FrancophonIA/ELRC3.0 huggingface dataset:
English: 800 mg Concentrate for solution for infusion
Croatian: 800 mg koncentrat za otopinu za infuziju primjena u venu bočica (staklo)
English: Frequency “Not known”
Croatian: Učestalost „nepoznato”
English: 2 Canagliflozin; canagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saxagliptin, dapagliflozin
Croatian: 2 Kanagliflozin; kanagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saksagliptin, dapagliflozin
English: Footnotes:
Croatian: Napomene:
English: 2 The following text should replace any current information regarding serious skin reactions in section Warnings and precautions.
Croatian: 2 Sljedeći tekst treba zamijeniti sve postojeće informacije o ozbiljnim kožnim reakcijama u dijelu Upozorenja i mjere opreza.
English: Adopted at the 2-5 September 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a 2. - 5. rujna 2019.
English: Stop using <product name> if you develop these symptoms and seek medical attention immediately.
Croatian: Prestanite primjenjivati lijek <naziv lijeka> u slučaju nastanka tih simptoma i odmah potražite liječničku pomoć.
English: 1 Only if the already existing AGEP ADR in section 4.8 is listed specifically for pseudoephedrine.
Croatian: 1 Samo ako je već postojeća nuspojava AGEP u dijelu 4.8 posebno navedena za pseudoefedrin.
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Croatian: Čini se kako je najveći rizik pojave ovih reakcija na samom početku terapije, a reakcije su u većini slučajeva nastupile tijekom prvog mjeseca liječenja.
English: In both cases, tTreatment with <product name> may be restarted once when the ketone values are normal and the patient's condition has stabilised.
Croatian: U oba slučaja, lLiječenje lijekom <naziv lijeka> može se ponovno započeti nakon kada se razine ketona vrate u normalu i stanje bolesnika stabilizira.
English: Latency from the initiation of treatment with ibrutinib to the onset of ischemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasizing the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8).
Croatian: Latencija od početka liječenja ibrutinibom do nastupa ishemijskih vaskularnih stanja središnjeg živčanog sustava bila je u većini slučajeva više od nekoliko mjeseci (više od jednog mjeseca u 78 % slučajeva i više od šest mjeseci u 44 % slučajeva), zbog čega je naglašena potreba redovitog praćenja bolesnika (vidjeti dio 4.4 Aritmija srca i hipertenzija i dio 4.8).
English: What you need to know before you use <product name>
Croatian: Što morate znati prije nego počnete primjenjivati <naziv lijeka>
English: Tell a doctor straight away if you notice any of the following side effects: Uncommon (may affect up to 1 in 100 people): temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Croatian: Odmah obavijestite liječnika ako primijetite bilo koju od sljedećih nuspojava: Manje često (mogu se javiti u do 1 na 100 osoba): privremena epizoda poremećaja neurološke funkcije uzrokovana gubitkom protoka krvi, moždani udar.
English: Serious skin reactions have been reported in association with <product name> treatment.
Croatian: Ozbiljne kožne reakcije prijavljene su povezano s liječenjem lijekom <naziv lijeka>.
English: A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Croatian: Crveni, ljuskavi, prošireni osip s kvržicama ispod kože i mjehurićima uglavnom lokaliziran na naborima kože, trupu i gornjim udovima popraćen vrućicom na početku liječenja (akutna generalizirana egzantematozna pustuloza).
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors2New information on the known association between SGLT2 inhibitors and diabetic ketoacidosis in surgical patients (EPITT no 19355)
Croatian: Inhibitori suprijenosnika natrija i glukoze 2 (SGLT2)2nove informacije o poznatoj povezanosti između SGLT2 inhibitora i dijabetičke ketoacidoze u kirurških bolesnika (EPITT br. 19355)
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8).
Croatian: Ozbiljne kožne reakcije, neke od njih i sa smrtnim ishodom, uključujući eksfolijativni dermatitis, Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, rijetko su prijavljene povezano s primjenom nesteroidnih protuupalnih lijekova (NSAIL) (vidjeti dio 4.8).
English: Teriflunomide - Psoriasis (EPITT no 19366)
Croatian: Teriflunomid - psorijaza (EPITT br. 19366)
English: You should stop taking <product name> and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction.
Croatian: Potrebno je prekinuti uzimanje lijeka <naziv lijeka> i odmah potražiti liječničku pomoć ako Vam se pojavi bilo kakav osip na koži, oštećenje sluznice, mjehurići ili drugi znakovi alergije jer to mogu biti prvi znakovi vrlo ozbiljne kožne reakcije.
English: Ibuprofen - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 19409)
Croatian: Ibuprofen - akutna generalizirana egzantematozna pustuloza (AGEP)(EPITT br. 19409)
English: Special warnings and precautions for use Diabetic ketoacidosis
Croatian: Posebna upozorenja i mjere opreza pri uporabi Dijabetička ketoacidoza
English: Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Croatian: Liječenje ibuprofenom potrebno je prekinuti pri prvoj pojavi znakova i simptoma teških kožnih reakcija, poput kožnog osipa, mukoznih lezija ili bilo kojeg drugog znaka preosjetljivosti.
English: Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: Psoriasis (including pustular psoriasis)b b: see section 4.4
Croatian: Poremećaji kože i potkožnog tkiva Učestalost nepoznata: psorijaza (uključujući pustularnu psorijazu)b b: vidjeti dio 4.4
English: For ibuprofen monotherapy or ibuprofen in combinations excluding combinations with pseudoephedrine
Croatian: Kod monoterapije ibuprofenom ili primjene ibuprofena u kombinacijama s drugim lijekovima, isključujući pseudoefedrin
English: Warnings and precautions - Take special care with <product name> Skin reactions2
Croatian: Upozorenja i mjere opreza - Potreban je poseban oprez pri primjeni lijeka <naziv lijeka> Kožne reakcije2
English: Uncommon: cerebrovascular accident, transient ischaemic attack, ischaemic stroke
Croatian: Manje često: cerebrovaskularni inzult, prolazni ishemijski napadaj, ishemijski moždani udar
English: Ibrutinib - Ischaemic stroke (EPITT no 19369)
Croatian: Ibrutinib - ishemijski moždani udar (EPITT br. 19369)
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
Croatian: Teške kožne reakcije, kao što je akutna generalizirana egzantematozna pustuloza (AGEP), mogu se javiti kod primjene lijekova koji sadrže ibuprofen i pseudoefedrin.
English: Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Croatian: Uzimajući u obzir bolest i anamnezu bolesnika, može se razmotriti prekid liječenja i uvođenje postupka ubrzane eliminacije lijeka.
English: New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been reported during the use of teriflunomide.
Croatian: Prilikom primjene teriflunomida prijavljen je novi nastup psorijaze (uključujući pustularnu psorijazu) i pogoršanje postojeće psorijaze.
English: Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Croatian: Akutna generalizirana egzantematozna pustuloza (AGEP) prijavljena je povezano s liječenjem lijekovima koji sadrže ibuprofen.
English: Special warnings and precautions for use Severe skin reactions
Croatian: Posebna upozorenja i mjere opreza pri uporabi Teške kožne reakcije
English: For ibuprofen and pseudoephedrine combinations 4.4.
Croatian: Kod kombinacija ibuprofena i pseudoefedrina
English: Special warnings and precautions for use Skin reactions
Croatian: Posebna upozorenja i mjere opreza pri uporabi Kožne reakcije
English: Undesirable effects Tabulated list of adverse reactions Nervous system disorders
Croatian: Poremećaji živčanog sustava
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Croatian: Većina ovih reakcija bila je blaga do umjerena i nije dugo trajala.
English: The children were followed up until the end of their second year of life.
Croatian: Djeca su praćena sve do kraja njihove druge godine života.
English: The full EPAR for Synflorix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Synflorix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The children were followed up for an average of around 2 years.
Croatian: Djeca su u prosjeku praćena otprilike 2 godine.
English: The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children.
Croatian: Cjepivo se daje injekcijom u bedreni mišić u dojenčadi ili u rameni mišić u mlađe djece.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infection.
Croatian: Cjepiva djeluju „učeći” imunosni sustav (prirodnu obranu tijela) kako obraniti tijelo od infekcije.
English: For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
Croatian: Što se tiče tri dodatna polisaharida (1, 5, 7F), Synflorix je bio učinkovit u poticanju proizvodnje protutijela.
English: The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.
Croatian: Raspored cijepljenja lijekom Synflorix ovisi o dobi djeteta i treba se temeljiti na službenim preporukama.
English: This is a summary of the European public assessment report (EPAR) for Synflorix.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Synflorix.
English: Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Croatian: Synflorix sadrži polisaharide iz 10 različitih tipova bakterije S. pneumoniae (serotipovi 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F i 23F).
English: These polysaccharides have been purified, then conjugated (attached) to a carrier to help them to be recognised by the immune system.
Croatian: Ovi su polisaharidi pročišćeni, zatim „konjugirani” (vezani) na prenositelja koji im pomaže da ih imunosni sustav prepozna.
English: Synflorix is available as a suspension for injection.
Croatian: Lijek Synflorix dostupan je kao suspenzija za injekciju.
English: Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
Croatian: Dodatna su ispitivanja istražila djelovanje doza docjepljivanja i cjepiva u starije dojenčadi i djece.
English: The vaccine is also adsorbed (fixed) onto an aluminium compound to stimulate a better response.
Croatian: Cjepivo se također „adsorbira” (fiksira) u aluminijski spoj kako bi se simulirao bolji odgovor.
English: In Europe, it is estimated that these are responsible for 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of 5 years.
Croatian: Procjenjuje se da su u Europi ti serotipovi odgovorni za otprilike 56 % do 90 % slučajeva invazivne bolesti uzrokovane bakterijom S. pneumoniae u djece mlađe od pet godina.
English: The most common side effects with Synflorix (which may affect more than 1 in 10 people) are pain, redness and swelling at the injection site, fever, drowsiness, irritability and loss of appetite.
Croatian: Najčešće nuspojave zabilježene s lijekom Synflorix (koje se mogu javiti u više od 1 na 10 osoba) jesu bol, crvenilo i oticanje na mjestu ubrizgavanja, groznica, pospanost, razdražljivost i gubitak apetita.
English: The immune system will then be able to produce antibodies more quickly when it comes into contact with the bacterium again.
Croatian: Imunosni sustav može zatim brže stvarati protutijela pri ponovnom izlaganju bakteriji.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as ‘foreign' and makes antibodies against them.
Croatian: Nakon što osoba primi cjepivo, imunosni sustav prepoznaje dijelove bakterije koji se nalaze u cjepivu kao „strano tijelo” i proizvodi protutijela protiv njih.
English: The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.
Croatian: Postotak djece koja su imala bakterijsku upalu pluća bio je 2,3 % (240 na više od 10 000) među djecom koja su primila Synflorix u usporedbi s 3 % (304 na više od 10 000) među djecom koja su primila komparatorsko cjepivo.
English: The response to Synflorix in 2 to 5 year olds was similar to the younger age group, with better results in children who received two doses.
Croatian: Odgovor na Synflorix u djece stare između 2 i 5 godina bio je sličan odgovoru u mlađoj dobnoj skupini, uz bolje rezultate u djece koja su primila dvije doze.
English: In studies in infants and older children, although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group.
Croatian: U ispitivanjima provedenima u dojenčadi i starije djece, iako je Synflorix proizvodio manji odgovor na protutijela nego komparatorsko cjepivo, ispunio je prethodno utvrđene kriterije i smatra se prihvatljivim u toj dobnoj skupini.
English: What measures are being taken to ensure the safe and effective use of Synflorix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Synflorix?
English: Invasive disease results from the bacterium spreading through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia.
Croatian: Invazivna bolest nastupa nakon što se bakterija raširi kroz tijelo uzrokujući infekcije poput septikemije (infekcije krvi), meningitisa (infekcije membrana oko mozga i kralježnice) i upale pluća (infekcije pluća).
English: The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between 6 and 12 weeks.
Croatian: Sposobnost lijeka Synflorix da potakne stvaranje protutijela (imunogenost) procijenjena je u jednom glavnom ispitivanju koje je obuhvatilo 1 650 zdrave dojenčadi u dobi između šest i 12 tjedana.
English: However, children aged under 6 months with conditions that make them more likely to catch these invasive diseases, such as those with human immunodeficiency virus (HIV) infection, sickle cell disease or spleen problems, should be given three doses followed by a booster dose.
Croatian: Međutim, djeca mlađa od 6 mjeseci s bolestima koje ih čine manje otpornima na te invazivne bolesti, kao što su djeca s infekcijom virusom humane imunodeficijencije (HIV), djeca koja pate od bolesti srpastih stanica ili problema sa slezenom, trebaju dobivati tri doze, nakon čega slijedi doza docjepljivanja.
English: The children received one dose of Synflorix in the first study and two doses in the second study.
Croatian: Djeca su primila jednu dozu lijeka Synflorix u prvom ispitivanju te dvije doze u drugom ispitivanju.
English: Other information about Synflorix
Croatian: Ostale informacije o lijeku Synflorix
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synflorix on 30 March 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Synflorix u promet koje je na snazi u Europskoj uniji od 30. ožujka 2009.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synflorix 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 Synflorix nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Croatian: Synflorix sadrži male količine polisaharida (tipa šećera) ekstrahiranog iz „kapsule” koja okružuje bakteriju S. pneumoniae.
English: • When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), a course of two doses may be given 2 months apart, from the age of 6 weeks, followed by a booster dose at least 6 months later.
Croatian: • U slučaju kada se Synflorix daje kao dio rutinskog programa imunizacije dojenčadi (kada se sva dojenčad u određenom području cijepi otprilike u isto vrijeme), dvije se doze mogu dati s dva mjeseca razmaka, počevši u dobi od dva mjeseca, nakon čega slijedi doza docjepljivanja nakon najmanje šest mjeseci.
English: Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine's benefit in preventing community acquired pneumonia.
Croatian: Synflorix je također ispitan u velikom ispitivanju koje je obuhvatilo otprilike 24 000 djece u dobi između 6 i 16 tjedana i bilo usredotočeno uglavnom na koristi cjepiva u sprječavanju upale pluća stečene u zajednici.
English: Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F).
Croatian: Synflorix je bio jednako učinkovit kao i komparator u poticanju proizvodnje protutijela protiv pet polisaharida zajednička dvama cjepivima (4, 9V, 14, 18C i 19F), ali bio je manje učinkovit nego komparator za dva polisaharida (6B i 23F).
English: What is Synflorix and what is it used for?
Croatian: Što je Synflorix i za što se koristi?
English: It is not intended to provide practical advice on how to use Synflorix.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Synflorix.
English: Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus).
Croatian: Synflorix je cjepivo koje sadrži dijelove bakterije Streptococcus pneumoniae (S. pneumoniae, također se naziva pneumokokom).
English: The Agency also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe and therefore decided that Synflorix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je također napomenula da Synflorix sadrži dodatne polisaharide iz tipova bakterije S. pneumoniae koji su odgovorni za bolest u Europi te je stoga zaključila da koristi od lijeka Synflorix nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Synflorix was effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster dose, one case occurred among the 10,000 children given two doses of Synflorix and a booster dose and 12 cases occurred in 10,000 children given the comparator vaccine.
Croatian: Synflorix je bio učinkovit u zaštiti od invazivnih bolesti: nije zabilježen nijedan slučaj među 10 000 djece koja su primila tri doze lijeka Synflorix i dozu docjepljivanja, zabilježen je jedan slučaj među 10 000 djece koja su primila dvije doze lijeka Synflorix i dozu docjepljivanja te 12 slučajeva među 10 000 djece koja su primila komparatorsko cjepivo.
English: In particular, two clinical studies in children aged 2 to 5 years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups.
Croatian: Dvama kliničkim ispitivanjima provedenim u djece u dobi od 2 do 5 godina osobito se ispitivala sposobnost lijeka Synflorix da proizvede protutijela u toj dobnoj skupini u usporedbi s drugim dobnim skupinama.
English: For more information about treatment with Synflorix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Synflorix pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The studies showed that Synflorix led to an increase in antibody production following booster vaccinations.
Croatian: Ispitivanja su pokazala da je Synflorix doveo do povećanja u proizvodnji protutijela nakon docjepljivanja.
English: Synflorix is a vaccine that protects against infections caused by S. pneumoniae.
Croatian: Synflorix je cjepivo koje štiti od infekcija uzrokovanih bakterijom S. pneumoniae.
English: The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the investigational vaccine compared with those given the comparator.
Croatian: Pojava prve epizode akutne upale srednjeg uha uzrokovane bakterijom S. pneumoniae bila je gotovo prepolovljena među djecom koja su primila ispitivano cjepivo u usporedbi s djecom koja su primila komparator.
English: Synflorix must not be used in children who have a high fever, but it can be given in children who have a mild infection such as a cold. For the full list of restrictions, see the package leaflet.
Croatian: Synflorix se ne smije koristiti u djece koja imaju visoku temperaturu, no može se dati djeci koja imaju blagu infekciju, poput prehlade.
English: It is used to protect infants and children aged between 6 weeks and 5 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Croatian: Synflorix se koristi za zaštitu dojenčadi i djece u dobi između šest tjedana i pet godina protiv invazivne bolesti, upale pluća (infekcije pluća) i akutne otitis media (upale srednjeg uha), uzrokovane bakterijom S. pneumoniae.
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Cjepivo protiv pneumokoka, polisaharidno, konjugirano (adsorbirano)
English: What are the risks associated with Synflorix?
Croatian: Koji su rizici povezani s lijekom Synflorix?
English: The study involved almost 5,000 infants aged 3 months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae (in this case, a vaccine against hepatitis A virus).
Croatian: Ispitivanje je obuhvatilo otprilike 5 000 djece u dobi od tri mjeseca te je usporedilo ispitivano cjepivo koje sadrži iste polisaharide kao Synflorix s drugim cjepivom koje nije djelotvorno protiv infekcije bakterijom S. pneumoniae (u ovom slučaju, cjepivo protiv virusa hepatitisa A).