FrancophonIA/ELRC3.0 huggingface dataset:
English: Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
Slovenian: V tri študije so bili vključeni bolniki, ki so se prenehali odzivati na botulinski toksin vrste A (druga vrsta botulinskega toksina, ki se prav tako lahko uporablja za zdravljenje cervikalne distonije), v četrto študijo pa so bili vključeni le bolniki, ki so se odzivali na toksin vrste A. Učinkovitost so merili z opazovanjem sprememb simptomov (resnost, bolečina in nezmožnost) po štirih tednih, ki so jih zabeležili z uporabo lestvice za oceno spazmičnega tortikolisa Toronto Western (Toronto Western Spasmodic Torticollis Rating Scale - TWSTRS).
English: NeuroBloc contains the active substance botulinum toxin type B.
Slovenian: Zdravilo NeuroBloc vsebuje učinkovino botulinski toksin vrste B.
English: How is NeuroBloc used?
Slovenian: Kako se zdravilo NeuroBloc uporablja?
English: London, 26 April 2007 Doc.
Slovenian: London, 26. aprila 2007 Sklic dok.
English: ‘Primary' means that there is no known reason for the insensitivity.
Slovenian: „Primarno“ pomeni, da za neobčutljivost ni znanih razlogov;
English: In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
Slovenian: V študiji je 27 otrok (starih od 3 do 15 let) prejemalo zdravilo IPLEX do največ enega leta.
English: International non-proprietary name (INN): mecasermin rinfabate
Slovenian: Mednarodno nelastniško ime (INN): mekasermin rinfabat
English: The main measure of effectiveness was based on the speed of growth during the study, compared to that in the year before the study began.
Slovenian: Glavno merilo učinkovitosti je temeljilo na primerjavi hitrosti rasti med študijo in hitrosti v letu pred začetkom študije.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preizkušanje ali program sočutne uporabe in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: Patients had also not been treated for long enough to show that the medicine's effect continues when used for longer than one year.
Slovenian: Zdravljenje bolnikov poleg tega ni trajalo dovolj dolgo, da bi lahko dokazalo učinkovanje zdravila tudi pri uporabi, daljši od enega leta.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo IPLEX
English: Its effectiveness has been studied in one clinical trial, which is still ongoing.
Slovenian: Učinkovitost zdravila se preučuje v enem kliničnem preizkušanju, ki še vedno poteka.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Slovenian: Ko CHMP izda mnenje, potrebuje Evropska komisija še približno dva meseca, da izda dovoljenje.
English: Because the number of patients with these diseases is low, they are considered ‘rare', and mecasermin rinfabate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 June 2006.
Slovenian: Ker je število bolnikov s temi boleznimi majhno, bolezen velja za redko, zato je bil mekasermin rinfabat 20. junija 2006 opredeljen kot zdravilo sirota (zdravilo za redke bolezni).
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila IPLEX?
English: • they have primary insensitivity to the hormone, so that injected growth hormone has no effect.
Slovenian: • so primarno neobčutljivi na hormon, tako da vbrizgan hormon nima nikakršnih učinkov.
English: The effects of IPLEX were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila IPLEX so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: Ko podjetje predloži odgovore na vprašanja, jih CHMP pregleda, pred izdajo mnenja pa lahko na 180. dan zaprosi podjetje še za odgovore na dodatna vprašanja.
English: In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
Slovenian: IGF-I v zdravilu IPLEX je vezano na IGFBP-3, ker se s tem posnema način, po katerem se IGF-1 prenaša po telesu.
English: IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because:
Slovenian: Zdravilo IPLEX naj bi se uporabljalo pri otrocih majhne postave, katerih telesa imajo težave z rastnim hormonom, ker:
English: Ref. EMEA/111199/2007
Slovenian: EMEA/231332/2007
English: Mecasermin rinfabate is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Slovenian: Mekasermin rinfabat se izdeluje z metodo, ki se imenuje „tehnologija rekombinantne DNA“: tvori ga celica, ki je prejela gen (DNA), zaradi katerega lahko tvori mekasermin rinfabat.
English: They also had major concerns regarding the way in which the medicine's effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Slovenian: Glavni zadržki CHMP so se nanašali tudi na način ocenjevanja učinkovitosti zdravila, zlasti glede tipov bolnikov, ki so jih vključili v klinično preizkušanje.
English: This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Slovenian: Zaradi tega lahko IGF-I po telesu kroži pri večji koncentraciji in dlje časa kakor nevezani IGF-I.
English: The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Slovenian: Podjetje je CHMP obvestilo, da umik vloge ne bo imel vpliva na potekajočo klinično študijo varnosti in učinkovitosti zdravila IPLEX pri zdravljenju sindroma neobčutljivosti na rastni hormon.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da koristi zdravila IPLEX niso bile zadostno dokazane in niso večje od znanih tveganj.
English: IPLEX is a solution for injection containing 60 mg/ml mecasermin rinfabate as the active substance.
Slovenian: Zdravilo IPLEX je raztopina za injiciranje, ki kot zdravilno učinkovino vsebuje 60 mg/ml mekasermin rinfabata.
English: In the body, natural growth hormone promotes growth in children by stimulating the body to produce IGF-I. IGF-I then stimulates the bones to grow.
Slovenian: Naravni rastni hormon pospešuje telesno rast otrok, tako da telo spodbuja k tvorjenju IGF-I, ta pa nadalje spodbuja rast kosti.
English: • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
Slovenian: • niso sposobni proizvajati rastnega hormona in so v preteklosti prejemali rastni hormon, a so proti njemu razvili protitelesa, posebne beljakovine, ki vbrizganemu hormonu preprečujejo, da bi imel kakršne koli učinke.
English: What is IPLEX?
Slovenian: Kaj je zdravilo IPLEX?
English: On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Slovenian: Dne 26. marca 2007 je podjetje Insmed Europe Ltd uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom IPLEX, ki je namenjeno zdravljenju bolnikov s primarno neobčutljivostjo na rastni hormon in bolnikov z delecijo gena rastnega hormona, ki so razvili protitelesa za nevtralizacijo rastnega hormona.
English: The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Slovenian: Mekasermin rinfabat, ki je zdravilna učinkovina zdravila IPLEX, je dvojna beljakovina, sestavljena iz dveh beljakovin, ki ju telo proizvaja v normalnih pogojih: insulinu podobnega rastnega faktorja (IGFI) in insulinu podobnega veznega proteina 3 (IGFBP-3).
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Slovenian: Na podlagi pregleda podatkov, ki so bili na razpolago v času umika vloge, je imel CHMP nekaj zadržkov in je izdal začasno mnenje, da zdravila IPLEX ni mogoče odobriti za zdravljenje bolnikov s primarno neobčutljivostjo na rastni hormon in bolnikov z delecijo gena rastnega hormona, ki so razvili protitelesa za nevtralizacijo rastnega hormona.
English: The CHMP had major concerns regarding the way the medicine is manufactured, and they were unsure that the medicine that would have been marketed would have been comparable to the one used in the clinical trial.
Slovenian: Glavni zadržki CHMP so se nanašali na način proizvodnje zdravila, saj CHMP ni bil prepričan, da bo za tržišče proizvedeno zdravilo primerljivo tistemu, ki se uporablja v kliničnem preizkušanju.
English: IPLEX provides IGF-I directly, as part of the binary protein, and this allows bone growth while bypassing the need for growth hormone itself.
Slovenian: Zdravilo IPLEX telo oskrbuje neposredno z IGF-I, ki je del dvojne beljakovine, in s tem omogoča rast kosti brez potrebe po samem rastnem hormonu.
English: What was IPLEX expected to be used for?
Slovenian: Za kaj naj bi se zdravilo IPLEX uporabljalo?
English: How is IPLEX expected to work?
Slovenian: Kako naj bi zdravilo IPLEX delovalo?
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Slovenian: Podjetje še ni odgovorilo na ta vprašanja.
English: The application was at day 120 when the company withdrew.
Slovenian: Podjetje je umaknilo vlogo na 120. dan. CHMP je pripravil seznam vprašanj, na katere naj bi podjetje odgovorilo.
English: The divergent positions are appended to this opinion.
Slovenian: Razhajajoča se stališča so priložena temu mnenju.
English: On 15 July 2011, Germany triggered a referral under Article 31 of Directive 2001/83/EC.
Slovenian: Nemčija je 15. julija 2011 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES.
English: This effect is well demonstrated in several animal models.
Slovenian: Učinek je bil dokazan na različnih živalskih modelih.
English: Tolperisone-containing products are currently approved in the following EU countries: Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
Slovenian: Zdravila, ki vsebujejo tolperizon, so trenutno odobrena v naslednjih državah EU: v Bolgariji, na Cipru, v Češki republiki, Nemčiji, na Madžarskem, v Latviji, Litvi, na Poljskem, v Romuniji ter v Slovaški republiki.
English: The precise mechanism of action is not fully known.
Slovenian: Natančen mehanizem njegovega delovanja ni povsem znan.
English: Therefore, in accordance with Article 32(4)(d) of Directive 2001/83/EC, the CHMP recommended:
Slovenian: CHMP je torej v skladu s členom 32(4)(d) Direktive 2001/83/ES priporočil:
English: There are a few studies where a parenteral formulation was used.
Slovenian: Obstaja nekaj študij, v katerih je bila uporabljena parenteralna oblika.
English: The CHMP also consulted its Neurology Scientific Advisory Group (SAG).
Slovenian: CHMP se je posvetoval tudi s svojo znanstveno svetovalno skupino za nevrologijo (SAG).
English: It is well known that the safety profile of a product may vary depending on the formulation.
Slovenian: Splošno znano je, da je varnostni profil zdravila lahko različen glede na formulacijo.
English: In addition, all patients started by receiving doses above the approved dose.
Slovenian: Poleg tega so vsi bolniki na začetku prejemali odmerke, višje od odobrenih.
English: Tolperisone exerts its action at 3 levels:
Slovenian: Tolperizon deluje na 3 ravneh:
English: The following indications have been approved in at least one Member State (specific wording of the indication may vary from product to product):
Slovenian: Najmanj ena od držav članic je potrdila indikacije, naštete v nadaljevanju (besedilo indikacije se lahko od zdravila do zdravila razlikuje):
English: In contrast, the prematurely terminated Avigen study AV650-018 (2007) failed to demonstrate any effect in the multiple sclerosis population.
Slovenian: Po drugi strani predčasno zaključena študija AV650-018 podjetja Avigen (2007) ni pokazala nobenih učinkov pri populaciji bolnikov z multiplo sklerozo.
English: This indication is mainly supported by the Stamenova (2005) study, which is of acceptable quality.
Slovenian: Ta indikacija pretežno temelji na študiji, ki jo je izvedla Stamenova (2005), in je sicer sprejemljive kakovosti.
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for medicinal products containing tolperisone, and associated names should be maintained, varied, suspended or withdrawn.
Slovenian: Zato je bil CHMP zaprošen za mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo tolperizon, in povezanimi imeni ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: The CHMP therefore carried out a new assessment of the available efficacy data in the concerned indication.
Slovenian: CHMP je torej opravil novo oceno razpoložljivih podatkov o učinkovitosti pri zadevni indikaciji.
English: The conditions affecting the marketing authorisations are set out in Annex IV.
Slovenian: Pogoji za dovoljenja za promet z zdravilom so določeni v Prilogi IV.
English: In particular, the CHMP re-assessed 4 pooled analyses (Alken-2005, Farkas-2011, Varga2011a and Varga-2011b) of randomised clinical trials (Pratzel 1995, Struck 2002 and Struck 2004) and requested the Biostatistics Working Party (BSWP) to give its view on the pooled analyses data.
Slovenian: Zlasti je znova ocenil štiri združene analize (Alken 2005, Farkas 2011, Varga 2011a in Varga 2011b) randomiziranih kliničnih preskušanj (Pratzel 1995, Struck 2002 in Struck 2004) ter zaprosil delovno skupino za biostatistiko (BSWP), naj poda svoje mnenje o podatkih združenih analiz.
English: Overall summary of the scientific evaluation of tolperisone-containing products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo tolperizon (glejte Prilogo I)
English: It is therefore considered that efficacy in these indications has not been demonstrated.
Slovenian: Zato velja, da učinkovitost zdravila v zvezi s temi indikacijami ni dokazana.
English: The data available on this indication comes from two observational studies (1986 and 1989) with a total of 166 patients, where 450 mg tolperisone were given daily for a few weeks.
Slovenian: Podatke, na voljo v zvezi s to indikacijo, sta zagotovili dve opazovalni študiji (1986 in 1989), ki sta skupaj zajeli 166 bolnikov, ki so nekaj tednov dnevno prejemali 450 mg tolperizona.
English: Overall, the SAG considered that the analyses has not been performed appropriately and that the provided data did not allow an assessment of how the various population and treatment characteristics were taken into account for the analyses.
Slovenian: Na splošno je menila, da analize niso bile ustrezno izvedene in da na podlagi predloženih podatkov ni mogoče oceniti, kako so bile pri analizah upoštevane značilnosti različnih populacij in zdravljenja.
English: Tolperisone is a centrally acting muscle relaxant first synthesized in 1956, and used in clinical practice since the 1960's.
Slovenian: Tolperizon je mišični relaksant, ki deluje na osrednje živčevje in je bil prvič sintetiziran leta 1956, v klinični praksi pa so ga začeli uporabljati v 60. letih prejšnjega stoletja.
English: Annex II Scientific conclusions and grounds for Variation to the terms of the Marketing Authorisations (oral formulations) and Revocation of the Marketing Authorisations (parenteral formulations)
Slovenian: Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom (peroralne oblike) ter preklic dovoljenj za promet z zdravilom (parenteralne oblike)
English: Hypotheses include structural similarity to the local anaesthetic lidocaine, so the risk for cross-reactions needs to be consistently described in the product information.
Slovenian: Ena izmed hipotez je, da obstaja strukturna podobnost z lokalnim anestetikom lidokainom, zato mora biti tveganje za navzkrižne reakcije dosledno opisano v informacijah o zdravilu.
English: The interim analysis results indicated that it failed to achieve statistical significance in any evaluated efficacy endpoint.
Slovenian: Vmesni rezultati analiz so pokazali, da učinki niso dosegli statistične značilnosti v nobenem od zaključenih opazovanih dogodkov učinkovitosti.
English: It is also noted that the reporting rates in Germany appear to be significantly higher than those calculated through the MAH's database.
Slovenian: Ugotovljeno je bilo tudi, da je stopnja pogostosti poročanja v Nemčiji verjetno znatno višja, kot kažejo izračuni na podlagi podatkovne baze imetnika dovoljenja za promet z zdravilom.
English: It was noted that information in the Summary of Product Characteristics regarding interactions, effects on ability to drive and use machines and effect of food on pharmacokinetic parameters was not reflecting the latest available data.
Slovenian: Ugotovljeno je bilo, da informacije v povzetku glavnih značilnosti zdravila o medsebojnem delovanju zdravil, vplivu na sposobnost vožnje in upravljanje s stroji ter vplivu hrane na farmakokinetične parametre ne odražajo najnovejših razpoložljivih podatkov.
English: Due to lack of adequate data, no firm conclusions on the influence of renal or hepatic function can be drawn, although the existing data does not raise cause for concern.
Slovenian: Zaradi pomanjkanja ustreznih podatkov ni mogoče podati zanesljivih zaključkov glede vpliva na delovanje ledvic in jeter, vendar pa na podlagi obstoječih podatkov ni razloga za skrb.
English: The actively controlled study was open label, used pentoxyphyllin as control and involved a total of 70 patients.
Slovenian: Aktivno nadzorovana študija je bila odprtega tipa, za kontrolno sredstvo je bil uporabljen pentoksifilin, skupno pa je bilo vključenih 70 bolnikov.
English: The product information should also be updated so that all products contain consistent and updated information on interactions, effects on ability to drive and use machines, the effect of food on bioavailability, influence of renal or hepatic function and adverse reactions.
Slovenian: Poleg tega je treba informacije o zdravilu posodabljati, da se zagotovi, da vsi izdelki vsebujejo dosledne in posodobljene informacije o medsebojnem delovanju zdravil, vplivu na sposobnost vožnje in upravljanje s stroji, vplivu hrane na biološko uporabnost, vplivu na delovanje ledvic in jeter ter o neželenih učinkih.
English: The CHMP also considered a recently conducted meta-analysis presented during the October 2012 oral explanation but raised concerns with regard to the methodology of the analysis and the quality of the included individual studies and therefore concluded that this meta-analysis did provide any additional support of the efficacy of tolperisone.
Slovenian: CHMP je upošteval tudi nedavno izvedeno metaanalizo, predstavljeno med ustno razlago oktobra 2012, vendar je izrazil pomisleke v zvezi z metodologijo analize in kakovostjo vključenih posamičnih študij ter zato sklenil, da ta metaanaliza ne zagotavlja nobene dodatne potrditve učinkovitosti tolperizona.
English: The mechanism of tolperisone-related hypersensitivity is unknown.
Slovenian: Mehanizem preobčutljivosti, povezane s tolperizonom, ni znan.
English: It was also noted that not all products mentioned the adverse events confusion and hyperhidrosis in the product information and that this should be harmonised.
Slovenian: Prav tako je bilo ugotovljeno, da nista bila pri vseh izdelkih v informacije o zdravilu vključena neželena dogodka zmedenost in hiperhidroza, kar bi bilo treba poenotiti.
English: The currently approved product information does not seem to adequately reflect the risk or communicate it to patients in order to allow early identification of signs of hypersensitivity.
Slovenian: Zdi se, da trenutno odobrene informacije o zdravilu neustrezno odražajo tveganja oziroma jih bolnikom ne posredujejo na način, ki bi omogočal zgodnje prepoznavanje znakov preobčutljivosti.
English: The Ashworth scale used in this study is a validated instrument generally accepted for the clinical evaluation of degree of spasticity.
Slovenian: Ashworthova lestvica, uporabljena v študiji, je potrjen instrument, ki se splošno uporablja za klinično vrednotenje stopnje spastičnosti.
English: Neurolahyrism affects predominantly young adult males at time of famine and generally does not occur in European countries, therefore generalisation of the study results to the existing indication is questionable.
Slovenian: Nevrolatirizem pretežno prizadene mlajše odrasle moške ob pomanjkanju hrane in se načeloma ne pojavlja v evropskih državah, zato je vprašljivo, ali je rezultate študije mogoče posplošiti in vključiti v obstoječe indikacije.
English: There is a discrepancy between the patterns of spontaneous reports and the reports from studies.
Slovenian: Med vzorcema spontanih poročil in poročil, ki so jih zagotovile študije, obstajajo določena razhajanja.
English: It is capable of inhibiting the pathological peripheral impulse condition induced by pain, which could start various motoric or vegetative reflexes that would lead to increased muscular tone.
Slovenian: Pomaga lahko zavirati patološko vzdraženost perifernih receptorjev, ki jo sproži bolečina in lahko povzroči različne motorične ali vegetativne reflekse, ki bi vodili do povišanega mišičnega tonusa.
English: However, it only included patients with spasticity caused by neurolathyrism.
Slovenian: Vendar pa je študija zajela samo bolnike s spastičnostjo, ki jo povzroča nevrolatirizem.
English: • The Committee considered that the risk of hypersensitivity reactions is more significant than previously identified.
Slovenian: • da je odbor ocenil, da je tveganje za preobčutljivostne reakcije večje, kot je bilo sprva ugotovljeno;
English: The only studies that exist are of observational nature, were conducted in a heterogeneous population and contain extremely limited information.
Slovenian: Edine obstoječe študije so opazovalne narave, poleg tega pa so zajele heterogeno populacijo bolnikov in so ponudile izjemno omejene informacije.