natgillin/translations-raw huggingface dataset:
Tell your doctor straight away if you get any of the following:
Če pride do katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika:
Pharmacokinetics of imatinib
Zdravilo Imatinib
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Pri mnogih od teh živali sta se zvišala sečnina in kreatinin.
9/l and/or platelets < 50 x 10
9/l in/ali koncentracija trombocitov < 50 x 10
Common: Uncommon:
nespečnost občasni:
DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
= intramuskularno, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2-merkaptoetan sulfonat, iii= oziroma dokler koncentracija MTX ni < 0,1 μM, Gy= Gray
Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Imatinib medac 400 mg trde kapsule Ena trda kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
Imatinib medac is also a treatment for children and adolescents for:
Zdravilo Imatinib medac je tudi zdravilo za otroke in mladostnike:
NAME OF THE MEDICINAL PRODUCT Imatinib medac 100 mg hard capsules Imatinib
IME ZDRAVILA Imatinib medac 100 mg trde kapsule imatinib
i.v.
MESNA i.v.
Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
palpitacije, tahikardija, kongestivno popuščanje srca
How to store Imatinib medac
Shranjevanje zdravila Imatinib medac
A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
V odprto, multicentrično preskušanje faze II z eno skupino so vključili skupno 51 pediatričnih bolnikov z na novo diagnosticirano in nezdravljeno KML v kronični fazi.
9/l and/or platelets < 10 x 10
9/l in/ali koncentracija trombocitov < 10 x 10
DEX (6 mg/m2/day, PO): days 1-7 and 15-21
zdravljenje (prilagojeno na starost): 1. in 15. dan DEX (6 mg/m2/dan, peroralno): 1.-7. dan in 15.-21. dan
The dose of
IME ZDRAVILA
An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Pri bolnikih z mieloproliferativnimi neoplazmami s preureditvijo PDGFR-β, ki so se zdravili z zdravilom Imatinib medac, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
Consolidation block 2 (3 weeks)
2. konsolidacijski blok (3 tedne)
9/l) and thrombocytopenias (platelet count < 50 x 10
9/l) in trombocitopenija (koncentracija trombocitov < 50 x 10
Table 1 Tabulated summary of adverse reactions Infections and infestations
Preglednica 1 Preglednica neželenih učinkov
VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
daunorubicin 45 mg/m² i.v., 6.-7., 13.-14. dan indukcijsko zdravljenje II
• Rash.
• modrice,
Active substances that may decrease imatinib plasma concentrations Substances that are inducers of CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Snovi, ki inducirajo aktivnost CYP3A4 (na primer deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ali Hypericum perforatum, znan tudi pod imenom šentjanževka),
Consolidation block 1 (3 weeks)
1. konsolidacijski blok (3 tedne)
• Muscle cramps or joint, muscle or bone pain, during Imatinib medac treatment or after you have stopped taking Imatinib medac
Imatinib medac ali po prenehanju jemanja zdravila,
Thrombosis/embolism* Respiratory, thoracic and mediastinal disorders
pogostnost neznana: tromboza/embolija* Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti: občasni:
• Nose bleeds.
• krvavitve iz nosu,
Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Imatinib medac 100 mg trde kapsule Oranžen trup in pokrovček, trde kapsule velikosti ”3”.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or
• izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje
Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
plevritična bolečina, pljučna fibroza, pljučna hipertenzija, pljučna krvavitev pogostnost neznana: akutna respiratorna odpoved
Severe elevation of transaminases (< 5 %) or bilirubin (< 1 %) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Navadno so to urejali z zmanjšanjem odmerka ali s prekinitvijo zdravljenja (povprečno trajanje teh epizod je bilo približno en teden).
• Rapid weight gain.
• povečanje telesne mase.
Triple IT therapy (age-adjusted): days 1, 29
zdravljenje (prilagojeno na starost): 1. in 29. dan 2/dan, i.v.
VP-16 (100 mg/m2/day, IV): days 1-5
VP-16 (100 mg/m i.v.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
V 3 publikacijah so objavljeni podatki treh (3) bolnikov s HES oziroma CEL s preureditvijo gena za PDGFR.
Pericarditis*, cardiac tamponade* Vascular disorders
pogostnost neznana: perikarditis*, tamponada srca* Žilne bolezni pogosti: občasni:
oral, days 1-7, 15-21;
prednizon 60 mg/m² peroralno, 1.-7., 15.-21. dan;
(1 h), days 28-31, 35-38, 42-45;
(1 ura), 28.-31., 35.-38., 42.-45. dan; 6-MP 60 mg/m² peroralno, 26.-46. dan konsolidacijsko zdravljenje
(1 h), days 26, 46; Ara-C 75 mg/m i.v.
(1 ura), 1.-5. dan; VM26 60 mg/m² i.v.
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
draženje očesa, bolečine v očesu, orbitalni edem, krvavitev v beločnico, krvavitev v mrežnico, vnetje veke, makularni edem redki:
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section
ciklosporinom, pimozidom, takrolimusom, sirolimusom, z ergotaminom, diergotaminom, s fentanilom, z alfentanilom, s terfenadinom, bortezomibom, z docetakselom, s kinidinom) ali z varfarinom in drugimi derivati kumarina (glejte poglavje 4.5).
G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
G-CSF (5 μg/kg, s.c.): 5.-14. dan oziroma do ANC > 1500 po doseženem najnižjem številu trojno i.t.
Metabolism and nutrition disorders
Toksičnost zaradi nevtropenije in trombocitopenije
However if it is nearly time for the next
Če je že skoraj čas za naslednji odmerek, izpustite pozabljeni odmerek.
• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+)
• pediatričnih bolnikov z na novo diagnosticirano kronično mieloično levkemijo (KML), s prisotnim kromosomom Philadelphia (bcr-abl) (Ph+), pri katerih presaditev kostnega mozga kot zdravljenje prve izbire ne pride v poštev,
Mild
zmedenost
Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Ena trda kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
): 1. in 15. dan levkovorin (75 mg/m
Imatinib adverse events, i.e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Poročali so, da bi bila lahko sočasna uporaba L-asparaginaze povezana z bolj izraženo toksičnostjo za jetra (glejte poglavje 4.8).
Common: Uncommon: Rare:
3, pljučni edem redki:
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
hipertenzija, hematom, subduralni hematom, hladni distalni deli udov,
Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
metotreksat (5 g/m v času 24 ur, i.v.
Flushing, haemorrhage
hiperkaliemija, hipomagneziemija
IV or PO q6h x 6 doses)iii:
ali peroralno vsakih 6 ur x 6 odmerkov) iii: 2. in 3. dan trojno i.t.
Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision
edem vek, povečano solzenje, veznična krvavitev, vnetje veznice, suhe oči, zamegljen vid občasni:
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
VCR (1,5 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan DEX (6 mg/m2/dan, peroralno): 11.-56. dan (prekiniti 6-MP na 6.-10. dan 6-MP (75 mg/m obsevanja glave z začetkom štetja na 1. dan 5. ciklusa; ponovno začeti 6-MP na 1. dan po zaključenem obsevanju glave.)
Maintenance (8-week cycles) Cycles 1-4
): 44. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 1.-4. ciklus v času 24 ur, i.v.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Po peroralnem dajanju zdravim prostovoljcem je bil t1/2 približno 18 ur, kar kaže na ustreznost enega odmerka na dan. Zvečevanje povprečne AUC z večanjem odmerka je bilo po peroralnem dajanju linearno in sorazmerno odmerku v območju 25-1.000 mg imatiniba.
During treatment with Imatinib medac, tell your doctor straight away if you put on weight very quickly.
Če med jemanjem zdravila Imatinib medac začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Pri uporabi imatiniba so opažali primere poškodbe jeter, vključno z odpovedjo in nekrozo jeter.
Liver dysfunction
Disfunkcija jeter blaga
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).
V zvezi z zaviralci tirozinske kinaze BCR-ABL1 so poročali o reaktivaciji hepatitisa B. V nekaterih primerih je prišlo do akutne odpovedi jeter ali fulminantnega hepatitisa in posledično do presaditve jeter ali smrtnega izida (glej poglavje 4.4).
(q 12 h), days 2-3, for
(na 12 ur), 2.-3. dan, v 4 ciklusih vzdrževanje
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• občutek slabosti s siljenjem na bruhanje (navzea), bruhanje, driska ali prebavne težave,
The starting dose is 400 mg, to be taken as 1 capsule of 400 mg once a day.
• Če se zdravite zaradi MDS/MPD: Začetni odmerek je 400 mg, kar vzamete kot 1 kapsulo po 400 mg enkrat na dan.
(1 h) days 4-5;
(3 ure), 1.-4. dan;
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
(3 ure), 1. dan; daunorubicin 60 mg/m² i.v.
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
): 1. in 2. dan 2/odmerek vsakih 12 ur x 4 odmerki, i.v.
This will help protect you from stomach problems when
Tako boste laže preprečili težave z želodcem, do katerih pride pri jemanju zdravila Imatinib medac.
Dose increases from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Če se ugotovi nezadosten odziv na zdravljenje, pri tem pa ni nobenih neželenih učinkov, velja pri takih bolnikih razmisliti o povečanju odmerka s 100 mg na 400 mg.
Ara-C 2x 2 g/m i.v.
Ara-C 75 mg/m² i.v.
Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5 % of newly diagnosed CML patients taking imatinib.
Pri približno 2,5 % bolnikov z na novo diagnosticirano KML, ki so jemali imatinib, so poročali o pojavih težke retence tekočine (plevralni izliv, edemi, pljučni edem, ascites, površinski edem).
Triple IT therapy (age-adjusted): days 1 and 22 2/day, IV): days 22-26 2/day, IV): days 22-26 2/day, IV): days 22-26 G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir 2, q12h, IV): days 43, 44 2, IM): day 44
): 22.-26. dan G-CSF (5 μg/kg, s.c.):27.-36. dan oziroma do ANC > 1500 po doseženem2, vsakih 12 ur, i.v.
Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Ta študija je vključevala 7 bolnikov z MDS/MPD, ki so bili zdravljeni z odmerkom imatiniba 400 mg na dan. Trije bolniki so dosegli popolni hematološki odziv (CHR), en bolnik pa je dosegel delni hematološki odziv (PHR).
Induction-consolidation therapy i.v.
Študija AUS01 indukcijskokonsolidacijsko zdravljenje hyper-CVAD shema: CP 300 mg/m² i.v.
Increased intracranial pressure, convulsions, optic neuritis
zvišan intrakranialni tlak, konvulzije, optični nevritis pogostnost neznana: možganski edem* Očesne bolezni pogosti:
What Imatinib medac contains
Kaj vsebuje zdravilo Imatinib medac
These patients received imatinib for a median of 47
Ti bolniki so prejemali imatinib mediano 47 mesecev (razpon 24 dni - 60 mesecev).
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Pri KML so v vseh študijah redno ugotavljali citopenije, posebno nevtropenijo in trombocitopenijo.
(3 h, q 12 h), days 1-3; i.v.
): 1. in 15. dan 36 ur po začetku, i.v.
Blood amylase increased
Krvavitev iz prebavil
VP-16 (100 mg/m 2, IV): days 29-33
): 22.-26. dan VP-16 (100 mg/m 2/dan, i.v.
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
• občutek slabosti s siljenjem na bruhanje (navzea), zadihanost, neredno bitje srca, moten urin, utrujenost in/ali bolečine v sklepih skupaj z nenormalnimi izvidi laboratorijskih preiskav (na primer z visokimi vrednostmi kalija, sečne kisline in kalcija ter nizko vrednostjo fosforja v krvi).
If any of these affects you severely, tell your doctor.
Če imate težko obliko katerega od zgoraj navedenih učinkov, obvestite zdravnika.
over 24 hours, IV): day 1 at hour 36, IV; 15 mg/m
(3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m² i.v.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5
): 1.-5. dan 2/odmerek vsake 3 ure, x 8 odmerkov/dan, i.v.
Depending on the condition being treated, the patients can also be given other medicines.
Odvisno od zdravljene bolezni lahko bolniki prejmejo tudi druga zdravila.
Further information on MabThera can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mabthera.
Nadaljnje informacije za zdravilo MabThera so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/mabthera.
What measures are being taken to ensure the safe and effective use of MabThera?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila MabThera?
These patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they experience symptoms of infection.
Ti bolniki morajo prejeti tudi opozorilno kartico, ki jo morajo imeti stalno pri sebi in na kateri je navedeno, da se morajo takoj posvetovati z zdravnikom, če občutijo simptome okužbe.
MabThera received a marketing authorisation valid throughout the EU on 2 June 1998.
Za zdravilo MabThera je bilo 2. junija 1998 izdano dovoljenje za promet, veljavno po vsej EU.
Some results from the main studies on the benefits of MabThera are described below:
Nekateri rezultati glavnih študij o koristih zdravila MabThera so opisani spodaj:
The European Medicines Agency decided that MabThera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evropska agencija za zdravila je zaključila, da so koristi zdravila MabThera večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
In addition, the medicine should be given under the close supervision of an experienced healthcare professional and in an environment where facilities for resuscitating patients are immediately available.
Poleg tega se zdravilo lahko daje samo pod skrbnim nadzorom izkušenega zdravstvenega delavca in v okolju, kjer je vedno na voljo oprema za oživljanje.
A second study in 117 patients looked at the proportion of patients whose condition came back within 28 months.
V drugi študiji, ki je vključevala 117 bolnikov, so opazovali, pri kolikšnem deležu bolnikov se je bolezen v 28 mesecih ponovila.
All doctors administering MabThera under the skin will also receive educational material to minimise the risk of improper use or errors.
Vsi zdravniki, ki dajejo zdravilo MabThera v podkožje, bodo prejeli tudi izobraževalni material za zmanjševanje tveganja za nepravilno uporabo ali napake.
As for all medicines, data on the use of MabThera are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila MabThera stalno spremljajo.
Other information about MabThera
Druge informacije o zdravilu MabThera
An overview of MabThera and why it is authorised in the EU
Pregled zdravila MabThera in zakaj je odobreno v EU
Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever).
Pred vsakim infundiranjem ali injiciranjem je treba bolniku dati antihistaminik (za preprečitev alergijskih reakcij) in antipiretik (zdravilo za znižanje povišane telesne temperature).
Why is MabThera authorised in the EU?
Zakaj je bilo zdravilo MabThera odobreno v EU?
Patients with blood cancers can switch to an injection given under the skin after they have received one full dose of the infusion.
Bolniki s krvnim rakom lahko preidejo na injiciranje v podkožje, ko prejmejo en celoten odmerek v obliki infuzije.
Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid.
Odvisno od stanja, za katero se uporablja, se zdravilo MabThera lahko daje kot samostojno zdravilo ali s kemoterapijo, metotreksatom ali kortikosteroidom.
Studies show MabThera to be effective in treating all the conditions for which it is approved.
Študije kažejo, da je zdravilo MabThera učinkovito pri zdravljenju vseh stanj, za katera je odobreno.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MabThera have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila MabThera upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The formulation injected under the skin must also not be used in patients who are allergic to a substance called hyaluronidase.
Formulacija za injiciranje v podkožje se ne sme uporabljati pri bolnikih, ki so alergični na hialuronidazo.
For more information about using MabThera, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila MabThera glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
MabThera is a medicine used to treat the following blood cancers and inflammatory conditions:
Zdravilo MabThera se uporablja za zdravljenje naslednjih vrst krvnega raka in vnetnih bolezni:
Side effects reported with MabThera are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu MabThera, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is MabThera and what is it used for?
Kaj je zdravilo MabThera in za kaj se uporablja?
MabThera must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system.
Zdravila MabThera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali katero koli drugo sestavino zdravila, ali bolniki s hudo okužbo ali močno oslabljenim imunskim sistemom.
What benefits of MabThera have been shown in studies?
Kakšne koristi je zdravilo MabThera izkazalo v študijah?
What is the risk associated with MabThera?
Kakšna tveganja so povezana z zdravilom MabThera?
The company that markets MabThera will also submit reports from a study on the effectiveness of MabThera in previously diagnosed pemphigus vulgaris patients and on the long-term effects of the medicine on the progression of the disease.
Podjetje, ki trži zdravilo MabThera, bo predložilo tudi poročila iz študije o učinkovitosti zdravila MabThera pri bolnikih s predhodno ugotovljenim navadnim pemfigusom in o dolgoročnih učinkih zdravila na razvoj bolezni.
‘Autoimmune' means that the disease is caused by the immune system (the body's natural defences) attacking the body's own cells.
ki jo povzroči imunski sistem (naravni obrambni organizem telesa), ki napada lastne celice.
• chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
• kronične limfocitne levkemije (KLL, druge vrste krvnega raka, ki prizadene bele krvničke);
Following 2 years of treatment, 90% of patients treated with MabThera and shortterm (up to 6 months) prednisone were in complete remission (meaning that skin and mucosa had healed and there were no new or old lesions) after stopping prednisone for 2 months or more, compared with 28% of patients treated with prednisone alone.
Po dveh letih zdravljenja je bilo 90 % bolnikov, zdravljenih z zdravilom MabThera, ki so kratkotrajno (do šest mesecev) prejemali prednizon, in potem, ko so prednizon prenehali jemati za dva meseca ali več, popolnoma ozdravljenih (koža in sluznice so se v celoti zacelile, na njih pa ni bilo ne novih ne starih lezij), v primerjavi z 28 % bolnikov, ki so bili zdravljeni samo s prednizonom.
The most common side effects with MabThera intravenous infusions are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heart-related problems.
Najpogostejši neželeni učinki intravenskih infuzij zdravila MabThera so reakcije, povezane z infuzijo (kot so povišana telesna temperatura, mrzlica in drgetanje), najpogostejši resni neželeni učinki pa so reakcije, povezane z infuzijo, okužbe in težave, povezane s srcem.
The active substance in MabThera, rituximab, is a monoclonal antibody designed to recognise and attach to a protein called CD20 present on the surface of B-lymphocytes.
Učinkovina zdravila MabThera, rituksimab, je monoklonsko protitelo, zasnovano tako, da prepozna beljakovino, imenovano CD20, ki je prisotna na površini limfocitov B, in se veže nanjo.
The study showed that only 5% of patients treated with MabThera had a relapse, compared with 29% of patients treated with azathioprine (another medicine used to treat GPA and MPA).
V študiji je bilo ugotovljeno, da se je bolezen ponovila pri samo 5 % bolnikov, zdravljenih z zdravilom MabThera, v primerjavi z 29 % bolnikov, zdravljenih z azatioprinom (drugim zdravilom, ki se uporablja za zdravljenje GPA in MPA).