natgillin/translations-raw huggingface dataset:
However, each individual who has not been admitted as a speaker has the right to submit, prior to the public hearing, a written statement for consideration by the PRAC.
Vendar pa ima vsak posameznik, ki ni bil sprejet za govornika, pravico, da pred javno obravnavo predloži pisno izjavo, ki jo bo preučil odbor PRAC.
Public hearings can add various elements to the considerations of the PRAC.
Javne obravnave lahko prispevajo različne elemente k razmislekom odbora PRAC.
Public hearings at the PRAC - a definition
Javne obravnave v odboru PRAC - opredelitev
However, it may decline a request to speak at the public hearing if the outline of the planned intervention addresses a matter that is not prima facie related to the subject matter of the public hearing.
Vendar lahko zahtevek za govorno predstavitev na javni obravnavi zavrne, če se v opisu predvidenega govora obravnava tema, ki ni povezana prima facie s temo javne obravnave.
Following the opening of the public hearing, the PRAC Rapporteur and/ or PRAC Co-Rapporteur give(s) an overview of the procedure, including the main issues and present(s) the questions on which public input is sought.
Po uvodnem delu javne obravnave poročevalec in/ali soporočevalec odbora PRAC predstavi pregled postopka, vključno z glavnimi vprašanji, in navede vprašanja, v zvezi s katerimi se išče prispevek javnosti.
However, if they do wish to be present in the room, they must register in advance.
Če pa želijo biti medijske organizacije prisotne v prostoru obravnave, se morajo prijaviti vnaprej.
All individuals admitted as speakers will receive confirmation in advance of the hearing.
Vsi posamezniki, ki bodo sprejeti za govornike, bodo prejeli potrditev pred obravnavo.
Where time permits, the PRAC Chair can open the floor to all participants in the room, for additional statements on the points made during the hearing.
Če je na voljo dovolj časa, lahko predsednik odbora PRAC da besedo vsem udeležencem v prostoru za morebitne dodatne objave o točkah, izpostavljenih med obravnavo.
Each speaker will be asked to briefly introduce himself or herself, clearly state their name and the organisation/group the speaker represents, where applicable, and to declare any interests related to the medicinal products/medicinal substances, including their competitors, discussed at the meeting.
Vsak govornik bo pozvan, naj se na kratko predstavi, jasno navede svoje ime in ime organizacije/skupine, ki jo predstavlja, kadar je to ustrezno, ter prijavi morebitne interese, ki jih ima v zvezi z zdravilom/zdravilnimi učinkovinami, vključno z zdravilom in zdravilnimi učinkovinami konkurentov, o katerem oziroma katerih se bo razpravljalo na srečanju.
The Agency will prepare a list of speakers and a draft agenda for the public hearing, stating the time allocated to each group of speakers, grouped by capacity, and each speaker within a group.
Agencija bo pripravila seznam govornikov in osnutek dnevnega reda za javno obravnavo, pri čemer bo navedla čas, dodeljen vsaki skupini govornikov, razvrščenih po vlogi, in vsakemu govorniku v neki skupini.
Modalities of participation
Načini sodelovanja
When discussing the merits of holding a public hearing, the PRAC should consider the following elements:
Pri razpravi o prednostih izvedbe javne obravnave mora odbor PRAC upoštevati naslednje elemente:
All members of the public who wish to attend the public hearing as a speaker should submit their request in advance of the meeting, by the deadline specified in the Agency's announcement of the public hearing.
Vsi predstavniki javnosti, ki se želijo udeležiti javne obravnave v vlogi govornika, morajo predložiti svoj zahtevek pred srečanjem, in sicer do roka, navedenega v najavi javne obravnave, ki jo objavi agencija.
The Committee shall endeavour to reach agreement on holding a public hearing by consensus.
Odbor poskuša doseči soglasni dogovor o izvedbi javne obravnave.
• Speakers can make an intervention in person or via teleconferencing facilities (Adobe Connect) where possible and feasible (See section 3.3 for more information on how to submit a request to participate as a speaker).
Connect), če je to mogoče in izvedljivo (glej razdelek 3.3 za več informacij, kako vložiti zahtevo za udeležbo v vlogi govornika).
The assessment report will reference how the outcome of the public hearing has been addressed during the considerations at the level of the PRAC.
V poročilu o oceni bo navedeno, kako je bil izid javne obravnave upoštevan med razpravami na ravni odbora PRAC.
However, if a large number of requests have been received to attend the public hearing as a speaker, the Agency may reduce the time allocated for each speaker and/or extend the duration of the public hearing.
Če agencija prejme veliko število zahtevkov za udeležbo na javni obravnavi v vlogi govornika, lahko skrajša čas, dodeljen posameznim govornikom, in/ali podaljša trajanje javne obravnave;
Participants are encouraged to use English during the public hearing.
Udeležencem se priporoča, naj med obravnavo uporabljajo angleški jezik.
Public hearings will take place as part of meetings of the PRAC, with attendance of the Committee members.
Javne obravnave bodo potekale v okviru srečanj odbora PRAC in se jih bodo udeležili njegovi člani.
Different modalities of participation help to ensure that as many citizens as possible have access to the public hearing process.
Različni načini sodelovanja bodo pomagali zagotoviti, da ima dostop do postopka javne obravnave kar največ državljanov.
Requesters will receive a confirmation of their request in advance of the hearing.
Vlagatelji zahtevkov bodo potrditev svojega zahtevka prejeli pred obravnavo.
Different modalities of participation will help to ensure that as many citizens as possible have access to the public hearing.
Različni načini sodelovanja bodo pomagali zagotoviti, da ima kar največ državljanov dostop do javne obravnave.
He or she will be assisted by Agency staff on any administrative and organisational issues.
Javne obravnave vodi predsednik odbora PRAC, ki mu pri vseh upravnih ali organizacijskih vprašanjih pomaga osebje agencije.
Impact on PRAC opinion
Vpliv na mnenje odbora PRAC
For organisational reasons, participants must register in advance.
Udeleženci se morajo iz organizacijskih razlogov prijaviti vnaprej.
The value of a public hearing is considered to be greater in that phase of the process where the PRAC has assessed the scientific evidence coming from different sources and where different regulatory options to manage and/or minimise risks are to be considered in a wider public health context, before reaching its conclusion.
Šteje se, da je pomen javne obravnave večji v tisti fazi postopka, v kateri odbor PRAC pred sprejetjem sklepa oceni znanstvene dokaze iz različnih virov ter v kateri je treba v širšem javnozdravstvenem okviru pretehtati različna regulativna mnenja za obvladovanje in/ali zmanjšanje tveganj.
A public hearing is a forum to which the public is invited to express its views, guided by a pre-defined set of questions, on issues related to the safety of a particular medicinal product, a medicinal substance or a therapeutic class, whilst also considering the therapeutic effects of these products.
Javna obravnava je forum, k sodelovanju na katerem je pozvana javnost, da bi izrazila svoja stališča; temelji pa na vnaprej določenem sklopu vprašanj o zadevah v zvezi z varnostjo posebnih zdravil, zdravilne učinkovine ali terapevtske skupine, pri čemer se v njegovem okviru upoštevajo tudi terapevtski učinki teh izdelkov.
The Committee can reconsider its previous decision not to hold a public hearing during the course of the referral procedure, on the basis of new information.
Odbor lahko na podlagi novih informacij med postopkom napotitve spremeni svojo prejšnjo odločitev, da ne bo opravil javne obravnave.
Opening statements
Uvodne izjave
Requests for participation as an observer at the public hearing should also be sent to the Agency.
Na agencijo je treba nasloviti tudi zahtevke za udeležbo na javni obravnavi v vlogi opazovalca.
These documents will be published in advance of the public hearing on the Agency's website.
Ti dokumenti bodo pred javno obravnavo objavljeni na spletišču agencije.
Supporting documentation presented by the speakers during the intervention will be published on the Agency's website following the public hearing.
Podporna dokumentacija, ki jo govorniki predstavijo med govorno predstavitvijo, bo po javni obravnavi objavljena na spletišču agencije.
• The proceedings of the public hearing can also be observed via video broadcast on the Agency's website.
• Postopek javne obravnave je mogoče spremljati tudi prek video prenosa na spletišču agencije.
and will allocate time to each group, giving priority to civil society representatives, such as patients, consumers, healthcare professionals and academic research groups or organisations, particularly those relevant to the therapeutic area.
Agencija bo razvrstila govornike v skupine glede na njihovo vlogo (glej razdelek 3.3) in vsaki skupini dodelila čas, pri čemer bo prednostno obravnavala predstavnike civilne družbe, kot so pacienti, potrošniki, zdravstveni delavci in akademske raziskovalne skupine ali organizacije, zlasti tiste, ki so pomembne za zadevno terapevtsko področje.
“Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
„Če nujnost zadeve to dovoljuje, Odbor za ocenjevanje tveganja na področju farmakovigilance lahko opravi javno obravnavo, in če to šteje za primerno na podlagi utemeljenih razlogov, zlasti kar zadeva obseg in resnost varnostnega zadržka.
1.4. Who can attend a public hearing
Kdo se lahko udeleži javne obravnave?
Any requests by a marketing authorisation holder or another person to present in a non-public hearing data, considered confidential, relevant to the subject matter of the procedure should also be made at the time of submitting the request to participate.
Tudi imetnik dovoljenja za promet ali druga oseba mora zahtevek za predstavitev podatkov, ki se štejejo za zaupne in so pomembni za vsebino postopka, na obravnavi, zaprti za javnost, vložiti ob predložitvi zahtevka za udeležbo na javni obravnavi.
Where the number of requests within a group cannot be accommodated during the time allocated, people interested in speaking at the public hearing are encouraged to team-up among themselves.
Če v dodeljenem času ni mogoče odobriti vseh zahtevkov v skupini, se osebam, ki želijo imeti govorno predstavitev na javni obravnavi, priporoča, naj se medsebojno povežejo.
At the end of the interventions the PRAC Chair summarises the interventions heard.
Predsednik odbora PRAC na koncu govornih predstavitev povzame opravljene govorne predstavitve.
Organisation of a public hearing - before the hearing
Organizacija javne obravnave - pred obravnavo
Public hearings give the PRAC a channel to hear the public's views and concerns and take them into account in its opinion-making, particularly where options for regulatory actions to manage and/or minimise risks will need to be considered in a wider public health context.
Na njej se lahko odbor PRAC seznani z mnenji in zadržki javnosti ter jih upošteva pri odločanju, zlasti če je treba možnosti za regulativne ukrepe za obvladovanje in/ali zmanjšanje tveganj obravnavati v širšem javnozdravstvenem okviru.
The information gathered in the public hearing will be taken into account during the considerations within the PRAC.
Informacije, ki se zberejo v okviru javne obravnave, bodo upoštevane med razpravami v okviru odbora PRAC.
In the absence of the PRAC Chair, the PRAC Vice-Chair will chair the public hearing.
V odsotnosti predsednika javno obravnavo vodi podpredsednik odbora PRAC.
A record of the meeting, the list of speakers and all other participants, including their affiliation, their declared interests, any supporting documentation presented by speakers and a summary of the conclusions of the meeting will be made available following the public hearing on the Agency's website.
Na spletišču agencije se po javni obravnavi objavi poročilo o srečanju, seznam govornikov in vseh drugih udeležencev, vključno z njihovo povezavo, prijavljenimi interesi, podporno dokumentacijo, ki jo predložijo govorniki, in povzetkom sklepnih ugotovitev srečanja.
The announcement of a public hearing is made in advance of the hearing.
Najava javne obravnave se opravi pred obravnavo.
Detailed information on how to follow the broadcast will be made available via the Agency's website.
Podrobna navodila za spremljanje prenosa bodo na voljo na spletišču agencije.
The proceedings of the public hearing can also be followed via video broadcast on the Agency's website.
Postopek javne obravnave je mogoče spremljati tudi prek video prenosa na spletišču agencije.
The decision to hold a public hearing is taken by the Committee on a case-by-case basis, depending on the urgency of the matter in question and on other justified grounds, particularly with regard to the extent and seriousness of the safety issue.
Odbor sprejme odločitev o izvedbi javne obravnave za vsak primer posebej, odvisno od resnosti konkretne zadeve in drugih utemeljenih razlogov, zlasti kar zadeva obseg in resnost varnostnih zadržkov.
The PRAC Chair opens the public hearing.
Predsednik odbora PRAC začne javno obravnavo.
The information submitted to the Agency will be made public for all participants who make an intervention at the public hearing, with the exception of any personal contact details.2
V zvezi z vsemi udeleženci, ki bodo imeli govorno predstavitev na javni obravnavi, bodo objavljene informacije, ki se predložijo agenciji, izjema so osebni kontaktni podatki.2
• General ground rules guiding the public hearing.
• splošnimi osnovnimi pravili o javni obravnavi;
• Where space permits, requests to observe the public hearing in person without making an intervention will be accommodated.
• Če je na voljo dovolj prostora, se izpolnijo zahteve za udeležbo na javni obravnavi v vlogi opazovalca brez govorne predstavitve.
The Committee takes the decision to hold a public hearing on a case-by-case basis, where the urgency of the matter in question permits and after considering that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Odbor sprejme sklep o izvedbi javne obravnave za vsak primer posebej, kjer to dovoljuje nujnost konkretne zadeve in če to šteje za primerno na podlagi utemeljenih razlogov, zlasti kar zadeva obseg in resnost varnostnega zadržka.
The requests to speak at the public hearing will be reviewed by the Agency.
Agencija bo preučila zahtevke za govorno predstavitev na javni obravnavi.
Cancellation
Odpoved
Conduct of a public hearing - during the hearing
Vodenje javne obravnave - med obravnavo
The marketing authorisation holder(s) has/have the opportunity to present its/their view(s) to the participants of the public hearing.
Imetniki dovoljenja za promet lahko udeležencem javne obravnave predstavijo svoje mnenje.
Submitting a request to speak at the public hearing
Predložitev zahtevka za govorno predstavitev na javni obravnavi
Concluding the hearing
Zaključek javne obravnave
• Information on the location of the public hearing.
• informacijami o kraju javne obravnave;
Evaluating the need for a public hearing
Preučitev potrebe po javni obravnavi
Follow-up to the public hearing
Naknadno spremljanje javne obravnave
Interventions
Govorne predstavitve
Anybody who has submitted a request to speak at the public hearing to the Agency and who has not been admitted
Hkrati bodo obveščeni tudi vsi, ki so predložili zahtevek za govorno predstavitev na javni obravnavi, vendar niso bili sprejeti za govornike.
The contributions made by the public during a public hearing will be considered by the PRAC.
Odbor PRAC bo preučil prispevke, ki jih med javno obravnavo predloži javnost.
Purpose of a public hearing
Namen javne obravnave
3.5. Review of requests to speak at the public hearing
Preučitev zahtevkov za govorno predstavitev na javni obravnavi
Announcement of the public hearing
Najava javne obravnave
The questions asked by the PRAC to be addressed during the hearing determine the target audience.
Ciljno občinstvo se določi na podlagi vprašanj, ki jih je postavil odbor PRAC in o katerih se razpravlja med obravnavo.
Decision to hold a public hearing
Sklep o izvedbi javne obravnave
This summary was last updated in 01-2017.
Povzetek je bil nazadnje posodobljen 05-2016.
The main measure of effectiveness in this study was how long it took for the symptoms to start improving.
Glavno merilo učinkovitosti v tej študiji je bil čas, po katerem so se simptomi začeli izboljševati.
The European Commission granted a marketing authorisation valid throughout the European Union for Cinryze on 15 June 2011.
Evropska komisija je dovoljenje za promet z zdravilom Cinryze, veljavno po vsej Evropski uniji, izdala 15. junija 2011.
What measures are being taken to ensure the safe and effective use of Cinryze?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cinryze?
In addition, the company will maintain a patient registry to provide further data on long-term safety and the way the medicine is used in practice.
Poleg tega bo družba vodila register bolnikov, s čimer bo zagotovila dodatne podatke o dolgoročni varnosti in načinu uporabe zdravila v praksi.
The full EPAR for Cinryze 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 Cinryze je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Pri bolnikih z nizkimi ravnmi te beljakovine ta dva sistema delujeta prekomerno, kar povzroči simptome angioedema.
Other information about Cinryze
Druge informacije o zdravilu Cinryze
This is a summary of the European public assessment report (EPAR) for Cinryze.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cinryze.
There will also be a training leaflet for patients that should be kept at home.
Priložena bodo tudi navodila za usposabljanje za bolnike, ki jih morajo hraniti doma.
For more information about treatment with Cinryze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cinryze preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
Za drugo študijo so bili izbrani bolniki s pogostimi napadi, povprečno z vsaj dvema napadoma na mesec.
A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Drug odmerek 1 000 enot se lahko injicira, če se bolnik po eni uri ne odziva zadostno, ali prej pri napadih v grlu (organ za govor) oziroma če je bil začetek zdravljenja uveden z zamudo.
The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Družba, ki proizvaja zdravilo Cinryze, bo zagotovila, da bodo vsi zdravstveni delavci v vseh državah članicah, za katere se pričakuje, da bodo predpisovali zdravilo Cinryze, prejeli izobraževalno gradivo z navodili, da morajo biti negovalci in bolniki, ki si bodo zdravilo injicirali sami doma, za to ustrezno usposobljeni.
The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections or the dose according to how the patient is responding.
Zdravnik mora redno ocenjevati potrebo po preprečevanju in lahko prilagodi pogostnost injiciranja glede na odziv bolnika.
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 Cinryze.
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.
Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Bolniki z dednim angioedemom imajo napade otekanja, ki se lahko pojavijo kjer koli na telesu, na primer na obrazu, udih ali okoli prebavil, ter povzročajo nelagodje in bolečino.
Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) je na podlagi dokazov iz študij zaključil, da so koristi zdravila Cinryze večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
What are the risks associated with Cinryze?
Kakšna tveganja so povezana z zdravilom Cinryze?
The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Edini pogosti neželeni učinek, opažen v študijah z zdravilom Cinryze (opažen pri 1 do 10 bolnikih od 100), je izpuščaj, ki pa ni resen in se običajno pojavi na rokah, prsih, trebuhu ali mestu injiciranja.
The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Beljakovina zaviralec C1 je potrebna za urejanje sistema komplementa in kontaktnega sistema, skupino beljakovin v krvi, ki se borijo proti okužbam in povzročajo vnetje.
For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Cinryze glejte navodilo za uporabo.
Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
Zdravilo Cinryze se uporablja za nadomeščanje manjkajočega zaviralca C1 ter tako odpravlja pomanjkanje in pomaga pri preprečevanju ali zdravljenju napadov angioedema.
Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
V prvi študiji se je pri več kot 50 % bolnikov, ki so prejemali zdravilo Cinryze, pokazalo izboljšanje v dveh urah po začetku zdravljenja v primerjavi s 33 % bolnikov, ki so prejemali placebo.
C1 inhibitor (human)
Cinryze zaviralec C1 (humani)
What benefits of Cinryze have been shown in studies?
Kakšne koristi je zdravilo Cinryze izkazalo med študijami?
The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
V drugi glavni študiji, v kateri je sodelovalo 24 bolnikov iz prve študije, so proučevali število napadov v 12-tedenskem obdobju, v katerem so bolniki za preprečevanje napadov prejemali zdravilo Cinryze ali placebo.
The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Zdravilna učinkovina zdravila Cinryze, humani zaviralec C1, je beljakovina, pridobljena iz človeške krvi.
Why has Cinryze been approved?
Zakaj je bilo zdravilo Cinryze odobreno?