FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed is converted into its active form more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Pemetreksed se u stanicama raka pretvara u djelatni oblik brže nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: Because Pemetrexed Krka 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 Pemetrexed Krka generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Side effects reported with Pemetrexed Krka are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Pemetrexed Krka pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Alimta.
Croatian: To znači da Pemetrexed Krka sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EUu pod nazivom Alimta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Krka 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 Krka nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Pemetrexed Krka (pemetrexed)
Croatian: Pemetrexed Krka (pemetreksed)
English: An overview of Pemetrexed Krka and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Pemetrexed Krka i zašto je odobren u EU-u
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes involved in producing nucleotides (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: Pemetreksed se u tijelu pretvara u djelatni oblik koji onemogućuje djelovanje enzima uključenih u proizvodnju nukleotida (temeljnih sastavnica DNK-a i RNK-a, odnosno genskog materijala stanice).
English: What are the benefits and risks of Pemetrexed Krka?
Croatian: Koje su koristi i rizici lijeka Pemetrexed Krka?
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Croatian: • malignog pleuralnog mezotelioma (raka ovojnice pluća koji je obično uzrokovan izlaganjem azbestu), pri čemu se koristi u kombinaciji s cisplatinom u bolesnika s neoperabilnim rakom koji prethodno nisu primali kemoterapiju;
English: Why is Pemetrexed Krka authorised in the EU?
Croatian: Zašto je lijek Pemetrexed Krka odobren u EU-u?
English: As for every medicine, the company provided studies on the quality of Pemetrexed Krka.
Croatian: Kao za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Pemetrexed Krka.
English: This is because Pemetrexed Krka is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: To je zbog toga što se lijek Pemetrexed Krka daje infuzijom u venu te tako djelatna tvar dospijeva izravno u krvotok.
English: When Pemetrexed Krka is given with cisplatin, an antiemetic medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Pemetrexed Krka primjenjuje s cisplatinom, prije ili nakon doze cisplatina bolesniku također treba dati „antiemetik” (za sprečavanje povraćanja) i tekućinu (za sprečavanje dehidracije).
English: Pemetrexed Krka is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed Krka dostupan je kao prašak za pripremu otopine za infuziju (drip) u venu.
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 naziva „neskvamozne stanice”, pri čemu se koristi u kombinaciji s cisplatinom u bolesnika koji nisu prethodno liječeni ili kao monoterapija u bolesnika koji su prethodno primali terapiju protiv raka.
English: Other information about Pemetrexed Krka
Croatian: Ostale informacije o lijeku Pemetrexed Krka
English: As for all medicines, data on the use of Pemetrexed Krka are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Pemetrexed Krka kontinuirano se prate.
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 Krka.
Croatian: Kako bi se ublažile nuspojave lijeka, bolesnici tijekom terapije lijekom Pemetrexed Krka trebaju uzimati kortikosteroid (vrsta lijeka koji smanjuje upalu) i folnu kiselinu (vrsta vitamina) te primati injekcije vitamina B12.
English: Therefore, the Agency's view was that, as for Alimta, the benefit of Pemetrexed Krka outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist lijeka Pemetrexed Krka, kao i kod lijeka Alimta, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood cell counts are low or who have certain other side effects.
Croatian: U bolesnika s niskim brojem krvnih stanica ili u bolesnika koji imaju određene druge nuspojave terapiju je potrebno odgoditi ili prekinuti ili je potrebno smanjiti dozu.
English: The active substance in Pemetrexed Krka, 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 lijeka Pemetrexed Krka, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice raka), a ubraja se u grupu „antimetabolita”.
English: How has Pemetrexed Krka been studied?
Croatian: Kako je Pemetrexed Krka ispitivan?
English: Pemetrexed Krka contains the active substance pemetrexed.
Croatian: Pemetrexed Krka sadrži djelatnu tvar pemetreksed.
English: How does Pemetrexed Krka work?
Croatian: Kako djeluje Pemetrexed Krka?
English: How is Permetrexed Krka used?
Croatian: Kako se Pemetrexed Krka koristi?
English: 1 year.
Croatian: 1 godina.
English: Risk Management plan (RMP)
Croatian: Plan upravljanja rizicima (RMP)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12 August 2010
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 12. kolovoza 2010.
English: Please consult the Product Information of:
Croatian: Molimo pogledajte informacije o proizvodu za:
English: • if you have a severe infection with a high temperature (over 38°C).
Croatian: • ako imate tešku infekciju uz povišenu temperaturu (iznad 38°C).
English: Tell your doctor if you have any known allergies.
Croatian: Recite svome liječniku ako imate bilo koje poznate alergije.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: CHMP je suglasan sa znanstvenim zaključcima PRAC-a.
English: Packs of 1 and 10.
Croatian: Pakovanja od 1 i 10.
English: The immune response to the seasonal antigens was satisfactory.
Croatian: Imunološki odgovor na sezonske antigene bio je zadovoljavajući.
English: For the adjuvant, see section 2.
Croatian: Za adjuvans, vidjeti dio 2.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Croatian: Ako se ovo odnosi na vas, cijepljenje će vjerojatno biti odgođeno dok se ne budete osjećali bolje.
English: Very common (affects more than 1 user in 10):
Croatian: Vrlo često (pogađa više od 1 korisnika na 10):
English: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Croatian: Bellaria - 53018 Rosia - Sovicille (SI) Italija
English: Ask your pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte svog ljekarnika kako zbrinuti lijekove koji Vam više nisu potrebni.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Croatian: • ako radite krvne pretrage radi dokaza infekcije određenim virusima.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Croatian: Liječnici su svjesni te mogućnosti, zbog čega imaju spremno hitno liječenje u takvim slučajevima.
English: The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and 5.1.
Croatian: Kod primjene druge doze treba uzeti u obzir podatke navedene u dijelovima 4.4, 4.8 i 5.1.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvorit će vlastitu zaštitu (protutijela) protiv bolesti.
English: Other medicines and Focetria
Croatian: Drugi lijekovi i Focetria
English: Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Croatian: Prijavljene nuspojave navedene su prema sljedećoj učestalosti: Vrlo često (≥1/10),
English: • If a specific notification system has been put in place, how to report adverse reactions.
Croatian: • Ako se koristi poseban sustav obavješćivanja, kako prijaviti nuspojave.
English: including the elderly.
Croatian: uključujući starije osobe.
English: The physician should inform you about the possibility to experience convulsion, in particular if you have had previous history of epilepsy.
Croatian: Liječnik bi Vas trebao obavijestiti o mogućnosti pojave konvulzija, naročito ako ste nekada imali epilepsiju.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Croatian: Liječnik ili medicinska sestra će primijeniti cjepivo u skladu sa službenim preporukama.
English: - Adjuvant:
Croatian: - Adjuvans:
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescriptionor have recently been given any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta ili ako ste nedavno primili bilo koje drugo cjepivo.
English: None of the ingredient in the vaccine can cause flu.
Croatian: Nijedan sastojak cjepiva ne može uzrokovati gripu.
English: Do not receive Focetria:
Croatian: Nemojte primiti Focetriu:
English: What you need to know before you receive FOCETRIA
Croatian: Što morate znati prije nego što primite FOCETRIU
English: What FOCETRIA is and what it is used for
Croatian: Što je FOCETRIA i za što se koristi
English: In the first few weeks after vaccination with Focetria the results of these tests may not be correct.
Croatian: U prvih nekoliko tjedana nakon cijepljenja Focetriom rezultati tih pretraga možda neće biti točni.
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Croatian: Možda neće doći do zaštitnog odgovora u svih cjepljenika (vidjeti dio 5.1).
English: You or your child will receive one dose of 0.5 ml vaccine.
Croatian: Vi ili Vaše dijete primit ćete jednu dozu od 0,5 ml cjepiva.
English: The vaccine contains an ‘adjuvant' (MF59C.1) to stimulate a better response.
Croatian: Cjepivo sadrži ‘adjuvans' (MF59C.1) za poticanje boljeg odgovora.
English: Tell the doctor requesting these tests that you have recently been given Focetria.
Croatian: Liječniku koji je propisao te pretrage recite da ste nedavno primili Focetriu.
English: Anti-HA antibody
Croatian: Anti-HA protutijelo
English: • Post-marketing surveillance
Croatian: • Postmarketinško praćenje
English: A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Focetria,
Croatian: Blaga infekcija, poput prehlade, ne bi trebala biti problem, no liječnik ili medicinska sestra savjetovat će možete li se ipak cijepiti Focetriom,
English: No data are available in children aged less than 6 months (see sections 4.8 and 5.1).
Croatian: Podaci za djecu mlađu od 6 mjeseci nisu dostupni (vidjeti dijelove 4.8 i 5.1).
English: Packs of 10.
Croatian: Pakovanje od 10.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Croatian: • Kada su primljene nove informacije koje mogu utjecati na važeći Sigurnosni profil lijeka, Farmakovigilancijski plan ili aktivnosti smanjenja rizika
English: • The correct way to prepare the vaccine prior to administration.
Croatian: • Ispravan način pripreme cjepiva prije primjene.
English: Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters.
Croatian: Podaci o sigurnosti dostupni su za trudnice izložene lijeku Focetria, osobito tijekom drugog i trećeg tromjesečja.
English: Italy.
Croatian: Italija.
English: • Safety and immunogenicity data obtained after administration of a one or two doses of Focetria
Croatian: • podaci o sigurnosti i imunogenosti dobiveni nakon primjene jedne ili dvije doze Focetrie
English: Children aged less than 6 months of age: Vaccination is currently not recommended in this age group.
Croatian: Djeca u dobi manje od 6 mjeseci: Cijepljenje se trenutačno ne preporučuje za ovu dobnu skupinu.
English: The majority of febrile convulsions occurred in paediatric subjects.
Croatian: Do većine febrilnih konvulzija došlo je u pedijatrijskih ispitanika.
English: Most of the reactions were mild in nature and of short duration.
Croatian: Većina reakcija bila je blage naravi i kratkog trajanja.
English: Adjuvant MF59C.1 containing: squalene
Croatian: Adjuvans MF59C.1 sadrži: skvalen
English: These side effects may occur with Focetria.
Croatian: Ove nuspojave mogu se pojaviti uz Focetriu.
English: Rare: Low blood platelet count which can result in bleeding or bruising.
Croatian: Rijetko: Nizak broj krvnih pločica koji može rezultirati krvarenjem ili stvaranjem modrica.
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
Croatian: Osim toga, niže navedene nuspojave pojavile su se u danima ili tjednima nakon cijepljenja adjuvantiranim ili neadjuvantiranim cjepivima koja se rutinski daju svake godine radi sprječavanja gripe.
English: Health care providers need to assess the benefits and potential risks of administering Focetria vaccine to pregnant women, taking into consideration official recommendations.
Croatian: Pružatelji zdravstvene skrbi trebaju procijeniti koristi i moguće rizike davanja cjepiva Focetria trudnicama uzimajući u obzir službene preporuke.
English: Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Croatian: Dostupni su podaci koji ukazuju na mogućnost uporabe višedoznih bočica do najviše 72 sata nakon prvog izvlačenja, no takva produžena razdoblja čuvanja treba izbjegavati.
English: What Focetria looks like and contents of the pack Focetria is a milky-white liquid.
Croatian: Kako Focetria izgleda i sadržaj pakovanja Focetria je mliječnobijela tekućina.
English: The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Croatian: Niže navedene nuspojave pojavile su se s Focetriom u kliničkim ispitivanjima u odraslih, uključujući starije osobe:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti:
English: There were fewer reactions after the second vaccination compared with the first.
Croatian: Nakon drugog cijepljenja bilo je manje reakcija u usporedbi s prvim.
English: Local
Croatian: Lokalna
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Croatian: * umnožen na jajima ** izraženo u mikrogramima hemaglutinina.
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Croatian: Osim nuspojava prijavljenih u kliničkim ispitivanjima, sljedeće su prijavljene tijekom postmarketinškog iskustva s Focetriom H1N1v:
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
Croatian: • Štetni događaji koje je prvenstveno važno prijaviti, npr. fatalne i po život opasne nuspojave, neočekivane teške nuspojave, štetni događaji od posebnog interesa (AESI).
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Croatian: Istodobna primjena nije bila povezana s višim stopama lokalnih ili sistemskih reakcija u usporedbi s primjenom samo Focetrie.
English: A clinical study was conducted with the same vaccine in children.
Croatian: Kliničko ispitivanje s istim cjepivom provedeno je u djece.
English: Induration was a common reaction in toddlers but was less common in infants.
Croatian: Otvrdnuće je bila česta reakcija u male djece, ali manje česta u dojenčadi.
English: Like all medicines, Focetria can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Focetria može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: What Focetria is and what it is used for What you need to know before you receive Focetria How Focetria is given
Croatian: Što je Focetria i za što se koristi Što morate znati prije nego što primite Focetriu Kako se Focetria primjenjuje Moguće nuspojave
English: Focetria should be used in accordance with Official Guidance.
Croatian: Focetriu treba primjenjivati prema službenim preporukama.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Kao i kod svih cjepiva koja se injiciraju, odgovarajuće liječenje i medicinski nadzor trebaju uvijek biti lako dostupni u slučaju rijetkog anafilaktičkog događaja nakon primjene cjepiva.
English: Name and address of the manufacturers of the biological active substance
Croatian: Nazivi i adrese proizvođača bioloških djelatnih tvari
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Croatian: Treba obratiti posebnu pažnju na ispitanike koje boluju od epilepsije, a liječnik treba ispitanike (ili roditelje) obavijestiti o mogućnosti pojave konvulzija (vidjeti dio 4.8).
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.
Croatian: Preporuke za doziranje uzimaju u obzir podatke o sigurnosti i imunogenosti iz kliničkih ispitivanja u zdravih ispitanika.
English: 9.75 milligrams polysorbate 80
Croatian: 9,75 miligrama polisorbat 80
English: Safety data after the first and second dose in children and adolescents suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation.
Croatian: Podaci o sigurnosti nakon prve i druge doze u djece i adolescenata ukazuju na sigurnosni profil usporediv s onime prijavljenim za formulaciju „mock-up“ cjepiva H5N1.
English: • Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Direktive 2001/83/EC kako je izmijenjena, službeno puštanje serije lijeka u promet preuzet će državni laboratoriji ili laboratorij određen za tu svrhu.
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Croatian: Većina reakcija bila je blage naravi, kratkog trajanja i kvalitativno slična onima koje izazivaju konvencionalna sezonska cjepiva protiv influence.
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Croatian: Međutim, ako se to ne može izbjeći, cjepiva treba injicirati u suprotne udove.
English: The side effects listed below have occurred in the days or weeks after vaccination with Focetria.
Croatian: Niže navedene nuspojave pojavile su se u danima ili tjednima nakon cijepljenja Focetriom.
English: Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Croatian: Stoga, na temelju dostupnih podataka o upotrebi lijeka Focetria tijekom trudnoće, PRAC smatra da su izmjene informacija o lijeku opravdane.
English: Dispose of in accordance with local regulations.
Croatian: Zbrinuti sukladno lokalnim propisima.
English: If they persist, CONSULT YOUR DOCTOR.
Croatian: Ako potraju, OBRATITE SE LIJEČNIKU.
English: Take special care with Focetria:
Croatian: Budite posebno oprezni s Focetriom:
English: The vaccine will be injected into a muscle (usually in the upper arm).
Croatian: Cjepivo se primjenjuje u mišić (obično nadlaktice).
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Focetria.
Croatian: • Nositelj odobrenja će s državama članicama dogovoriti mehanizme koji će bolesnicima i zdravstvenim djelatnicima omogućavati kontinuirani pristup nadopunjenim informacijama u vezi Focetrie.
English: Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Croatian: Uzimajući u obzir PRAC-ovo Izvješće o ocjeni periodičkih izvješća o neškodljivosti (PSUR) za lijek Focetria, znanstveni zaključci PRAC-a su sljedeći:
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Croatian: Stoga zdravstveni djelatnici moraju procijeniti koristi i moguće rizike primjene cjepiva u osoba s trombocitopenijom ili bilo kojim poremećajem krvarenja zbog kojeg bi bila kontraindicirana intramuskularna injekcija, osim ako moguća korist nadilazi rizik od krvarenja.
English: In the event that a second dose is to be administered it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Focetria with other H1N1v vaccines.
Croatian: U slučaju primjene druge doze, treba uzeti u obzir da nema podataka o sigurnosti, imunogenosti ili djelotvornosti koji bi poduprli međusobnu zamjenjivost Focetrie s drugim H1N1v cjepivima.
English: 4.9 Overdose No case of overdose has been reported.
Croatian: 4.9 Predoziranje Nisu prijavljeni slučajevi predoziranja.
English: - The active substance is:
Croatian: - Djelatna tvar je:
English: Side effects from clinical studies in children
Croatian: Nuspojave iz kliničkih ispitivanja u djece