FrancophonIA/ELRC3.0 huggingface dataset:
English: The rSBA GMTs were significantly lower in the subjects who had received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix, however 100% of subjects achieved rSBA titers ≥8 for all four meningococcal groups (A, C, W-135, Y) (see section 4.4).
Croatian: Imunološki odgovor (rSBA titar ≥8) je zapažen u svim grupama (A, C, W-135, Y) u svih ispitanika bez obzira na prethodno cijepljenje meningokoknim cjepivom. rSBA GMTi su bili značajno niži u ispitanika koji su 30 do 42 mjeseca prije cjepiva Nimenrix primili dozu ACWY-PS cjepiva, međutim 100% ispitanika je dostiglo rSBA titre≥8 za sve četiri grupe meninkgokoka (A, C, W-135, Y) (vidjeti dio 4.4).
English: 1 vial: powder 1 pre-filled syringe: solvent 2 needles
Croatian: 1 bočica: prašak 1 napunjena štrcaljka: otapalo 2 igle
English: Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against Neisseria meningitidis
Croatian: Odgovor na docjepljivanje u ispitanika koji su prethodno cijepljeni konjugiranim meningokoknim cjepivom protiv bakterije Neisseria meningitidis
English: Powder and solvent for solution for injection in ampoule
Croatian: Prašak i otapalo za otopinu za injekciju u ampuli
English: Nimenrix must be reconstituted by adding the entire content of the pre-filled syringe of solvent to the vial containing the powder.
Croatian: Nimenrix se mora rekonstituirati dodavanjem cijelog sadržaja otapalom napunjene štrcaljke u bočicu koja sadrži prašak.
English: Needle protector
Croatian: Zaštita igle
English: Table 8: 5 years persistence data in toddlers aged 12-23 months at vaccination (study MenACWY-TT-032; extension of study 027)
Croatian: Tablica 8: Petogodišnji podaci o postojanosti u male djece cijepljene u dobi od 12 do 23 mjeseca (ispitivanje MenACWY-TT-032; produžetak ispitivanja 027)
English: Powder and solvent for solution for injection in a pre-filled syringe
Croatian: Prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki
English: The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each time-point.
Croatian: Analiza imunogenosti je provedena na ATP-kohorti za postojanost prilagođenu za svaku vremensku točku.
English: What you need to know before you receive Nimenrix Nimenrix should not be given if:
Croatian: Što morate znati prije nego što primite Nimenrix
English: MenCTT vaccine
Croatian: MenCTT cjepivo
English: Injection site induration Injection site pruritus Injection site warmth Injection site anaesthesia
Croatian: Induracija na mjestu injiciranja Svrbež na mjestu injiciranja Toplina na mjestu injiciranja Anestezija na mjestu injiciranja nepoznato***
English: In the second year of life, Nimenrix can also be given concomitantly with combined diphtheriatetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBVIPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine.
Croatian: U drugoj godini života, Nimenrix se također može dati istodobno s kombiniranim cjepivom protiv difterije, tetanusa i nestaničnog pertusisa (DTaP), uključujući kombinaciju DTaP cjepiva i cjepiva protiv hepatitisa B, dječje paralize (inaktivirano) ili Haemophilus influenzae tipa b (HBV, IPV ili Hib), kao što je cjepivo DTaP-HBV-IPV/Hib i 13-valentnim konjugiranim pneumokoknim cjepivom.
English: Table 10: 44 months persistence data in children 2-10 years of age at vaccination (Study MenACWY-TT-088; extension of study 081)
Croatian: Podaci o postojanosti nakon 44 mjeseca u djece cijepljene u dobi od 2 do 10 godina pri cijepljenju (Ispitivanje MenACWY-TT-088; produžetak ispitivanja 081)
English: The clinical relevance of this finding is unknown.
Croatian: Klinička važnost ovog nalaza nije poznata.
English: Nimenrix MenCCRM vaccine W-135 Nimenrix
Croatian: Nimenrix 354 cjepivo MenC-CRM W-135 Nimenrix 354
English: N VR (95% CI)
Croatian: VR (95 % CI)
English: How to store Nimenrix
Croatian: Kako primijeniti Nimenrix
English: Persistence of the immune response was evaluated by hSBA up to 5 years after vaccination in adolescents and adults initially vaccinated in MenACWY-TT-052 (Table 14) (see section 4.4).
Croatian: Postojanost imunološkog odgovora je procjenjivana pomoću hSBA do pet godina nakon cijepljenja u adolescenata i odraslih koji su inicijalno cijepljeni u ispitivanju MenACWY-TT-052 (Tablica 14) (vidjeti dio 4.4).
English: Neisseria meningitidis group W-135 polysaccharide1
Croatian: 5 mikrograma polisaharid Neisseria meningitidis grupe W-135
English: Table 12: Bactericidal antibody responses (rSBA*) to Nimenrix and the ACWY-PS vaccine in adolescents aged 11-17 years and adults aged ≥ 18 years 1 month after vaccination
Croatian: Tabela 12: Odgovori baktericidnih protutijela (rSBA*) na Nimenrix i cjepivo ACWY-PS u adolescenata u dobi od 11 do 17 godina i odraslih u dobi
English: ≥1:8 and ≥1:128 and hSBA titres ≥1:4 and ≥1:8.
Croatian: Mjesec dana nakon prve doze cjepiva i mjesec dana nakon druge doze slični postotci ispitanika u ove dvije skupine imali su rSBA titre ≥ 1:8 i ≥ 1:128 te hSBA titre ≥ 1:4 i ≥ 1:8.
English: Table 2: Bactericidal antibody responses (rSBA* and hSBA**) in infants after two doses given 2 months apart and after a booster dose at 12 months of age (Study MenACWY-TT-083)
Croatian: Tablica 2: Odgovori baktericidnih protutijela (rSBA* i hSBA**) u dojenčadi nakon 2 doze dane u razmaku od 2 mjeseca i nakon docjepljivanja u 12. mjesecu (ispitivanje MenACWYTT-083)
English: Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y.
Croatian: Nimenrix je cjepivo koje pomaže u zaštiti protiv infekcija koje uzrokuju bakterije nazvane "Neisseria meningitidis" tipa A, C, W-135 i Y.
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva manje često
English: • received your first dose at age 6-14 months and could be at particular risk of infection caused by Neisseria meningitidis types W-135 and Y
Croatian: • primili svoju prvu dozu u dobi od 6 do 14 mjeseci i mogli biste biti u posebnoj opasnosti od infekcije koju uzrokuje
English: Persistence of the immune response was evaluated in children initially vaccinated in MenACWY-TT081 (Table10).
Croatian: Postojanost imunološkog odgovora procijenjena u djece koja su primarno cijepljena u ispitivanju MenACWY-TT-081 (Tablica 10).
English: The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity.
Croatian: Analiza imunogenosti provedena je na primarnoj kohorti u skladu s protokolom (engl. according to protocol, ATP) za imunogenost.
English: 10 vials: powder 10 pre-filled syringes: solvent 20 needles
Croatian: 10 bočica: prašak 10 napunjenih štrcaljki: otapalo 20 igala
English: EU/1/12/767/007 - pack of 100
Croatian: EU/1/12/767/007 - pakiranje od 100
English: Table 9: Bactericidal antibody responses (rSBA*) to Nimenrix and the ACWY-PS vaccine in children aged 2-10 years 1 month after vaccination (study MenACWY-TT-038)
Croatian: Tablica 9: Odgovori baktericidnih protutijela (rSBA*) na Nimenrix i cjepivo ACWY-PS u djece u dobi od 2 do 10 godina mjesec dana nakon cijepljenja (ispitivanje MenACWY-TT
English: Pruritus Rash**
Croatian: Svrbež Osip**
English: Although similar responses to groups A and C were observed with both dosing schedules, a single primary dose in infants at 6 months was associated with lower hSBA responses to groups W-135 and Y as measured by the percentage of subjects with hSBA titres ≥8 [87.2% (95% CI: 74.3, 95.2) and 92.3% (95% CI:
Croatian: Iako su opaženi slični odgovori na grupe A i C uz obje primjene lijeka, jednokratna primarna doza u dojenčadi u dobi od 6 mjeseci bila je povezana s nižim odgovorima hSBA na grupe W-135 i Y, izmjerene postotkom ispitanika s hSBA titrima ≥8 [87,2 % (95 % CI: 74,3; 95,2), odnosno 92,3 % (95 % CI: 81,5; 97,9)] u usporedbi s tri primarne doze u dobi od 2, 4 i 6 mjeseci [100 % (95 % CI: 96,6; 100), odnosno 100 % (95 % CI: 97,1; 100)] (vidjeti dio 4.4).
English: Study MenACWY-TT-104(1)
Croatian: Studija MenACWY-TT-104
English: EU/1/12/767/005 - pack of 1
Croatian: EU/1/12/767/005 - pakiranje od 1
English: Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al
Croatian: Tablica 13: Petogodišnji podaci postojanosti (rSBA*) u adolescenata cijepljenih u dobi od 11 do 17 godina
English: • at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., pre-vaccination rSBA titre ≥8)
Croatian: • barem četverostrukim povećanjem u titrima rSBA od statusa prije cijepljenja do statusa nakon cijepljenja za inicijalno seropozitivne ispitanike (tj. titar prije cijepljenja rSBA ≥8) * ispitano u laboratorijima tvrtke GSK
English: Effect of pre-vaccination antibody to tetanus toxoid The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib) in the second year of life.
Croatian: Nimenrix je procjenjivana kad je primijenjen nakon ili istodobnno s cjepivom koje sadrži toksoide difterije i tetanusa, nestanični pertusis, inaktivirane polioviruse (tipova 1, 2 i 3), površinski antigen virusa hepatitisa B i poliribozilribitolfosfat iz Haemophilus influenzae tip B konjugiran na toksoid tetanusa (DTaP-HBV-IPV/Hib) u drugoj godini života.
English: Month 1 356 82.0% (77.6; 85.9) Year 1 350 29.1% (24.4; 34.2) Year 5 141 48.9% (40.4; 57.5)
Croatian: 1.mjesec 356 82,0% (77,6; 85,9) 1. godina 350 29,1% (24,4; 34,2) 5. godina 141 48,9 % (40,4; 57,5)
English: (95% CI) N ≥8 (95% CI)
Croatian: (95% CI) (95% CI)
English: Overall, at one month post-vaccination the percentage of vaccines with rSBA titres ≥ 128 ranged from 93% (group C) to 97% (group Y).
Croatian: Ukupno gledano mjesec dana nakon cijepljenja postotak cjepiva s titrovima rSBA ≥128 bio je u rasponu od 93% (grupa C) do 97% (grupa Y).
English: The clinical relevance of the findings is unknown.
Croatian: Klinička važnost nalaza nije poznata.
English: The analysis of immunogenicity was conducted on ATP cohort for persistence.
Croatian: Analiza imunogenosti je provedena na ATP-kohorti za postojanost.
English: Very common Appetite lost
Croatian: Gubitak apetita
English: MenC-CRM
Croatian: MenC-TT cjepivo
English: EU/1/12/767/006 - pack of 10
Croatian: EU/1/12/767/006 - pakiranje od 10
English: Pfizer BV Tel: +31 (0)10 406 43 01
Croatian: Tel: +31 (0)10 406 43 01
English: Month 1 334 91.0% (87.4; 93.9) Year 1 327 98.5% (96.5; 99.5) Year 5 138 87.0% (80.2; 92.1)
Croatian: 1.mjesec 334 91,0% (87,4; 93,9) 1. godina 327 98,5% (96,5; 99,5) 5. godina 138 87,0% (80,2; 92,1)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE AMPULA S OTAPALOM
English: Meningococcal group A, C, W-135 and Y conjugate vaccine
Croatian: Neisseria meningitidis grupe A, C, W-135 i Y.
English: A Nimenrix
Croatian: C Nimenrix
English: Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine
Croatian: Nimenrix prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Cjepivo protiv meningokoka grupe A, C, W-135 i Y, konjugirano
English: The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
Croatian: Analiza imunogenosti je provedena na ATP-kohorti za imunogenost.
English: *rSBA testing performed at PHE laboratories in UK ** tested at GSK laboratories
Croatian: *rSBA testiranje provedeno je u laboratorijima Zavoda za javno zdravstvo Engleske (PHE) u Ujedinjenom Kraljevstvu **hSBA testiran u laboratorijima GSK
English: Study MenACWY-TT-039(1)
Croatian: Ispitivanje MenACWY-TT-039
English: Neisseria meningitidis group C polysaccharide1
Croatian: 5 mikrograma polisaharid Neisseria meningitidis grupe C
English: Month 1 359 96.1% (93.5; 97.9) Year 1 336 94.9% (92.0; 97.0) Year 5 140 92.9% (87.3; 96.5)
Croatian: 1.mjesec 359 96,1% (93,5; 97,9) 1. godina 336 94,9% (92,0; 97,0) 5. godina 140 92,9% (87,3; 96,5)
English: Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al
Croatian: Tablica 4: Odgovori baktericidnih protutijela (rSBA*) u male djece u dobi od 12 do 23 mjeseca Menin gokok serogr upe
English: Solvent for Nimenrix IM
Croatian: Otapalo za Nimenrix i.m.
English: 100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml)
Croatian: 100 bočica: prašak 100 ampula: otapalo 100 x 1 doza (0,5 ml)
English: Very common Fever Swelling at injection site Pain at injection site Redness at injection site Fatigue
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često Vrućica Oticanje na mjestu injekcije Bol na mjestu injekcije Crvenilo na mjestu injekcije Umor često
English: The clinical relevance of this observation is unknown.
Croatian: Nije poznata klinička važnost ovog opažanja.
English: Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal
Croatian: Tablica 5: Odgovori baktericidnih protutijela (hSBA*) u male djece u dobi od 12 do 23 mjeseca Meningokok serogrupe
English: In the subgroup aged >65 years the percentage of vaccines with rSBA titres ≥128 at one month post-vaccination ranged from 90% (group A) to 97% (group Y).
Croatian: U podskupini u dobi većoj od 65 godina postotak cjepiva s titrima≥ 128 mjesec dana nakon cijepljenja bio je u rasponu od 90% (grupa A) do 97% (grupa Y).
English: Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine
Croatian: Nimenrix prašak i otapalo za otopinu za injekciju u ampuli Cjepivo protiv meningokoka grupe A, C, W-135 i Y, konjugirano
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA S OTAPALOM
English: Study MenACWY-TT-040(2)
Croatian: Ispitivanje MenACWY-TT-040
English: 1 vial: powder 1 pre-filled syringe: solvent 1 dose (0.5 ml)
Croatian: 1 bočica: prašak 1 napunjena štrcaljka: otapalo 1 doza (0,5 ml)
English: GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1.
Croatian: GlaxoSmithKine Biologicals Kft.
English: The clinical relevance of these observations is unknown.
Croatian: Nije poznata klinička važnost tih opažanja.
English: 1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml)
Croatian: 1 bočica: prašak 1 ampula: otapalo 1 doza (0,5 ml)
English: A decline in antibody titres over time has been observed for groups A, C, W-135 and Y. The clinical relevance of the waning antibody titres is unknown.
Croatian: Opadanje titra protutijela tijekom vremena primjećeno je za grupe A, C, W-135 i Y.
English: Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe
Croatian: Upute za rekonstituciju cjepiva s otapalom raspoloživim u napunjenoj štrcaljki
English: Neisseria meningitidis group Y polysaccharide1
Croatian: polisaharid Neisseria meningitidis grupe
English: Serum bactericidal activity was also measured using hSBA as a secondary endpoint.
Croatian: Kao sekundarna mjera ishoda također je mjerena baktericidna aktivnost u serumu primjenom hSBA.
English: 10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml)
Croatian: 10 bočica: prašak 10 ampula: otapalo 10 x 1 doza (0,5 ml)
English: GMT (95% CI) N
Croatian: GMT (95 % CI)
English: Pfizer Luxembourg SARL
Croatian: Slovenská republika Pfizer Luxembourg SARL, organizačná zložka
English: Instructions for reconstitution of the vaccine with the solvent presented in ampoules
Croatian: Upute za pripremu cjepiva s otapalom pripremljenim u ampule
English: However, if an individual is expected to be at particular risk of exposure to group A and received a dose of Nimenrix more than approximately one year previously, consideration may be given to administering a booster dose.
Croatian: Međutim, ako se očekuje da je pojedinac u osobitom riziku od izlaganja grupi
English: (1) blood sampling performed 42 to 56 days post vaccination
Croatian: uzorkovanje krvi provedeno je 21 do 48 dana nakon cijepljenja
English: 10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml)
Croatian: 10 bočica: prašak 10 napunjenih štrcaljki: otapalo 10 x 1 doza (0,5 ml)
English: The clinical relevance of the waning of hSBA antibody titres against group A is unknown.
Croatian: Klinička važnost opadanja titra protutijela protiv grupe
English: Vaccine group rSBA*
Croatian: Cjepivo rSBA*
English: Table 7: Bactericidal antibody responses (hSBA)* in toddlers aged 12-14 months Meningococcal
Croatian: Tablica 7: Odgovori baktericidnih protutijela (hSBA)* u male djece u dobi od 12 do 14 mjeseci Meningokok serogrupe
English: After reconstitution, use promptly.
Croatian: Primijeniti odmah nakon rekonstitucije.
English: Thrombocytopenia and coagulation disorders
Croatian: Trombocitopenija i poremećaji zgrušavanja krvi
English: Nimenrix 89 ACWY-PS 32
Croatian: ACWY-PS 32
English: Pfizer Kft Tel: +36 1 488 3700
Croatian: Pfizer Croatia d.o.o. Tel: + 385 1 3908 777
English: Meningo coccal Group
Croatian: Meningo kok serogrup
English: Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal
Croatian: Tablica 6: Odgovori baktericidnog protutijela (rSBA)* u male djece u dobi od 12 do 14 mjeseci Meningokok serogrupe
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination * tested at Public Health England laboratories
Croatian: Nakon 2. doze Analiza imunogenosti provedena je na kohorti prema protokolu (ATP) za imunogenost uzorkovanje krvi provedeno 21-48 dana nakon cijepljenja *testirano u laboratorijima Zavoda za javno zdravstvo Engleske
English: organizačná zložka
Croatian: FARMACEUTSKI PODACI
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at GSK laboratories
Croatian: Nakon 2. doze Analiza imunogenosti provedena je na kohorti prema protokolu (ATP) za imunogenost uzorkovanje krvi provedeno 21-48 dana nakon cijepljenja *testirano u laboratorijima tvrtke GSK
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at Public Health England laboratories
Croatian: Nakon 2. doze Analiza imunogenosti provedena je na ATP kohorti prema protokolu (ATP) za imunogenost uzorkovanje krvi provedeno 21-48 dana nakon cijepljenja *testirano u laboratorijima Zavoda za javno zdravstvo Engleske
English: VR: vaccine response * tested at GSK laboratories Persistence of the immune response was evaluated up to 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 13).
Croatian: Postojanost imunološkog odgovora je procjenjivana do 5 godina nakon cijepljenja u adolescenata koji su primarno cijepljeni u ispitivanju MenACWY-TT-036 (Tablica 13).
English: Syringe cap
Croatian: MenCCRM cjepivo
English: A 594 C 691
Croatian: C 691
English: Pfizer S.A./N.V.
Croatian: Pfizer BV
English: Timing
Croatian: Docjepljivanja
English: Nimenrix will only confer protection against Neisseria meningitidis group A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups.
Croatian: Nimenrix pruža zaštitu samo od Neisseria meningitidis grupe A, C, W-135 i Y.
English: Meningococcal Group
Croatian: Meningokok serogrupe
English: Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called “Neisseria meningitidis" types A, C, W-135 and Y. “Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as:
Croatian: “Neisseria meningitidis" tipa A, C, W-135 i Y mogu uzrokovati opasne bolesti kao što su:
English: Syringe plunger
Croatian: Menin gok serogr upe
English: Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
Croatian: Nimenrix je indiciran za aktivnu imunizaciju osoba u dobi od 6 tjedana protiv invazivnih meningokoknih bolesti koje uzrokuje
English: Post dose
Croatian: Nakon 2. doze
English: This overview was last updated in 01-2019.
Croatian: Ovaj sažetak posljednji je put ažuriran u 1. 2019.
English: The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Croatian: Doza ovisi o dobi i stanju bolesnika te o reakciji na liječenje, ali ne smije premašiti 800 mg dnevno.
English: Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg).
Croatian: Lijek Imatinib Actavis dostupan je u obliku kapsula (50, 100 i 400 mg) i tableta (100 i 400 mg).
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Croatian: Više informacija o lijeku Imatinib Actavis nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Croatian: Lijek se izdaje samo na recept, a liječenje smije započeti samo liječnik s iskustvom u liječenju osoba oboljelih od raka krvi.
English: This means that it blocks enzymes known as tyrosine kinases.
Croatian: To znači da blokira određene enzime poznate pod nazivom tirozin kinaze.
English: By blocking these receptors, Imatinib Actavis helps to control and slow down cell division.
Croatian: Blokiranjem tih receptora, Imatinib Actavis pomaže pri kontroliranju i usporavanju diobe stanica.
English: It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
Croatian: Također se primjenjuje u odraslih s Ph+ ALL-om koji se vratio nakon prethodnog liječenja ili ako drugi lijekovi ne djeluju.
English: This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Croatian: To znači da su se neki od njihovih gena prerasporedili tako da tvore poseban kromosom naziva Philadelphia kromosom.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Actavis.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Glivec i stoga ih nije potrebno ponavljati za Imatinib Actavis.
English: This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Glivec.
Croatian: To znači da Imatinib Actavis sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Glivec.
English: These enzymes can be found in some receptors on cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Croatian: Ti se enzimi nalaze u određenim receptorima stanica raka, uključujući i receptore koji sudjeluju u stimulaciji nekontrolirane diobe stanica.
English: Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Imatinib Actavis pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Imatinib Actavis is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Croatian: Lijek Imatinib Actavis uzima se na usta uz obrok i veliku čašu vode kako bi se smanjio rizik od iritacije želuca i crijeva.