natgillin/translations-raw huggingface dataset:
The three studies of short duration (up to 3 months) conducted against reference products of the time (e.g cinnarizine, piridoxilate ), included a small number of patients who presented very heterogeneous or poorly defined pathologies (n=19, n=24 and n=8 respectively for the Cornand (1982), Cordella (1982) and Perdriel (1988) studies).
Tri kratkotrajne študije (do 3 mesece), v katerih so primerjali referenčno zdravilo, ki se je takrat uporabljalo (npr. cinarizin, piridoksilat), so vključevale majhno količino bolnikov z zelo heterogenimi ali slabo opisanimi patologijami (št. = 19 za študijo Cornand (1982), št. = 24 za študijoCordella (1982) in št. = 8 za študijo Perdriel (1988)).
The main identified serious ADR is related to Parkinson syndrome and related symptoms.
Glavni opredeljeni resni neželeni učinek zdravila je povezan s parkinsonovim sindromom in povezanimi simptomi.
In the overall population, including both asymptomatic and symptomatic patients, trimetazidine failed to demonstrate a benefit on both ergometric (total exercise duration, time to onset of 1mm ST and time to onset angina) and clinical endpoints.
V celotni populaciji, ki vključuje asimptomatske in simptomatske bolnike, trimetazidin ni pokazal koristi za ergometrične (skupno trajanje vadbe, čas do 1-mm znižanja spojnice ST in čas do nastopa angine pektoris) in klinične opazovane dogodke.
The submitted data comparing TMZ to either placebo or the other reference products or based on cohorts without comparator provide insufficient demonstration of a relevant clinical benefit of trimetazidine in the ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
Predloženi podatki, ki primerjajo trimetazidin s placebom ali drugim referenčnim zdravilom ali ki temeljijo na kohortah brez primerjalnega zdravila, ne zadoščajo za dokaz pomembnih kliničnih koristi trimetazidina pri dodatnem zdravljenju motenj ostrine vida in vidnega polja zaradi ožilja.
The CHMP also agreed on a study protocol to assess the effect of renal impairment and age on trimetazidine pharmacokinetics for the study to be conducted.
CHMP se je strinjal tudi s protokolom študije, ki jo je treba izvesti, da se oceni učinke okvare ledvic in starosti na farmakokinetiko trimetazidina.
• The Committee also considered the cumulative efficacy and safety data submitted for the indications of the prophylactic treatment of attacks of angina pectoris, ancillary symptomatic treatment of vertigo and tinnitus and ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
• Odbor je obravnaval tudi kumulativne podatke o učinkovitosti in varnosti, predložene za indikacije profilaktičnega zdravljenja napadov angine pektoris, dodatnega simptomatskega zdravljenja vrtoglavice in tinitusa ter dodatnega zdravljenja motenj ostrine vida in vidnega polja zaradi ožilja.
The efficacy of trimetazidine is sufficiently demonstrated as add-on therapy in the shortmedium-term (weeks /months) treatment of symptomatic patients with angina who are inadequately controlled by or intolerant to first-line antianginal therapies.
Učinkovitost trimetazidina je zadostno dokazana kot dodatno zdravljenje h kratkotrajnemu ali srednje dolgemu (tedni/meseci) zdravljenju simptomatskih bolnikov z angino pektoris, pri katerih ni dosežen ustrezen nadzor ali ki ne prenašajo zdravil prve izbire proti angini pektoris.
However, in the subgroup of symptomatic patients (n= 1574) trimetazidine (140 mg) significantly improved total exercise duration (+23.8 s versus +13.1 s placebo; p=0.001) and time to onset of angina (+46.3 s versus +32.5 s placebo; p=0.005).
Vendar pa je v podskupini simptomatskih bolnikov (št. = 1574) trimetazidin (140 mg) pomembno izboljšal skupno trajanje vadbe (+23,8 s v primerjavi s +13,1 s za placebo; p = 0,001) in čas do nastopa angine pektoris (+46,3 s v primerjavi s +32,5 s za placebo; p = 0,005).
Thus, all of these elements deriving from post-approval data do not demonstrate a relevant clinical benefit of trimetazidine for patients suffering from tinnitus, dizziness or hearing loss.
Zato vsi ti elementi, ki so bili izpeljani po datumu odobritve, ne kažejo ustreznih kliničnih koristi trimetazidina za bolnike s tinitusom, vrtoglavico ali izgubo sluha.
This analysis showed that in patients with chronic stable angina trimetazidine given as add-on to atenolol significantly improved exercise tolerance (p<0.01), time to 1 mm ST segment depression and time to angina.
Slednja je pokazala, da je pri bolnikih s kronično stabilno angino pektoris, ki so trimetazidin prejemali kot dodatek k atenololu, pomembno izboljšal vadbeno toleranco (p < 0,01), čas do 1-mm znižanja spojnice ST in čas do pojava angine pektoris.
The CHMP concluded that the limited data generated by the clinical trials submitted for the ENT indication, insufficiently support the demonstration of a relevant clinical benefit of trimetazidine for patients suffering from tinnitus, vertigo or hearing loss and that either the currently ENT registered indication or the newly claimed indications cannot be supported.
CHMP je zaključil, da omejeni podatki iz kliničnih preskušanj, predloženi za indikacijo ORL, ne zadoščajo za podporo dokazov ustreznih kliničnih koristi trimetazidina za bolnike, ki imajo tinitus, vrtoglavico ali izgubo sluha, zato ni mogoče podpreti trenutno registrirane indikacije ORL ali na novo vloženih indikacij.
Therefore, considering these methodological weaknesses, the dossier is insufficient to conclude that trimetazidine has satisfactorily demonstrated a clinical benefit as adjuvant symptomatic treatment of dizziness, tinnitus or hearing loss.
Zato predložena dokumentacija, ob upoštevanju teh metodoloških slabosti, ne zadošča za zaključek, da ima trimetazidin dokazane ustrezne klinične koristi kot dodatno simptomatsko zdravljenje za vrtoglavico, tinitus ali izgubo sluha.
Favourable results from ‘Dizziness Handicap Inventory questionnaire' were suggested by the small Sterckers and Vitte studies.
Majhni študiji Sterckers in Vitte sta nakazovali ugodne rezultate iz „Vprašalnika o težavah zaradi vrtoglavice (Dizziness Handicap Inventory questionnaire)”.
Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function.
Pri starejših bolnikih je izpostavljenost trimetazidinu lahko večja zaradi starostno pogojenega poslabšanja delovanja ledvic.
Therefore, trimetazidine as add-on therapy may represent an optional treatment drug to be used in association with first-line anti-anginal drugs especially in those patients for whom optimally control of symptoms cannot be achieved with other anti-anginal drugs in monotherapy due to haemodynamic intolerance or chronotropic incompetence.
Zato lahko trimetazidin kot dodatno zdravljenje predstavlja možno zdravilo, ki se uporablja v povezavi z zdravili proti angini pektoris, ki so prva izbira zdravljenja, zlasti pri bolnikih, pri katerih ni mogoče doseči ustreznega nadzora simptomov z drugimi zdravili proti angini pektoris v monoterapiji zaradi hemodinamskega neprenašanja ali kronotropne inkompetence.
Trimetazidine-containing medicinal products are indicated for prophylactic treatment of angina pectoris crisis, ancillary symptomatic treatment of vertigo and tinnitus and ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
Zdravila, ki vsebujejo trimetazidin, so indicirana za profilaktično zdravljenje krize zaradi angine pektoris, pomožno simptomatsko zdravljenje vrtoglavice in tinitusa ter pomožno zdravljenje zmanjšane ostrine vida in motenj vidnega polja zaradi ožilja.
Considering all currently available data, the CHMP concluded that trimetazidine-containing medicinal products should be contraindicated in patients with severe renal impairment (creatinine clearance < 30ml/min).
Ob upoštevanju vseh trenutno razpoložljivih podatkov je CHMP zaključil, da morajo biti zdravila, ki vsebujejo trimetazidin, kontraindicirana pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).
• The Committee is of the opinion that the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or intolerant to other medicines for angina pectoris.
• CHMP je mnenja, da koristi še naprej odtehtajo tveganja pri bolnikih z angino pektoris, vendar pa je treba zdravljenje omejiti na dodatek že obstoječemu zdravljenju pri bolnikih, pri katerih angina pektoris ni pod ustreznim nadzorom ali ki drugih zdravil ne prenašajo.
The Committee, therefore, concluded that the benefit-risk balance of trimetazidine- containing medicinal products remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed, only as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line anti-anginal therapies.
Odbor je zato sklenil, da ostaja razmerje med tveganji in koristmi za zdravila, ki vsebujejo trimetazidin, pozitivno v običajnih pogojih uporabe, ob upoštevanju dogovorjenih omejitev, opozoril, spremenjenih informacij o zdravilu, dodatnih farmakovigilančnih aktivnosti in ukrepov za zmanjševanje tveganja, vendar le kot dodatno zdravljenje za simptomatsko zdravljenje bolnikov s stabilno angino pektoris, pri katerih z zdravili prve izbire proti angini pektoris bolezni ni mogoče ustrezno nadzirati ali ki teh zdravil ne prenašajo.
Therefore, the Committee concluded that the benefit-risk balance of trimetazidine- containing medicinal products in the add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies, remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Odbor je torej sklenil, da ostaja razmerje med tveganji in koristmi za zdravila, ki vsebujejo trimetazidin kot dodatno zdravljenje za simptomatsko zdravljenje bolnikov s stabilno angino pektoris, pri katerih z zdravili prve izbire proti angini pektoris bolezni ni mogoče ustrezno nadzirati ali ki teh zdravil ne prenašajo, pozitivna v običajnih pogojih uporabe, ob upoštevanju dogovorjenih omejitev, opozoril, spremenjenih informacij o zdravilu, dodatnih farmakovigilančnih aktivnostih in ukrepov za zmanjševanje tveganja.
223 patients were randomized for this double blind, placebo-controlled study where one 35 mg trimetazidine modified release tablet (b.i.d.)
223 bolnikov je bilo randomiziranih v to dvojno slepo, s placebom kontrolirano študijo, v kateri so 50 mg atenolola (enkrat na dan) dodajali 35 mg trimetazidina v obliki tablet s prirejenim sproščanjem (dvakrat na dan) v obdobju 8 tednov.
Accordingly, the SmPC has been amended to include dose information in the elderly and in patients with moderate renal impairment (creatinine clearance [30-60] ml/min).
Povzetek glavnih značilnosti zdravila je bil ustrezno spremenjen in zdaj vključuje informacije o odmerjanju pri starejših bolnikih in bolnikih z zmerno okvaro ledvic (očistek kreatinina [30-60] ml/min).
study) to address all important, potential and identified risks, particularly Parkinsonism and a drug utilization study to verify the compliance of prescribers regarding the restricted indication after marketing authorisation changes was also agreed.
Dogovorjeno je bilo tudi, da se izvede študija po odobritvi dovoljenja za promet z zdravilom, ki bo obravnavala vsa pomembna, možna in opredeljena tveganja, zlasti parkinsonizem, in študija uporabe zdravila, ki bo potrdila skladnost predpisovalcev z omejitvijo indikacij po spremembah dovoljenja za promet z zdravilom.
Trimetazidine was shown to have an effect very similar to that of non-heart rate−lowering anti-anginal agents: nicorandil, ranolazine, long-acting nitrates and dihydropyridines, with less than a few seconds differences in exercise tolerance test (ETT) ergometric parameters.
ranolazinu, dolgodelujočim nitratom in dihidropiridinom, z manj kot nekaj sekundami razlike v ergonomskih parametrih testov vadbene tolerance.
In conclusion, the data submitted for trimetazidine with respect to ENT indications, insufficiently support the demonstration of a relevant clinical benefit for these patients suffering from tinnitus, vertigo or hearing loss symptomatology who were targeted by the ENT therapeutic indications as mentioned currently in the European marketing authorisations.
Podatki, predloženi za trimetazidin v zvezi z indikacijami ORL, torej ne zadoščajo za podporo dokazov o ustreznih kliničnih koristih za bolnike s, simptomatiko tinitusa, vrtoglavice ali izgube sluha, na katere ciljajo terapevtske indikacije ORL, ki jih trenutno vsebujejo dovoljenja za promet z zdravilom v Evropi.
A PASS study to address all important, potential and identified risks, particularly Parkinsonism, and a Drug utilization study to monitor whether the risk minimization measures put in place as results of the referral procedure are effective have been requested by the CHMP.
CHMP je zahteval, da se opravi študija varnosti po pridobitvi dovoljenja za promet z zdravilom, z namenom da se naslovijo vsa pomembna, možna in opredeljena tveganja, zlasti parkinsonizem, in študija uporabe zdravila, da se lahko nadzoruje, ali so ukrepi za zmanjšanje tveganja, uvedeni kot rezultat napotitvenega postopka, učinkoviti.
Considering all currently available data, the CHMP concluded that trimetazidine-containing medicines should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Ob upoštevanju vseh trenutno razpoložljivih podatkov je CHMP sklenil, da morajo biti zdravila, ki vsebujejo trimetazidin, kontraindicirana pri bolnikih s parkinsonovo boleznijo, simptomi parkinsonove bolezni, tremorji, sindromom nemirnih nog in drugimi povezanimi motnjami gibanja.
Overall, the CHMP concluded that after assessing the newly available data, the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or intolerant to other medicines for angina pectoris.
CHMP je po oceni na novo razpoložljivih podatkov zaključil, da koristi še naprej odtehtajo tveganja pri bolnikih z angino pektoris, vendar pa je treba zdravljenje omejiti na dodatno zdravljenje k že obstoječemu pri bolnikih, pri katerih angina pektoris ni pod ustreznim nadzorom ali ki drugih zdravil ne prenašajo.
• Considering all the currently available safety data the Committee concluded that trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance < 30ml/min).
• Ob upoštevanju vseh trenutno razpoložljivih podatkov o varnosti je Odbor zaključil, da je treba trimetazidin kontraindicirati pri bolnikih s parkinsonovo boleznijo, simptomi parkinsonove bolezni, tremorji, sindromom nemirnih nog in drugimi povezanimi motnjami gibanja ter pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).
The CHMP considers that the revised indication is in line with the scientific evidence available at present for trimetazidine as add-on therapy and it is supported by trials that became available after the initial authorisation and considered to be of sufficient methodological quality and by meta-analyses that have come to similar conclusions.
Podpirajo jo tudi preskušanja, ki so postala razpoložljiva po prvotni odobritvi, za katera se meni, da so ustrezne metodološke kakovosti, ter metaanalize, pri katerih so prišli do podobnih zaključkov.
Considering all the currently available data the CHMP concluded that the trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance < 30ml/min).
Ob upoštevanju vseh trenutno razpoložljivih podatkov je CHMP zaključil, da je treba trimetazidin kontraindicirati pri bolnikih s parkinsonovo boleznijo, simptomi parkinsonove bolezni, tremorji, sindromom nemirnih nog in drugimi povezanimi motnjami gibanja ter pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).
No significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Za druge sekundarne opazovane dogodke (skupno trajanje vadbe, skupna obremenitev in klinične opazovane dogodke) ni bilo mogoče opaziti pomembnih razlik med skupinama.
was added to 50 mg atenolol (o.d.) for 8 weeks and produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a sub-group of patients (n=173), when compared to placebo, 12 hours after taking the drug.
To je pri podskupini bolnikov (št. = 173) 12 ur po prejemu zdravila povzročilo znatno zvišanje (+34,4s; p = 0,03) časa do 1-mm znižanja spojnice ST v vadbenih testih v primerjavi s placebom.
Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen (see Annex A)
Splošni povzetek znanstvenega vrednotenja zdravil Kogenate Bayer in Helixate NexGen (glejte Prilogo A)
Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC (see Annex A).
V skladu z določbami iz člena 20 Uredbe (ES) št. 726/2004 je CHMP po preučitvi priporočila odbora PRAC z dne 5. decembra 2013, podal mnenje, da je treba dovoljenja za promet z zdraviloma Kogenate Bayer in Helixate NexGen spremeniti v skladu s priporočili odbora PRAC (glejte Prilogo A).
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen (see annexes A).
• PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravili Kogenate Bayer in Helixate NexGen (glejte prilogi A);
The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Imetnik dovoljenj za promet z zdraviloma je predložil tudi podatke iz štirih intervencijskih kliničnih preskušanj in šestih opazovalnih študij, v katerih so proučevali varnost in učinkovitost zdravil Kogenate Bayer in Helixate NexGen pri bolnikih s hemofilijo A, vključno s študijama 200021EU in
The reference Member State (RMS) is the United Kingdom and 12 concerned Member States (CMS) are involved: Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain.
Referenčna država članica je Združeno kraljestvo, zadevnih članic pa je 12: Avstrija, Češka republika, Estonija, Finska, Francija, Nemčija, Grčija, Italija, Latvija, Nizozemska, Slovaška in Španija.
The opinion was converted into a Decision by the European Commission on 12 August 2013.
Mnenje je bilo dne 12. avgusta 2013 spremenjeno v sklep Evropske komisije.
The Committee appointed Mr J. Schefferlie as rapporteur and Ms H. Jukes as co-rapporteur.
Odbor je za poročevalca imenoval g. J. Schefferlieja, za soporočevalko pa go. H. Jukes.
International non-proprietary name (INN): doxycycline hyclate
Mednarodno nelastniško ime (INN): doksiciklinijev hiklat
The re-examination procedure started on 27 April 2013.
Postopek ponovne presoje se je začel 27. aprila 2013.
The detailed grounds for the re-examination request were submitted by Eurovet Animal Health BV on 26 April 2013.
Podrobne razloge za zahtevo za ponovno presojo je družba Eurovet Animal Health BV predložila 26. aprila 2013.
On 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a reexamination of the CVMP opinion of 7 March 2013.
22. marca 2013 je družba Eurovet Animal Health BV agencijo obvestila, da namerava zaprositi za ponovno presojo mnenja odbora CVMP z dne 7. marca 2013.
During its meeting of 9-11 April 2013 the CVMP appointed Prof. C. Friis as the rapporteur and Dr M. Holzhauser-Alberti as the co-rapporteur for the re-examination procedure.
Na zasedanju odbora CVMP, ki je potekalo od 9. do 11. aprila 2013, sta bila za poročevalca in soporočevalca v postopku ponovne presoje mnenja imenovana prof. C. Friis in dr. M. HolzhauserAlberti.
Potential serious risks were identified during the decentralised procedure by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal.
Med decentraliziranim postopkom je Nizozemska opozorila na morebitna resna tveganja v zvezi z ustrezno karenco za piščančje meso in organe.
It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Zdravilo je indicirano za uporabo pri piščancih za zmanjšanje smrtnosti, obolevnosti in kliničnih znakov ter za zmanjšanje lezij, ki so posledica pastereloze, ki jo povzroča bakterija Pasteurella multocida, ali za zmanjšanje obolevnosti in lezij pri okužbah dihal, ki jih povzroča bakterija Ornithobacterium rhinotracheale (ORT).
On 30 October 2012, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Referenčna država članica, Združeno kraljestvo, je 30. oktobra 2012 Evropsko agencijo za zdravila obvestila, da CMD(v) ni dosegla soglasja o zdravilu in je v skladu s členom 13(2) Direktive Komisije (ES) št. 1234/2008 zadevo napotila na CVMP.
Day 60 of the CMD(v) procedure was on 18 October 2012, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Na šestdeseti dan postopka CMD(v) dne 18. oktobra 2012 zadevne države članice niso dosegle soglasja o zdravilu, zato je bil postopek napoten na odbor CVMP.
On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 August 2012.
Ker ti pomisleki na 90. dan postopka še vedno niso bili rešeni, je bila zadeva 20. avgusta 2012 v skladu s členom 13(1) Direktive Komisije (ES) št. 1234/2008 napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (zdravila za uporabo v veterinarski medicini) (CMD(v)).
There are two authorised dosages: 10 mg/kg bw for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg bw for 4 consecutive days for which the withdrawal period is 12 days.
Odobrena sta dva odmerka: 10 mg/kg telesne mase 4 dni zapored, pri čemer je karenca 3 dni, in 20 mg/kg telesne mase 4 dni zapored, pri čemer je karenca 12 dni.
Written explanations were provided by the marketing authorisation holder on 8 January 2013.
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 8. januarja 2013 ter 5. marca 2013 podal še ustna pojasnila.