FrancophonIA/ELRC3.0 huggingface dataset:
English: However the CHMP noted that since the study did not have a replicate design, the IS-CV may in fact also include differences between products and is not true intra-subject CV.
Slovenian: Vendar je CHMP ugotovil, da študija ni imela zasnove s ponavljanjem, zato IS-CV morda dejansko vključuje razlike med zdraviloma in ni prava vrednost koeficienta variacije znotraj preiskovancev.
English: Furthermore the pooling of the pre-dose concentrations (Cmin) in the steady state study at day 10/11/12 as a proof of bioequivalence instead of standard non-pooled data (replicate design), was not considered to be acceptable by the CHMP.
Slovenian: Poleg tega je CHMP štel za nesprejemljivo združevanje predodmernih koncentracij (Cmin) v študiji dinamičnega ravnovesja 10., 11. in 12. dan kot dokaz biološke enakovrednosti namesto standardnih nezdruženih podatkov (zasnova s ponovitvami).
English: Strength Pharmaceutical Form Route of administration
Slovenian: Farmacevtska oblika
English: A single dose study with the 16 mg dose under fasting conditions
Slovenian: študija z enim odmerkom z jakostjo 16 mg pri teščih preiskovancih,
English: A single dose study with the 8 mg dose under fasting conditions
Slovenian: študija z enim odmerkom z jakostjo 8 mg pri teščih preiskovancih,
English: Three single dose studies and one steady state study have been conducted to establish bioequivalence of the prolonged release tablets Galantamine STADA in comparison to the reference product Reminyl prolonged release capsules.
Slovenian: Za določitev biološke enakovrednosti tablet s podaljšanim sproščanjem Galantamine STADA v primerjavi z referenčnim zdravilom Reminyl kapsule s podaljšanim sproščanjem so bile izvedene tri študije z enim odmerkom in ena študija v dinamičnem ravnovesju.
English: GALANTAX XL 16 mg prolonged-release tablets
Slovenian: GALANTAX XL 16 mg prolongedrelease tablets
English: GALANTAX XL 8 mg prolonged-release tablets
Slovenian: GALANTAX XL 8 mg prolongedrelease tablets
English: The CHMP were of the view that the requirements of this guideline are clear and they are based on the principle that using a derived parameter (such as %PTF) for the pharmacokinetic evaluation decreases the sensitivity to detect a possible difference between products
Slovenian: Smernica za peroralne in transdermalne odmerne oblike z modificiranim sproščanjem (CPMP/EWP/280/96 corr), kjer je navedeno, da za študije dinamičnega ravnovesja velja naslednje: „Ocenjevanje biološke enakovrednosti temelji na vrednostih AUCτ, Cmax in Cmin ob uporabi podobnih statističnih postopkov kot za formulacije s takojšnjim sproščanjem.“ CHMP je menil, da so zahteve te smernice jasne in temeljijo na načelu, da uporaba izpeljanega parametra (kot je % PTF) za farmakokinetično vrednotenje zmanjša občutljivost za odkrivanje možne razlike med zdravili.
English: However the CHMP highlighted Section 5 of the current CPMP Note for Guidance on Modified Release Oral and Transdermal Dosage Forms (CPMP/EWP/280/96 corr), which states that the following applies for the steady state study:
Slovenian: Vendar je CHMP poudaril 5. razdelek trenutno veljavnega dokumenta CPMP
English: Whereas
Slovenian: Jakost
English: Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním
Slovenian: Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním 24 mg
English: GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada
Slovenian: GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada 8 mg
English: GALANTAX XL 24 mg prolonged-release tablets 24 mg
Slovenian: GALANTAX XL 24 mg prolongedrelease tablets
English: GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada
Slovenian: GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada 16 mg
English: Cminss and peak-trough fluctuation (PTF) were considered as secondary parameters as well as all pharmacokinetic parameters for the other two dosage strengths The multiple dose study was designed to mirror clinical conditions by up-titration of all three doses.
Slovenian: Za drugi dve jakosti so bili obravnavani vsi farmakokinetični parametri.
English: EU Number
Slovenian: EU Številka
English: Invented name Strength
Slovenian: Izmišljeno ime Jakost
English: Packaging
Slovenian: Pakiranje
English: Ref. EMEA/599866/2007
Slovenian: EMEA/599866/2007
English: London, 24 January 2008 Doc.
Slovenian: London, 24. januar 2008 Sklic dok.
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 ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Dopis podjetja, s katerim je bila EMEA obveščena o umiku vloge, je na voljo tukaj.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SINEREM
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo
English: The application was at day 175 when the company withdrew.
Slovenian: Podjetje je umaknilo vlogo na 175. dan.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Sinerem?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Sinerem?
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Ko je CHMP ocenil odgovore podjetja na seznam vprašanj, je nekaj vprašanj še vedno ostalo nerešenih.
English: There was one main study of the effectiveness of Sinerem, involving a total of 271 patients with pelvic cancers.
Slovenian: Izvedli so eno glavno študijo učinkovitosti zdravila Sinerem, ki je vključevala skupaj 271 bolnikov z rakom v medeničnem predelu.
English: The very small size of the particles allows them to be carried in the body, and to enter the lymphatic system.
Slovenian: Zelo majhna velikost delcev jim omogoča, da se prenašajo po telesu in da vstopijo v limfni sistem.
English: How far into the evaluation was the application when it was withdrawn?
Slovenian: Kako daleč je bil postopek ocenjevanja vloge ob umiku vloge?
English: What documentation did the company present to support its application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
English: The effects of Sinerem were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Sinerem so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: The company informed the CHMP that compassionate use programmes using Sinerem are ongoing and will be reconsidered accordingly.
Slovenian: Podjetje je CHMP obvestilo, da programi sočutne uporabe zdravila Sinerem potekajo in bo o njih ponovno razmislilo skladno z navedenim.
English: Active substance: Superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate
Slovenian: Zdravilna učinkovina: Superparamagnetni nanodelci železovega oksida, stabilizirani z dekstranom in natrijevim citratom
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Slovenian: Na podlagi pregleda začetne dokumentacije CHMP na 120. dan pripravi seznam vprašanj, ki ga pošlje podjetju.
English: What were the reasons given by the company to withdraw the application?
Slovenian: Kakšni so bili razlogi podjetja za umik vloge?
English: What was the recommendation of the CHMP at that time?
Slovenian: Kakšno je bilo takrat mnenje CHMP?
English: It contains extremely small particles of iron oxide (nanoparticles).
Slovenian: Zdravilo vsebuje izjemno majhne delce železovega oksida (nanodelci).
English: These are part of the lymphatic system, a network of structures in the body involved in body defence (immune system).
Slovenian: Bezgavke predstavljajo del limfnega sistema, mrežo telesnih struktur, ki sodeluje pri obrambi telesa (imunski sistem).
English: This should help making a difference between normal lymph nodes that contain macrophages and therefore magnetic particles, and lymph nodes that are invaded with cancer cells and contain fewer macrophages and fewer magnetic particles.
Slovenian: Zaradi tega bi morala obstajati razlika med normalnimi bezgavkami, ki vsebujejo makrofage in s tem tudi magnetne delce, ter bezgavkami, v katere so prodrle rakaste celice ter imajo zato manj makrofagov in manj magnetnih delcev.
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, Evropska komisija v približno 2 mesecih izda dovoljenje.
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 pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko na 180. dan zaprosi podjetje še za odgovore na dodatna vprašanja.
English: On 13 December 2007, Guerbet officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sinerem, intended for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Slovenian: Podjetje Guerbet je 13. decembra 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Sinerem, ki je namenjeno za uporabo v diagnostiki za karakterizacijo bezgavk, ki postanejo vidne s slikanjem z magnetno resonanco pri ocenjevanju razširitve primarnih tumorjev pri raku v medeničnem predelu.
English: The patients then had an operation to remove the lymph nodes, and the results of the scans were compared by three different specialist readers to the results obtained when looking at the lymph nodes under a microscope to see if they contained any cancer cells.
Slovenian: Bolniki so nato prestali operacijo za odstranitev bezgavk, rezultate slikanj pa so trije različni specialisti primerjali z rezultati pregledov bezgavk pod mikroskopom, da bi ugotovili morebitno prisotnost rakastih celic.
English: Sinerem is a powder to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Sinerem je prašek, ki se uporablja za pripravo suspenzije za infundiranje (vnašanje po kapljicah v veno).
English: The active substance in Sinerem is iron oxide in the form of nanoparticles in a clear, colloidal (jellylike) solution of dextran, a type of sugar.
Slovenian: Zdravilna učinkovina v zdravilu Sinerem je železov oksid v obliki nanodelcev v bistri, koloidni (gelu podobni) raztopini dekstrana, ki je vrsta sladkorja.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefits of Sinerem as a diagnostic agent in the characterisation of lymph nodes in patients with pelvic cancer had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da koristi zdravila Sinerem kot diagnostičnega sredstva za karakterizacijo bezgavk bolnikov z rakom v medeničnem predelu niso zadostno dokazane in da morebitne koristi niso večje od znanih tveganj.
English: What is Sinerem?
Slovenian: Kaj je zdravilo Sinerem?
English: When a cancer is in the process of spreading, the cancer cells travel within the lymphatic system, and can be detected in the lymph nodes.
Slovenian: Kadar je rak v stadiju širjenja, rakaste celice potujejo po limfnem sistemu, zaradi česar jih lahko odkrijemo v bezgavkah.
English: When exposed to the action of an external magnet as during an MRI scan, the particles become magnetic, and they can be seen more easily on the scan image.
Slovenian: Če se ti delci izpostavijo delovanju zunanjega magneta, kot med slikanjem z magnetno resonanco, se delci namagnetijo, tako da se jih lahko bolje vidi na sliki, dobljeni s slikanjem z magnetno resonanco.
English: The main concern of the CHMP was that the effectiveness of Sinerem in enhancing the images seen in the MRI scan had not been shown.
Slovenian: Glavni zadržki CHMP so bili, da učinkovitost zdravila Sinerem pri ojačevanju slik, dobljenih s slikanjem z magnetno resonanco, ni bila dokazana.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sinerem could not have been approved for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo Sinerem ni mogoče odobriti dovoljenja za diagnostične namene za karakterizacijo bezgavk, ki postanejo vidne s slikanjem z magnetno resonanco pri ocenjevanju razširitve primarnih tumorjev pri raku v medeničnem predelu.
English: It was to be used as a ‘contrast agent' to help make internal body structure more visible on the scan.
Slovenian: Zdravilo bi se uporabljalo kot „kontrastno sredstvo”, ki na diagnostični sliki poudari notranje telesne strukture.
English: How is Sinerem expected to work?
Slovenian: Kako naj bi zdravilo Sinerem delovalo?
English: Pelvic cancers are cancers affecting organs in the lower abdomen, such as the prostate gland, the bladder, the womb or the cervix.
Slovenian: Rakasta obolenja v medeničnem predelu prizadenejo organe spodnjega dela trebuha, kot so prostata, sečni mehur, maternica ali maternični vrat.
English: There were inconsistencies between readers regarding any improvement Sinerem may have brought in detecting cancer spread in lymph nodes during an MRI scan, and Sinerem could not therefore be considered as useful in the management of patients with such conditions.
Slovenian: Med strokovnjaki, ki so razlagali slike, ni bilo skladnosti glede morebitnih izboljšav, ki bi jih zdravilo Sinerem lahko imelo pri odkrivanju širjenja raka v bezgavkah med slikanjem z magnetno resonanco, zaradi česar Odbor zdravila Sinerem ni mogel šteti za uporabnega pri zdravljenju bolnikov s takimi stanji.
English: What was Sinerem expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Sinerem uporabljalo?
English: Sinerem was to be used in patients with pelvic cancers.
Slovenian: Zdravilo Sinerem naj bi se uporabljalo pri bolnikih z rakom v medeničnem predelu.
English: Once in the lymphatic system, the nanoparticles are taken up by a certain type of immune system cell called ‘macrophages' within the lymph nodes.
Slovenian: Nanodelce po vstopu v limfni sistem v bezgavkah vsrkava vrsta celic imunskega sistema, ki jih imenujemo „makrofagi”.
English: The patients underwent two MRI scans to detect any cancer cells in their lymph nodes, one with Sinerem and one without.
Slovenian: Bolnike so dvakrat slikali z magnetno resonanco, da bi ugotovili prisotnost rakastih celic v njihovih bezgavkah, pri čemer so eno slikanje opravili z zdravilom Sinerem, drugo pa brez zdravila.
English: Sinerem was to be used to see if the cancer was spreading, by helping visualise the patients' lymph nodes.
Slovenian: Zdravilo Sinerem bi se uporabljalo za ugotavljanje morebitnega širjenja raka, in sicer kot pomoč pri prikazovanju bezgavk bolnikov.
English: Sinerem was to be used as a diagnostic agent in patients undergoing an MRI scan.
Slovenian: Zdravilo Sinerem je bilo namenjeno za uporabo kot diagnostično sredstvo pri bolnikih med slikanjem z magnetno resonanco.
English: 30 May 2013 EMA/318380/2013
Slovenian: 25. julij 2013 EMA/318380/2013
English: • Healthcare professionals will be sent a letter with further details.
Slovenian: • Zdravstveni delavci so prejeli dopis z dodatnimi podrobnostmi.
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Slovenian: Dodatne informacije o priporočilu odbora PRAC ter ozadju te presoje so na voljo na spletni strani agencije.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Presojo teh podatkov je najprej izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: • If you have any questions you should speak to your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se pogovorite s svojim zdravnikom ali farmacevtom.
English: Diane 35 was first authorised in 1985.
Slovenian: Zdravilo Diane 35 je bilo prvič odobreno leta 1985.
English: However, to minimise this risk, further measures should be implemented in addition to the updated product information.
Slovenian: Vendar je treba za zmanjšanje tega tveganja poleg posodobljenih informacij o zdravilu uvesti še dodatne ukrepe.
English: Healthcare professionals should follow these recommendations:
Slovenian: Informacije za zdravstvene delavce Zdravstveni delavci naj upoštevajo naslednja priporočila:
English: The CMDh is a medicines regulatory body representing the EU Member States.
Slovenian: CMDh je regulatorni organ za zdravila, ki zastopa države članice EU.
English: The risk of thromboembolism occurring with these medicines is low and well known.
Slovenian: Tveganje za tromboembolijo, ki se pojavlja pri teh zdravilih, je nizko in dobro znano.
English: The French decision followed a national review of the medicine by ANSM.
Slovenian: Francoska odločitev je sledila nacionalni presoji zdravila s strani ANSM.
English: These recommendations have been endorsed by the CMDh, a body representing EU Member States.
Slovenian: Ta priporočila je sprejel CMDh, organ, ki zastopa države članice EU.
English: The review of Diane 35 and its generics was initiated in February 2013 at the request of France, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Slovenian: Presoja zdravila Diane 35 in njegovih generičnih zdravil se je začela februarja 2013 na zahtevo Francije, v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot nujni postopek Unije.
English: • You should not stop taking these medicines before speaking to your doctor.
Slovenian: • Z jemanjem teh zdravil ne prenehajte, dokler se ne pogovorite s svojim zdravnikom.
English: • You should always read the package leaflet and be aware that there is a low risk of blood clots with these medicines.
Slovenian: • Vedno preberite navodila za uporabo in upoštevajte, da obstaja pri teh zdravilih nizko tveganje za nastanek krvnih strdkov.
English: These medicines work by blocking the effects of a class of hormones called androgens.
Slovenian: Ta zdravila delujejo tako, da zavirajo učinek skupine hormonov, imenovanih androgeni.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Priporočila odbora PRAC so bila posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
English: Its main responsibility is to resolve disagreements between Member States involved in mutual recognition or decentralised procedures, to ensure that patients have the same level of protection, no matter where they are in the EU.
Slovenian: Njegova glavna naloga je reševanje nesoglasij med državami članicami, vključenimi v postopke za medsebojno priznavanje in decentralizirani postopek, da se zagotovi enaka raven zaščite za bolnike po vsej EU.
English: Medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved via national procedures and are available on prescription under various trade names in all EU Member States except Cyprus.
Slovenian: Zdravila, ki vsebujejo ciproteron acetat 2 mg in etinilestradiol 35 mikrogramov so bila odobrena z nacionalnimi postopki in so na voljo na recept pod različnimi tržnimi imeni v vseh državah članicah EU, razen na Cipru.
English: • In the treatment of alopecia androgenetica and acne without androgenic features, the data on efficacy is limited.
Slovenian: • Za zdravljenje androgene alopecije in aken brez androgenih lastnosti so podatki o učinkovitosti omejeni.
English: The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Slovenian: Učinkovitost pri zmernih do hudih aknah s seborejo ali brez nje in/ali hirzutizmu je dokazana v več kot 30 kliničnih preskušanjih.
English: Despite the PRAC recommendation ANSM proceeded with the suspension of the marketing authorisation of these medicines in France.
Slovenian: ANSM je kljub priporočilu PRAC začasno umaknil dovoljenje za promet s temi zdravili v Franciji.
English: • If you are using these medicines for other conditions you should make a non-urgent appointment with your doctor to review your treatment.
Slovenian: • Če ta zdravila jemljete za druge namene, se dogovorite za nenujen obisk pri svojem zdravniku, ki bo izvedel presojo vašega zdravljenja.
English: Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Slovenian: Ciproteron prav tako zavira ovulacijo in zato deluje kot kontracepcijsko sredstvo.
English: The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Slovenian: Presojo zdravila Diane 35 in njegovih generičnih zdravil je sprožila francoska nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM) po odločitvi, da v treh mesecih začasno umakne zdravilo Diane 35 in njegova generična zdravila v Franciji.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority (26:1) the recommendation of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided that several measures are taken to minimise the risk of thromboembolism (formation of blood clots in blood vessels).
Slovenian: 29. maja 2013 je Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) z večino glasov (26:1) sprejela priporočilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) Evropske agencije za zdravila, v katerem so zaključili, da so koristi zdravila Diane 35 (ciproteron acetat 2 mg/etinilestradiol 35 mikrogramov) in njegovih generičnih zdravil večje od z njimi povezanih tveganj, pod pogojem, da se izvaja več ukrepov za zmanjšanje tveganja za trombembolijo (oblikovanja krvnih strdkov v krvnih žilah).
English: These include providing educational materials to prescribers and patients highlighting the risks of thromboembolism, for example a prescriber checklist to ensure that the risks, together with the signs and symptoms, are discussed with the patient.
Slovenian: Mednje spadajo izobraževalna gradiva za predpisovalce in bolnice, v katerih so jasno izpostavljena tveganja za tromboembolijo, na primer kontrolni seznam za predpisovalca, ki zagotavlja, da se predpisovalec z bolnico pogovori o tveganjih ter s tem povezanih znakih in simptomih.
English: • You should be aware that there are factors that can increase the risk of blood clots in blood vessels, such as increasing age, smoking, obesity and prolonged immobility.
Slovenian: • Upoštevajte, da lahko nekateri dejavniki povečajo tveganje za nastanek krvnih strdkov v krvnih žilah, na primer višja starost, kajenje, debelost in dolgotrajna gibalna nedejavnost.