natgillin/translations-raw huggingface dataset:
Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Pri bolnikih, zdravljenih z antiepileptičnimi zdravili (vključno z levetiracetamom) so bili opisani samomor, poskus samomora, samomorilno razmišljanje in vedenje.
After measuring the correct dose with an appropriate syringe, Levetiracetam Actavis Group oral solution may be diluted in a glass of water or baby's bottle.
Levetiracetam Actavis Group razredčite v kozarcu vode ali dojenčkovi steklenički.
100 mg (1 ml) twice daily
100 mg (1 ml) dvakrat na dan
250 mg twice daily
250 mg dvakrat na dan
Use the 3 ml oral syringe and adaptor included in the package
Uporabite 3-ml peroralno brizgo in nastavek, priložena v pakiranju.
If you take more Levetiracetam Actavis Group than you should
Če ste vzeli večji odmerek zdravila Levetiracetam Actavis Group, kot bi smel, se posvetujte z zdravnikom.
7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
7 do 21 mg/kg (0,07 do 10 do 30 mg/kg (0,10 do 0,21 ml/kg) dvakrat na dan
No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Okvara jeter Bolnikom z blago do zmerno okvaro jeter odmerka ni treba prilagoditi.
300 ml oral solution with a 1 ml oral syringe and an adaptor.
300 ml peroralne raztopine z 1-ml peroralno brizgo in nastavkom
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
300-ml steklenica (steklo tipa III) jantarne barve z belo, za otroke varno zaporko (polipropilen) v kartonski škatli, ki vsebuje tudi 3-ml peroralno brizgo z odmernimi oznakami (polipropilen, polietilen) in nastavek za brizgo (polietilen).
Levetiracetam Actavis Group 100 mg/ml oral solution Levetiracetam
Levetiracetam Actavis Group 100 mg/ml peroralna raztopina levetiracetam
Contact your doctor if you have missed one or more doses.
Če ste pozabili vzeti enega ali več odmerkov, se posvetujte z zdravnikom.
300 mg (3 ml) twice daily
300 mg (3 ml) dvakrat na dan
Mild
Hudo
(2) A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(2) Prvi dan zdravljenja z levetiracetamom je priporočljiv polnilni odmerek 10,5 mg/kg (0,105 ml/kg).
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
300-ml steklenica (steklo tipa III) jantarne barve z belo, za otroke varno zaporko (polipropilen) v kartonski škatli, ki vsebuje tudi 1-ml peroralno brizgo z odmernimi oznakami (polipropilen, polietilen) in nastavek za brizgo (polietilen).
1.25 ml twice daily
1,25 ml dvakrat na dan
300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene).
300-ml steklenica (steklo tipa III) jantarne barve z belo, za otroke varno zaporko (polipropilen) v kartonski škatli, ki vsebuje tudi 10-ml peroralno brizgo z odmernimi oznakami (polipropilen, polietilen).
Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
široko razširjen izpuščaj z mehurčki in luščenjem kože, še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in hujša oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza).
Metabolism and nutrition disorders
Infekcijske in parazitske bolezni nazofaringitis okužba
(3) A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
(3) Prvi dan zdravljenja z levetiracetamom je priporočljiv polnilni odmerek 15 mg/kg (0,15 mg/kg).
No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1,800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Pri uporabi odmerkov do 1.800 mg/kg/dan (6-kratni največji priporočeni odmerek za človeka glede na mg/m2 ali izpostavljenost) pri podganah niso opazili neželenih učinkov na plodnost ali reprodukcijsko sposobnost samcev in samic ne pri starših in ne v generaciji F1.
Use the 1 ml syringe and adaptor included in the package.
Uporabite 1-ml peroralno brizgo in nastavek, priložena v pakiranju.
250 to 500 mg twice daily
250 do 500 mg dvakrat na dan
600 mg (6 ml) twice daily
600 mg (6 ml) dvakrat na dan
7.5 ml twice daily
7,5 ml dvakrat na dan
3.5 to 10.5 mg/kg (0.035 to 0.105 ml/kg) twice daily
3,5 do 10,5 mg/kg (0,035 5 do 15 mg/kg (0,05 do do 0,105 ml/kg) dvakrat na dan
15 ml twice daily
15 ml dvakrat na dan
0.35 ml twice daily
0,35 ml dvakrat na dan
3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) twice daily
3,5 do 7 mg/kg (0,035 do 5 do 10 mg/kg (0,05 do 0,07 ml/kg) dvakrat na dan
Rare cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration, generally at the beginning of the treatment.
(nevtropenija, agranulocitoza, levkopenija, trombocitopenija in pancitopenija) v povezavi z uporabo levetiracetama.
200 mg (2 ml) twice daily
200 mg (2 ml) dvakrat na dan
0.6 ml twice daily
0,6 ml dvakrat na dan
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• depresija, sovražnost ali agresivnost, tesnoba, nespečnost, živčnost ali razdražljivost • konvulzije, motnje ravnotežja, omotica (občutek nesigurnosti), letargija (pomanjkanje energije in navdušenja), tremor (nehoteno tresenje)
How to store Levetiracetam Actavis Group
Shranjevanje zdravila Levetiracetam Actavis Group
0.8 ml twice daily
0,8 ml dvakrat na dan
Levetiracetam Actavis Group 100 mg/ml oral solution is a clear, faint yellowish-brown solution.
Zdravilo Levetiracetam Actavis Group 100 mg/ml peroralna raztopina je bistra, bledo rumenkastorjava raztopina.
Frequency category
Pogostnost
44.6% of the levetiracetam treated patients and 19.6% of the patients on placebo had a 50% or greater reduction from baseline in the partial onset seizure frequency per week.
Zmanjšanje tedenske pogostnosti napadov parcialnega izvora v primerjavi z izhodiščem za 50 % ali več je doseglo 44,6 % prejemnikov levetiracetama in 19,6 % prejemnikov placeba.
0.5 ml twice daily
0,5 ml dvakrat na dan
1.8 ml twice daily
1,8 ml dvakrat na dan
0.45 ml twice daily
0,45 ml dvakrat na dan
Group with or without food.
Zdravilo Levetiracetam Actavis Group lahko jemljete s hrano ali brez nje.
7 to 14 mg/kg (0.07 to 0.14 ml/kg) twice daily
7 do 14 mg/kg (0,07 do 10 do 20 mg/kg (0,10 do 0,14 ml/kg) dvakrat na dan
Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks.
Glede na klinični odziv in prenašanje je mogoče dnevni odmerek povečati do 1.500 mg dvakrat na dan. Odmerek se lahko spreminja v 500-mg povečanjih ali zmanjšanjih dvakrat na dan na dva do štiri tedne.
5 ml twice daily
5 ml dvakrat na dan
patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
V s placebom nadzorovanih in odprtih,
It is therefore recommended to adjust the maintenance daily dose of Levetiracetam Actavis Group, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Levetiracetam Actavis Group priporočljivo prilagoditi glede na očistek kreatinina (glejte poglavje
1 ml twice daily
1 ml dvakrat na dan
Glycerol (E422)
tekoči maltitol (E965)
6 ml twice daily
6 ml dvakrat na dan
1.05 ml twice daily
1,05 ml dvakrat na dan
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 10 ml syringe
PODATKI NA ZUNANJI OVOJNINI Škatla za steklenico s 300 ml in 10-ml brizgo
Sodium citrate
Očistek kreatinina
Convulsion, balance
glavobol konvulzije, motnje ravnotežja, omotica,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 1 ml syringe
PODATKI NA ZUNANJI OVOJNINI Škatla za steklenico s 300 ml in 1-ml brizgo
Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
amnezija, oslabljen spomin, poslabšana horeoatetoza, diskinezija,
0.3 ml twice daily
0,3 ml dvakrat na dan
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 3 ml syringe
PODATKI NA ZUNANJI OVOJNINI Škatla za steklenico s 300 ml in 3-ml brizgo
2.4 ml twice daily
2,4 ml dvakrat na dan
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 10 ml syringe
PODATKI NA PRIMARNI OVOJNINI Nalepka za steklenico s 300 ml in 10-ml brizgo
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 3 ml syringe
PODATKI NA PRIMARNI OVOJNINI Nalepka za steklenico s 300 ml in 3-ml brizgo
150 mg (1.5 ml) twice daily
150 mg (1,5 ml) dvakrat na dan 450 mg (4,5 ml) dvakrat na dan
Choreoathetosis,
Ušesne bolezni,
2 ml twice daily
2 ml dvakrat na dan
Clear, faint yellowish-brown solution.
peroralna raztopina Bistra, bledo rumenkasto-rjava raztopina.
Maximum dose: 30 mg/kg twice daily
Največji odmerek: 0,3 ml/kg dvakrat na dan
3 ml twice daily
3 ml dvakrat na dan
Starting dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily
Največji odmerek: 0,21 ml/kg dvakrat na dan
Diplopia, vision blurred
Očesne bolezni diplopija, zamegljen vid
Levetiracetam Actavis Group oral solution contains propylene glycol (E1520).
Zdravilo Levetiracetam Actavis Group peroralna raztopina vsebuje metilparahidroksibenzoat (E218)
Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Začetni odmerek 0,1 ml/kg dvakrat na dan
1.5 ml twice daily
1,5 ml dvakrat na dan
Oral solution.
- Navodilo shranite.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
otrocih in dojenčkih od enega meseca starosti • miokloničnih epileptičnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri odraslih in mladostnikih od 12. leta starosti, ki imajo juvenilno mioklonično epilepsijo • primarno generaliziranih tonično-kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti, ki imajo idiopatsko generalizirano epilepsijo (oblika epilepsije, za katero se domneva, da je genetskega izvora).
Starting dose: 7 mg/kg twice daily
Začetni odmerek 0,07 ml/kg dvakrat na dan
Talk to your doctor before taking Levetiracetam Actavis Group
Pred začetkom jemanja zdravila Levetiracetam Actavis Group se posvetujte s svojim zdravnikom.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema trombocitopenija levkopenija pancitopenija, nevtropenija, agranulocitoza
2.5 ml twice daily
2,5 ml dvakrat na dan
Check with your doctor or pharmacist if you are not sure.
Če ste negotovi, se posvetujte s svojim zdravnikom ali s farmacevtom.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 1 ml syringe
Nalepka za stekleničko s 300 ml in 1-ml brizgo
A joint study is encouraged.
Priporoča se izvedba skupne študije;
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 zbiranje podatkov.
Other published data from larger cohorts did not support the findings (Pol et al, 2016).
Drugi objavljeni podatki iz večjih kohort teh izsledkov niso podprli (Pol in drugi, 2016).
The product information should reflect these recommendations and inform healthcare professionals about this risk.
Informacije o zdravilu morajo odražati te smernice in zdravstvene delavce obveščati o tem tveganju.
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 odbora CHMP.
A feasibility assessment of the use of existing data sources for this purpose should be submitted for PRAC assessment by 15 June 2017.
Oceno izvedljivosti uporabe obstoječih podatkovnih virov za ta namen je treba odboru PRAC predložiti v ocenjevanje do 15. junija 2017.
The wording of the condition to the marketing authorisation has been amended accordingly.
Besedilo pogoja dovoljenja za promet z zdravilom je bilo ustrezno spremenjeno.
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 Risk Assessment Committee (PRAC).
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 and grounds for recommendation.
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s splošnimi znanstvenimi zaključki in podlago za priporočilo.
After further consideration of the timelines proposed for the submission of the final study report and taking into account that the protocol is due to be submitted by 15 June 2017, the CHMP was of the opinion that the date for the submission of the final study report should be postponed to Q2 2021 in order to allow sufficient time for agreement on a joint protocol and for collection of sufficient data to adequately respond to the scientific question.
Odbor CHMP je po ponovni preučitvi časovnic, predlaganih za predložitev končnega študijskega poročila, in z upoštevanjem, da je treba protokol predložiti do 15. junija 2017, menil, da je treba datum za predložitev končnega študijskega poročila preložiti na drugo četrtletje leta 2021, kar bo omogočilo dovolj časa za dogovor o skupnem protokolu in zbiranje zadostne količine podatkov, ki bodo ustrezno odgovorili na znanstveno vprašanje.
CHMP opinion and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Mnenje odbora CHMP in podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
In addition, ‘patients with previous HCC' should be considered as missing information, since this population was excluded from available clinical trials.
Poleg tega je treba bolnike s predhodnim hepatocelularnim karcinomom šteti za manjkajoče podatke, saj je bila ta populacija izključena iz razpoložljivih kliničnih preskušanj.
However, the difficulty of fully controlling confounding in this non-randomised comparison was recognised.
Vendar je bilo priznano, da je bilo v tej nerandomizirani primerjavi težko popolnoma nadzorovati zavajajoče dejavnike.
Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient required liver transplantation.
Nekateri ugotovljeni primeri z neposredno delujočimi protivirusnimi učinkovinami so imeli resne izide, s poslabšanjem jetrnega statusa in vsaj enim primerom, ko je bolnik potreboval presaditev jeter.
The product information will include a warning to inform about the risk of hepatitis B reactivation and reflect these recommendations.
Informacije o zdravilu bodo vključevale opozorilo za obveščanje o tveganju za reaktivacijo hepatitisa B in bodo odražale ta priporočila;
It was considered that in addition to the hepatitis B virus reactivation, the risk of hepatocellular carcinoma should also be further investigated and that consideration should be given for adequate measures to optimise the safe and effective use of these medicinal products.
Ocenjeno je bilo, da je treba poleg reaktivacije virusa hepatitisa B podrobneje preučiti tudi tveganje za hepatocelularni karcinom in da je treba razmisliti o ustreznih ukrepih za optimizacijo varne in učinkovite uporabe teh zdravil.
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 spremljanje.
The RMP of the relevant medicinal products will be updated accordingly.
V skladu s tem se bodo posodobili načrt za obvladovanje tveganj (RMP) za zadevna zdravila.
Literature cases (Balagopal et al., 2015; Collins et al., 2015; Ende et al., 2015) described HBV viral load increase after a rapid decline of HCV viral load in patients treated with direct acting antivirals (DAA) in interferon-free regimens, and further cases have been identified in EudraVigilance.
V primerih iz literature (Balagopal in drugi, 2015; Collins in drugi, 2015; Ende in drugi, 2015) so opisovali porast virusnega bremena HBV po hitrem znižanju virusnega bremena HCV pri bolnikih, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami v shemah zdravljenja brez interferonov, še drugi primeri pa so navedeni v sistemu EudraVigilance.
The protocol of this study shall be submitted to the PRAC by 15 June 2017 and the final study results by Q4 2019.
Protokol te študije morajo poslati odboru PRAC do 15. junija 2017, končne rezultate študije pa do zadnjega četrtletja 2019.
Direct-acting antiviral agents (DAAs) target specific non-structural proteins of the hepatitis C virus and result in disruption of viral replication and infection.
Neposredno delujoče protivirusne učinkovine ciljno delujejo proti določenim nestrukturnim beljakovinam virusa hepatitisa C in povzročijo motnje virusnega razmnoževanja in okužbe.
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 zdravljenju kroničnega hepatitisa C.
• 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 treatment chronic hepatitis C.
• 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;
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 unexpected early HCC recurrence.
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 karcinoma.
Although severe and even fatal cases of HBV reactivation have been described in the literature, the available data indicate that reactivation of HBV replication may mostly be mild and without clinical consequences.
Čeprav so v literaturi opisani resni in celo smrtni primeri reaktivacije HBV, razpoložljivi podatki kažejo, da je reaktivacija razmnoževanja HBV večinoma blaga in brez kliničnih posledic.
However, these cohorts were either not designed for assessing HCC recurrence, as is the case of the ANRS CO22 HEPATHER cohort, or included a limited number of patients with a previous HCC reaching complete radiological response and subsequently treated with DAAs as in the ANRS CO12 CirVir cohort.
Vendar te kohorte bodisi niso bile zasnovane za ocenjevanje ponovitve hepatocelularnega karcinoma, kot je bilo pri kohorti ANRS CO22 HEPATHER, bodisi so vključevale omejeno število bolnikov s predhodnim hepatocelularnim karcinomom, ki so dosegli popoln radiološki odziv in so se v nadaljevanju zdravili z neposredno delujočimi protivirusnimi učinkovinami, kot je bilo pri kohorti ANRS CO12 CirVir.
The research should capture prospectively the known risk factors for HCC and the periodic image testing for HCC diagnosis, according to current European clinical guidelines (EASL).
Raziskava mora prospektivno vključiti znane dejavnike tveganja za hepatocelularni karcinom in redno slikanje zaradi diagnoze hepatocelularnega karcinoma v skladu s trenutnimi evropskimi kliničnimi smernicami (EASL).
The PRAC was also of the view that ‘emergence of hepatocellular carcinoma' and ‘recurrence of hepatocellular carcinoma' should be considered as important potential risks.
Odbor PRAC je menil tudi, da je treba pojav hepatocelularnega karcinoma in ponovni pojav hepatocelularnega karcinoma šteti za pomembni morebitni tveganji.
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 minimise the risk.
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.
A study from Reig et al. (2016) showed a signal of HCC recurrence in patients treated with DAAs; similar results were obtained by Conti et al. (2016).
Reig in drugi, (2016) so v študiji dokazali signal za ponovitev hepatocelularnega karcinoma pri bolnikih, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, do podobnih rezultatov pa so prišli tudi Conti in drugi, (2016).
The impact of chronic HCV infection characteristics, such as HCV genotype, viral load and histopathologic staging, on the risk of occurrence of HBV reactivation could not be clarified from the available data.
Vpliva značilnosti kronične okužbe z virusom hepatitisa C, kot so genotip HCV, virusno breme in histopatološki stadij, na tveganje za pojav reaktivacije HBV iz razpoložljivih podatkov ni bilo mogoče razjasniti.
In addition, interim results should be submitted for PRAC assessment by Q4 2019.
Poleg tega je treba vmesne rezultate odboru PRAC predložiti v ocenjevanje do zadnjega četrtletja leta 2019.
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 hepatitisa C.
Overall, the PRAC considered that further studies were warranted to further characterise the risk of HCC recurrence associated with DAAs, in order to address remaining uncertainties about this potential risk and conclude on the need for any additional advice on clinical management.
Na splošno je odbor PRAC ocenil, da so potrebne nadaljnje študije za podrobnejšo opredelitev tveganja za ponovitev hepatocelularnega karcinoma, povezanega z neposredno delujočimi protivirusnimi učinkovinami, s čimer bi ocenili preostale negotovosti za ta morebitna tveganja in sprejeli sklep o potrebi po dodatnem svetovanju o kliničnem vodenju.