FrancophonIA/ELRC3.0 huggingface dataset:
English: It suppresses the activity of ‘T cells', immune system cells that can become involved in organ rejection.
Croatian: Ta tvar potiskuje aktivnost „T stanica”, stanica imunološkog sustava koje mogu dovesti do odbacivanja organa.
English: All patients were also treated with corticosteroids, mycophenolic acid, and basiliximab (an interleukin-2 receptor antagonist) during the first week after transplantation.
Croatian: Svi su bolesnici također primali kortikosteroide, mikofenolnu kiselinu i baziliksimab (antagonist receptora interleukina-2) tijekom prvog tjedna nakon presađivanja.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nulojix, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Nulojix nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP noted that Nulojix does not have the toxic effects on the kidneys seen with other immunosuppressive medicines commonly used in transplantation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) istaknuo je da Nulojix nema toksične učinke na bubrege koji su zabilježeni kod ostalih imunosupresiva koji se obično primjenjuju kod presađivanja.
English: In the first study, 97% of patients receiving Nulojix treatment survived with their kidneys intact (218 out of 226) compared with 93% of patients receiving cyclosporine A (206 out 221).
Croatian: Tijekom prvog ispitivanja 97 % bolesnika koji su primali Nulojix preživjelo je bez ikakvih posljedica po bubrege (218 od 226) u usporedbi s 93 % bolesnika koji su primali ciklosporin A (206 od 221).
English: In two main studies involving 1,209 patients who underwent a kidney transplant, Nulojix was compared with cyclosporine A (another medicine used to prevent organ rejection).
Croatian: U dva glavna ispitivanja u kojima je sudjelovalo 1209 bolesnika kojima je presađen bubreg, lijek Nulojix uspoređen je s ciklosporinom A (drugim lijekom koji se koristi za sprečavanje odbacivanja organa).
English: Nulojix is a powder that is made up into a solution for infusion (drip into a vein).
Croatian: Nulojix je prašak od kojeg se priprema otopina za infuziju (drip u venu).
English: In the second study, 89% (155 out of 175) of patients on Nulojix and 85% (157 out 184) of those on cyclosporine A survived with their kidneys intact.
Croatian: Tijekom drugog ispitivanja 89 % bolesnika (155 od 175) koji su primali Nulojix i 85 % bolesnika (157 od 184) koji su primali ciklosporin A preživjelo je bez ikakvih posljedica po bubrege.
English: Some patients were given intensive Nulojix treatment which involved a longer initial phase of six months.
Croatian: Neki su bolesnici podvrgnuti intenzivnoj terapiji lijekom Nulojix koja je uključivala dulju početnu fazu od šest mjeseci.
English: Nulojix is used in adults to prevent the body from rejecting a transplanted kidney.
Croatian: Nulojix se primjenjuje u odraslih bolesnika radi sprečavanja da tijelo odbaci transplantirani bubreg.
English: The proportion of patients who had an episode of organ rejection within one year was 17% for Nulojix and 7% for cyclosporine A.
Croatian: Omjer bolesnika u kojih je zabilježena epizoda odbacivanja organa unutar jedne godine bio je 17 % za Nulojix i 7 % za ciklosporin A.
English: Nulojix should only be prescribed and supervised by a doctor who has experience in the management of kidney transplant patients.
Croatian: Terapiju lijekom Nulojix mora propisati i nadzirati isključivo liječnik s iskustvom u području presađivanja bubrega.
English: Nulojix was shown to improve patient and organ survival following kidney transplantation.
Croatian: Nulojix se pokazao djelotvornim u smislu poboljšanja stope preživljavanja bolesnika i organa nakon presađivanja bubrega.
English: What is Nulojix?
Croatian: Što je Nulojix?
English: What is the risk associated with Nulojix?
Croatian: Koji su rizici povezani s lijekom Nulojix?
English: The CHMP therefore concluded that Nulojix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) stoga je zaključio da koristi od lijeka Nulojix nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Around 54% of patients receiving Nulojix and 78% of those receiving cyclosporine A had impaired kidney function.
Croatian: Približno 54 % bolesnika koji su primali Nulojix i 78 % bolesnika koji su primali ciklosporin A imali su oštećenu funkciju bubrega.
English: An interleukin-2 receptor antagonist medicine should also be used with Nulojix during the first week after the kidney transplant.
Croatian: Uz lijek Nulojix preporučuje se i primjena antagonista receptora interleukina-2 za vrijeme prvog tjedna nakon presađivanja bubrega.
English: This stops them activating the T cells, helping to prevent organ rejection.
Croatian: T stanice, čime se pomaže spriječiti odbacivanje organa.
English: Why has Nulojix been approved?
Croatian: Zašto je lijek Nulojix odobren?
English: What benefit has Nulojix shown during the studies?
Croatian: Koje su koristi lijeka Nulojix utvrđene u ispitivanjima?
English: What is Nulojix used for?
Croatian: Za što se Nulojix koristi?
English: How does Nulojix work?
Croatian: Kako Nulojix djeluje?
English: How is Nulojix used?
Croatian: Kako se Nulojix koristi?
English: For the full list of all side effects reported with Nulojix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Nulojix potražite u uputi o lijeku.
English: How has Nulojix been studied?
Croatian: Kako je Nulojix ispitivan?
English: The proportion of patients with impaired kidney function was 77% in patients on Nulojix and 85% in patients on cyclosporine A. Around 18% of patients on Nulojix had an episode of organ rejection within one year compared with 14% of patients on cyclosporine A.
Croatian: Omjer bolesnika s oštećenom funkcijom bubrega bio je 77 % u bolesnika koji su primali Nulojix i 85 % u bolesnika koji su primali ciklosporin A.
English: After the initial doses, it is usually given once every 8 weeks.
Croatian: Lijek se nakon početnih doza uglavnom daje jedanput svakih osam tjedana.
English: Further information on Zessly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Zessly možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Zessly and what is it used for?
Croatian: Što je Zessly i za što se koristi?
English: Zessly (infliximab)
Croatian: Zessly (infliksimab)
English: This means that it is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Croatian: Drugim riječima, Zessly je vrlo sličan drugom biološkom lijeku („referentni lijek“) koji je već odobren u EU-u.
English: What measures are being taken to ensure the safe and effective use of Zessly?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zessly?
English: What are the risks associated with Zessly?
Croatian: Koji su rizici povezani s lijekom Zessly?
English: Zessly is an anti-inflammatory medicine for treating the following diseases:
Croatian: Zessly je protuupalni lijek za liječenje sljedećih bolesti:
English: A similar proportion of patients achieved a 20% reduction with the two medicines (around 61.1% with Zessly and 63.5% with Remicade).
Croatian: Udio bolesnika u kojih je zabilježeno smanjenje od 20 % bio je sličan za oba lijeka (otprilike 61,1 % za lijek Zessly i 63,5 % za lijek Remicade).
English: Why is Zessly authorised in the EU?
Croatian: Zašto je lijek Zessly odobren u EU-u?
English: An overview of Zessly and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zessly i zašto je odobren u EU-u
English: To reduce the risk of infusion reactions, patients may be given other medicines before or during treatment with Zessly or the infusion may be slowed down.
Croatian: Kako bi se smanjio rizik od reakcija vezanih uz infuziju, bolesnicima se mogu davati drugi lijekovi prije ili nakon liječenja lijekom Zessly ili se infuzija može usporiti.
English: In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Croatian: Osobito će se takve informacije osiguravati za liječnike koji lijek namjeravaju propisivati djeci s Crohnovom bolešću ili ulceroznim kolitisom kako bi se objasnilo da u takvih bolesnika postoji veći rizik od razvoja infekcija te kako bi se podsjetilo na važnost redovitog cijepljenja.
English: For Crohn's disease and ulcerative colitis, it is also used in children from 6 years of age.
Croatian: Za liječenje Crohnove bolesti i ulceroznog kolitisa primjenjuje se i u djece u dobi od šest godina i više.
English: Zessly is used mainly in adults, usually when other medicines or treatments have failed or cannot be used.
Croatian: Zessly se uglavnom primjenjuje u odraslih osoba, obično u slučaju kada su se drugi lijekovi pokazali neuspješnima ili se ne mogu primjenjivati.
English: Other information about Zessly
Croatian: Ostale informacije o lijeku Zessly
English: By attaching to TNF-α, infliximab blocks its activity and thereby reduces inflammation and other symptoms of the diseases.
Croatian: Vezivanjem na TNF-α infliksimab inhibira njegovo djelovanje te tako smanjuje upalu i druge simptome bolesti.
English: Zessly is a ‘biosimilar medicine'.
Croatian: Zessly je „biosličan lijek”.
English: Zessly is given as an infusion (drip) into a vein over 2 hours.
Croatian: Lijek Zessly primjenjuje se intravenskom infuzijom (drip) u trajanju od dva sata.
English: Side effects reported with Zessly are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zessly pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The study looked at the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 14 weeks of treatment.
Croatian: U ispitivanju se promatrao udio bolesnika u kojih je zabilježeno smanjenje odgovora ACR od najmanje 20 % (mjera bolnih, natečenih zglobova i drugih simptoma) nakon 14 tjedana liječenja.
English: After each infusion, the patient should be monitored for 1 to 2 hours in case they have an allergic reaction, such as swelling of the mouth, face and throat, skin rash, and difficulty breathing.
Croatian: Potreban je nadzor bolesnika jedan do dva sata nakon svake infuzije u slučaju da imaju alergijsku reakciju kao što je oticanje usta, lica i grla, osip kože i otežano disanje.
English: In addition, Zessly was as effective as Remicade in a study of 650 rheumatoid arthritis patients whose previous treatment with methotrexate alone had not worked well enough.
Croatian: Osim toga, lijek Zessly bio je jednako učinkovit kao i lijek Remicade u ispitivanju u kojem je sudjelovalo 650 bolesnika s reumatoidnim artritisom u kojih prethodna monoterapija metotreksatom nije bila dovoljno djelotvorna.
English: For more information about using Zessly, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Zessly pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Because Zessly is a biosimilar medicine, the studies on effectiveness and safety carried out with Remicade do not all need to be repeated for Zessly.
Croatian: Budući da je lijek Zessly biosličan lijek, ispitivanja učinkovitosti i sigurnosti provedena za lijek Remicade nije potrebno ponavljati za lijek Zessly.
English: The most common side effects with Zessly (seen in more than 1 patient in 10) are viral infections (such as flu and cold sores), headache, upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusionrelated reactions and pain.
Croatian: Najčešće su nuspojave lijeka Zessly (zabilježene u više od 1 na 10 bolesnika) virusne infekcije (kao što su gripa i herpes), glavobolja, infekcije gornjeg respiratornog trakta (infekcija nosa i grla), sinusitis (upala sinusa), mučnina (osjećaj slabosti), abdominalna bol (bol u trbuhu), reakcije i bol povezani s infuzijom.
English: How does Zessly work?
Croatian: Kako djeluje Zessly?
English: The active substance in Zessly, infliximab, is a monoclonal antibody (a type of protein) that attaches to a substance in the body called tumour necrosis factor alpha (TNF-α).
Croatian: Djelatna tvar u lijeku Zessly, infliksimab, monoklonsko je protutijelo (vrsta proteina) koje se veže za tvar u tijelu zvanu faktor nekroze tumora alfa (TNF-α).
English: Zessly must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Croatian: Lijek Zessly ne smije se primjenjivati u bolesnika s tuberkulozom, drugim teškim infekcijama ili umjerenim ili teškim zatajenjem srca (nemogućnost srca da pumpa dovoljne količine krvi u tijelu).
English: Zessly can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Zessly is used to treat.
Croatian: Lijek Zessly izdaje se samo na liječnički recept, a liječenje je potrebno započeti i provoditi pod nadzorom liječnika specijalista s iskustvom u dijagnosticiranju i liječenju bolesti koje se liječe lijekom Zessly.
English: As for all medicines, data on the use of Zessly are continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Zessly kontinuirano se prate.
English: Zessly must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Zessly.
Croatian: Lijek Zessly ne smije se primjenjivati u bolesnika koji su preosjetljivi (alergični) na infliksimab, mišje proteine ili bilo koji drugi sastojak lijeka.
English: For some conditions, Zessly is also used in combination with another medicine, methotrexate.
Croatian: Za liječenje određenih bolesti Zessly se primjenjuje i u kombinaciji s drugim lijekom, metotreksatom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zessly have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zessly nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Zessly has been shown overall to have a comparable quality, safety and effectiveness to Remicade.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Zessly dokazao kakvoću, sigurnost i učinkovitost usporedivu s lijekom Remicade.
English: The reference medicine for Zessly is Remicade.
Croatian: Referentni lijek za Zessly je Remicade.
English: The dose of Zessly and how often it is given depends on the patient's body weight and the condition being treated.
Croatian: Doza i učestalost primjene lijeka Zessly ovisi o tjelesnoj težini bolesnika i stanju koje se liječi.
English: Laboratory studies comparing Zessly with Remicade have shown that the active substance in Zessly is highly similar to that in Remicade in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Zessly i Remicade pokazala su da je djelatna tvar u lijeku Zessly vrlo slična djelatnoj tvari u lijeku Remicade u pogledu strukture, čistoće i biološke aktivnosti.
English: The company that markets Zessly will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine.
Croatian: Tvrtka koja stavlja lijek Zessly u promet osigurat će karticu s upozorenjima za bolesnike te edukativne materijale sa sažetim sigurnosnim informacijama o lijeku za liječnike koji propisuju lijek.
English: What benefits of Zessly have been shown in studies?
Croatian: Koje su koristi lijeka Zessly dokazane u ispitivanjima?
English: • psoriasis (red, scaly patches on the skin)
Croatian: • psorijaze (crvene, ljuskave mrlje na koži)
English: Therefore, the Agency's view was that, as for Remicade, the benefit of Zessly outweighs the identified risk and it can be authorised.
Croatian: Stoga je stav Agencije da korist kod lijeka Zessly, kao i kod lijeka Remicade, nadmašuje identificirani rizik te da lijek može biti odobren.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Zessly is used to treat.
Croatian: Ta je tvar uključena u nastanak upale te se u visokim razinama nalazi u bolesnika oboljelih od bolesti koje se liječe lijekom Zessly.
English: • Crohn's disease (disease causing inflammation of the gut)
Croatian: • Crohnove bolesti (bolest koja uzrokuje upalu crijeva)
English: • ankylosing spondylitis (inflammation of spine causing back pain)
Croatian: • ankilozantnog spondilitisa (upala kralježnice koja uzrokuje bol u leđima)
English: Studies have also shown that giving Zessly produces similar levels of the active substance in the body to giving Remicade.
Croatian: U ispitivanjima je utvrđeno i da se primjenom lijeka Zessly stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Remicade.
English: • ulcerative colitis (inflammation and ulcers in the lining of the gut)
Croatian: • ulceroznog kolitisa (upala i čirevi na stijenci crijeva)
English: • psoriatic arthritis (psoriasis with inflammation of the joints).
Croatian: • psorijatičnog artritisa (psorijaza praćena upalom zglobova).
English: • rheumatoid arthritis (disease causing inflammation of the joints)
Croatian: • reumatoidnog artritisa (bolest koja uzrokuje upalu zglobova)
English: How is Zessly used?
Croatian: Kako se Zessly koristi?
English: For the full list of side effects of Zessly, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Zessly potražite u uputi o lijeku.
English: Version 10.1, 06/201902/2016
Croatian: Verzija 10.1, 06/201902/2016 Language rev.1, 04/2016
English: • <Additional risk minimisation measures>
Croatian: • <Dodatne mjere minimizacije rizika>
English: <- This medicine has been prescribed for you only.
Croatian: <- Ovaj je lijek propisan samo Vama.
English: What X is and what it is used for 2.
Croatian: Što je X i za što se koristi
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> <Not applicable.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.> <Nije primjenjivo.>
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/000
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/0/00/000/000
English: <X contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Croatian: <X sadrži istu djelatnu tvar i djeluje na isti način kao „referentni lijek”“ koji je već odobren u Europskoj uniji.
English: • Risk Mmanagement Pplan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Croatian: DATUM REVIZIJE TEKSTA <{MM/GGGG}> <{DD/MM/GGGG}> <{DD mjesec GGGG}>
English: <Absorption> <Distribution> <Biotransformation> <Elimination> <Linearity/non-linearity> <Pharmacokinetic/pharmacodynamic relationship(s)>
Croatian: <Apsorpcija> <Distribucija> <Biotransformacija> <Eliminacija> <Linearnost/nelinearnost> <Farmakokinetički/farmakodinamički odnos(i)>
English: OTHER <For autologous use only.>
Croatian: DRUGO <Samo za autolognu primjenu.>
English: - You must talk to a doctor if you do not feel better or if you feel worse <after {number of}
Croatian: Pogledajte dio 4. - Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije <nakon {broj}
English: <If you forget to <take> <use> X> <Do not take a double dose to make up for a forgotten <tablet> <dose> <…>.>
Croatian: <Ako ste zaboravili <uzeti> <primijeniti> X> <Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu <tabletu> <dozu> <…>.>
English: What X is and what it is used for <You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
Croatian: Što je X i za što se koristi <Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije <nakon {broj} dana>.>
English: 4.4 Special warnings and precautions for use <Traceability
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi <Sljedivost
English: <{(Invented) Nname} is a biosimilar medicinal product.
Croatian: <{(Novoizumljeno) ime} je biosličan lijek.
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Croatian: 16. PODACI NA BRAILLEOVOM PISMU <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.>
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP {VRSTA/TIP}
English: OTHER SPECIAL WARNING(S), IF NECESSARY <For autologous use only.>
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO <Samo za autolognu primjenu.>
English: <Mechanism of action> <Pharmacodynamic effects> <Clinical efficacy and safety> <Paediatric population>
Croatian: <Farmakodinamički učinci> <Klinička djelotvornost i sigurnost> <Pedijatrijska populacija>
English: <The requirements for submission of PSURs periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Croatian: <Zahtjevi za podnošenje PSUR-evaperiodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.>
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Mmarketing Aauthorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: 6.3 Shelf life <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...> 6.4 Special precautions for storage <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Croatian: 6.3 Rok valjanosti <...> <6 mjeseci> <...> <1 godina> <18 mjeseci> <2 godine> <30 mjeseci> <3 godine> <…> 6.4 Posebne mjere pri čuvanju lijeka <Uvjete čuvanja nakon <rekonstitucije>
English: 4.7 Effects on ability to drive and use machines <{(Invented) name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.> <Not relevant.>
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima <{Novoizumljeno ime} <ne utječe ili zanemarivo utječe> <malo utječe> <umjereno utječe> <značajno utječe> na sposobnost upravljanja vozilima i rada sa strojevima.>
English: <Paediatric population>
Croatian: <Pedijatrijska populacija>