natgillin/translations-raw huggingface dataset:
The CHMP considers however that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information.
Vendar pa CHMP meni, da višjega odmerka zdravila Mifepristone Linepharma kot 200 mg ni dovoljeno uporabiti, kar je treba v informacijah o zdravilu jasno navesti.
The current SmPC for the reference product mifepristone recommends mifepristone at the dose of 600 mg followed 36 to 48 hours later by 400 µg misoprostol orally or gemeprost 1 mg per vaginam for pregnancy termination up to 49 days of amenorrhea.
Trenutni povzetek glavnih značilnosti zdravila za referenčno zdravilo mifepristone priporoča 600 mg mifepristona, nato pa po 36 do 48 urah 400 µg misoprostola peroralno ali 1 mg gemeprosta vaginalno za prekinitev nosečnosti do 49. dneva amenoreje.
• The CHMP is of the opinion that a dose higher than 200 mg should not be administered and that this should be clearly indicated in the Product Information.
• CHMP meni, da višjega odmerka kot 200 mg zdravila Mifepristone Linepharma ni dovoljeno uporabiti, kar je treba v informacijah o zdravilu jasno navesti.
The approved posology is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Odobreno odmerjanje je 200 mg zdravila mifepristone v enem peroralnem odmerku, ki mu po 36 do 48 urah sledi vaginalna uporaba 1 mg gemeprosta, analoga prostaglandina.
An alternative of 200 mg of mifepristone was also approved to be used as a single dose, provided that this dose is followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Alternativno je odobreno tudi odmerjanje 200 mg zdravila mifepristone v enkratnem odmerku, če mu po 36 do 48 urah sledi vaginalna uporaba 1 mg gemeprosta, analoga prostaglandina.
The MAH provided the synopsis and abstract of this study.
Imetnik dovoljenja za promet z zdravilom je predložil pregled in povzetek teh študij.
The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Zdravilna učinkovina zdravila Pioglitazone ratiopharm GmbH, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone ratiopharm GmbH primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes.
Družba ratiopharm GmbH je dne 3. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm GmbH, namenjenim zdravljenju sladkorne bolezni tipa 2.
Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Ker je zdravilo Pioglitazone ratiopharm GmbH generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm GmbH for the treatment of type 2 diabetes.
Odbor je zato v času umika vloge izrazil pozitivno mnenje in priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm GmbH za zdravljenje sladkorne bolezni tipa 2.
This means that Pioglitazone ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
Pioglitazone ratiopharm GmbH was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Zdravilo Pioglitazone ratiopharm GmbH naj bi se uporabljalo za zdravljenje sladkorne bolezni tipa 2 pri odraslih, zlasti tistih s prekomerno telesno maso.
Pioglitazone ratiopharm GmbH was developed as a ‘generic medicine'.
Zdravilo Pioglitazone ratiopharm GmbH je bilo razvito kot „generično zdravilo“.
Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone.
Pioglitazone ratiopharm GmbH je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
Pioglitazone ratiopharm GmbH was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Zdravilo Pioglitazone ratiopharm GmbH naj bi se uporabljalo tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora.
What is Pioglitazone ratiopharm GmbH?
Kaj je zdravilo Pioglitazone ratiopharm GmbH?
How is Pioglitazone ratiopharm GmbH expected to work?
Kako naj bi zdravilo Pioglitazone ratiopharm GmbH delovalo?
Pioglitazone ratiopharm GmbH was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Prav tako naj bi se uporabljalo samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primeren.
What was Pioglitazone ratiopharm GmbH expected to be used for?
Za kaj naj bi se zdravilo Pioglitazone ratiopharm GmbH uporabljalo?
Pioglitazone ratiopharm GmbH was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Uporabljalo naj bi se tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom samim in za katere metformin ni primeren.
The safety and effectiveness of the product has not changed.
Varnost in učinkovitost zdravila se nista spremenili.
Consequently, the licence of the manufacturing site was withdrawn.
Posledično je bila licenca za proizvodno mesto preklicana.
Since 2013 MACI has been marketed in Denmark, Greece and the UK.
Od leta 2013 je zdravilo MACI na voljo na Danskem, v Grčiji in Združenem kraljestvu.
The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014.
Končno mnenje je bilo posredovano Evropski komisiji, ki je 19. novembra 2014 izdala pravno
MACI was on the market since 1998 in individual EU countries according to national procedures.
Zdravilo MACI je v posameznih državah EU v skladu z nacionalnimi postopki na voljo od leta 1998.
Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met.
Člen 118 Direktive 2001/83/ES, ki določa, da je treba dovoljenje za promet umakniti, če katera od zahtev iz člena 41 (npr., da morajo biti na voljo proizvodni prostori) ni več izpolnjena.
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
To je vrsta zdravila, ki vsebuje celice ali tkiva, ki so bila spremenjena tako, da lahko pomagajo pri popravljanju, obnavljanju ali nadomeščanju tkiva.
Because MACI is an advanced therapy medicine, the review was carried out by the Committee on Advanced Therapies (CAT), and was subsequently endorsed by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use.
Ker je zdravilo MACI namenjeno naprednemu zdravljenju, je pregled opravil Odbor za napredno zdravljenje (CAT), nato pa ga je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP), ki je odgovoren za vprašanja, povezana z zdravili za uporabo v humani medicini.
The European Medicines Agency has been working with the marketing authorisation holder since June 2014 to ensure that patients who had already started the treatment procedure were able to complete their treatment.
Evropska agencija za zdravila od junija 2014 sodeluje z imetnikom dovoljenja za promet z zdravilom, ki bo zagotovil, da bodo bolniki, ki so že začeli s postopkom zdravljenja, lahko zaključili zdravljenje.
Following the closure of the manufacturing site and because EU legislation1 requires authorised medicines to have a registered manufacturing site, a review was initiated at the request of the European Commission on 10 September 2014 (under Article 20 of Regulation (EC) No 726/2004) to determine whether the marketing authorisation for MACI should be suspended or revoked.
Po zaprtju proizvodnega mesta in na podlagi zakonodaje EU,1 ki zahteva, da imajo odobrena zdravila registrirano proizvodno mesto, je Evropska komisija 10. septembra 2014 uvedla pregled (v skladu s členom 20 Uredbe (ES) št. 726/2004), da bi ugotovila, ali je treba dovoljenje za promet z zdravilom MACI začasno umakniti ali preklicati.
MACI is an advanced therapy medicinal product called a ‘tissue engineered product'.
MACI je zdravilo za napredno zdravljenje, ki ga imenujemo „izdelek tkivnega inženirstva“.
MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Zdravilo MACI je implantat, ki se uporablja za odpravljanje hrustančnih okvar na koncih kosti kolenskega sklepa.
• Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI.
• Junija 2014 so bili kirurgi in bolnišnice, ki so uporabljali zdravilo MACI, obveščeni o načrtovanem zaprtju proizvodnega mesta za zdravilo MACI v EU.
In addition, surgeons were asked not to start new patients on MACI.
Poleg tega so kirurge prosili, naj zdravila MACI ne uvajajo pri novih bolnikih.
Closure of EU manufacturing site for MACI
Zaprtje proizvodnega mesta v EU za zdravilo MACI
• The closure was due to commercial reasons and is not related to any change in the safety and
• Razlogi za zaprtje so bili poslovni in niso povezani z nobeno spremembo varnosti ter učinkovitosti zdravila MACI.
It was subsequently evaluated through the European Medicines Agency to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the Agency in order to obtain an EU-wide marketing authorisation; this was obtained in 2013.
Pozneje so ga ocenjevale evropske agencije za zdravila, ki so preverjale skladnost z uredbo EU o naprednih oblikah zdravljenja, ki zahteva, da agencija oceni vse napredne oblike zdravljenja v državah članicah EU, preden pridobijo dovoljenje za promet z zdravilom po celotni EU; to je bilo pridobljeno leta 2003.
Arrangements in place for existing patients to complete their treatment
Uvedeni postopki, ki bodo obstoječim bolnikom omogočili zaključek
A letter was sent to healthcare professionals informing them of the site closure and requesting that they notify the marketing authorisation holder of those patients who wish to complete their treatment.
Zdravstveni delavci so prejeli dopis z obvestilom glede zaprtja proizvodnega mesta, v katerem so jih prosili, naj imetnika dovoljenja za promet z zdravilom obvestijo o bolnikih, ki želijo dokončati zdravljenje.
Based on the draft opinion adopted by the CAT, the CHMP adopted a final opinion on 25 September 2014, recommending the suspension of the marketing authorisation for MACI until a new manufacturing site is registered in the EU.
Na podlagi osnutka mnenja odbora CAT je odbor CHMP 25. septembra 2014 sprejel končno mnenje, s katerim je priporočil umik dovoljenja za promet z zdravilom MACI, dokler ne bo v EU registrirano novo proizvodno mesto.
• New patients should be treated with a suitable alternative and surgeons should not order new
• Nove bolnike je treba zdraviti z ustrezno alternativo, kirurgi pa ne smejo naročati novih biopsijskih kompletov za zdravilo MACI.
On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark.
Imetnik dovoljenja za promet z zdravilom MACI (na matriks naneseni karakterizirani avtologni gojeni hondrociti) za napredno zdravljenje je 5. septembra 2014 zaprl proizvodno mesto za zdravilo v EU, ki je bilo na Danskem.
Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete
Po zaprtju proizvodnega mesta so imetnika dovoljenja za promet z zdravilom prosili, naj shrani morebitne preostale biopsije, ki še niso bile uporabljene, za morebitno poznejše zdravljenje z zdravilom MACI, razen če sta bolnik in njegov lečeči kirurg izrecno navedla, da ne želita dokončati
• Patients who have already started treatment (i.e. those who have had their biopsies taken) should have been informed about the closure and should have discussed arrangements for completion of treatment with their treating surgeon.
• Bolnike, ki so že začeli zdravljenje (tj. pri katerih so že opravili biopsije), je treba obvestiti o zaprtju.
• The company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons explicitly indicated that they no longer wish
• Družba je uvedla postopke za shranjevanje vseh obstoječih biopsij, tako da lahko bolnik dokonča zdravljenje, razen če bolnik in njegov lečeči kirurg izrecno navedeta, da ne želita dokončati
The closure was due to commercial reasons and the safety and effectiveness of
Razlogi za zaprtje so bili poslovni; varnost ter učinkovitost zdravila MACI se nista spremenili.
• For patients who have already started treatment (i.e. those who have had their biopsies taken) company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons have explicitly indicated that they no longer wish to complete treatment with MACI.
• Pri bolnikih, ki so že začeli zdravljenje (tj. pri katerih so že opravili biopsijo), je družba uvedla postopke za shranjevanje vseh obstoječih biopsij, tako da lahko bolnik dokonča zdravljenje, razen če bolnik in njegov lečeči kirurg izrecno navedeta, da ne želita dokončati zdravljenja z zdravilom MACI.
MACI is unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Zdravilo MACI ne bo na voljo novim bolnikom v EU, dokler ne bo v EU registrirano novo proizvodno mesto.
The site has now been closed and MACI remains unavailable for new patients in the EU until a new manufacturing site has been registered in the EU.
Proizvodno mesto je zdaj zaprto, zato zdravilo MACI ne bo na voljo novim bolnikom v EU, dokler ne bo v EU registrirano novo proizvodno mesto.
Information to healthcare professionals
Stopite v stik z našimi tiskovnimi predstavniki
(frequency cannot be estimated from the available data)
(ni mogoče oceniti iz razpoložljivih podatkov)
Date of first authorisation: 9 March 2000 Date of latest renewal: 9 March 2010
Datum prve odobritve: 9. marec 2000 Datum zadnjega podaljšanja: 9. marec 2010
§, increased appetite
§, povečan apetit
- if you have severe heart disease.
- če imate hudo srčno bolezen.
Please read the instructions carefully and follow them step by step.
Natančno jih preberite in sledite vsakemu koraku posebej.
Any or all of these activities may contribute to interferon's therapeutic effects.
Kateri koli ali vsi od teh učinkov lahko prispevajo k terapevtskemu delovanju interferona.
The effect on human pregnancy is not known.
Učinek na nosečnost pri človeku ni znan.
Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.
Zdravila pa si ne skušajte injicirati, če niste prepričani, da razumete postopek in zahteve za samoinjiciranje.
The infusion must be prepared immediately prior to use.
Infuzijo je treba pripraviti tik pred uporabo.
• Genotype 1: The recommended duration of treatment is one year.
• Genotip 1: Priporočeno trajanje zdravljenja je 1 leto.
There are no data on long term effects on sexual maturation.
Ni podatkov o dolgoročnih učinkih zdravila na spolno zorenje.
- if you have advanced decompensated (uncontrolled) liver disease.
- če imate napredovano dekompenzirano (nenadzorovano) jetrno bolezen.
Interactions between IntronA and other medicinal products have not been fully evaluated.
Interakcij med zdravilom IntronA in drugimi zdravili še niso v celoti ovrednotili.
Need for adequate hydration
Potreba po ustrezni hidraciji
They are produced and secreted by cells in response to viral infections or various synthetic and biological inducers.
Izdelujejo in izločajo jih celice kot odziv na virusne okužbe ali različne sintetične ali biološke induktorje.
• Genotype 2/3: The recommended duration of treatment is 24 weeks.
• Genotip 2/3: Priporočena dolžina zdravljenja je 24 tednov.
§, influenza-like symptoms
§, gripi podobni simptomi
Undesirable effects were usually managed by dose adjustment.
Neželene učinke so običajno obvladovali s prilagajanjem odmerkov.
if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
če imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda želel bolj skrbno spremljati.
Studies with other interferons have demonstrated species specificity.
Tudi raziskave z drugimi interferoni so pokazale vrstno specifičnost.
Overall Response a (n=118)
Skupni odziv a (n=118)
For storage conditions of the medicinal product, see section 6.3.
Za pogoje shranjevanja zdravila glejte poglavje 6.3.
Patients with advanced disease may require a daily dose of 5 million IU.
Pri bolnikih z napredovano boleznijo je lahko potreben odmerek 5 milijonov i.e. na dan.
- if you have cirrhosis or other liver problems (other than hepatitis B or C).
- če imate cirozo ali druge težave z jetri (razen hepatitisa B ali C).
Duration of treatment for children and adolescents
Trajanje zdravljenja za otroke in mladostnike
6 IU/kg/day for 3 months.
6 i.e./kg na dan 3 mesece.
Some children did not reach their projected height within 10-12 years after completing treatment.
Nekateri otroci tudi niso dosegli pričakovane telesne višine v obdobju 10 do 12 let po zaključku zdravljenja.
Do not use IntronA - if you are allergic to interferon or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila IntronA - če ste alergični na interferon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Do not use this medicine if you notice changes in the appearance of IntronA.
Ne uporabljajte tega zdravila, če opazite spremembe videza zdravila IntronA.
(%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
(%)) pri predhodno nezdravljenih otrocih in mladostnikih po genotipu in dolžini zdravljenja - vsi preizkušanci n = 107 24 tednov
- if you have thyroid disease that is not well controlled.
- če imate bolezen ščitnice, ki ni dobro nadzorovana.
§, virilism
§, virilizem
Laboratory Tests
Laboratorijske preiskave
Authorized Representative: BD, Laagstraat 57, B-9140 Temse, Belgium
Pooblaščeni predstavnik: BD, Laagstraat 57, B-9140 Temse, Belgija
The detectable titres are low in almost all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s kakršnim koli drugim avtoimunskim pojavom.
Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Kadar koli je mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
The clear and colourless solution is contained in a glass vial.
Bistra in brezbarvna raztopina je v stekleni viali.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC.)
Za pediatrične bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsul, glejte SPC za peroralno raztopino ribavirina.)
Not all dose forms and strengths are appropriate for some indications.
Vse farmacevtske oblike in jakosti niso primerne za vse indikacije.
6 IU/kg/day for 3 months caused no remarkable toxicity.
6 i.e./kg na dan 3 mesece ni povzročilo pomembne toksičnosti.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Bolnike je treba skrbno spremljati, da se ugotovi morebitne znake ali simptome psihiatričnih motenj.
Another 4 % had a transient decrease below the lower limit of normal.
Pri nadaljnjih 4 % bolnikov je prišlo do prehodnega zmanjšanja vrednosti pod spodnjo mejo normale.
Insert the needle into the pinched skin at an angle of 45° to 90°.
Iglo vbodite v kožno gubo pod kotom 45 do 90.
This will lessen the chance for ribavirin to be left in the woman's body.
Tako boste zmanjšali možnost za prehajanje ribavirina v telo ženske.
Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.
Čeprav optimalni (minimalni) odmerek za doseganje polnega kliničnega učinka ni znan, morate bolnike zdraviti s priporočenim odmerkom, z opisanim zmanjšanjem odmerka v primeru toksičnosti.
The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Optimalna dolžina zdravljenja z zdravilom IntronA samim še ni bila dokončno ugotovljena, vendar svetujemo, naj zdravljenje traja od 12 do 18 mesecev.
Other in-use storage times and conditions are the responsibility of the user.
Za čas shranjevanja in druge pogoje shranjevanja zdravila med uporabo je odgovoren uporabnik.
Table 6 Sustained virological response rates (n a,b
Preglednica 6 Deleži trajnega virološkega odziva (n a,b
Although interferon is generally recognised as being species specific, toxicity studies in animals were conducted.
Čeprav interferon na splošno velja za vrstno specifičnega, so bile opravljene predklinične raziskave toksičnosti na živalih.
IntronA is usually intended for subcutaneous use.
Zdravilo IntronA je običajno namenjeno subkutani uporabi.
It has demonstrated significant immunomodulatory activity in vitro.
In vitro je pokazal znatno imunomodulatorno delovanje.
Treatment must be initiated by a physician experienced in the management of the disease.
Zdravljenje mora uvesti zdravnik z izkušnjami pri zdravljenju bolezni.
IntronA is given either daily (5 or 7 times a week), or three times a week, every other day, for example on Monday, Wednesday, and Friday.
Zdravilo IntronA se daje bodisi vsak dan (5 ali 7-krat na teden), ali 3-krat na teden vsak drugi dan, na primer v ponedeljek, sredo in petek.
Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Učinkovitost so opredelili kot trajen virološki odziv 6 mesecev po koncu zdravljenja.
This means that IntronA is injected with a short needle into the fatty tissue just under the skin.
To pomeni, da se injicira s kratko iglo v maščobno tkivo tik pod kožo.
§, hyperuricemia, increased appetite
§, hiperurikemija, povečan apetit
The usual starting dose for each condition follows; however, individual doses may vary, and the doctor may change your dose based on your specific needs:
Običajni začetni odmerki za posamezne bolezni ali motnje so navedeni v nadaljevanju, vendar pa posamezni odmerki lahko odstopajo in zdravnik lahko spremeni vaš odmerek glede na vaše specifične potrebe: