natgillin/translations-raw huggingface dataset:
On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage. 
Podjetje ISTA Pharma Limited je dne 25. aprila 2007 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da se je odločilo umakniti vlogo za dovoljenje za promet z zdravilom Vitragan, namenjenim za zdravljenje krvavitev v steklovino.
It was to be made up into a solution for injection into the eye. 
Namenjen je za pripravo raztopine za injiciranje v oko.
This was intended to improve vision and to help doctors in their diagnosis of underlying problems in the retina (the light-sensitive surface at the back of the eye). 
Namenjeno bi naj bilo za izboljšanje vida in kot pomoč zdravnikom pri diagnosticiranju osnovnih težav v mrežnici (na svetlobo občutljivi površini na zadnji strani očesa).
The company also presented the results of two main studies involving 1,306 patients with vitreous haemorrhage, where the effects of a single injection of Vitragan were compared with those of placebo (a dummy treatment). 
Podjetje je predstavilo tudi rezultate dveh glavnih študij s 1306 bolniki s krvavitvami v steklovino, v katerih so učinke posamične injekcije zdravila Vitragan primerjali z učinki placeba.
When the acid is broken down, the vitreous humour turns from a jelly into a liquid, allowing cells to move more freely through the vitreous humour. 
Ko se kislina razgrajuje, se steklovina spreminja iz želatine v tekočino, kar omogoča celicam prosto gibanje skozi steklovino.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vitragan? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Vitragan?
What is Vitragan? 
Kaj je zdravilo Vitragan?
This was expected to allow phagocytes (specialised ‘scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour. 
To naj bi omogočilo fagocitom (specializirane „čistilne“ celice imunskega sistema) odstranjevanje krvnih strdkov iz steklovine.
The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep. 
Zdravilna učinkovina v zdravilu Vitragan, hialuronidaza (ovčja), je encim, pridobljen iz ovc.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage. 
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo Vitragan ni mogoče odobriti dovoljenja za zdravljenje krvavitev v steklovino.
Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults. 
Zdravilo Vitragan naj bi se uporabljalo za zdravljenje krvavitev v steklovino (želatini podobno tekočino v osrednji očesni komori) pri odraslih.
The application was at day 180 when the company withdrew. 
Ko jo je podjetje umaknilo, je bila vloga v postopku 180. dan.
Vitragan is a powder containing the active substance hyaluronidase (ovine). 
Zdravilo Vitragan je prašek, ki vsebuje zdravilno učinkovino hialuronidazo (ovčjo).
The CHMP had concerns over the benefits of Vitragan, since the main studies had not shown convincingly that it was more effective than available options for managing vitreous haemorrhage. 
CHMP je imel zadržke glede koristi zdravila Vitragan, saj glavni študiji nista prepričljivo pokazali, da bi bilo zdravilo pri zdravljenju krvavitev v steklovino učinkovitejše od razpoložljivih možnosti.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vitragan had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je bil v času umika CHMP mnenja, da koristi zdravila Vitragan niso zadostno dokazane in da niso večje od znanih tveganj.
What was Vitragan expected to be used for? 
Za kaj naj bi se zdravilo Vitragan uporabljalo?
The company informed the CHMP that there are currently no clinical trials or compassionate use programmes with Vitragan. 
Podjetje je CHMP obvestilo, da klinična preizkušanja ali programi sočasne uporabe zdravila Vitragan trenutno ne potekajo.
How is Vitragan expected to work? 
Kako naj bi zdravilo Vitragan delovalo?
It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid. 
Ta encim naj bi razgrajeval molekule v steklovini, imenovane hialuronska kislina.
MA (EU) number (Invented) name Strength Pharmaceutical 
Številka (EU) dovoljenja za promet
Long-term extension in Study 1 and Study 2 
Dolgoročno podaljšanje v Študiji 1 in Študiji 2
Day 5, Day 14 and Day 28 
5. dan, 14. dan in 28. dan
Date of latest renewal: 18 February 2016 
Datum zadnjega podaljšanja: 18. februar 2016
Polyomavirus 4.8 
Poliomavirus 4,8
No pattern was identified in the causes of death. 
Pri ugotavljanju vzrokov smrti niso ugotovili nobenih skupnih vzorcev.
(See section 2) 
(Glejte poglavje 2)
Study 2: extended criteria donors 
Študija 2: darovalci po razširjenih kriterijih
Keep this Alert Card with you at all times. 
To opozorilno kartico imejte vedno pri sebi.
The safety and efficacy of belatacept in children and adolescents 0 to 18 years of age have not yet been established. 
Varnost in učinkovitost belatacepta pri otrocih in mladostnikih, starih od 0 do 18 let, še nista bili dokazani.
Unopened vials 3 years 
Zaprte viale 3 leta
The most common CNS infection was cryptococcal meningitis. 
Najpogostejša okužba CŽS je bil kriptokokni meningitis.
Immunosuppressant therapy may affect response to vaccination. 
Imunosupresivno zdravljenje lahko vpliva na odziv na cepljenje.
Plasmapheresis may accelerate removal of belatacept. 
Plazmafereza lahko pospeši odstranitev belatacepta.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
Up to Year 3*,** 
do 1. leta do 3. leta*,**
** Includes all events reported over a median of 3.3 years in the Phase 3 studies, and a median of approximately 7 years in the Phase 2 study. 
** Mediani čas pojavnosti vseh sporočenih primerov v študijah 3. faze je 3,3 leta, v študiji 2. faze pa približno 7 let.
Belatacept should not be used in pregnant women unless clearly necessary. 
Belatacepta se ne sme uporabljati pri nosečnicah, razen če je nujno potrebno.
* See section “Description of selected adverse reactions”. 
* Glejte poglavje “Opis izbranih neželenih učinkov”.
The clinical relevance of such antibodies is unclear. 
Klinični pomen teh protiteles ni pojasnjen.
For a list of symptoms please see section 4, “Possible side effects”. 
Za seznam simptomov glejte poglavje 4 “Možni neželeni učinki”.
Day of transplantation, prior to implantation (Day 1) 
Dan presaditve, pred vsaditvijo (1. dan)
The effects of NULOJIX in pregnant women are not known. 
Učinki zdravila NULOJIX pri nosečnicah niso znani.
Direct the stream of fluid to the glass wall of the vial and not into the powder. 
Curek tekočine usmerite v stekleno steno viale in ne neposredno v prašek.
These are medicines that reduce the activity of the immune system, the body's natural defences. 
Ta zdravila zmanjšujejo aktivnost imunskega sistema, ki je naravni obrambni mehanizem telesa.
There are no adequate data from use of belatacept in pregnant women. 
Ni zadostnih podatkov o uporabi belatacepta pri nosečnicah.
Studies in adult mice and monkeys have not demonstrated similar findings. 
Pri študijah pri odraslih miših in opicah o takih ugotovitvah niso poročali.
The accumulation index for belatacept at steady state is 1.1. 
Indeks akumulacije belatacepta v stanju dinamičnega ravnovesja je 1,1.
Start (Day of Transplant):_______________ Most recent: _________________________ Next treatment date:____________________ Patient's Name:_______________________ Doctor's Name:_______________________ Doctor's Phone:_______________________ If NULOJIX is stopped, keep this card with you for an additional 3 months. 
Prvi odmerek (dan presaditve):____________ Zadnji odmerek: _________________________ Datum naslednjega odmerka:_____________ Ime in priimek bolnika:__________________ Ime in priimek zdravnika:_________________ Telefonska številka zdravnika:_____________ To opozorilno kartico imejte pri sebi še vsaj 3 mesece po prekinitvi zdravljenja z zdravilom NULOJIX.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving or operating machines. 
Bolnikom je treba naročiti, da se morajo v primeru pojava teh simptomov izogibati potencialno nevarnim opravilom, kot so vožnja ali upravljanje s stroji.
This medicine will be stored in the healthcare facility where it is administered. 
Zdravilo bo shranjeno v zdravstveni ustanovi, kjer vam ga bodo tudi aplicirali.
Common depression 
Pogosti depresija
In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment. 
Titri protiteles so bili na splošno nizki, običajno niso bili persistentni, pri nadaljevanju zdravljenja pa so pogosto postali nedokazljivi.
The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100). 
Kategorije pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100).
NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group. 
Uporabe zdravila NULOJIX pri otrocih in mladostnikih, mlajših od 18 let, niso raziskovali, zato uporaba tega zdravila v tej starostni skupini ni priporočljiva.
Ciclosporin Belatacept LI 
ciklosporin belatacept MI
The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis. 
Tuberkuloza se je v večini primerov pojavila pri bolnikih, ki živijo ali so v preteklosti živeli v državah z visoko prevalenco tuberkuloze.
Tell your family or caregiver about your treatment. 
Svoje družinske člane ali skrbnike seznanite z vašim zdravljenjem.
The safety and efficacy of retreatment with belatacept has not been studied. 
Varnosti in učinkovitosti ponovne uvedbe zdravljenja z belataceptom niso raziskovali.
The distribution of the card will also prompt dialogue on any new or changes in symptoms since the prior visit. 
Izročitev opozorilne kartice za bolnika bo tudi spodbudila pogovor o pojavu kakršnihkoli novih simptomov ali o spremembi simptomov od prejšnjega obiska.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011 
Datum prve odobritve: 17. junij 2011
Take all medicines as instructed by your doctor. 
Redno jemljite vsa zdravila, ki vam jih je predpisal zdravnik.
It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses. 
Možno je, da je večja dovzetnost za oportunistične okužbe, opažena pri mladičih podgan, povezana z izpostavljenostjo abataceptu pred razvojem spominskega odziva.
Tests may show: 
Preiskave lahko pokažejo:
Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml. 
Injekcijske brizge imajo oznake v enotah po 0,5 ml, zato izračunani odmerek zaokrožite na najbližjih 0,5 ml.
If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before. 
Če zdravljenje z zdravilom NULOJIX prekinete za daljši čas in med tem ne jemljete nobenega drugega zdravila za preprečevanje zavrnitve, ni znano, če bo po ponovnem začetku zdravljenja učinek belatacepta enak kot pred tem.
Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation. 
Profilaksa pnevmocistične pljučnice je priporočljiva še vsaj 6 mesecev po presaditvi.
Ciclosporin N= 476 
ciklosporin n = 476
You might get symptoms that you might not be aware of yourself. 
Med zdravljenjem se lahko pojavijo nekateri simptomi, ki jih sami morda ne boste opazili.
Infections and infestations Serious infections Viral infections 
Infekcijske in parazitske bolezni Resne okužbe Virusne okužbe
The card will have your doctor's name and phone number and the date when you started treatment, your last treatment visit, and your next visit for treatment. 
Zdravnik bo na kartonček vpisal svoje ime in priimek, telefonsko številko, datum začetka zdravljenja, datum zadnjega odmerka zdravila in datum naslednjega odmerka zdravila.
The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional. 
Priporočeni odmerek zdravila je odvisen od vaše telesne mase (v kg) in ga bo izračunal zdravstveni delavec.
CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection. 
Profilaksa CMV je priporočljiva še vsaj 3 mesece po presaditvi, še posebej pri bolnikih z visokim tveganjem za okužbo s CMV.
PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus. 
Progresivna multifokalna levkoencefalopatija (PML) PML je redka, pogosto hitro napredujoča in usodna oportunistična okužba CŽS, ki jo povzroča virus John Cunningham (JC).
Approximately 80% of AR episodes occurred by Month 3 and were infrequent after Month 6. 
Približno 80 % primerov akutne zavrnitve se je zgodilo do 3. meseca, po 6. mesecu pa so bile redke.
From week 4 after transplant, you will receive treatment with NULOJIX every 4 weeks. 
Zdravilo NULOJIX boste od 4. tedna po presaditvi prejemali na vsake 4 tedne.
Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A. 
Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - ZDA
Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes. 
Reverzibilni farmakološki učinki so obsegali minimalno zmanjšanje koncentracije serumskih IgG in minimalno do hudo izgubo germinalnih limfatičnih centrov v vranici in/ali bezgavkah.
During the first month post-transplantation, 85% saturation of CD86 was maintained. 
Med prvim mesecem po presaditvi se je zasičenost CD86 ohranila pri 85 %.
Any unused portion in the vials must be discarded in accordance with local requirements. 
Neporabljeno vsebino vial morate zavreči v skladu z lokalnimi predpisi.
The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well. 
V študiji z belataceptom virusnega statusa niso ugotavljali, ker pa je ta virus pri opicah zelo razširjen, je verjetno, da je bil prisoten tudi pri tej populaciji opic.
If you have not been exposed to EBV prior to your transplant 
če pred presaditvijo še niste bili izpostavljeni virusu EBV.
Single doses up to 20 mg/kg have been administered without apparent toxic effect. 
Pri aplikaciji enkratnih odmerkov do 20 mg/kg niso poročali o pojavu toksičnih učinkov.
Table 4: Infections occurring by treatment group (%) 
Preglednica 4: Pojavnost okužb po skupinah zdravljenja (%)
Because of abatacept's similarity to belatacept in structure and mechanism of action and its higher activity in rodents, abatacept was used as a more active homolog for belatacept in rodents. 
Ker je abatacept po strukturi in mehanizmu delovanja podoben belataceptu, njegova aktivnost pri glodavcih pa je večja, so abatacept pri glodavcih uporabili kot aktivnejši homolog od belatacepta.
Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea. 
Belatacept ima blag vpliv na sposobnost vožnje in upravljanja s stroji, ker lahko povzroči utrujenost, splošno slabo počutje in/ali slabost.
If you have not been exposed to the Epstein-Barr virus (EBV) or are uncertain of previous exposure, you must not be treated with NULOJIX. 
če niste bili izpostavljeni virusu Epstein-Barr (EBV) ali ne veste, če ste v preteklosti bili izpostavljeni, se z zdravilom NULOJIX ne smete zdraviti.
Tell your doctor immediately if you or your family notice any symptoms listed below: 
Nemudoma obvestite zdravnika, če opazite ali kdo od družinskih članov pri vas opazi kateregakoli od naslednjih simptomov:
Studies in rats have shown excretion of belatacept in milk. 
Študije pri podganah so pokazale, da se belatacept izloča v mleko.
The European Medicines Agency has deferred the obligation to submit the results of studies with belatacept in one or more subsets of the paediatric population in renal transplantation (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z belataceptom za eno ali več skupin pediatrične populacije s presajeno ledvico (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Each pack of the medicine contains an alert card that should be given to the patient. 
Vsakemu pakiranju zdravila je priložen opozorilni kartonček za bolnika.
Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers. 
Belatacept nima nobenih pomembnih neposrednih učinkov na vrednosti citokinov pri bolnikih s presajenimi jetri ali pri zdravih prostovoljcih.
It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept. 
Ni znano, če te spremembe kažejo na tveganje za razvoj avtoimunskih bolezni pri človeku po in utero izpostavljenosti abataceptu ali belataceptu.
With NULOJIX treatment, this more often develops in the brain and can lead to death. 
Pri zdravljenju z zdravilom NULOJIX le-ta pogosteje prizadene možgane in se lahko konča s smrtjo.
Based on population pharmacokinetic analysis of 944 renal transplant patients up to 1 year posttransplant, the pharmacokinetics of belatacept were similar at different time periods post-transplant. 
Na osnovi podatkov analize populacijske farmakokinetike, izvedene pri 944 bolnikih s presajeno ledvico do 1 leta po presaditvi, je bila farmakokinetika belatacepta v različnih časovnih obdobjih po presaditvi podobna.
There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy). 
V skupini zdravljenja s ciklosporinom (Študija 1) so poročali o enem primeru PML 82 mesecev po presaditvi (več kot 56 dni po prekinitvi zdravljenja).
Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal. 
Od 6 primerov PTLB pri MI režimu, so 3 prizadeli CŽS in so se končali s smrtjo.
In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies. 
Pri 153 bolnikih, ki so bili na protitelesa ovrednoteni vsaj 56 dni (približno 7 razpolovnih časov) po prekinitvi zdravljenja z belataceptom, so protitelesa odkrili še pri dodatnih 10 bolnikih (6,5 %).
PML often leads to severe disability or death. 
Progresivna multifokalna levkoencefalopatija pogosto povzroči hudo invalidnost ali smrt.
Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS). 
Pri bolnikih, ki so se zdravili z belataceptom, je PTLB v 9 od 14 primerov prizadela CŽS, znotraj opazovalnega obdobja se je 8 od 14 primerov končalo s smrtjo (v 6 smrtnih primerih je bil prizadet CŽS).
Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of renal transplant patients. 
Zdravljenje mora predpisati in nadzirati zdravnik specialist, ki ima izkušnje z vodenjem imunosupresivnega zdravljenja in bolnikov s presajeno ledvico.
Gently mix the infusion container. 
Infuzijski vsebnik nežno premešajte.
Activated T cells are the predominant mediators of immunologic response to the transplanted kidney. 
Aktivirani limfociti T so poglaviten posrednik imunskega odziva po presaditvi ledvice.
Therapeutic monitoring of belatacept is not required. 
Spremljanje terapevtskih koncentracij belatacepta ni potrebno.
It is unknown whether belatacept is excreted in human milk (see section 5.3). 
Ni znano, če se belatacept izloča v materino mleko (glejte poglavje 5.3).
Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors 
Preglednica 5: Ključni izidi učinkovitosti po 1. in 3. letu zdravljenja Študija 1: živi ali umrli darovalci (standardni kriteriji za darovalca)
Patients with high PRA often require increased immunosuppression. 
Pri bolnikih z visoko vrednostjo PRA je pogosto potrebna močnejša imunosupresija.
MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/694/001
NULOJIX weakens the body's ability to fight infections. 
Zdravilo NULOJIX zmanjša sposobnost telesa za obrambo pred okužbami.
**Median follow-up for PTLD for pooled studies is 1,199 days for MI, 1,206 days for LI, and 1,139 days for ciclosporin. 
**Mediani čas spremljanja za PTLB za združene študije je 1.199 dni za BI režim, 1.206 dni za MI režim in 1.139 dni za ciklosporin.
Anti-belatacept antibody development was not associated with altered clearance of belatacept. 
Pojavnost protiteles proti belataceptu ni bila povezana s spremembo očistka belatacepta.
Early diagnosis and treatment may mitigate the impact of PML. 
Z zgodnjim odkritjem in zdravljenjem se potek PML lahko ublaži.
Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains. 
Aktivnost belatacepta pri glodavcih je manjša od aktivnosti abatacepta, fuzijskega proteina, ki se od belatacepta razlikuje v dveh aminokislinah na CD80/86 vezavnih domenah.
Do not store any unused portion of the solution for infusion for reuse. 
Neporabljene raztopine za infundiranje ne shranjujte za ponovno uporabo.
There are no data on use of belatacept and effect on fertility in humans. 
O uporabi belatacepta in vplivu na plodnost pri človeku ni podatkov.
By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups. 
Do 3. leta je bila ponovitev akutne zavrnitve podobna v vseh skupinah (< 3 %), subklinična akutna zavrnitev, odkrita z biopsijo po protokolu po 1 letu, pa je bila v obeh skupinah 5 %.
The recommended dose is based on patient body weight (kg). 
Priporočeni odmerek je odvisen od telesne mase bolnika (kg).
Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation. 
Zdravljenje z zdravilom NULOJIX bo predpisal in nadziral zdravnik specialist s področja presaditve ledvic.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28. 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA28.