natgillin/translations-raw huggingface dataset:
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. 
zabloda, bes, nočne more, depersonalizacija, halucinacije, psihoze, neprimerno vedenje, ekstrovertiranost, ki se zdi pretirana, ter drugi vedenjski učinki se lahko pojavijo ob uporabi benzodiazepinov ali njim sorodnih učinkovin.
CZ 100 10 Praha 10 
7 trdih kapsul 10 trdih kapsul 14 trdih kapsul
There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug. 
Po uporabi enkratnega odmerka (10 mg oziroma 50 mg) posameznega zdravila ne pride do farmakokinetičnih interakcij med zaleplonom in difenhidraminom.
Elderly 
Presnova
Skin and subcutaneous tissue disorders Uncommon: 
Bolezni kože in podkožja
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS 
PRETISNI OMOTI S 5 MG KAPSULAMI
capsule, hard 
kapsula, trda
Invented name Strength 
Izmišljeno ime
Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states 
Priloga I Seznam izmišljenih imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
Pharmaceutical Form Route of administration 
Farmacevtska oblika Pot uporabe
Ikelan solution for injection or infusion 50mg/5ml injection 
Ikelan solution for injection or infusion 50mg/5ml injekcija intramuskularna in intravenska uporaba
LOFTON 150 mg/ml gotas orales en solución oral drops solution 
LOFTON 150 mg/ml gotas orales en solución peroralne kapljice, raztopina
LOFTON 150 mg comprimidos recubiertos coated tablet 
LOFTON 150 mg comprimidos recubiertos obložena tableta
INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR 
INTRAVENSKO INFUNDIRANJE, INTRAVENSKO INJICIRANJE, INTRAMUSKULARNA UPORABA
SOLUTION FOR INJECTION 
RAZTOPINA ZA INJICIRANJE
LOFTYL 50 mg/5 ml, solution injectable 
LOFTYL 50 mg/5 ml, solution injectable 50 mg/5 ml raztopina za injiciranje intramuskularna in intravenska uporaba
BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg 
BUFLOMEDIL SANDOZ 150 mg, comprimé 150 mg tableta
solution for injection intramuscular and intravenous use 
raztopina za injiciranje intramuskularna in intravenska uporaba
oral drop, solution 
peroralne kapljice, raztopina
BUFLOMEDIL ARROW 150 mg, comprimé 150 mg 
BUFLOMEDIL ARROW 150 mg, comprimé 150 mg tableta
Buvasodil film coated tablets 
Buvasodil filmsko obložene tablete peroralna uporaba
BUFLOMEDIL CRISTERS 150 mg, comprimé 
BUFLOMEDIL CRISTERS 150 mg, comprimé tableta
BUFLOMEDIL ACTAVIS 150 mg, comprimé 
BUFLOMEDIL ACTAVIS 150 mg, comprimé tableta
BUFLOMEDIL ZYDUS 150 mg, comprimé 
BUFLOMEDIL ZYDUS 150 mg, comprimé tableta
CONTROLLED RELEASE TABLET 
TABLETA S PRIREJENIM SPROŠČANJEM
Buflomedil-CT 50mg/5ml Ampullen 
Buflomedil-CT 50mg/5ml Ampullen 50mg / 5ml raztopina za injiciranje, raztopina za infundiranje intravenska in intramuskularna uporaba
BUFLOMEDIL RPG 150 mg, comprimé 
BUFLOMEDIL RPG 150 mg, comprimé tableta
Complamin Buflomedil Injekt 
Complamin Buflomedil Injekt raztopina za injiciranje intravenska in intramuskularna uporaba
coated tablet 
OBLOŽENA TABLETA peroralna uporaba
Pharmaceutical Form Route of Administration 
Farmacevtska oblika Pot uporabe
Content Package size 
Velikost pakiranja
EU Number 
Številka EU Zaščiteno ime
Packaging 
Ovojnina
Content (concentration) 
Pot uporabe Stična ovojnina Vsebina (koncentracija)
MA (EU) number (Invented) name Strength 
Številka (EU) dovoljenja za promet
Immediate Packaging 
Stična ovojnina Velikost pakiranja e
The main areas harmonised include: 
Med glavnimi usklajenimi področji so:
Other changes 
Druge spremembe
Outcome of a procedure under Article 30 of Directive 2001/83/EC 
Izid postopka po členu 30 Direktive 2001/83/ES
22 May 2012 
22. maj 2012
The amended information to doctors and patients is available here. 
Spremenjene informacije za zdravnike in bolnike so na voljo tukaj.
The European Commission issued a decision on 22 May 2012. 
Evropska komisija je sklep izdala dne 22. maja 2012.
Why was Femara reviewed? 
Zakaj je bilo zdravilo Femara pregledano?
The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4. 
CHMP je menil, da je ustreznejša vključitev zadevnih opozoril v poglavje 4.4.
Femara is authorised in the EU via national procedures. 
Zdravilo Femara so odobrili v EU z nacionalnimi postopki.
On 15 March 2012, the European Medicines Agency completed a review of Femara. 
Evropska agencija za zdravila je 15. marca 2012 dokončala pregled zdravila Femara.
Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan. 
Zdravilo Femara se trži v vseh državah članicah EU in je na voljo tudi pod drugimi tržnimi imeni: Femar, Fémara in Loxifan.
What is Femara? 
Kaj je zdravilo Femara?
On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU. 
Evropska komisija je 31. avgusta zadevo napotila na CHMP z namenom uskladitve dovoljenj za promet z zdravilom Femara v EU.
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) 
Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete)
Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EMA/180824/2012 
Vprašanja in odgovori o zdravilu Femara in povezanih imenih (letrozol, 2,5 mg tablete) EMA/180824/2012
The company that markets these medicines is Novartis. 
Ta zdravila trži farmacevtska družba Novartis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o predpisovanju zdravila Femara v Evropski uniji (EU).
The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects). 
CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.6 (nosečnost in dojenje) in 4.8 (neželeni učinki).
After reviewing the available data supporting the medicine's use, the CHMP agreed that Femara should be used in postmenopausal women for the following: 
Po pregledu razpoložljivih podatkov, ki podpirajo uporabo zdravila, je CHMP soglašal, da se sme zdravilo Femara uporabljati pri ženskah po menopavzi za naslednje indikacije:
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, kjer se zdravilo trži.
Femara is a medicine that contains the active substance letrozole. 
Femara je zdravilo, ki vsebuje zdravilno učinkovino letrozol.
Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function. 
Po uskladitvi indikacij je CHMP uskladil tudi priporočila o odmerkih, trajanju zdravljenja in uporabi zdravila Femara pri bolnicah z zmanjšanim delovanjem ledvic ali jeter.
In harmonising the contraindications, the CHMP decided against including two contraindications that were in the SmPCs of some EU countries: liver impairment and pre-operative use in patients whose receptor status is negative or unknown. 
Pri usklajevanju kontraindikacij se je CHMP odločil za izključitev dveh kontraindikacij iz povzetkov glavnih značilnosti zdravila v nekaterih državah EU: okvare jeter in predoperativne uporabe pri bolnicah z negativnim ali neznanim receptorskim statusom.
By blocking the activity of aromatase and thereby reducing the amount of oestrogen produced, the medicine slows or stops the growth and spread of the cancer. 
Ker zdravilo Femara zavira delovanje aromataze in s tem zmanjša količino estrogena, ki nastaja v telesu, posledično upočasni ali ustavi rast in širjenje raka.
It is used as hormonal treatment in postmenopausal women with breast cancer. 
Uporablja se kot hormonsko zdravljenje raka dojke pri ženskah po menopavzi.
• Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens. 
• napredovali rak dojke ob ponovitvi ali napredovanju bolezni pri ženskah z naravnim ali umetno povzročenim pomenopavznim endokrinim stanjem, ki so se prej zdravile z antiestrogeni;
The active substance in Femara, letrozole, is an ‘aromatase inhibitor'. 
Zdravilna učinkovina v zdravilu Femara, letrozol, je „zaviralec aromataze“.
The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v odboru odločil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v vsej EU.
Femara is used in postmenopausal women because aromatase is involved in producing most of the oestrogen in this population. 
Zdravilo Femara se uporablja pri ženskah po menopavzi, ker v tej skupini bolnic aromataza sodeluje pri tvorbi večine estrogena.
In some types of breast cancer (hormone receptor positive or hormone-dependent types), oestrogen is known to stimulate the growth of the cancer cells. 
Znano je, da estrogen pri nekaterih vrstah raka dojke (s pozitivnimi hormonskimi receptorji ali hormonsko odvisnih vrstah) spodbuja rast rakastih celic.
• Neo-adjuvant (pre-surgery) treatment of hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated. 
• neoadjuvantno (predoperativno) zdravljenje HER-2-negativnega raka dojke s pozitivnimi hormonskimi receptorji, kadar kemoterapija ni primerna in takojšnji kirurški poseg ni indiciran.
• Extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years. 
• podaljšano adjuvantno zdravljenje invazivnega hormonsko odvisnega raka dojke pri ženskah, ki so se pred tem pet let zdravile s standardno adjuvantno terapijo s tamoksifenom;
• First-line treatment for hormone-dependent advanced breast cancer. 
• prva izbira za zdravljenje napredovalega hormonsko odvisnega raka dojke;
This means that it works by blocking the action of an enzyme called ‘aromatase', which is involved in the production of the hormone oestrogen. 
To pomeni, da deluje z zaviranjem delovanja encima aromataze, ki sodeluje pri tvorbi hormona estrogena.
• Adjuvant (post-surgery) treatment of hormone receptor positive invasive early breast cancer. 
• adjuvantno (pooperativno) zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji;
Femara was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Femara potrebna uskladitev.
The process takes about 6 to 8 weeks. 
Postopek traja od 6 do 8 tednov.
72 hours 
72 ur
This may take up to one year. 
To lahko traja do enega leta.
The physician will be informed immediately. 
Zdravnik bo o tem nemudoma obveščen.
The program may take up to one year depending on the recommendation of the physician. 
Program lahko traja do enega leta, odvisno od zdravnikovih priporočil.
The treatment groups were balanced with respect to size, demography and disease background. 
Skupine zdravljenja so bile uravnotežene glede na velikost, demografijo in ozadje bolezni.
Dispose of in accordance with local requirements. 
Odstranite v skladu z lokalnimi zahtevami.
Your doctor might have to select an alternative treatment for you. 
Zdravnik bo morda za vas moral izbrati drugo zdravljenje.
The subchondral plate should not be damaged. 
Subhondralna plošča ne sme biti poškodovana.
Remaining spheroids must not be stored for later application. 
Preostali sferoidi ne smejo biti shranjeni za nadaljnjo uporabo.
Additional statistical assessments were performed 24 and 36 months after treatment. 
Dodatni statistični oceni sta bili opravljeni 24 in 36 mesecev po zdravljenju.
In general, these side effects are quite mild and disappear during the weeks following surgery. 
Na splošno so precej blagi in v tednih po operaciji izginejo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10th July 2017 
Datum prve odobritve: 10. julij 2017
Summary of safety profile 
Povzetek varnostnega profila
• If you have any further questions, ask your doctor. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Also it needs to be checked if the correct order number (lot number) is on the primary package. 
Preveriti je treba tudi, ali je na primarni ovojnini pravilna številka naročila (številka serije).
• Specific testing and examination of the patient to ensure compliance with strictly defined clinical criteria 
• bolnika je treba posebej testirati in pregledati, da je zagotovljena skladnost s strogo opredeljenimi kliničnimi merili,
The intention-to-treat (ITT) population consisted of 73 patients. 
Populacija z namenom zdravljenja (ITT-intention-to-treat) je bila sestavljena iz 73 bolnikov.
Tell your doctor if you are using, have recently used or might use any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
How quickly this occurs depends for example on your body weight and the size of the cartilage defect. 
Kako hitro se bo to zgodilo, je odvisno, na primer, od vaše telesne mase in velikosti poškodbe hrustanca.
Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4). 
Bolniki, zdravljeni z zdravilom Spherox, morajo opraviti poseben rehabilitacijski program (glejte poglavje 4.4).
Store at temperatures between 1 °C and 10 °C. 
Shranjujte pri temperaturi med 1 °C in 10 °C.
Information on adverse reactions in 177 patients from pivotal clinical trials are available. 
Na voljo so informacije o neželenih učinkih pri 177 bolnikih iz osrednjih kliničnih preskušanj.
The spheroids look like small white to yellowish pearls. 
Sferoidi so videti kot majhni beli do rumenkasti biseri.
In absence of compatibility studies, this medicinal product should not be mixed with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
These defects can be caused by acute injury, such as a fall. 
Te poškodbe lahko nastanejo zaradi akutne poškodbe, npr. padca.
During the rehabilitation period, the amount of weight you can put on the joint will increase gradually. 
V rehabilitacijskem obdobju bo masa, s katero obremenite sklep, postopno naraščala.
Therefore, patients should consult their treating physician and follow his/her advice strictly. 
Zato se morajo bolniki posvetovati s svojim lečečim zdravnikom in strogo upoštevati njegove nasvete.
ICRS grades were mostly IV A, followed by IIIB and IIIA (56, 23 and 10 patients respectively). 
Stopnja po ICRS je bila v glavnem IV A, ki sta ji sledili IIIB in IIIA (56, 23 oziroma 10 bolnikov).
It protects the bones and allows our joints to work smoothly. 
Ščiti kosti in omogoča brezhibno delovanje sklepov.
• Patients with not fully closed epiphyseal growth plate in the affected joint. 
• Bolniki, pri katerih epifizealna rastna plošča v prizadetem sklepu ni popolnoma zaprta.
They can also be caused by repetitive injury, such as long-term incorrect weight bearing on the joint. 
Lahko jih povzročijo tudi ponavljajoče se poškodbe, kot je dolgoročna nepravilna obremenitev sklepa.
In order to allow your joint to recover well, you will have to follow an individual rehabilitation program. 
Da bo vaš sklep dobro okreval, boste morali izvajati individualni rehabilitacijski program.
Read all of this leaflet carefully before you are given with this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
• Training materials for surgeons and training materials for other health professionals 
• gradivo za usposabljanje kirurgov in gradivo za usposabljanje drugih zdravstvenih delavcev,
A complete graft delamination is a serious complication which can be accompanied by pain. 
Popolna delaminacija presadka je resen zaplet, ki ga lahko spremlja bolečina.
• the bones in the joint have not finished growing 
• kosti v sklepu še niso nehale rasti;
In cases where the recommended dose was significantly exceeded (up to 170 spheroids/cm² in an investigator-initiated trial with a follow-up period of 12 months), no negative effects were observed. 
V primerih, pri katerih je bil priporočeni odmerek znatno presežen (do 170 sferoidov/cm² pri preskušanju na pobudo raziskovalca z obdobjem spremljanja 12 mesecev), neželeni učinki niso bili opaženi.
After implantation, the patient should follow an appropriate rehabilitation schedule. 
Po vsaditvi mora bolnik slediti ustreznemu časovnemu načrtu rehabilitacije.
None of the patients had received prior treatment with microfracture for their lesion less than one year before screening. 
Pri nobenem od bolnikov lezije prej niso bile zdravljene z mikrofrakturiranjem manj kot eno leto pred presejanjem.
Further follow-up assessments of up to 5 years will be performed to generate long-term efficacy data on the treatment with Spherox. 
Nadaljnja ocena za do 5-letno spremljanje bo opravljena za pridobitev dolgoročnih podatkov o učinkovitosti zdravljenja z zdravilom Spherox.
Side effects can occur with the following frequencies: Very common: may affect more than 1 in 10 people 
Neželeni učinki se lahko pojavijo z naslednjo pogostnostjo: zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
This suggests that there are no risks for the use of spheroids in humans. 
To kaže, da pri uporabi sferoidov pri človeku ni tveganj.
Risk factors are in particular non-treatment of concomitant diseases, such as subchondral bone oedema. 
Dejavnik tveganja je zlasti nezdravljenje sočasnih bolezni, kot je edem subhondralne kosti.
Prior to use, it must be verified if patient name matches the information of the patient/donor provided on the shipping documents and the product label. 
Pred uporabo je treba preveriti, ali se ime bolnika ujema z informacijami o bolniku/darovalcu, navedenimi v odpremnih dokumentih in ovojnini zdravila.
Syringe: EXP {DD month YYYY} at {hours} CET 
EXP {DD mesec LLLL} ob {čas} CET
Pivotal efficacy data were based on an interim analysis at 12 months after treatment. 
Osrednji podatki o učinkovitosti temeljijo na vmesni analizi 12 mesecev po zdravljenju.
• The other ingredient is sodium chloride used as transport solution. 
• Druga sestavina zdravila je natrijev klorid, uporabljen kot transportna raztopina.
Changes within each dose group were of similar magnitude, and the three between-group (pairwise) analyses did not reveal any statistically significant differences between the groups. 
Spremembe znotraj posamezne skupine odmerkov so bile po velikosti podobne, v treh analizah med skupinami (parno) pa ni bilo odkritih nobenih statistično pomembnih razlik med skupinami.
This can occur because the sample taken is not of sufficient quality to manufacture the product. 
Do tega lahko pride, če odvzeti vzorec ni dovolj kakovosten za proizvodnjo zdravila.
To be submitted annually Final study report: 
Končno poročilo o študiji:
You may in that case notice symptoms, for example swelling or pain of the tissues around the joint. 
V tem primeru lahko opazite simptome, kot so na primer oteklina ali bolečine tkiva okoli sklepa.
Post-authorisation efficacy study (PAES): 60-month follow-up data for study cod 16 HS 13. 
Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): kontrolni podatki za obdobje 60 mesecev za študijo z oznako 16 HS 13.
• Infection with the hepatitits B virus (HBV), hepatitis C virus (HCV) or HIV I/II viruses. 
• Okužba z virusom hepatitisa B (HBV), virusom hepatitisa C (HCV) ali virusom HIV I/II.
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 using this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom,
4.6 Fertility, pregnancy and lactation 
4.6 Plodnost, nosečnost in dojenje Nosečnost in dojenje
• reopening of a closed wound 
• odprtje zaprte rane;
The total MOCART scores 3, 12, 18, 24 and 36 months after treatment did not differ substantially between the two treatment groups. 
Skupne vrednosti MOCART 3, 12, 18, 24 in 36 mesecev po zdravljenju se med zdravljenima skupinama niso bistveno razlikovale.
(≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). 
občasni (od ≥ 1/1 000 do < 1/100), redki (od ≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000) in neznana pogostnost (iz razpoložljivih podatkov je ni mogoče oceniti).
Furthermore, a multicentre, prospective, randomised, controlled clinical Phase III study is ongoing. 
Nadalje poteka multicentrična prospektivna randomizirana kontrolirana klinična študija III. faze.
Compliance with an adequate rehabilitation programme after implantation (especially for patients with mental disorders or addiction) should be warranted. 
Po vsaditvi je treba zagotoviti skladnost z ustreznim rehabilitacijskim programom (še posebej pri bolnikih z duševnimi motnjami ali zasvojenostjo).
Interim reports: 
Vmesna poročila:
The following requirements need to be fulfilled before the product is prescribed and dispensed: 
Pred predpisovanjem in izdajanjem zdravila je treba izpolniti naslednje zahteve:
The main objectives of the educational programme are to provide training to surgeons and other health professionals on proper procurement, storage, handling and administration of Spherox. 
Glavni cilj izobraževalnega programa je zagotavljanje usposabljanja kirurgov in drugih zdravstvenih delavcev o pravilnem naročanju, shranjevanju in dajanju zdravila Spherox ter ravnanju z njim.
It must be administered by a specialised orthopedic surgeon and in a medical facility. 
Dajati ga mora specialist ortopedski kirurg in v zdravstveni ustanovi.
Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments. 
Sferoidi morajo biti na površino poškodbe naneseni enakomerno in po potrebi po vsem območju poškodbe razmazani s kirurškimi instrumenti.
The treatment of adults with Spherox is a two-step procedure: 
Zdravljenje odraslih z zdravilom Spherox poteka v dveh korakih:
2.2 Qualitative and quantitative composition 
2.2 Kakovostna in količinska sestava
No suspicion of potential tumourigenesis or increased prevalence of tumours due to the implanted spheroids was observed. 
Opažen ni bil noben sum morebitne tumorogeneze ali povečane prevalence tumorjev zaradi implantiranih sferoidov.
If you get any of the following serious side effects, you should immediately contact a doctor: 
Če opazite katerega koli od naslednji hudih neželenih učinkov, se takoj posvetujte z zdravnikom: