natgillin/translations-raw huggingface dataset:
In the ITT analysis, a CR rate of 23.6% (95% CI: 13.2, 37) was observed in 13/55 subjects treated with Dacogen.
V ITT populaciji je bil pri bolnikih, ki so prejemali Dacogen, delež tistih, ki so dosegli popolno remisijo, 23,6% (95-odstotni IZ: 13,2; 37)(13/55).
• Your doctor, nurse or pharmacist is responsible for disposing of any unused Dacogen correctly.
• Za ustrezno odstranjevanje morebitnega neuporabljenega zdravila Dacogen je odgovoren vaš zdravnik, medicinska sestra ali farmacevt.
Haematologic adverse drug reactions
Hematološki neželeni učinki
However, the population pharmacokinetic analysis of decitabine indicated that race had no apparent effect on the exposure to decitabine.
Bolniki v študijah so bili večinoma belci, vendar rezultati analize populacijske farmakokinetike decitabina kažejo, da rasna pripadnosti nima očitnega vpliva na izpostavljenost decitabinu.
Thus; CYP-mediated metabolic drug interactions are not anticipated, and decitabine is unlikely to interact with agents metabolized through these pathways.
Zato ni pričakovati presnovnih interakcij v povezavi z encimskim sistemom CYP oziroma medsebojnega delovanja s snovmi, ki se presnavljajo po tej poti.
Uncommon Cardiomyopathy
Srčne bolezni občasni kardiomiopatija
Very common hepatic function abnormal Common hyperbilirubinaemia
Bolezni jeter, žolčnika in žolčevodov zelo pogosti nenormalno delovanje jeter pogosti hiperbilirubinemija
Dacogen 50 mg powder for infusion decitabine
Dacogen 50 mg prašek za koncentrat za raztopino za infundiranje decitabin
Progression-free survival and Event-free survival were tertiary endpoints.
Terciarna cilja opazovanja pa sta bila preživetje brez napredovanja bolezni in preživetje brez dogodkov.
• urine infection
• okužba sečil
The most common adverse drug reactions (≥ 35%) reported are pyrexia, anaemia and thrombocytopaenia.
Najpogosteje poročani neželeni učinki (≥ 35%), so zvišana telesna temperatura, anemija in trombocitopenija.
Each vial of powder contains 50 mg decitabine.
Ena viala s praškom vsebuje 50 mg decitabina.
Talk to your doctor, pharmacist or nurse before using Dacogen if you have
Pred začetkom uporabe zdravila Dacogen se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate:
Studies in patients with renal impairment have not been conducted.
Študij pri bolnikih z okvaro ledvic niso izvedli.
Very common headache
Bolezni živčevja zelo pogosti glavobol
For the shelf-life and the precautions for storage after reconstitution, see section 5 of the leaflet.
Za rok uporabnosti in previdnostne ukrepe pri shranjevanju rekonstituiranega zdravila glejte poglavje 5 v navodilu za uporabo zdravila.
Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
Če vas zanima, kako zdravilo Dacogen deluje ali zakaj so vam predpisali to zdravilo, se obrnite na svojega zdravnika ali medicinsko sestro.
Use in patients with hepatic impairment has not been established.
Uporabe zdravila pri bolnikih z okvaro jeter niso določili.
• bleeding or bruising more easily - these may be signs of a drop in the number of blood platelets
• krvavitve ali podplutbe brez posebnega vzroka - so lahko znaki zmanjšanega števila krvnih ploščic (trombocitopenije)
Thirty-six percent of subjects had poor-risk cytogenetics at baseline.
Šestintrideset odstotkov preiskovancev je imelo ob izhodišču nizko citogenetsko stopnjo tveganja, preostali preiskovanci pa so imeli srednjo citogenetsko stopnjo tveganja.
What Dacogen is used for
Za kaj uporabljamo zdravilo Dacogen
How to store Dacogen
Shranjevanje zdravila Dacogen
Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.
Bolezni dihal, prsnega koša in mediastinalnega prostora Pri bolnikih, ki so prejemali decitabin so poročali o primerih intersticijske bolezni pljuč (ILDInterstitial Lung Disease) (vključno s pljučnimi infiltrati, organizirano pljučnico in pljučno fibrozo) brez znakov infekcijske etiologije.
Cases of interstitial lung disease (including pulmonary infiltrates, organising pneumonia and pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.
Bolezni dihal, prsnega koša in mediastinalnega prostora Pri bolnikih, ki so prejemali decitabin so poročali o primerih intersticijske bolezni pljuč (vključno s pljučnimi infiltrati, organizirano pljučnico in pljučno fibrozo) brez znakov infekcijske etiologije.
Thus, decitabine exposure is not likely to be affected in patients with impaired renal function.
Okvara jeter torej verjetno ne vpliva na izpostavljenost decitabinu.
Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been reported during treatment with decitabine.
Med zdravljenjem z decitabinom so poročali o pojavu enterokolitisa, vključno z nevtropeničnim kolitisom in vnetjem slepega črevesa.
If you get side effects, talk to your doctor, pharmacist or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
vključuje infekcijski enterokolitis vključuje krvavitve, ki so povezane s trombocitopenijo, vključno s smrtnimi primeri vključuje prednostne izraze: preobčutljivost, preobčutljivost na zdravilo, anafilaktična reakcija, anafilaktični šok, anafilaktoidna reakcija in anafilaktoidni šok
The PK of decitabine have not been formally studied in patients with hepatic impairment.
Pri bolnikih z okvaro ledvic niso formalno proučevali farmakokinetike decitabina.
This may be a sign of bleeding in the stomach or gut (common).
• Krvavitev: mednje sodi tudi prisotnost krvi v blatu, ki je lahko znak krvavitve v želodcu ali črevesju (pogosto).
Tell your doctor immediately if you become pregnant during treatment with Dacogen.
Če med zdravljenjem z zdravilom Dacogen zanosite, takoj obvestite zdravnika.
This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Za uspešno zdravljenje je zelo pomembno, da pridete na vsak dogovorjeni obisk.
Studies in patients with hepatic impairment have not been conducted.
Študij pri bolnikih z okvaro jeter niso izvedli.
Very common diarrhoea vomiting nausea Common stomatitis Not known enterocolitis, including neutropaenic colitis, caecitis*
Bolezni prebavil zelo pogosti driska bruhanje navzea pogosti stomatitis neznana pogostnost enterokolitis, vključno z nevtropeničnim kolitisom, vnetjem slepega črevesa neznana neznana
Very common febrile neutropaenia* neutropaenia* thrombocytopaenia*
Bolezni krvi in limfatičnega sistema zelo pogosti febrilna nevtropenija nevtropenija trombocitopenija
Very common hyperglycaemia
Presnovne in prehranske motnje zelo pogosti hiperglikemija
, e anaemia leukopaenia
*, e anemija levkopenija občasni pancitopenija
Excipients
citotoksično
• Your doctor will work out your dose of Dacogen.
• Zdravnik bo izračunal, kolikšen odmerek zdravila Dacogen potrebujete, kar je odvisno od vaše telesne višine in mase (oziroma od telesne površine).
• nose bleeds
• krvavitve iz nosu
Tell your doctor or nurse immediately if you notice any of the following serious side effects
Če opazite katerega od naslednjih resnih neželenih učinkov, takoj obvestite zdravnika ali medicinsko sestro
No. of Subjects at Risk DACOGEN Total TC
Št. ogroženih preiskovancev DACOGEN izbr.
The usual dose is 160 mg once a day, at about the same time each day.
Običajni odmerek je 160 mg enkrat na dan vedno ob istem času.
Further information on Xtandi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xtandi.
Nadaljnje informacije o zdravilu Xtandi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Xtandi.
Xtandi is not for use in women and must not be given to women who are or who may be pregnant.
Zdravilo Xtandi ni namenjeno uporabi pri ženskah in se ne sme dajati ženskam, ki so ali bi lahko bile noseče.
What measures are being taken to ensure the safe and effective use of Xtandi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xtandi?
Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.
Za zdravilo Xtandi je bilo 21. junija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The Agency therefore concluded that Xtandi's benefits are greater than its risks and it can be authorised for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Xtandi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription.
Zdravilo Xtandi je na voljo v obliki kapsul (40 mg) in tablet (40 mg in 80 mg), njegovo predpisovanje in izdaja pa je le na recept.
• treatment with docetaxel (a cancer medicine) has not worked or no longer works; or
• zdravljenje z docetakselom (zdravilom proti raku) ni delovalo ali ne deluje več ali
Why is Xtandi authorised in the EU?
Zakaj je zdravilo Xtandi odobreno v EU?
As for all medicines, data on the use of Xtandi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xtandi stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xtandi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xtandi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells).
Drugi pomembni neželeni učinki so padci, kognitivna motnja (težave z razmišljanjem, učenjem in spominom) in nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic).
The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure).
Najpogostejši neželeni učinki zdravila Xtandi (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, zlomi kosti, vročinski oblivi in hipertenzija (visok krvni tlak).
An overview of Xtandi and why it is authorised in the EU
Pregled zdravila Xtandi in zakaj je odobreno v EU
What benefits of Xtandi have been shown in studies?
Kakšne koristi je zdravilo Xtandi izkazalo v študijah?
The European Medicines Agency considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life for patients with metastatic disease is important for patients.
Evropska agencija za zdravila je ocenila, da so protirakavi učinki zdravila Xtandi jasno dokazani in da je njegova korist glede podaljševanja življenja bolnikov z metastatskim rakom pomembna za bolnike.
The medicine contains the active substance enzalutamide.
Zdravilo vsebuje zdravilno učinkovino enzalutamid.
Other information about Xtandi
Druge informacije o zdravilu Xtandi
What is Xtandi and what is it used for?
Kaj je zdravilo Xtandi in za kaj se uporablja?
• hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment).
• hormonsko zdravljenje ni delovalo in bolnik nima simptomov oziroma ima blage simptome in kemoterapija (druga vrsta zdravljenja raka) pri njem še ni potrebna.
For more information about using Xtandi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Xtandi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In addition, seizures (fits) can occur in around 4 patients in 1,000.
Poleg tega lahko pri približno štirih bolnikih od 1 000 pride do epileptičnih napadov (krčev).
It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:
Uporablja se, kadar je rak metastaziral (se razširil na druge dele telesa), je odporen na kastracijo (se poslabšuje kljub zdravljenju za zmanjšanje tvorjenja testosterona ali po kirurški odstranitvi testisov) in kadar bodisi:
Side effects reported with Xtandi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Xtandi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Xtandi?
Kakšna tveganja so povezana z zdravilom Xtandi?
Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer.
Ker rak prostate za preživetje in rast potrebuje testosteron in druge moške hormone, enzalutamid z zaviranjem teh hormonov upočasni rast raka prostate.
Xtandi has also been shown to delay the development of metastatic disease.
Dokazano je bilo tudi, da zdravilo Xtandi zakasni razvoj metastatske oblike bolezni.
The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens.
Zdravilna učinkovina v zdravilu Xtandi, enzalutamid, deluje tako, da zavira delovanje moškega hormona testosterona in drugih moških hormonov, imenovanih androgeni.
The company that markets Xtandi will provide the results of an ongoing study on the long-term effects of Xtandi in men with non-metastatic prostate cancer.
Podjetje, ki trži zdravilo Xtandi, bo zagotovilo rezultate tekoče študije o dolgoročnih učinkih zdravila Xtandi pri moških z nemetastatskim rakom prostate.
Enzalutamide does this by blocking the receptors to which these hormones attach.
Enzalutamid zavira njihovo delovanje tako, da zavre receptorje, na katere se ti hormoni vežejo.
Xtandi can also be used for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so.
Zdravilo Xtandi se lahko uporablja tudi za zdravljenje na kastracijo odpornega raka prostate, ki še ni metastaziral (se ni razširil), vendar obstaja velika nevarnost, da se bo.
Xtandi is a cancer medicine used to treat men with prostate cancer.
Xtandi je zdravilo proti raku, ki se uporablja za zdravljenje raka prostate pri moških.
Regarding its safety, the side effects with Xtandi were generally mild and could be managed appropriately.
Kar zadeva varnost, so bili neželeni učinki zdravila Xtandi v splošnem blagi in jih je bilo mogoče ustrezno obravnavati.
Treatment with Xtandi should be started and monitored by a doctor who has experience in treating prostate cancer.
Zdravljenje z zdravilom Xtandi mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo.
Poleg tega so bolniki, zdravljeni z zdravilom Xtandi, dlje živeli brez znakov poslabšanja bolezni, vidnih na radiografski sliki, in sicer 20 mesecev v primerjavi s pet mesecev pri bolnikih, ki so prejemali placebo.
Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy.
Zdravilo Xtandi so primerjali s placebom tudi v drugi glavni študiji, ki je vključevala 1 717 bolnikov z metastatskim rakom prostate, odpornim na kastracijo, pri katerih hormonsko zdravljenje ni bilo uspešno, ki pa niso imeli simptomov oziroma so imeli le blage simptome in predhodno niso bili zdravljeni s kemoterapijo.
The doctor may have to reduce the dose or interrupt treatment if a patient gets certain side effects.
Če se pri bolniku pojavijo določeni neželeni učinki, bo zdravnik morda zmanjšal odmerek ali začasno prekinil zdravljenje.
In this study, Xtandi was more effective than placebo at prolonging patients' lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo.
V tej študiji je zdravilo Xtandi učinkoviteje od placeba podaljšalo življenje bolnikov: povprečno so bolniki, zdravljeni z zdravilom Xtandi, živeli 18 mesecev, bolniki, zdravljeni s placebom, pa 14 mesecev.
How does Xtandi work?
Kako zdravilo Xtandi deluje?
How is Xtandi used?
Kako se zdravilo Xtandi uporablja?
Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic.
Zdravilo Xtandi so primerjali s placebom v študiji, ki je zajela 1 401 bolnika z rakom prostate, odpornim na kastracijo, za katerega obstaja velika nevarnost, da bo metastaziral.
Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel.
Zdravilo Xtandi so primerjali s placebom (zdravilom brez učinkovine) v glavni študiji, ki je vključevala 1 199 bolnikov z metastatskim rakom prostate, odpornim na kastracijo, ki so bili predhodno zdravljeni z docetakselom.
The average survival of patients treated with Xtandi was around 32 months compared with 30 months for patients treated with placebo.
Povprečno skupno preživetje pri bolnikih, ki so bili zdravljeni z zdravilom Xtandi, je bilo približno 32 mesecev, pri bolnikih, ki so bili zdravljeni s placebom, pa 30 mesecev.
Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo.
Bolniki, ki so prejemali zdravilo Xtandi, so v povprečju živeli 37 mesecev brez metastaz, medtem ko je bilo pri bolnikih, ki so prejemali placebo, to obdobje dolgo okoli 15 mesecev.
For the full list of side effects with Xtandi, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xtandi, glejte navodilo za uporabo.
Strength Pharmaceutical form Route of administration
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
The European Commission issued a decision on 06 March 2009.
Evropska komisija je odločbo izdala dne 6. marca 2009.
Ref. EMEA/CHMP/173455/2009
EMEA/CHMP/173453/2009
Dr. Antonio Addis (Italy)
dr. Antonio Addis (Italija)
Dr Catherine Moraiti (Greece)
dr. Catherine Moraiti (Grčija)
The company wanted the authorisation to be recognised in Austria, Denmark, Germany, Greece, Hungary, Poland, Portugal and Sweden (the concerned Member States).
Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Avstriji, na Danskem, v Nemčiji, Grčiji, na Madžarskem, Poljskem, Portugalskem in Švedskem (zadevne države članice).
Why was Uman Big reviewed?
Zakaj je bilo zdravilo Uman Big pregledano?
London, 09 March 2009 Doc.
London, 9. marca 2009 Sklic na dok.
virus; including those whose vaccination is incomplete or status unknown;
vključno s tistimi, pri katerih cepljenje ni popolno ali je status neznan;
On 31 October 2008, the Italian medicines agency, Agenzia Italiana del Farmaco, referred the matter to the CHMP.
Italijanska agencija za zdravila Agenzia Italiana del Farmaco je 31. oktobra 2008 zadevo napotila na CHMP.
The grounds for the referral were concerns over the insufficiency of the clinical data submitted to establish the efficacy of the product.
Razlogi za napotitev so bili zadržki glede nezadostnih kliničnih podatkov, predloženih za določitev učinkovitosti zdravila.
• in haemodialysed patients (patients whose kidneys have failed and who rely on a blood purification technique called haemodialysis), until vaccination has become effective;
• pri hemodializnih bolnikih (bolnikih, pri katerih so ledvice odpovedale in ki so odvisni od tehnike prečiščevanja krvi, imenovane hemodializa), dokler cepljenje ne postane učinkovito;
What is Uman Big?
Kaj je zdravilo Uman Big?
Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP's Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states.
Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj Odbora ter njegove Delovne skupine za krvne proizvode je CHMP zaključil, da koristi zdravila Uman Big odtehtajo njegova tveganja ter da je zato treba dovoljenje za promet z zdravilom Uman Big odobriti v vseh zadevnih državah članicah.
• in subjects who did not show an immune response after vaccination (and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
• pri osebah, pri katerih se ni pokazal imunski odziv po cepljenju (in pri katerih je stalno preprečevanje nujno zaradi stalnega tveganja za okužbo s hepatitisom B).
The review was carried out under an ‘Article 29' referral1.
Pregled se je opravil v skladu z napotitvijo iz člena 291.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Uman Big outweigh its risks, and that the marketing authorisation granted in Italy can be recognised in other Member States of the European Union and the European Economic Area.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Uman Big odtehtajo njegova tveganja ter se lahko dovoljenje za promet z zdravilom, odobreno v Italiji, prizna v drugih državah članicah Evropske unije in Evropskega gospodarskega prostora.
In addition, the absence of product specific safety data or postmarketing safety data was raised as a concern.
Poleg tega se je pojavil zadržek zaradi pomanjkanja varnostnih podatkov ali postmarketinških podatkov o varnosti za to zdravilo.
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ml, solution for injection.
Evropska agencija za zdravila (EMEA) je zaključila napotitveni postopek na podlagi nesoglasja med državami članicami Evropske unije v zvezi z odobritvijo zdravila Uman Big i.e./ml, raztopine za injiciranje.
• in case of accidental exposure in people who have not been vaccinated against the hepatitis B
• v primeru nenamerne izpostavitve virusu pri ljudeh, ki niso bili cepljeni proti virusu hepatitisa B,
Kedrion S.p.A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979.
je predložila vlogo za medsebojno priznavanje zdravila Uman Big na podlagi prvotnega dovoljenja za promet z zdravilom, odobrenega v Italiji dne 2. junija 1979.
• in the newborn of a hepatitis B virus carrier-mother;
• pri novorojenčkih, katerih mati je prenašalka virusa hepatitisa B;
Uman Big is given as an intramuscular (into the muscle) injection to prevent hepatitis B in the following cases:
Imunoglobulini proti hepatitisu B vsebujejo zelo visoke ravni protiteles proti virusu hepatitisa B. Zdravilo Uman Big se daje kot intramuskularna injekcija (v mišico) za preprečevanje hepatitisa B v naslednjih primerih:
Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Uman Big humani imunoglobulini proti hepatitisu B, 180 i.e./ml, raztopina za injiciranje
Immunoglobulins are blood proteins that have been extracted from donor plasma.
Zdravilo Uman Big je raztopina humanih imunoglobulinov proti hepatitisu B. Imunoglobulini so krvne beljakovine, ki se pridobivajo iz darovane plazme.
The European Commission issued a decision on 25 May 2012.
Evropska komisija je odločbo izdala 25. maja 2012.