FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-hoc subgroup analyses of modified PFS per IRF for patients with Stage IV disease were performed including age, region, baseline extranodal sites, number of IPFP risk factors, baseline B symptoms, baseline ECOG status and gender.
Croatian: Post-hoc analize mPFS prema IRF u podskupinama bolesnika s bolesti u 4. stadiju provedene su prema starosnoj dobi, lokalizaciji, ekstranodalnoj proširenosti na početku liječenja, broju IPFP rizičnih čimbenika, B simptomima na početku liječenja, ECOG statusu na početku liječenja i spolu.
English: Table 4 provides a summary of the baseline patient and disease characteristics.
Croatian: U tablici 4 sažete su početne karakteristike bolesnika i bolesti.
English: have new or worsening shortness of breath or cough as these may be symptoms of a serious and potentially fatal lung complication (pulmonary toxicity) are taking, or have previously taken, medicines which may affect your immune system, such as chemotherapy or immunosuppressive agents have, or think you have, an infection.
Croatian: Trebate također obavijestiti svog partnera ili skrbnika o svom liječenju, budući da oni mogu primijetiti neke simptome kojih Vi niste svjesni. - imate jake i uporne bolove u trbuhu, s ili bez mučnine i povraćanja, jer to mogu biti simptomi ozbiljnog i potencijalno smrtonosnog stanja poznatog kao pankreatitis (upala gušterače). - imate pojavu ili pogoršanje nedostatka zraka ili kašalj jer to mogu biti simptomi ozbiljne i potencijalno smrtonosne komplikacije na plućima (plućna toksičnost) - uzimate ili ste prethodno uzimali lijekove koji mogu utjecati na Vaš imunološki sustav, kao što je kemoterapija ili imunosupresivni lijekovi - imate ili mislite da imate infekciju.
English: Median age (range)
Croatian: Medijan dobi (raspon)
English: Immunogenicity
Croatian: Monoterapija
English: The recommended starting dose in patients with mild hepatic impairment is 0.9 mg/kg administered as an intravenous infusion over 30 minutes every 2 weeks.
Croatian: Preporučena početna doza za bolesnike s blagim oštećenjem funkcije jetre je 0,9 mg/kg primijenjena kao intravenska infuzija tijekom 30 minuta svaka 2 tjedna.
English: Sodium content in excipients
Croatian: Sadržaj natrija u pomoćnim tvarima
English: Frequency not known: Progressive multifocal leukoencephalopathy Blood and lymphatic system disorders Very common:
Croatian: Učestalost nepoznata: Progresivna multifokalna leukoencefalopatija
English: Median Cmax and AUC of ADC after a single 1.8 mg/kg dose were 29.8 µg/ mL and 67.9 µg*day/ mL, respectively, in patients < 12 years of age and 34.4 µg/mL and 77.8 µg*day/mL, respectively, in patients ≥ 12 years of age.
Croatian: Medijan Cmax i AUC za ADC nakon jedne doze od 1,8 mg/kg bili su 29,8 µg/ml odnosno 67,9 µg*dan/ml u bolesnika u dobi
English: Extranodal involvement at time of pre-ASCT relapse
Croatian: Ekstranodularna zahvaćenost u vrijeme relapsa prije ASCT-a B simptomi
English: Tel: +43 (0) 800-20 80 50
Croatian: Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 50
English: MARKETING AUTHORISATION NUMBER
Croatian: BROJODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Via Crosa, 86
Croatian: Delpharm Novara S.r.l. Via Crosa, 86
English: ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.
Croatian: Ako se dijagnoza akutnog pankreatitisa potvrdi, primjenu lijeka ADCETRIS treba prekinuti.
English: Grade 1 (< LLN-1500/mm < LLN-1.5 x 10
Croatian: Stupanj 1 (<DGN - 1500/mm < DGN - 1,5 x 10 9/l)
English: Ten (10) patients (17%) received 16 cycles of ADCETRIS; the median number of cycles received was 7 (range, 1 to 16).
Croatian: Deset (10) bolesnika (17%) primilo je 16 ciklusa lijeka ADCETRIS.
English: Takeda Pharma Ges.m.b.H.
Croatian: Magyarország Takeda Pharma Kft.
English: Thrombocytopenia
Croatian: Demijelinizirajuća polineuropatija
English: The recommended starting dose in patients with severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Croatian: Preporučena početna doza u bolesnika s teškim oštećenjem funkcije bubrega je 1,2 mg/kg primijenjena kao intravenska infuzija tijekom 30 minuta svaka 3 tjedna.
English: ANNEX II
Croatian: PRILOG II,
English: The recommended starting dose in patients with hepatic impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Croatian: Preporučena početna doza u bolesnika s oštećenjem funkcije jetre je 1,2 mg/kg primijenjena kao intravenska infuzija tijekom 30 minuta svaka 3 tjedna.
English: Table 13 provides a summary of the baseline patient and disease characteristics.
Croatian: Tablica 13 pruža sažeti prikaz osobina bolesnika i značajki bolesti na početku ispitivanja.
English: This medicine is given to you into a vein (intravenously) as an infusion.
Croatian: Adcetris se daje u venu (intravenski) kao infuzija tijekom 30 minuta.
English: Gently swirl the vial to aid dissolution.
Croatian: 2. Nježno vrtite bočicu kružnim pokretima da se sadržaj lakše otopi.
English: Additional follow up and evaluation may be warranted if no alternative diagnosis can be established.
Croatian: Ako se ne postavi druga dijagnoza, potrebno je daljnje praćenje i procjenjivanje bolesnika.
English: Takeda AS
Croatian: Takeda Italia S.p.A.
English: Median number of skin-directed therapies (range) Median number of systemic therapies (range) MF, n (%)
Croatian: Medijan broja sistemskih liječenja (raspon)
English: MMAE has been shown to have aneugenic properties in an in vivo rat bone marrow micronucleus study.
Croatian: U in vivo ispitivanju na mikronukleusima koštane srži štakora pokazalo se da MMAE ima aneugenična svojstva.
English: NA
Croatian: U
English: Demyelinating polyneuropathy Respiratory, thoracic and mediastinal disorders Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često:
English: Refractory
Croatian: Imunogenost
English: See Table 9 below for a summary of baseline patient and disease characteristics.
Croatian: Vidjeti tablicu 9 za sažeti prikaz karakteristika bolesnika i značajki bolesti na početku ispitivanja.
English: The median number of cycles received was 6
Croatian: Medijan primljenih ciklusa bio je 6 (raspon 1 do 6 ciklusa).
English: pneumonia - blisters which may crust or scab - sore, creamy-yellow, raised patches in the mouth (thrush) - itching - increased level of blood sugar
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) - infekcija krvi (sepsa) i/ili septički šok (oblik sepse ozbiljan po život); upala pluća - mjehuri na kojima se može stvoriti kora ili kraste - bolne, svijetle do žućkaste uzdignute naslage u ustima (uzrokovane gljivicom kandidom) - svrbež - povećana razina šećera u krvi
English: System organ class Adverse reactions (monotherapy)
Croatian: Nuspojave (monoterapija)
English: Breastfeeding
Croatian: Omaglica
English: Febrile neutropenia Immune system disorders Uncommon:
Croatian: Poremećaji imunološkog sustava Manje često:
English: Takeda Polska Sp. z o.o tel. + 48 22 608 13 00
Croatian: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
English: Median time from HL diagnosis to first dose (range) 0.92 mo (0.1-21.4)
Croatian: 0,92 mj. (0,1-21,4)
English: If patient's weight is more than 100 kg, the dose calculation should use 100 kg. d. The maximal recommended dose for combination therapy is 120 mg.
Croatian: d. Maksimalna preporučena doza u kombiniranoj terapiji je 120 mg.
English: Due date
Croatian: Broj događaja
English: Although side effects were common, they appeared to be within acceptable limits.
Croatian: Premda su nuspojave učestale, čini se da su unutar prihvatljivih granica.
English: These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.
Croatian: Ti proteini pričvršćeni su za sastojak koji sadržava aluminij (adsorbirani), koji pomaže u njihovoj stabilizaciji, omogućavajući imunosnom sustavu da odgovori na njih.
English: It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder.
Croatian: Dostupan je u napunjenoj štrcaljki i daje se injekcijom u mišić, najbolje u rame.
English: Other information about Trumenba
Croatian: Ostale informacije o lijeku Trumenba
English: The full EPAR for Trumenba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Trumenba nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Trumenba.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Trumenba.
English: Further planned or ongoing studies are expected to provide more information on Trumenba's effectiveness.
Croatian: Očekuje se da će daljnja planirana ispitivanja ili ona koja su u tijeku pružiti više informacija o učinkovitosti lijeka Trumenba.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that based on available data Trumenba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je na temelju dostupnih podataka da koristi lijeka Trumenba nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Trumenba?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trumenba?
English: What is Trumenba and what is it used for?
Croatian: Što je Trumenba i za što se koristi?
English: When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Croatian: Ako osoba poslije bude izložena bakteriji, ta protutijela zajedno s drugim dijelovima imunosnog sustava moći će ubiti bakterije i pomoći pri zaštiti od bolesti.
English: Trumenba can only be obtained with a prescription and should be used according to official recommendations.
Croatian: Lijek Trumenba izdaje se samo na recept te se treba primjenjivati u skladu sa službenim preporukama.
English: In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.
Croatian: U bolesnika s povećanim rizikom od invazivne meningokokne bolesti naknadno se može razmotriti dodatna doza docjepljivanja.
English: Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later.
Croatian: Primarno cijepljenje može uključivati 2 injekcije primijenjene u razmaku od barem 6 mjeseci ili 2 injekcije primijenjene u razmaku od barem 1 mjeseca, nakon čega slijedi treća injekcija koja se primjenjuje barem 4 mjeseca kasnije.
English: The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.
Croatian: Najčešće nuspojave lijeka Trumenba (koje se mogu javiti u više od 1 na 10 osoba) jesu bol, crvenilo ili oticanje na mjestu primjene injekcije, glavobolja, umor, zimica, proljev, mučnina (slabost) te bol u mišićima i zglobovima.
English: Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).
Croatian: Invazivna bolest nastupa kad se te bakterije prošire tijelom uzrokujući ozbiljne infekcije kao što su meningitis (upala ovojnice mozga i kralježničke moždine) i sepsa (trovanje krvi).
English: What are the risks associated with Trumenba?
Croatian: Koji su rizici povezani s lijekom Trumenba?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trumenba 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 Trumenba nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Trumenba.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Trumenba.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium contained 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: Why is Trumenba approved?
Croatian: Zašto je lijek Trumenba odobren?
English: Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Croatian: Provedena su i popratna ispitivanja u kojima se pokazalo da su 2 doze cjepiva ostvarile gotovo istovjetan odgovor protutijela kao i 3 doze te da se razine zaštitnih protutijela, unatoč tome što se s vremenom smanjuju, mogu poboljšati dodatnom dozom docjepljivanja nakon oba režima cijepljenja s 2 ili 3 doze.
English: In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants.
Croatian: U drugom ispitivanju proizvedena je dostatna količina protutijela u 79 - 90 % slučajeva, a zaštitne razine protutijela protiv sva 4 soja pronađene su u 85 % sudionika.
English: Trumenba meningococcal group B vaccine (recombinant, adsorbed)
Croatian: Trumenba cjepivo protiv meningokoka grupe B (rekombinantno, adsorbirano)
English: Antibody responses were also seen against the 10 secondary strains and confirmed the responses seen with the 4 main strains.
Croatian: Primijećen je i odgovor protutijela protiv 10 sekundarnih sojeva te su potvrđeni odgovori uočeni kod 4 glavna soja.
English: For more information about treatment with Trumenba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Trumenba pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Croatian: Trumenba je cjepivo koje se primjenjuje za zaštitu osoba u dobi od 10 godina i starije od invazivne meningokokne bolesti uzrokovane grupom bakterija Neisseria meningitidis grupe B.
English: The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Croatian: U ovim se ispitivanjima promatrao i odgovor na 10 drugih, sekundarnih sojeva bakterije N. meningitidis grupe B.
English: Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
Croatian: Proizvedena je dostatna količina protutijela koja pruža zaštitu od 4 glavna testna soja u 80 - 90 % ispitanika u prvom ispitivanju, ovisno o soju, a u 84 % osoba koje su dobile cjepivo testiranjem je utvrđeno da imaju zaštitna protutijela protiv sva 4 soja bakterije.
English: For practical information about using Trumenba, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Trumenba bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Trumenba have been shown in studies?
Croatian: Koje su koristi lijeka Trumenba dokazane u ispitivanjima?
English: For the full list of all side effects and restrictions with Trumenba, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Trumenba potražite u uputi o lijeku.
English: As the protection provided seemed to decline over time, a booster dose should be considered in recipients who were thought to be at continued risk of invasive meningococcal disease.
Croatian: S obzirom na to da pružena zaštita s vremenom slabi, u osoba za koje se smatra da su izložene kontinuiranom riziku od invazivne meningokokne bolesti potrebno je razmotriti dozu docjepljivanja.
English: How does Trumenba work?
Croatian: Kako djeluje Trumenba?
English: The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
Croatian: Prvo ispitivanje uključivalo je otprilike 3 600 sudionika u dobi od 10 do 18 godina, a drugo 3 300 mladih u dobi od 18 do 25 godina, pri čemu nijedan od sudionika prethodno nije bio cijepljen protiv bakterije N. meningitidis grupe B.
English: How is Trumenba used?
Croatian: Kako se Trumenba koristi?
English: Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria.
Croatian: Lijek Trumenba sadrži dva sastojka, proteine koji se nalaze na vanjskim opnama bakterije
English: The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Croatian: Neisseria meningitidis grupe B koja se trenutačno može pronaći u Europi, i to s pomoću oba režima cijepljenja s 3 ili 2 doze.
English: This may take up to 60 minutes.
Croatian: To može potrajati do 60 minuta.
English: Participation in the registry is voluntary.
Croatian: Sudjelovanje u registru je dobrovoljno.
English: These reactions usually go away within a few days.
Croatian: Te reakcije uglavnom nestaju u roku od nekoliko dana.
English: If this happens, you should wait until the reactions have disappeared.
Croatian: Ako se to dogodi, morate pričekati dok reakcije ne nestanu.
English: Prepare a clean work area.
Croatian: Pripremite čisto radno područje.
English: Potential complications can often be avoided by:
Croatian: Potencijalne komplikacije mogu se često izbjeći:
English: Allow to dry (at least 30 seconds).
Croatian: Pričekajte da se osuši (najmanje 30 sekundi).
English: Protein (grams)
Croatian: Protein (grami)
English: It is very important to infuse the medicine at the correct speed.
Croatian: Vrlo je važno dati infuziju lijeka ispravnom brzinom.
English: These include:
Croatian: To uključuje:
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2.
English: This medicinal product does not contain sugars.
Croatian: Ovaj lijek ne sadrži šećere.
English: Signs or symptoms of these rare allergic reactions include:
Croatian: Znakovi ili simptomi tih rijetkih alergijskih reakcija uključuju sljedeće:
English: 10 minutes
Croatian: 10 minuta
English: See sections 4.2 and 4.8.
Croatian: Vidjeti dijelove 4.2 i 4.8.
English: The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product.
Croatian: Svrha takvog registra je prikupljanje i dijeljenje podataka samo s javnim zdravstvenim ustanovama koje su odgovorne za nadziranje sigurnosti ovog lijeka.
English: (purity of at least 98% IgG)
Croatian: (čistoće od najmanje 98% IgG-a)
English: Sometimes your doctor may recommend that larger doses are split and given at two sites at once.
Croatian: Ponekad Vaš liječnik može preporučiti da se veće doze podijele i daju istodobno na dva mjesta.
English: Interval/Minutes
Croatian: Interval/minute
English: Direct Coombs' test positive
Croatian: Pretrage izravan Coombsov test pozitivan
English: Infusions of medicines like HyQvia can occasionally result in serious, but rare, allergic reactions.
Croatian: Infuzije lijekova kao što je HyQvia mogu povremeno izazvati ozbiljne, ali rijetke, alergijske reakcije.
English: It is usually prepared from pooled human plasma from not fewer than 1,000 donations.
Croatian: Obično se priprema iz sakupljene ljudske plazme od najmanje 1000 donacija.
English: • Depending on the severity of associated reaction, and medical practice, pre-medication may prevent this type of reaction.
Croatian: • Ovisno o težini povezanih reakcija i o medicinskoj praksi, premedikacija može spriječiti takvu vrstu reakcije.
English: Prepare the pump: Follow the manufacturer's instructions for preparing the pump.
Croatian: Pripremite pumpu: Pridržavajte se uputa proizvođača prilikom pripreme pumpe.
English: Produced from the plasma of human donors.
Croatian: Proizvedeno iz plazme ljudskih davatelja.
English: Wash hands:
Croatian: Operite ruke:
English: Thrombosis may also occur in the absence of known risk factors.
Croatian: Također je moguća pojava tromboze u odsutnosti poznatih faktora rizika.
English: Excipients with known effects:
Croatian: Pomoćne tvari s poznatim učincima:
English: Gather all supplies: Collect all items for your infusion.
Croatian: Prikupite sav isporučen materijal: Sakupite sve predmete potrebne za infuziju.
English: • Please also see section 2 of this leaflet about the risk of allergic reactions and using HyQvia at home.
Croatian: • Molimo pročitajte također dio 2 ove upute o riziku alergijskih reakcija i primjeni lijeka HyQvia kod kuće.
English: Slowly and carefully push the plunger to remove any remaining air.
Croatian: Polako i pažljivo gurajte klip kako biste izbacili sav preostali zrak.
English: Replacement therapy in adults, children and adolescents (0-18 years) in:
Croatian: Nadomjesna terapija u odraslih, djece i adolescenata (0-18 godina):
English: The safety of IG 10% has been demonstrated in several non-clinical studies.
Croatian: Sigurnost IG 10% dokazana je u nekoliko nekliničkih ispitivanja.
English: Tmax [days]
Croatian: Tmax [dani]
English: Do not use heating devices including microwaves.
Croatian: Ne upotrebljavajte uređaje za zagrijavanje, uključujući mikrovalne uređaje.
English: Do not mix the components of this medicinal product.
Croatian: Nemojte miješati komponente ovog lijeka.
English: Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers.
Croatian: Čvrsto uhvatite nabor kože od približno 2 do 2,5 cm između dva prsta.
English: Non-clinical data reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti.
English: Antibodies are part of the immune system (the body's natural defences) and help your body to fight infections.
Croatian: Protutijela su dio imunološkog sustava (prirodnog obrambenog sustava tijela) i pomažu Vašem tijelu u borbi protiv infekcija.
English: • This medicinal product is comprised of two vials.
Croatian: • Ovaj lijek sastoji se od dvije bočice.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: Direktive 2001/83/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratorij ili laboratorij određen za tu svrhu.