FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Pemetrexed Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Pemetrexed Fresenius Kabi generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Fresenius Kabi have 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 Pemetrexed Fresenius Kabi nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Fresenius Kabi has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, potvrđeno da je lijek Pemetrexed Fresenius Kabi usporediv s lijekom Alimta.
English: Pemetrexed Fresenius Kabi is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed Fresenius Kabi lijek je za liječenje raka koji se koristi za liječenje dvaju tipova raka pluća:
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Fresenius Kabi.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) Pemetrexed Fresenius Kabi.
English: It is not intended to provide practical advice on how to use Pemetrexed Fresenius Kabi.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Pemetrexed Fresenius Kabi.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Croatian: • uznapredovalog raka pluća nemalih stanica pod nazivom „neskvamozne stanice”, pri čemu se koristi u kombinaciji s cisplatinom u prethodno neliječenih bolesnika ili kao monoterapija u bolesnika koji su prethodno primili terapiju protiv raka.
English: When Pemetrexed Fresenius Kabi is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se lijek Pemetrexed Fresenius Kabi primjenjuje s cisplatinom, prije ili nakon davanja doze cisplatina bolesniku je također potrebno dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprečavanje dehidracije).
English: For more information about treatment with Pemetrexed Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pemetrexed Fresenius Kabi pročitajte u uputi lijeka (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Pemetrexed Fresenius Kabi is a ‘generic medicine'.
Croatian: Pemetrexed Fresenius Kabi je „generički lijek”.
English: No additional studies were needed as Pemetrexed Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Dodatna ispitivanja nisu bila potrebna jer je lijek Pemetrexed Fresenius Kabi generički lijek koji se daje infuzijom i koji sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Fresenius Kabi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed Fresenius Kabi?
English: The Committee recommended that Pemetrexed Fresenius Kabi be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Pemetrexed Fresenius Kabi u EU-u.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Croatian: U bolesnika s abnormalnim brojem krvnih stanica ili u bolesnika koji imaju određene druge nuspojave terapiju je potrebno odgoditi ili prekinuti ili je potrebno smanjiti dozu.
English: Other information about Pemetrexed Fresenius Kabi
Croatian: Ostale informacije o lijeku Pemetrexed Fresenius Kabi
English: For practical information about using Pemetrexed Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Pemetrexed Fresenius Kabi pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What is Pemetrexed Fresenius Kabi and what is it used for?
Croatian: Što je Pemetrexed Fresenius Kabi i za što se koristi?
English: The active substance in Pemetrexed Fresenius Kabi, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar u lijeku Pemetrexed Fresenius Kabi, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele kao što su stanice raka) koji se ubraja u skupinu „antimetabolita”.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Fresenius Kabi.
Croatian: Kako bi se ublažile nuspojave, tijekom terapije lijekom Pemetrexed Fresenius Kabi bolesnici trebaju uzimati kortikosteroid (vrsta lijeka koji smanjuje upalu) i folnu kiselinu (vrsta vitamina) te primati injekcije vitamina B12.
English: Pemetrexed Fresenius Kabi pemetrexed
Croatian: Pemetrexed Fresenius Kabi pemetreksed
English: Pemetrexed Fresenius Kabi is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Pemetrexed Fresenius Kabi dostupan je u obliku praška od kojeg se priprema otopina za intravensku infuziju (drip).
English: What are the benefits and risks of Pemetrexed Fresenius Kabi?
Croatian: Koje su koristi i rizici lijeka Pemetrexed Fresenius Kabi?
English: Pemetrexed Fresenius Kabi contains the active substance pemetrexed.
Croatian: Pemetrexed Fresenius Kabi sadrži djelatnu tvar pemetreksed.
English: Why is Pemetrexed Fresenius Kabi approved?
Croatian: Zašto je lijek Pemetrexed Fresenius Kabi odobren?
English: How is Pemetrexed Fresenius Kabi used?
Croatian: Kako se Pemetrexed Fresenius Kabi koristi?
English: How has Pemetrexed Fresenius Kabi been studied?
Croatian: Kako je Pemetrexed Fresenius Kabi ispitivan?
English: How does Pemetrexed Fresenius Kabi work?
Croatian: Kako djeluje Pemetrexed Fresenius Kabi?
English: For adults with a weakened immune system (the body's natural defences), it is given for 10 days.
Croatian: Za odrasle osobe s oslabljenim imunosnim sustavom (prirodna obrana tijela) daje se tijekom 10 dana.
English: Further information on Ebilfumin can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebilfumin.
Croatian: Više informacija o lijeku Ebilfumin nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/ebilfumin.
English: Ebilfumin is available as capsules (30 mg, 45 mg, and 75 mg).
Croatian: Lijek Ebilfumin je dostupan u obliku kapsula (30 mg, 45 mg i 75 mg).
English: Ebilfumin received a marketing authorisation valid throughout the EU on 22 May 2014.
Croatian: Lijek Ebilfumin dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 22. svibnja 2014.
English: Ebilfumin does not replace flu vaccination, and its use should be based on official recommendations.
Croatian: Ebilfumin ne može zamijeniti cjepivo protiv gripe, a njegova se primjena treba temeljiti na službenim preporukama.
English: For children who weigh less than 40 kg, the dose is calculated according to the child's weight.
Croatian: Za djecu čija je težina manja od 40 kg doza se izračunava prema tjelesnoj težini djeteta.
English: Ebilfumin can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu).
Croatian: Ebilfumin se može primjenjivati i kao preventivna terapija u iznimnim slučajevima, primjerice kada sezonsko cjepivo protiv gripe ne može pružiti dovoljnu zaštitu te u slučaju pandemije (globalne epidemije gripe).
English: What measures are being taken to ensure the safe and effective use of Ebilfumin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ebilfumin?
English: What are the benefits and risks of Ebilfumin?
Croatian: Koje su koristi i rizici od lijeka Ebilfumin?
English: Ebilfumin is an antiviral medicine used to treat or prevent influenza (flu).
Croatian: Ebilfumin je antivirusni lijek za liječenje ili sprječavanje influence (gripe).
English: Other information about Ebilfumin
Croatian: Ostale informacije o lijeku Ebilfumin
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Tamiflu, and do not need to be repeated for Ebilfumin.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Tamiflu i stoga ih nije potrebno ponavljati za Ebilfumin.
English: Side effects reported with Ebilfumin are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ebilfumin pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The active substance in Ebilfumin, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuraminidases.
Croatian: Djelatna tvar lijeka Ebilfumin, oseltamivir, djeluje na virus gripe, inhibirajući pojedine enzime na njegovoj površini poznate pod nazivom neuraminidaze.
English: Oseltamivir works on the neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Croatian: Oseltamivir djeluje na neuraminidaze virusa influence A (najčešćeg tipa) i influence B.
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for 10 days after contact with an infected person.
Croatian: Uobičajena doza za odrasle osobe i djecu tjelesne težine veće od 40 kg iznosi 75 mg jedanput na dan tijekom 10 dana nakon kontakta sa zaraženom osobom.
English: This means that Ebilfumin contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Tamiflu.
Croatian: To znači da Ebilfumin sadržava istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Tamiflu.
English: • To treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;
Croatian: • Za liječenje gripe primjenjuje se u odraslih osoba i djece (uključujući novorođenčad rođenu na vrijeme) koji imaju simptome gripe, kada se virus gripe širi u zajednici.
English: Because Ebilfumin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Ebilfumin generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ebilfumin have 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 Ebilfumin nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: When Ebilfumin is used during a flu epidemic, it is given for up to 6 weeks.
Croatian: Ako se Ebilfumin primjenjuje tijekom epidemije gripe, uzima se najviše šest tjedana.
English: What is Ebilfumin and what is it used for?
Croatian: Što je Ebilfumin i za što se primjenjuje?
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days.
Croatian: Uobičajena doza za odrasle osobe i djecu tjelesne težine veće od 40 kg iznosi 75 mg dvaput na dan tijekom pet dana.
English: An overview of Ebilfumin and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ebilfumin i zašto je odobren u EU-u
English: As for every medicine, the company provided studies on the quality of Ebilfumin.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kakvoći lijeka Ebilfumin.
English: During a flu pandemic, Ebilfumin can also be used to prevent flu in babies below 1 year of age.
Croatian: Tijekom pandemije gripe Ebilfumin se može primjenjivati i za sprječavanje gripe u dojenčadi mlađe od godinu dana.
English: • To prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community.
Croatian: • Za sprječavanje gripe može se primjenjivati u odraslih osoba i djece starije od jedne godine koji su bili u kontaktu s osobom oboljelom od gripe i ako u zajednici kruži gripa.
English: Why is Ebilfumin authorised in the EU?
Croatian: Zašto je lijek Ebilfumin odobren u EU-u?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ebilfumin has been shown to have comparable quality and to be bioequivalent to Tamiflu.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Ebilfumin posjeduje usporedivu kakvoću te da je bioekvivalentan lijeku Tamiflu.
English: For more information about using Ebilfumin, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ebilfumin pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: As for all medicines, data on the use of Ebilfumin are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ebilfumin kontinuirano se prate.
English: This is generally done on a caseby-case basis.
Croatian: To se liječenje načelno provodi od slučaja do slučaja.
English: In the treatment of flu, Ebilfumin must be started within two days of the onset of symptoms.
Croatian: Za liječenje gripe terapiju lijekom Ebilfumin treba započeti u roku od dva dana od pojave simptoma.
English: Therefore, the Agency's view was that, as for Tamiflu, the benefit of Ebilfumin outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Ebilfumin, kao i od lijeka Tamiflu, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Ebilfumin contains the active substance oseltamivir.
Croatian: Ebilfumin sadržava djelatnu tvar oseltamivir.
English: In the prevention of flu, Ebilfumin must be started within two days of contact with someone who has flu.
Croatian: Za sprječavanje gripe terapiju lijekom Ebilfumin treba započeti u roku od dva dana od kontakta s osobom koja ima gripu.
English: How does Ebilfumin work?
Croatian: Kako djeluje Ebilfumin?
English: How has Ebilfumin been studied?
Croatian: Kako je Ebilfumin ispitivan?
English: The recommended dose is 800 mg on days 1 and 8 of each 3-week cycle.
Croatian: Preporučena doza je 800 mg prvog i osmog dana svakog trotjednog ciklusa.
English: Why is Portrazza approved?
Croatian: Zašto je Portrazza odobren?
English: Most of the patients (95%) had cancer cells with EGFR.
Croatian: Većina bolesnika (95 %) imala je stanice raka s EGFR-om.
English: The full EPAR and risk management plan summary for Portrazza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Portrazza nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Portrazza
Croatian: Ostale informacije o lijeku Portrazza
English: The risk of reactions can be reduced by adjusting the dose or infusion rate or by using preventive medicines.
Croatian: Rizik od reakcija može se smanjiti prilagodbom doze ili brzine infuzije ili uporabom preventivnih lijekova.
English: What is Portrazza and what is it used for?
Croatian: Što je Portrazza i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Portrazza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Portrazza?
English: Portrazza must not be used in patients who have had a severe or life-threatening reaction to any of the ingredients of the medicine.
Croatian: Portrazza se ne smije primjenjivati u bolesnika koji su imali teške ili po život opasne reakcije na bilo koji od sastojaka lijeka.
English: During infusions, resources should be available to deal with reactions that may occur.
Croatian: Tijekom davanja infuzija moraju biti dostupni odgovarajući resursi za tretiranje reakcija do kojih može doći.
English: The most common side effects with Portrazza (which may affect more than 1 in 10 people) are skin reactions, vomiting, stomatitis (inflammation of the lining of the mouth), fever, weight loss and low blood measurements of various minerals (magnesium, calcium, phosphate and potassium).
Croatian: Najčešće nuspojave lijeka Portrazza (mogu se javiti u više od 1 na 10 osoba) jesu kožne reakcije, povraćanje, stomatitis (upala sluznice usne šupljine), vrućica, gubitak težine i niske razine raznih minerala u krvi (magnezija, kalcija, fosfata i kalija).
English: In case of a severe infusion or skin reaction, treatment may have to be stopped permanently.
Croatian: U slučaju ozbiljne reakcije na infuziju ili kožne reakcije liječenje će možda biti potrebno trajno prekinuti.
English: In addition, the company that markets the medicine will provide doctors with educational material with information on risk of blood clots and on the small number of cardiac arrest cases seen in studies.
Croatian: Osim toga, tvrtka koja lijek stavlja u promet liječnicima će osigurati edukativne materijale s informacijama o riziku od krvnih ugrušaka te o malom broju slučajeva srčanog zastoja zabilježenih u ispitivanjima.
English: The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients).
Croatian: Najčešće teške nuspojave su teške kožne reakcije (u 6 % bolesnika) i krvni ugrušci (u 4 % bolesnika).
English: Portrazza is given as a one hour infusion (drip) into a vein.
Croatian: Portrazza se daje putem intravenske infuzije (drip) u trajanju od jednog sata.
English: What are the risks associated with Portrazza?
Croatian: Koji su rizici povezani s lijekom Portrazza?
English: This is a summary of the European public assessment report (EPAR) for Portrazza.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Portrazza.
English: In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months versus 9.9 months).
Croatian: U okviru tog ispitivanja, bolesnici liječeni lijekom Portrazza kao dodatnim liječenjem uz kemoterapiju u prosjeku su živjeli 1,6 mjeseci dulje od bolesnika koji su liječeni samo kemoterapijom (11,5 mjeseci naspram 9,9 mjeseci).
English: A risk management plan has been developed to ensure that Portrazza is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Portrazza.
English: It is not intended to provide practical advice on how to use Portrazza.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Portrazza.
English: EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing them to divide uncontrollably.
Croatian: EGFR obično kontrolira rast i dijeljenje stanica, no u stanicama raka on je često prekomjerno aktivan uzrokujući nekontrolirano dijeljenje stanica.
English: Portrazza is a medicine for treating advanced stages of a type of lung cancer known as squamous nonsmall cell lung cancer.
Croatian: Portrazza je lijek za liječenje naprednih stadija vrste raka pluća poznate pod nazivom rak skvamoznih nemalih stanica pluća.
English: Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.
Croatian: Portrazza se primjenjuje isključivo u odraslih čije stanice raka imaju specifičan protein (EGFR) na svojoj površini, a koristi se u kombinaciji s kemoterapijom gemcitabinom i cisplatinom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Portrazza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Portrazza nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival.
Croatian: Glavno ispitivanje provedeno na 1 093 bolesnika s naprednim stadijem raka skvamoznih nemalih stanica pluća pokazalo je da primjena lijeka Portrazza u kombinaciji s kemoterapijom gemcitabinom i cisplatinom može rezultirati umjerenim poboljšanjem u pogledu preživljavanja.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Portrazza, 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 Portrazza nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.
Croatian: U prvih šest ciklusa, Portrazza se daje u kombinaciji s kemoterapijom gemcitabinom i cisplatinom, a zatim se daje kao monoterapija onoliko dugo koliko bolest ostane stabilna i sve dok bolesnik može podnositi lijek.
English: By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer.
Croatian: Vezivanjem za EGFR i zaustavljanjem njegova djelovanja necitumumab pomaže u smanjenju rasta i širenja raka.
English: What benefits of Portrazza have been shown in studies?
Croatian: Koje su koristi od lijeka Portrazza utvrđene u ispitivanjima?
English: In the main study, adding Portrazza to gemcitabine and cisplatin chemotherapy improved survival by a modest one and a half months without causing significant worsening in overall patient health.
Croatian: U glavnom ispitivanju, primjena lijeka Portrazza kao dodatnog liječenja uz kemoterapiju gemcitabinom i cisplatinom rezultirala je poboljšanjem u pogledu preživljavanja za skromnih mjesec i pol dana, pri čemu lijek nije uzrokovao znatna pogoršanja općeg zdravlja bolesnika.
English: Portrazza is available as a concentrate for making a solution and can only be obtained with a prescription.
Croatian: Lijek Portrazza dostupan je kao koncentrat od kojeg se priprema otopina i izdaje se samo na recept.
English: For more information about treatment with Portrazza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Portrazza pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.