosti Cmin po preskušanem zdravilu verjetno bistveno nižje v primerjavi z referenčnim zdravilom.
English: In the study protocol of the multiple dose study, AUCT and Cmaxss after the 24 mg dose were proposed as primary parameters (for which bioequivalence was shown in the conventional bioequivalence range), while Cminss was not defined as primary pharmacokinetic parameter.
Slovenian: V študijskem protokolu študije z več odmerki sta bila kot primarna parametra (za katera je bila biološka enakovrednost dokazana v običajnem razponu biološke enakovrednosti) predlagani vrednosti AUCT in Cmaxss po 24-miligramskem odmerku, vrednost Cminss pa ni bila opredeljena kot primarni farmakokinetični parameter.
English: IS-CV of the single dose studies had been taken into account for the sample size calculation of the multiple dose study and that the study was not powered for the higher IS-CV of Cminss.
Slovenian: Predlagatelj je razložil, da so vrednost IS-CV iz študij z enim odmerkom upoštevali pri izračunu velikosti vzorca za študijo z več odmerki in da študija ni imela zadostne moči za večje vrednosti IS-CV za Cminss.
English: It was noted that while Cmin and Ctrough should be the same for immediate release products, they usually differ for prolonged release products.
Slovenian: Ugotovljeno je bilo, da se vrednosti Cmin in Ctrough pri zdravilih s podaljšanim sproščanjem običajno razlikujeta, čeprav bi morali biti enaki kot pri zdravilih s takojšnim sproščanjem.
English: 16 mg for 4 days each with dosing after a light meal).
Slovenian: (8 mg in 16 mg za 4 dni z jemanjem zdravila po lahkem obroku).