natgillin/translations-raw huggingface dataset:
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.
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.
The impact of growth hormone treatment on these clinically relevant endpoints in this indication is unclear.
Učinek zdravljenja z rastnim hormonom na te klinično pomembne končne točke za to indikacijo je neznan.
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.
Diagnozo motnje rasti je treba potrditi s točkami standardnega odklona trenutne telesne višine <-2 ali hitrosti rasti < -1, izmerjeno v obdobju vsaj 12 mesecev.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Dodatek I Seznam imen, farmacevtskih oblik, jakosti Zdravila, poti uporabe, imetnikov dovoljenj Za promet v državah članicah
Based on the above, the CHMP concluded that the application does not satisfy the criteria for authorisation in respect of safety and efficacy.
Na podlagi opisanega je CHMP zaključil, da vloga ne izpolnjuje meril za odobritev z vidika varnosti in učinkovitosti.
Due to the chronic nature of the disease with recurrent flares, long term therapy with glucocorticoids is often necessary after the initial diagnosis.
Zaradi kronične narave bolezni z zagoni je po prvotni diagnozi pogosto potrebno dolgotrajno zdravljenje z glukokortikoidi.
Therefore it is considered by the Committee that efficacy in the proposed dose for the proposed indication is not adequately demonstrated.
Zato Odbor šteje, da učinkovitost predlaganega odmerka za predlagano indikacijo ni zadostno dokazana.
In addition, information on quality of life was not collected in any of the sponsored trials.
Poleg tega v nobenem sponzoriranem preskušanju niso bile zbrane informacije o kakovosti življenja.
Netherlands Pfizer BV Postbus 37
Nizozemska Pfizer BV Postbus 37
This dose was not used in the pivotal trials or in the supportive trials.
Tega odmerka niso uporabili niti v ključnih niti v podpornih preskušanjih.
The application submitted by the MAH contained 4 company sponsored studies, including 2 pivotal trials, and 2 investigator initiative studies:
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:
• The Committee, as a consequence, concluded that the variation application does not satisfy the criteria for authorisation in respect of safety and efficacy.
• Posledično je Odbor zaključil, da vloga za spremembo ne izpolnjuje meril za odobritev z vidika varnosti in učinkovitosti.
Growth disturbance in children with severe forms of juvenile idiopathic arthritis (JIA), requiring long term glucocorticoid treatment, for improvement of growth and body composition.
Motnje rasti pri otrocih s hudimi oblikami juvenilnega idiopatskega artritisa (JIA), ki zahtevajo dolgotrajno zdravljenje z glukokortikoidom, za izboljšanje rasti in telesne sestave.
However, even if it is understood that the population eligible for treatment is limited, the efficacy database in absolute numbers is small.
Čeprav se šteje, da je populacija, primerna za zdravljenje, omejena, so absolutne številke v zbirki učinkovitosti majhne.
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.
Čeprav zdravljenje z glukokortikoidi bistveno izboljša znake in simptome, je pri večini zdravljenih otrok povezano z bistvenim zastojem rasti in spremembami telesne sestave.
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.
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.
• 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.
• 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.
The CHMP was requested to give its opinion on whether the marketing authorisations should be varied to include the indication:
CHMP so prosili za mnenje, ali se lahko dovoljenja za promet z zdravilom spremenijo tako, da se doda naslednja indikacija:
In all the studies presented, growth velocity increased with Genotropin treatment above control and/or baseline values.
V vseh predloženih študijah se je po zdravljenju z zdravilom Genotropin hitrost rasti povečala nad kontrolno in/ali izhodiščno vrednost.
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).
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).
The long term effects of the combination between growth hormone and corticosteroids are not known, and were not investigated in the studies presented.
Dolgoročni učinki kombinacije rastnega hormona in kortikosteroidov niso znani in niso raziskani v predloženih študijah.
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.
Vendar je za končno višino v ključnih preskušanjih na voljo zelo malo podatkov, zato korist zdravljenja predlagane indikacije ni zadostno dokazana.
Dose selection
Izbira odmerka
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.
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.
Final height
Končna telesna višina
The CHMP SAG on Diabetes/Endocrinology was consulted and expressed concerns regarding the long-term safety of the product.
SAG za sladkorno bolezen/endokrinologijo pri CHMP je po posvetovanju izrazil zadržke glede dolgotrajne varnosti zdravila.
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.
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.
The pivotal trials supporting the application did not include information on quality of life, in addition to the lack of information on final height.
Ključna preskušanja, ki podpirajo vlogo, poleg pomanjkanja informacij o končni višini tudi niso vsebovala informacij o kakovosti življenja.
• The Committee considered that the benefit risk balance of the product in the proposed indication is not positive.
• Odbor je upošteval, da razmerje med koristmi in tveganji za zdravilo za predlagano indikacijo ni pozitivno.
• 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;
• 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.
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.
Juvenilni idiopatski artritis (JIA) je vnetna bolezen, ki povzroči otekanje, sinovitis, bolečine, okorelost in/ali občutljivost enega ali več sklepov.
Two investigator-initiated studies (Bechtold and Grote) were also included in the application.
Vlogi sta priloženi tudi dve študiji na pobudo raziskovalcev (Bechtold in Grote).
Whilst the acute safety was considered to raise little concern, the uncertainty regarding long-term safety was highlighted by the SAG experts.
Strokovnjaki SAG menijo, da akutna varnost predstavlja manjšo skrb, vendar poudarjajo negotovost glede dolgotrajne varnosti.
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.
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.
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.
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.
The long term safety of the combination between glucocorticoids and growth hormone was not addressed in the trials conducted.
Dolgoročna varnost kombinacije kortikosteroidov in rastnega hormona ni bila raziskana v izvedenih preskušanjih.
The study population included 13 children who had previously completed CTC-1.
Populacija študije je zajela 13 otrok, ki so že sodelovali v študiji
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.
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.
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.
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.
A total of only 68 subjects treated with Genotropin were included in the 6 studies submitted with the application.
V 6 študijah, priloženih vlogi, je bilo z zdravilom Genotropin skupno zdravljenih le 68 preiskovancev.
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.
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.
In CTC-2, all subjects received Genotropin 0.066 mg/kg/day for 36 months.
V študiji CTC-2 so vsi preiskovanci 36 mesecev prejemali Genotropin v odmerku 0,066 mg/kg/dan.
Product name Strength
Izmišljeno ime
Pivotal study CTC-3 was a phase 3, open-label, randomised, controlled, 36-months prospective, single center study that evaluated early treatment with Genotropin versus untreated controls in the prevention of growth retardation of children with severe JIA requiring long-term corticosteroid therapy.
Ključna študija CTC-3 je bila nezaslepljena, randomizirana, kontrolirana, 36-mesečna prospektivna študija 3. faze v enem raziskovalnem središču, v kateri so primerjali zgodnje zdravljenje z zdravilom Genotropin in kontrolo brez zdravljenja pri preprečevanju zastoja rasti pri otrocih s hudo JIA, ki potrebujejo dolgotrajno kortikosteroidno zdravljenje.
Pivotal study CTC-4 was a phase 3, non-randomised, non-controlled, 36-month, open-label study that evaluated genotropin in prepubertal or pubertal children with short stature secondary to longterm glucocorticoid therapy for treatment of JIA or nephritic syndrome.
Ključna študija CTC-4 je bila nerandomizirana, nekontrolirana, 36-mesečna nezaslepljena študija 3. faze, v kateri so vrednotili zdravilo Genotropin pri predpubertetnikih in pubertetnikih nižje rasti po dolgotrajnem glukokortikoidnem zdravljenju JIA ali nefrotskega sindroma.
Marketing Authorisation Holder
Imetnik dovoljenja za promet z zdravilom, naslov
Supportive study CTC-2 was a non-randomised, non-controlled, open-label, single center study that evaluated Genotropin in children with JIA and short stature secondary to glucocorticoid therapy.
Podporna študija CTC-2 je bila nerandomizirana, nekontrolirana, nezaslepljena študija v enem raziskovalnem središču, v kateri so vrednotili zdravilo Genotropin pri otrocih z JIA in nižje rasti po glukokortikoidnem zdravljenju.
These were randomized, controlled studies that compared Genotropin versus an untreated control group in JIA children with severe growth retardation.
Študiji sta bili randomizirani in kontrolirani, pri čemer so pri otrocih z JIA in hudim zastojem rasti primerjali skupino, ki je prejemala zdravilo Genotropin, in kontrolno skupino brez zdravljenja.
Supportive study CTC-1 was a non-randomised, non-controlled, open-label, single center pilot study that evaluated Genotropin in prepubertal children with short stature secondary to long-term glucocorticoid therapy for treatment of JIA.
Podporna študija CTC-1 je bila nerandomizirana, nekontrolirana, nezaslepljena pilotska študija v enem raziskovalnem središču, v kateri so vrednotili zdravilo Genotropin pri predpubertetnikih nižje rasti po dolgotrajnem glukokortikoidnem zdravljenju JIA.
In the pivotal trials conducted by the MAH, a dose higher than the dose proposed was used and, as very limited final height data is available, the clinical relevance of the effect was not demonstrated.
Ker je na voljo zelo malo podatkov o končni telesni višini, kliničen pomen učinka ni bil dokazan.
The Bechtold study, the only one where the proposed dose (0.047 mg/kg/day) was used, did not reveal any glucose abnormalities.
V Bechtoldovi študiji, ki je edina, v kateri so uporabili predlagani odmerek (0,047 mg/kg/dan), niso odkrili nenormalnosti v zvezi z glukozo, vendar pri teh bolnikih sladkorna bolezen ostaja težava, saj dolgoročni učinki kombinacije rastnega hormona in kortikosteroidov niso znani in niso bili raziskani.
The study was conducted in 2 centers in France and included a total of 30 subjects who received Genotropin at the dose of 0.066 mg/kg/day.
Zajela je skupno 30 bolnikov, ki so prejemali zdravilo Genotropin v odmerku 0,066 mg/kg/dan.
The European Commission granted a marketing authorisation valid throughout the European Union for Enbrel on 3 February 2000.
Evropska komisija je dovoljenje za promet z zdravilom Enbrel, veljavno po vsej Evropski uniji, izdala 3. februarja 2000.
What measures are being taken to ensure the safe and effective use of Enbrel?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Enbrel?
In all of the studies, the main measure of effectiveness was the change in symptoms.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba simptomov.
The full EPAR for Enbrel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Enbrel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Običajni priporočeni odmerek pri odraslih je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis.
Zdravljenje s 50 mg dvakrat na teden se lahko uporabi tudi v prvih 12 tednih zdravljenja psoriaze v plakih.
This is a summary of the European public assessment report (EPAR) for Enbrel.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Enbrel.
A risk management plan has been developed to ensure that Enbrel is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Enbrel je bil pripravljen načrt obvladovanja tveganj.
The CHMP decided that Enbrel's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Enbrel večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
For patients below 18 years of age, the dose depends on body weight.
Pri bolnikih, mlajših od 18 let, je treba količino odmerka prilagoditi telesni masi.
By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Z zaviranjem TNF etanercept zmanjša vnetje in blaži druge simptome bolezni.
Enbrel was also compared with placebo in 51 children with polyarticular juvenile idiopathic arthritis, 205 adults with psoriatic arthritis, 357 adults with ankylosing spondylitis, 1,263 adults and 211 children with plaque psoriasis, as well as in 225 patients with non-radiographic axial spondyloarthritis.
Zdravilo Enbrel so primerjali tudi s placebom pri 51 otrocih s poliartikularnim juvenilnim idiopatskim artritisom, 205 odraslih s psoriatičnim artritisom, 357 odraslih z ankilozirajočim spondilitisom, 1 263 odraslih in 211 otrocih s psoriazo v plakih ter pri 225 bolnikih z neradiografskim aksialnim spondilitisom.
What benefit has Enbrel shown during the studies?
Kakšne koristi je zdravilo Enbrel izkazalo med študijami?
Other information about Enbrel
Druge informacije o zdravilu Enbrel
The most common side effects with Enbrel (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Najpogostejši neželeni učinki zdravila Enbrel (opaženi pri več kot 1 od 10 bolnikov) so reakcije na mestu injiciranja (vključno s krvavitvami, podplutbami, pordelostjo, srbenjem, bolečino in otekanjem) in okužbe (vključno s prehladi ter okužbami pljuč, mehurja in kože).
Etanercept is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) that makes them able to produce etanercept.
Etanercept se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori etanercept.
Enbrel must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.
Zdravila Enbrel ne smejo uporabljati bolniki, ki imajo sepso ali pri katerih obstaja nevarnost sepse (ko bakterije in toksini krožijo v krvi in začnejo povzročati poškodbe organov) ali bolniki z okužbami.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Enbrel.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Enbrel?
Kakšna tveganja so povezana z zdravilom Enbrel?
For all other diseases studied, Enbrel produced a greater improvement in symptoms than placebo after three to four months.
Pri vseh drugih boleznih, ki so jih raziskovali, je zdravilo Enbrel po treh do štirih mesecih povzročilo večje izboljšanje simptomov kot placebo.
The studies in children with polyarticular juvenile idiopathic arthritis and plaque psoriasis were followed up with long term studies to assess the safety of long term treatment in children.
Študijam pri otrocih s poliartikularnim juvenilnim idiopatskim artritisom in psoriazo v plakih so sledile dolgotrajne študije, da bi ocenili varnost dolgotrajnega zdravljenja pri otrocih.
The company that makes Enbrel will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled pen correctly) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Družba, ki proizvaja zdravilo Enbrel, bo zagotovila izobraževalno gradivo za zdravnike, ki naj bi predpisovali zdravilo (za učenje pravilne uporabe predhodno napolnjenega peresnika) in bolnike (da bi lahko prepoznali morebitne resne neželene učinke ter tako vedeli, kdaj naj nujno poiščejo pomoč pri zdravniku).
For more information about treatment with Enbrel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Enbrel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Enbrel can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
Zdravilo Enbrel se lahko uporablja tudi pri bolnikih s hudim revmatoidnim artritisom, ki pred tem metotreksata niso jemali;
Patients who take Enbrel must be given the special alert card that summarises important safety information about the medicine.
Bolniki, ki jemljejo zdravilo Enbrel, morajo prejeti posebno opozorilno kartico, ki povzema varnostne podatke o zdravilu.
• certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints) in the following groups:
• določenih oblik juvenilnega idiopatskega artritisa (redke otroške bolezni, ki povzroča vnetje več sklepov) pri naslednjih skupinah:
The patient or carer can give the injection if they have been trained appropriately.
Zdravilo lahko injicira bolnik ali njegov negovalec, če sta za to ustrezno usposobljena.
In the study of patients who had not taken methotrexate before, those receiving 25 mg Enbrel twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
V študiji, v kateri so sodelovali bolniki, ki pred tem metotreksata niso jemali, so po 12 in 24 mesecih pri bolnikih, ki so prejemali 25 mg zdravila Enbrel dvakrat na teden, ugotovili manj poškodb sklepov kot pri tistih, ki so jemali samo metotreksat.
Enbrel is given by injection under the skin.
Zdravilo Enbrel se injicira pod kožo.
Enbrel has been studied in five main studies in rheumatoid arthritis, involving about 2,200 patients and lasting from three months to two years.
Zdravilo Enbrel so pri revmatoidnem artritisu raziskovali v petih glavnih študijah, v katerih je sodelovalo približno 2 200 bolnikov, trajale pa so od treh mesecev do dveh let.
Why has Enbrel been approved?
Zakaj je bilo zdravilo Enbrel odobreno?