FrancophonIA/ELRC3.0 huggingface dataset:
English: [For all chlormadinone containing combined hormonal contraceptives listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za vsa zdravila, ki vsebujejo klormadinon, navedena v Prilogi I, se obstoječe informacije o zdravilu spremenijo (vstaviti, nadomestiti ali izbrisati besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains gestodene such as [invented name] between about 9 and 12 women will develop a blood clot in a year.
Slovenian: - Pri 10.000 ženskah, ki uporabljajo kombinirane hormonske kontraceptive ki vsebujejo gestoden kot je zdravilo [izmišljeno ime], bo krvni strdek nastal pri približno 9-12 ženskah na leto.
English: It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.
Slovenian: Ocenjuje se, da se bo v enem letu VTE pojavila pri približno 61 od 10.000 žensk, ki uporabljajo kombinirane hormonske kontraceptive, ki vsebujejo levonorgestrel.
English: [For all etonogestrel containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za vsa zdravila, ki vsebujejo etonogestrel, navedena v Prilogi I/A, se obstoječe informacije o zdravilu spremenijo (vstaviti, nadomestiti ali izbrisati besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]
English: [For all drospirenone containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za vsa zdravila, ki vsebujejo drospirenon, navedena v Prilogi I, se obstoječe informacije o zdravilu spremenijo (vstaviti, nadomestiti ali izbrisati besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]
English: [For all gestodene containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Za vsa zdravila, ki vsebujejo dienogest, navedena v Prilogi I, se obstoječe informacije o zdravilu spremenijo (vstaviti, nadomestiti ali izbrisati besedila, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]
English: The procedure was initiated on 17 November 2009.
Slovenian: Postopek se je začel dne 17. novembra 2009.
English: Grounds for refusal
Slovenian: Podlage za zavrnitev
English: Overall summary of the scientific evaluation of Genotropin and associated names (see annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Genotropin in povezanih imen (glejte Prilogo I)
English: • The Committee considered the referral made under article 6(12) of Commission Regulation (EC) No 1084/2003;
Slovenian: • Odbor je upošteval napotitev v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003.
English: 2900AA Capelle aan den Ijssel
Slovenian: 2900AA Capelle aan den Ijssel The Netherlands
English: Data from the German national JIA registry indicates that, in 2007, around 20% of the 1941 subjects under the age of 18 required ongoing systemic glucocorticoid treatment.
Slovenian: Podatki iz nemškega nacionalnega registra JIA kažejo, da je v letu 2007 približno 20 % od 1 941 preiskovancev, mlajših od 18, potrebovalo stalno sistemsko zdravljenje z glukokortikoidi.
English: The etiology is largely unknown, but it is likely that autoimmune factors play a role.
Slovenian: Etiologija je večinoma neznana, vendar je verjetna vpletenost avtoimunskih dejavnikov.
English: In about 20% of the optimal treated patients, glucocorticoid treatment is necessary.
Slovenian: Približno 20 % optimalno zdravljenih bolnikov potrebuje zdravljenje z glukokortikoidi.
English: As the Reference and Concerned member States were not able to reach an agreement in respect of the variation, on 28 October 2009, the Netherlands triggered a referral under Article 6(12) of Commission Regulation EC No 1084/2003.
Slovenian: Ker referenčna država članica in zadevne države članice niso dosegle dogovora glede te spremembe, je dne 28. oktobra 2009 Nizozemska sprožila napotitveni postopek po členu 6(12) Uredbe Komisije ES št. 1084/2003.
English: Clinical benefits
Slovenian: Klinične koristi
English: Genotropin and associated names is a recombinant human growth hormone that has received marketing authorisation in the European Union under the different names listed in annex I.
Slovenian: Zdravilo Genotropin in z njim povezana imena so rekombinantni humani rastni hormon, ki ima v Evropski uniji dovoljenje za promet pod različnimi imeni, ki so navedena v Prilogi I.
English: The proposed dose, 0.047 mg/kg/day, was only used in one of the investigator published studies.
Slovenian: Predlagani odmerek, 0,047 mg/kg/dan, so uporabili le v eni študiji, ki jo je objavil raziskovalec.
English: On 30 July 2008, the MAH submitted a type II variation via the mutual recognition procedure for Genotropin and associated names (DK/H/0012/001,004-6,008-024/II/118), to request an extension of the indications.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dne 30. julija 2008 za zdravilo Genotropin in z njim povezana imena vložil vlogo za spremembo vrste II po postopku z medsebojnim priznavanjem (DK/H/0012/001,004-6,008-024/II/118) za razširitev indikacij.
English: It should be noted that baseline IGF-1 is usually low in JIA patients and may be further reduced by steroids.
Slovenian: Upoštevati je treba, da je izhodiščna raven IGF-1 pri bolnikih z JIA običajno nizka, lahko pa se še zniža s steroidi.
English: Biological therapies are not effective in all patients therefore, while in absolute figures the population under discussion may now be smaller than in the past, there is still an unmet medical need.
Slovenian: Biološko zdravljenje ni učinkovito pri vseh bolnikih, in čeprav so absolutne številke v obravnavani populaciji sedaj morda manjše kot v preteklosti, še vedno obstaja neizpolnjena zdravstvena potreba.
English: Overall, in the studies presented, the safety profile was comparable to that of other Genotropin indications and consistent with its pharmacological class.
Slovenian: Na splošno je v predloženih študijah varnostni profil primerljiv drugim indikacijam zdravila Genotropin ter dosleden s svojo farmakološko skupino.
English: The diagnosis is made by exclusion of other known, specific conditions causing arthritis and requires objective evidence of arthritis of at least 6 weeks duration in children younger than 16 at time of onset.
Slovenian: Diagnoza se postavi z izključevanjem drugih znanih, specifičnih stanj, ki povzročajo artritis, pri čemer je potreben objektiven dokaz artritisa, ki traja vsaj 6 tednov, pri otrocih, ki so bili ob pojavu bolezni mlajši od 16 let.
English: However the potential for development of malignancies may be higher in this patient group than in other indications, in view of the concomitant immunosuppression required in JIA.
Slovenian: Vendar je lahko potencial za razvoj malignih bolezni v tej skupini bolnikov večji kot pri drugih indikacijah zaradi sočasne imunosupresije, ki jo zahteva JIA.
English: Only 4 of the 6 studies were conducted by the MAH (the remaining were investigator initiated published studies), and only 1 of these 4 included a control group.
Slovenian: Le 4 od 6 študij je opravil imetnik dovoljenja za promet z zdravilom (ostale so objavljene študije na pobudo raziskovalcev), samo 1 od teh 4 pa je vsebovala kontrolno skupino.
English: The acute diabetogenic effect of growth hormone is well-known.
Slovenian: Akutni diabetogeni učinek rastnega hormona je dobro znan.
English: Despite the recent introduction of biological therapies as an alternative for JIA patients, the medical need for treatment in the proposed population still exists.
Slovenian: Kljub nedavni uvedbi biološkega zdravljenja kot alternativnega za bolnike z JIA zdravstvene potrebe po zdravljenju v predlagani populaciji še niso izpolnjene.
English: The absence of such information makes the scarce data available of limited value.
Slovenian: Ker teh informacij ni, imajo redki razpoložljivi podatki omejeno vrednost.
English: Although the benefits of increased height in quality of life are accepted in some of the other indications (growth hormone deficiency), they have not been clearly demonstrated in this indication.
Slovenian: Čeprav so koristi povečane telesne višine pri kakovosti življenja sprejete pri nekaterih drugih indikacijah (pomanjkanje rastnega hormona), pa niso bile jasno dokazane v tej indikaciji.
English: the CHMP has recommended the refusal of the variation of the Marketing Authorisations.
Slovenian: CHMP je priporočil zavrnitev spremembe dovoljenj za promet z zdravilom.
English: The SAG also expressed the opinion that, while this treatment could potentially represent a significant benefit for some patients, the data submitted did not demonstrate the occurrence of clinical benefits such as protection against bone loss, improvement in lean body mass, muscle strength or well being in the subjects of the studies.
Slovenian: SAG je izrazila tudi mnenje, da čeprav to zdravljenje potencialno predstavlja bistveno korist za določene bolnike, predloženi podatki ne dokazujejo kliničnih koristi, kot so zaščita pred izgubljanjem kostnine, izboljšanje puste telesne mase, mišične jakosti ali dobrega počutja preiskovancev v študijah.
English: While it is recognized that data from different sources seems to be consistent and to indicate a possible positive effect of growth hormone on growth velocity in this indication, the existing data is too limited to draw a conclusion on the efficacy.
Slovenian: Čeprav se šteje, da se zdijo podatki iz različnih virov dosledni in kažejo možen pozitiven učinek rastnega hormona na hitrost rasti pri tej indikaciji, je obstoječih podatkov premalo za zaključke o učinkovitosti.
English: The impact of growth hormone treatment on these clinically relevant endpoints in this indication is unclear.
Slovenian: Učinek zdravljenja z rastnim hormonom na te klinično pomembne končne točke za to indikacijo je neznan.
English: The diagnosis of growth disturbance should be confirmed by a current height SDS <-2 or a growth velocity SDS < -1, measured over a period of at least 12 months.
Slovenian: Diagnozo motnje rasti je treba potrditi s točkami standardnega odklona trenutne telesne višine <-2 ali hitrosti rasti < -1, izmerjeno v obdobju vsaj 12 mesecev.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Dodatek I Seznam imen, farmacevtskih oblik, jakosti Zdravila, poti uporabe, imetnikov dovoljenj Za promet v državah članicah
English: Based on the above, the CHMP concluded that the application does not satisfy the criteria for authorisation in respect of safety and efficacy.
Slovenian: Na podlagi opisanega je CHMP zaključil, da vloga ne izpolnjuje meril za odobritev z vidika varnosti in učinkovitosti.
English: Due to the chronic nature of the disease with recurrent flares, long term therapy with glucocorticoids is often necessary after the initial diagnosis.
Slovenian: Zaradi kronične narave bolezni z zagoni je po prvotni diagnozi pogosto potrebno dolgotrajno zdravljenje z glukokortikoidi.
English: Therefore it is considered by the Committee that efficacy in the proposed dose for the proposed indication is not adequately demonstrated.
Slovenian: Zato Odbor šteje, da učinkovitost predlaganega odmerka za predlagano indikacijo ni zadostno dokazana.
English: In addition, information on quality of life was not collected in any of the sponsored trials.
Slovenian: Poleg tega v nobenem sponzoriranem preskušanju niso bile zbrane informacije o kakovosti življenja.
English: Netherlands Pfizer BV Postbus 37
Slovenian: Nizozemska Pfizer BV Postbus 37
English: This dose was not used in the pivotal trials or in the supportive trials.
Slovenian: Tega odmerka niso uporabili niti v ključnih niti v podpornih preskušanjih.
English: The application submitted by the MAH contained 4 company sponsored studies, including 2 pivotal trials, and 2 investigator initiative studies:
Slovenian: Vloga imetnika dovoljenja za promet z zdravilom je vsebovala 4 študije, ki jih je sponzorirala družba, vključno z 2 ključnima preskušanjema, ter 2 študiji na pobudo raziskovalcev:
English: Sweden Pfizer AB , 191 90 Sollentuna, Sverige
Slovenian: Pfizer AB , 191 90 Sollentuna, Sverige
English: • The Committee, as a consequence, concluded that the variation application does not satisfy the criteria for authorisation in respect of safety and efficacy.
Slovenian: • Posledično je Odbor zaključil, da vloga za spremembo ne izpolnjuje meril za odobritev z vidika varnosti in učinkovitosti.
English: Growth disturbance in children with severe forms of juvenile idiopathic arthritis (JIA), requiring long term glucocorticoid treatment, for improvement of growth and body composition.
Slovenian: Motnje rasti pri otrocih s hudimi oblikami juvenilnega idiopatskega artritisa (JIA), ki zahtevajo dolgotrajno zdravljenje z glukokortikoidom, za izboljšanje rasti in telesne sestave.
English: However, even if it is understood that the population eligible for treatment is limited, the efficacy database in absolute numbers is small.
Slovenian: Čeprav se šteje, da je populacija, primerna za zdravljenje, omejena, so absolutne številke v zbirki učinkovitosti majhne.
English: Although glucocorticoid therapy leads to significant improvement of signs and symptoms, it is invariably associated with substantial growth impairment and alterations in body composition in the majority of treated children.
Slovenian: Čeprav zdravljenje z glukokortikoidi bistveno izboljša znake in simptome, je pri večini zdravljenih otrok povezano z bistvenim zastojem rasti in spremembami telesne sestave.
English: The most severe forms of JIA often require aggressive therapy with disease modifying antirheumatic drugs (DMARDs), including biologicals, methotrexate, cyclosporine and glucocorticoids to control inflammation, arthritis and other clinical manifestations.
Slovenian: Najhujše oblike JIA pogosto zahtevajo agresivno zdravljenje z antirevmatiki, ki modulirajo bolezen (DMARD), vključno z biološkimi zdravili, metotreksatom, ciklosporinom in glukokortikoidi za obvladovanje vnetja, artritisa in drugih kliničnih manifestacij.
English: • The Committee considered that the Marketing Authorisation Holders did not present data demonstrating the efficacy of Genotropin in the proposed indication and for the proposed posology.
Slovenian: • Odbor je upošteval, da imetniki dovoljenja za promet z zdravilom niso predložili podatkov, ki bi dokazali učinkovitost zdravila Genotropin za predlagano indikacijo in za predlagano odmerjanje.
English: The CHMP was requested to give its opinion on whether the marketing authorisations should be varied to include the indication:
Slovenian: CHMP so prosili za mnenje, ali se lahko dovoljenja za promet z zdravilom spremenijo tako, da se doda naslednja indikacija:
English: In all the studies presented, growth velocity increased with Genotropin treatment above control and/or baseline values.
Slovenian: V vseh predloženih študijah se je po zdravljenju z zdravilom Genotropin hitrost rasti povečala nad kontrolno in/ali izhodiščno vrednost.
English: Lagoas Park, Edifício 10
Slovenian: Lagoas Park,
English: The study designs and efficacy endpoints were similar as those of the pivotal/supportive studies, except that smaller doses were used (0.0290.047 mg/kg/day in Bechtold and 0.045 mg/kg/day in Grote).
Slovenian: Zasnovi študij in končni točki učinkovitosti sta bili podobni kot pri ključnih/podpornih študijah, vendar so uporabili manjše odmerke (0,029-0,047 mg/kg/dan v Bechtoldovi študiji in 0,045 mg/kg/dan v Grotejevi študiji).
English: The long term effects of the combination between growth hormone and corticosteroids are not known, and were not investigated in the studies presented.
Slovenian: Dolgoročni učinki kombinacije rastnega hormona in kortikosteroidov niso znani in niso raziskani v predloženih študijah.
English: However very limited data is available on final height for the pivotal trials, so the benefit of the treatment in the proposed indication was not adequately demonstrated.
Slovenian: Vendar je za končno višino v ključnih preskušanjih na voljo zelo malo podatkov, zato korist zdravljenja predlagane indikacije ni zadostno dokazana.
English: Dose selection
Slovenian: Izbira odmerka
English: The CHMP Scientific Advisory Group (SAG) on Diabetes/Endocrinology was consulted on these issues and took the view that the data were suggestive of a short-term benefit of therapy, however there is little information on final height so considerable extrapolation would be required to conclude on the efficacy in this indication.
Slovenian: Znanstvena svetovalna skupina (SAG) za sladkorno bolezen/endokrinologijo pri CHMP je po posvetovanju zavzela stališče, da podatki nakazujejo kratkotrajno korist zdravljenja, vendar je malo informacij o končni telesni višini, zato bi bila za zaključek o učinkovitosti pri tej indikaciji potrebna bistvena ekstrapolacija.
English: Final height
Slovenian: Končna telesna višina
English: The CHMP SAG on Diabetes/Endocrinology was consulted and expressed concerns regarding the long-term safety of the product.
Slovenian: SAG za sladkorno bolezen/endokrinologijo pri CHMP je po posvetovanju izrazil zadržke glede dolgotrajne varnosti zdravila.
English: The majority of data on final height comes from 13 Genotropin subjects in the Bechtold study, where many of the confounding factors were not adequately addressed, therefore it is not possible to draw conclusions from these data.
Slovenian: Glavnina podatkov o končni višini je na voljo od 13 preiskovancev, ki so prejemali zdravilo Genotropin v Bechtoldovi študiji, v kateri pa niso primerno obravnavali številnih begavih dejavnikov, zato na osnovi teh podatkov ni možno napraviti zaključkov.
English: The pivotal trials supporting the application did not include information on quality of life, in addition to the lack of information on final height.
Slovenian: Ključna preskušanja, ki podpirajo vlogo, poleg pomanjkanja informacij o končni višini tudi niso vsebovala informacij o kakovosti življenja.
English: • The Committee considered that the benefit risk balance of the product in the proposed indication is not positive.
Slovenian: • Odbor je upošteval, da razmerje med koristmi in tveganji za zdravilo za predlagano indikacijo ni pozitivno.
English: • The Committee considered that there are potential long term risks associated with growth hormone treatment (such as tumour promotion or diabetes), which may be aggravated in this indication by the prolonged concomitant administration of corticosteroids;
Slovenian: • Odbor je upošteval, da obstajajo morebitna dolgoročna tveganja, povezana z zdravljenjem z rastnim hormonom (kot so pospeševanje tumorjev in sladkorna bolezen), ki se lahko izrazijo pri tej indikaciji zaradi dolgotrajnega sočasnega dajanja kortikosteroidov.
English: Luxembourg Pfizer SA 17, Boulevard de la Plaine B-1050 Bruxelles Belgium
Slovenian: Luksemburg Pfizer SA 17, Boulevard de la Plaine B-1050 Bruxelles Belgium
English: Juvenile idiopathic arthritis (JIA) is an inflammatory disorder, causing swelling, synovitis, pain, stiffness, and/or tenderness of one or multiple joints, and may also cause inflammation of other organs.
Slovenian: Juvenilni idiopatski artritis (JIA) je vnetna bolezen, ki povzroči otekanje, sinovitis, bolečine, okorelost in/ali občutljivost enega ali več sklepov.
English: Two investigator-initiated studies (Bechtold and Grote) were also included in the application.
Slovenian: Vlogi sta priloženi tudi dve študiji na pobudo raziskovalcev (Bechtold in Grote).
English: Whilst the acute safety was considered to raise little concern, the uncertainty regarding long-term safety was highlighted by the SAG experts.
Slovenian: Strokovnjaki SAG menijo, da akutna varnost predstavlja manjšo skrb, vendar poudarjajo negotovost glede dolgotrajne varnosti.
English: Improvement in body composition and Bone Mineral Density (BMD) In the studies conducted by the MAH, no clear and significant effect of Genotropin therapy was demonstrated on improvement of body composition or BMD.
Slovenian: Izboljšanje telesne sestave in mineralne gostote kosti V študijah, ki jih je opravil imetnik dovoljenja za promet z zdravilom, niso dokazali jasnega in pomembnega učinka zdravila Genotropin na izboljšanje telesne sestave ali mineralne gostote kosti.
English: A total of 15 patients received Genotropin for 12 months at the dose of 0.066 mg/kg/day followed by 12 months without Genotropin treatment.
Slovenian: Zdravilo Genotropin je 12 mesecev prejemalo 15 bolnikov v odmerku 0,066 mg/kg/dan, čemur je sledilo 12 mesecev brez zdravljenja z zdravilom Genotropin.
English: The long term safety of the combination between glucocorticoids and growth hormone was not addressed in the trials conducted.
Slovenian: Dolgoročna varnost kombinacije kortikosteroidov in rastnega hormona ni bila raziskana v izvedenih preskušanjih.
English: The study population included 13 children who had previously completed CTC-1.
Slovenian: Populacija študije je zajela 13 otrok, ki so že sodelovali v študiji
English: Regarding safety, concerns exist on the potential long term risks associated with growth hormone treatment (such as tumour promotion or diabetes), which may be aggravated in this indication by the prolonged concomitant administration of corticosteroids.
Slovenian: V zvezi z varnostjo obstajajo zadržki glede morebitnih dolgoročnih tveganj, povezanih z zdravljenjem z rastnim hormonom (kot so pospeševanje tumorjev in sladkorna bolezen), ki se lahko izrazijo pri dolgotrajnem sočasnem dajanju kortikosteroidov.
English: Data from the MAH sponsored trials, as well as the Bechtold study, failed to prove a clinically relevant effect on final height, BMD and body composition.
Slovenian: Podatki iz preskušanj, ki jih je sponzoriral imetnik dovoljenja za promet z zdravilom, ter Bechtoldove študije, ne dokazujejo klinično pomembnega učinka na končno višino, mineralno gostoto kosti in sestavo telesa.
English: A total of only 68 subjects treated with Genotropin were included in the 6 studies submitted with the application.
Slovenian: V 6 študijah, priloženih vlogi, je bilo z zdravilom Genotropin skupno zdravljenih le 68 preiskovancev.
English: Pharmacia Laboratories Limited
Slovenian: Pharmacia Laboratories Limited Ramsgate Road
English: Belgium PFIZER S.A. Boulevard de la Plaine, 17 1050 Brussels Belgium
Slovenian: Boulevard de la Plaine, 17 1050 Brussels Belgium
English: The study included a total of 30 patients randomized to receive no treatment (controls) or Genotropin at the dose of 0.066 mg/mg/day.
Slovenian: Študija je zajela skupno 30 bolnikov, ki so bili naključno razporejeni v (kontrolno) skupino brez zdravljenja ali skupino, ki je prejemala zdravilo Genotropin v odmerku 0,066 mg/kg/dan.
English: In CTC-2, all subjects received Genotropin 0.066 mg/kg/day for 36 months.
Slovenian: V študiji CTC-2 so vsi preiskovanci 36 mesecev prejemali Genotropin v odmerku 0,066 mg/kg/dan.
English: GENOTROPIN (WITH
Slovenian: GENOTROPIN (WITH PRESERVATIVE)
English: Product name Strength
Slovenian: Izmišljeno ime
English: 00330 Helsinki, Finland
Slovenian: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland