FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
Croatian: - ako izgubite apetit, imate mučninu, povraćanje, proljev, tamno obojenu mokraću i svijetlo obojenu stolicu, bol u trbuhu, žuticu (žuto obojenje kože i očiju) ili ako se općenito loše osjećate, to mogu biti simptomi upale jetre (hepatitisa) ili oštećenja jetre (zatajenje jetre); - ako mokrite malo ili nimalo mokraće, ili osjetite omamljenost, mučninu, povraćanje, nedostatak zraka, gubitak apetita i/ili slabost (ovo mogu biti znakovi akutnog zatajenja bubrega/zatajenja bubrega).
English: For storage conditions after dilution of the medicinal product, see section 6.3
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
English: Pharmacokinetics in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of multiple doses of clofarabine by intravenous infusion
Croatian: Farmakokinetika u bolesnika u dobi između 2 i 19 godina s relapsnom ili refraktornom ALL
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on the reference medicinal product.The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary accordingly to the reference medicinal product SmPC.
Croatian: Europska agencija za lijekove svake će godine procjenjivati sve nove informacije koje postanu dostupne te će se tekst sažetka opisa svojstava lijeka ažurirati prema potrebi, u skladu s tekstom sažetka opisa svojstava referentnog lijeka.
English: Therefore, clofarabine should be used with caution in patients with mild to moderate renal insufficiency (see section 4.2 for dose adjustments).
Croatian: Stoga klofarabin treba primjenjivati uz oprez u bolesnika s blagim do umjerenim zatajivanjem bubrežne funkcije (vidjeti dio 4.2. za prilagodbu doze).
English: Response category
Croatian: Način primjene
English: Eleven events in 115 patients were considered to be related to clofarabine, none of which were serious and the most frequently reported cardiac disorder was tachycardia (35%) (see section 4.4); 6.1% (7/115) patient's tachycardia were considered to be related to clofarabine.
Croatian: Jedanaest događaja prijavljenih u 115 bolesnika smatralo se povezanima s klofarabinom; nijedan nije bio ozbiljan, a najčešće je prijavljivana tahikardija (35%) (vidjeti dio 4.4).
English: Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Croatian: Prilikom liječenja klofarabinom prijavljeni su slučajevi hepatitisa i zatajenja jetre, uključujući smrtne ishode (vidjeti dio 4.8).
English: • Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events.
Croatian: • Radi ublažavanja učinaka lize tumora i drugih događaja, bolesnicima je tijekom petodnevnog razdoblja primjene klofarabina potrebna intravenska hidracija.
English: Common: Hypersensitivity
Croatian: Poremećaji imunološkog sustava često: preosjetljivost
English: OTHER
Croatian: Ako
English: Systemic inflammatory response syndrome (SIRS) or capillary leak syndrome SIRS, capillary leak syndrome (signs and symptoms of cytokine release, e.g., tachypnea, tachycardia, hypotension, pulmonary oedema) were reported as an adverse reaction in 5% (6/115) of paediatric patients (5 ALL, 1 AML) (see section 4.4).
Croatian: Sindrom sistemskog upalnog odgovora (SIRS) ili sindrom povećane propusnosti kapilara Sindrom sistemskog upalnog odgovora, sindrom povećane propusnosti kapilara (znakovi i simptomi otpuštanja citokina, npr. tahnipneja, tahikardija, hipotenzija, plućni edem) prijavljeni su kao nuspojave u
English: Clofarabine may cause serious birth defects when administered during pregnancy.
Croatian: Ako se primjenjuje tijekom trudnoće, klofarabin može prouzročiti ozbiljne prirođene mane.
English: Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported in patients who were receiving or had recently been treated with clofarabine.
Croatian: U bolesnika koji su primali klofarabin ili su nedavno njim bili liječeni, prijavljeni su Stevens-Johnsonov sindrom (SJS) i toksična epidermalna nekroliza (TEN), uključujući i smrtne slučajeve.
English: Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Croatian: Dobroćudne i zloćudne novotvorine (uključujući ciste i polipe) i poremećaji imunološkog sustava
English: Very common: Febrile neutropenia Common: Neutropenia
Croatian: Poremećaji krvi i limfnog sustava vrlo često: neutropenijska vrućica često: neutropenija
English: • Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias.
Croatian: U bolesnika liječenih klofarabinom treba pažljivo nadzirati sljedeće parametre: • kompletnu krvnu sliku i broj trombocita treba kontrolirati redovito, a češće u bolesnika u kojih se pojave citopenije.
English: - feeling numb or weak in the arms and legs, numbness of the skin, sleepiness, dizziness, tremor; - hearing problems; - water collecting around the heart, fast heartbeat; - low blood pressure, lump due to bad bruising; - leaking from tiny blood vessels, rapid breathing, nosebleeds, breathing difficulties,
Croatian: - nizak krvni tlak, nastanak oteklina zbog jakih podljeva krvi; - krvarenje iz malih krvnih žila, ubrzano disanje, krvarenje iz nosa, otežano disanje, nedostatak zraka,
English: Each vial of Ivozall contains 70.77 mg of sodium.
Croatian: Jedna bočica lijeka Ivozall sadrži 70,77 mg natrija, što odgovara količini od 3,08 mmol (ili 70,77 mg)
English: *ITT = intention to treat.
Croatian: *ITT = svi uključeni bolesnici (engl. intent to treat)
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta često: hipoakuzija
English: Suggested dilution schedule based on the recommended dosage of 52 mg/m2/day clofarabine
Croatian: Predložena shema razrjeđivanja utemeljena na preporučenoj dozi klofarabina od
English: Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Croatian: herpes zoster, herpes simplex, oralna kandidijaza učestalost nepoznata: kolitis uzrokovan C. difficile
English: Tell your doctor if any of these conditions apply to you.
Croatian: Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika.
English: If you use more Ivozall than you should If you think you may have been given too much medicine, tell your doctor straight away.
Croatian: Ako mislite da ste primili previše lijeka, odmah se obratite svome liječniku.
English: Thus, the concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period (see sections 4.4, 4.8 and 5.2).
Croatian: pentamidin, ciklosporin, takrolimus, aciklovir i valganciklovir, naročito tijekom petodnevnog razdoblja primjene klofarabina (vidjeti dijelove 4.4, 4.8 i 5.2).
English: If a patient experiences a hematologic toxicity of Grade 4 neutropaenia (ANC < 0.5 x 10
Croatian: Ako se u bolesnika pojavi jedna ili više teških toksičnosti (toksičnosti 3. stupnja prema Zajedničkim kriterijima toksičnosti (engl.
English: Hepatic effects were observed in rats following chronic administration of clofarabine.
Croatian: Nakon dugotrajne primjene klofarabina u štakora su primijećeni učinci na jetru.
English: It should be visually inspected for particulate matter and discolouration prior to administration.
Croatian: Prije primjene treba vizualno provjeriti sadrži li otopina čestice i je li promijenila boju.
English: Common: Pain in extremity, myalgia, bone pain, chest wall pain, arthralgia, neck and back pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva često: bol u udovima, mialgija, bol u kostima, bol u stjenci prsnog koša, artralgija, bol u vratu i leđima
English: What Ivozall looks like and contents of the pack Ivozall is a concentrate for solution for infusion.
Croatian: Kako Ivozall izgleda i sadržaj pakiranja
English: Systemic clearance
Croatian: Sustavni klirens
English: Each box contains 1vial.
Croatian: Jedna kutija sadrži
English: Treatment failure
Croatian: Neuspješno liječenje nije primjenjivo
English: Warnings and precautions Tell your doctor if any of these apply to you.
Croatian: Drugi lijekovi i Ivozall Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove:
English: NAME OF THE MEDICINAL PRODUCT Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Croatian: Uputa o lijeku: Informacije za korisnika Ivozall 1 mg/ml koncentrat za otopinu za infuziju klofarabin
English: After 24 hours, about 60% of the dose is excreted unchanged in the urine.
Croatian: doze izluči se mokraćom u nepromijenjenom obliku.
English: Common: Pericardial effusion*, tachycardia*
Croatian: Srčani poremećaji često: perikardni izljev*, tahikardija*
English: weight loss; - agitation, irritability, or restlessness;
Croatian: - tjeskoba, glavobolja, vrućica, umor; - mučnina i povraćanje, proljev;
English: The majority of elevations in
Croatian: MATERIJALA KOJI POTJEČU
English: Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Croatian: U bolesnika liječenih klofarabinom primijećena je teška supresija koštane srži, uključujući neutropeniju, anemiju i trombocitopeniju.
English: The vaccine has been authorised under ‘exceptional circumstances'.
Croatian: Ovaj lijek je odobren u „iznimnim okolnostima“.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Croatian: Europska agencija za lijekove će svake godine procjenjivati sve nove informacije o ovom lijeku te će se ova uputa ažurirati prema potrebi.
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Croatian: Cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
English: Adjupanrix is a vaccine for use in adults to protect against ‘pandemic' flu.
Croatian: Adjupanrix je cjepivo za primjenu kod odraslih starijih od 18 godina za sprječavanje pandemijske gripe (influence).
English: The vaccine would be given according to official recommendations.
Croatian: uzimajući u obzir službene preporuke.
English: The vaccine can only be obtained with a prescription.
Croatian: Lijek se izdaje na recept.
English: The full EPAR for Adjupanrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Croatian: Kada osoba primi cjepivo, prirodni tjelesni obrambeni sustav (imunološki sustav) stvoriti će svoju vlastitu zaštitu (protutijela) od bolesti.
English: When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Croatian: Za vrijeme pandemije, podnositelj će prikupiti podatke o kliničkoj sigurnosti i učinkovitosti pandemijskog cjepiva i te će informacije predati CHMP-u na ocjenu.
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Croatian: • ako ste imali bilo koju alergijsku reakciju, izuzev iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak cjepiva Adjupanrix (naveden u dijelu 6.) ili na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid, gentamicinsulfat (antibiotik) ili natrijev deoksikolat.
English: The vaccine contains a flu strain called ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
Croatian: Virus influence (inaktiviran, fragmentiran), sadrži antigene koji odgovaraju soju: A/VietNam/1194/2004 (H5N1) poput kojeg je korišten soj (NIBRG-14)
English: If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Croatian: Međutim, u slučaju pandemije, može se primijeniti cjepivo, ali je potrebno osigurati da jedinica za reanimaciju bude odmah dostupna u slučaju potrebe.
English: Other information about Adjupanrix
Croatian: Drugi lijekovi i Adjupanrix
English: For more information about treatment with this vaccine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se liječniku ili medicinskoj sestri.
English: EMA/754413/2012 EMEA/H/C/001206
Croatian: Tel.: + 36-1-2255300
English: This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Croatian: To znači da zbog znanstvenih razloga nije bilo moguće dobiti potpune informacije o ovom lijeku.
English: People who have not previously been vaccinated against the pandemic flu with a ‘prepandemic' vaccine should receive two single 0.5 ml doses of the vaccine at least three weeks apart.
Croatian: Osobe koje nisu ranije primile cjepivo Prepandrix Odrasle osobe starije od 18 godina: Jedna doza od 0,5 ml odabranog datuma.
English: The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Croatian: Vrlo često: otvrdnuće, oticanje, bol i crvenilo na mjestu injiciranja, vrućica, umor Često: drhtanje, bolest nalik gripi, reakcije na mjestu injiciranja (poput topline, pruritusa)
English: What is Adjupanrix?
Croatian: Kako se primjenjuje Adjupanrix
English: There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.
Croatian: U kliničkom ispitivanju, djeca u dobi od 3 do 9 godina su primila dvije doze (0,5 ml) za odrasle ili dvije polovice (0,25 ml) doze za odrasle.
English: EPAR summary for the public
Croatian: - učestalost prema ispitaniku omamljenost
English: Adjupanrix is a vaccine that is given by injection.
Croatian: Adjupanrix suspenzija i emulzija za emulziju za injekciju.
English: Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent.
Croatian: NAČIN PRIMJENE LIJEKA Prije primjene pomiješati u suspenziju antigena.
English: The vaccine is given by injection into the shoulder or thigh muscle.
Croatian: • Oni će Vam dati Adjupanrix injekcijom u mišić.
English: Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder) with a second double dose three weeks later.
Croatian: Temeljem vrlo ograničenih podataka, za postizanje imunološkog odgovora u odraslih osoba starijih od 80 godina može biti potrebna dvostruka doza cjepiva Adjupanrix: odabranog datuma i ponovno nakon razmaka od najmanje tri tjedna (vidjeti dio 5.1).
English: This summary was last updated in 11-2012.
Croatian: Datum posljednje obnove odobrenja: 18. srpnja 2014.
English: This will help to protect against the disease caused by the virus.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Croatian: Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije u ispitanika koji su primili cjepivo u razmaku od 12 mjeseci iznosila je 84,0%, a stopa odgovora na cjepivo 100%.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Croatian: Četverostruki porast titra neutralizirajućih protutijela u serumu zamijećen je 21 dan nakon prve doze u
English: During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Croatian: Tijekom pandemijske situacije, resursi se moraju koncentrirati na pravovremen i učinkovit nadzor sigurnosnog profila cjepiva protiv influence koja se koriste tijekom pandemije.
English: A study in 405 children three to nine years of age looked at the immunogenicity triggered by a vaccine containing half the amount of haemagglutinins compared with the vaccine containing the full amount.
Croatian: U ispitanika u dobi od 3 do 5 i od 6 do 9 godina koji su primili ili dvije pune doze ili dvije polovine doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja
English: This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Croatian: Niže navedene nuspojave su zabilježene s H1N1 cjepivima koja sadrže AS03.
English: How is this vaccine used?
Croatian: NAČIN PRIMJENE LIJEKA
English: Adjupanrix is a ‘mock-up' vaccine.
Croatian: Adjupanrix se može primjenjivati u dojilja.
English: In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study.
Croatian: Štoviše, u skupini djece koja su primila pola doze cjepiva, stope ispitanika s titrom neutralizirajućih protutijela iznad 1:80 ostao je visok sve do 24 mjeseca nakon prve doze.
English: The injections were given 21 days apart.
Croatian: Nakon miješanja, cjepivo upotrijebite unutar 24 sata.
English: What information is still awaited?
Croatian: Nije prijavljen slučaj predoziranja.
English: The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
Croatian: prema svakom od dva soja, neovisno o tipu hemaglutinina u cjepivu ili o broju prethodnih doza.
English: The virus has first been inactivated so that it does not cause any disease.
Croatian: Ni jedan sastojak cjepiva ne može izazvati gripu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adjupanrix.
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Croatian: Ovo cjepivo odgovara preporukama Svjetske zdravstvene organizacije i odluci Europske unije za pandemiju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adjupanrix on 19 October 2009.
Croatian: Datum prvog odobrenja: 19. listopada 2009.
English: The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.
Croatian: U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
English: The company that made the Pandemrix H5N1 mock-up vaccine has agreed that its scientific data can be used for this vaccine.
Croatian: U ispitanika D-Pan-H5N1-010 je praćena postojanost imunološkog odgovora.
English: The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Croatian: Klinički podaci u djece mlađe od 6 godina koja su primila dvije doze cjepiva spremnog protiv pandemijske influence (engl. pandemic preparedness vaccine) ili cjepiva protiv zoonozne influence (engl. zoonotic influenza vaccine) H5N1 ukazuju na povećanu učestalost vrućice (≥ 38ºC aksilarno) nakon primjene druge doze.
English: This is a summary of the European public assessment report (EPAR) for Adjupanrix.
Croatian: Na 50. dan se Izvjestiteljev izvještaj o procjeni predaje članovima CHMP.
English: What is this vaccine used for?
Croatian: Ovo je cjepivo propisano samo Vama.
English: In children aged three to nine years, the half-dose vaccine was shown bring about levels of antibodies that were comparable with the full-dose vaccine.
Croatian: Nakon svake doze zamijećena je razlika u učestalosti lokalnih i općih praćenih nuspojava između pune i pola doze za odrasle.
English: This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Croatian: Cjepivo koje sadrži AS03 i hemaglutinine soja H1N1v je davano ženama u svakom trimestru trudnoće.
English: The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria.
Croatian: U drugom ispitivanju, 49 ispitanika u dobi od 18 do 60 godina primilo je dvije doze AS03adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina iz soja A/Indonesia/05/2005 i to 0. te 21. dana.
English: A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja cjepiva Adjupanrix u jednoj ili više podskupina pedijatrijske populacije s infekcijom influence uzrokovane sojem virusa influence sadržanog u cjepivu ili povezane sa sojem sadržanim u cjepivu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Croatian: Za suspenziju: višedozna bočica koja sadrži antigen, Za emulziju: višedozna bočica koja sadrži adjuvans.