natgillin/translations-raw huggingface dataset:
Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided.
Če se izkaže, da uporaba obstoječih podatkovnih virov ni izvedljiva, je treba podati predlog za prospektivno
CHMP opinion and detailed explanation of the scientific grounds for the differences from the
Mnenje odbora CHMP in podrobna obrazložitev znanstvene podlage za odstopanja od
As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance
Ker sta obe zahtevi za sprožitev postopka posledica vrednotenja podatkov, ki izhajajo iz dejavnosti farmakovigilance, je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP), da sprejme mnenje na podlagi priporočila Odbora za oceno tveganja na področju farmakovigilance (PRAC).
Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s splošnimi znanstvenimi
Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient
Nekateri ugotovljeni primeri z neposredno delujočimi protivirusnimi učinkovinami so imeli resne izide, s poslabšanjem jetrnega statusa in vsaj enim primerom, ko je bolnik
The RMP should be updated accordingly within 3 months of this CHMP opinion.
Načrt za obvladovanje tveganja je treba ustrezno posodobiti v treh mesecih po izdaji tega mnenja
In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required.
Poleg tega je treba bolnikom svetovati, naj se obrnejo na zdravnika, če so bili kdaj okuženi z virusom hepatitisa B, saj je potrebno skrbno
The European Commission therefore extended the scope of the procedure in April 2016 to allow consideration of other data to assess the risk of hepatocellular carcinoma and its impact on the benefit-risk balance for all DAAs in the treatment of chronic hepatitis C.
Evropska komisija je zato aprila 2016 razširila obseg postopka in vanj vključila še upoštevanje drugih podatkov za oceno tveganja za hepatocelularni karcinom in njegovega učinka na razmerje med tveganji in koristmi za vse neposredno delujoče protivirusne učinkovine pri
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za neposredno delujoče protivirusne učinkovine, indicirane za zdravljenje kroničnega hepatitisa C;
The product information will include a warning to inform about the risk of hepatitis B reactivation and
Informacije o zdravilu bodo vključevale opozorilo za obveščanje o tveganju za reaktivacijo hepatitisa B in bodo odražale ta priporočila;
Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested
Po začetku tega pregleda so rezultati študije (Reig in drugi, 2016), opravljene med oktobrom 2014 in decembrom 2015 na oddelkih za hepatologijo štirih španskih univerzitetnih bolnišnic pri bolnikih s kroničnim hepatitisom C in anamnezo hepatocelularnega karcinoma, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, pokazali nepričakovano hiter ponovni pojav hepatocelularnega
The European Association for the Study of the Liver (EASL) recommendations on treatment of hepatitis C makes reference to the potential risk of HBV reactivation during or after HCV clearance.
Priporočila Evropskega združenja za bolezni jeter (EASL) o zdravljenju hepatitisa C navajajo morebitno tveganje za reaktivacijo virusa hepatitisa B ob ali po odstranitvi virusa
The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax še naprej ugodno, če se upoštevajo zgoraj opisane spremembe
The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to
Trenutni napotitveni postopek je sprožila Evropska komisija, da bi omogočila nadaljnjo preiskavo tveganja za razmnoževanje virusa hepatitisa B po začetku zdravljenja z neposredno delujočimi protivirusnimi učinkovinami in priporočila ustrezne ukrepe za zmanjšanje tveganja.
• The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral
• odbor PRAC je pregledal vse podatke, ki so jih pisno in z ustno obrazložitvijo predložili imetniki dovoljenj za promet z zdravilom v povezavi s tveganjem za reaktivacijo hepatitisa B in s pomisleki, ki so se pojavili med poročili o hepatocelularnem karcinomu pri bolnikih, ki uporabljajo neposredno delujoče protivirusne učinkovine, ter izid sestanka znanstvene svetovalne skupine o HIV/virusnih boleznih;
Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk
Na splošno je odbor PRAC menil, da obstajajo dokazi o tveganju za reaktivacijo HBV pri bolnikih s sočasno okužbo s HBV/HCV, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, zato je treba reaktivacijo HBV pri bolnikih s sočasno okužbo upoštevati kot pomembno ugotovljeno tveganje, ki ga je treba skrbno spremljati z rutinskimi dejavnostmi za zmanjševanje tveganja.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili Daklinza, Exviera, Harvoni, Olysio,
In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and
Da bi ovrednotili ponovitev hepatocelularnega karcinoma, povezano z neposredno delujočimi protivirusnimi učinkovinami, bodo imetniki dovoljenj za promet z zdravilom v skladu s priporočilom odbora PRAC opravili prospektivno študijo varnosti in predložili njene rezultate, in sicer z uporabo podatkov iz kohorte dobro opredeljene skupine bolnikov na podlagi dogovorjenega protokola, ki določa merila za vključitev in spremljanje bolnikov glede časa in metode presejalnega testiranja.
Therefore data on HBV reactivation with DAAs mostly arose post-marketing.
Zato podatki o reaktivaciji virusa hepatitisa B z neposredno delujočimi protivirusnimi učinkovinami večinoma
20.5 - 25 ml
Intravenska uporaba viala (steklena) 20.5 - 25 ml
1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack)
1 ml (100 mg/ml) 3 (3 x 1) napolnjeni injekcijski peresniki (večkratno pakiranje)
1 ml (100 mg/ml) 1 pre-filled syringe
1 ml (100 mg/ml) 1 napolnjena injekcijska brizga
1 ml (100 mg/ml) 1 pre-filled pen
1 ml (100 mg/ml) 1 napolnjen injekcijski peresnik
23 May 2013
23. maj 2013
The opinion was converted into a Decision by the European Commission on 23 May 2013.
Mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 23. maja 2013.
The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur.
Odbor je imenoval prof. Christiana Friisa za poročevalca in dr. Cornelio Ibrahim za soporočevalko.
International non-proprietary name (INN): florfenicol
Mednarodno nelastniško ime (INN): florfenikol
The decentralised procedure started on 17 December 2010.
Decentralizirani postopek se je začel 17. decembra 2010.
Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure (DE/V/0132/001/DC) with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Zdravilo Florgane 300 mg/ml suspenzija za injiciranje je bilo odobreno za uporabo pri govedu kot hibrid zdravila Nuflor 300 mg/ml raztopina za injiciranje z decentraliziranim postopkom (DE/V/0132/001/DC) z Nemčijo kot referenčno državo članico ter Avstrijo, Belgijo, Bolgarijo, Češko, Dansko, Francijo, Grčijo, Madžarsko, Irsko, Italijo, Litvo, Luksemburgom, Nizozemsko, Poljsko, Portugalsko, Romunijo, Slovaško, Španijo in Združenim kraljestvom kot zadevnimi državami članicami.
The referral procedure started on 15 May 2012.
Napotitveni postopek se je začel 15. maja 2012.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s povzetkom glavnih značilnosti zdravila in navodilom za uporabo v Prilogi III.
Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.
Florfenikol je strukturno soroden tiamfenikolu in ima podoben farmakološki profil.
Potential serious risks were identified during the decentralised procedure by Denmark regarding the efficacy of the product and the potential for development of antimicrobial resistance to florfenicol.
Med decentraliziranim postopkom je Danska ugotovila možna resna tveganja, povezana z učinkovitostjo zdravila in nevarnostjo za razvoj odpornosti mikrobov proti florfenikolu.
On 19 April 2012, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Referenčna država članica, Nemčija, je 19. aprila 2012 obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
Written explanations were provided by the applicant on 11 September 2012 and 9 January 2013.
Predlagatelj je 11. septembra 2012 in 9. januarja 2013 predložil pisna pojasnila, 5. marca 2013 pa še ustna pojasnila.
The proposed dose is 22.5 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Predlagani odmerek je 22,5 mg florfenikola na kilogram telesne mase, ki se daje intramuskularno z enkratnim injiciranjem.
On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 February 2012.
Ker ta vprašanja na 210. dan še vedno niso bila rešena, je bila zadeva 20. februarja 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
The reference product was Nuflor Swine Injectable Solution 300 mg/ml (FR/V/0118/001).
Referenčno zdravilo je bilo zdravilo Nuflor Swine 300 mg/ml raztopina za injiciranje (FR/V/0118/001).
This extension application (DE/V/0132/001/DX/001) was submitted according to the same procedure (DCP) and type of application (hybrid, according to Article 13(3) of Directive 2001/82/EC) as for the initial application for cattle, to the same Member States.
Vloga za razširitev (DE/V/0132/001/DX/001) je bila predložena po istem postopku (DCP) in istim državam članicam kot prva vloga za govedo, šlo pa je tudi za isto vrsto vloge (hibridna, v skladu s členom 13(3) Direktive 2001/82/ES).
Florgane 300 mg/ml suspension for injection for cattle and pigs contains florfenicol as active ingredient and is intended for use in pigs for the treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Zdravilo Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče vsebuje zdravilno učinkovino florfenikol in je namenjeno za uporabo pri prašičih za zdravljenje akutnih izbruhov bolezni dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, občutljivi na florfenikol.
Day 60 of the CMD(v) procedure was on 19 April 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Ker na 60. dan postopka, 19. aprila 2012, zadevne države članice še vedno niso dosegle soglasja v zvezi z zdravilom, je bil postopek napoten na CVMP.
Therefore, the Committee adopted by majority a positive opinion on 6 March 2013 recommending the granting of a marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Odbor je zato 6. marca 2013 z večino sprejel pozitivno mnenje, v katerem je priporočil odobritev dovoljenja za promet z zdravilom Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče ter povezanimi imeni.
Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Florgane 300 mg/ml suspension for injection for cattle and pigs is positive.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je razmerje med tveganji in koristmi za zdravilo Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče pozitivno.
The applicant, Emdoka bvba, submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Predlagatelj, Emdoka bvba, je predložil vlogo za decentralizirani postopek za zdravilo Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče ter povezana imena.
This application is an extension to add pigs as a target species to the existing 300 mg florfenicol/ml suspension for injection product authorised for use in cattle.
Pri vlogi gre za razširitev, s katero bi prašiče dodali kot novo ciljno vrsto k obstoječemu zdravilu 300 mg florfenikol/ml suspenzija za injiciranje, ki je odobreno za uporabo pri govedu.
Opinion following an Article 33(4)0F referral for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names EMA/324042/2013
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče ter povezana imena stran 2/2
Opinion following an Article 33(4)1 referral for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names
za zdravilo Florgane 300 mg/ml suspenzija za injiciranje za govedo in prašiče ter povezana imena
It is available as tablets (300 mg/150 mg/300 mg).
Na voljo je v obliki tablet (300 mg/150 mg/300 mg).
The recommended dose of Trizivir is one tablet twice a day.
Priporočeni odmerek zdravila je ena tableta dvakrat na dan.
Other information about Trizivir:
Druge informacije o zdravilu Trizivir:
No specific clinical studies have been carried out to assess the safety and effectiveness of the combined tablet.
Posebnih kliničnih študij za ocenitev varnosti in učinkovitosti kombinirane tablete niso izvedli.
The European Commission granted a marketing authorisation valid throughout the EU for Trizivir on 28 December 2000.
Evropska komisija je dovoljenje za promet z zdravilom Trizivir, veljavno po vsej Evropski uniji, izdala 28. decembra 2000.
The full EPAR for Trizivir 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 Trizivir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Trizivir?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trizivir?
Trizivir reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Trizivir zniža količino virusa HIV v krvi in jo ohranja na nizki ravni.
Patients should have been taking the three active substances separately for at least six to eight weeks before switching to Trizivir.
Bolniki morajo ločeno jemati vse tri zdravilne učinkovine vsaj šest do osem tednov, preden preidejo na zdravilo Trizivir.
All three active substances have been available in the European Union (EU) for a number of years: abacavir has been authorised as Ziagen since 1999, lamivudine has been authorised as Epivir since 1996, and zidovudine has been available in the EU since the mid-1980s.
Vse tri zdravilne učinkovine so v Evropski uniji (EU) na voljo že vrsto let: abakavir je odobren kot zdravilo Ziagen od leta 1999, lamivudin kot zdravilo Epivir od leta 1996, zidovudin pa je v EU na voljo od sredine osemdesetih let prejšnjega stoletja.
In patients with high levels of HIV in the blood (above 100,000 copies/ml), the choice of treatment requires special consideration.
Pri bolnikih z visoko ravnjo virusa HIV v krvi (nad 100 000 kopijami/ml) je treba ustrezno zdravljenje izbrati po skrbnem premisleku.
This document is a summary of the European Public Assessment Report (EPAR) for Trizivir.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trizivir.
A risk management plan has been developed to ensure that Trizivir is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Trizivir je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Trizivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Trizivir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Patients will also receive an alert card summarising key safety information on hypersensitivity reactions with this medicine.
Bolniki bodo prejeli tudi opozorilno kartico, ki povzema ključne varnostne informacije o tem zdravilu.
In the studies carried out for the development of Ziagen, the combination of the three active substances was shown to be at least as effective as the comparator combinations in keeping viral loads low.
V študijah, ki jih je družba opravila med razvojem zdravila Ziagen, se je kombinacija treh zdravilnih učinkovin izkazala za enako učinkovito kot primerjalne kombinacije pri ohranjanju nizke ravni virusnega bremena.
Because it contains zidovudine, Trizivir must not be used by patients with low neutrophil counts (low levels of a type of white blood cell) or anaemia (low red blood cell counts).
Ker zdravilo Trivizir vsebuje zidovudin, ga ne smejo uporabljati bolniki z nizkim številom nevtrofilcev v krvi (nizko ravnjo vrste belih krvnih celic) ali anemijo (nizkim številom rdečih krvnih celic).
The risk of hypersensitivity is higher in patients who have the HLA-B (type 5701) gene.
Tveganje za pojav preobčutljivosti je večje pri bolnikih, ki imajo gen HLA-B (tip 5701).
The combination tablet was absorbed in the body in the same way as the separate tablets.
Kombinirano tableto je telo absorbiralo enako kot ločene tablete.
The most common effects with Trizivir (seen in more than 1 patient in 10) are headache and nausea (feeling sick).
Najpogostejša neželena učinka zdravila Trizivir (opažena pri več kot 1 bolniku od 10) sta glavobol in navzeja (slabost).
What benefit has Trizivir shown during the studies?
Kakšne koristi je zdravilo Trizivir izkazalo med študijami?
Hypersensitivity reactions (allergic reactions) occur in patients taking Trizivir, usually within the first six weeks of treatment, and can be life-threatening.
Preobčutljivostne (alergijske) reakcije se pojavijo pri približno 3 % bolnikov, ki jemljejo zdravilo Trizivir, običajno v prvih šestih tednih zdravljenja, in so lahko smrtno nevarne.
The CHMP noted that the reduction in the number of tablets that patients need to take may help patients stick to their treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da lahko z zmanjšanjem števila tablet, ki jih mora bolnik jemati, bolniki lažje vztrajajo pri zdravljenju.
Trizivir is used to treat adults who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Trizivir se uporablja za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
Trizivir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo ne zdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do pojava okvare imunskega sistema ter razvoja okužb in bolezni, ki so povezane z aidsom.
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 Trizivir.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Trizivir, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate tablets.
Raziskala je tudi, kako telo absorbira kombinirane tablete v primerjavi z ločenimi tabletami.
Patients with this gene are at an increased risk of having an allergic reaction to abacavir so they should not take Trizivir.
Bolniki s tem genom so izpostavljeni višjemu tveganju za pojav alergijske reakcije na abakavir, zato ne smejo jemati zdravila Trizivir.
The company presented the results of studies with abacavir, lamivudine and zidovudine taken together, which were carried out during the development of Ziagen.
Družba je predstavila rezultate študij o skupni uporabi abakavirja, lamivudina in zidovudina, ki jih je izvedla pri razvoju zdravila Ziagen.
Before prescribing Trizivir, doctors should consider the expected improved ability of the patient to stick to their treatment, the expected effectiveness of the medicine, and the risks associated with the active substances.
Zdravniki naj zdravilo Trizivir predpišejo šele po premisleku o pričakovani izboljšani zmožnosti, da bolnik vztraja pri zdravljenju, pričakovani učinkovitosti zdravila in tveganjih, povezanih z zdravilnimi učinkovinami.
It also noted that the benefit of Trizivir has mainly been shown in patients who have had little or no previous HIV treatment and who do not have advanced disease.
Ugotovil je tudi, da so se koristi zdravila Trizivir izkazale zlasti pri bolnikih, ki so se zaradi okužbe z virusom HIV zdravili krajši čas ali se sploh niso zdravili in pri katerih bolezen ni napredovala.