natgillin/translations-raw huggingface dataset:
In another clinical study (D-Pan-H5N1-010), 297 subjects aged > 60 years (stratified in ranges from 61 to 70, 71 to 80 and > 80 years of age) received either a single or a double dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days. 
U drugom kliničkom ispitivanju (D-Pan-H5N1-010), 297 ispitanika u dobi > 60 godina (stratificirani u raspone od 61 do 70, 71 do 80 i > 80 godina) primilo je ili jednostruku ili dvostruku dozu AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
Month 6 N=48 
mjesec N=48
STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams) 
Sadržaj: AS03 adjuvans sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama)
2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4fold increase in titre; 
2stopa serokonverzije: udio ispitanika koji su bili seronegativni prije cijepljenja pa su nakon cijepljenja postigli zaštitni titar od ≥1:40, ili koji su bili seropozitivni prije cijepljenja pa su nakon cijepljenja postigli četverostruko povećanje titra;
Immune response to A/Vietnam/1194/2004 6-9 years 
Imunološki odgovor na A/Vietnam/1194/2004 6-9 godina
A 4-fold increase in serum neutralising antibody titres against A/Vietnam was obtained in 49% of subjects twenty-one days after the first dose, 67.3% twenty-one days after the second dose and 44.9% six months after the second dose. 
21 dan nakon prve doze kod 49% ispitanika, 21 dan nakon druge doze kod 67,3% ispitanika i šest mjeseci nakon druge doze kod 44,9% ispitanika.
After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows: 
Nakon primjene dvije doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005, na 0. i 21. dan kod 140 ispitanika u dobi od 18-60 godina, odgovor anti-HA
• one pack containing 50 vials of 2.5 ml suspension (antigen) 
• jedno pakiranje s 50 bočica s 2,5 ml suspenzije (antigen) • dva pakiranja s 25 bočica s 2,5 ml emulzije (adjuvans)
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 6 months apart were 83.3% and 100%, respectively. 
Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 6 mjeseci iznosila je 83,3%, a stopa odgovora na cjepivo 100%.
Immune response to A/Vietnam/1194/2004 12 months after vaccination 
Imunološki odgovor na A/Vietnam/1194/2004 12 mjeseci nakon cijepljenja
Full dose (N=29) 
Cijela doza (N=29)
In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below. 
Prepandrix koji sadrži 3,75 mikrograma HA/AS03 iz soja A/Indonesia/05/2005 (H5N1) bile su komparabilne onima navedenima u nastavku.
Half dose (N=27) 
Pola doze (N=27)
Half dose (N=37) 
Pola doze (N=37)
Double dose N=43 
Dvostruka doza N=43
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21. 
U kliničkom ispitivanju (D-Pan-H5N1-012), ispitanici u dobi od 18-60 godina primili su dozu AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog ili iz soja A/Vietnam/1194/2004 ili Indonesia/5/2005 i to šest mjeseci nakon što su primili jednu ili dvije početne doze AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 i to na 0. dan ili na 0. i 21. dan.
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany 
KG Zirkusstraße 40, D-01069 Dresden
Full dose N=44 
Cijela doza N=44
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate in subjects who received the vaccine 12 months apart were 84.0% and 100%, respectively. 
Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 12 mjeseci iznosila je 84,0%, a stopa odgovora na cjepivo 100%.
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection. 
Prepandrix suspenzija i emulzija za emulziju za injekciju.
Half dose (N=47) 
Pola doze (N=47)
Full dose (N=27) 
Cijela doza (N=27)
Half dose N=49 
Pola doze N=49
Immune response to A/Vietnam/1194/2004 3 to 5 years 
Imunološki odgovor na A/Vietnam/1194/2004 3 do 5 godina
Immune response to A/Vietnam/1194/2004 6 months after vaccination 
Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon cijepljenja
METHOD OF ADMINISTRATION Mix with adjuvant emulsion before use 
Prije primjene pomiješati s emulzijom adjuvansa.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 50 VIALS OF SUSPENSION 
PAKIRANJE S 50 BOČICA SUSPENZIJE
Immune response to A/Vietnam/1194/2004 3-5 years 
Imunološki odgovor na A/Vietnam/1194/2004 3-5 godina
Nervous system disorders Febrile convulsions 
Febrilne konvulzije
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious. 
Međutim, ako se istodobna primjena ne može izbjeći, drugo cjepivo treba primijeniti u drugu ruku.
Full dose N=42 
Cijela doza N=42
METHOD OF ADMINISTRATION Mix into Antigen suspension before use 
Prije primjene pomiješati u suspenziju antigena.
Half dose N=42 
Pola doze N=42
Half dose N=47 
Pola doze N=47
Month 6 N=40 
mjesec N=40
Half dose N=43 
Pola doze N=43
Half dose N=40 
Pola doze N=40
It is essentially sodium- and potassium-free. 
zanemarive količine natrija i kalija.
The per-dose frequency of adverse reactions was as follows: 
Učestalost nuspojava prema dozi bila je sljedeća:
3 % of subjects reaching a serum neutralising antibody titre of at least 1:80 
2 % ispitanika s titrom ≥1:28 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain. 
AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz tog istog soja komparabilni imunološkom odgovoru na soj A/Vietnam/1194/2004 izazvanom AS03-adjuvantiranim cjepivom koje sadrži 3,75 µg hemaglutinina dobivenog iz tog istog soja.
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections 
polisorbat 80 oktoksinol 10 tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) magnezijev klorid (MgCl2) voda za injekcije
• Warmth, itching or bruising where the injection was given 
• osjećaj topline, svrbež ili stvaranje modrica na mjestu davanja injekcije • pojačano znojenje, drhtanje, simptomi nalik gripi
minutes) before each withdrawal. 
Protresti prije primjene.
Fainting can occur following, or even before, any needle injection. 
Nakon bilo kojeg uboda iglom, ili čak i prije uboda, može doći do gubitka svijesti.
List of adverse reactions Adverse reactions reported are listed according to the following frequency: 
Prijavljene nuspojave navedene su prema sljedećoj učestalosti: Kategorije učestalosti su:
Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
Stopa seroprotekcije1 1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains: 
KVALITATIVNI I KVANTITATIVNI SASTAV Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži: fragmentirani virus influence, inaktiviran, koji sadrži antigen* koji odgovara soju:
Pain 
Nuspojave
Full dose N=43 
Cijela doza N=43
Seroprotection rate1 1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
Stopa seroprotekcije1 stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
Common: may affect up to 1 in 10 people 
• bol u mišićima, bol u zglobovima Česte: mogu se javiti u do 1 na 10 osoba
Immune response to A/Vietnam/1194/2004 6 months after the 1st dose 
Imunološki odgovor na A/Vietnam/1194/2004 6 mjeseci nakon 1. doze N=256
Sodium chloride Disodium hydrogen phosphate Potassium dihydrogen phosphate Potassium chloride Magnesium chloride Water for injections 
polisorbat 80 oktoksinol 10 tiomersal natrijev klorid natrijev hidrogenfosfat kalijev dihidrogenfosfat kalijev klorid magnezijev klorid voda za injekcije
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PACK OF 25 VIALS OF EMULSION 
PAKIRANJE S 25 BOČICA S EMULZIJOM
• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. 
Obratite se svom liječniku ili medicinskoj sestri prije nego primite Prepandrix: • ako ste imali bilo koju alergijsku reakciju, izuzev iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak ovog cjepiva (naveden u dijelu 6) ili na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid, gentamicinsulfat (antibiotik) ili natrijev deoksikolat.
Induration 
Doziranje
Immune response to A/Vietnam/1194/2004 Day 21 
Imunološki odgovor na A/Vietnam/1194/2004 21. dan N=140
PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion 
OBLIK I SADRŽAJ Emulzija adjuvansa za injekciju
• Feeling dizzy 
- učestalost prema dozi
This can cause skin rashes, joint pain and kidney problems 
Poremećaji kože i potkožnog tkiva
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
GlaxoSmithKline Biologicals s.a.
Uncommon: may affect upt o 1 in 100 people 
• otečene žlijezde na vratu, u pazusima ili preponama Manje česte: mogu se javiti u do 1 na 100 osoba
From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: 
Iz postmarketinškog iskustva s cjepivima koja sadrže AS03 i 3,75 µg HA dobivenih od soja
It should be given at the same time each day. 
Treba se primjenjivati u isto vrijeme svakog dana.
The values were lowered by about 8-10 mmHg. 
Vrijednosti su snižene za oko 8-10 mmHg.
The full EPAR for Ganfort can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Cjeloviti EPAR za lijek Ganfort nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Ganfort? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ganfort?
If more than one type of eye drop is being used, each one should be given at least five minutes apart. 
Ako se koristi više vrsta kapi, između njihove primjene mora proći barem pet minuta.
Ganfort lowered the pressure to less than 18 mmHg in 18.7% of these patients compared with 10.2% with bimatoprost only. 
Ganfort je snizio očni tlak na manje od 18 mmHg u 18,7 % tih bolesnika u usporedbi s 10,2 % onih koji su primali samo bimatoprost.
This is a summary of the European public assessment report (EPAR) for Ganfort. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Ganfort.
In addition, more patients given Ganfort had a drop in pressure of more than 20% (67.9% against 48.9%). 
Nadalje, kod dodatnog broja bolesnika koji su primali Ganfort očni je tlak snižen za više od 20 % (67,9 % u odnosu na 48,9 %).
The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006. 
Europska komisija izdala je odobrenje za stavljanje u promet lijeka Ganfort koje vrijedi na prostoru Europske unije od 19. svibnja 2006.
Ganfort is an eye drops solution that contains two active substances: bimatoprost (0.3 mg/ml) and timolol (5 mg/ml). 
Ganfort je otopina kapi za oči koja sadrži dvije djelatne tvari: bimatoprost (0,3 mg/ml) i timolol (5 mg/ml).
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 Ganfort. 
Objašnjava kako je Odbor za lijekove za humanu uporabu ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke za primjenu lijeka Ganfort.
It is used in adults with ‘open angle glaucoma' or ocular hypertension who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions). 
Koristi se u odraslih s „glaukomom otvorenog kuta” ili očnom hipertenzijom koji dovoljno ne reagiraju na kapi za oči koje sadrže analogne lijekove beta blokatorima ili prostaglandinima (druge lijekove za liječenje tih stanja).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ganfort have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ganfort nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
For more information about treatment with Ganfort, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom Ganfort pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
Ganfort contains two active substances, bimatoprost and timolol, which lower the pressure in the eye in different ways. 
Ganfort sadrži dvije djelatne tvari, bimatoprost i timolol, koje smanjuju očni tlak na različite načine.
The main measures of effectiveness were the average reduction in eye pressure or the number of patients whose eye pressure fell below the target of 18 mmHg (making it within the normal range). 
Glavna mjera djelotvornosti bilo je prosječno smanjenje očnog tlaka ili broj bolesnika čiji je očni tlak snižen na vrijednost manju od ciljane vrijednosti od 18 mmHg (odnosno na normalan raspon tlaka).
Four main studies have been performed involving 1,964 adults with ocular hypertension or glaucoma. 
Provedena su četiri glavna ispitivanja na 1964 odraslih osoba s očnom hipertenzijom ili glaukomom.
‘Ocular hypertension' is when the pressure in the eye is higher than normal. 
„Očna hipertenzija” je očni tlak koji je viši od normalnog.
Ganfort is given as one drop in the affected eye(s) once a day, either in the morning or the evening. 
Lijek Ganfort primjenjuje se ukapavanjem jedne kapi u oboljelo oko ili oči jedanput dnevno, ujutro ili navečer.
Ganfort was, however, more effective than bimatoprost in patients whose pressure was not controlled with eye drops containing prostaglandins alone. 
Međutim, Ganfort je bio djelotvorniji od bimatoprosta u bolesnika čiji se očni tlak nije mogao kontrolirati kapima za oči koje su sadržavale samo prostaglandine.
Ganfort is used to reduce the pressure inside the eye. 
Ganfort se koristi za snižavanje tlaka u oku.
Ganfort must not be used in patients who have asthma or severe lung disease, or in patients with some heart conditions. 
Ganfort se ne smije primjenjivati u bolesnika s astmom ili ozbiljnim bolestima pluća kao ni u bolesnika s određenim srčanim problemima.
What is the risk associated with Ganfort? 
Koji su rizici povezani s lijekom Ganfort?
The studies compared Ganfort with bimatoprost, timolol, or bimatoprost and timolol given at the same time after three weeks to four months of treatment. 
U ispitivanjima je Ganfort uspoređen s bimatoprostom, timololom ili bimatoprostom i timololom koji su davani istovremeno nakon tri tjedna do četiri mjeseca terapije.
In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye. 
Kod glaukoma otvorenog kuta, visoki tlak nastaje zbog nemogućnosti istjecanja tekućine iz oka.
Other information about Ganfort 
Ostale informacije o lijeku Ganfort:
The CHMP decided that Ganfort's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka Ganfort nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Raised pressure in the eye causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. 
Povišeni tlak u oku oštećuje mrežnicu (membranu osjetljivu na svjetlost smještenu na stražnjem dijelu očne jabučice) kao i očni živac kojim se iz oka šalju signali prema mozgu.
What is Ganfort? 
Što je Ganfort?
The most common side effect (seen in more than 1 patient in 10) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye). 
Najčešća nuspojava (zabilježena u više od 1 na 10 bolesnika) je konjunktivalna hiperemija (povećan dotok krvi u oko što dovodi do crvenila oka).
Overall, the studies showed that Ganfort is effective in lowering eye pressure. 
Općenito su ispitivanja pokazala da je Ganfort djelotvoran u snižavanju očnog tlaka.
The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone. 
Kombinacija tih dviju djelatnih tvari ima kumulativno djelovanje, snižavajući krvni tlak više nego samo jedan lijek samostalno.
By lowering the pressure, Ganfort reduces the risk of damage. 
Snižavanjem tlaka lijek Ganfort smanjuje rizik od oštećenja.
What benefit has Ganfort shown during the studies? 
Koje su koristi lijeka Ganfort dokazane u ispitivanjima?
In addition, Ganfort was shown to be as effective as bimatoprost and timolol given at the same time. 
Osim toga, pokazalo se da je Ganfort jednako djelotvoran kao bimatoprost i timolol kad ih se daje zajedno.
Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been commonly used to treat glaucoma since the 1970s. 
Timolol se uobičajeno koristi za liječenje glaukoma od 1970-tih.
Ganfort was more effective than timolol on its own and was as effective as bimatoprost. 
Lijek Ganfort pokazao se djelotvornijim od timolola kada se zasebno uzima i jednako djelotvornim kao i bimatoprost.
For the full list of all side effects reported with Ganfort, see the package leaflet. 
Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Ganfort potražite u uputi o lijeku.
Bimatoprost is a prostaglandin analogue, (a copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Bimatoprost on its own has already been approved in the European Union under the name Lumigan. 
Bimatoprost je analogan prostaglandinu (kopija prirodne tvari prostaglandina) koji djeluje povećanim izlučivanjem tekućine iz oka.
Why has Ganfort been approved? 
Zašto je lijek Ganfort odobren?
How is Ganfort used? 
Kako se Ganfort koristi?
What is Ganfort used for? 
Za što se Ganfort koristi?
How has Ganfort been studied? 
Kako je Ganfort ispitivan?
How does Ganfort work? 
Kako djeluje Ganfort?
This may be because of manufacturing issues. 
Do toga može doći zbog problema u proizvodnji.
Common (≥ 1/100 to < 1/10) 
(≥1/100 do < 1/10)
Some of these side effects may be serious and may lead to hospitalization. 
Neke od ovih nuspojava mogu biti ozbiljne i mogu dovesti do hospitalizacije.
What to check before infusion 
Što provjeriti prije infuzije
March 2021 
ožujak 2021.
Your doctor will closely supervise the treatment therapy. 
Vaš liječnik će pozorno nadzirati terapiju.
• You have not received the Certificate of Analysis. 
• Niste primili certifikat o analizi.
It is unlikely that you will be given too much. 
Nije vjerojatno da ćete primiti previše lijeka.
Studies in animals have not been performed. 
Ispitivanja na životinjama nisu provedena.
Please inform your doctor if you are taking, have recently taken or might take any other medicines. 
Molimo Vas da obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
The safety and efficacy in children and adolescents (less than 18 years) have not been established. 
Sigurnost i djelotvornost u djece i adolescenata (mlađih od 18 godina) nisu ustanovljene.
This will ensure that the cells can be eliminated before they can cause damage to the patient's cells. 
To će osigurati da stanice budu eliminirane prije nego uzrokuju štetu stanicama bolesnika.
There were no GvHD-related deaths or long-term complications. 
Nije bilo slučajeva smrti niti dugoročnih komplikacija povezanih s GvHD-om.
The clinical study report should be submitted by March 2021. 
Izvješće o kliničkom ispitivanju treba podnijeti do ožujka 2021.
Acute GvHD (33% of patients) 
Akutni GvHD (33 % bolesnika)
Progress updates should be submitted yearly with the annual renewal. 
Nadopune o napretku treba podnijeti jednom godišnje s godišnjom obnovom.
Non clinical safety data obtained in two different immunedeficient animal models for GvHD did not indicate special hazards for humans, but allowed only a very limited safety assessment. 
Neklinički podaci o sigurnosti primjene dobiveni u dva različita imunodeficijentna životinjska modela za GvHD nisu ukazali na posebne opasnosti za ljude, već su omogućili vrlo ograničenu ocjenu sigurnosti.
MARKETING AUTHORISATION NUMBER EU/1/16/1121/001 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1121/001
However, the risk of transmitting infectious viruses to healthcare professionals cannot be totally excluded. 
Ipak, rizik prenošenja infektivnih virusa na zdravstvene radnike ne može se u potpunosti isključiti.
As this medicine is prescribed by a doctor, each dose is prepared for you only and each preparation consists of a single dose. 
S obzirom da ovaj lijek propisuje liječnik, svaka doza pripremljena je isključivo za Vas i svaki pripravak čini jednu dozu.
The hospital staff are responsible for the correct storage of the product both before and during its use, as well as for correct disposal. 
Osoblje bolnice odgovorno je za pravilno čuvanje lijeka prije i tijekom korištenja, kao i za pravilno zbrinjavanje.
• The product integrity has been breached in anyway. 
• Integritet lijeka je narušen na bilo koji način.
In vitro evaluation of oncological potential indicate that the risk of malignant transformation is low. 
In vitro procjena onkološkog potencijala ukazuje na mali rizik od maligne transformacije.
Donor code: 
Oznaka donora:
• Put the bag into two plastic envelopes (double envelopment) to avoid direct contact with water. 
• Vrećicu stavite u dva plastična omota (dvostruki omot) kako bi se izbjegao njen direktni doticaj s vodom.
20132 Milano Italy 
20132 Milano Italija
• Proceed with the infusion as quickly as possible, avoiding keeping the bag in the water bath after thawing. 
• Krenite s infuzijom što je prije moguće, izbjegavajući držanje vrećice u vodenoj kupelji nakon odmrzavanja.