FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Djelatna tvar lijekova Fulphila i Neulasta, pegfilgrastim, sastoji se od filgrastima koji je „pegiliran” (spojen s kemijskom tvari pod nazivom polietilen glikol).
English: What was Fulphila expected to be used for?
Croatian: Za što se Fulphila trebao koristiti?
English: Fulphila is a medicine that contains the active substance pegfilgrastim.
Croatian: Fulphila je lijek koji sadrži djelatnu tvar pegfilgrastim.
English: Withdrawal of the marketing authorisation application for Fulphila (pegfilgrastim) EMA/577551/2017
Croatian: (pegfilgrastim) EMA/577551/2017
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila could not have been approved to reduce neutropenia in patients taking cancer treatments.
Croatian: Na temelju pregleda podataka u trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Fulphila za smanjenje neutropenije u bolesnika koji se liječe od raka.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila could not be obtained in the time available.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev jer ne može na vrijeme dobiti certifikat dobre proizvođačke prakse za proizvodnu lokaciju lijeka Fulphila.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the quality of Fulphila had not been demonstrated.
Croatian: Stoga je CHMP u vrijeme povlačenja smatrao kako nije dokazana kvaliteta lijeka Fulphila.
English: The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Fulphila.
Croatian: Tvrtka je obavijestila CHMP da povlačenje zahtjeva ne utječe na klinička ispitivanja koja su u tijeku.
English: The CHMP was assessing the company's responses to the questions at the time of the withdrawal.
Croatian: U trenutku povlačenja CHMP je procjenjivao odgovore na pitanja koje je tvrtka dostavila.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila, for reducing neutropenia in patients taking cancer treatments.
Croatian: Dana 3. kolovoza 2017. tvrtka Mylan S.A.S. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Fulphila za smanjenje neutropenije u bolesnika koji se liječe od raka.
English: Powder : 200mg Solvent: 20 ml (10 mg/ml)
Croatian: Prašak: 200 mg Otapalo: 20 ml (10 mg/ml)
English: 1 vial +1 infusion bag +1 syringe +1 vial adaptor
Croatian: 1 bočica + 1 vrećica za infuziju + 1 štrcaljka + 1 adapter za bočicu
English: 1 vial
Croatian: 1 boca
English: Intravenous use vial (glass)
Croatian: U venu Bočica (staklena)
English: Intravenous use Powder: vial (glass) Solvent: infusion bag
Croatian: U venu Prašak: bočica (staklena)
English: Powder and solvent for solution for infusion
Croatian: 200 mg Prašak i otapalo za otopinu za infuziju
English: Film-coated tablet
Croatian: 100 tablets
English: Powder for solution for infusion
Croatian: Otapalo: vrećica za infuziju
English: Powder for oral suspension
Croatian: Prašak za oralnu suspenziju Kroz usta Boca (HDPE)
English: They should be taken within one hour after morning and evening meals.
Croatian: Potrebno ih je uzeti unutar sat vremena nakon jutarnjeg i večernjeg obroka.
English: The tablets are taken twice a day on certain days of each treatment cycle.
Croatian: Tablete se uzimaju dva puta dnevno u određene dane terapijskog ciklusa.
English: The Agency considered that the measures put in place are adequate to manage these risks.
Croatian: Agencija je smatrala da su uspostavljene mjere dostatne za kontrolu tih rizika.
English: Lonsurf (trifluridine / tipiracil)
Croatian: Lonsurf (trifluridin/tipiracil)
English: Lonsurf is available as tablets (15 mg trifluridine and 6.14 mg tipiracil; 20 mg trifluridine and 8.19 mg tipiracil) and is given in treatment cycles of 28 days.
Croatian: Lonsurf je dostupan u obliku tableta (15 mg trifluridina i 6,14 mg tipiracila; 20 mg trifluridina i 8,19 mg tipiracila) te se daje u terapijskim ciklusima od 28 dana.
English: Colorectal cancer
Croatian: Rak želudca
English: Lonsurf received a marketing authorisation valid throughout the European Union on 25 April 2016.
Croatian: Lijek Lonsurf dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 25. travnja 2016.
English: What measures are being taken to ensure the safe and effective use of Lonsurf?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lonsurf?
English: Further information on Lonsurf can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lonsurf.
Croatian: Više informacija o lijeku Lonsurf nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/lonsurf Pregled informacija posljednji je put ažuriran u 9. 2019.
English: Other information about Lonsurf
Croatian: Ostale informacije o lijeku Lonsurf
English: All patients had previously received other treatments.
Croatian: Svi su bolesnici prethodno primili barem dvije terapije.
English: Why is Lonsurf authorised in the EU?
Croatian: Zašto je lijek Lonsurf odobren u EU-u?
English: What is Lonsurf and what is it used for?
Croatian: Što je Lonsurf i za što se koristi?
English: In the body, trifluridine is converted into an active form that is incorporated into DNA, the genetic material of cells.
Croatian: Trifluridin se u tijelu pretvara u djelatni oblik koji se ugrađuje u DNK, genetički materijal stanica.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lonsurf 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 Lonsurf nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency decided that Lonsurf's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Lonsurf nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The conversion of trifluridine into its active form occurs 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: Pretvaranje trifluridina u njegov djelatni oblik odvija se brže u stanicama raka nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: An overview of Lonsurf and why it is authorised
Croatian: Pregled informacija o lijeku Lonsurf i zašto je odobren
English: The most common side effects with Lonsurf (which may affect more than 3 in 10 people) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), feeling sick, tiredness and anaemia (low red blood cell counts).
Croatian: Najčešće nuspojave lijeka Lonsurf (koje se mogu javiti u više od 3 na 10 osoba) su neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica koje se bore protiv infekcija), mučnina, umor i anemija (niska razina crvenih krvnih stanica).
English: As for all medicines, data on the use of Lonsurf are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Lonsurf kontinuirano se prate.
English: Side effects reported with Lonsurf are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Lonsurf pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: For more information about using Lonsurf, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Lonsurf pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Lonsurf?
Croatian: Koji su rizici povezani s lijekom Lonsurf?
English: Regarding its safety, although Lonsurf's side effects can be serious they are in line with what can be expected for this type of medicine.
Croatian: U pogledu sigurnosti, iako nuspojave lijeka Lonsurf mogu biti teške, one su u skladu s očekivanjima za citotoksičan lijek.
English: It contains two active substances: trifluridine and tipiracil.
Croatian: Sadrži dvije djelatne tvari: trifluridin i tipiracil.
English: Tipiracil increases the level of trifluridine in the blood by slowing its breakdown.
Croatian: Tipiracil povećava razinu trifluridina u krvi usporavanjem njegove razgradnje, što pojačava djelovanje trifluridina.
English: The most serious side effects are bone marrow suppression (when the bone marrow produces fewer blood cells than normal) and effects on the gut (diarrhoea and feeling sick).
Croatian: Najteže su nuspojave supresija koštane srži (kada koštana srž proizvodi manje krvnih stanica nego što je normalno) te učinci na crijeva (proljev i mučnina).
English: This reduces the growth of cancer cells, while normal cells are only slightly affected.
Croatian: Time se smanjuje razvoj stanica raka, dok je utjecaj na normalne stanice nizak.
English: In a study involving 507 adults with metastatic gastric cancer, patients treated with Lonsurf lived on average for 5.7 months compared with 3.6 months for patients who received placebo.
Croatian: U ispitivanju koje je uključivalo 507 odraslih osoba s metastatskim rakom želudca, bolesnici koji su primali Lonsurf živjeli su u prosjeku 5,7 mjeseci u usporedbi s 3,6 mjeseci koliko su živjeli bolesnici koji su primali placebo.
English: Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells).
Croatian: Lonsurf je citotoksičan lijek (lijek koji ubija stanice koje se dijele, poput stanica raka).
English: All patients received supportive care.
Croatian: Svi bolesnici koji su sudjelovali u ispitivanju primali su potpornu skrb.
English: In one main study involving 800 patients, those treated with Lonsurf lived on average for 7.1 months compared with 5.3 months for patients who were treated with placebo (a dummy treatment).
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 800 bolesnika pokazalo se da su bolesnici koji su primali Lonsurf živjeli u prosjeku 7,1 mjesec, u usporedbi s 5,3 mjeseci koliko su živjeli bolesnici koji su primali placebo (prividno liječenje).
English: Treatment with Lonsurf should be prescribed by a doctor who is experienced in the use of cancer medicines.
Croatian: Terapiju lijekom Lonsurf mora propisati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Lonsurf is a medicine used to treat adults with colorectal cancer (cancer of the large bowel) and gastric (stomach) cancer.
Croatian: Lonsurf je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s rakom debelog crijeva (kolorektalnim rakom) i rakom želudca (gastričnim rakom).
English: Treatment with Lonsurf should continue for as long as benefits can be seen and the side effects are tolerable.
Croatian: Terapija lijekom Lonsurf treba trajati sve dok su vidljive koristi od liječenja i sve dok bolesnik može podnositi nuspojave.
English: How does Lonsurf work?
Croatian: Kako djeluje Lonsurf?
English: It is used when the cancer is metastatic (has spread to other parts of the body) in patients who have already been treated with, or who cannot be given, other treatments for their cancer.
Croatian: Primjenjuje se kod metastatskog raka (koji se proširio na druge dijelove tijela) u bolesnika koji su prethodno prošli druge terapije protiv raka ili kod kojih druge terapije nisu moguće.
English: As a result, trifluridine interferes with DNA function and prevents the cells from dividing to make more cells.
Croatian: Kao rezultat toga, trifluridin ometa funkciju DNK-a te sprečava diobu kojom se stvara više stanica.
English: How is Lonsurf used?
Croatian: Kako se Lonsurf koristi?
English: Lonsurf contains the active substances trifluridine and tipiracil.
Croatian: Lonsurf sadrži djelatne tvari trifluridin i tipiracil.
English: The doctor may reduce the dose or interrupt treatment if certain side effects develop.
Croatian: Ako se razviju određene nuspojave, liječnik može smanjiti dozu ili privremeno prekinuti liječenje.
English: What benefits of Lonsurf have been shown in studies?
Croatian: Koje su koristi od lijeka Lonsurf utvrđene u ispitivanjima?
English: The Agency considered that the benefit of Lonsurf in prolonging survival in patients with metastatic colorectal and metastatic gastric cancer who have received previous treatment was important.
Croatian: Agencija je smatrala da su koristi od lijeka Lonsurf bitne u produljenju života bolesnika s metastatskim rakom debelog crijeva i metastatskim rakom želudca koji su prethodno primali druge terapije.
English: For the full list of side effects and restrictions of Lonsurf, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Lonsurf potražite u uputi o lijeku.
English: Lonsurf prolonged overall survival of patients with metastatic colorectal cancer and in patients with metastatic gastric cancer.
Croatian: Lijek Lonsurf produžio je život bolesnicima s metastatskim rakom debelog crijeva koji su prethodno primali druge terapije.
English: 2007 to 2014
Croatian: Od 2007. do 2014. godine
English: It usually occurs in one part of the body and can last for several weeks.
Croatian: Obično nastaje na jednom dijelu tijela i može trajati nekoliko tjedana.
English: What is PHN?
Croatian: Što je PHN?
English: Average VE§
Croatian: Prosječna VE§
English: • if you have a fever
Croatian: • ako imate vrućicu
English: - This vaccine has been prescribed for you only.
Croatian: - Ovo je cjepivo propisano samo Vama.
English: • if you have or have had any medical problems or any allergies
Croatian: • ako imate ili ste imali neki zdravstveni problem ili bilo kakvu alergiju
English: Some of these reactions may be serious and may include difficulty in breathing or swallowing.
Croatian: Neke od tih reakcija mogu biti ozbiljne i mogu uključivati otežano disanje ili gutanje.
English: North Carolina 27712 U.S.A
Croatian: North Carolina 27712 SAD
English: If you have an allergic reaction, call your doctor right away.
Croatian: Ako imate alergijsku reakciju, odmah se javite liječniku.
English: What ZOSTAVAX is and what it is used for
Croatian: Što je ZOSTAVAX i za što se koristi
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego primite ovo cjepivo jer sadrži Vama važne podatke.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or vaccines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove ili cjepiva.
English: Date of first authorisation: 19 May 2006 Date of latest renewal: 11 February 2016
Croatian: Datum posljednje obnove odobrenja: 11. veljače 2016.
English: After the shingles blisters heal, pain can last for months or years and may be severe.
Croatian: Nakon što mjehurići herpes zostera zacijele, bol može trajati mjesecima ili godinama i može biti jaka.
English: The safety and efficacy of ZOSTAVAX in children and adolescents have not been established.
Croatian: Sigurnost i djelotvornost cjepiva ZOSTAVAX u djece i adolescenata nisu ustanovljene.
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment
Croatian: • ako Vam je liječnik rekao da imate oslabljeni imunološki sustav zbog bolesti, lijekova ili drugih oblika liječenja
English: • Active untreated tuberculosis.
Croatian: • Aktivna neliječena tuberkuloza.
English: Adults receiving additional doses/revaccination
Croatian: Odrasli koji su primili dodatne doze/docijepljeni
English: • if you have HIV infection
Croatian: • ako imate HIV-infekciju
English: The adverse reactions are assigned frequency categories using the following convention: Very Common (≥1/10);
Croatian: Nuspojave su raspoređene prema kategorijama učestalosti sukladno sljedećoj konvenciji: Vrlo često (≥1/10);
English: ZOSTAVAX is given as a single dose.
Croatian: ZOSTAVAX se daje kao jednokratna doza.
English: Avoid contact with disinfectants as they may inactivate the vaccine virus.
Croatian: Izbjegavati kontakt s dezinficijensima, jer mogu inaktivirati virus cjepiva.
English: The two vaccines should be given as separate injections at different body sites.
Croatian: Ta dva cjepiva moraju se dati zasebnim injekcijama na različita mjesta na tijelu.
English: Neomycin allergy generally manifests as a contact dermatitis.
Croatian: Alergija na neomicin općenito se manifestira kao kontaktni dermatitis.
English: What you need to know before you receive ZOSTAVAX
Croatian: Što morate znati prije nego primite ZOSTAVAX
English: Headache and pain in the extremity were the most common systemic adverse reactions.
Croatian: Glavobolja i bol u ekstremitetima bile su najčešće sistemske nuspojave.
English: See sections 4.3 and 4.4.
Croatian: Vidjeti dijelove 4.3 i 4.4.
English: Individuals should receive a single dose (0.65 mL).
Croatian: Osobe trebaju primiti jednokratnu dozu (0,65 ml).
English: Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) mogu nastati alergijske reakcije.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovo cjepivo.
English: Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation has a safety profile comparable to that of the frozen formulation.
Croatian: Podaci iz jednog kliničkog ispitivanja (n=368) pokazali su da sadašnja ohlađena formulacija ima sigurnosni profil usporediv s profilom zamrznute formulacije.
English: Reconstitution instructions intended for healthcare professionals are included at the end of the leaflet.
Croatian: Upute za pripremu namijenjene zdravstvenim radnicima nalaze se na kraju ove upute.
English: A decision must be made whether to discontinue breast-feeding or to not administer ZOSTAVAX taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili ne primijeniti cjepivo ZOSTAVAX uzimajući u obzir korist dojenja za dijete i korist cjepljenja za ženu.
English: This vaccine may contain traces of neomycin.
Croatian: Ovo cjepivo može sadržavati neomicin u tragovima.
English: Produced in human diploid (MRC-5) cells
Croatian: Umnožen na ljudskim diploidnim (MRC-5) stanicama
English: ZOSTAVAX is available in packs of 1 or 10.
Croatian: ZOSTAVAX je dostupan u pakiranjima od 1 ili 10.
English: After reconstitution, the vaccine should be used immediately.
Croatian: Nakon rekonstitucije, cjepivo se mora odmah primijeniti.
English: In an interim analysis of the 2007 to 2014 study period, out of 1,355,720 study individuals, 392,677 received ZOSTAVAX.
Croatian: U interim analizi razdoblja ispitivanja od 2007. do 2014. godine, od 1 355 720 ispitanika, njih 392 677 primilo je ZOSTAVAX.
English: Your doctor will decide if ZOSTAVAX should be given.
Croatian: Vaš liječnik će odlučiti smijete li primiti ZOSTAVAX.
English: • if you have a blood disorder or any type of cancer that weakens your immune system
Croatian: • ako imate krvni poremećaj ili bilo koju vrstu raka koja slabi imunološki sustav
English: Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
Croatian: Manje često mogu nastati bakterijske infekcije kože, slabost, paraliza mišića, gubitak sluha ili vida.
English: In clinical trials, general safety has been evaluated in more than 57,000 adults vaccinated with ZOSTAVAX.
Croatian: U kliničkim ispitivanjima opća sigurnost procijenjena je na više od 57 000 odraslih osoba cijepljenih cjepivom ZOSTAVAX.
English: Other medicines and ZOSTAVAX
Croatian: Drugi lijekovi i ZOSTAVAX
English: Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin or any of the ingredients listed under section 6) before you receive this vaccine.
Croatian: Obavijestite svog liječnika ako ste ikad imali alergijsku reakciju na neki od sastojaka (uključujući neomicin ili bilo koji sastojak naveden u dijelu 6.) prije nego što primite ovo cjepivo.
English: Number of PHN cases
Croatian: Broj slučajeva PHN-a
English: Although, ZOSTAVAX is indicated as a single dose regimen (see section 4.2), a two-dose regimen was used.
Croatian: Iako je ZOSTAVAX indiciran kao režim s jednokratnom dozom (vidjeti dio 4.2), primijenio se režim s dvije doze.
English: Adverse events were followed up to Day 42 post vaccination and serious adverse events throughout the entire study period (i.e. through Day 180).
Croatian: Štetni događaji su bili praćeni do 42. dana nakon cijepljenja, a ozbiljni štetni događaji tijekom cijelog trajanja ispitivanja (tj. do 180. dana).
English: • if you are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see
Croatian: • ako ste trudni (štoviše, trudnoću treba izbjegavati mjesec dana nakon cijepljenja, vidjeti
English: d. Special populations
Croatian: Posebne populacije
English: Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.
Croatian: Imunizaciju treba odgoditi u osoba koje imaju umjerenu do tešku akutnu febrilnu bolest ili infekciju.
English: It may lead to severe and long-lasting pain and scarring.
Croatian: Može dovesti do jakih i dugotrajnih bolova i stvaranja ožiljka.
English: Inject the vaccine.
Croatian: Ubrizgajte cjepivo.
English: The requirements for submission of periodic safety update reports for this medicinal products 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 periodičkih 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: However, data collected in a large observational study did not indicate increased risk for developing herpes zoster after concomitant administration of the two vaccines.
Croatian: Međutim, podaci prikupljeni u velikom opservacijskom ispitivanju nisu ukazali na povećan rizik od razvoja herpes zostera nakon istodobne primjene ova dva cjepiva.
English: However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Croatian: Međutim, prethodni kontaktni dermatitis zbog neomicina nije kontraindikacija na primanje živih virusnih cjepiva.
English: It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Croatian: Važno je u svakog pojedinog bolesnika uporabiti zasebnu sterilnu štrcaljku i iglu, kako bi se spriječio prijenos infektivnih uzročnika s jedne osobe na drugu.
English: No data are currently available regarding concomitant use with other vaccines.
Croatian: Za sada nema dostupnih podataka o istodobnoj primjeni s drugim cjepivima.