natgillin/translations-raw huggingface dataset:
Based on the totality of the data assessed during the procedure and on the advice from the Scientific Advisory Group, the PRAC concluded that the benefit-risk balance of Procoralan/Corlentor remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activity agreed.
Na podlagi celotnih podatkov, ocenjenih med postopkom, in nasveta Znanstvene svetovalne skupine je odbor PRAC sklenil, da razmerje med tveganji in koristmi zdravil Procoralan/Corlentor ostaja pozitivno, če se upoštevajo spremembe informacij o zdravilu in ukrepi za zmanjševanje tveganja ter izvajajo dodatne dogovorjene farmakovigilančne dejavnosti.
However, AF was not related to the higher outcome risk as patients with AF in relation to the proportion of patients with a subsequent endpoint was similar for ivabradine as for the placebo patients.
Vendar atrijska fibrilacija ni bila povezana z večjim tveganjem izida, saj je bil delež bolnikov z atrijsko fibrilacijo glede na delež bolnikov s poznejšim opazovanim dogodkom podoben v skupini z ivabradinom kot pri placebu.
The increased incidence of bradycardia in relation to the increased observed CV risk while on treatment with the higher initial dose and maximum dose (as in the SIGNIFY study), or concomitant diltiazem/verapamil or strong CYP3A4 inhibitors, indicates that the heart rate should not be extensively reduced.
Povečana incidenca bradikardije, povezana s povečanim opaženim kardiovaskularnim tveganjem med zdravljenjem z večjim začetnim odmerkom in največjim odmerkom (kot v študiji SIGNIFY) ali sočasnim zdravljenjem z diltiazemom/verapamilom ali močnimi zaviralci CYP3A4, kaže, da se srčni utrip ne sme preveč upočasniti.
Furthermore a drug utilisation study shall be performed to describe the characteristics of users of ivabradine, patterns of use and assess adherence to the risk minimisation measures.
Poleg tega bo opravljena študija o uporabi zdravila, s katero bodo opisali značilnosti uporabnikov ivabradina in vzorce uporabe ter ocenili upoštevanje ukrepov za zmanjševanje tveganja.
On the basis of efficacy and safety data from studies that became available after the initial marketing authorisation including the BEAUTIFUL1 study, the indication was extended in October 2009 to include combination with beta-blockers in patients whose angina is inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60 bpm.
Na podlagi podatkov o učinkovitosti in varnosti iz študij, ki so bile izdane po prvotni izdaji dovoljenja za promet z zdravilom, vključno s študijo BEAUTIFUL1, so indikacijo oktobra 2009 razširili na kombinacijo z betaadrenergičnimi antagonisti pri bolnikih s srčnim utripom > 60 udarcev/min, pri katerih angina pektoris ni zadostno nadzorovana z optimalnim odmerkom betaadrenergičnih antagonistov.
The SIGNIFY study in patients with CAD without clinical heart failure using doses higher than currently approved also showed no benefit in terms of CV outcome, but demonstrated a small significant increased risk on CV outcome for patients with symptomatic angina in a pre-specified analysis.
V študiji SIGNIFY pri bolnikih s koronarno arterijsko boleznijo brez kliničnega srčnega popuščanja, v kateri so se uporabili odmerki, večji od trenutno odobrenih, prav tako niso dokazali koristi glede kardiovaskularnega izida, vendar so v vnaprej opredeljeni analizi ugotovili pomembno, rahlo povečano tveganje za kardiovaskularne izide pri bolnikih s simptomatsko angino pektoris.
Although baseline heart rate ≥ 70 bpm was an inclusion criteria in the SIGNIFY study, data from BEAUTIFUL study indicate a significant p-value for interaction for the primary composite endpoint when patient are divided around the 70 bpm cut-off level, although a significant beneficial effect was only observed for the MI endpoint in the heart rate ≥70 subgroup.
Čeprav je bilo vključitveno merilo v študiji SIGNIFY izhodiščni srčni utrip  70 udarcev/min, podatki iz študije BEAUTIFUL kažejo pomembno vrednost p pri interakciji primarnega sestavljenega opazovanega dogodka, kadar so bolniki razdeljeni glede na omejitev 70 udarcev/min, čeprav so pri podskupini s srčnim utripom ≥ 70 pomemben koristen učinek opazili samo za opazovani dogodek miokardnega infarkta.
• Concomitant treatment with moderate CYP3A4 inhibitors with heart rate reducing properties such as diltiazem or verapamil is now contraindicated.
• sočasno zdravljenje z zmernimi zaviralci CYP3A4 z lastnostmi upočasnitve srčnega utripa, kot sta diltiazem in verapamil, je zdaj kontraindicirano;
However the results of SIGNIFY highlight the need to make it explicit in the product information that ivabradine use in CAD patients has no benefits on CV outcomes and it will only have an effect on symptoms of angina pectoris.
Vendar so rezultati študije SIGNIFY izpostavili potrebo po poudarku v informacijah o zdravilu, da uporaba ivabradina pri bolnikih s KAD nima nobenih koristi na kardiovaskularne izide in bo imela učinek samo na simptome angine pektoris.
The PRAC is therefore of the opinion that the benefit-risk balance of ivabradine remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
odbor PRAC zato meni, da razmerje med tveganji in koristmi ivabradina ostaja pozitivno, če se upoštevajo spremembe informacij o zdravilu in ukrepi za zmanjševanje tveganja ter izvajajo dodatne dogovorjene farmakovigilančne dejavnosti.
This indication concerns use in chronic heart failure New York Heart Association (NYHA) class II to IV with systolic dysfunction, in patients in sinus rhythm with heart rate ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Ta indikacija je povezana z uporabo pri kroničnem srčnem popuščanju razreda II do IV po razvrstitvi Newyorškega kardiološkega združenja (NYHA) s sistolično disfunkcijo pri bolnikih s sinusnim ritmom in srčnim utripom ≥ 75 udarcev/min v kombinaciji s standardnim zdravljenjem, ki vključuje betaadrenergične antagoniste, ali kadar je zdravljenje z betaadrenergičnimi antagonisti kontraindicirano ali ga bolnik ne prenaša.
In February 2012, ivabradine was approved for the treatment of heart failure in the European Union based on the results of the SHIFT2 study.
Na podlagi rezultatov študije SHIFT2 so februarja 2012 ivabradin v Evropski uniji odobrili za zdravljenje srčnega popuščanja.
These findings appear contradictory with findings from previous ivabradine studies in patients with CAD.
Te ugotovitve nasprotujejo ugotovitvam iz prejšnjih študij ivabradina pri bolnikih s koronarno arterijsko boleznijo.
The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisations for Corlentor and Procoralan should be varied.
Po preučitvi priporočila odbora PRAC se je odbor CHMP strinjal z njegovimi splošnimi znanstvenimi zaključki in menil, da je treba dovoljenji za promet z zdraviloma Procoralan in Corlentor spremeniti.
In addition to CAD, ivabradine is currently also indicated for treatment of chronic heart failure on the basis of results from the previous SHIFT study.
Poleg KAD je ivabradin na podlagi rezultatov iz predhodne študije SHIFT trenutno indiciran tudi za zdravljenje kroničnega srčnega popuščanja.
• The PRAC concluded that there are clinically relevant benefits to the symptomatic treatment of angina pectoris with ivabradine.
• odbor PRAC je sklenil, da so koristi simptomatskega zdravljenja angine pektoris z ivabradinom klinično pomembne;
The MAH will conduct a drug utilisation study to describe the characteristics of users of ivabradine, as well as describing the patterns of use of ivabradine and adherence to the risk minimisation measures.
Imetnik dovoljenja za promet z zdravilom bo izvedel študijo o uporabi zdravila, s katero bo opisal značilnosti uporabnikov ivabradina in vzorce uporabe ivabradina ter upoštevanja ukrepov za zmanjševanje tveganja.
Patients exposed to the 10 mg dose seemed to be at increased risk of a CV endpoint in comparison to patients not exposed to the 10 mg dose based on a time model evaluation.
Na podlagi ocene časovnega modela je videti, da so imeli bolniki, izpostavljeni odmerku 10 mg, povečano tveganje za kardiovaskularni opazovani dogodek v primerjavi z bolniki, ki niso bili izpostavljeni odmerku 10 mg.
There were also no significant differences between the two groups in the incidences of the components of the primary composite endpoint (death from CV causes and nonfatal MI).
Prav tako ni bilo pomembnih razlik v incidenci komponent primarnega sestavljenega opazovanega dogodka med obema skupinama (smrt zaradi kardiovaskularnih vzrokov in nesmrtni miokardni infarkt).
Although it does not fully explain the findings, a contributor to the increased risk of CV events appears to be the high starting dose and maximum dose used in the SIGNIFY study, exceeding the currently approved maximum dose.
Videti je, da je bil dejavnik, ki je prispeval k povečanemu tveganju za kardiovaskularne dogodke, velik začetni odmerek in največji odmerek v študiji SIGNIFY, ki je presegel trenutno odobreni največji odmerek, vendar s tem ni mogoče popolnoma razložiti ugotovitev.
Concomitant use of diltiazem/verapamil (which also have an additional heart rate lowering effect) and strong CYP3A4 inhibitors have also shown to increase the incidence of bradycardia events and the risk of MI. Concomitant treatment is currently not recommended but this should be strengthened to a contraindication to minimize the risk of clinically relevant interactions.
Pokazali so tudi, da sočasna uporaba diltiazema/verapamila (ki ima prav tako dodaten učinek na upočasnitev srčnega utripa) in močnih zaviralcev CYP3A4 poveča incidenco dogodkov bradikardije in tveganje miokardnega infarkta.
MorBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction.
1 Ocena obolevnosti in umrljivosti za zaviralec If, ivabradin, pri bolnikih s koronarno boleznijo in disfunkcijo levega prekata.
Additional clarifications were also introduced in the DHPC.
Dodatna pojasnila so vključena tudi v dopis za neposredno komunikacijo z zdravstvenimi delavci.
The SIGNIFY is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, event-driven study which was designed to test the hypothesis that heart rate lowering with ivabradine reduces cardiovascular (CV) event rates in patients with stable coronary artery disease (CAD).
SIGNIFY je multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija z vzporednimi skupinami, ki je temeljila na neželenih dogodkih.
Although not reaching statistical significance, similar trends were observed for the individual components of CV death and non-fatal myocardial infarction (MI).
Podobno gibanje so opazili pri posameznih komponentah kardiovaskularne smrti in nesmrtnega miokardnega infarkta (MI), vendar niso dosegli statistične pomembnosti.
Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease.
3 Študija za ocenjevanje koristi zaviralca If, ivabradina, za obolevnost in umrljivost pri bolnikih s koronarno arterijsko boleznijo.
Scientific conclusions 1 - PRAC recommendation
- Priporočilo odbora PRAC
Systolic Heart failure treatment with the If inhibitor ivabradine Trial.
2 Preskušanje zdravljenja sistoličnega srčnega popuščanja z zaviralcem If, invabradinom.
Ivabradine, a specific heart rate lowering agent, has demonstrated symptomatic improvement of angina symptoms in patients with stable CAD. A large study in patients with CAD and left ventricular dysfunction (BEAUTIFUL study) could not demonstrate a benefit in terms of CV outcome.
Pri ivabradinu, posebni učinkovini za upočasnitev srčnega utripa, so dokazali simptomatsko izboljšanje simptomov angine pektoris pri bolnikih s stabilno koronarno arterijsko boleznijo.
dose in the SIGNIFY study (higher than the current approved 7.5 mg b.i.d.
Pri bolnikih v študiji SIGNIFY, pri katerih so odmerek povečali na največ 10 mg dvakrat na dan (več kot trenutno odobreni odmerek 7,5 mg dvakrat na dan), se je večina opazovanih dogodkov pojavila, ko so bolniki jemali največji odmerek.
BACKGROUND INFORMATION
OSNOVNE INFORMACIJE
A Decision was issued by the European Commission on 4 July 2006.
Odločbo je Evropska Komisija izdala dne 4. julija 2006.
The referral procedure started on 19 September 2005.
Postopek se je začel dne 19. septembra 2005.
The divergences identified at the start of the referral were resolved.
Razlike, ugotovljene na začetku napotitvenega postopka, so bile odpravljene.
• Travelling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary).
• ki potujejo v katerokoli državo, ki za vstop zahteva Mednarodno potrdilo o cepljenju (kar je lahko odvisno ali neodvisno od predhodnega potovalnega načrta)
• Travelling to, passing through or living in an endemic area.
• ki potujejo, se prehodno zadržujejo ali živijo na endemičnem področju,
Active immunisation against yellow fever in persons from 9 months of age:
aktivna imunizacija proti rumeni mrzlici pri osebah, starih več kot 9 mesecev:
• Handling potentially infectious materials (e.g. laboratory personnel).
• ki rokujejo s potencialno kužnimi snovmi (npr. laboratorijsko osebje).
The CHMP gave a positive opinion on 27 April 2006 recommending the harmonisation of the SPC for STAMARIL and associated names.
CHMP je 27. aprila 2004 izdal pozitivno mnenje, s katerim priporoča uskladitev SPC za STAMARIL in z njim povezana imena.
STAMARIL is a viral vaccine and the antigen of the vaccine act prophylactic by stimulating an immune response against the above-yellow fever.
STAMARIL je virusno cepivo in antigen cepiva deluje profilaktično tako, da stimulira imunski odgovor proti zgoraj omenjeni rumeni mrzlici.
The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of STAMARIL and associated names is considered to be positive in the following indications:
Ob upoštevanju poročil o oceni zdravila poročevalca in so-poročevalca, znanstvenih razprav znotraj odbora in pripomb imetnikov dovoljenj za promet z zdravilom (MAH) je CHMP menil, da je razmerje med koristmi in tveganji zdravila STAMARIL in z njim povezanih imen pozitivno v naslednjih indikacijah:
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj z dopolnjenim Povzetkom glavnih značilnosti zdravila (SPC) v Dodatku III.
The active substance of STAMARIL is a live attenuated yellow fever virus.
Zdravilna učinkovina v zdravilu STAMARIL je živ, oslabljen virus rumene mrzlice.
On 11 August 2005, Sanofi Pasteur MSD on behalf of all the Marketing Authorisation Holders (see Annex I) presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product STAMARIL and associated names.
Dne 11. avgusta 2005 je Sanofi Pasteur MSD v imenu vseh imetnikov dovoljenj za promet (glej Dodatek I) na EMEA predložil predlog za postopek v skladu s členom 30 Direktive 2001/83/ES, kot je bila spremenjena, za uskladitev nacionalnih Povzetkov glavnih značilnosti (SPC) zdravila STAMARIL in z njim povezanih imen.
London, 4 July 2006 EMEA/169383/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 30 OF COUNCIL DIRECTIVE 2001/83/EC FOR STAMARIL and associated names (See Annex I) International Non-Proprietary Name (INN): Live attenuated yellow fever virus
London, 4.7. 2006 EMEA/169383/2006 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) POVZETEK MNENJA PO POSTOPKU, IZVEDENEM V SKLADU S ČLENOM 30 DIREKTIVE SVETA 2001/83/ES ZA STAMARIL in z njim povezana imena (Glej Dodatek I) Mednarodno nelastniško ime (INN): Živ, oslabljen virus rumene mrzlice
Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
Na podlagi nacionalnih, različnih odločitev pristojnih organov v državah članicah EU so bili odobreni različni Povzetki glavnih značilnosti zdravila (SPC).
London, 20 November 2008 Doc.
London, 20. novembra 2008 Sklic dok.
In both cases, all medicines were to be started at the same time.
V obeh primerih bi se vsa zdravila uvedla sočasno.
In both groups, trastuzumab treatment was continued for a year.
V obeh skupinah je zdravljenje s trastuzumabom trajalo eno leto.
The main measure of effectiveness was how long the patients survived until their cancer came back.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov do ponovitve raka.
The evaluation had finished and the CHMP had given a negative opinion.
Postopek ocenjevanja je bil zaključen in CHMP je izrazil negativno mnenje.
The company had initiated an appeal process, but this had not yet finished when the company withdrew.
Družba je sprožila pritožbeni postopek, vendar se ta še ni zaključil, ko je družba podala zahtevek za umik.
International non-proprietary name (INN): docetaxel
Mednarodno nelastniško ime (INN): docetaksel
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje ter potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The letters from the company notifying the EMEA of the withdrawal of the application are available here and here.
Dopisa, s katerima družba agencijo EMEA obvešča o umiku vloge, sta na voljo tukaj in tukaj.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Docetaksel blokira sposobnost celic za uničevanje notranjega „skeleta“, ki jim omogoča deljenje in razmnoževanje.
What were the main concerns of the CHMP?
Kateri so bili glavni zadržki CHMP?
With the skeleton still in place, the cells cannot divide and they eventually die.
Ker skelet ostane nespremenjen, se celice ne morejo deliti in sčasoma odmrejo.
The study compared the effectiveness of the following treatment combinations, which were used in addition to surgery:
V študiji so primerjali uèinkovitost naslednjih kombinacij zdravil, ki so se uporabila poleg operativnega posega:
Docetaxel affects not only cancer cells, but also non-cancer cells such as blood cells, which can cause side effects.
Docetaksel ne vpliva le na rakave celice, ampak tudi na nerakave celice, kot so krvne celice, kar lahko povzroči neželene učinke.
There are no consequences on the use of Taxotere/Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila Taxotere/Docetaxel Winthrop za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
It is used in breast cancer that is advanced or ‘metastatic' (has spread to other parts of the body), and in breast cancer that can be treated with surgery.
Uporablja se pri raku dojke, ki je napredoval ali ima zasevke (se je razširil na druge dele telesa), ter pri raku dojke, ki ga je možno zdraviti z operativnim posegom.
• together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide;
• skupaj s trastuzumabom (drugim zdravilom proti raku) po zdravljenju z doksorubicinom in ciklofosfamidom;
• together with trastuzumab and carboplatin (another anticancer medicine).
• skupaj s trastuzumabom in karboplatinom (drugim zdravilom proti raku).
The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/Docetaxel Winthrop, carboplatin and trastuzumab.
Odbor je menil tudi, da družba ni predložila zadostnih kliniènih dokazov za utemeljitev uporabe kombinacije zdravila Taxotere/Docetaxel Winthrop, karboplatina in trastuzumaba.
On 14 November 2008, Sanofi-Aventis Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Taxotere/Docetaxel Winthrop, to add the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Družba Sanofi-Aventis Pharma S.A. je dne 14. novembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo Taxotere/Docetaxel Winthrop, tj. za dodatek zdravljenja bolnic z operabilnim rakom dojke, katerega tumorji imajo čezmerno izražajo HER2, v kombinaciji s trastuzumabom in karboplatinom ali brez njega.
The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed.
CHMP je menil, da ni bilo mogoèe ugotoviti koristi kombinacij zdravljenja, vkljuèno z zdravilom Taxotere/Docetaxel Winthrop, kot dodatkov po operativnem posegu zaradi naèina zasnove edine glavne študije.
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Taxotere/Docetaxel Winthrop
Vprašanja in odgovori v zvezi z umikom vloge za spremembo dovoljenja za promet z zdravilom Taxotere/Docetaxel Winthrop
Taxotere/Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be ‘expressing' large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.
Zdravilo Taxotere/Docetaxel Winthrop naj bi se uporabljalo za zdravljenje raka dojke, ki ga je mogoèe zdraviti z operativnim posegom, èe se ugotovi, da rak „izraža“ velike kolièine HER2: to je vrsta raka, ki na površini rakavih celic v velikih kolièinah tvori (izraža) doloèeno beljakovino, imenovano HER2.
It contains the active substance docetaxel.
Vsebuje zdravilno uèinkovino docetaksel.
Taxotere/Docetaxel Winthrop is an anticancer medicine.
Taxotere/Docetaxel Winthrop je zdravilo proti raku.
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 given a negative opinion and did not recommend a marketing authorisation for Taxotere/Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Taxotere/Docetaxel Winthrop, namenjenim zdravljenju bolnikov z rakom dojke, ki ga je možno zdraviti z operativnim posegom in katerega tumorji čezmerno izražajo HER2, v kombinaciji s trastuzumabom in s karboplatinom ali brez njega.
Taxotere/Docetaxel Winthrop has been studied in one main study involving over 3,000 women with HER2-expressing breast cancer that could be treated with surgery.
Zdravilo Taxotere/Docetaxel Winthrop je bilo prouèeno v eni glavni študiji, v katero je bilo vkljuèenih veè kot 3 000 žensk z rakom dojke, ki je izražal HER2 in ga je bilo možno zdraviti z operativnim posegom.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/Docetaxel Winthrop.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Taxotere/Docetaxel Winthrop.