natgillin/translations-raw huggingface dataset:
These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase.
Pri teh bolnikih zaradi prirojenih napak proizvodnja primarne žolčne kisline henodeoksiholne kisline ni zadostna, kar ima za posledico pomanjkanje jetrnega encima sterol 27-hidroksilaze.
The full EPAR for Chenodeoxycholic acid Leadiant 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 Henodeoksiholna kislina Leadiant je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.
Ime zdravila je bilo 12. maja 2017 spremenjeno v Henodeoksiholna kislina Leadiant.
Previously known as Chenodeoxycholic acid sigma-tau.
Prej znano kot Henodeoksiholna kislina sigma-tau.
What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Henodeoksiholna kislina Leadiant?
Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years.
Zdravilo Henodeoksiholna kislina Leadiant so proučevali v študiji, v kateri so pregledali bolniške kartoteke 35 bolnikov s cerebrotendinozno ksantomatozo, ki so prejemali henodeoksiholno kislino približno 9 let.
Chenodeoxycholic acid is one of the main primary bile acids produced by the liver.
Henodeoksiholna kislina je ena od glavnih primarnih žolčnih kislin, ki jih tvorijo jetra.
Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production.
Predpisovanje in izdaja zdravila Henodeoksiholna kislina Leadiant je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem cerebrotendinozne ksantomatoze ali drugih bolezni tvorjenja primarne žolčne kisline.
For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Henodeoksiholna kislina Leadiant naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'.
Zdravilo Henodeoksiholna kislina Leadiant je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis.
Zdravilo Henodeoksiholna kislina Leadiant se uporablja za zdravljenje odraslih in otrok, starih en mesec ali več, s cerebrotendinozno ksantomatozo.
What is Chenodeoxycholic acid Leadiant and what is it used for?
Kaj je zdravilo Henodeoksiholna kislina Leadiant in za kaj se uporablja?
Other information about Chenodeoxycholic acid Leadiant
Druge informacije o zdravilu Henodeoksiholna kislina Leadiant
What benefits of Chenodeoxycholic acid Leadiant have been shown in studies?
Kakšne koristi je zdravilo Henodeoksiholna kislina Leadiant izkazalo v študijah?
Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'.
Zdravilo Henodeoksiholna kislina Leadiant je „hibridno zdravilo“.
What are the risks associated with Chenodeoxycholic acid Leadiant?
Kakšna tveganja so povezana z zdravilom Henodeoksiholna kislina Leadiant?
The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid.
Henodeoksiholna kislinav tem zdravilu nadomesti henodeoksiholno kislino, ki je primanjkuje bolniku.
Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid.
Henodeoksiholna kislina Leadiant je zdravilo, ki vsebuje zdravilno učinkovino henodeoksiholno kislino.
What information is still awaited for Chenodeoxycholic acid Leadiant?
Katere informacije o zdravilu Henodeoksiholna kislina Leadiant še pričakujemo?
Why is Chenodeoxycholic acid Leadiant approved?
Zakaj je bilo zdravilo Henodeoksiholna kislina Leadiant odobreno?
The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox.
Henodeoksiholna kislina Leadiant je zdravilo Xenbilox.
chenodeoxycholic acid
Henodeoksiholna kislina Leadiant henodeoksiholna kislina
How is Chenodeoxycholic acid Leadiant used?
Kako se zdravilo Henodeoksiholna kislina Leadiant uporablja?
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease.
Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
How does Chenodeoxycholic acid Leadiant work?
Kako zdravilo Henodeoksiholna kislina Leadiant deluje?
21 February 2011
21. februar 2011
This leads to improvement in the patient's symptoms.
Posledica tega je izboljšanje bolnikovih simptomov.
The European Commission issued a decision on this referral on 21 February 2011.
Evropska komisija je izdala odločbo o tej napotitvi dne 21. februarja 2011.
Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure.
Alfred E. Tiefenbacher GmbH & Co KG je avstrijski regulatorni agenciji za zdravila predložil zdravilo Galantamine Stada v presojo po decentraliziranem postopku.
This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Estonia, Finland, Ireland, Portugal, Slovakia and Spain).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Avstrija) oceni zdravilo z namenom odobritve dovoljenja za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Češka republika, Danska, Estonija, Finska, Irska, Portugalska, Slovaška in Španija).
It is used to treat symptoms of mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Uporablja se za zdravljenje simptomov blage do zmerno hude Alzheimerjeve demence, napredujoče možganske bolezni, ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
Why was Galantamine Stada reviewed?
Zakaj je bilo zdravilo Galantamine Stada pregledano?
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada.
Evropska agencija za zdravila je zaradi nesoglasja med državami članicami Evropske unije (EU) glede odobritve zdravila Galantamine Stada zaključila arbitražni postopek.
Following the CHMP opinion on 23 September 2010, the Agency was informed on 15 October 2010 that the company withdrew the applications for marketing authorisation in all concerned Member States.
Na podlagi mnenja odbora CHMP z dne 23. septembra 2010 je bila dne 15. oktobra 2010 agencija obveščena, da je podjetje umaknilo vloge za dovoljenje za promet z zdravilom v vseh zadevnih državah članicah.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has not been shown.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je slednji zaključil, da bioekvivalenca za referenčno zdravilo ni bila dokazana.
However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010.
Ker omenjene države članice niso dosegle soglasja, je Češka republika dne 26. marca 2010 zadevo napotila na odbor CHMP v arbitražo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Galantamine Stada ne odtehtajo z njim povezanih tveganj, in da se dovoljenje za promet z zdravilom ne more odobriti v Avstriji ali v drugih državah članicah EU: v Češki republiki, na Danskem, Finskem, Irskem, Portugalskem, Slovaškem in v Španiji.
The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Odbor CHMP je zato sklenil, da koristi zdravila Galantamine Stada ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne odobri.
Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl.
Galantamine Stada je generično zdravilo, ki temelji na „referenčnem zdravilu“, zdravilu Reminyl.
By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function.
Z zaviranjem tega encima galantamin omogoči dvig ravni acetilholina v tistih delih možganov, ki so povezani z intelektualnimi sposobnostmi.
What is Galantamine Stada?
Kaj je zdravilo Galantamine Stada?
The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive.
Razlog za napotitev je bilo dejstvo, da študije bioekvivalence, ki naj bi dokazale, da zdravilo Galantamine Stada ustvari enake koncentracije zdravilne učinkovine v telesu kot zdravilo Reminyl, niso bile prepričljive.
In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine.
Pri bolnikih z Alzheimerjevo boleznijo nekatere živčne celice v možganih odmrejo, kar se odraža v nizkih ravneh živčnega prenašalca acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo živčnih celic).
Galantamine Stada is a medicine that contains the active substance galantamine.
Galantamine Stada je zdravilo, ki vsebuje zdravilno učinkovino galantamin.
EMA/83112/2012
Vprašanja in odgovori o zdravilu Galantamine Stada in povezanih imenih (galantamin 8, 16 in 24 mg tablete s podaljšanim sproščanjem) EMA/83112/2012
The Safety Information Communication should contain the following:
Dopis o varnostnih informacijah mora vsebovati:
The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Topotecan Eagle are provided with a Safety Information Communication.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob začetku trženja zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali in/ali predpisovali zdravilo Topotekan Eagle, prejeli dopis o varnostnih informacijah.
The anticipated effects of overdose (e.g. bone marrow suppression).
• pričakovane učinke prevelikega odmerjanja (npr. supresija kostnega mozga);
Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information.
Imetnik dovoljenja za promet z zdravilom se bo, preden da zdravilo v promet, v vsaki državi članici s pristojnim nacionalnim organom dogovoril o vsebini in obliki dopisa o varnostnih informacijah, vključno s potrebo po morebitnih naknadnih dopisih o varnostnih informacijah in njihovo časovno uskladitvijo ter seznamom prejemnikov tega dopisa.
The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
• navedbe glede tveganja za napačno zdravljenje zaradi večje koncentracije v primerjavi z razredčeno koncentracijo originatorskega zdravila, z možnimi življenjsko nevarnimi
Reference to the vial collar as visual reminder of this difference and the instruction that it must
• sklic na obroček na viali kot vidni opomnik te razlike ter navodilo, da se ga ne sme nikoli
An encouragement of reporting of actual medication errors and any safety events that might be
• spodbudo k poročanju o dejanskih napakah pri zdravljenju ter vseh varnostnih ukrepih, ki bi bili lahko posledica napake pri zdravljenju;
Annex
DODATEK
• Information on crisis or infections
• Informacije pri krizi ali okužbi
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
• Key signs and symptoms of serious adverse reactions
• Bistvene znake in simptome resnih neželenih učinkov
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisanimi v nadaljevanju:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo pred sprostitvijo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Siklos, dobili informacije za zdravnika, ki bodo vsebovale naslednje:
• Information on growth follow-up of treated children for their parents
• Informacije o spremljanju rasti zdravljenih otrok za njihove starše
• When to seek urgent attention from the health care provider
• Kdaj poiskati nujno zdravstveno pomoč
• Need for periodic blood counts and dose adjustment
• Zahteva po periodičnem preverjanju krvne slike in prilagoditvi odmerka
• Growth follow-up of treated children
• Spremljanje rasti zdravljenih otrok
• Need for periodic blood counts
• Potreba po periodičnem preverjanju krvne slike
• Patient information pack
• Informativni komplet za bolnika
The treatment guide for physicians should contain the following key elements:
Vodnik za zdravljenje za zdravnika mora vsebovati:
The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Pred prihodom zdravila na tržišče v vsaki državi članici se bo imetnik dovoljenja za promet dogovoril glede vsebine in oblike izobraževalnega gradiva z nacionalnim organom, pristojnim za zdravila.
• Management of adverse drug reactions
• Načrt upravljanja z neželenimi učinki zdravila
• Treatment guide for physicians
• Vodnik za zdravljenje za zdravnika
This summary was last updated in 02-2016.
Povzetek je bil nazadnje posodobljen 06-2015.
The full EPAR for Clopidogrel Teva Pharma 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 Clopidogrel HCS je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
• peripheral arterial disease (problems with blood flow in the arteries);
• bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah);
In acute coronary syndrome and atrial fibrillation, Clopidogrel Teva Pharma is used together with aspirin, the dose of which should not be higher than 100 mg.
Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Clopidogrel HCS uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Običajni odmerek zdravila Clopidogrel HCS je ena 75-miligramska tableta enkrat dnevno.
This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
For more information about treatment with Clopidogrel Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Clopidogrel HCS preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• recently had a myocardial infarction (heart attack).
• bolnikom, ki so nedavno doživeli miokardni infarkt (srčni napad).
This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST-segment-elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Temu sledi običajni 75-miligramski odmerek enkrat na dan za najmanj štiri tedne (pri miokardnem infarktu z elevacijo spojnice ST) ali največ 12 mesecev (pri nestabilni angini pektoris ali pri miokardnem infarktu brez zobca Q).
It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Uporablja se pri bolnikih, ki imajo vsaj en dejavnik tveganja za dogodke, kot so srčni napad ali kap, ki ne smejo jemati antagonistov vitamina K (drugih zdravil, ki preprečujejo krvne strdke) in pri katerih je tveganje za krvavitve majhno.
Clopidogrel Teva Pharma can be started between a few days and 35 days after the attack;
Zdravilo se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel HCS.
Because Clopidogrel Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Ker je zdravilo Clopidogrel HCS generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
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 Clopidogrel Teva Pharma.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel HCS, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What are the benefit and risk of Clopidogrel Teva Pharma?
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel HCS?
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel HCS primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
• atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
• bolnikom z atrijsko fibrilacijo (nerednim hitrim krčenjem srčnih preddvorov), pri katerih se mora dajati skupaj z aspirinom.
Because Clopidogrel Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Clopidogrel HCS generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Pri akutnem koronarnem sindromu se zdravljenje načeloma uvede z udarnim odmerkom štirih tablet.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel HCS, veljavno po vsej Evropski uniji, izdala 28. oktobra 2010.
Clopidogrel Teva Pharma can be started between seven days and six months after the stroke;
Zdravilo se lahko začne jemati od sedem dni po kapi do šest mesecev po njej;
Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Zdravilo Clopidogrel HCS se uporablja pri odraslih za preprečevanje težav, ki jih povzročajo krvni strdki.
The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel HCS izda dovoljenje za promet.
Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Clopidogrel HCS je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel HCS, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel Teva Pharma been approved?
Zakaj je bilo zdravilo Clopidogrel HCS odobreno?
• recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
• bolnikom, ki so nedavno doživeli ishemično kap (kap, ki jo povzroči prekinitev dotoka krvi v del možganov).
Clopidogrel Teva Pharma is a ‘generic medicine'.
Zdravilo Clopidogrel HCS je generično zdravilo.
• a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
• bolnikom z akutnim koronarnim sindromom (bolezenskim stanjem, za katerega je značilen zmanjšan dotok krvi v srce) , pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov), vključno z bolniki, ki jim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zamašitev).
Other information about Clopidogrel Teva Pharma:
Druge informacije o zdravilu Clopidogrel HCS
What is Clopidogrel Teva Pharma used for?
Za kaj se zdravilo Clopidogrel HCS uporablja?
How has Clopidogrel Teva Pharma been studied?
Kako je bilo zdravilo Clopidogrel HCS raziskano?
How does Clopidogrel Teva Pharma work?
Kako zdravilo Clopidogrel HCS deluje?
How is Clopidogrel Teva Pharma used?
Kako se zdravilo Clopidogrel HCS uporablja?
Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Lahko se uporablja tudi pri bolnikih, ki nimajo nenormalnega zapisa na EKG, če imajo nestabilno angino pektoris (hudo obliko bolečine v prsih) ali so doživeli miokardni infarkt brez zobca Q.
What is Clopidogrel Teva Pharma?
Kaj je zdravilo Clopidogrel HCS?
Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Bolnike je treba med zdravljenjem skrbno nadzorovati glede morebitnega pojava resnih ali oportunističnih okužb.
Adopted at the 2-5 May 2017 PRAC
Sprejeto na seji odbora PRAC med 2. in 5. majem 2017
Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Brentuksimab vedotin - reaktivacija citomegalovirusa (CMV) (EPITT št. 18789)