natgillin/translations-raw huggingface dataset:
Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment. 
Pogosto so opažali prehodna, asimptomatska zvišanja jetrnih aminotransferaz, alaninske transferaze (ALT) in aspartatne transferaze (AST), posebno na začetku zdravljenja.
Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine Glenmark Europe 20 mg orodispersible tablets 
Olanzapin Glenmark Europe 5 mg orodisperzibilne tablete Olanzapin Glenmark Europe 10 mg orodisperzibilne tablete Olanzapin Glenmark Europe 15 mg orodisperzibilne tablete Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete olanzapin
Mild, transient anticholinergic effects including constipation and dry mouth 
Bolezni prebavil blagi prehodni antiholinergičn i učinki, vključno z zaprtjem in suhimi usti
56 orodispersible tablets 
56 orodisperzibilnih tablet
In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % versus 1.5 %, respectively). 
V kliničnih preskušanjih, kontroliranih s placebom (ki so trajali 6-12 tednov), pri starejših bolnikih s psihozo, povezano z demenco in/ali vedenjskimi motnjami (povprečna starost 78 let), je bilo 2-kratno povečanje incidence smrti pri bolnikih, zdravljenih z olanzapinom, v primerjavi z bolniki, zdravljenimi s placebom (3,5 % v primerjavi z 1,5 %).
Elevated glucose levels4 
zvišane ravni glukoze4
There is no specific antidote for olanzapine. 
Ravnanje Za olanzapin ni specifičnega antidota.
Olanzapine Glenmark Europe orodispersible tablet contains aspartame, which is a source of phenylalanine. 
Zdravilo Olanzapin Glenmark Europe orodisperzibilne tablete vsebuje aspartam, ki je vir fenilalanina.
28 orodispersible tablets 
28 orodisperzibilnih tablet
14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high 
14Opazovano pri osnovnih normalnih ravneh na tešče (< 1,016 mmol/l), ki so se povišale na visoke
8 In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin value. 
8V kliničnih preskušanjih, ki so trajala do 12 tednov, so pri 30 % bolnikov z normalno začetno vrednostjo prolaktina, ki so se zdravili z olanzapinom, ugotovili povečanje plazemske koncentracije prolaktina nad zgornjo mejo normalne vrednosti.
Olanzapine Glenmark Europe contains aspartame Olanzapine Glenmark Europe contains a source of phenylalanine. 
Zdravilo Olanzapin Glenmark Europe vsebuje aspartam Zdravilo Olanzapin Glenmark Europe vsebuje vir fenilalanina.
Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4) 
Bolezni jeter, žolčnika in žolčevodov prehodna asimptomatska zvišanja jetrnih aminotransfera z (ALT, AST), posebno na začetku zdravljenja (glejte poglavje 4.4)
Fluvoxamine, a specific CYP1A2 inhibitor, has been shown to significantly inhibit the metabolism of olanzapine. 
Zaviranje CYP1A2 Fluvoksamin, specifični zaviralec CYP1A2, je pokazal pomembno zaviranje presnove olanzapina.
20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), 
Pomožne snovi so manitol (E 421), mikrokristalna celuloza, aspartam (E 951), krospovidon, magnezijev stearat.
Olanzapine Glenmark Europe belongs to a group of medicines called antipsychotics. 
Zdravilo Olanzapin Glenmark Europe spada v skupino zdravil, imenovanih antipsihotiki in se uporablja za zdravljenje naslednjih bolezni:
(≥ 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l - < 1.467 mmol/l) to high (≥ 1.467 mmol/l). 
(≥ 1,467 mmol/l) in spremembe v ravneh trigliceridov na tešče z mejnih osnovnih vrednosti (≥ 1,016 mmol/l - < 1,467 mmol/l) na visoke (≥ 1,467 mmol/l).
Do not drink any alcohol if you have been given Olanzapine Glenmark Europe as together with alcohol it may make you feel drowsy. 
Jemanje zdravila Olanzapin Glenmark Europe skupaj alkoholom Če ste dobili zdravilo Olanzapin Glenmark Europe, ne pijte nobenega alkohola, saj lahko zdravilo Olanzapin Glenmark Europe in alkohol skupaj povzročita občutek zaspanosti.
• Restless legs syndrome 
• sindrom nemirnih nog
Neuroleptic malignant syndrome (see section 
Sindrom nemirnih nog nevroleptični maligni sindrom (glejte poglavje odtegnitveni simptomi712
What Olanzapine Glenmark Europe looks like and contents of the pack 
Izgled zdravila Olanzapin Glenmark Europe in vsebina pakiranja
Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term-exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 
Zvečanje osnovne telesne mase za ≥ 7 %, ≥ 15 % in ≥ 25 % se je pri dolgoročni izpostavljenosti bolnikov (vsaj 48 tednov) pojavljalo zelo pogosto (v 64,4 %, 31,7 % in 12,3 %).
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila Olanzapin Glenmark Europe prehajajo v materino mleko.
Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite. 
Zelo pogosti: povečanje telesne mase13, zvišane ravni trigliceridov14, povečan apetit Pogosti: Zvišane ravni holesterola15
Tardive dyskinesia11 
Tardivne diskinezije11
Very common: Weight gain13, elevated triglyceride levels 14, increased appetite. 
Zelo pogosti: povečanje telesne mase13, zvišane ravni trigliceridov14, povečan apetit Pogosti: zvišane ravni holesterola15
Nervous system disorders Somnolence Dizziness Akathisia6 
Bolezni živčevja zaspanost omotica akatizija6
There is a risk of feeling drowsy when you are given Olanzapine Glenmark Europe. 
Vpliv na sposobnost upravljanja vozil in strojev Obstaja tveganje, da se boste po tem, ko ste dobili zdravilo Olanzapin Glenmark Europe, počutili zaspane.
Parkinsonism6 
parkinsonizem diskinezije6
Rare side effects (may affect up to 1 in 1000 people) include: 
Redki neželeni učinki (lahko prizadenejo do 1 od 1.000 bolnikov) vključujejo
Uncommon side effects (may affect up to 1 in 100 people) include: 
• Občasni neželeni učinki(lahko prizadenejo do 1 od 100 bolnikov) vključujejo
How to store Olanzapine Glenmark Europe 
Shranjevanje zdravila Olanzapin Glenmark Europe
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite katerikoli neželeni učinek, se posvetuje s svojim zdravnikom ali s farmacevtom.
Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 
Razvoj ali poslabšanje sladkorne bolezni, občasno povezane s ketoacidozo ali komo, vključno z nekaj smrtnimi primeri (glejte hipotermija12
13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %). 
13S kratkotrajnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), ≥ 15 % pogosto (7,1 %) in za ≥ 25 % občasno (2,5 %).
13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 
13S kratkotrajnim zdravljenjem (srednje trajanje 22 dni) povezano povečanje telesne mase za ≥ 7 % od osnovne telesne mase (kg) je bilo zelo pogosto (40,6 %), ≥ 15 % pogosto (7,1 %) in za ≥ 25 %
Very rare side effects (may affect up to 1 in 10,000) include: 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) vključujejo:
Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose). 
Pri nekaj psih, ki so prejemali 8 ali 10 mg/kg/dan (celotno izpostavljanje olanzapinu [AUC] je 12- do 15-krat večje kot pri človeku, ki dobi 12-miligramski odmerek), se je razvila reverzibilna nevtropenija, trombocitopenija ali anemija.
- High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark Europe. 
Pri bolnikih, ki so jemali zdravilo Olanzapin Glenmark Europe, so opazili visok nivo sladkorja v krvi in visok nivo maščob (trigliceridov in holesterola).
• Heart disease 
Žilne bolezni
What Olanzapine Glenmark Europe contains 
Kaj vsebuje zdravilo Olanzapin Glenmark Europe
phosphokinase11 
Trombocitop enija11
Ventricular tachycardia/fibrillation, sudden death (see section 
Srčne bolezni bradikardija podaljšanje QTc (glejte poglavje prekatna tahikardija/fi brilacija, nenadna smrt (glejte poglavje
Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side. 
Rumene, okrogle, ploščate tablete z zaobljenim robom in oznako 'B' na eni strani.
15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly. 
15Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti (< 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
Talk to your doctor or pharmacist before you take Olanzapine Glenmark Europe - The use of Olanzapine Glenmark Europe in elderly patients with dememtia is not recommended as it may have serious side effects. 
Uporaba zdravila Olanzapin Glenmark Europe ni priporočljiva pri starejših bolnikih z demenco, saj lahko povzroči resne neželene učinke.
Marketing Authorisation Holder Glenmark Arzneimittel GmbH Industriestr. 
IMETNIK DOVOLJENJA ZA PROMET Glenmark Arzneimittel GmbH Industriestr.
• Inflammation of the pancreas causing severe stomach pain, fever and sickness. 
• ki povzroča hude bolečine v predelu želodca, zvišano telesno temperaturo in slabost, obolenje jeter,
Rhabdomyolysis11 
Rabdomioliz a11
• Unusual movements (dyskinesias). 
nenavadne gibe (diskinezijo),
Olanzapine Glenmark Europe 5mg is supplied as: yellow coloured circular flat bevelled edge orodispersible tablets with ‘B' debossed on one side. 
Olanzapin Glenmark Europe 5 mg je na voljo kot: rumena, okrogla, ploščata tableta z zaobljenim robom in oznako 'B' na eni strani.
Olanzapine Glenmark Europe 20 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘F' debossed on other side. 
Olanzapin Glenmark Europe 20 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'F' na drugi strani.
Increased total bilirubin levels8 
Visoka raven zvišan celokupni bilirubin gamaglutamiltransfe raze10
Other medicines and Olanzapine Glenmark Europe Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers). 
Druga zdravila in zdravilo Olanzapin Glenmark Europe Med zdravljenjem z zdravilom Olanzapin Glenmark Europe jemljite druga zdravila samo, če vam zdravnik pove, da smete.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/588/001 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/588/001
Respiratory, thoracic and mediastinal disorders Epistaxis9 
Bolezni dihal, prsnega koša in mediastinal nega prostora
Olanzapine Glenmark Europe 10 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘D' debossed on other side. 
Olanzapin Glenmark Europe 10 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
Excipient with known effect: Each orodispersible tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1 
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,23 mg aspartama.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/588/007 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/588/007
- Weight gain has been seen in patients taking Olanzapine Glenmark Europe. 
Pri bolnikih, ki so jemali zdravilo Olanzapin Glenmark Europe, so opazili porast telesne teže.
Olanzapine Glenmark Europe 15 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘E' debossed on other side. 
Olanzapin Glenmark Europe 15 mg: rumena, okrogla, ploščata tableta z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'E' na drugi strani.
EU/1/09/588/001 EU/1/09/588/002 
EU/1/09/588/007 EU/1/09/588/008 EU/1/09/588/009
Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on one side. 
Rumene, okrogle, ploščate tablete z zaobljenim robom, z oznako 'OL' na eni strani in oznako 'D' na drugi strani.
Olanzapine Glenmark Europe 20 mg orodispersible tablets Olanzapine 
Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 20 mg orodispersible tablets 
IME ZDRAVILA Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥ 1/100 to < 1/10 %), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available). 
Našteti izrazi pogostnosti so definirani kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ocena ni možna iz danih podatkov).
Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine 
Olanzapin Glenmark Europe 5 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 10 mg orodispersible tablets 
IME ZDRAVILA Olanzapin Glenmark Europe 10 mg orodisperzibilne tablete
Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine 
Olanzapin Glenmark Europe 15 mg orodisperzibilne tablete olanzapin
• Abnormal rhythms of the heart. 
• motnje srčnega ritma,
Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine 
Olanzapin Glenmark Europe 10 mg orodisperzibilne tablete olanzapin
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 15 mg orodispersible tablets 
IME ZDRAVILA Olanzapin Glenmark Europe 15 mg orodisperzibilne tablete
NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 5 mg orodispersible tablets 
IME ZDRAVILA Olanzapin Glenmark Europe 5 mg orodisperzibilne tablete
- The active substance is olanzapine - Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or 
Ena orodisperzibilna tableta zdravila Olanzapin Glenmark Europe vsebuje 5 mg, 10 mg, 15 mg ali 20 mg olanzapina.
• Prostate problems 
• težave pri mokrenju,
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 10 mg olanzapina.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg Olanzapine Excipient with known effect: Each orodispersible tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1 
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,69 mg aspartama.
High Gamma Glutamyltransferase 
Visoka raven gamaglutamiltransfe raze10
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 15 mg olanzapina.
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported very rarely (≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly. 
Relo redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine Excipient with known effect: Each orodispersible tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1 
Pomožne snovi z znanim učinkom: Ena orodisperzibilna tableta vsebuje 0,92 mg aspartama.
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena orodisperzibilna tableta vsebuje 20 mg olanzapina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena orodisperzibilna tableta vsebuje 5 mg olanzapina.
• Dry mouth. 
• vnetje trebušne slinavke,
Urinary hesitation11 
okvaro jeter)11
Olanzapine Glenmark Europe 20 mg orodispersible tablets 17. 
Olanzapin Glenmark Europe 20 mg orodisperzibilne tablete
The CHMP noted there was inadequate information in several areas of the application, including on the manufacture of the medicine, its testing in humans and animals and its safety. 
Odbor CHMP je poudaril, da so bile informacije na več področjih vloge pomanjkljive, vključno z informacijami o proizvodnji zdravila, njegovem preskušanju pri ljudeh in živalih ter njegovi varnosti.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide requested data on the medicine's manufacture within the required time frame. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da v zahtevanem časovnem okviru ne bi mogla zagotoviti potrebnih podatkov o proizvodnji zdravila.
Once attached to these receptors, it damages the walls of the blood vessels supplying the tumours, thereby helping to slow down the growth of the cancer. 
Po vezavi na te receptorje poškoduje stene žil, ki oskrbujejo tumorje, in tako pomaga upočasniti rast raka.
The medicine was intended for those patients whose cancer has worsened within 6 months of treatment with cancer medicines including pemetrexed. 
Zdravilo naj bi bilo namenjeno bolnikom, pri katerih se je rak v šestih mesecih zdravljenja z zdravili za zdravljenje raka, vključno s pemetreksedom, poslabšal.
With regard to the medicine's effectiveness, the main study did not show convincingly that Zafiride was better than placebo at prolonging lives in the intended patients. 
Kar zadeva učinkovitost zdravila, z glavno študijo ni bilo prepričljivo dokazano, da je zdravilo Zafiride boljše od placeba pri podaljševanju življenja pri bolnikih, ki jim je zdravilo namenjeno.
The company's application included results from a main study in 400 patients which looked at how long patients lived when treated with Zafiride in combination with other cancer medicines. 
Vloga družbe je vključevala rezultate glavne študije pri 400 bolnikih, v kateri so proučevali, kako dolgo so živeli bolniki, zdravljeni z zdravilom Zafiride v kombinaciji z drugimi zdravili za zdravljenje raka.
Zafiride was expected to be used for treating adults with advanced malignant pleural mesothelioma, a cancer of the lining of the lungs usually caused by exposure to asbestos. 
Zdravilo Zafiride naj bi se uporabljalo za zdravljenje odraslih z napredovalim malignim plevralnim mezoteliomom, rakom pljučne sluznice, ki ga običajno povzroči izpostavljenost azbestu.
What is Zafiride? 
Kaj je zdravilo Zafiride?
On 1 June 2017, MolMed S.p.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma. 
je 1. junija 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zafiride, namenjenim zdravljenju napredovalega malignega plevralnega mezotelioma.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Zafiride. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zafiride.
Zafiride is a medicine containing the active substance NGR-human tumour necrosis factor alpha. 
Zdravilo Zafiride vsebuje zdravilno učinkovino NGR-humani tumorje nekrotizirajoči faktor alfa.
Zafiride was compared with placebo (a dummy treatment), and all patients in the study had previously been treated with pemetrexed-based chemotherapy. 
Zdravilo Zafiride so primerjali s placebom (zdravilom brez zdravilne učinkovine), vsi bolniki v študiji pa so bili predhodno zdravljeni s kemoterapijo na osnovi pemetrekseda.
Zafiride was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 3 June 2008 for malignant mesothelioma. 
Zdravilo Zafiride je bilo dne 3. junija 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje malignega mezotelioma.
What was Zafiride expected to be used for? 
Za kaj naj bi se zdravilo Zafiride uporabljalo?
The active substance in Zafiride is thought to work by attaching to targets called CD13 and TNF receptors, found on new blood vessels forming around tumours. 
Zdravilna učinkovina zdravila Zafiride naj bi delovala tako, da se veže na tarče, imenovane receptorji CD13 in TNF, ki se nahajajo na novih žilah, ki nastajajo okrog tumorjev.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zafiride did not outweigh its risks. 
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Zafiride ne odtehtajo z njim povezanih tveganj.
Based on the review of the data, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Zafiride could not be approved for the second-line treatment of advanced malignant pleural mesothelioma in patients whose disease had worsened within 6 months of treatment with pemetrexed. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Zafiride ni mogoče odobriti za zdravljenje druge izbire napredovalega malignega plevralnega mezotelioma pri bolnikih, pri katerih se je bolezen v šestih mesecih zdravljenja s pemetreksedom poslabšala.
How does Zafiride work? 
Kako zdravilo Zafiride deluje?
This summary was last updated in 08-2019. 
Povzetek je bil nazadnje posodobljen 08-2019.
The usual recommended infusion time is approximately 60 minutes. 
Priporočeni čas infundiranja znaša približno 60 minut.
Here are some of the main results from these studies: 
V nadaljevanju so podani nekateri najpomembnejši izsledki iz teh študij.
This was switched to a full marketing authorisation on 15 January 2015. 
To je bilo 15. januarja 2015 spremenjeno v običajno dovoljenje za promet.
Further information on Vectibix can be found on the Agency's website ema.europa.eu/ medicines/human/EPAR/vectibix. 
Nadaljnje informacije o zdravilu Vectibix so na voljo na spletni strani agencije: ema.europa.eu/ medicines/human/EPAR/vectibix.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval. 
Ker je podjetje predložilo dodatne zahtevane informacije, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
The recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks. 
Priporočeni odmerek zdravila Vectibix znaša 6 mg na kilogram telesne mase, daje pa se enkrat na dva tedna.
The European Medicines Agency decided that Vectibix's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Vectibix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.