natgillin/translations-raw huggingface dataset:
This plan shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about: a) The intravitreal procedure as it was performed in the pivotal clinical studies b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events 
Ta program mora biti sestavljen iz ukrepov, katerih cilj je kar najbolj zmanjšati neželene dogodke, povezane s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), prek ustreznega izobraževanja o: a) intravitrealnem postopku, kot so ga opravljali v ključnih kliničnih študijah b) sterilnih tehnikah za zmanjševanje tveganja okužbe na najmanjšo mogočo mero c) uporabi antibiotikov d) uporabi povidon jodida e) opravljanju čiščenja vek f) uporabi anestetika za preprečevanje neprijetnosti postopka za bolnika g) tehnikah intravitrealnega injiciranja h) urejanju intraokularnega tlaka (IOP - »intraocular pressure«) i) zdravljenju endoftalmitisa j) poznavanju dejavnikov tveganja za nastanek endoftalmitisa k) prijavljanju resnih neželenih dogodkov
• An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product. 
• Izobraževalni program za bolnike, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider 
Ta program mora biti sestavljen iz ukrepov za ustrezno izobraževanje glede: l) ključnih znakov in simptomov resnih neželenih dogodkov, povezanih s postopkom injiciranja v steklovino m) tega, kdaj naj bolnik poišče urgentno pomoč zdravstvenega delavca.
• An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product. 
• Izobraževalni program za zdravnike in zdravstvene delavce, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
¾ The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) prior to marketing. 
¾ Države članice morajo zagotoviti, da bodo v izobraževalne programe za zdravnike, zdravstvene delavce in bolnike vključeni ukrepi od a) do m), kot je navedeno v nadaljevanju, in da bodo ti programi primerni za cilj kar najbolj učinkovitega zmanjševanja neželenih dogodkov, povezanih s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), pred dajanjem zdravila v promet.
84 x 1 capsules (unit dose) 
84 x 1 kapsul (posamični odmerek)
100 mg Capsule, hard Oral use blister (PVC/ PCTFE/Alu) 
100 mg kapsula, trda peroralna uporaba pretisni omot (PVC/PCTFE/alu)
EMA Number 
Številka EMA
Yargesa 
Jakost
Immediate Packaging 
Pot uporabe Stična ovojnina Velikost pakiranja
Similar results were seen after a year. 
Podobne rezultate so opazili tudi po enem letu.
This summary was last updated in 10-2008. 
Povzetek je bil nazadnje posodobljen 10-2008.
The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008. 
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 9. oktobra 2003 in 9. oktobra 2008.
Other information about Simulect: 
Druge informacije o zdravilu Simulect:
The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998. 
Evropska komisija je dovoljenje za promet z zdravilom Simulect, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 9. oktobra 1998.
The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant. 
Glavno merilo učinkovitosti je bilo število neuspelih zdravljenj (smrt, izguba nove ledvice ali znaki zavrnitve) v prvem letu po presaditvi.
Simulect was more effective than placebo. 
Zdravilo Simulect je bilo učinkovitejše od placeba.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SIMULECT EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) SIMULECT Povzetek EPAR za javnost
Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant. 
Zdravilo Simulect so proučevali v treh glavnih študijah, ki so vključevale skupaj 1 067 odraslih, pri katerih je bila opravljena presaditev ledvice.
Simulect is given as two injections. 
Zdravilo Simulect se daje v obliki dveh injekcij.
The Committee recommended that Simulect be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Simulect odobri dovoljenje za promet.
The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney. 
Prvo injekcijo je treba dati največ dve uri pred kirurškim posegom presaditve, drugo pa štiri dni po presaditvi, razen če se pri bolniku ne pojavijo hude preobčutljivostne (alergijske) reakcije ali se po posegu pojavijo zapleti, kot so izguba nove ledvice.
The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose. 
Študije pri otrocih in mladostnikih so pokazale, da je za otroke primeren manjši odmerek zdravila Simulect in da mladostniki lahko uporabljajo odmerek za odrasle.
It should be given under qualified medical supervision. 
Zdravilo se mora dajati pod strokovnim medicinskim nadzorom.
What benefit has Simulect shown during the studies? 
Kakšne koristi je zdravilo Simulect izkazalo med študijami?
Simulect should not be given unless it is absolutely certain that the patient will receive the transplant and other medicines to prevent rejection. 
Zdravilo Simulect bolnik ne sme prejeti, če ni popolnoma gotovo, da bo dobil presadek in druga zdravila za preprečitev zavrnitve.
This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected. 
Tako se zmanjša število aktiviranih limfocitov T in s tem tudi tveganje zavrnitve presadka.
Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359). 
Iz rezultatov prvih dveh študij skupaj je razvidno, da zdravljenje v šestih mesecih ni uspelo pri 40 % bolnikov, ki so zdravilo Simulect prejemali poleg dvotirnega zdravljenja (145 od 363), v primerjavi s 56 % bolnikov, ki so prejemali placebo (201 od 359).
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body. 
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je zasnovano tako, da prepozna in se veže na določeno strukturo (imenovano antigen), ki se nahaja na določenih celicah telesa.
Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant. 
Zdravilo Simulect lahko predpiše le zdravnik, ki ima izkušnje z imunosupresivnim zdravljenjem po presaditvi organov.
What is the risk associated with Simulect? 
Kakšna tveganja so povezana z zdravilom Simulect?
Simulect is given into a vein, either as a ‘bolus' injection (given all at once) or as an infusion over 20 to 30 minutes. 
Zdravilo Simulect se daje v veno bodisi kot „bolusna“ injekcija (bolnik prejme celo injekcijo naenkrat) ali kot infuzija, ki traja 20 do 30 minut.
Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney. 
Zdravilo Simulect se uporablja pri odraslih in otrocih, starejših od enega leta, za preprečevanje zavrnitve nove ledvice po presaditvi.
In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil. 
V prvih dveh študijah je večina od 722 bolnikov jemala tudi ciklosporin in kortikosteroide (dvotirno zdravljenje), nekateri bolniki pa so jemali tudi azatioprin ali mofetilmikofenolat.
In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds). 
Najpogostejši neželeni učinki pri odraslih (opaženi pri več kot 20 % bolnikov) so bili zapeka, okužbe sečil (okužbe struktur, po katerih se prenaša urin), bolečine, občutek slabosti, periferni edem (oteklina), hipertenzija (povišan krvni tlak), anemija (majhno število rdečih krvnih celic), glavobol, hiperkaliemija (visoke ravni kalija v krvi), hiperholesterolemija (visoke ravni holesterola v krvi), pooperativni zapleti ran, povečanje telesne mase, zvišana vrednost kreatinina v krvi (označevalec ledvičnih težav), hipofosfatemija (nizke ravni fosfata v krvi), driska in okužbe zgornjih dihal (prehladi).
In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses. 
Pri otrocih, ki tehtajo manj kot 35 kg, celotni odmerek znaša 20 mg, ki se daje v obliki dveh odmerkov po 10 mg.
In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses. 
Pri odraslih in otrocih, ki tehtajo več kot 35 kg, je priporočeni celotni odmerek 40 mg, ki ga bolnik prejme kot dva odmerka po 20 mg.
Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents. 
V dveh dodatnih študijah so opazovali, kakšni so odzivi na zdravilo Simulect v telesu otrok, starejših od enega leta, ali mladostnikov.
Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients. 
Zdravila Simulect ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za baziliksimab ali katero koli drugo sestavino zdravila.
In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines. 
Neželeni učinki v študijah so bili podobni pri bolnikih, ki so jemali zdravilo Simulect in placebo v kombinaciji z drugimi zdravili.
In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘triple therapy'). 
V tretji študiji je vseh 345 odraslih jemalo ciklosporin, steroide in azatioprin (trotirno zdravljenje).
Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants). 
Učinkovina baziliksimab je bila zasnovana tako, da se veže na antigen, imenovan CD25, ki je prisoten na površini limfocitov T (vrste belih krvničk, ki sodeluje pri zavrnitvi presajenih organov).
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Simulect za zaščito pred akutno zavrnitvijo organa pri de novo alogeni presaditvi ledvice pri odraslih bolnikih in otrocih večje od z njim povezanih tveganj.
In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%). 
V tretji študiji je bilo število bolnikov, pri katerih je bilo zdravljenje neuspešno, manjše pri bolnikih, ki so prejemali zdravilo Simulect sočasno s trotirnim zdravljenjem (26 %), kot pri bolnikih, ki so prejemali placebo (40 %).
Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein). 
Zdravilo Simulect je prašek in vehikel, ki se uporabljata za pripravo raztopine za injiciranje ali infundiranje (vnašanje tekočine v veno po kapljicah).
Why has Simulect been approved? 
Zakaj je bilo zdravilo Simulect odobreno?
For the full list of all side effects reported with Simulect, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Simulect, glejte navodilo za uporabo.
Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil. 
Zdravilo Simulect se uporablja v kombinaciji z drugimi zdravili, kot so ciklosporin, kortikosteroidi, azatioprin in mofetilmikofenolat, za preprečevanje zavrnitve organov.
By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply. 
Baziliksimab z vezanjem na CD25 blokira aktivnost interlevkina-2 in tako zmanjša hitrost, s katero se limfociti razmnožujejo.
CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide. 
CD25 je receptor za sporočilno molekulo interlevkin-2, ki spodbuja limfocite T k razmnoževanju.
In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation. 
Pri otrocih so bili neželeni učinki, opaženi pri več kot 20 % bolnikov, okužbe sečil, hipertrihoza (čezmerna poraščenost telesa), rinitis (zamašen nos ter izcedek iz nosu), zvišana telesna temperatura, hipertenzija, okužba zgornjih dihal, virusna okužba, sepsa (okužba krvi) in zapeka.
Simulect must not be used during pregnancy or breast-feeding. 
Zdravila Simulect ne smejo prejeti nosečnice ali doječe matere.
The active substance in Simulect, basiliximab, is a monoclonal antibody. 
Zdravilna učinkovina v zdravilu Simulect, baziliksimab, je monoklonsko protitelo.
All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment). 
V vseh treh študijah so učinkovitost zdravila Simulect primerjali s placebom (zdravilom brez zdravilne učinkovine).
The full EPAR for Simulect can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Simulect je na voljo tukaj.
How has Simulect been studied? 
Kako je bilo zdravilo Simulect raziskano?
What is Simulect used for? 
Za kaj se zdravilo Simulect uporablja?
How is Simulect used? 
Kako se zdravilo Simulect uporablja?
It contains the active substance basiliximab. 
Zdravilo vsebuje zdravilno učinkovino baziliksimab.
What is Simulect? 
Kaj je zdravilo Simulect?
How does Simulect work? 
Kako zdravilo Simulect deluje?
This is usually reached within three to five months. 
Te ravni so običajno dosežene v treh do petih mesecih.
It is available as tablets (500 mg). 
Na voljo je v obliki tablet (500 mg).
Treatment should continue as long as there is a benefit. 
Zdravljenje je treba nadaljevati, dokler ima koristne učinke.
Levels above 20 mg/l may cause severe side effects without increasing the medicine's effectiveness. 
Ravni nad 20 mg/l lahko povzročijo resne neželene učinke, ne da bi se pri tem povečala učinkovitost zdravila.
The recommended starting dose in adults is 2 to 3 g per day, divided into two or three doses, taken with meals containing fatty food. 
Priporočeni začetni odmerek za odrasle je 2 do 3 g na dan, razdeljen v dva ali tri odmerke, ki se vzamejo z obroki, ki vsebujejo mastna živila.
The European Commission granted a marketing authorisation valid throughout the European Union for Lysodren on 28 April 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Lysodren, veljavno po vsej Evropski uniji, odobrila dne 28. aprila 2004.
If there is no improvement in symptoms after three months of treatment at the optimal dose, treatment should be stopped. 
Če izboljšanje simptomov ni opazno po treh mesecih jemanja optimalnega odmerka, je treba zdravljenje prekiniti.
The most common side effects with Lysodren (seen in more than 1 patient in 10) are increased blood levels of liver enzymes, cholesterol and triglycerides (a type of fat), leucopenia (low white blood cell counts), prolonged bleeding time, ataxia (difficulty co-ordinating movements), paraesthesia (abnormal sensations like pins and needles), vertigo (a spinning sensation), sleepiness, mucositis (inflammation of the mucous membranes, such as the lining of the mouth), vomiting, diarrhoea, nausea (feeling sick), epigastric discomfort (discomfort around the stomach), skin rash, myasthenia (muscle weakness), adrenal insufficiency (reduced adrenal gland activity), loss of appetite, asthenia (weakness), gynaecomastia (breast enlargement) and confusion. 
Najpogostejši neželeni učinki zdravila Lysodren (opaženi pri več kot 1 od 10 bolnikov) so povišane ravni jetrnih encimov, holesterola in trigliceridov (vrste maščob) v krvi, levkopenija (nizke ravni belih krvnih celic), podaljšan čas krvavenja, ataksija (težave pri usklajevanju gibov), parastezija (nenavadni občutki, kot je mravljinčenje), vertigo (vrtoglavica), zaspanost, mukozitis (vnetje sluznic, kot je ustna sluznica), bruhanje, driska, navzeja (slabost), epigastrično neugodje (neugoden občutek okoli želodca), kožni izpuščaji, miastenija (šibkost mišičja), adrenalna insuficienca (zmanjšano delovanje nadledvične žleze), izguba teka, astenija (šibkost), ginekomastija (povečanje dojk) in zmedenost.
This is a summary of the European public assessment report (EPAR) for Lysodren. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lysodren.
It may also alter the breakdown of these hormones. 
Zdravilo lahko morda spremeni tudi proces razgrajevanja teh hormonov.
It should also be used with caution in elderly patients, with frequent monitoring of blood levels. 
Previdno ga je treba uporabljati tudi pri starejših bolnikih in obenem redno spremljati njegove ravni v krvi.
Treatment with Lysodren should be started and followed by a specialist who has suitable experience. 
Zdravljenje z zdravilom Lysodren mora začeti in spremljati specialist z ustreznimi izkušnjami.
It is used when the cancer is unresectable (cannot be removed by surgery), is metastatic (has spread to other parts of the body), or has relapsed (returned after treatment). 
Uporablja se, kadar je rak neizrezljiv (neodstanljiv s kirurškim posegom), metastatski (se je razširil na druge dele telesa) oziroma relapsiran (se je ponovil po zdravljenju).
There was insufficient evidence to support its use as an add-on to other anticancer medicines. 
Dokazov, ki bi bili v prid uporabi tega zdravila kot dodatka drugim zdravilom proti raku, je bilo premalo.
The studies included over 500 adults and children, who were treated for various lengths of time with mitotane, either alone or in combination with other anticancer medicines. 
Študije so vključevale več kot 500 odraslih in otrok, ki so se različno dolgo zdravili z mitotanom kot samostojnim zdravilom ali v kombinaciji z drugimi zdravili proti raku.
The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre. 
Ravni zdravilne učinkovine v krvi je treba pogosto spremljati, končni odmerek pa mora povzročiti ravni od 14 do 20 mg na liter krvi.
Limited information was available on the use of mitotane in children, but overall, the children remained disease free for an average of seven months when taking the medicine. 
O uporabi mitotana pri otrocih so na voljo le omejene informacije, vendar se pri otrocih, ki so jemali zdravilo, bolezen v povprečju ni pojavila sedem mesecev.
The main measures of effectiveness in the studies included survival time, the reduction in tumour size and the time spent free of the symptoms of the disease. 
Glavna merila učinkovitosti v študijah so vključevala čas preživetja, zmanjšanje velikosti tumorja in čas, ko bolniki niso kazali simptomov bolezni.
It also reduced the symptoms of the disease, particularly in patients whose cancer was producing high hormone levels. 
Zdravilo je prav tako ublažilo simptome bolezni, še zlasti pri bolnikih, pri katerih je rak povzročal visoke ravni hormonov.
The summary of opinion of the Committee for Orphan Medicinal Products for Lysodren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Lysodren je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
For more information about treatment with Lysodren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Lysodren preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
When this area develops cancer, levels of these hormones can increase, causing the symptoms of the disease. 
Če se rak razvije v tem predelu, se lahko ravni teh hormonov povečajo, kar povzroči simptome bolezni.
There is limited information on the use of Lysodren in children, but a daily starting dose of 1.5 to 3.5 g per square metre body surface area (calculated using the child's height and weight) is recommended. 
Informacije o zdravljenju otrok z zdravilom Lysodren so omejene, vendar pa se priporoča začetni dnevni odmerek 1,5 do 3,5 g na kvadratni meter telesne površine (izračunane na podlagi otrokove višine in telesne mase).
Lysodren is a medicine that contains the active substance mitotane. 
Lysodren je zdravilo, ki vsebuje zdravilno učinkovino mitotan.
It presented the results of 220 studies published since 1990 on the use of the medicine in unresectable, metastatic adrenal cortical carcinoma. 
Predstavila je rezultate 220 objavljenih študij, ki so jih o uporabi zdravila pri neizrezljivem metastatskem karcinomu skorje nadledvične žleze, opravili od leta 1990.
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 Lysodren. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Lysodren, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Lysodren 
Druge informacije o zdravilu Lysodren
Patients who take Lysodren should receive the ‘Lysodren patient card' that they should carry with them in case of emergency, to inform healthcare professionals (such as doctors and nurses) that they are taking the medicine. 
Bolniki, ki jemljejo zdravilo Lysodren, bi morali prejeti „kartico za bolnike“, ki jo morajo nositi s seboj zaradi morebitnih nujnih primerov, v katerih bo kartica zdravstvene delavce (kot so zdravniki in medicinske sestre) opozorila, da bolnik jemlje to zdravilo.
Together, these effects reduce the levels of the hormones in the body, improving the symptoms of the disease. 
Ti učinki skupaj zmanjšajo ravni hormonov v telesu in ublažijo simptome bolezni.