natgillin/translations-raw huggingface dataset:
[EMA/MB/579729/2010] The Management Board noted the report.
[EMA/MB/579729/2010] Upravni odbor se je seznanil s poročilom.
• The upcoming meeting with the European Generics Association (EGA) in the margins of the HMA
• prihodnjim sestankom z evropskim združenjem za generična zdravila (EGA) ob robu sestanka vodij agencij za zdravila dne 26. oktobra;
The proposal received a favourable opinion from the European Commission.
Evropski komisar je predlog odobril.
[EMA/MB/581808/2010; EMA/MB/581875/2010] The Management Board endorsed the EMA Policy on access to documents (related to medicinal products for human and veterinary use) and noted the document outlining outputs of the policy.
[EMA/MB/581808/2010; EMA/MB/581875/2010] Upravni odbor je potrdil politiko agencije EMA o dostopu do dokumentov (v povezavi z zdravili za uporabo v humani in veterinarski medicini) in se seznanil z dokumentom, ki opisuje učinke politike.
Held in London on 7 October 2010
V Londonu,7.
[EMA/MB/559867/2010] The Management Board endorsed the proposal to establish a joint CVMP/CHMP ad-hoc expert group on the application of the 3Rs in the development of medicinal products.
[EMA/MB/559867/2010] Upravni odbor je potrdil predlog o ustanovitvi skupne strokovne skupine odborov CVMP in CHMP za uporabo zamenjave, zmanjšanja in izboljšane uporabe živali pri razvoju zdravil.
Product suspension
Začasni umik zdravila
Doctors' organisations to Commissioner John Dallli on the proposed revised EMA Policy on the
• Dopis predstavnika Evropskega parlamenta upravnemu odboru in predstavnika organizacij zdravnikov komisarju Johnu Sallliju o predlagani revidirani politike agencije EMA o obravnavi primerov navzkrižja interesov članov in strokovnjakov znanstvenega odbora
• [EMA/MB/539466/2010] MBTC's Telematics Implementation Group: Chair's appointment procedure and role
• [EMA/MB/539466/2010] Skupina za izvajanje odbora za telematiko pri upravnem odboru agencije:
AOB
Razno
• Presentation on the EMA accommodation strategy
• Predstavitev strategije za iskanje prihodnjih prostorov agencije
The company applied for a change (variation) to the marketing authorisation to add a new indication to be recognised by Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Podjetje je zaprosilo za spremembo dovoljenja za promet z zdravilom, da bi vanj vključili novo indikacijo, ki bi jo priznali Avstrija, Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Finska, Francija, Grčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo („zadevne države članice“).
Why was Seresto reviewed?
Zakaj je bilo zdravilo Seresto pregledano?
The company that markets the product is Bayer Vital GmbH.
Podjetje, ki zdravilo trži, je Bayer Vital GmbH.
Seresto is an antiparasitic collar containing 10% imidacloprid and 4.5% flumethrin.
Zdravilo Seresto je protiparazitna ovratnica, ki vsebuje 10 % imidakloprida in 4,5 % flumetrina.
Seresto is authorised in the European Union (EU) under the decentralised procedure with Germany as the reference Member State.
Zdravilo Seresto je bilo v Evropski Uniji (EU) odobreno po decentraliziranem postopku, pri čemer je bila Nemčija referenčna država članica.
Because these Member States were not able to reach an agreement, the German Federal Office of Consumer Protection and Food Safety (BVL) referred the matter to the CVMP for arbitration on 18 August 2017.
Ker zadevne države članice niso mogle doseči soglasja, je nemški zvezni urad za varstvo potrošnikov in varnost hrane (BVL) 18. avgusta 2017 zadevo napotil na odbor CVMP v arbitražo.
It is indicated for the treatment and prevention of infestations with fleas, ticks and lice in dogs and cats, and provides indirect protection against the diseases babesiosis and ehrlichiosis, which can be transmitted to dogs by ticks.
Zdravilo Seresto je namenjeno zdravljenju in preprečevanju infestacij z bolhami, klopi in ušmi pri psih in mačkah ter nudi posredno zaščito proti boleznima babeziozi in ehrlichiozi, s katerima lahko pse okužijo klopi.
Questions and answers on Seresto and its associated name Foresto EMA/392857/2018
Vprašanja in odgovori v zvezi z zdravilom Seresto in povezanim imenom Foresto EMA/468950/2018
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the efficacy of Seresto in the reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months had been sufficiently demonstrated and therefore the variation to the marketing authorisation can be approved in all concerned Member States.
Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj Odbora je odbor CVMP odločil, da je učinkovitost zdravila Seresto pri zmanjševanju tveganja okužbe s parazitom Leishmania infantum po prenosu s flebotomi v do osmih mesecih zadostno dokazana, zato je odobril spremembo dovoljenja za promet z zdravilom Seresto v vseh zadevnih državah članicah.
The proposed new indication was against the disease leishmaniosis, which is caused by the parasite Leishmania infantum and transmitted to dogs by sand flies.
Predlagana nova indikacija je bila proti bolezni leishmaniozi, ki jo povzroča parazit Leishmania infantum, na pse pa jo prenašajo flebotomi.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se lahko odobri sprememba dovoljenja za promet z zdravilom Seresto z vključitvijo nove indikacije.
On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto.
Evropska agencija za zdravila (v nadaljnjem besedilu: agencija) je 15. februarja 2018 zaključila arbitražo za zdravilo Seresto in povezano ime Foresto.
What is Seresto?
Kaj je zdravilo Seresto?
Seresto, sometimes under its associated name Foresto, is authorised in nearly all EU/EEA Member States.
Zdravilo Seresto je odobreno v skoraj vseh državah članicah EU/EGP, včasih pod povezanim imenom Foresto.
Questions and answers on Seresto and its associated name Foresto
Vprašanja in odgovori v zvezi z zdravilom Seresto in povezanim imenom Foresto
The European Commission issued an EU-wide legally binding decision to implement the CVMP recommendations on Seresto on 25 May 2018.
Evropska komisija je 25. maja 2018 izdala končni pravno zavezujoč sklep za vse države članice EU, da uvedejo priporočila odbora CVMP o zdravilu Seresto.
The grounds for the referral were the concerns of the UK that the efficacy of the product in repelling sand flies had not been sufficiently demonstrated.
Razlog za napotitev v arbitražo so bili dvomi Združenega kraljestva o učinkovitosti zdravila, saj njegova sposobnost odbijanja flebotomov ni bila zadostno dokazana.
However, the CVMP recommended inclusion of the statement, in the product information of Seresto, that the demonstrated repellent efficacy against sand flies was variable.
Odbor CVMP je vseeno priporočil, da se v informacije o zdravilu Seresto doda navedba, da je bila dokazana učinkovitost zdravila pri odbijanju flebotomov spremenljiva.
10 ml (3.5 mg/ml) 5 (5 x 1) vial (multipack)
10 ml (3,5 mg/ml) 5 (5 x 1) vial (večje pakiranje)
blister (aclar/alu) 56 tablets blister (aclar/alu);card
Stična ovojnina Velikost pakiranja peroralna uporaba plastenka (HDPE) 56 tablet peroralna uporaba pretisni omot (aclar/alu)
Pack size bottle (HDPE)
peroralna uporaba pretisni omot (aclar/alu); zgibanka
4 (1x4) vials
4 (1x4) viale
150 mg/ml Solution for injection
150 mg/ml raztopina za injiciranje subkutana uporaba
It was expected to be available as a powder and solvent to make up a solution for injection (500, 1,000 and 1,500 units).
Na voljo naj bi bilo v obliki praška in vehikla za pripravo raztopine za injiciranje (500, 1000 in 1500 enot).
This causes problems with blood clotting, leading to bleeding into the joints, muscles and internal organs.
Posledica so težave s strjevanjem krvi, ki privedejo do krvavitev v sklepe, mišice in notranje organe.
The company expressed its intention to re-apply for marketing authorisation once the data were available.
Družba je navedla, da namerava ponovno vložiti vlogo za pridobitev dovoljenja za promet z zdravilom, ko bodo ti podatki na voljo.
Effectiveness was measured by the patients' assessment of how well bleeding was controlled, and by the number of bleeding episodes that occurred while receiving the medicine.
Učinkovitost so merili na podlagi ocene bolnikov o tem, kako dobro so bile nadzorovane krvavitve, in števila krvavitev, ki so se pojavile v času uporabe zdravila.
The company refined the manufacturing process for IXinity to remove these proteins, but it was not clear if the refined medicine would act in the same way as the original product in the studies, and the CHMP recommended further study in patients.
Družba je izboljšala postopek izdelave zdravila IXinity, da bi odstranila te beljakovine, vendar ni jasno, ali bi izboljšano zdravilo delovalo na enak način, kot je v študijah delovalo originalno zdravilo, zato je CHMP priporočil dodatno študijo pri bolnikih.
What is IXinity?
Kaj je zdravilo IXinity?
On 13 June 2013, Cangene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prevention of bleeding in patients with haemophilia B.
Družba Cangene Europe Ltd. je dne 13. junija 2013 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom IXinity, namenjenim zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo B.
The company presented the results of studies involving 42 patients with moderate or severe haemophilia B who were given IXinity for treatment or prevention of bleeding, including some patients undergoing surgery.
Družba je predložila rezultate študij, v katerih je sodelovalo 42 bolnikov z zmerno ali hudo hemofilijo B, ki so prejemali zdravilo IXinity za zdravljenje ali preprečevanje krvavitev, vključno z nekaj bolniki, pri katerih je bil opravljen operativni poseg.
The company informed the CHMP that patients currently included in clinical trials would continue to receive IXinity and would be switched to the refined product once revised rules for the conduct of the trials had been approved.
Družba je CHMP obvestila, da bodo bolniki, ki trenutno sodelujejo v kliničnih preskušanjih, še naprej prejemali zdravilo IXinity, po odobritvi spremenjenih pravil za izvedbo preskušanj pa bodo prešli na izboljšano zdravilo.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that based on the currently available data the balance of the benefit and risks of the refined IXinity product was negative.
Posledično je CHMP v času umika menil, da je na podlagi trenutno razpoložljivih podatkov razmerje med koristmi in tveganji za izboljšano zdravilo IXinity negativno.
IXinity is a medicine that contains the active substance trenonacog alfa (recombinant human factor IX).
IXinity je zdravilo, ki vsebuje zdravilno učinkovino trenonakog alfa (rekombinantni humani faktor IX).
IXinity was expected to be used to prevent and treat bleeding episodes in patients at least 12 years of age with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Zdravilo IXinity naj bi se uporabljalo za preprečevanje in zdravljenje krvavitev pri bolnikih, starih najmanj 12 let, s hemofilijo B (dedno motnjo strjevanja krvi zaradi pomanjkanja faktorja IX).
Although the studies had shown evidence of the effectiveness of IXinity, they had also revealed that patients developed an unexpectedly high level of antibodies against proteins from the cells used to make IXinity, which were also present in the medicine.
Čeprav so v študijah pridobili dokaze o učinkovitost zdravila IXinity, so opazili tudi, da so se pri bolnikih tvorile nepričakovano visoke ravni protiteles proti beljakovinam iz celic, uporabljenih za izdelavo zdravila IXinity, ki so bile prisotne v zdravilu.
Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa)
Umik vloge za pridobitev dovoljenja za promet z zdravilom IXinity (trenonakog alfa)
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that IXinity could not have been approved for the prevention and treatment of bleeding episodes in patients with haemophilia B.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila IXinity ni mogoče odobriti za preprečevanje in zdravljenje krvavitev pri bolnikih s hemofilijo B.
Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa) EMA/379048/2013
Umik vloge za pridobitev dovoljenja za promet z zdravilom IXinity (trenonakog alfa) EMA/442989/2013
Patients with haemophilia B do not have sufficient levels of factor IX, a protein in the blood that helps it to clot normally.
Bolniki s hemofilijo B nimajo zadostnih količin faktorja IX, tj. beljakovine v krvi, ki pomaga pri normalnem strjevanju krvi.
The active substance in IXinity, trenonacog alfa, is a form of human factor IX that replaces the missing factor IX in the blood, temporarily controlling the bleeding disorder.
Zdravilna učinkovina v zdravilu IXinity, trenonakog alfa, je oblika humanega faktorja IX, ki nadomesti manjkajoči faktor IX v krvi, s čimer omogoča začasno obvladovanje motnje strjevanja krvi.
In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the fact that the additional data required to address the CHMP's concerns could not be made available within the regulatory timeframe.
Družba je v uradnem dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik odločila na podlagi dejstva, da v zakonsko predpisanem roku ne more zagotoviti dodatnih podatkov, s katerimi bi lahko odgovorila na zadržke odbora CHMP.
The active substance in IXinity is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce the clotting factor.
Zdravilna učinkovina zdravila IXinity se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri je v celice vstavljen gen (DNK), s pomočjo katerega lahko tvorijo faktor strjevanja krvi.
What was IXinity expected to be used for?
Za kaj naj bi se zdravilo IXinity uporabljalo?
How is IXinity expected to work?
Kako naj bi zdravilo IXinity delovalo?
There are no special requirements for disposal.
Ni posebnih zahtev za odstranjevanje.
Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Datum prve odobritve: 20. september 2007 Datum zadnjega podaljšanja: 28. avgust 2017
2 Week Follow-up e
Spremljanje po 2 tednih e
C. albicans Non-albicans species
C. albicans Vrsta ne-albicans
98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
98,3-odstotni interval zaupanja, prilagojen post hoc za multiple primerjave sekundarnih časovnih točk
Twenty one (16.3%) had concomitant candidemia.
Enaindvajset (16,3 %) jih je sočasno imelo kandidemijo.
You should not be given a double dose by doctor.
Zdravnik vam ne sme dati dvojnega odmerka.
A successful global response required clinical improvement and microbiological eradication.
Uspešen globalni odziv je zahteval klinično izboljšanje in mikrobiološko izkoreninjenje.
The reconstituted solution has a pH of 3.5 to 5.5.
Rekonstituirana raztopina ima pH od 3,5 do 5,5.
This medicine contains fructose (a type of sugar).
To zdravilo vsebuje fruktozo (vrsto sladkorja).
Both regimens were welltolerated by these patients.
Ti bolniki so obe shemi dobro prenašali.
Not known (frequency cannot be estimated from the available data) are:
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
For the clinical relevance of these findings see “Clinical efficacy and safety.”
Za klinični pomen teh izsledkov glejte poglavje »Klinična učinkovitost in varnost«.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo ne smejo dobiti tega zdravila.
ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
Zdravilo ECALTA bo vedno pripravil in vam ga dal zdravnik ali zdravstveni delavec (več informacij o načinu priprave je na koncu tega navodila v poglavju, namenjenemu samo zdravstvenim delavcem).
Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Zdravljenje je mogoče uvesti, preden so znani rezultati kulture, in ga ustrezno prilagoditi, ko so rezultati na voljo.
A total of 129 patients were included in the analysis.
V analizo so vključili skupno 129 bolnikov.
HIV positivity
HIV-pozitivnost
A total of 46 patients were included in the analysis.
V analizo so vključili skupno 46 bolnikov.
The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established.
Varnost in učinkovitost zdravila ECALTA pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
Zdravnik bo določil, koliko časa bo trajalo vaše zdravljenje in koliko zdravila ECALTA boste dobili dnevno; prav tako bo spremljal vaš odziv in vaše stanje.
Most clinical cases involve caspofungin treatment.
Večina kliničnih primerov vključuje zdravljenje s kaspofunginom.
However tell your doctor or pharmacist if you think that a dose has been forgotten.
Vendar pa zdravniku ali farmacevtu povejte, če mislite, da je bil odmerek pozabljen.
If you receive more ECALTA than you should
Če dobite več zdravila ECALTA, kot bi smeli
Apache II score ≤ 20 Apache II score  20
Seštevek Apache II ≤ 20 Seštevek Apache II  20
Patients were followed for six weeks beyond the end of all therapy.
Bolnike so spremljali šest tednov po koncu celotnega zdravljenja.
The table below provides the volumes required for each dose.
Spodnja preglednica navaja količine, potrebne za vsak odmerek.
A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Ugotovili so majhno interindividualno variabilnost v sistemski izpostavljenosti (koeficient variacije ~25 %).
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili ali elektroliti, razen s tistimi, ki so omenjena/-i v poglavju 6.6.
In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
V študijah z več odmerki pri bolnikih je bil očistek zdravila pri moških nekoliko večji (za približno 22 %).
The mean APACHE II score was 14.9 (range, 2 - 44).
Povprečni seštevek APACHE II je bil 14,9 (razpon 2-44).
Efficacy data, both overall and by various subgroups, are presented below in Table 3.
Podatki o učinkovitosti, tako celotni kot po raznih podskupinah, so zajeti v preglednici 3, spodaj.
Some of these side effects will be noted by your doctor while monitoring your response and condition.
Nekatere od teh neželenih učinkov bo opazil zdravnik, ko bo spremljal vaš odziv na zdravljenje in vaše stanje.
Effective contraception should be used in women of childbearing age.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo.
The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Večina bolnikov je imela seštevek Apache II ≤ 20 in zelo redki so bili nevtropenični.
- Life-threatening allergic reactions
- življenjsko ogrožajoče alergijske reakcije
Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Trajanje zdravljenja Praviloma je treba antimikotično zdravljenje nadaljevati vsaj še 14 dni po zadnji pozitivni kulturi.
Anidulafungin has negligible renal clearance (<1%).
Anidulafungin ima zanemarljiv ledvični očistek (< 1 %).
Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Zdravljenje invazivne kandidoze pri odraslih bolnikih (glejte poglavji 4.4 in 5.1).
Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Druge vrste Candida nezadostni dokazi
The majority of patients had candidemia only.
Večina bolnikov je imela samo kandidemijo.
The clearance of anidulafungin is about 1 l/h.
Očistek anidulafungina je približno 1 l/h.
Treatment was administered for at least 14 and not more than 42 days.
Zdravljenje so prejemali vsaj 14 in ne več kot 42 dni.
This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Infundiranje bo trajalo vsaj 1,5 ure za vzdrževalni odmerek in 3 ure za polnilni odmerek.
Anidulafungin is extensively bound (>99%) to human plasma proteins.
Anidulafungin je v veliki meri (> 99 %) vezan na beljakovine v človeški plazmi.
Waste materials should be disposed of in accordance with local requirements.
Odpadni material zavrzite v skladu z lokalnimi predpisi.
The reconstitution time can be up to 5 minutes.
Čas rekonstitucije je lahko do 5 minut.
These medicines are used to treat serious fungal infections.
Ta zdravila uporabljamo za zdravljenje hudih glivičnih okužb.
The majority of patients had candidemia only (84.8%; 39/46).
Večina bolnikov je imela samo kandidemijo (84,8 %; 39/46).
Minimum duration of infusion
Minimalno trajanje infuzije
Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Koncentracija anidulafungina je padla pod spodnjo mejo kvantifikacije 6 dni po odmerku.
No clinical adverse reactions were reported.
O kliničnih neželenih učinkih niso poročali.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z zdravnikom.
All-cause mortality by Day 28 was 10/35 (28.6%).
Umrljivost zaradi vseh vzrokov je bila do 28. dneva 10/35 (28,6 %).
Global Response of Success at EOIVT
Uspešnost globalnega odziva ob EOIVT
The majority of patients had candidemia only (85.7%).
Večina bolnikov je imela samo kandidemijo (85,7 %).
Activity in vitro
Delovanje in vitro
ECALTA prevents normal development of fungal cell walls.
Zdravilo ECALTA preprečuje normalen razvoj celične stene glivic.
The expiry data refers to the last day of that month.
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Total reconstituted volume
Celotna rekonstituirana količina
Mortality Anidulafungin Fluconazole
Umrljivost anidulafungin flukonazol
Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
Na zdravljenje so randomizirali 256 bolnikov, starih od 16 do 91 let, ki so prejeli vsaj en odmerek preskušanega zdravila.
Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of anidulafungin.
Dolgoročne študije na živalih za oceno kancerogenega potenciala anidulafungina niso bile izvedene.