natgillin/translations-raw huggingface dataset:
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.
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.
Table 10: 44 months persistence data in children 2-10 years of age at vaccination (Study MenACWY-TT-088; extension of study 081)
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)
The clinical relevance of this finding is unknown.
Klinička važnost ovog nalaza nije poznata.
Nimenrix MenCCRM vaccine W-135 Nimenrix
Nimenrix 354 cjepivo MenC-CRM W-135 Nimenrix 354
N VR (95% CI)
VR (95 % CI)
How to store Nimenrix
Kako primijeniti Nimenrix
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).
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).
Neisseria meningitidis group W-135 polysaccharide1
5 mikrograma polisaharid Neisseria meningitidis grupe W-135
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
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
≥1:8 and ≥1:128 and hSBA titres ≥1:4 and ≥1:8.
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.
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)
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)
Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y.
Nimenrix je cjepivo koje pomaže u zaštiti protiv infekcija koje uzrokuju bakterije nazvane "Neisseria meningitidis" tipa A, C, W-135 i Y.
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva manje često
• 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
• primili svoju prvu dozu u dobi od 6 do 14 mjeseci i mogli biste biti u posebnoj opasnosti od infekcije koju uzrokuje
Persistence of the immune response was evaluated in children initially vaccinated in MenACWY-TT081 (Table10).
Postojanost imunološkog odgovora procijenjena u djece koja su primarno cijepljena u ispitivanju MenACWY-TT-081 (Tablica 10).
The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity.
Analiza imunogenosti provedena je na primarnoj kohorti u skladu s protokolom (engl. according to protocol, ATP) za imunogenost.
10 vials: powder 10 pre-filled syringes: solvent 20 needles
10 bočica: prašak 10 napunjenih štrcaljki: otapalo 20 igala
EU/1/12/767/007 - pack of 100
EU/1/12/767/007 - pakiranje od 100
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)
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
Pruritus Rash**
Svrbež Osip**
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:
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).
Study MenACWY-TT-104(1)
Studija MenACWY-TT-104
EU/1/12/767/005 - pack of 1
EU/1/12/767/005 - pakiranje od 1
Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al
Tablica 13: Petogodišnji podaci postojanosti (rSBA*) u adolescenata cijepljenih u dobi od 11 do 17 godina
• 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)
• 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
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.
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.
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)
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)
(95% CI) N ≥8 (95% CI)
(95% CI) (95% CI)
Overall, at one month post-vaccination the percentage of vaccines with rSBA titres ≥ 128 ranged from 93% (group C) to 97% (group Y).
Ukupno gledano mjesec dana nakon cijepljenja postotak cjepiva s titrovima rSBA ≥128 bio je u rasponu od 93% (grupa C) do 97% (grupa Y).
The clinical relevance of the findings is unknown.
Klinička važnost nalaza nije poznata.
The analysis of immunogenicity was conducted on ATP cohort for persistence.
Analiza imunogenosti je provedena na ATP-kohorti za postojanost.
Very common Appetite lost
Gubitak apetita
MenC-CRM
MenC-TT cjepivo
EU/1/12/767/006 - pack of 10
EU/1/12/767/006 - pakiranje od 10
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)
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)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH SOLVENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE AMPULA S OTAPALOM
Meningococcal group A, C, W-135 and Y conjugate vaccine
Neisseria meningitidis grupe A, C, W-135 i Y.
A Nimenrix
C Nimenrix
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine
Nimenrix prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Cjepivo protiv meningokoka grupe A, C, W-135 i Y, konjugirano
The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
Analiza imunogenosti je provedena na ATP-kohorti za imunogenost.
*rSBA testing performed at PHE laboratories in UK ** tested at GSK laboratories
*rSBA testiranje provedeno je u laboratorijima Zavoda za javno zdravstvo Engleske (PHE) u Ujedinjenom Kraljevstvu **hSBA testiran u laboratorijima GSK
Study MenACWY-TT-039(1)
Ispitivanje MenACWY-TT-039
Neisseria meningitidis group C polysaccharide1
5 mikrograma polisaharid Neisseria meningitidis grupe C
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)
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)
Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al
Tablica 4: Odgovori baktericidnih protutijela (rSBA*) u male djece u dobi od 12 do 23 mjeseca Menin gokok serogr upe
Solvent for Nimenrix IM
Otapalo za Nimenrix i.m.
100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml)
100 bočica: prašak 100 ampula: otapalo 100 x 1 doza (0,5 ml)
Very common Fever Swelling at injection site Pain at injection site Redness at injection site Fatigue
Opći poremećaji i reakcije na mjestu primjene vrlo često Vrućica Oticanje na mjestu injekcije Bol na mjestu injekcije Crvenilo na mjestu injekcije Umor često
The clinical relevance of this observation is unknown.
Nije poznata klinička važnost ovog opažanja.
Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal
Tablica 5: Odgovori baktericidnih protutijela (hSBA*) u male djece u dobi od 12 do 23 mjeseca Meningokok serogrupe
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).
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).
Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine
Nimenrix prašak i otapalo za otopinu za injekciju u ampuli Cjepivo protiv meningokoka grupe A, C, W-135 i Y, konjugirano
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH SOLVENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA S OTAPALOM
Study MenACWY-TT-040(2)
Ispitivanje MenACWY-TT-040
1 vial: powder 1 pre-filled syringe: solvent 1 dose (0.5 ml)
1 bočica: prašak 1 napunjena štrcaljka: otapalo 1 doza (0,5 ml)
GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1.
GlaxoSmithKine Biologicals Kft.
The clinical relevance of these observations is unknown.
Nije poznata klinička važnost tih opažanja.
1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml)
1 bočica: prašak 1 ampula: otapalo 1 doza (0,5 ml)
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.
Opadanje titra protutijela tijekom vremena primjećeno je za grupe A, C, W-135 i Y.
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe
Upute za rekonstituciju cjepiva s otapalom raspoloživim u napunjenoj štrcaljki
Neisseria meningitidis group Y polysaccharide1
polisaharid Neisseria meningitidis grupe
Serum bactericidal activity was also measured using hSBA as a secondary endpoint.
Kao sekundarna mjera ishoda također je mjerena baktericidna aktivnost u serumu primjenom hSBA.
10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml)
10 bočica: prašak 10 ampula: otapalo 10 x 1 doza (0,5 ml)
GMT (95% CI) N
GMT (95 % CI)
Pfizer Luxembourg SARL
Slovenská republika Pfizer Luxembourg SARL, organizačná zložka
Instructions for reconstitution of the vaccine with the solvent presented in ampoules
Upute za pripremu cjepiva s otapalom pripremljenim u ampule
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.
Međutim, ako se očekuje da je pojedinac u osobitom riziku od izlaganja grupi
(1) blood sampling performed 42 to 56 days post vaccination
uzorkovanje krvi provedeno je 21 do 48 dana nakon cijepljenja
10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml)
10 bočica: prašak 10 napunjenih štrcaljki: otapalo 10 x 1 doza (0,5 ml)
The clinical relevance of the waning of hSBA antibody titres against group A is unknown.
Klinička važnost opadanja titra protutijela protiv grupe
Vaccine group rSBA*
Cjepivo rSBA*
Table 7: Bactericidal antibody responses (hSBA)* in toddlers aged 12-14 months Meningococcal
Tablica 7: Odgovori baktericidnih protutijela (hSBA)* u male djece u dobi od 12 do 14 mjeseci Meningokok serogrupe
After reconstitution, use promptly.
Primijeniti odmah nakon rekonstitucije.
Thrombocytopenia and coagulation disorders
Trombocitopenija i poremećaji zgrušavanja krvi
Nimenrix 89 ACWY-PS 32
ACWY-PS 32
Pfizer Kft Tel: +36 1 488 3700
Pfizer Croatia d.o.o. Tel: + 385 1 3908 777
Meningo coccal Group
Meningo kok serogrup
Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal
Tablica 6: Odgovori baktericidnog protutijela (rSBA)* u male djece u dobi od 12 do 14 mjeseci Meningokok serogrupe
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
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
organizačná zložka
FARMACEUTSKI PODACI
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
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
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
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
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).
Postojanost imunološkog odgovora je procjenjivana do 5 godina nakon cijepljenja u adolescenata koji su primarno cijepljeni u ispitivanju MenACWY-TT-036 (Tablica 13).
Syringe cap
MenCCRM cjepivo
Pfizer S.A./N.V.
Pfizer BV
Timing
Docjepljivanja
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.
Nimenrix pruža zaštitu samo od Neisseria meningitidis grupe A, C, W-135 i Y.
Meningococcal Group
Meningokok serogrupe
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:
“Neisseria meningitidis" tipa A, C, W-135 i Y mogu uzrokovati opasne bolesti kao što su:
Syringe plunger
Menin gok serogr upe
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.
Nimenrix je indiciran za aktivnu imunizaciju osoba u dobi od 6 tjedana protiv invazivnih meningokoknih bolesti koje uzrokuje
Post dose
Nakon 2. doze
This overview was last updated in 01-2019.
Ovaj sažetak posljednji je put ažuriran u 1. 2019.
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.
Doza ovisi o dobi i stanju bolesnika te o reakciji na liječenje, ali ne smije premašiti 800 mg dnevno.
Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg).
Lijek Imatinib Actavis dostupan je u obliku kapsula (50, 100 i 400 mg) i tableta (100 i 400 mg).
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Više informacija o lijeku Imatinib Actavis nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
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.
Lijek se izdaje samo na recept, a liječenje smije započeti samo liječnik s iskustvom u liječenju osoba oboljelih od raka krvi.
This means that it blocks enzymes known as tyrosine kinases.
To znači da blokira određene enzime poznate pod nazivom tirozin kinaze.
By blocking these receptors, Imatinib Actavis helps to control and slow down cell division.
Blokiranjem tih receptora, Imatinib Actavis pomaže pri kontroliranju i usporavanju diobe stanica.
It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
Također se primjenjuje u odraslih s Ph+ ALL-om koji se vratio nakon prethodnog liječenja ili ako drugi lijekovi ne djeluju.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To znači da su se neki od njihovih gena prerasporedili tako da tvore poseban kromosom naziva Philadelphia kromosom.
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.
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.
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.
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.
These enzymes can be found in some receptors on cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti se enzimi nalaze u određenim receptorima stanica raka, uključujući i receptore koji sudjeluju u stimulaciji nekontrolirane diobe stanica.
Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Imatinib Actavis pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
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.
Lijek Imatinib Actavis uzima se na usta uz obrok i veliku čašu vode kako bi se smanjio rizik od iritacije želuca i crijeva.
What measures are being taken to ensure the safe and effective use of Imatinib Actavis?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imatinib Actavis?
Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je lijek Imatinib Actavis generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Actavis have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Imatinib Actavis nalaze se u sažetku opisa svojstava i u uputi o lijeku.
The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Actavis has been shown to have comparable quality and to be bioequivalent to Glivec.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Imatinib Actavis posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Glivec.
Imatinib Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body.
Lijek Imatinib Actavis primjenjuje se u liječenju odraslih bolesnika s DFSP-om koji se ne može kirurški odstraniti i odraslih bolesnika koji ne mogu ići na kirurški zahvat kada se rak vrati nakon prethodnog liječenja ili se proširio na druge dijelove tijela.
What are the benefits and risks of Imatinib Actavis?
Koje su koristi i rizici od lijeka Imatinib Actavis?
An overview of Imatinib Actavis and why it is authorised in the EU
Pregled informacija o lijeku Imatinib Actavis i zašto je odobren u EU-u
For more information about using Imatinib Actavis, see the package leaflet or contact your doctor or pharmacist.
Više informacija o primjeni lijeka Imatinib Actavis pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Imatinib Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Imatinib Actavis primjenjuje se s drugim lijekovima protiv raka u odraslih i djece u kojih je tek dijagnosticiran Ph+ ALL.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
• dermatofibrosarkoma protuberans (DFSP), vrste raka (sarkoma) kod kojeg se stanice u tkivu ispod kože nekontrolirano dijele.
What is Imatinib Actavis and what is it used for?
Što je Imatinib Actavis i za što se primjenjuje?
As for every medicine, the company provided studies on the quality of Imatinib Actavis.
Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće lijeka Imatinib Actavis.
Why is Imatinib Actavis authorised in the EU?
Zašto je Imatinib Actavis odobren u EU-u?
Imatinib Actavis is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Imatinib Actavis primjenjuje se za liječenje odraslih bolesnika s HES-om ili KEL-om sa specifičnom preraspodjelom dvaju gena naziva FIP1L1 i PDGFRα;
Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013.
Lijek Imatinib Actavis dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 17. travnja 2013.
As for all medicines, data on the use of Imatinib Actavis are continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Imatinib Actavis kontinuirano se prate.
Other information about Imatinib Actavis
Ostale informacije o lijeku Imatinib Actavis
The active substance in Imatinib Actavis, imatinib, is a protein-tyrosine-kinase inhibitor.
Djelatna tvar lijeka Imatinib Actavis je imatinib, inhibitor protein-tirozin kinaze.
Imatinib Actavis is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Imatinib Actavis koristi se za liječenje odraslih bolesnika s MD/MPD-om s preraspodjelom gena za receptor faktora rasta koji potječe od trombocita (PDGFR);