natgillin/translations-raw huggingface dataset:
No teratogenic effects were observed in rats or rabbits at maternally toxic doses.
Pri podganah in kuncih pri odmerkih, toksičnih za matere, niso opazili teratogenih učinkov.
Nevirapine 200 mg twice daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Nevirapin 200 mg dvakrat na dan (atazanavir 300 mg enkrat na dan z ritonavirjem 100 mg enkrat na dan)
Cobicistat Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Kobicistat Pri bolnikih s hudo okvaro jeter (Child-Pugh C) uporabe kobicistata niso raziskovali.
Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of EVOTAZ with sildenafil.
Za nadaljnje informacije o sočasni uporabi zdravila EVOTAZ in sildenafila glejte tudi PLJUČNA ARTERIJSKA HIPERTENZIJA v tej tabeli.
No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Pri sočasni uporabi atazanavirja pomembnega vpliva na koncentracije lamivudina in zidovudina niso opazili.
Atazanavir and cobicistat are metabolised by the hepatic system.
Atazanavir in kobicistat se presnavljata v jetrih.
Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Vezava kobicistata na serumske beljakovine pri človeku je 97-98-odstotna.
It is important that you do not miss any doses of EVOTAZ or your other anti-HIV medicines.
Pomembno je, da zdravilo EVOTAZ ali druga zdravila za zdravljenje okužbe z virusom HIV jemljete redno.
EVOTAZ may affect how well your kidneys work.
Zdravilo EVOTAZ lahko vpliva na delovanje ledvic.
EVOTAZ should be used with caution in patients with mild hepatic impairment.
Pri bolnikih z blago okvaro jeter je treba zdravilo EVOTAZ uporabljati previdno.
Tenofovir alafenamide 10 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Alafenamidtenofovirat 10 mg enkrat na dan (atazanavir 300 mg enkrat na dan s kobicistatom 150 mg enkrat na dan)
Some patients have reported dizziness when taking atazanavir or cobicistat, active substances of EVOTAZ.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri bolniki so pri jemanju atazanavirja ali kobicistata, učinkovin zdravila EVOTAZ, poročali o pojavu omotice.
Concentrations of these medicinal products may be increased when co-administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ se koncentracije teh zdravil lahko povečajo.
Concentration of fluconazole may be increased if co-administered with cobicistat.
Pri sočasni uporabi kobicistata se koncentracije flukonazola lahko povečajo.
Plasma concentrations of drospirenone are increased following administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat.
Pri uporabi drospirenona/etinilestradiola skupaj z atazanavirjem/kobicistatom se povečajo koncentracije drospirenona v plazmi.
No dose adjustment is required for telaprevir if co-administered with EVOTAZ.
Odmerka telaprevirja pri sočasni uporabi zdravila EVOTAZ ni treba prilagajati.
Co-administration with EVOTAZ has the potential to increase warfarin plasma concentrations.
Pri sočasni uporabi zdravila EVOTAZ se lahko povečajo koncentracije varfarina v plazmi.
Co-administration of EVOTAZ with alfuzosin is contraindicated (see section 4.3)
Sočasna uporaba zdravila EVOTAZ in alfuzosina je kontraindicirana (glejte poglavje 4.3).
Co-administration of boceprevir and EVOTAZ is not recommended.
Sočasna uporaba boceprevirja in zdravila EVOTAZ ni priporočljiva.
Interaction table
Prikaz interakcij v obliki tabele
OPIOIDS
ZDRAVILA
The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Mehanizem interakcije je zaviranje CYP3A4 z atazanavirjem in kobicistatom.
Co-administration with EVOTAZ is expected to increase dolutegravir plasma concentrations.
Pri sočasni uporabi zdravila EVOTAZ pričakujemo povečanje koncentracij dolutegravirja v plazmi.
ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Grazoprevir 200 mg enkrat na dan (atazanavir 300 mg/ritonavir 100 mg enkrat na dan)
Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs (see section 4.5).
Zaviralci protonske črpalke povečajo pH vrednost želodčne vsebine, topnost atazanavirja pa se pri tem zmanjša (glejte poglavje 4.5).
ERGOT DERIVATES
DERIVATI ERGOT ALKALOIDOV
Telaprevir AUC ↓20% (↓24% Telaprevir Cmax ↓21% (↓26% Telaprevir Cmin ↓15% (↓25% ↓2%) Atazanavir AUC ↑17% (↓3% Atazanavir Cmax ↓15% (↓27% Atazanavir Cmin ↑85% (↑40%
Telaprevir AUC ↓20% (↓24% Telaprevir Cmax ↓21% (↓26% Telaprevir Cmin ↓15% (↓25%
Co-administration of EVOTAZ with medicinal products that are moderate to weak inducers of CYP3A may result in decreased plasma concentration of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir.
Pri sočasni uporabi se lahko koncentracije atazanavirja in/ali kobicistata zmanjšajo, kar lahko privede do izgube terapevtskega učinka in možnega razvoja odpornosti proti atazanavirju.
The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat.
Mehanizem interakcije je zaviranje CYP3A z atazanavirjem in kobicistatom.
Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 5.2).
Pri bolnikih z okvaro jeter so opažali zvišanje njegovih koncentracij v plazmi (glejte poglavji 4.2 in 5.2).
Co-administration of atorvastatin with EVOTAZ is not recommended.
Sočasna uporaba atorvastatina in zdravila EVOTAZ ni priporočljiva.
Atazanavir with ritonavirf
Okvara ledvic Atazanavir
Amiodarone, dronedarone, quinidine and systemic lidocaine have a narrow therapeutic window and are contraindicated due to potential inhibition of CYP3A by EVOTAZ (see section 4.3).
Amiodaron, dronedaron, kinidin in lidokain za sistemsko uporabo imajo ozko terapevtsko okno.
The combination of avanafil and EVOTAZ is contraindicated (see section 4.3).
Uporaba avanafila v kombinaciji z zdravilom EVOTAZ je kontraindicirana (glejte poglavje 4.3).
Integrase Inhibitors
Zaviralci integraze
Concentrations of ethinyl estradiol and norethindrone are increased when a combined oral contraceptive containing those agents is co-administered with atazanavir.
Pri sočasni uporabi kombiniranih peroralnih kontraceptivov z etinilestradiolom in noretindronom ter atazanavirja so se koncentracije etinilestradiola in noretindrona povečale.
Alternative antiretroviral therapy to EVOTAZ may be considered if jaundice or scleral icterus is unacceptable to a patient.
Če so zlatenica ali rumene beločnice za bolnika nesprejemljive, se lahko razmisli o drugem protiretrovirusnem zdravljenju namesto zdravljenja z zdravilom EVOTAZ.
No dose adjustment is required for raltegravir if co-administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ odmerka raltegravirja ni treba prilagajati.
Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Pri sočasni uporabi z močnimi zaviralci CYP3A se njegove koncentracije v plazmi povečajo.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ in antacidov, vključno z zdravili, ki vsebujejo pufre, se zaradi zvišanja pH vrednosti želodčne vsebine lahko zmanjšajo koncentracije atazanavirja.
Co-administration of EVOTAZ with medicinal products containing ritonavir or cobicistat, which are strong inhibitors of CYP3A, may result in additional boosting and increased plasma concentration of atazanavir.
Sočasna uporaba zdravila EVOTAZ in zdravil, ki vsebujejo ritonavir ali kobicistat, ki sta močna zaviralca CYP3A.
If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Če je od pozabljenega odmerka zdravila EVOTAZ minilo že več kot 12 ur, pozabljeni odmerek izpustite in vzemite le naslednji odmerek ob običajnem času.
No significant effect on methadone concentrations was observed when co-administered with atazanavir.
Pri sočasni uporabi atazanavirja pomembnega vpliva na koncentracije metadona niso opazili.
The mechanism of this interaction is CYP3A4 inhibition by atazanavir and cobicistat.
Mehanizem te interakcije je zaviranje CYP3A4 z atazanavirjem in kobicistatom.
Posology
ritonavirjemf
Co-administration of EVOTAZ with medicinal products that are strong inducers of CYP3A (such as carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort [Hypericum perforatum]) may result in decreased plasma concentrations of atazanavir and/or cobicistat, leading to loss of therapeutic effect and possible development of resistance to atazanavir (see section 4.3 and Table 1).
Sočasna uporaba zdravila EVOTAZ in zdravil, ki so močni induktorji CYP3A (kot so karbamazepin, fenobarbital, fenitoin, rifampicin in šentjanževka [Hypericum perforatum]).
If trazodone is co-administered with EVOTAZ, the combination should be used with caution and a lower dose of trazodone should be considered.
Pri sočasni uporabi trazodona in zdravila EVOTAZ je potrebna previdnost.
Concentrations of beta-blockers may be increased when co-administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ se koncentracije antagonistov adrenergičnih receptorjev beta lahko povečajo.
Plasma concentrations of digoxin may be increased when co-administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ se koncentracije digoksina v plazmi lahko povečajo.
Rifabutin AUC ↑48% (↑19% Rifabutin Cmax ↑149% (↑103% Rifabutin Cmin ↑40% (↑5% 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin Cmax 25-O-desacetyl-rifabutin Cmin *When compared to rifabutin 150 mg once daily alone.
*Pri primerjavi z uporabo samega rifabutina v odmerku 150 mg enkrat na dan. Skupna vrednost AUC rifabutina in 25-O-dezacetil-rifabutina: ↑119%
Studies in animals have been shown excretion of cobicistat/metabolites in milk Because of both the potential for HIV transmission and the potential for serious adverse reactions in breast-feeding infants, women should be instructed not to breast-feed if they are receiving EVOTAZ.
Ženskam je treba pojasniti, da med zdravljenjem z zdravilom EVOTAZ ne smejo dojiti, tako zaradi možnosti prenosa virusa HIV kot možnega pojava resnih neželenih učinkov pri dojenih otrocih.
In HIV-infected adult patients (n=33, combined studies), the mean half-life within a dosing interval for atazanavir was
Pri odraslih bolnikih, okuženih z virusom HIV (n=33, kombinirane študije), je pri uporabi atazanavirja v odmerku 300 mg enkrat na dan in ritonavirja v odmerku 100 mg enkrat na dan skupaj z lahkim obrokom povprečni razpolovni čas atazanavirja v odmernem intervalu v stanju dinamičnega ravnovesja znašal 12 ur.
Contraception requirements
Kontracepcija
Co-administration with bepridil is contraindicated (see section 4.3).
Sočasna uporaba bepridila je kontraindicirana (glejte poglavje 4.3).
Proton pump inhibitors
Zaviralci protonske črpalke
Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ.
Pri sočasni uporabi zdravila EVOTAZ se koncentracije metformina lahko povečajo.
Results are normally seen within 2 or 3 weeks of starting treatment.
Rezultati so običajno vidni po dveh ali treh tednih po začetku zdravljenja.
‘Essential' means that the disease has no obvious cause.
„Esencialna“ pomeni, da za pojav bolezni ni očitnega vzroka.
After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people).
Po enem tednu se odmerek vsak teden poveča za 0,5 mg na dan, dokler število krvnih ploščic pri bolniku ne doseže vrednosti pod 600 milijonov na mililiter, v najboljšem primeru med 150 in 400 milijoni na mililiter (raven, ki je običajna pri zdravih ljudeh).
Treatment should only be started by a doctor who has experience in treating essential thrombocythaemia.
Zdravljenje sme uvesti samo zdravnik, ki ima izkušnje z zdravljenjem esencialne trombocitemije.
The full EPAR for Anagrelide Mylan 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 Anagrelid Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended starting dose is one 0.5 mg capsule twice a day.
Priporočeni začetni odmerek je ena 0,5-miligramska kapsula dvakrat na dan.
This puts the patient at risk of developing blood clots or bleeding problems.
Bolnik je tako izpostavljen tveganju za pojav krvnih strdkov ali težav s krvavitvami.
This is a summary of the European public assessment report (EPAR) for Anagrelide Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Anagrelid Mylan.
As for every medicine, the company provided studies on the quality of Anagrelide Mylan.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Anagrelid Mylan.
This means that Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Xagrid.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Xagrid.
What measures are being taken to ensure the safe and effective use of Anagrelide Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Anagrelid Mylan?
Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Anagrelid Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This reduces the platelet count, helping to improve symptoms in patients with the disease.
To zmanjša njihovo število in tako pomaga bolnikom s to boleznijo pri obvladovanju simptomov.
Anagrelide Mylan is used when the patient's current treatment does not work well enough or has unacceptable side effects, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Zdravilo Anagrelid Mylan se uporablja pri bolnikih, pri katerih trenutno zdravljenje ni dovolj učinkovito ali povzroča nesprejemljive neželene učinke, in pri bolnikih, pri katerih obstaja tveganje zaradi starosti (nad 60 let), zelo velikega števila krvnih ploščic ali predhodnih težav s strjevanjem krvi.
Anagrelide Mylan is available as capsules (0.5 and 1 mg).
Zdravilo Anagrelid Mylan je na voljo v obliki kapsul (0,5 mg in 1 mg).
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Xagrid, zato jih ni treba ponoviti za zdravilo Anagrelid Mylan.
The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Anagrelid Mylan primerljivo raven kakovosti kot referenčno zdravilo Xagrid ter da mu je biološko enakovredno.
The Agency recommended that Anagrelide Mylan be approved for use in the EU.
Priporočila je, da se zdravilo Anagrelid Mylan odobri za uporabo v EU.
Anagrelide Mylan is also a ‘hybrid medicine' because it is available in an additional strength.
Zdravilo Anagrelid Mylan je tudi „hibridno zdravilo“, ker je na voljo v dodatni jakosti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anagrelide Mylan have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Anagrelid Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood).
Zdravilo Anagrelid Mylan se uporablja za zmanjšanje števila krvnih ploščic (sestavine v krvi, ki sodeluje pri strjevanju krvi) pri bolnikih z esencialno trombocitemijo (boleznijo, pri kateri je v krvnem obtoku preveč krvnih ploščic).
For more information about treatment with Anagrelide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Anagrelid Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Anagrelide Mylan
Druge informacije o zdravilu Anagrelid Mylan
Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets.
Esencialna trombocitemija je bolezen, pri kateri kostni mozeg proizvaja preveč krvnih ploščic.
The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.
Največji priporočeni odmerek zdravila Anagrelid Mylan znaša 2,5 mg naenkrat.
It is not intended to provide practical advice on how to use Anagrelide Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the benefits and risks of Anagrelide Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Anagrelid Mylan?
For practical information about using Anagrelide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Anagrelid Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Zdravilna učinkovina v zdravilu Anagrelid Mylan, anagrelid, zavira razvoj in rast celic kostnega mozga, imenovanih megakariociti, ki proizvajajo krvne ploščice.
Therefore, the Agency's view was that, as for Xagrid, the benefit outweighs the identified risk.
Zato je menila, da njegove koristi enako kot pri zdravilu Xagrid odtehtajo znana tveganja.
Anagrelide Mylan contains the active substance anagrelide and is a ‘generic medicine'.
Zdravilo Anagrelid Mylan vsebuje zdravilno učinkovino anagrelid in je „generično zdravilo“.
What is Anagrelide Mylan and what is it used for?
Kaj je zdravilo Anagrelid Mylan in za kaj se uporablja?
Why is Anagrelide Mylan approved?
Zakaj je bilo zdravilo Anagrelid Mylan odobreno?
How has Anagrelide Mylan been studied?
Kako je bilo zdravilo Anagrelid Mylan raziskano?
Anagrelide Mylan can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Anagrelid Mylan je le na recept.
How is Anagrelide Mylan used?
Kako se zdravilo Anagrelid Mylan uporablja?
Anagrelide Mylan anagrelide
Anagrelid Mylan anagrelid
How does Anagrelide Mylan work?
Kako zdravilo Anagrelid Mylan deluje?
United Kingdom Genus Pharmaceuticals Holdings Limited, Park View House, 65
Velika Britanija Genus Pharmaceuticals Holdings Limited, Park View House, 65
Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Dodatek I Seznam izmišljenih imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
United Kingdom Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
Velika Britanija Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
2 g of meprobamate (in combination with magnesium oxide, magnesium sulphate, kaolin, sterculia gum)
2 g meprobamata (v kombinaciji z magnezijevim oksidom, magnezijevim sulfatom, kaolinom, gumi sterkulijo)
1106 Budapest Hungary
Keresztúri út 30-38. 1106 Budapest Hungary
200 mg of meprobamate (in combination with medroxyprogesterone acetate bendroflumethiazide)
200 mg meprobamata (v kombinaciji z medroksiprogesteron acetat bendroflumetiazidom)
400 mg of meprobamate (in combination with aceprometazine)
400 mg meprobamata (v kombinaciji z aceprometazinom)
150 mg of meprobamate (in combination with quinine)
150 mg meprobamata (v kombinaciji s kininom)
Within 30 days after Commission Decision
V roku 30 dni po sklepu Komisije
Clinical/safety
Klinični vidik/varnost
2015:pilot study 31 December 2016: main cohort (1 year results)
31. marec 2015: osrednja študija 31. december 2016: glavna kohorta (1letni rezultati)
Conditions to the marketing authorisations
Pogoji dovoljenja za promet z zdravilom
The final study protocol will be submitted within 60 days from Commission decision to MSs/RMS to be finally agreed prior to starting the study.
Končni protokol študije bo predložen v 60 dneh po sklepu Komisije državiam članiciam ali referenčnim državiam članiciam v dokončno potrditev pred začetkom študije.
The MAH should perform a drug utilization study to verify the compliance of prescribers regarding the restricted indication after marketing authorisation changes.
Imetnik dovoljenja za promet z zdravilom mora izvesti študijo uporabe zdravila, da preveri skladnost predpisovalcev z omejitvami indikacij po spremenjenem dovoljenju za promet z zdravilom.
DHPC Communication circulation according to the CHMP agreed action plan and conditions.
Neposredno obvestilo zdravstvenim delavcem v skladu z načrtom in pogoji, dogovorjenimi s CHMP.
The full study protocol for the nested case-control study within the European Society of Cardiology cohort, to investigate the potential association between extrapyramidal symptoms (EPS) and trimetazidine will be submitted to the MSs/RMS within 60 days after Commission Decision to be finalised prior to starting the study.
Celoten protokol študije za ugnezdeno študijo „primer-kontrola” v kohorti Evropskega združenja za kardiologijo bo za raziskavo možne povezave med ekstrapiramidalnimi simptomi in trimetazidinom predložen državi(am) članici(am) ali referenčni(im) državi(am) članici(am) v roku 60 dni po sklepu Komisije v finalizacijo pred začetkom študije.
National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Pristojne nacionalne agencije držav(e) članic(e) ali referenčne(ih) držav(e) članic(e) bodo zagotovile, kjer je to ustrezno, da imetnik(i) dovoljenj(a) za promet z zdravilom izpolni(jo) naslednje pogoje:
The MAH will perform a PASS study to address all important, potential and identified risks, particularly Parkinsonism.
Imetnik dovoljenja za promet z zdravilom bo izvedel študijo po odobritvi dovoljenja za promet z zdravilom, v kateri bo obravnaval vsa pomembna, možna in opredeljena tveganja, zlasti parkinsonizem.
The MAH should perform a PK study assessing the effect of renal impairment and age on trimetazidine pharmacokinetics according to the CHMP agreed protocol.
Imetnik dovoljenja za promet z zdravilom mora izvesti farmakokinetično študijo, da oceni učinek okvare ledvic in starosti na farmakokinetiko trimetazidina v skladu s protokolom, dogovorjenim s CHMP.
The final study report will be submitted to MSs/RMS by:
Končno poročilo študije bo predloženo državi(am) članici(am) ali referenčni(im) državi(am) članici(am):
The final study report will be submitted to NCAs/RMS by:
Končno poročilo študije bo predloženo nacionalnim agencijam držav(e) članic(e) ali referenčne(ih) držav(e) članic(e):