FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with known or suspected allergy to cow's milk must not be administered <invented name and strength(s)> (see section 4.3).
Croatian: Bolesnici s poznatom alergijom na kravlje mlijeko ili sumnjom na nju ne smiju primati <novoizumljeno ime i jačina(e)> (vidjeti dio 4.3).
English: Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>)
Croatian: [Potrebno je uključiti sljedeće objašnjenje u zagradama u slučaju kombiniranog sažetka opisa svojstava lijeka s jačinom (jačinama) koja nije(nisu) uključena(e) u Prilog I.] (sljedeći odlomci odnose se samo na <novoizumljeno ime i jačina(e)>)
English: <Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4).
Croatian: <Novoizumljeno ime i jačina(e)> je kontraindiciran(a) u bolesnika s poznatom alergijom na kravlje mlijeko ili sumnjom na nju (vidjeti dio 4.4).
English: 4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects
Croatian: [Potrebno je uključiti sljedeće upozorenje] Učinci na imunološki sustav
English: Serious allergic reactions have occurred in patients allergic to cow's milk.
Croatian: U bolesnika koji su alergični na kravlje mlijeko pojavile su se ozbiljne alergijske reakcije.
English: <invented name and strength(s)> contains cow's milk proteins If you are allergic or suspected to be allergic to cow's milk, you must not be given this medicine as it may contain trace amounts of cow's milk proteins.
Croatian: Ako ste alergični na kravlje mlijeko ili se sumnja na to, ne smijete primiti ovaj lijek jer može sadržavati proteine kravljeg mlijeka u tragovima.
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Zaštićeno) name
English: The main measure of effectiveness was the duration of severe neutropenia.
Croatian: Glavna mjera djelotvornosti bilo je trajanje teške neutropenije.
English: Severe neutropenia lasted on average for 1.4 days.
Croatian: Ozbiljna neutropenija trajala je u prosjeku 1,4 dana.
English: This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim.
Croatian: Ovo je bilo usporedivo s 1,6 dana i 1,8 dana prijavljenih u drugim ispitivanjima u literaturi dostupnoj za filgrastim.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Accofil na snazi u Europskoj uniji od 18. rujna 2014.
English: The full EPAR and risk management plan summary for Accofil 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 Accofil nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Accofil is a medicine that is used to stimulate the production of white blood cells in the following situations:
Croatian: Accofil je lijek koji se koristi za stimulaciju proizvodnje bijelih krvnih stanica u sljedećim situacijama:
English: Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil the next day and daily for up to 14 days.
Croatian: Bolesnice su primile kemoterapiju na 1. dan trotjednog ciklusa, te su zatim primile jednu dozu lijeka Accofil svakog sljedećeg dana u trajanju od 14 dana.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for.
Croatian: Druge nuspojave mogu biti uočene u više od 1 na 10 osoba, ovisno o stanju za koje se Accofil koristi.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Croatian: Podaci iz objavljenih ispitivanja ukazuju da su koristi i sigurnost filgrastima bile slične u odraslih i djece koji su primali kemoterapiju.
English: The way Accofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Croatian: Način primjene lijeka Accofil, njegova doza i trajanje liječenja ovise o razlogu primjene, tjelesnoj težini bolesnika i odgovoru na liječenje.
English: What is Accofil and what is it used for?
Croatian: Što je Accofil i za što se koristi?
English: This means that Accofil is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, Accofil je sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je u skladu sa zahtjevima EU-a za bioslične lijekove dokazano da lijek Accofil posjeduje usporedivu razinu kvalitete, sigurnosti i djelotvornosti kao i Neupogen.
English: Other information about Accofil
Croatian: Ostale informacije o lijeku Accofil
English: This is a summary of the European public assessment report (EPAR) for Accofil.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Accofil.
English: Why is Accofil approved?
Croatian: Zašto je Accofil odobren?
English: Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia.
Croatian: Accofil je ispitivan u jednom glavnom ispitivanju koje je obuhvatilo 120 odraslih ženskih bolesnika s rakom dojke liječenih kemoterapijom za koju je poznato da uzrokuje neutropeniju.
English: It is not intended to provide practical advice on how to use Accofil.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Accofil.
English: What measures are being taken to ensure the safe and effective use of Accofil?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Accofil?
English: The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Croatian: Najčešće nuspojave lijeka Accofil (mogu se javiti u više od 1 na 10 osoba) su mišićnokoštana bol (bol u mišićima i kostima).
English: A risk management plan has been developed to ensure that Accofil is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Accofil.
English: Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Croatian: Filgrastim djeluje na isti način kao prirodno proizveden G-CSF, potičući koštanu srž na stvaranje više bijelih krvnih stanica.
English: It is given by injection under the skin or infusion into a vein.
Croatian: Primjenjuje se supkutanom injekcijom ili infuzijom u venu.
English: Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.
Croatian: Provedena su ispitivanja kako bi se dokazalo da Accofil stvara iste razine djelatne tvari u tijelu kao Neupogen te povećava broj neutrofila na usporediv način.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Accofil, 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 Accofil nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine'.
Croatian: Accofil, koji sadrži djelatnu tvar filgrastim, je „biosličan lijek”.
English: What are the risks associated with Accofil?
Croatian: Koji su rizici povezani s lijekom Accofil?
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
Croatian: Stoga je stav CHMP-a da u pogledu lijeka Neupogen koristi nadmašuju utvrđene rizike i preporučio je izdavanje odobrenja za stavljanje u promet lijeka u EU-u.
English: • to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Croatian: • za liječenje perzistentne neutropenije u bolesnika s uznapredovalom HIV-infekcijom, kako bi se smanjio rizik od bakterijskih infekcija kad druge mogućnosti liječenja neutropenije nisu prikladne.
English: Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes.
Croatian: Accofil dostupan je kao otopina za injekciju ili infuziju (drip) u napunjenim injekcijama.
English: The filgrastim in Accofil is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.
Croatian: Filgrastim u lijeku Accofil proizvodi se metodom „tehnologije rekombinatne DNK”: proizvodi ga bakterija u čiji gen (DNK) je umetnut filgrastim.
English: The reference medicine for Accofil is Neupogen.
Croatian: Referentni lijek za Accofil je Neupogen.
English: The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Croatian: Djelatna tvar lijeka Accofil, filgrastim, je vrlo slična humanom proteinu naziva čimbenikom poticanja rasta granulocitnih kolonija (G-CSF).
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);
Croatian: • za smanjenje trajanja neutropenije (malog broja neutrofila, tipa bijelih krvnih stanica) i incidencije febrilne neutropenije (neutropenija praćena groznicom) u bolesnika liječenih citotoksičnom kemoterapijom (lijekovima protiv raka koji ubijaju stanice);
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Croatian: • za povećanja razina neutrofila i smanjenje rizika od infekcija u bolesnika s neutropenijom koji imaju povijest ozbiljnih, opetovanih infekcija;
English: For more information about treatment with Accofil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Accofil pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: More information can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Više informacija dostupno je u sažetku opisa svojstva lijeka (također dio EPAR-a).
English: For the full list of all side effects and restrictions reported with Accofil, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Accofil potražite u uputi o lijeku.
English: It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Croatian: Lijek se izdaje samo na liječnički recept, te se smije primjenjivati samo u suradnji s onkološkim centrom.
English: This summary was last updated in 09-2014.
Croatian: Sažetak je posljednji put ažuriran:09.
English: • to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
Croatian: • za pomoć u otpuštanju stanica iz koštane srži u bolesnika koji će donirati matične stanice za transplataciju;
English: For practical information about using Accofil, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Accofil pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Accofil work?
Croatian: Kako djeluje Accofil?
English: What benefits of Accofil have been shown in studies?
Croatian: Koje su koristi lijeka Accofil utvrđene u ispitivanjima?
English: How is Accofil used?
Croatian: Kako se Accofil koristi?
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Croatian: • za smanjenje trajanja neutropenije u bolesnika koji prolaze mijeloablativnu terapiju prije transplantacije koštane srži (primjerice u pojedinih bolesnika oboljelih od leukemije) i u kojih se smatra da postoji povećan rizik od produljene teške neutropenije;
English: 10 (2 x 5) pre-filled pens (multipack)
Croatian: 10 (2 x 5) napunjenih brizgalica (višestruko pakiranje)
English: Carmustine Obvius (carmustine) EMA/273425/2018
Croatian: Carmustine Obvius (karmustin) EMA/273425/2018
English: The medicine is used when initial treatment has not worked or the cancer has come back.
Croatian: Lijek se primjenjuje kada početno liječenje nije bilo djelotvorno ili kada se rak vrati.
English: Carmustine Obvius is a ‘generic medicine'.
Croatian: Carmustine Obvius jest „generički lijek”.
English: A dose based on the patient's weight and height is given at intervals of at least 6 weeks, and should be adjusted according to the patient's blood cell counts.
Croatian: Doza određena na temelju bolesnikove težine i visine daje se u razmaku od najmanje šest tjedana i treba se prilagođavati prema broju krvnih stanica bolesnika.
English: Further information on Carmustine Obvius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Carmustine Obvius nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Informacije o referentnom lijeku također se nalaze na internetskim stranicama Agencije.
English: • Hodgkin's lymphoma and non-Hodgkin's lymphomas, types of cancer that originate from white blood cells.
Croatian: • Hodgkinova limfoma i ne-Hodgkinovih limfoma, vrsta raka koji se razvija u bijelim krvnim stanicama.
English: • brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
Croatian: • tumora na mozgu, koji se razvijaju izravno u mozgu i drugih vrsta raka koje su se proširile iz drugih dijelova tijela (metastatski tumori na mozgu);
English: It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply.
Croatian: On remeti normalnu funkciju i obnovu DNA i RNA, genetskih uputa potrebnih za rad i umnožavanje stanica.
English: Carmustine Obvius (carmustine)
Croatian: Carmustine Obvius (karmustin)
English: By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading.
Croatian: Oštećivanjem DNA stanica raka karmustin doprinosi njihovom odumiranju i sprječavanju razvoja i širenja raka.
English: Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Carmustine Obvius generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What is Carmustine Obvius and what is it used for?
Croatian: Što je Carmustine Obvius i za što se koristi?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Carmustine Obvius usporediv s lijekom Carmubris.
English: This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Carmubris.
Croatian: To znači da Carmustine Obvius sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Carmubris.
English: Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Carmustine Obvius pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: There was no need for ‘bioequivalence' studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Carmustine Obvius slično referentnom lijeku kako bi doveo do iste razine djelatne tvari u krvi.
English: Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Carmubris i stoga ih nije potrebno ponavljati za lijek Carmustine Obvius.
English: An overview of Carmustine Obvius and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Carmustine Obvius i zašto je odobren u EU-u
English: What measures are being taken to ensure the safe and effective use of Carmustine Obvius?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Carmustine Obvius?
English: It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription.
Croatian: Lijek se mora primjenjivati pod nadzorom liječnika s iskustvom u uporabi lijekova protiv raka i izdaje se samo na liječnički recept.
English: Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:
Croatian: Carmustine Obvius lijek je protiv raka koji se primjenjuje kao monoterapija ili u kombinaciji s drugim lijekovima protiv raka i terapijama s ciljem liječenja sljedećih vrsta raka:
English: Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent.
Croatian: Karmustin, djelatna tvar ovoga lijeka, vrsta je lijeka protiv raka poznatog pod nazivom alkilirajući agens.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius 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 Carmustine Obvius nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Carmustine Obvius authorised in the EU?
Croatian: Zašto je lijek Carmustine Obvius odobren u EU-u?
English: Other information about Carmustine Obvius
Croatian: Ostale informacije o lijeku Carmustine Obvius
English: What are the benefits and risks of Carmustine Obvius?
Croatian: Koje su koristi i rizici od lijeka Carmustine Obvius?
English: This is because Carmustine Obvius 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 Carmustine Obvius daje infuzijom u venu te tako djelatna tvar dospijeva izravno u krvotok.
English: For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Carmustine Obvius pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Carmustine Obvius is given by infusion (drip) into a vein.
Croatian: Lijek Carmustine Obvius daje se intravenskom infuzijom (drip).
English: As for all medicines, data on the use of Carmustine Obvius are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Carmustine Obvius kontinuirano se prate.
English: As for every medicine, the company provided studies on the quality of Carmustine Obvius.
Croatian: Kao za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Carmustine Obvius.
English: Therefore, the Agency's view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Carmustine Obvius, kao i od lijeka Carmubris, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Because cancer cells tend to grow and multiply more than normal
Croatian: S obzirom na to da, u odnosu na normalne stanice, stanice raka uobičajeno više rastu i umnožavaju se, lijek na njih jače djeluje.
English: How does Carmustine Obvius work?
Croatian: Kako djeluje Carmustine Obvius?
English: How is Carmustine Obvius used?
Croatian: Kako se Carmustine Obvius koristi?
English: How has Carmustine Obvius been studied?
Croatian: Kako je Carmustine Obvius ispitivan?
English: That expiry date refers to the last day of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: Results beyond 48 weeks of treatment:
Croatian: Rezultati nakon 48 tjedana liječenja:
English: Baraclude with food and drink
Croatian: Baraclude s hranom i pićem
English: In most cases you may take Baraclude with or without food.
Croatian: U većini slučajeva možete uzimati Baraclude s hranom ili bez nje.
English: After each use, rinse the spoon with water and allow it to air dry.
Croatian: Nakon svake uporabe, isperite žlicu vodom i ostavite da se osuši na zraku.
English: Baraclude will not control your HIV infection.
Croatian: Baraclude neće kontrolirati Vašu HIV infekciju.
English: Your doctor will monitor you regularly while you are receiving Baraclude.
Croatian: Liječnik će Vas redovito pratiti dok primate Baraclude.
English: Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011
Croatian: Datum prvog odobrenja: 26. lipnja 2006.
English: PC: SN: <NN:>
Croatian: SN: <NN:>
English: Baraclude reduces the amount of virus in your body, and improves the condition of the liver.
Croatian: Baraclude smanjuje količinu virusa u Vašem tijelu i poboljšava stanje jetre.
English: The randomization was stratified by age group (2 to 6 years; > 6 to 12 years; and > 12 to < 18 years).
Croatian: Randomizacija je stratificirana prema dobnim skupinama (2 do 6 godina; > 6 do12 godina i > 12 do< 18 godina).
English: Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose.
Croatian: Držite žlicu u okomitom položaju (uspravno) i postupno je napunite do oznake koja odgovara propisanoj dozi.
English: What Baraclude is and what it is used for What you need to know before you take Baraclude How to take Baraclude
Croatian: Što je Baraclude i za što se koristi Što morate znati prije nego počnete uzimati Baraclude
English: Stable or improved CTP scoreb,d MELD score
Croatian: Stabilan ili poboljšan CTP indeksb,d
English: When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.
Croatian: Nakon prestanka liječenja lijekom Baraclude, liječnik će Vas tijekom nekoliko mjeseci nastaviti pratiti i raditi krvne pretrage.