FrancophonIA/ELRC3.0 huggingface dataset:
English: Persistence of the immune response was evaluated by rSBA and hSBA up to 5 years in children initially vaccinated in study MenACWY-TT-027 (Table 8).
Slovenian: Trajanje imunskega odziva so ocenili z rSBA in hSBA do 5 let pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-027 (preglednica 8).
English: Table 3: Bactericidal antibody responses (rSBA* and hSBA**) in infants after one dose at 6 months of age and after a booster dose at 15-18 months of age (Study MenACWY-TT-087)
Slovenian: Preglednica 3: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po enem odmerku pri 6 mesecih starosti in po obnovitvenem odmerku pri 15-18 mesecih starosti (študija MenACWY-TT-087)
English: Nimenrix is a powder and a solvent for solution for injection.
Slovenian: Cepivo Nimenrix vsebuje prašek in vehikel za raztopino za injiciranje.
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)
Slovenian: Preglednica 2: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po dveh odmerkih, danih v presledku 2 mesecev, in po obnovitvenem odmerku pri 12 mesecih starosti (študija MenACWY-TT-083)
English: Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Slovenian: Omedlevica se lahko pojavi po vsakem injiciranju z iglo ali celo pred njim.
English: Neisseria meningitidis group C polysaccharide1
Slovenian: Polisaharid Neisseria meningitidis skupine C
English: (1) blood sampling performed 42 to 56 days post vaccination (2) blood sampling performed 30 to 42 days post vaccination * tested at GSK laboratories
Slovenian: odvzem krvi so opravili od 42 do 56 dni po cepljenju odvzem krvi so opravili od 30 do 42 dni po cepljenju * testirano v laboratorijih družbe GSK
English: From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
Slovenian: Od prvega leta starosti naprej se cepivo Nimenrix lahko uporabi hkrati s katerimkoli od naslednjih cepiv: cepiva proti hepatitisu A (HAV) in hepatitisu B (HBV), cepivo proti ošpicam-mumpsu-rdečkam (MMR), cepivo proti ošpicam-mumpsu-rdečkam-noricam (MMRV), 10-valentno konjugirano pnevmokokno cepivo in cepivo proti sezonski gripi brez adjuvansa.
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Powder and solvent for solution for injection in a pre-filled syringe
Slovenian: prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
English: Meningo coccal Group
Slovenian: Meningo kokna skupina
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)
Slovenian: Preglednica 9: Odziv baktericidnih protiteles (rSBA*) na cepivi Nimenrix in ACWY-PS pri otrocih, starih od 2 do 10 let, 1 mesec po cepljenju (študija MenACWY-TT-038) Meningokokna skupina
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).
Slovenian: Trajanje imunskega odziva so ocenili s hSBA do 5 let po cepljenju pri mladostnikih in odraslih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-052 (preglednica 14) (glejte poglavje 4.4).
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)
Slovenian: • z vsaj 4-kratnim porastom titrov rSBA od pred cepljenjem do po cepljenju pri uvodoma seropozitivnih preskušancih (tj. titer rSBA pred cepljenjem ≥ 8) * testirano v laboratorijih družbe GSK
English: MenCCRM vaccine
Slovenian: Nimenrix cepivo MenCCRM
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)
Slovenian: Nimenrix mesec 1 334 91,0 % (87,4; 93,9) leto 1 327 98,5 % (96,5; 99,5) leto 5 138 87,0 % (80,2; 92,1)
English: Powder for Nimenrix MenACWY Conjugate IM
Slovenian: prašek za cepivo Nimenrix Konjugat MenACWY i.m.
English: 1conjugated to tetanus toxoid carrier protein
Slovenian: 5 mikrogramov konjugiran na nosilno beljakovino tetanusnega toksoida
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)
Slovenian: Nimenrix mesec 1 359 96,1 % (93,5; 97,9) leto 1 336 94,9 % (92,0; 97,0) leto 5 140 92,9 % (87,3; 96,5)
English: Persistence of immunogenicity was analysed using the year 5 ATP cohort.
Slovenian: Za analizo trajanja imunogenosti so uporabili kohorto ATP za leto 5.
English: Meningococcal Group
Slovenian: Meningokokna skupina
English: Study MenACWY-TT-104(1)
Slovenian: Študija MenACWY-TT-104
English: 10 vials: powder 10 pre-filled syringes: solvent 20 needles
Slovenian: 10 napolnjenih injekcijskih brizg: vehikel 20 igel
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:
Slovenian: Čeprav so pri obeh shemah odmerjanja ugotovili podobne odzive proti skupinama A in C, je bil enkratni osnovni odmerek pri dojenčkih, starih 6 mesecev, povezan z manjšimi odzivi hSBA proti skupinama W-135 in Y, merjeno z odstotkom preskušancev s titri hSBA ≥ 8 [87,2 % (95 % IZ: 74,3; 95,2) oz. 92,3 % (95 % IZ: 81,5; 97,9)], v primerjavi s 3 osnovnimi odmerki pri starosti 2, 4 in 6 mesecev [100 % (95 % IZ: 96,6; 100) oz. 100 % (95 % IZ: 97,1; 100)] (glejte poglavje 4.4).
English: Nimenrix is not likely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo Nimenrix vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
English: Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine
Slovenian: Nimenrix prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
English: MenCTT vaccine
Slovenian: em odmerku cepivo MenC-TT
English: Study MenACWY-TT-039(1)
Slovenian: Študija MenACWY-TT-039
English: The clinical relevance of these observations is unknown.
Slovenian: Klinični pomen teh opažanj ni znan.
English: Serum bactericidal activity was also measured using hSBA as a secondary endpoint.
Slovenian: Kot sekundarni opazovani dogodek so merili tudi baktericidno delovanje v serumu, in sicer s hSBA.
English: Very common Fever Swelling at injection site Pain at injection site Redness at injection site Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti zvišana telesna temperatura oteklina na mestu injiciranja bolečina na mestu injiciranja pordelost na mestu injiciranja utrujenost pogosti hematom na mestu injiciranja*
English: Instructions for reconstitution of the vaccine with the solvent presented in ampoules
Slovenian: Navodila za rekonstitucijo cepiva z vehiklom, priloženim v ampuli
English: EU/1/12/767/007 - pack of 100
Slovenian: EU/1/12/767/007 - pakiranje po 100
English: Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al
Slovenian: Preglednica 13: Podatki o trajanju imunskega odziva (rSBA*) 5 let po cepljenju pri mladostnikih, ob cepljenju starih od 11 do 17 let
English: EU/1/12/767/005 - pack of 1
Slovenian: EU/1/12/767/005 - pakiranje po 1
English: Infants from 6 weeks to less than 12 months of age: One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix.
Slovenian: En obnovitveni odmerek pri starosti 12 mesecev, najmanj 2 meseca po zadnjem odmerku cepiva Nimenrix.
English: Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine
Slovenian: Nimenrix prašek in vehikel za raztopino za injiciranje v ampuli cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
English: Study MenACWY-TT-040(2)
Slovenian: Študija MenACWY-TT-040
English: Mening ococcal Group
Slovenian: Mening okokna skupina
English: Vaccine group rSBA*
Slovenian: Skupina, ki je prejemala cepivo rSBA*
English: Pfizer Luxembourg SARL
Slovenian: Pfizer BV
English: Pfizer BV Tel: +31 (0)10 406 43 01
Slovenian: Tel: +31 (0)10 406 43 01
English: Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe:
Slovenian: Navodilo za rekonstitucijo cepiva, pri katerem je vehikel v napolnjeni injekcijski brizgi:
English: Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal
Slovenian: Preglednica 5: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
English: Very common Irritability Uncommon
Slovenian: Psihiatrične motnje zelo pogosti razdražljivost občasni nespečnost jok
English: The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity.
Slovenian: Analizo imunogenosti so opravili na kohortah ATP (ATP - According-to-Protocol) za imunogenost.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija bolečina v okončinah
English: Toddlers aged 12-14 months had similar rSBA responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart.
Slovenian: Imunski odzivi pri malčkih, starih od 12 do 14 mesecev Malčki, stari od 12 do 14 mesecev, so imeli en mesec po enem odmerku cepiva Nimenrix ali en mesec po dveh odmerkih cepiva Nimenrix, danih v presledku 2 mesecev, podobne odzive rSBA proti skupinam A, C, W-135 in Y.
English: EU/1/12/767/006 - pack of 10
Slovenian: EU/1/12/767/006 - pakiranje po 10
English: Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe
Slovenian: Navodila za rekonstitucijo cepiva z vehiklom, priloženim v napolnjeni injekcijski brizgi
English: 100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml)
Slovenian: 100 vial: prašek 100 ampul: vehikel 100 x 1 odmerek (0,5 ml)
English: 1 vial: powder 1 pre-filled syringe: solvent 2 needles
Slovenian: 1 napolnjena injekcijska brizga: vehikel 2 igli
English: How Nimenrix works
Slovenian: Kako deluje cepivo Nimenrix
English: Previously vaccinated individuals 12 months of age and older: Please tell your doctor if you have received a previous injection with another meningococcal vaccine than Nimenrix.
Slovenian: Obvestite zdravnika, če ste bili predhodno cepljeni z drugim meningokoknim cepivom kot je cepivo Nimenrix.
English: The analysis of immunogenicity was conducted on ATP cohort for persistence.
Slovenian: Analizo imunogenosti so opravili na kohorti ATP za trajanje.
English: Table 7: Bactericidal antibody responses (hSBA)* in toddlers aged 12-14 months Meningococcal
Slovenian: Preglednica 7: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 14 mesecev Meningokokna skupina
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
Slovenian: odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih PHE (Public Health England)
English: The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
Slovenian: Analizo imunogenosti so opravili na kohorti ATP za imunogenost.
English: 1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml)
Slovenian: 1 viala: prašek 1 ampula: vehikel 1 odmerek (0,5 ml)
English: Neisseria meningitidis group Y polysaccharide1
Slovenian: Polisaharid Neisseria meningitidis skupine Y
English: Check with your doctor or nurse before you receive this vaccine if:
Slovenian: Preden prejmete to cepivo, se posvetujte z zdravnikom ali medicinsko sestro:
English: 10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml)
Slovenian: 10 vial: prašek 10 ampul: vehikel 10 x 1 odmerek (0,5 ml)
English: How to store Nimenrix
Slovenian: Kako se daje cepivo Nimenrix
English: Persistence of the immune response was evaluated in children initially vaccinated in MenACWY-TT081 (Table10).
Slovenian: Trajanje imunskega odziva so ocenili z rSBA in hSBA pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-081 (preglednica 10).
English: The clinical relevance of the findings is unknown.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: MenC-CRM
Slovenian: cepivo MenC-CRM 121
English: Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al
Slovenian: Preglednica 4: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
English: Intramuscular use.
Slovenian: NAPOLNJENA INJEKCIJSKA BRIZGA Z VEHIKLOM
English: The clinical relevance of this finding is unknown.
Slovenian: Klinični pomen tega izsledka ni znan.
English: Syringe cap
Slovenian: Pokrovček brizge
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).
Slovenian: Trajanje imunskega odziva so ocenili do 5 let po cepljenju pri mladostnikih, ki so prejeli osnovno cepljenje v študiji MenACWY-TT-036 (preglednica 13).
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:
Slovenian: Bakterije “Neisseria meningitidis" tipov A, C, W-135 in Y lahko povzročijo resne bolezni, na primer:
English: N ≥8 (95% CI)
Slovenian: Časovna točka n  8 (95 % IZ)
English: W-135 Nimenrix 354 100% Y Nimenrix 354 100%
Slovenian: W-135 Nimenrix 1 odmerek po 1. odmerku
English: Timepoint
Slovenian: Časovni okvir
English: Adverse reactions
Slovenian: Obnovitveni odmerki
English: Pfizer Kft Tel: +36 1 488 3700
Slovenian: Tel: +36 1 488 3700
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
Slovenian: odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih družbe GSK
English: Nimenrix MenCCRM vaccine W-135 Nimenrix
Slovenian: Shranjevanje cepiva Nimenrix
English: Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal
Slovenian: Preglednica 6: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 14 mesecev
English: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
Slovenian: Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
English: 1 year CSR Q1 2017 3 year CSR Q1 2019 5 year CSR Q1 2021
Slovenian: Poročilo o klinični študiji za 3. leto - 1. četrtletje 2019
English: 1 vial: powder 1 pre-filled syringe: solvent 1 dose (0.5 ml)
Slovenian: 1 napolnjena injekcijska brizga: vehikel 1 odmerek (0,5 ml)
English: • itching
Slovenian: • jok
English: Nimenrix 2 doses
Slovenian: Nimenrix 2 odmerka po 1. odmerku po 2. odmerku
English: 10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg: vehikel 10 x 1 odmerek (0,5 ml)
English: Very common Drowsiness Headache
Slovenian: Bolezni živčevja zelo pogosti zaspanost glavobol občasni hipestezija omotica
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH SOLVENT
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH MEN ACWY CONJUGATE POWDER
Slovenian: VIALA S PRAŠKOM KONJUGATA MEN ACWY
English: Пфайзер Люксембург САРЛ, Клон България
Slovenian: Magyarország Pfizer Kft
English: Sucrose
Slovenian: Pfizer
English: Y 657 93.8%
Slovenian: leto 1 356 97,8 % (95,6; 99,0)
English: • Keep this medicine out of the sight and reach of children.
Slovenian: • Cepivo shranjujte nedosegljivo otrokom!
English: • crying
Slovenian: • utrujenost
English: Post dose Post dose
Slovenian: po 2. odmerku po obnovitven
English: Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg).
Slovenian: Zdravilo Imatinib Actavis je na voljo v obliki kapsul (50, 100 in 400 mg) in tablet (100 in 400 mg).
English: It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another medicine used to treat cancer), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Slovenian: Uporablja se tudi pri otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi).
English: 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.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Imatinib Actavis, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Slovenian: Nadaljnje informacije o zdravilu Imatinib Actavis so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/imatinib-actavis Informacije o referenčnem zdravilu so prav tako na voljo na spletni strani agencije.
English: What measures are being taken to ensure the safe and effective use of Imatinib Actavis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Actavis?
English: 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.
Slovenian: Ker je zdravilo Imatinib Actavis generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
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.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Glivec, zato jih ni treba ponoviti za zdravilo Imatinib Actavis.
English: 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.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Actavis primerljivo raven kakovosti in je bioekvivalentno z zdravilom Glivec.
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.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
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.
Slovenian: Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
English: As for every medicine, the company provided studies on the quality of Imatinib Actavis.
Slovenian: Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Imatinib Actavis.
English: An overview of Imatinib Actavis and why it is authorised in the EU
Slovenian: Pregled zdravila Imatinib Actavis in zakaj je odobreno v EU
English: Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Imatinib Actavis, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: As for all medicines, data on the use of Imatinib Actavis are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imatinib Actavis stalno spremljajo.
English: What are the benefits and risks of Imatinib Actavis?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Actavis?
English: This means that it blocks enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
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.
Slovenian: Uporablja se tudi samostojno pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravljenja;
English: 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.
Slovenian: Zdravilo Imatinib Actavis se uporablja za zdravljenje odraslih s to boleznijo, pri kateri sarkoma ni mogoče odstraniti s kirurškim posegom, ter odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
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.
Slovenian: To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Glivec, ki je že odobreno v Evropski uniji (EU).
English: Why is Imatinib Actavis authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Imatinib Actavis odobreno v EU?
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.
Slovenian: Zdravilo Imatinib Actavis se zaužije peroralno s hrano in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
English: What is Imatinib Actavis and what is it used for?
Slovenian: Kaj je zdravilo Imatinib Actavis in za kaj se uporablja?
English: Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013.
Slovenian: Zdravilo Imatinib Actavis je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 17. aprila 2013.
English: The medicine is used in children who have been newly diagnosed with Ph+ CML and who cannot have a bone marrow transplant.
Slovenian: Zdravilo se uporablja pri otrocih, pri katerih je bila Ph+ KML na novo diagnosticirana in niso primerni za presaditev kostnega mozga.
English: Other information about Imatinib Actavis
Slovenian: Druge informacije o zdravilu Imatinib Actavis
English: Imatinib Actavis is a ‘generic medicine'.
Slovenian: Zdravilo Imatinib Actavis je „generično zdravilo“.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Slovenian: • mielodisplastičnih ali mieloproliferativnih bolezni (MDS/MPD), tj. skupine bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.