natgillin/translations-raw huggingface dataset:
The generous birthday tributes paid to the Agency by so many of its partners and stakeholders were a welcome endorsement of its efforts to maintain and further develop an effective regulatory environment for medicines in the EU.
Ob tej priložnosti je Agenciji čestitalo in ji zaželelo vse najboljše mnogo njenih partnerjev in interesnih skupin, kar je več kot dobrodošla potrditev njenih naporov za vzdrževanje in nadaljnji razvoj učinkovitega zakonodajnega okolja za zdravila v EU.
The Committee released for public consultation the first draft Community herbal monographs - for Valerian root, Psyllium seed, Linseed, Ispaghula husk and Ispaghula seed.
Odbor je za namene javnega posvetovanja objavil prvi osnutek rastlinskih monografij Skupnosti - za baldrijanovo korenino, trpotčevo seme, laneno seme, semensko lupino jajčastega trpotca in seme jajčastega trpotca.
Eleven initial marketing authorisation applications were received, 10 of which were for pharmaceuticals and 1 for an immunological.
Prejetih je bilo enajst začetnih vlog za izdajo dovoljenja za promet z zdravilom, od katerih jih je bilo 10 za farmacevtske izdelke in 1 za imunološko zdravilo.
With the aim of promoting innovation and the development of new medicinal products by micro, small and medium-sized enterprises, the Agency launched the ‘SME Office', dedicated to addressing the particular needs of smaller companies, following the entry into force of the new SME Regulation3
Po začetku veljavnosti nove Uredbe MSP2 je Agencija je s ciljem spodbujanja inovacij in razvoja novih zdravil s strani mikro, malih in srednje velikih podjetij ustanovila "Urad za MSP", ki obravnava posebne potrebe manjših podjetij, za izvajanje določb v novi farmacevtski zakonodaji EU, ki so povezane s spodbudami za MSP.
This included the finalisation of the structure of the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products and the template for Community herbal monographs and the organisation of training sessions for EU assessors.
Te so vključevale dokončno oblikovanje seznama rastlinskih snovi Skupnosti, njihovih pripravkov in kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora, oblikovanje predloge za rastlinsko monografijo Skupnosti ter organizacijo usposabljanja za ocenjevalce EU.
It presents key data relating to medicinal products authorised via the centralised procedure and has multiple-field search functionality that allows searching by product name, active substance etc.
V njej so zajeti ključni podatki, ki se nanašajo na zdravila, za katera so bila izdana dovoljenja prek centraliziranega postopka, omogoča pa tudi iskanje po več področjih, na primer po imenu izdelka, zdravilnih učinkovinah itd.
Eight applications for extension of a marketing authorisation were received: 6 related to pharmaceuticals and 2 to immunologicals.
Prejetih je bilo osem vlog za razširitev dovoljenja za promet z zdravilom: 6 se jih je nanašalo na farmacevtske izdelke, 2 pa na imunološka zdravila.
3.1.2 Scientific advice and protocol assistance
3.1.2 Znanstveno svetovanje in pomoč pri protokolu
Initial-evaluation applications 2003-2005
Vloge za začetno vrednotenje v obdobju 2003-2005
Twenty-two of these defect reports resulted in a product recall (20 related to human medicinal products and 2 related to veterinary medicinal products); the remainder were classified as minor.
Pri dvaindvajsetih poročilih o pomanjkljivostih je bil potreben umik izdelkov (20 se jih je nanašalo na zdravila za uporabo v humani medicini in 2 na zdravila za uporabo v veterinarski medicini); druga poročila so bila razvrščena kot manj pomembna.
A sub-group with representatives from the CMD(h), CHMP, the EMEA and the European Commission was created to lay down a list of human medicinal products for which a harmonised SPC should be drawn up.
Oblikovana je bila tudi podskupina, sestavljena iz predstavnikov CMD(h), CHMP, EMEA in Evropske komisije, za določitev seznama zdravil za humano uporabo, za katere je treba pripraviti usklajen povzetek glavnih značilnosti zdravila (Summary of Product Characteristics - SPC).
Deferral of the fee payable for an application for marketing authorisation or related inspection
odlog plačila pristojbine za vlogo za izdajo dovoljenja za promet z zdravilom ali povezane inšpekcijske preglede;
The EMEA issues certificates of medicinal products to confirm the marketing authorisation status of products that have been authorised through the centralised procedure, or of products for which a centralised marketing authorisation application has been submitted to the EMEA.
EMEA izdaja potrdila za zdravila, da bi potrdila status dovoljenja za promet za zdravila, za katera so bila izdana dovoljenja po centraliziranem postopku, ali zdravila, za katera je bila oddana vloga na EMEA za centralizirani postopek.
4.2 Medicines for veterinary use
4.2 Zdravila za uporabo v veterinarski medicini
Thirty-nine medicinal products were included within the scope of the 2005 programme of sampling and testing of centrally authorised products.
Devetintrideset zdravil je bilo vključenih v program vzorčenja in preizkušanja zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku.
An additional 2 were applications for opinions in the context of cooperation with the World Health Organization (WHO) for medicinal products intended exclusively for markets outside of the EU.
Dve drugi vlogi sta bili vlogi za mnenja v okviru sodelovanja s Svetovno zdravstveno organizacijo (WHO) za zdravila, namenjena izključno trgom zunaj EU.
New medicines for the treatment of HIV/AIDS
novimi zdravili za zdravljenje HIV/AIDS;
4.1 Medicines for human use
4.1 Zdravila za uporabo v humani medicini
3.1 Medicines for human use 3.1.1 Orphan designation
3.1 Zdravila za uporabo v humani medicini 3.1.1 Določitev zdravil sirot
its evaluation of available scientific data (well-established use) or on the historic use of that product in the European Community (traditional use).
Rastlinska monografija Skupnosti vključuje znanstveno mnenje HMPC o določenem zdravilu rastlinskega izvora, ki temelji na vrednotenju razpoložljivih znanstvenih podatkov (dobro uveljavljene uporabe) ali zgodovinski uporabi tega izdelka v Evropski skupnosti (tradicionalni uporabi).
New medicines for the treatment of neurodegenerative disorders
novimi zdravili za zdravljenje nevrodegenerativnih bolezni;
Opinions in 2005 In 2005, the CVMP adopted a total of 5 positive opinions for initial marketing authorisation applications.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v letu 2005 sprejel skupno 5 pozitivnih mnenj za začetne vloge za izdajo dovoljenja za promet z zdravilom.
The EMEA Management Board extended a pilot scheme to provide free scientific advice and protocol assistance to companies willing to develop medicines for MUMS.
Upravni odbor EMEA je razširil pilotni program za zagotavljanje brezplačnega znanstvenega svetovanja in pomoči pri protokolu podjetjem, ki so pripravljena razvijati zdravila za manjšo uporabo in manj pomembne vrste (MUMS).
Thereof, 73,198 ICSRs were received electronically for CAPs corresponding to 80% of the total adverse reaction reports received for CAPs in 2005.
Od tega je bilo 73.198 varnostnih poročil o posameznih primerih elektronsko prejetih za zdravila, za katera so bila izdana dovoljenja po centraliziranem postopku, kar ustreza 80 % vseh poročil o neželenih učinkih, prejetih v zvezi z zdravili, za katera so bila izdana dovoljenja po centraliziranem postopku, v letu
New applications in 2005
Nove vloge v letu 2005
8 HERBAL MEDICINES
8 ZDRAVILA RASTLINSKEGA IZVORA
EU and non-EU adverse drug reaction (ADR) reports
Poročila o neželenih učinkih zdravil iz EU in tistih, ki niso iz EU, v obdobju
The new legislation contains new tools to reinforce the Agency's capacity to ensure the safety of medicines, especially new pharmacovigilance obligations on companies and new provisions for submission of risk management plans.
da zagotavlja varnost zdravil, zlasti nove obveznosti v zvezi s farmakovigilanco za podjetja in nove določbe za predložitev načrtov za obvladovanje tveganja.
By August 2005, 500 GMP inspections had been completed since the start of the operation of the centralised procedure.
Od začetka izdajanja dovoljenj po centraliziranem postopku do avgusta 2005 je bilo zaključenih 500 inšpekcijskih pregledov dobre proizvodne prakse.
Incentives, including fee waivers for scientific advice, were introduced in 2005 to encourage companies to use the core-dossier approach.
Za spodbujanje podjetij k uporabi pristopa temeljne dokumentacije so bile v letu 2005 uvedene spodbude, vključno z oprostitvami plačila pristojbin za znanstveno svetovanje.
3 EVALUATION OF MEDICINES
3 VREDNOTENJE ZDRAVIL
Total staff-related expenditure
Skupni izdatki z osebje
Level of applications
Število vlog
Safety of medicines for human and veterinary use continued to be a top priority for the EMEA in 2005.
Tudi v letu 2005 je bila za EMEA najpomembnejša prednostna naloga varnost zdravil za uporabo v humani in veterinarski medicini.
Major increase in requests for scientific advice
Prejeti zahtevki za znanstveno svetovanje v letih
New medicines for the treatment of cancer
novimi zdravili za zdravljenje raka;
Welcomed two representatives of patients', one representative of doctors' and one representative of veterinarians' organisations as members of the Board Welcomed observers from Bulgaria and Romania Reappointed Thomas Lönngren as Executive Director of the EMEA Adopted strengthened rules on the handling of conflicts of interest of committee members and experts
pozdravil dva predstavnika organizacije bolnikov, enega predstavnika organizacije zdravnikov in enega predstavnika organizacije veterinarjev kot nove člane upravnega odbora; pozdravil opazovalce iz Bolgarije in Romunije; ponovno imenoval Thomasa Lönngrena za izvršnega direktorja EMEA; sprejel okrepljena pravila o reševanju navzkrižja interesov članov odbora in strokovnjakov; uvedel revidirana izvedbena pravila za pristojbine, ki določajo zlasti stopnjevanje ravni pristojbin, ki se plačujejo za nekatere nove vrste vlog; sprejel skupni proračun v višini 111.935.000 EUR za leto 2005 (12-odstotno povečanje v primerjavi s prejšnjim letom) skupaj z načrtom delovnih mest, na podlagi katerega bo skupno število delovnih mest začasnih uslužbencev Agencije znašalo 379.
Notification to the EMEA became mandatory following the implementation of the revised pharmaceutical legislation.
Z začetkom izvajanja revidirane farmacevtske zakonodaje je pošiljanje obvestil Agencji postalo obvezno.
The recommendations by the ad hoc working group to look at policy, compliance and regulatory aspects relating to EudraVigilance were adopted by the Heads of Medicines Agencies and the EMEA Management Board.
Vodje nacionalnih agencij za zdravila in upravni odbor EMEA so sprejeli priporočila ad hoc delovne skupine, ki je pozvala k preučitvi politike, skladnosti in regulativnih vidikov, povezanih z EudraVigilance.
Orphan drug fund
zdravili sirotami.
Scientific-advice and protocol-assistance requests received
Prejeti zahtevki za znanstveno svetovanje in pomoč pri protokolu
Applications received 2003-2005
Prejete vloge v letih 2003-2005
1 GXP means 'good clinical practice' (GCP), 'good manufacturing practice' (GMP) and 'good laboratory practice' (GLP) collectively.
Dobra proizvodna praksa Dobra klinična praksa Dobra laboratorijska praksa
5.1 GMP, GCP, GLP inspections
5.1 Inšpekcijski pregledi dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse
New medicines for the treatment of diabetes
novimi zdravili za zdravljenje sladkorne bolezni;
Positive opinions
Od 5 pozitivnih mnenj:
Applications for new MRLs Generic applications Applications for new medicinal products
Vloge za nove mejne vrednosti ostankov (MRL) Generične vloge
Among the 5 positive opinions were: 1 for a third-generation cephalosporin used to treat bacterial infections in pigs 1 for a novel combination endoparasiticide to treat roundworms and tapeworms in cats 3 vaccines for horses, against equine influenza and tetanus.
je bilo 1 mnenje za cefalosporin tretje generacije, ki se uporablja za zdravljenje bakterijskih okužb pri prašičih;
Submitted
Oddane vloge
Basic EU and EEA contribution
Osnovni prispevek EU in EGP 18 430 000 EUR
5.4 Certificates of a medicinal product
5.4 Potrdila za zdravila
Number of inspections 2003-2005
Število inšpekcijskih pregledov v obdobju
EU telematics strategy
Telematska strategija EU 7 500 000 EUR
The infusion should last around 4 hours.
Infuzija mora trajati približno 4 ure.
The recommended dose is 2 mg per kilogram body weight, given once a week.
Priporočeni odmerek je 2 mg na kilogram telesne mase, ki se daje enkrat na teden.
These are usually mild or moderate and more frequent in the first 12 weeks of treatment.
Neželeni učinki so običajno blagi ali zmerni in se pogosteje pojavijo v prvih 12 tednih zdravljenja.
The European Commission granted a marketing authorisation valid throughout the European Union for Vimizim on 28 April 2014.
Evropska komisija je dovoljenje za promet z zdravilom Vimizim, veljavno po vsej Evropski uniji, izdala 28. aprila 2014.
What measures are being taken to ensure the safe and effective use of Vimizim?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vimizim?
The company will also set up a registry to assess the long-term benefits and risks of Vimizim.
Prav tako bo družba vzpostavila register za oceno dolgoročnih koristi in tveganj, povezanih z zdravilom Vimizim.
If the enzyme is not present, or only present in very small quantities, GAGs cannot be broken down and they build up in bones and organs.
Če tega encima ni ali če je prisoten le v zelo majhnih količinah, se glikozaminoglikani ne morejo razgraditi in se kopičijo v kosteh in organih.
This is a summary of the European public assessment report (EPAR) for Vimizim.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vimizim.
This causes the signs of the disease, the most noticeable being short bones, difficulty moving and breathing, clouding of the eyes and hearing loss.
To povzroči znake bolezni, med katerimi so najopaznejši kratke kosti, težave pri gibanju in dihanju, zamotnitev oči ter izguba sluha.
What benefits of Vimizim have been shown in studies?
Kakšne koristi je zdravilo Vimizim izkazalo v študijah?
In addition, the company that makes Vimizim must ensure that all healthcare professionals expected to prescribe or use the medicine are provided with educational material, informing them of how the medicine should be used and the risk of severe allergic reactions.
Poleg tega mora družba, ki izdeluje zdravilo Vimizim, zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi predpisovali ali uporabljali zdravilo, prejeli izobraževalno gradivo, s katerim se jih bo seznanilo z načinom uporabe zdravila in tveganjem za hude alergijske reakcije.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim'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) pri agenciji je zaključil, da so koristi zdravila Vimizim večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected.
Odbor je prav tako menil, da je varnostni profil zdravila Vimizim obvladljiv in da resni neželeni učinki niso pogosti, vendar pa se morajo pridobiti dodatni podatki o dolgoročni varnosti.
The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache).
Najpogostejši neželeni učinki zdravila Vimizim (ki lahko prizadenejo več kot 1 osebo od 10) so reakcije, povezane z infundiranjem, ki vključujejo glavobol, navzeo (slabost), bruhanje, povišano telesno temperaturo, mrzlico in bolečine v trebuhu (bolečine v želodcu).
The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional.
Izdaja zdravila je le na recept, dajati pa ga mora ustrezno usposobljen zdravstveni delavec.
A risk management plan has been developed to ensure that Vimizim is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Vimizim je bil pripravljen načrt obvladovanja tveganj.
Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme.
Elosulfaza alfa se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“: izdelajo jo celice, v katere so vstavili gen (DNA), s pomočjo katerega lahko tvorijo ta encim.
Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction).
Resne, vendar ne pogoste reakcije, povezane z infundiranjem, vključujejo anafilakso (hudo alergijsko reakcijo).
Patients may also be given a medicine to prevent fever.
Bolniki lahko prejmejo tudi zdravilo za preprečevanje zvišanja telesne temperature.
The summary of the opinion of the Committee for Orphan Medicinal Products for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Vimizim je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
What are the risks associated with Vimizim?
Kakšna tveganja so povezana z zdravilom Vimizim?
The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA.
Nadomestni encim pomaga razgraditi glikozaminoglikane in prepreči njihovo kopičenje v celicah, s čimer izboljša simptome MPS IVA.
It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome).
Uporablja se za zdravljenje bolnikov z mukopolisaharidozo tipa IVA (MPS IVA, ki jo imenujemo tudi Morquijev sindrom tipa A).
Enzyme replacement therapy provides patients with the enzyme they are lacking.
Encimsko nadomestno zdravljenje bolnikom zagotovi encim, ki jim ga primanjkuje.
Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Ker je bolnikov z MPS IVA malo, velja ta bolezen za redko, zato je bilo zdravilo Vimizim 24. julija 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Why is Vimizim approved?
Zakaj je bilo zdravilo Vimizim odobreno?
It is not intended to provide practical advice on how to use Vimizim.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Zdravljenje z zdravilom Vimizim mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem MPS IVA ali podobnih bolezni.
What is Vimizim and what is it used for?
Kaj je zdravilo Vimizim in za kaj se uporablja?
The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Odbor CHMP je zaključil, da se je zdravilo Vimizim po 6 mesecih zdravljenja izkazalo za učinkovito pri izboljšanju razdalje, ki so jo bolniki lahko prehodili v šestih minutah, poleg tega pa so opazili še druge koristne učinke, vključno z izboljšanjem sposobnosti opravljanja vsakodnevnih dejavnosti.
Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Preden bolnik prejme zdravilo Vimizim, mora dobiti zdravilo za preprečevanje alergijske reakcije na zdravilo Vimizim.
Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Zdravilo Vimizim so raziskali v eni glavni študiji s 176 bolniki z MPS IVA, v kateri so zdravilo Vimizim primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment.
Glavno merilo učinkovitosti je bila sprememba razdalje, ki so jo bolniki po 6 mesecih zdravljenja lahko prehodili v šestih minutah.
Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew.
Rezultati študije so pokazali tudi, da lahko zdravilo pri bolnikih izboljša dihanje in zmožnost hoje po stopnicah ter izboljša rast pri otrocih.
Before treatment, the patients could walk on average just over 200 metres in six minutes.
Bolniki so pred zdravljenjem v povprečju lahko prehodili nekaj več kot 200 metrov v šestih minutah.
For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Vimizim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The full EPAR and risk management plan summary for Vimizim 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) in povzetek načrta obvladovanja tveganj za zdravilo Vimizim sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Bolezen povzroča pomanjkanje encima, imenovanega N-acetilgalaktozamin-6-sulfataza, ki je potreben za razgradnjo snovi v telesu, imenovanih glikozaminoglikani (GAG).
After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Po 6 mesecih so bolniki, zdravljeni s priporočenim odmerkom zdravila Vimizim, v povprečju lahko prehodili dodatnih 37 metrov v šestih minutah, medtem ko se je pri bolnikih, ki so prejemali placebo, razdalja podaljšala za 14 metrov.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Vimizim in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim.
Zdravilo Vimizim se ne sme uporabljati pri bolnikih, ki so imeli smrtno nevarne alergijske reakcije na elosulfazo alfa ali katero koli drugo sestavino zdravila Vimizim.
The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Zdravilna učinkovina v zdravilu Vimizim, elosulfaza alfa, je kopija humanega encima N-acetilgalaktozamin-6-sulfataze.
Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Zdravilo Vimizim je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalno infuzijo) v veno.
For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Vimizim naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Vimizim
Druge informacije o zdravilu Vimizim
For the full list of all side effects reported with Vimizim, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vimizim, glejte navodilo za uporabo.