FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection/infusion 1 vial of 5 ml.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju/infuziju
English: (CCG-1962) and IV (AALL07P4) provides maintenance of L-asparagine depletion for approximately two weeks following dosing.
Croatian: Na temelju rezultata iz ta dva ispitivanja, doza od 2500 U/m2 BSA (površine tijela) lijeka Oncaspar uz i.m. (CCG-1962) i i.v. (AALL07P4) primjenu omogućuje održavanje smanjenja L-asparagina približno dva tjedna nakon doziranja.
English: Particularly in patients with known hypersensitivity to the other forms of L-asparaginase, hypersensitivity reactions to Oncaspar can occur during the therapy, e.g., anaphylaxis.
Croatian: Reakcije preosjetljivosti na Oncaspar, primjerice anafilaksija, mogu se pojaviti tijekom terapije naročito u bolesnika s poznatom preosjetljivošću na druge oblike L-asparaginaze.
English: This medicinal product can cause irritation on contact.
Croatian: Ovaj lijek može uzrokovati nadražaj uslijed doticaja.
English: Common (may affect up to 1 in 10 people) - Decreased number of red blood cells; - Build-up of fluid in the stomach (ascites); - Fever and flu-like symptoms; - Mouth sores; - Back, joint or abdominal pain; - High levels of fat and cholesterol in your blood; low potassium in your blood.
Croatian: - bolovi u leđima, zglobovima ili trbuhu; - visoke razine masnoće i kolesterola u krvi; niske razine kalija u krvi.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous or intramuscular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat hidrat natrijev klorid saharoza natrijev hidroksid (za prilagodbu pH) kloridna kiselina (za prilagodbu pH)
English: Servier Nederland Farma B.V. Tel: + 31 (0)71 5246700
Croatian: Tel: +31 (0)71 5246700
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion.
Croatian: NAZIV LIJEKA Oncaspar 750 U/ml prašak za otopinu za injekciju/infuziju.
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Oncaspar 750 U/ml prašak za otopinu za injekciju/infuziju. pegaspargaza
English: If you are given too much Oncaspar
Croatian: Ako primite više lijeka Oncaspar nego što ste trebali
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml solution for injection/infusion.
Croatian: NAZIV LIJEKA Oncaspar 750 U/ml otopina za injekciju/infuziju.
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Oncaspar 750 U/ml otopina za injekciju/infuziju. pegaspargaza
English: MARKETING AUTHORISATION HOLDER Les Laboratoires Servier 50, rue Carnot
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Les Laboratoires Servier
English: Effective non-oral method of contraception must be used during Oncaspar treatment and for at least 6 months after Oncaspar discontinuation.
Croatian: Za vrijeme trajanja liječenja, kao i najmanje 6 mjeseci nakon prekida primjene lijeka Oncaspar, mora se primjenjivati učinkovita kontracepcija koja nije oralna.
English: Posology
Croatian: Nuspojava
English: Native E. coli L-asparaginase (6,000 Units/m2 BSA intramuscular) was administered 3 times weekly for 9 doses during induction.
Croatian: Nativna L-asparaginaza iz E. coli (6000 jedinica/m2 BSA
English: Not known (frequency cannot be estimated from the available data) - Decreased number of white blood cells and platelets; - Palpitations; - Cysts in your pancreas, swelling of the salivary glands; - High levels of urea in your blood; antibodies against Oncaspar; high levels of ammonia in your blood; decreased blood sugar levels; - Sleepiness, confusion, mild twitching of the fingers.
Croatian: - visoke razine ureje u Vašoj krvi; protutijela protiv lijeka Oncaspar; visoka razina amonijaka u krvi; smanjene razine šećera u krvi
English: 14 October 2016 EMA/656265/2016 EMEA/H/C/004003
Croatian: EMA/656265/2016 EMEA/H/C/004003
English: What is Zemfirza?
Croatian: Što je Zemfirza?
English: It was to be available as tablets.
Croatian: Lijek je trebao biti dostupan u obliku tableta.
English: The main measure of effectiveness was the length of time patients lived without their disease getting worse (progression-free survival).
Croatian: Glavno mjerilo učinkovitosti bilo je vrijeme preživljenja bolesnica bez pogoršanja bolesti (preživljenje bez napredovanja bolesti).
English: Withdrawal of the marketing authorisation application for Zemfirza (cediranib)
Croatian: Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Zemfirza (cediranib)
English: The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine.
Croatian: Tvrtka je predstavila rezultate glavnog ispitivanja u kojemu je sudjelovalo 456 bolesnica s rakom jajnika koji se ponovno pojavio 6 ili više mjeseci nakon jednog prethodnog liječenja lijekom temeljenim na platini.
English: On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer.
Croatian: Dana 19. rujna 2016., tvrtka AstraZeneca AB službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Zemfirza za liječenje raka jajnika.
English: It was to be used in patients whose disease had come back after previous treatment.
Croatian: Lijek se trebao koristiti za liječenje bolesnica čija se bolest ponovno pojavila nakon prethodnog liječenja.
English: By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.
Croatian: Budući da blokira VEGF receptore, očekuje se da će ovaj lijek smanjiti opskrbu stanica raka krvlju te time usporiti rast i širenje bolesti.
English: The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP).
Croatian: CHMP je izrazio zabrinutost u pogledu pouzdanosti rezultata ispitivanja nakon što je proveo rutinsku inspekciju mjesta provođenja kliničkog ispitivanja kojom je utvrđeno da provedeno ispitivanje nije u potpunosti sukladno načelima dobre kliničke prakse (GCP).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnice koje su u ovom trenutku uključene u klinička ispitivanja u kojima se koristi lijek Zemfirza.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio dokumentaciju koju je tvrtka dostavila te je sastavio popis pitanja.
English: In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.
Croatian: Osim toga, opaženo produljenje vremena preživljenja bez napredovanja bolesti s lijekom Zemfirza smatralo se skromnim, a postojali su problemi u vezi s nuspojavama lijeka, posebice proljev i umor, koje su dovele do toga da su mnoge bolesnice ranije prekinule liječenje.
English: In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period.
Croatian: Lijek Zemfirza u ispitivanju je uspoređen s placebom (prividno liječenje), a primjenjivan je u kombinaciji s lijekovima temeljenima na platini tijekom inicijalnog liječenja te zatim samostalno u razdoblju održavanja.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review.
Croatian: Tvrtka je u svojem dopisu u kojem Agenciju obavještava o povlačenju zahtjeva navela da povlači svoj zahtjev zato što u ovoj kasnoj fazi pregleda još uvijek postoje nedoumice.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zemfirza could not have been approved for the treatment of ovarian cancer.
Croatian: Na temelju pregleda podataka te odgovora tvrtke na popise pitanja CHMP-a, u trenutku povlačenja, CHMP je smatrao da postoje problemi te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Zemfirza za liječenje raka jajnika.
English: What was Zemfirza expected to be used for?
Croatian: Za što se lijek Zemfirza trebao koristiti?
English: These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells.
Croatian: Ovi se receptori u velikom broju nalaze u stanicama krvnih žila i sudjeluju u nastanku novih krvnih žila koje opskrbljuju stanice raka hranjivim tvarima.
English: Zemfirza is a cancer medicine that contains the active substance cediranib.
Croatian: Zemfirza je lijek protiv raka koji sadrži djelatnu tvar cediranib.
English: Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen).
Croatian: Lijek Zemfirza trebao se koristiti za liječenje žena koje boluju od raka jajnika, kao i raka jajovoda koji povezuju jajnike s maternicom i raka peritoneuma (potrbušnice).
English: The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors.
Croatian: Djelatna tvar u lijeku Zemfirza, cediranib, blokira aktivnost receptora za vaskularni endotelni čimbenik rasta (VEGF).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company.
Croatian: Sukladno navedenome, u vrijeme povlačenja, CHMP je smatrao kako koristi lijeka Zemfirza ne nadmašuju s njim povezane rizike te je od tvrtke zatražio dodatno pojašnjenje.
English: The company had not responded to the last round of questions at the time of the withdrawal.
Croatian: U trenutku povlačenja tvrtka još nije bila dostavila svoje odgovore na posljednji popis pitanja.
English: How does Zemfirza work?
Croatian: Kako djeluje lijek Zemfirza?
English: Zemfirza was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer.
Croatian: Lijek Zemfirza bio je označen kao lijek za liječenje rijetkih i teških bolesti dana 29. srpnja 2014. za rak jajnika.
English: Further information on the orphan designation can be found here.
Croatian: Dodatne informacije o uvrštenju lijekova u skupinu lijekova za rijetke bolesti možete pronaći ovdje.
English: Higher doses may be justified in some clinical circumstances.
Croatian: Više doze mogu biti opravdane u nekim kliničkim okolnostima.
English: You produce many different kinds of antibodies.
Croatian: Vaše tijelo proizvodi mnogo različitih vrsta protutijela.
English: • It is possible to have a serious allergic reaction to LeukoScan.
Croatian: • Moguće su teške alergijske reakcije na LeukoScan.
English: No interactions with other medicines have been described to date.
Croatian: Do danas nisu opisane interakcije s drugim lijekovima.
English: This material will then be injected into your vein.
Croatian: Dobiveni će se materijal ubrizgati u Vašu venu.
English: If you take more LeukoScan than you should
Croatian: Ako primite više LeukoScana nego što ste trebali
English: The doctor can also determine how much disease there is.
Croatian: Liječnik također može odrediti koliko je bolest proširena.
English: It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction.
Croatian: Ipak je potrebno napomenuti da ta ispitivanja nisu procjenjivala genotoksičnost, kancerogeni potencijal ili reproduktivnu toksičnost.
English: The radiolabelled product should not contain more than 10% free technetium.
Croatian: Radioobilježeni lijek ne smije sadržavati više od 10 % slobodnog tehnecija.
English: Reconstituted and radiolabelled material - 4 hours.
Croatian: Rekonstituirani i radioaktivno obilježeni materijal - 4 sata.
English: It is produced in mice and purified so that it can be used in humans.
Croatian: Proizvodi se u tijelu miša i pročišćava kako bi se mogla upotrijebiti u ljudi.
English: No studies effects of food/drink have been performed.
Croatian: Nisu provedena ispitivanja u učinku hrane/pića na lijek.
English: Appropriate cardiopulmonary resuscitation facilities and trained personnel should be available for immediate use in the event of an adverse reaction.
Croatian: Odgovarajuća oprema za kardiopulmonalnu resuscitaciju i educirano osoblje mora biti odmah dostupno u slučaju neželjene reakcije.
English: Human Anti-mouse Antibody (HAMA)
Croatian: Ljudsko anti-mišje protutijelo (Human Anti-mouse Antibody - HAMA)
English: This will help the doctor determine whether there is infection in the bone and what kind of treatment to use.
Croatian: To pomaže liječniku odrediti postoji li u kosti infekcija i koje liječenje poduzeti.
English: Patients have been given four times the amount you will receive with no adverse reactions.
Croatian: Bolesnici su primali količine četiri puta veće od one koju ćete Vi primiti bez nuspojava.
English: This dose of radioactivity is safe and will be gone from the body in about 24
Croatian: Ova doza radioaktivnosti je bezopasna i izlučit će se iz tijela za otprilike 24 sata.
English: Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
Croatian: Njegovo preuzimanje, čuvanje, korištenje, premještanje i zbrinjavanje regulirano je propisima i/ili odgovarajućim dozvolama koje izdaju nacionalna nadležna službena tijela.
English: There are, as yet, limited data on safety following repeated use.
Croatian: Za sada, podaci o sigurnosti ponovne primjene su ograničeni.
English: Average Dose µGy/MBq
Croatian: Prosječna doza µGy/MBq
English: These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging
Croatian: Polučena korist bila je također popraćena značajnim smanjenjem (85,4 %) broja bolesnika kojima su bile potrebni drugi dijagnostički
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove,
English: Date of approval of latest variation or transfer: MM/YYYY
Croatian: Datum odobrenja posljednje promjene ili prijenosa odobrenja: MM/GGGG
English: If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to
Croatian: Ako Vaš liječnik odluči ponovo Vam ga dati nakon nekoliko tjedana ili nekoliko mjeseci, potrebno je prethodno učiniti pretragu krvi i vidjeti jeste li razvili
English: LeukoScan is prepared for a single injection.
Croatian: LeukoScan se priprema za jednokratnu injekciju.
English: The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Croatian: Dobivena otopina ima pH 4,5-5,5 i namijenjena je samo za
English: Immunoscintigraphy should be performed one to eight hours after injection.
Croatian: Imunoscintigrafija mora se učiniti jedan do osam sati nakon injiciranja.
English: In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
Croatian: Primijećeno je in vitro pozitivno vezivanje na limfocite do 2-6 %.
English: LeukoScan is contraindicated in pregnancy.
Croatian: LeukoScan je kontraindiciran u trudnoći.
English: Calculate the percent free technetium as follows:
Croatian: Izračunajte postotak slobodnog tehnecija prema sljedećoj formuli:
English: It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv.
Croatian: Obično se savjetuje ponovno započeti s dojenjem kada razina radioaktivnosti u mlijeku neće predstavljati dozu zračenja za dijete veću od 1 mSv.
English: 6.2 Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or
Croatian: Ovaj se lijek ne smije miješati s drugim lijekovima osim onima navedenima u dijelu 6.6 ili 12.
English: * Effective Dose Equivalent and Effective Dose are in units of µSv/MBq.
Croatian: * Ekvivalent efektivne doze i efektivna doza izraženi su u µSv/MBq.
English: Reconstituted and radiolabelled material - Do not store above 25ºC.
Croatian: Rekonstituirani i radioaktivno obilježeni materijal - ne čuvati na temperaturi iznad 25°C.
English: LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Croatian: LeukoScan [99mTc] može se upotrijebiti nakon deset minuta i mora se iskoristiti unutar četiri sata od pripreme.
English: For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv.
Croatian: Za većinu dijagnostičkih pretraga koje koriste postupke nuklearne medicine, isporučena doza zračenja (efektivna doza / EDE) iznosi manje od 20 mSv.
English: After injection, any remaining portion of the reconstituted solution should be discarded.
Croatian: Nakon injiciranja, sva preostala količina rekonstituirane otopine mora se baciti.
English: Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
Croatian: Potrebno je poduzeti odgovarajuće aseptičke mjere, poštivajući zahtjeve dobre proizvođačke prakse za farmaceutske proizvode.
English: There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Croatian: Nije bilo bitne razlike u utvrđivanju postojanja ili nepostojanja osteomijelitisa između vremenskih točki 1-2 sata i 5-8 sati nakon injiciranja.
English: The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Croatian: Klinički rezultati ukazuju na to da kod različitih oblika osteomijelitisa LeukoScan može pokazati različite rezultate.
English: None of these were considered serious, and all resolved without sequelae.
Croatian: Niti jedna nije smatrana teškom i sve su prošle bez posljedica.
English: Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Croatian: Single photon emission computed tomography - SPECT) također se može izvesti i može pomoći u razlikovanju osteomijelitisa od infekcije mekih tkiva.
English: When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Croatian: Kada granična linija otapala bude unutar 1 cm od gornjeg kraja trake, prerežite traku na dvije polovice i svaku polovicu stavite u staklenu cijev.
English: Image acquisition in analogue and/or digital word-mode and at least a 128 x 128 matrix is recommended.
Croatian: Preporučuje se dobivanje snimaka u analognom i/ili digitalnom word-modusu i s matricom najmanje 128 x 128.
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Croatian: Izlaganje ionizirajućem zračenju povezano je s indukcijom raka i potencijalnim razvojem nasljednih oštećenja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1997
Croatian: Datum prvog odobrenja: 14. veljače 1997.
English: In subjects with HAMA, there may be a greater chance of hypersensitivity reactions and
Croatian: U osoba s HAMA može biti veća mogućnost pojave reakcija preosjetljivosti i manje
English: Radiolabelling must take place immediately after reconstitution of product.
Croatian: Radioobilježavanje mora se izvesti odmah nakon rekonstitucije lijeka.
English: For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Croatian: Za svakog bolesnika izlaganje ionizirajućem zračenju može biti opravdano na temelju moguće koristi.
English: The kit does not include the radioisotope.
Croatian: Komplet ne sadrži radioizotop.
English: The following minor, self-limiting, rare adverse events were reported in the clinical trials and considered at least possibly related to LeukoScan: eosinophilia (3); and facial rash (1).
Croatian: Sljedeće manje značajne, rijetke nuspojave koje prolaze same od sebe prijavljene su tijekom kliničkih ispitivanja i smatrane barem moguće povezane s LeukoScanom: eozinofilija (3) i osip lica (1).
English: LeukoScan is used to determine the presence of infections in long bones.
Croatian: LeukoScan se koristi za utvrđivanje postojanja infekcija u dugim kostima.
English: An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Croatian: Protutijelo je prirodna tvar koju proizvodi tijelo i koja se veže na strane tvari i time pomaže njihovo odstranjivanje iz organizma.
English: Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12).
Croatian: Prije primjene otopinu je potrebno vizualno pregledati na sadržaj čestica i promjenu boje, te izvršiti kontrolu kvalitete (vidjeti dio 12).
English: Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Croatian: Postupci s radionuklidima koji se izvode u trudnica također uključuju doze radijacije i za fetus.
English: Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Croatian: Farmakoterapijska skupina: Dijagnostički radiofarmaceutici.
English: Data processing by filtered backprojection and reconstruction in three planes (transaxial, coronal, and sagittal)
Croatian: Preporučuje se obrada podataka filtriranim unazadnim projiciranjem i rekonstrukcijom u tri ravnine (transaksijalna, koronalna i
English: The eosinophil count increased from 2.7% preinjection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant.
Croatian: Veličina porasta broja eozinofila sa 2,7 % prije injekcije na 2,9 % 24 sata nakon injekcije, i na 3,9 % 10. dana, bila je statistički značajna za oba porasta.
English: These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Croatian: Ovo uključuje mali porast određene vrste bijelih krvnih stanica koje se nazivaju eozinofili (ali bez vidljivih simptoma) i osip.
English: Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
Croatian: Kada to nije sigurno, važno je da izloženost zračenju bude najmanja potrebna za dobivanje željenog kliničkog podatka.